SUBCHAPTER XVIII—HEALTH INSURANCE FOR AGED AND DISABLED
Executive Documents
Ex. Ord. No. 13890. Protecting and Improving Medicare for Our Nation's Seniors
Ex. Ord. No. 13890, Oct. 3, 2019, 84 F.R. 53573, provided:
By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:
America's seniors are overwhelmingly satisfied with their Medicare coverage. The vast majority of seniors believe that the program delivers high-quality health outcomes. Medicare empowers seniors to choose their own providers and the type of health insurance that works best for them, whether it is fee-for-service (FFS) Medicare, in which the Federal Government pays for covered services, or Medicare Advantage (MA), in which Medicare dollars are used to purchase qualified private health insurance. "Medicare for All" would take away the choices currently available within Medicare and centralize even more power in Washington, harming seniors and other Medicare beneficiaries. Throughout their lives, workers and their employers have contributed their own money to the Medicare Trust Fund. It would be a mistake to eliminate Americans' healthcare choices and to force them into a new system that is effectively a Government takeover of their healthcare.
"Medicare for All" would not only hurt America's seniors, it would also eliminate health choices for all Americans. Instead of picking the health insurance that best meets their needs, Americans would generally be subject to a single, Government-run system. Private insurance for traditional health services, upon which millions of Americans depend, would be prohibited. States would be hindered from offering the types of insurance that work best for their citizens. The Secretary of Health and Human Services (Secretary) would have the authority to control and approve health expenditures; such a system could create, among other problems, delays for patients in receiving needed care. To pay for this system, the Federal Government would compel Americans to pay more in taxes. No one—neither seniors nor any American—would have the same options to choose their health coverage as they do now.
Instead of ending the current Medicare program and eliminating health choices for all Americans, my Administration will continue to protect and improve Medicare by building on those aspects of the program that work well, including the market-based approaches in the current system. The MA component, for example, delivers efficient and value-based care through choice and private competition, and has improved aspects of the Medicare program that previously failed seniors. The Medicare program shall adopt and implement those market-based recommendations developed pursuant to Executive Order 13813 of October 12, 2017 (Promoting Healthcare Choice and Competition Across the United States) [former
(i) encourage innovative MA benefit structures and plan designs, including through changes in regulations and guidance that reduce barriers to obtaining Medicare Medical Savings Accounts and that promote innovations in supplemental benefits and telehealth services;
(ii) include a payment model that adjusts supplemental MA benefits to allow Medicare beneficiaries to share more directly in the savings from the program, including through cash or monetary rebates, thus creating more incentives to seek high-value care; and
(iii) ensure that, to the extent permitted by law, FFS Medicare is not advantaged or promoted over MA with respect to its administration.
(b) The Secretary, in consultation with the Chairman of the Council of Economic Advisers, shall submit to the President, through the Assistants to the President for Domestic and Economic Policy, a report within 180 days from the date of this order that identifies approaches to modify Medicare FFS payments to more closely reflect the prices paid for services in MA and the commercial insurance market, to encourage more robust price competition, and otherwise to inject market pricing into Medicare FFS reimbursement.
(a) the competitiveness of the health market in the States in which such plans operate, including whether those States maintain certificate-of-need laws or other anti-competitive restrictions on health access; and
(b) the enhanced access to health outcomes made possible through telehealth services or other innovative technologies.
(a) proposing a regulation that would eliminate burdensome regulatory billing requirements, conditions of participation, supervision requirements, benefit definitions, and all other licensure requirements of the Medicare program that are more stringent than applicable Federal or State laws require and that limit professionals from practicing at the top of their profession;
(b) proposing a regulation that would ensure appropriate reimbursement by Medicare for time spent with patients by both primary and specialist health providers practicing in all types of health professions; and
(c) conducting a comprehensive review of regulatory policies that create disparities in reimbursement between physicians and non-physician practitioners and proposing a regulation that would, to the extent allowed by law, ensure that items and services provided by clinicians, including physicians, physician assistants, and nurse practitioners, are appropriately reimbursed in accordance with the work performed rather than the clinician's occupation.
(a) streamlining the approval, coverage, and coding process so that innovative products are brought to market faster, and so that such products, including breakthrough medical devices and advances in telehealth services and similar technologies, are appropriately reimbursed and widely available, consistent with the principles of patient safety, market-based policies, and value for patients. This process shall include:
(i) adopting regulations and guidance that minimize and eliminate, as appropriate, the time and steps between approval by the Food and Drug Administration (FDA) and coverage decisions by the Centers for Medicare and Medicaid Services (CMS);
(ii) clarifying the application of coverage standards, including the evidence standards CMS uses in applying its reasonable-and-necessary standard, the standards for deciding appeals of coverage decisions, and the prioritization and timeline for each National Coverage Determination process in light of changes made to local coverage determination processes; and
(iii) identifying challenges to the use of parallel FDA and CMS review and proposing changes to address those challenges; and
(b) modifying the Value-Based Insurance Design payment model to remove any disincentives for MA plans to cover items and services that make use of new technologies that are not covered by FFS Medicare when those items and services can save money and improve the quality of care.
(b) Within 1 year of the date of this order, the Secretary shall use Medicare claims data to give health providers additional information regarding practice patterns for services that may pose undue risks to patients, and to inform health providers about practice patterns that are outliers or that are outside recommended standards of care.
(b) The Secretary shall study and, within 180 days of the date of this order, recommend approaches to transition toward true market-based pricing in the FFS Medicare program. The Secretary shall submit the results of this study to the President through the Assistants to the President for Domestic and Economic Policy. Approaches studied shall include:
(i) shared savings and competitive bidding in FFS Medicare;
(ii) use of MA-negotiated rates to set FFS Medicare rates; and
(iii) novel approaches to information development and sharing that may enable markets to lower cost and improve quality for FFS Medicare beneficiaries.
(b) Within 1 year of the date of this order, the Secretary shall identify and remove unnecessary barriers to private contracts that allow Medicare beneficiaries to obtain the care of their choice and facilitate the development of market-driven prices.
(i) the authority granted by law to an executive department or agency, or the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
Donald J. Trump.
§1395. Prohibition against any Federal interference
Nothing in this subchapter shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person.
(Aug. 14, 1935, ch. 531, title XVIII, §1801, as added
Statutory Notes and Related Subsidiaries
Short Title
For short title of title I of
Protecting and Improving Guaranteed Medicare Benefits
"(a)
"(b)
§1395a. Free choice by patient guaranteed
(a) Basic freedom of choice
Any individual entitled to insurance benefits under this subchapter may obtain health services from any institution, agency, or person qualified to participate under this subchapter if such institution, agency, or person undertakes to provide him such services.
(b) Use of private contracts by medicare beneficiaries
(1) In general
Subject to the provisions of this subsection, nothing in this subchapter shall prohibit a physician or practitioner from entering into a private contract with a medicare beneficiary for any item or service—
(A) for which no claim for payment is to be submitted under this subchapter, and
(B) for which the physician or practitioner receives—
(i) no reimbursement under this subchapter directly or on a capitated basis, and
(ii) receives no amount for such item or service from an organization which receives reimbursement for such item or service under this subchapter directly or on a capitated basis.
(2) Beneficiary protections
(A) In general
Paragraph (1) shall not apply to any contract unless—
(i) the contract is in writing and is signed by the medicare beneficiary before any item or service is provided pursuant to the contract;
(ii) the contract contains the items described in subparagraph (B); and
(iii) the contract is not entered into at a time when the medicare beneficiary is facing an emergency or urgent health care situation.
(B) Items required to be included in contract
Any contract to provide items and services to which paragraph (1) applies shall clearly indicate to the medicare beneficiary that by signing such contract the beneficiary—
(i) agrees not to submit a claim (or to request that the physician or practitioner submit a claim) under this subchapter for such items or services even if such items or services are otherwise covered by this subchapter;
(ii) agrees to be responsible, whether through insurance or otherwise, for payment of such items or services and understands that no reimbursement will be provided under this subchapter for such items or services;
(iii) acknowledges that no limits under this subchapter (including the limits under
(iv) acknowledges that Medigap plans under
(v) acknowledges that the medicare beneficiary has the right to have such items or services provided by other physicians or practitioners for whom payment would be made under this subchapter.
Such contract shall also clearly indicate whether the physician or practitioner is excluded from participation under the medicare program under
(3) Physician or practitioner requirements
(A) In general
Paragraph (1) shall not apply to any contract entered into by a physician or practitioner unless an affidavit described in subparagraph (B) is in effect during the period any item or service is to be provided pursuant to the contract.
(B) Affidavit
An affidavit is described in this subparagraph if—
(i) the affidavit identifies the physician or practitioner and is in writing and is signed by the physician or practitioner;
(ii) the affidavit provides that the physician or practitioner will not submit any claim under this subchapter for any item or service provided to any medicare beneficiary (and will not receive any reimbursement or amount described in paragraph (1)(B) for any such item or service) during the applicable 2-year period (as defined in subparagraph (D)); and
(iii) a copy of the affidavit is filed with the Secretary no later than 10 days after the first contract to which such affidavit applies is entered into.
(C) Enforcement
If a physician or practitioner signing an affidavit under subparagraph (B) knowingly and willfully submits a claim under this subchapter for any item or service provided during the applicable 2-year period (or receives any reimbursement or amount described in paragraph (1)(B) for any such item or service) with respect to such affidavit—
(i) this subsection shall not apply with respect to any items and services provided by the physician or practitioner pursuant to any contract on and after the date of such submission and before the end of such period; and
(ii) no payment shall be made under this subchapter for any item or service furnished by the physician or practitioner during the period described in clause (i) (and no reimbursement or payment of any amount described in paragraph (1)(B) shall be made for any such item or service).
(D) Applicable 2-year periods for effectiveness of affidavits
In this subsection, the term "applicable 2-year period" means, with respect to an affidavit of a physician or practitioner under subparagraph (B), the 2-year period beginning on the date the affidavit is signed and includes each subsequent 2-year period unless the physician or practitioner involved provides notice to the Secretary (in a form and manner specified by the Secretary), not later than 30 days before the end of the previous 2-year period, that the physician or practitioner does not want to extend the application of the affidavit for such subsequent 2-year period.
(4) Limitation on actual charge and claim submission requirement not applicable
(5) Posting of information on opt-out physicians and practitioners
(A) In general
Beginning not later than February 1, 2016, the Secretary shall make publicly available through an appropriate publicly accessible website of the Department of Health and Human Services information on the number and characteristics of opt-out physicians and practitioners and shall update such information on such website not less often than annually.
(B) Information to be included
The information to be made available under subparagraph (A) shall include at least the following with respect to opt-out physicians and practitioners:
(i) Their number.
(ii) Their physician or professional specialty or other designation.
(iii) Their geographic distribution.
(iv) The timing of their becoming opt-out physicians and practitioners, relative, to the extent feasible, to when they first enrolled in the program under this subchapter and with respect to applicable 2-year periods.
(v) The proportion of such physicians and practitioners who billed for emergency or urgent care services.
(6) Definitions
In this subsection:
(A) Medicare beneficiary
The term "medicare beneficiary" means an individual who is entitled to benefits under part A or enrolled under part B.
(B) Physician
The term "physician" has the meaning given such term by paragraphs (1), (2), (3), and (4) of
(C) Practitioner
The term "practitioner" has the meaning given such term by
(D) Opt-out physician or practitioner
The term "opt-out physician or practitioner" means a physician or practitioner who has in effect an affidavit under paragraph (3)(B).
(Aug. 14, 1935, ch. 531, title XVIII, §1802, as added
Editorial Notes
Amendments
2015—Subsec. (b)(3)(B)(ii).
Subsec. (b)(3)(C).
Subsec. (b)(3)(D).
Subsec. (b)(5).
Subsec. (b)(5)(D).
Subsec. (b)(6).
2003—Subsec. (b)(5)(B).
1997—
Statutory Notes and Related Subsidiaries
Effective Date of 2015 Amendment
Effective Date of 1997 Amendment
Updating the Welcome to Medicare Package
"(a)
"(b)
Report to Congress on Effect of Private Contracts
§1395b. Option to individuals to obtain other health insurance protection
Nothing contained in this subchapter shall be construed to preclude any State from providing, or any individual from purchasing or otherwise securing, protection against the cost of any health services.
(Aug. 14, 1935, ch. 531, title XVIII, §1803, as added
Statutory Notes and Related Subsidiaries
Impact of Increased Investments in Health Research on Future Medicare Costs
National Bipartisan Commission on the Future of Medicare
Exclusion From Wages and Compensation of Refunds Required From Employers To Compensate for Duplication of Medicare Benefits by Health Care Benefits Provided by Employers
"(a)
"(b)
"(c)
"(1)
"(2)
"(3)
"(d)
"(e)
United States Bipartisan Commission on Comprehensive Health Care
Maintenance of Effort Regarding Duplicative Benefits
Task Force on Long-Term Health Care Policies
§1395b–1. Incentives for economy while maintaining or improving quality in provision of health services
(a) Grants and contracts to develop and engage in experiments and demonstration projects
(1) The Secretary of Health and Human Services is authorized, either directly or through grants to public or private agencies, institutions, and organizations or contracts with public or private agencies, institutions, and organizations, to develop and engage in experiments and demonstration projects for the following purposes:
(A) to determine whether, and if so which, changes in methods of payment or reimbursement (other than those dealt with in section 222(a) of the Social Security Amendments of 1972) for health care and services under health programs established by this chapter, including a change to methods based on negotiated rates, would have the effect of increasing the efficiency and economy of health services under such programs through the creation of additional incentives to these ends without adversely affecting the quality of such services;
(B) to determine whether payments for services other than those for which payment may be made under such programs (and which are incidental to services for which payment may be made under such programs) would, in the judgment of the Secretary, result in more economical provision and more effective utilization of services for which payment may be made under such program, where such services are furnished by organizations and institutions which have the capability of providing—
(i) comprehensive health care services,
(ii) mental health care services (as defined by section 2691(c) 1 of this title),
(iii) ambulatory health care services (including surgical services provided on an outpatient basis), or
(iv) institutional services which may substitute, at lower cost, for hospital care;
(C) to determine whether the rates of payment or reimbursement for health care services, approved by a State for purposes of the administration of one or more of its laws, when utilized to determine the amount to be paid for services furnished in such State under the health programs established by this chapter, would have the effect of reducing the costs of such programs without adversely affecting the quality of such services;
(D) to determine whether payments under such programs based on a single combined rate of reimbursement or charge for the teaching activities and patient care which residents, interns, and supervising physicians render in connection with a graduate medical education program in a patient facility would result in more equitable and economical patient care arrangements without adversely affecting the quality of such care;
(E) to determine whether coverage of intermediate care facility services and homemaker services would provide suitable alternatives to posthospital benefits presently provided under this subchapter; such experiment and demonstration projects may include:
(i) counting each day of care in an intermediate care facility as one day of care in a skilled nursing facility, if such care was for a condition for which the individual was hospitalized,
(ii) covering the services of homemakers for a maximum of 21 days, if institutional services are not medically appropriate,
(iii) determining whether such coverage would reduce long-range costs by reducing the lengths of stay in hospitals and skilled nursing facilities, and
(iv) establishing alternative eligibility requirements and determining the probable cost of applying each alternative, if the project suggests that such extension of coverage would be desirable;
(F) to determine whether, and if so which type of, fixed price or performance incentive contract would have the effect of inducing to the greatest degree effective, efficient, and economical performance of agencies and organizations making payment under agreements or contracts with the Secretary for health care and services under health programs established by this chapter;
(G) to determine under what circumstances payment for services would be appropriate and the most appropriate, equitable, and noninflationary methods and amounts of reimbursement under health care programs established by this chapter for services, which are performed independently by an assistant to a physician, including a nurse practitioner (whether or not performed in the office of or at a place at which such physician is physically present), and—
(i) which such assistant is legally authorized to perform by the State or political subdivision wherein such services are performed, and
(ii) for which such physician assumes full legal and ethical responsibility as to the necessity, propriety, and quality thereof;
(H) to establish an experimental program to provide day-care services, which consist of such personal care, supervision, and services as the Secretary shall by regulation prescribe, for individuals eligible to enroll in the supplemental medical insurance program established under part B of this subchapter and subchapter XIX of this chapter, in day-care centers which meet such standards as the Secretary shall by regulation establish;
(I) to determine whether the services of clinical psychologists may be made more generally available to persons eligible for services under this subchapter and subchapter XIX of this chapter in a manner consistent with quality of care and equitable and efficient administration;
(J) to develop or demonstrate improved methods for the investigation and prosecution of fraud in the provision of care or services under the health programs established by this chapter; and
(K) to determine whether the use of competitive bidding in the awarding of contracts, or the use of other methods of reimbursement, under part B of subchapter XI would be efficient and effective methods of furthering the purposes of that part.
For purposes of this subsection, "health programs established by this chapter" means the program established by this subchapter and a program established by a plan of a State approved under subchapter XIX of this chapter.
(2) Grants, payments under contracts, and other expenditures made for experiments and demonstration projects under paragraph (1) shall be made in appropriate part from the Federal Hospital Insurance Trust Fund (established by
(b) Waiver of certain payment or reimbursement requirements; advice and recommendations of specialists preceding experiments and demonstration projects
In the case of any experiment or demonstration project under subsection (a), the Secretary may waive compliance with the requirements of this subchapter and subchapter XIX of this chapter insofar as such requirements relate to reimbursement or payment on the basis of reasonable cost, or (in the case of physicians) on the basis of reasonable charge, or to reimbursement or payment only for such services or items as may be specified in the experiment; and costs incurred in such experiment or demonstration project in excess of the costs which would otherwise be reimbursed or paid under such subchapters may be reimbursed or paid to the extent that such waiver applies to them (with such excess being borne by the Secretary). No experiment or demonstration project shall be engaged in or developed under subsection (a) until the Secretary obtains the advice and recommendations of specialists who are competent to evaluate the proposed experiment or demonstration project as to the soundness of its objectives, the possibilities of securing productive results, the adequacy of resources to conduct the proposed experiment or demonstration project, and its relationship to other similar experiments and projects already completed or in process.
(
Editorial Notes
References in Text
Section 222(a) of the Social Security Amendments of 1972, referred to in subsec. (a)(1)(A), is section 222(a) of
Codification
Section is comprised of subsecs. (a) and (b) of section 402 of
Section was enacted as a part of the Social Security Amendments of 1967, and not as a part of the Social Security Act which comprises this chapter.
Amendments
1984—Subsec. (a)(1).
1982—Subsec. (a)(1)(K).
1981—Subsec. (a)(1).
Subsec. (a)(2).
Subsec. (b).
1977—Subsec. (a)(1)(J).
1972—Subsec. (a).
Subsec. (b).
Statutory Notes and Related Subsidiaries
Change of Name
"Secretary of Health and Human Services" substituted in text for "Secretary of Health, Education, and Welfare" pursuant to section 509(b)
Effective Date of 1984 Amendment
Amendment by
Effective Date of 1982 Amendment
Amendment by
Effective Date of 1981 Amendment, Savings, and Transitional Provisions
For effective date, savings, and transitional provisions relating to amendment by
Community-Based Care Transitions Program
"(a)
"(b)
"(1)
"(A) A subsection (d) hospital (as defined in section 1886(d)(1)(B) of the Social Security Act (
"(B) An appropriate community-based organization that provides care transition services under this section across a continuum of care through arrangements with subsection (d) hospitals (as so defined) to furnish the services described in subsection (c)(2)(B)(i) and whose governing body includes sufficient representation of multiple health care stakeholders (including consumers).
"(2)
"(A) Cognitive impairment.
"(B) Depression.
"(C) A history of multiple readmissions.
"(D) Any other chronic disease or risk factor as determined by the Secretary.
"(3)
"(4)
"(5)
"(6)
"(c)
"(1)
"(A)
"(B)
"(2)
"(A)
"(i)
"(ii)
"(B)
"(i) Initiating care transition services for a high-risk Medicare beneficiary not later than 24 hours prior to the discharge of the beneficiary from the eligible entity.
"(ii) Arranging timely post-discharge follow-up services to the high-risk Medicare beneficiary to provide the beneficiary (and, as appropriate, the primary caregiver of the beneficiary) with information regarding responding to symptoms that may indicate additional health problems or a deteriorating condition.
"(iii) Providing the high-risk Medicare beneficiary (and, as appropriate, the primary caregiver of the beneficiary) with assistance to ensure productive and timely interactions between patients and post-acute and outpatient providers.
"(iv) Assessing and actively engaging with a high-risk Medicare beneficiary (and, as appropriate, the primary caregiver of the beneficiary) through the provision of self-management support and relevant information that is specific to the beneficiary's condition.
"(v) Conducting comprehensive medication review and management (including, if appropriate, counseling and self-management support).
"(C)
"(3)
"(A) participate in a program administered by the Administration on Aging to provide concurrent care transitions interventions with multiple hospitals and practitioners; or
"(B) provide services to medically underserved populations, small communities, and rural areas.
"(d)
"(e)
"(f)
Pilot Testing Pay-for-Performance Programs for Certain Medicare Providers
"(a)
"(b)
"(1) Psychiatric hospitals (as described in clause (i) of section 1886(d)(1)(B) of such Act (
"(2) Long-term care hospitals (as described in clause (iv) of such section).
"(3) Rehabilitation hospitals (as described in clause (ii) of such section).
"(4) PPS-exempt cancer hospitals (as described in clause (v) of such section).
"(5) Hospice programs (as defined in section 1861(dd)(2) of such Act (
"(c)
"(d)
"(e)
"(1) the Secretary determines that such expansion is expected to—
"(A) reduce spending under title XVIII of the Social Security Act [
"(B) improve the quality of care and reduce spending;
"(2) the Chief Actuary of the Centers for Medicare & Medicaid Services certifies that such expansion would reduce program spending under such title XVIII; and
"(3) the Secretary determines that such expansion would not deny or limit the coverage or provision of benefits under such title XIII [XVIII] for Medicare beneficiaries."
Medicare Medical Home Demonstration Project
"(a)
"(1) care management fees are paid to persons performing services as personal physicians; and
"(2) incentive payments are paid to physicians participating in practices that provide services as a medical home under subsection (d).
For purposes of this subsection, the term 'high-need population' means individuals with multiple chronic illnesses that require regular medical monitoring, advising, or treatment.
"(b)
"(1)
"(2)
"(3)
"(A) The expansion of the project is expected to improve the quality of patient care without increasing spending under the Medicare program (not taking into account amounts available under subsection (g)).
"(B) The expansion of the project is expected to reduce spending under the Medicare program (not taking into account amounts available under subsection (g)) without reducing the quality of patient care.
"(c)
"(1)
"(A) meets the requirements described in paragraph (2); and
"(B) performs the services described in paragraph (3).
Nothing in this paragraph shall be construed as preventing such a physician from being a specialist or subspecialist for an individual requiring ongoing care for a specific chronic condition or multiple chronic conditions (such as severe asthma, complex diabetes, cardiovascular disease, rheumatologic disorder) or for an individual with a prolonged illness.
"(2)
"(A) The physician is a board certified physician who provides first contact and continuous care for individuals under the physician's care.
"(B) The physician has the staff and resources to manage the comprehensive and coordinated health care of each such individual.
"(3)
"(A) Advocates for and provides ongoing support, oversight, and guidance to implement a plan of care that provides an integrated, coherent, cross-discipline plan for ongoing medical care developed in partnership with patients and including all other physicians furnishing care to the patient involved and other appropriate medical personnel or agencies (such as home health agencies).
"(B) Uses evidence-based medicine and clinical decision support tools to guide decision-making at the point-of-care based on patient-specific factors.
"(C) Uses health information technology, that may include remote monitoring and patient registries, to monitor and track the health status of patients and to provide patients with enhanced and convenient access to health care services.
"(D) Encourages patients to engage in the management of their own health through education and support systems.
"(d)
"(1) is in charge of targeting beneficiaries for participation in the project; and
"(2) is responsible for—
"(A) providing safe and secure technology to promote patient access to personal health information;
"(B) developing a health assessment tool for the individuals targeted; and
"(C) providing training programs for personnel involved in the coordination of care.
"(e)
"(1)
"(2)
"(3)
"(f)
"(1)
"(2)
"(g)
"(h)
Post-Acute Care Payment Reform Demonstration Program
"(a)
"(1)
"(2)
"(3)
"(b)
"(c)
"(d)
Medicare Care Management Performance Demonstration
"(a)
"(1)
"(A) promoting continuity of care;
"(B) helping stabilize medical conditions;
"(C) preventing or minimizing acute exacerbations of chronic conditions; and
"(D) reducing adverse health outcomes, such as adverse drug interactions related to polypharmacy.
"(2)
"(A) two shall be in an urban area;
"(B) one shall be in a rural area; and
"(C) one shall be in a State with a medical school with a Department of Geriatrics that manages rural outreach sites and is capable of managing patients with multiple chronic conditions, one of which is dementia.
"(3)
"(4)
"(b)
"(1)
"(A) the use of health information technology to manage the clinical care of eligible beneficiaries consistent with paragraph (3); and
"(B) the electronic reporting of clinical quality and outcomes measures in accordance with requirements established by the Secretary under the demonstration program.
"(2)
"(3)
"(A) to assess each eligible beneficiary for conditions other than chronic conditions, such as impaired cognitive ability and co-morbidities, for the purposes of developing care management requirements;
"(B) to serve as the primary contact of eligible beneficiaries in accessing items and services for which payment may be made under the medicare program;
"(C) to establish and maintain health care information system for such beneficiaries;
"(D) to promote continuity of care across providers and settings;
"(E) to use evidence-based guidelines and meet such clinical quality and outcome measures as the Secretary shall require;
"(F) to promote self-care through the provision of patient education and support for patients or, where appropriate, family caregivers;
"(G) when appropriate, to refer such beneficiaries to community service organizations; and
"(H) to meet such other complex care management requirements as the Secretary may specify.
The guidelines and measures required under subparagraph (E) shall be designed to take into account beneficiaries with multiple chronic conditions.
"(c)
"(d)
"(1)
"(2)
"(e)
"(1)
"(2)
"(f)
"(g)
"(h)
"(1)
"(A) is entitled to benefits under part A and enrolled for benefits under part B of title XVIII of the Social Security Act [
"(B) has one or more chronic medical conditions specified by the Secretary (one of which may be cognitive impairment).
"(2)
Demonstration Project for Disease Management for Severely Chronically Ill Medicare Beneficiaries
Cancer Prevention and Treatment Demonstration for Ethnic and Racial Minorities
"(a)
"(1)
"(A) improve the quality of items and services provided to target individuals in order to facilitate reduced disparities in early detection and treatment of cancer;
"(B) improve clinical outcomes, satisfaction, quality of life, and appropriate use of medicare-covered services and referral patterns among those target individuals with cancer;
"(C) eliminate disparities in the rate of preventive cancer screening measures, such as pap smears and prostate cancer screenings, among target individuals; and
"(D) promote collaboration with community-based organizations to ensure cultural competency of health care professionals and linguistic access for persons with limited English proficiency.
"(2)
"(b)
"(1)
"(2)
"(A) Two projects for each of the four following major racial and ethnic minority groups:
"(i) American Indians, including Alaska Natives, Eskimos, and Aleuts.
"(ii) Asian Americans and Pacific Islanders.
"(iii) Blacks.
"(iv) Hispanics.
The two projects must target different ethnic subpopulations.
"(B) One project within the Pacific Islands.
"(C) At least one project each in a rural area and inner-city area.
"(3)
"(A) reduce expenditures under the medicare program under title XVIII of the Social Security Act [
"(B) do not increase expenditures under the medicare program and reduce racial and ethnic health disparities in the quality of health care services provided to target individuals and increase satisfaction of beneficiaries and health care providers;
the Secretary shall continue the existing demonstration projects and may expand the number of demonstration projects.
"(c)
"(1)
"(2)
"(A) A description of the demonstration projects.
"(B) An evaluation of—
"(i) the cost-effectiveness of the demonstration projects;
"(ii) the quality of the health care services provided to target individuals under the demonstration projects; and
"(iii) beneficiary and health care provider satisfaction under the demonstration projects.
"(C) Any other information regarding the demonstration projects that the Secretary determines to be appropriate.
"(d)
"(e)
"(1)
"(A)
"(B)
"(2)
Lifestyle Modification Program Demonstration
"(a)
"(1) The project shall include no fewer than 1,800 medicare beneficiaries who complete under the project the entire course of treatment under the Lifestyle Modification Program.
"(2) The project shall be conducted over a course of 4 years.
"(b)
"(1)
"(2)
"(A)
"(B)
Medicare Coordinated Care Demonstration Project
"(a)
"(1)
"(A) improve the quality of items and services provided to target individuals; and
"(B) reduce expenditures under the medicare program under title XVIII of the Social Security Act (
"(2)
"(b)
"(1)
"(2)
"(A) 5 projects in urban areas;
"(B) 3 projects in rural areas; and
"(C) 1 project within the District of Columbia which is operated by a nonprofit academic medical center that maintains a National Cancer Institute certified comprehensive cancer center.
"(3)
"(A)
"(i) reduce expenditures under the medicare program; or
"(ii) do not increase expenditures under the medicare program and increase the quality of health care services provided to target individuals and satisfaction of beneficiaries and health care providers;
the Secretary shall continue the existing demonstration projects and may expand the number of demonstration projects.
"(B)
"(c)
"(1)
"(2)
"(A) A description of the demonstration projects conducted under this section.
"(B) An evaluation of—
"(i) the cost-effectiveness of the demonstration projects;
"(ii) the quality of the health care services provided to target individuals under the demonstration projects; and
"(iii) beneficiary and health care provider satisfaction under the demonstration project.
"(C) Any other information regarding the demonstration projects conducted under this section that the Secretary determines to be appropriate.
"(d)
"(e)
"(1)
"(A)
"(i)
"(ii)
"(B)
"(2)
Informatics, Telemedicine, and Education Demonstration Project
"(a)
"(1)
"(2)
"(A)
"(B)
"(3)
"(4)
"(b)
"(1) Improving patient access to and compliance with appropriate care guidelines for individuals with diabetes mellitus through direct telecommunications link with information networks in order to improve patient quality-of-life and reduce overall health care costs.
"(2) Developing a curriculum to train health professionals (particularly primary care health professionals) in the use of medical informatics and telecommunications.
"(3) Demonstrating the application of advanced technologies, such as video-conferencing from a patient's home, remote monitoring of a patient's medical condition, interventional informatics, and applying individualized, automated care guidelines, to assist primary care providers in assisting patients with diabetes in a home setting.
"(4) Application of medical informatics to residents with limited English language skills.
"(5) Developing standards in the application of telemedicine and medical informatics.
"(6) Developing a model for the cost-effective delivery of primary and related care both in a managed care environment and in a fee-for-service environment.
"(c)
"(1) The consortium is located in an area with a high concentration of medical schools and tertiary care facilities in the United States and has appropriate arrangements (within or outside the consortium) with such schools and facilities, universities, and telecommunications providers, in order to conduct the project.
"(2) The consortium submits to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require, including a description of the use to which the consortium would apply any amounts received under the project.
"(3) The consortium guarantees that it will be responsible for payment for all costs of the project that are not paid under this section and that the maximum amount of payment that may be made to the consortium under this section shall not exceed the amount specified in subsection (d)(3).
"(d)
"(1)
"(2)
"(A)
"(B)
"(i) The acquisition of telemedicine equipment for use in patients' homes or at sites providing health care to patients located in medically underserved areas.
"(ii) Curriculum development and training of health professionals in medical informatics and telemedicine.
"(iii) Payment of telecommunications costs (including salaries and maintenance of equipment), including costs of telecommunications between patients' homes and the eligible network and between the network and other entities under the arrangements described in subsection (c)(1).
"(iv) Payments to practitioners and providers under the medicare programs.
"(C)
"(i) The purchase or installation of transmission equipment (other than such equipment used by health professionals for activities related to the project).
"(ii) The establishment or operation of a telecommunications common carrier network.
"(iii) Construction (except for minor renovations related to the installation of reimbursable equipment) or the acquisition or building of real property.
"(3)
"(4)
"(e)
"(f)
"(1)
"(2)
"(3)
Clarification of Secretarial Waiver Authority for Rural Hospital Demonstrations
Volunteer Senior Aides Demonstration Projects for Basic Medical Assistance and Support to Families With Disabled or Ill Children
"(a)
"(b)
"(1)
"(2)
"(3)
"(c)
"(d)
"(1) $1,000,000 for each of the fiscal years 1990 and 1991; and
"(2) $2,000,000 for each of the fiscal years 1992, 1993, and 1994.
"(e)
Treatment of Certain Nursing Education Programs
"(a)
"(1) The Secretary of Health and Human Services shall provide for demonstration programs under this subsection in each of 5 hospitals for cost reporting periods beginning on or after July 1, 1989, and before July 1, 1994.
"(2) Under each demonstration project, subject to paragraph (4), the reasonable costs incurred by a hospital pursuant to a written agreement with an educational institution for the activities described in paragraph (3) conducted as part of an approved educational program that—
"(A) involves a substantial clinical component (as determined by the Secretary), and
"(B) leads to a master's or doctoral degree in nursing,
shall be allowable as reasonable costs under title XVIII of the Social Security Act [
"(3) The activities described in this paragraph are the activities for which the reasonable costs of conducting such activities are allowable under title XVIII of the Social Security Act if conducted under a hospital-operated approved educational program (other than an approved graduate medical education program), but only to the extent such activities are directly related to the operation of the educational program conducted pursuant to the written agreement between the hospital and the educational institution.
"(4) The amount paid under a demonstration program under this subsection to a hospital for a cost reporting period may not exceed $200,000.
"(5) The Secretary shall report to Congress, by not later than January 1, 1995, on the demonstration programs conducted under this subsection and on the supply and characteristics of nurses trained under such programs.
"(b)
Research on Long-Term Care Services for Medicare Beneficiaries
Adjustment of Contracts With Prepaid Health Plans
For requirement that Secretary of Health and Human Services modify contracts with health maintenance organizations under subsec. (a) of this section and section 222(a) of
Case Management Demonstration Projects
"(1)
"(2)
"(A) the project proposed to be conducted by Providence Hospital for case management of the elderly at risk for acute hospitalization as described in Project No. 18–P–99379/5–01;
"(B) the project proposed to be conducted by the Iowa Foundation for Medical Care to study patients with chronic congestive conditions to reduce repeated hospitalizations of such patients as described in Project No. P–99399/4–01; and
"(C) the project proposed to be conducted by Key Care Health Resources, Inc., to examine the effects of case management on 2,500 high cost medicare beneficiaries as described in Project No. 18–P–99396/5.
"(3)
"(4)
Demonstration Projects With Respect to Chronic Ventilator-Dependent Units in Hospitals
Research and Demonstration Projects on Rural and Inner-City Health Issues
"(a)
"(2) Not less than ten percent of the total amounts annually appropriated to, and expended by, the Health Care Financing Administration for the conduct of research and demonstration projects in fiscal years 1988, 1989, and 1990 shall be expended for research and demonstration projects relating exclusively or substantially to issues of providing health care in inner-city areas, including (but not limited to) the impact of the payment methodology under section 1886(d) of the Social Security Act on the financial viability of inner-city hospitals and the impact of medicare policies on access to (and the quality of) health care in inner-city areas.
"(b)
Alzheimer's Disease Demonstration Projects
Special Treatment of States Formerly Under Waiver
For treatment of hospitals in States which have had a waiver approved under this section, upon termination of waiver, see section 9202(j) of
Extension of Certain Medicare Municipal Health Services Demonstration Projects
"(a) The Secretary of Health and Human Services shall extend through December 31, 1997, approval of four municipal health services demonstration projects (located in Baltimore, Cincinnati, Milwaukee, and San Jose) authorized under section 402(a) of the Social Security Amendments of 1967 [
"(b) The Secretary shall work with each such demonstration project to develop a plan, to be submitted to the Committee on Ways and Means and the Committee on Commerce of the House of Representatives and the Committee on Finance of the Senate by March 31, 1998, for the orderly transition of demonstration projects and the project participants to a non-demonstration project health care delivery system, such as through integration with a private or public health plan, including a medicaid managed care or Medicare+Choice plan.
"(c) A demonstration project under subsection (a) which does not develop and submit a transition plan under subsection (b) by March 31, 1998, or, if later, 6 months after the date of the enactment of the Balanced Budget Act of 1997 [Aug. 5, 1997], shall be discontinued as of December 31, 1998. The Secretary shall provide appropriate technical assistance to assist in the transition so that disruption of medical services to project participants may be minimized."
[References to Medicare+Choice deemed to refer to Medicare Advantage, see section 201(b) of
Demonstration Program for Reduction of Disability and Dependency Through Provision of Preventive Health Services Under Medicare
Payment for Costs of Hospital-Based Mobile Intensive Care Units
"(a)(1) In the case of a project described in subsection (b), the Secretary of Health and Human Services shall provide, except as provided in paragraph (2), that the amount of payments to hospitals covered under the project during the period described in paragraph (3) shall include payments for their operation of hospital-based mobile intensive care units (as defined by State statute) if the State provides satisfactory assurances that the total amount of payments to such hospitals under titles XVIII and XIX of the Social Security Act [
"(2) Paragraph (1) shall not apply if the State in which the project is located notifies the Secretary, within 30 days after the date of the enactment of this section [July 18, 1984], that the State does not want paragraph (1) to apply to that project.
"(3) The period referred to in paragraph (1) begins on the date of the enactment of this section and continues so long as the Secretary continues the Statewide waiver referred to in subsection (b), but in no case ends earlier than 90 days after the date final regulations to implement section 1886(c) of the Social Security Act [
"(b) The project referred to in subsection (a) is the statewide demonstration project established in the State of New Jersey under section 402 of the Social Security Amendments of 1967, as amended by section 222(b) of the Social Security Amendments of 1972 (
"(c) Payment for services described in this section shall be considered to be payments for services under part A of title XVIII of the Social Security Act [
Continuation of Secretary's Authority Regarding Experiments and Demonstration Projects
"(1) Except as provided in paragraph (2), the amendments made by this title [amending
"(2) The Secretary shall provide that, upon the request of a State which has a demonstration project, for payment of hospitals under title XVIII of the Social Security Act [
Alternative Care Demonstration Projects in Hospitals Short of Skilled Nursing Facilities
Continuation of Hospice Demonstration Projects; Report to Congress
"(1) Notwithstanding any provision of law which has the effect of restricting the time period of a hospice demonstration project in effect on July 15, 1982, pursuant to section 402(a) of the Social Security Amendments of 1967 [
"(2) Prior to September 30, 1983, the Secretary shall submit to Congress a report on the effectiveness of demonstration projects referred to in paragraph (1), including an evaluation of the cost-effectiveness of hospice care, the reasonableness of the 40-percent cap amount for hospice care as provided in section 1814(i) of the Social Security Act [
"(3)(A) Notwithstanding the provisions of paragraph (1), the Secretary of Health and Human Services, upon request of the hospice involved, shall permit continuation of a hospice demonstration project described in paragraph (1) until September 30, 1986, if the hospice involved in such demonstration project does not provide hospice care directly but acts as a channeling agency for the provision of hospice care.
"(B) During the period after the date on which a hospice demonstration project described in subparagraph (A) would otherwise have terminated under the provisions of paragraph (1), and prior to September 30, 1986, any such hospice demonstration project shall be subject to the same requirements as are imposed under the hospice program provided for under the amendments made by this section [amending
State Medicare Hospital Reimbursement Demonstration Project Limitation
Study of Need for Dual Participation of Skilled Nursing Facilities
Demonstration Projects for Physician-Directed Clinics in Urban Medically Underserved Areas; Report Submitted No Later Than January 1, 1981
Scope of Grants for Experiments and Demonstration Projects To Determine Methods for Prospective Payments to Hospitals, Skilled Nursing Facilities, and Other Providers of Services
"(1) the applicant for such grant is a State or an agency thereof,
"(2) such participant is an individual practice association which has been in existence for at least 3 years prior to the date of enactment of this section [Dec. 31, 1975] and which has in effect a contract with such State (or an agency thereof), entered into prior to the date on which the grant is approved by the Secretary, under which such association will, for a period which begins before and ends after the date such grant is so approved, provide health care services for individuals entitled to care and services under the State plan of such State which is approved under title XIX of the Social Security Act [
"(3) the purpose of the inclusion of the project of such association is to test the utility of a particular rate-setting methodology, designed to be employed in prepaid health plans, in an individual practice association operation, and
"(4) the applicant for such grant affirms that the use of moneys from such grant to make such payments to such individual practice association is necessary or useful in assuring that such association will be able to continue in operation and carry out the project described in clause (3)."
Experiments and Demonstration Projects To Determine Methods for Prospective Payments to Hospitals, Skilled Nursing Facilities, and Other Providers of Services for Care and Services Furnished; Scope; Waiver of Payment Requirements; Source and Manner of Payments for Grants, etc.; Reports to Congress
"(1) The Secretary of Health, Education, and Welfare [now Health and Human Services], directly or through contracts with, or grants to, public or private agencies or organizations, shall develop and carry out experiments and demonstration projects designed to determine the relative advantages and disadvantages of various alternative methods of making payment on a prospective basis to hospitals, skilled nursing facilities, and other providers of services for care and services provided by them under title XVIII of the Social Security Act [
"(2) The experiments and demonstration projects developed under paragraph (1) shall be of sufficient scope and shall be carried out on a wide enough scale to permit a thorough evaluation of the alternative methods of prospective payment under consideration while giving assurance that the results derived from the experiments and projects will obtain generally in the operation of the programs involved (without committing such programs to the adoption of any prospective payment system either locally or nationally).
"(3) In the case of any experiment or demonstration project under paragraph (1), the Secretary may waive compliance with the requirements of titles XVIII and XIX of the Social Security Act [
"(4) Grants, payments under contracts, and other expenditures made for experiments and demonstration projects under this subsection shall be made in appropriate part from the Federal Hospital Insurance Trust Fund (established by section 1817 of the Social Security Act [
"(5) The Secretary shall submit to the Congress no later than July 1, 1974, a full report on the experiments and demonstration projects carried out under this subsection and on the experience of other programs with respect to prospective reimbursement together with any related data and materials which he may consider appropriate. Such report shall include detailed recommendations with respect to the specific methods which could be used in the full implementation of a system of prospective payment to providers of services under the programs involved."
1 See References in Text note below.
§1395b–2. Notice of medicare benefits; medicare and medigap information
(a) Notice of medicare benefits
The Secretary shall prepare (in consultation with groups representing the elderly and with health insurers) and provide for distribution of a notice containing—
(1) a clear, simple explanation of the benefits available under this subchapter and the major categories of health care for which benefits are not available under this subchapter,
(2) the limitations on payment (including deductibles and coinsurance amounts) that are imposed under this subchapter, and
(3) a description of the limited benefits for long-term care services available under this subchapter and generally available under State plans approved under subchapter XIX.
Such notice shall be mailed annually to individuals entitled to benefits under part A or part B of this subchapter and when an individual applies for benefits under part A or enrolls under part B.
(b) Medicare and medigap information
The Secretary shall provide information via a toll-free telephone number on the programs under this subchapter. The Secretary shall provide, through the toll-free telephone number 1–800–MEDICARE, for a means by which individuals seeking information about, or assistance with, such programs who phone such toll-free number are transferred (without charge) to appropriate entities for the provision of such information or assistance. Such toll-free number shall be the toll-free number listed for general information and assistance in the annual notice under subsection (a) instead of the listing of numbers of individual contractors.
(c) Contents of notice
The notice provided under subsection (a) shall include—
(1) a statement which indicates that because errors do occur and because medicare fraud, waste, and abuse is a significant problem, beneficiaries should carefully check any explanation of benefits or itemized statement furnished pursuant to
(2) a statement of the beneficiary's right to request an itemized statement for medicare items and services (as provided in
(3) a description of the program to collect information on medicare fraud and abuse established under
(4) a toll-free telephone number maintained by the Inspector General in the Department of Health and Human Services for the receipt of complaints and information about waste, fraud, and abuse in the provision or billing of services under this subchapter.
(d) Medicare opioid safety education
The notice provided under subsection (a) shall include—
(1) references to educational resources regarding opioid use and pain management;
(2) a description of categories of alternative, non-opioid pain management treatments covered under this subchapter; and
(3) a suggestion for the beneficiary to talk to a physician regarding opioid use and pain management.
(Aug. 14, 1935, ch. 531, title XVIII, §1804, as added
Editorial Notes
Amendments
2018—Subsec. (d).
2003—Subsec. (b).
1997—Subsec. (c).
1994—
Statutory Notes and Related Subsidiaries
Effective Date of 2018 Amendment
Effective Date of 1997 Amendment
Effective Date of 1994 Amendment
Amendment by
Effective Date
Monitoring Accuracy
"(A)
"(B)
State Regulatory Programs
For provisions relating to changes required to conform State regulatory programs to amendments by section 171 of
Demonstration Projects
Notice of Changes Under Repeal of Medicare Catastrophic Coverage
Benefits Counseling and Assistance Demonstration Project for Certain Medicare and Medicaid Beneficiaries
§1395b–3. Health insurance advisory service for medicare beneficiaries
(a) In general
The Secretary of Health and Human Services shall establish a health insurance advisory service program (in this section referred to as the "beneficiary assistance program") to assist medicare-eligible individuals with the receipt of services under the medicare and medicaid programs and other health insurance programs.
(b) Outreach elements
The beneficiary assistance program shall provide assistance—
(1) through operation using local Federal offices that provide information on the medicare program,
(2) using community outreach programs, and
(3) using a toll-free telephone information service.
(c) Assistance provided
The beneficiary assistance program shall provide for information, counseling, and assistance for medicare-eligible individuals with respect to at least the following:
(1) With respect to the medicare program—
(A) eligibility,
(B) benefits (both covered and not covered),
(C) the process of payment for services,
(D) rights and process for appeals of determinations,
(E) other medicare-related entities (such as peer review organizations, fiscal intermediaries, and carriers), and
(F) recent legislative and administrative changes in the medicare program.
(2) With respect to the medicaid program—
(A) eligibility, benefits, and the application process,
(B) linkages between the medicaid and medicare programs, and
(C) referral to appropriate State and local agencies involved in the medicaid program.
(3) With respect to medicare supplemental policies—
(A) the program under
(B) how to make informed decisions on whether to purchase such policies and on what criteria to use in evaluating different policies,
(C) appropriate Federal, State, and private agencies that provide information and assistance in obtaining benefits under such policies, and
(D) other issues deemed appropriate by the Secretary.
The beneficiary assistance program also shall provide such other services as the Secretary deems appropriate to increase beneficiary understanding of, and confidence in, the medicare program and to improve the relationship between beneficiaries and the program.
(d) Educational material
The Secretary, through the Administrator of the Centers for Medicare & Medicaid Services, shall develop appropriate educational materials and other appropriate techniques to assist employees in carrying out this section.
(e) Notice to beneficiaries
The Secretary shall take such steps as are necessary to assure that medicare-eligible beneficiaries and the general public are made aware of the beneficiary assistance program.
(f) Report
The Secretary shall include, in an annual report transmitted to the Congress, a report on the beneficiary assistance program and on other health insurance informational and counseling services made available to medicare-eligible individuals. The Secretary shall include in the report recommendations for such changes as may be desirable to improve the relationship between the medicare program and medicare-eligible individuals.
(
Editorial Notes
Codification
Section was enacted as part of the Omnibus Budget Reconciliation Act of 1990, and not as part of the Social Security Act which comprises this chapter.
Amendments
2003—Subsec. (d).
Statutory Notes and Related Subsidiaries
State Health Insurance Assistance Program Reporting Requirements
"(1) The amount of Federal funding provided to each such State for such program for the period involved and the amount of Federal funding provided by each such State for such program to each such entity for the period involved.
"(2) Information as the Secretary may specify, with respect to such programs carried out through such grants, consistent with the terms and conditions for receipt of such grants."
Medicare Enrollment Assistance
"(a)
"(1)
"(A)
"(B)
"(i) for fiscal year 2009, of $7,500,000;
"(ii) for the period of fiscal years 2010 through 2012, of $15,000,000;
"(iii) for fiscal year 2013, of $7,500,000;
"(iv) for fiscal year 2014, of $7,500,000;
"(v) for fiscal year 2015, of $7,500,000;
"(vi) for fiscal year 2016, of $13,000,000;
"(vii) for fiscal year 2017, of $13,000,000;
"(viii) for fiscal year 2018, of $13,000,000;
"(ix) for fiscal year 2019, of $13,000,000;
"(x) for fiscal year 2020, of $13,000,000;
"(xi) for fiscal year 2021, $15,000,000;
"(xii) for fiscal year 2022, $15,000,000;
"(xiii) for fiscal year 2023, $15,000,000; and
"(xiv) for the period beginning on October 1, 2023, and ending on September 30, 2025, $30,000,000.
Amounts appropriated under this subparagraph shall remain available until expended.
"(2)
"(3)
"(A)
"(B)
"(4)
"(b)
"(1)
"(A)
"(B)
"(i) for fiscal year 2009, of $7,500,000;
"(ii) for the period of fiscal years 2010 through 2012, of $15,000,000;
"(iii) for fiscal year 2013, of $7,500,000;
"(iv) for fiscal year 2014, of $7,500,000;
"(v) for fiscal year 2015, of $7,500,000;
"(vi) for fiscal year 2016, of $7,500,000;
"(vii) for fiscal year 2017, of $7,500,000;
"(viii) for fiscal year 2018, of $7,500,000;
"(ix) for fiscal year 2019, of $7,500,000;
"(x) for fiscal year 2020, of $7,500,000;
"(xi) for fiscal year 2021, $15,000,000;
"(xii) for fiscal year 2022, $15,000,000;
"(xiii) for fiscal year 2023, $15,000,000; and
"(xiv) for the period beginning on October 1, 2023, and ending on September 30, 2025, $30,000,000.
Amounts appropriated under this subparagraph shall remain available until expended.
"(2)
"(3)
"(A)
"(B)
"(c)
"(1)
"(A)
"(B)
"(i) for fiscal year 2009, of $5,000,000;
"(ii) for the period of fiscal years 2010 through 2012, of $10,000,000;
"(iii) for fiscal year 2013, of $5,000,000;
"(iv) for fiscal year 2014, of $5,000,000;
"(v) for fiscal year 2015, of $5,000,000;
"(vi) for fiscal year 2016, of $5,000,000;
"(vii) for fiscal year 2017, of $5,000,000;
"(viii) for fiscal year 2018, of $5,000,000;
"(ix) for fiscal year 2019, of $5,000,000;
"(x) for fiscal year 2020, of $5,000,000;
"(xi) for fiscal year 2021, $5,000,000;
"(xii) for fiscal year 2022, $5,000,000;
"(xiii) for fiscal year 2023, $5,000,000; and
"(xiv) for the period beginning on October 1, 2023, and ending on September 30, 2025, $10,000,000.
Amounts appropriated under this subparagraph shall remain available until expended.
"(2)
"(d)
"(1)
"(A) maintain and update web-based decision support tools, and integrated, person-centered systems, designed to inform older individuals (as defined in section 102 of the Older Americans Act of 1965 (
"(B) utilize cost-effective strategies to find older individuals with the greatest economic need (as defined in such section 102) and inform the individuals of the programs;
"(C) develop and maintain an information clearinghouse on best practices and the most cost-effective methods for finding older individuals with greatest economic need and informing the individuals of the programs; and
"(D) provide, in collaboration with related Federal agency partners administering the Federal programs, training and technical assistance on the most effective outreach, screening, and follow-up strategies for the Federal and State programs.
"(2)
"(i) for fiscal year 2009, of $5,000,000;
"(ii) for the period of fiscal years 2010 through 2012, of $5,000,000;
"(iii) for fiscal year 2013, of $5,000,000;
"(iv) for fiscal year 2014, of $5,000,000;
"(v) for fiscal year 2015, of $5,000,000;
"(vi) for fiscal year 2016, of $12,000,000;
"(vii) for fiscal year 2017, of $12,000,000;
"(viii) for fiscal year 2018, of $12,000,000;
"(ix) for fiscal year 2019, of $12,000,000;
"(x) for fiscal year 2020, of $12,000,000;
"(xi) for fiscal year 2021, $15,000,000;
"(xii) for fiscal year 2022, $15,000,000;
"(xiii) for fiscal year 2023, $15,000,000; and
"(xiv) for the period beginning on October 1, 2023, and ending on September 30, 2025, $30,000,000.
Amounts appropriated under this subparagraph shall remain available until expended.
"(e)
"(f)
"(g)
[
Beneficiary Outreach Demonstration Program
"(a)
"(b)
"(1)
"(2)
"(c)
"(d)
"(1)
"(A) utilization of, and satisfaction of those individuals referred to in subsection (a) with, the assistance provided under the program; and
"(B) the cost-effectiveness of providing beneficiary assistance through out-stationing medicare specialists at local offices of the Social Security Administration.
"(2)
Qualified Medicare Beneficiary Outreach
§1395b–4. Health insurance information, counseling, and assistance grants
(a) Grants
The Secretary of Health and Human Services (in this section referred to as the "Secretary") shall make grants to States, with approved State regulatory programs under
(b) Grant applications
(1) In submitting an application under this section, a State may consolidate and coordinate an application that consists of parts prepared by more than one agency or department of such State.
(2) As part of an application for a grant under this section, a State shall submit a plan for a State-wide health insurance information, counseling, and assistance program. Such program shall—
(A) establish or improve upon a health insurance information, counseling, and assistance program that provides counseling and assistance to eligible individuals in need of health insurance information, including—
(i) information that may assist individuals in obtaining benefits and filing claims under this subchapter and subchapter XIX of this chapter;
(ii) policy comparison information for medicare supplemental policies (as described in
(iii) information regarding long-term care insurance; and
(iv) information regarding other types of health insurance benefits that the Secretary determines to be appropriate;
(B) in conjunction with the health insurance information, counseling, and assistance program described in subparagraph (A), establish a system of referral to appropriate Federal or State departments or agencies for assistance with problems related to health insurance coverage (including legal problems), as determined by the Secretary;
(C) provide for a sufficient number of staff positions (including volunteer positions) necessary to provide the services of the health insurance information, counseling, and assistance program;
(D) provide assurances that staff members (including volunteer staff members) of the health insurance information, counseling, and assistance program have no conflict of interest in providing the counseling described in subparagraph (A);
(E) provide for the collection and dissemination of timely and accurate health care information to staff members;
(F) provide for training programs for staff members (including volunteer staff members);
(G) provide for the coordination of the exchange of health insurance information between the staff of departments and agencies of the State government and the staff of the health insurance information, counseling, and assistance program;
(H) make recommendations concerning consumer issues and complaints related to the provision of health care to agencies and departments of the State government and the Federal Government responsible for providing or regulating health insurance;
(I) establish an outreach program to provide the health insurance information and counseling described in subparagraph (A) and the referrals described in subparagraph (B) to eligible individuals; and
(J) demonstrate, to the satisfaction of the Secretary, an ability to provide the counseling and assistance required under this section.
(c) Special grants
(1) A State that is conducting a health insurance information, counseling, and assistance program that is substantially similar to a program described in subsection (b)(2) shall, as a requirement for eligibility for a grant under this section, demonstrate, to the satisfaction of the Secretary, that such State shall maintain the activities of such program at least at the level that such activities were conducted immediately preceding the date of the issuance of any grant during the period of time covered by such grant under this section.
(2) If the Secretary determines that the existing health insurance information, counseling, and assistance program is substantially similar to a program described in subsection (b)(2), the Secretary may waive some or all of the requirements described in such subsection and issue a grant to the State for the purpose of increasing the number of services offered by the health insurance information, counseling, and assistance program, experimenting with new methods of outreach in conducting such program, or expanding such program to geographic areas of the State not previously served by the program.
(d) Criteria for issuing grants
In issuing a grant under this section, the Secretary shall consider—
(1) the commitment of the State to carrying out the health insurance information, counseling, and assistance program described in subsection (b)(2), including the level of cooperation demonstrated—
(A) by the office of the chief insurance regulator of the State, or the equivalent State entity;
(B) other officials of the State responsible for overseeing insurance plans issued by nonprofit hospital and medical service associations; and
(C) departments and agencies of such State responsible for—
(i) administering funds under subchapter XIX of this chapter, and
(ii) administering funds appropriated under the Older Americans Act [
(2) the population of eligible individuals in such State as a percentage of the population of such State; and
(3) in order to ensure the needs of rural areas in such State, the relative costs and special problems associated with addressing the special problems of providing health care information, counseling, and assistance eligible 1 individuals residing in rural areas of such State.
(e) Annual State report
A State that receives a grant under this section shall, not later than 180 days after receiving such grant, and annually thereafter during the period of the grant, issue a report to the Secretary that includes information concerning—
(1) the number of individuals served by the health insurance information, counseling and assistance program of such State;
(2) an estimate of the amount of funds saved by the State, and by eligible individuals in the State, in the implementation of such program; and
(3) the problems that eligible individuals in such State encounter in procuring adequate and appropriate health care coverage.
(f) Report to Congress
Beginning with 1992, and annually thereafter, the Secretary shall issue a report to the Committee on Finance of the Senate, the Special Committee on Aging of the Senate, the Committee on Ways and Means of the House of Representatives, and the Committee on Energy and Commerce of the House of Representatives that—
(1) summarizes the allocation of funds authorized for grants under this section and the expenditure of such funds;
(2) outlines the problems that eligible individuals encounter in procuring adequate and appropriate health care coverage;
(3) makes recommendations that the Secretary determines to be appropriate to address the problems described in paragraph (3); 2 and
(4) in the case of the report issued 2 years after November 5, 1990, evaluates the effectiveness of counseling programs established under this program, and makes recommendations regarding continued authorization of funds for these purposes.
(g) Authorization of appropriations for grants
There are authorized to be appropriated, in equal parts from the Federal Hospital Insurance Trust Fund and from the Federal Supplementary Medical Insurance Trust Fund, $10,000,000 for each of fiscal years 1991, 1992, 1993, 1994, 1995, and 1996, to fund the grant programs described in this section.
(
Editorial Notes
References in Text
The Older Americans Act, referred to in subsec. (d)(1)(C)(ii), probably means the Older Americans Act of 1965, which is
Codification
Section was enacted as part of the Omnibus Budget Reconciliation Act of 1990, and not as part of the Social Security Act which comprises this chapter.
Amendments
1998—Subsec. (f).
1994—Subsec. (b)(2)(A)(ii).
Subsec. (b)(2)(D).
Subsec. (b)(2)(I).
Subsec. (c)(1).
Subsec. (d)(3).
Subsec. (e).
Subsec. (e)(1).
Subsec. (f).
Subsec. (f)(2) to (5).
Subsec. (g).
Statutory Notes and Related Subsidiaries
Change of Name
Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of
Effective Date of 1994 Amendment
Amendment by
Demonstration To Improve Care to Previously Uninsured
"(a)
"(b)
"(c)
"(d)
"(1) An analysis of the effectiveness of outreach activities targeting beneficiaries who were previously uninsured, such as revising outreach and enrollment materials (including the potential for use of video information), providing one-on-one counseling, working with community health workers, and amending the Medicare and You handbook.
"(2) The effect of such outreach on beneficiary access to care, utilization of services, efficiency and cost-effectiveness of health care delivery, patient satisfaction, and select health outcomes."
State Regulatory Programs
For provisions relating to changes required to conform State regulatory programs to amendments by section 171 of
1 So in original. Probably should be preceded by "to".
2 So in original. Probably should be paragraph "(2)".
§1395b–5. Beneficiary incentive programs
(a) Repealed. Pub. L. 105–33, title IV, §4311(b)(2), Aug. 5, 1997, 111 Stat. 386
(b) Program to collect information on fraud and abuse
(1) Establishment of program
Not later than 3 months after August 21, 1996, the Secretary shall establish a program under which the Secretary shall encourage individuals to report to the Secretary information on individuals and entities who are engaging in or who have engaged in acts or omissions which constitute grounds for the imposition of a sanction under
(2) Payment of portion of amounts collected
If an individual reports information to the Secretary under the program established under paragraph (1) which serves as the basis for the collection by the Secretary or the Attorney General of any amount of at least $100 (other than any amount paid as a penalty under
(c) Program to collect information on program efficiency
(1) Establishment of program
Not later than 3 months after August 21, 1996, the Secretary shall establish a program under which the Secretary shall encourage individuals to submit to the Secretary suggestions on methods to improve the efficiency of the Medicare program.
(2) Payment of portion of program savings
If an individual submits a suggestion to the Secretary under the program established under paragraph (1) which is adopted by the Secretary and which results in savings to the program, the Secretary may make a payment to the individual of such amount as the Secretary considers appropriate.
(
Editorial Notes
References in Text
The Internal Revenue Code of 1986, referred to in subsec. (b)(2), is classified generally to Title 26, Internal Revenue Code.
Codification
Section was enacted as part of the Health Insurance Portability and Accountability Act of 1996, and not as part of the Social Security Act which comprises this chapter.
Amendments
1997—Subsec. (a).
§1395b–6. Medicare Payment Advisory Commission
(a) Establishment
There is hereby established as an agency of Congress the Medicare Payment Advisory Commission (in this section referred to as the "Commission").
(b) Duties
(1) Review of payment policies and annual reports
The Commission shall—
(A) review payment policies under this subchapter, including the topics described in paragraph (2);
(B) make recommendations to Congress concerning such payment policies;
(C) by not later than March 15,1 submit a report to Congress containing the results of such reviews and its recommendations concerning such policies; and
(D) by not later than June 15 of each year, submit a report to Congress containing an examination of issues affecting the medicare program, including the implications of changes in health care delivery in the United States and in the market for health care services on the medicare program and including a review of the estimate of the conversion factor submitted under
(2) Specific topics to be reviewed
(A) Medicare+Choice program
Specifically, the Commission shall review, with respect to the Medicare+Choice program under part C, the following:
(i) The methodology for making payment to plans under such program, including the making of differential payments and the distribution of differential updates among different payment areas.
(ii) The mechanisms used to adjust payments for risk and the need to adjust such mechanisms to take into account health status of beneficiaries.
(iii) The implications of risk selection both among Medicare+Choice organizations and between the Medicare+Choice option and the original medicare fee-for-service option.
(iv) The development and implementation of mechanisms to assure the quality of care for those enrolled with Medicare+Choice organizations.
(v) The impact of the Medicare+Choice program on access to care for medicare beneficiaries.
(vi) Other major issues in implementation and further development of the Medicare+Choice program.
(B) Original medicare fee-for-service system
Specifically, the Commission shall review payment policies under parts A and B, including—
(i) the factors affecting expenditures for the efficient provision of services in different sectors, including the process for updating hospital, skilled nursing facility, physician, and other fees,
(ii) payment methodologies, and
(iii) their relationship to access and quality of care for medicare beneficiaries.
(C) Interaction of medicare payment policies with health care delivery generally
Specifically, the Commission shall review the effect of payment policies under this subchapter on the delivery of health care services other than under this subchapter and assess the implications of changes in health care delivery in the United States and in the general market for health care services on the medicare program.
(3) Comments on certain secretarial reports
If the Secretary submits to Congress (or a committee of Congress) a report that is required by law and that relates to payment policies under this subchapter, the Secretary shall transmit a copy of the report to the Commission. The Commission shall review the report and, not later than 6 months after the date of submittal of the Secretary's report to Congress, shall submit to the appropriate committees of Congress written comments on such report. Such comments may include such recommendations as the Commission deems appropriate.
(4) Agenda and additional reviews
The Commission shall consult periodically with the chairmen and ranking minority members of the appropriate committees of Congress regarding the Commission's agenda and progress towards achieving the agenda. The Commission may conduct additional reviews, and submit additional reports to the appropriate committees of Congress, from time to time on such topics relating to the program under this subchapter as may be requested by such chairmen and members and as the Commission deems appropriate.
(5) Availability of reports
The Commission shall transmit to the Secretary a copy of each report submitted under this subsection and shall make such reports available to the public.
(6) Appropriate committees of Congress
For purposes of this section, the term "appropriate committees of Congress" means the Committees on Ways and Means and Commerce of the House of Representatives and the Committee on Finance of the Senate.
(7) Voting and reporting requirements
With respect to each recommendation contained in a report submitted under paragraph (1), each member of the Commission shall vote on the recommendation, and the Commission shall include, by member, the results of that vote in the report containing the recommendation.
(8) Examination of budget consequences
Before making any recommendations, the Commission shall examine the budget consequences of such recommendations, directly or through consultation with appropriate expert entities.
(9) Review and annual report on Medicaid and commercial trends
The Commission shall review and report on aggregate trends in spending, utilization, and financial performance under the Medicaid program under subchapter XIX and the private market for health care services with respect to providers for which, on an aggregate national basis, a significant portion of revenue or services is associated with the Medicaid program. Where appropriate, the Commission shall conduct such review in consultation with the Medicaid and CHIP Payment and Access Commission established under
(10) Coordinate and consult with the Federal Coordinated Health Care Office
The Commission shall coordinate and consult with the Federal Coordinated Health Care Office established under section 2081 2 of the Patient Protection and Affordable Care Act before making any recommendations regarding dual eligible individuals.
(11) Interaction of Medicaid and Medicare
The Commission shall consult with MACPAC in carrying out its duties under this section, as appropriate. Responsibility for analysis of and recommendations to change Medicare policy regarding Medicare beneficiaries, including Medicare beneficiaries who are dually eligible for Medicare and Medicaid, shall rest with the Commission. Responsibility for analysis of and recommendations to change Medicaid policy regarding Medicaid beneficiaries, including Medicaid beneficiaries who are dually eligible for Medicare and Medicaid, shall rest with MACPAC.
(c) Membership
(1) Number and appointment
The Commission shall be composed of 17 members appointed by the Comptroller General.
(2) Qualifications
(A) In general
The membership of the Commission shall include individuals with national recognition for their expertise in health finance and economics, actuarial science, health facility management, health plans and integrated delivery systems, reimbursement of health facilities, allopathic and osteopathic physicians, and other providers of health services, and other related fields, who provide a mix of different professionals, broad geographic representation, and a balance between urban and rural representatives.
(B) Inclusion
The membership of the Commission shall include (but not be limited to) physicians and other health professionals, experts in the area of pharmaco-economics or prescription drug benefit programs, employers, third-party payers, individuals skilled in the conduct and interpretation of biomedical, health services, and health economics research and expertise in outcomes and effectiveness research and technology assessment. Such membership shall also include representatives of consumers and the elderly.
(C) Majority nonproviders
Individuals who are directly involved in the provision, or management of the delivery, of items and services covered under this subchapter shall not constitute a majority of the membership of the Commission.
(D) Ethical disclosure
The Comptroller General shall establish a system for public disclosure by members of the Commission of financial and other potential conflicts of interest relating to such members. Members of the Commission shall be treated as employees of Congress for purposes of applying subchapter I of
(3) Terms
(A) In general
The terms of members of the Commission shall be for 3 years except that the Comptroller General shall designate staggered terms for the members first appointed.
(B) Vacancies
Any member appointed to fill a vacancy occurring before the expiration of the term for which the member's predecessor was appointed shall be appointed only for the remainder of that term. A member may serve after the expiration of that member's term until a successor has taken office. A vacancy in the Commission shall be filled in the manner in which the original appointment was made.
(4) Compensation
While serving on the business of the Commission (including traveltime), a member of the Commission shall be entitled to compensation at the per diem equivalent of the rate provided for level IV of the Executive Schedule under
(5) Chairman; Vice Chairman
The Comptroller General shall designate a member of the Commission, at the time of appointment of the member as Chairman and a member as Vice Chairman for that term of appointment, except that in the case of vacancy of the Chairmanship or Vice Chairmanship, the Comptroller General may designate another member for the remainder of that member's term.
(6) Meetings
The Commission shall meet at the call of the Chairman.
(d) Director and staff; experts and consultants
Subject to such review as the Comptroller General deems necessary to assure the efficient administration of the Commission, the Commission may—
(1) employ and fix the compensation of an Executive Director (subject to the approval of the Comptroller General) and such other personnel as may be necessary to carry out its duties (without regard to the provisions of title 5 governing appointments in the competitive service);
(2) seek such assistance and support as may be required in the performance of its duties from appropriate Federal departments and agencies;
(3) enter into contracts or make other arrangements, as may be necessary for the conduct of the work of the Commission (without regard to
(4) make advance, progress, and other payments which relate to the work of the Commission;
(5) provide transportation and subsistence for persons serving without compensation; and
(6) prescribe such rules and regulations as it deems necessary with respect to the internal organization and operation of the Commission.
(e) Powers
(1) Obtaining official data
The Commission may secure directly from any department or agency of the United States information necessary to enable it to carry out this section. Upon request of the Chairman, the head of that department or agency shall furnish that information to the Commission on an agreed upon schedule.
(2) Data collection
In order to carry out its functions, the Commission shall—
(A) utilize existing information, both published and unpublished, where possible, collected and assessed either by its own staff or under other arrangements made in accordance with this section,
(B) carry out, or award grants or contracts for, original research and experimentation, where existing information is inadequate, and
(C) adopt procedures allowing any interested party to submit information for the Commission's use in making reports and recommendations.
(3) Access of GAO to information
The Comptroller General shall have unrestricted access to all deliberations, records, and nonproprietary data of the Commission, immediately upon request.
(4) Periodic audit
The Commission shall be subject to periodic audit by the Comptroller General.
(f) Authorization of appropriations
(1) Request for appropriations
The Commission shall submit requests for appropriations in the same manner as the Comptroller General submits requests for appropriations, but amounts appropriated for the Commission shall be separate from amounts appropriated for the Comptroller General.
(2) Authorization
There are authorized to be appropriated such sums as may be necessary to carry out the provisions of this section. Sixty percent of such appropriation shall be payable from the Federal Hospital Insurance Trust Fund, and 40 percent of such appropriation shall be payable from the Federal Supplementary Medical Insurance Trust Fund.
(Aug. 14, 1935, ch. 531, title XVIII, §1805, as added
Editorial Notes
References in Text
The Patient Protection and Affordable Care Act, referred to in subsec. (b)(10), is
Codification
In subsec. (d)(3), "
Amendments
2022—Subsec. (c)(2)(D).
2018—Subsec. (b)(4) to (9).
2010—Subsec. (b)(1)(C).
Subsec. (b)(1)(D).
Subsec. (b)(4).
Subsec. (b)(5) to (8).
Subsec. (b)(9).
Subsec. (b)(10), (11).
2007—Subsec. (a).
2003—Subsec. (b)(2)(B)(i).
Subsec. (b)(8).
Subsec. (c)(2)(B).
Subsec. (c)(2)(D).
2000—Subsec. (b)(1)(D).
Subsec. (b)(7).
1999—Subsec. (b)(1)(D).
1998—Subsec. (c)(1).
Statutory Notes and Related Subsidiaries
Change of Name
References to Medicare+Choice deemed to refer to Medicare Advantage or MA, subject to an appropriate transition provided by the Secretary of Health and Human Services in the use of those terms, see section 201 of
Effective Date of 2003 Amendment
Effective Date of 2000 Amendment
Effective Date of 1999 Amendment
Amendment by
Effective Date; Transition; Transfer of Functions
"(1)
"(2)
"(3)
MedPAC Review of Payments to Rural Emergency Hospitals
Appointment of Experts in Prescription Drugs
MedPAC Analysis of Impact of Volume on Per Unit Cost of Rural Hospitals With Psychiatric Units
"(1) in such study an analysis of the impact of volume on the per unit cost of rural hospitals with psychiatric units; and
"(2) in its report under subsection (b) of such section a recommendation on whether special treatment for such hospitals may be warranted."
MedPAC Study on Complexity of Medicare Program and Levels of Burdens Placed on Providers Through Federal Regulations
MedPAC Report
MedPAC Study of Rural Providers
Quality Improvement Standards
"(1)
"(A) each type of Medicare+Choice plan described in section 1851(a)(2) of the Social Security Act (
"(B) the original medicare fee-for-service program under parts A and B [sic] title XVIII of such Act (
"(2)
"(3)
Initial Terms of Additional Members
"(1)
"(A) One member shall be appointed for one year.
"(B) One member shall be appointed for two years.
"(2)
Information Included in Annual Recommendations
2 See References in Text note below.
§1395b–7. Explanation of medicare benefits
(a) In general
The Secretary shall furnish to each individual for whom payment has been made under this subchapter (or would be made without regard to any deductible) a statement which—
(1) lists the item or service for which payment has been made and the amount of such payment for each item or service; and
(2) includes a notice of the individual's right to request an itemized statement (as provided in subsection (b)).
(b) Request for itemized statement for medicare items and services
(1) In general
An individual may submit a written request to any physician, provider, supplier, or any other person (including an organization, agency, or other entity) for an itemized statement for any item or service provided to such individual by such person with respect to which payment has been made under this subchapter.
(2) 30-day period to furnish statement
(A) In general
Not later than 30 days after the date on which a request under paragraph (1) has been made, a person described in such paragraph shall furnish an itemized statement describing each item or service provided to the individual requesting the itemized statement.
(B) Penalty
Whoever knowingly fails to furnish an itemized statement in accordance with subparagraph (A) shall be subject to a civil money penalty of not more than $100 for each such failure. Such penalty shall be imposed and collected in the same manner as civil money penalties under subsection (a) of
(3) Review of itemized statement
(A) In general
Not later than 90 days after the receipt of an itemized statement furnished under paragraph (1), an individual may submit a written request for a review of the itemized statement to the Secretary.
(B) Specific allegations
A request for a review of the itemized statement shall identify—
(i) specific items or services that the individual believes were not provided as claimed, or
(ii) any other billing irregularity (including duplicate billing).
(4) Findings of Secretary
The Secretary shall, with respect to each written request submitted under paragraph (3), determine whether the itemized statement identifies specific items or services that were not provided as claimed or any other billing irregularity (including duplicate billing) that has resulted in unnecessary payments under this subchapter.
(5) Recovery of amounts
The Secretary shall take all appropriate measures to recover amounts unnecessarily paid under this subchapter with respect to a statement described in paragraph (4).
(c) Format of statements from Secretary
(1) Electronic option beginning in 2016
Subject to paragraph (2), for statements described in subsection (a) that are furnished for a period in 2016 or a subsequent year, in the case that an individual described in subsection (a) elects, in accordance with such form, manner, and time specified by the Secretary, to receive such statement in an electronic format, such statement shall be furnished to such individual for each period subsequent to such election in such a format and shall not be mailed to the individual.
(2) Limitation on revocation option
(A) In general
Subject to subparagraph (B), the Secretary may determine a maximum number of elections described in paragraph (1) by an individual that may be revoked by the individual.
(B) Minimum of one revocation option
In no case may the Secretary determine a maximum number under subparagraph (A) that is less than one.
(3) Notification
The Secretary shall ensure that, in the most cost effective manner and beginning January 1, 2017, a clear notification of the option to elect to receive statements described in subsection (a) in an electronic format is made available, such as through the notices distributed under
(Aug. 14, 1935, ch. 531, title XVIII, §1806, as added
Editorial Notes
Amendments
2015—Subsec. (c).
Statutory Notes and Related Subsidiaries
Effective Date
"(A)
"(B)
Encouraged Expansion of Electronic Statements
"(1) apply an option similar to the option described in subsection (c)(1) of section 1806 of the Social Security Act (
"(2) provide such Medicare Summary Notice and any such other statements and notifications on a more frequent basis than is otherwise required under such title."
Inclusion of Additional Information in Notices to Beneficiaries About Skilled Nursing Facility Benefits
"(a)
"(b)
§1395b–8. Chronic care improvement
(a) Implementation of chronic care improvement programs
(1) In general
The Secretary shall provide for the phased-in development, testing, evaluation, and implementation of chronic care improvement programs in accordance with this section. Each such program shall be designed to improve clinical quality and beneficiary satisfaction and achieve spending targets with respect to expenditures under this subchapter for targeted beneficiaries with one or more threshold conditions.
(2) Definitions
For purposes of this section:
(A) Chronic care improvement program
The term "chronic care improvement program" means a program described in paragraph (1) that is offered under an agreement under subsection (b) or (c).
(B) Chronic care improvement organization
The term "chronic care improvement organization" means an entity that has entered into an agreement under subsection (b) or (c) to provide, directly or through contracts with subcontractors, a chronic care improvement program under this section. Such an entity may be a disease management organization, health insurer, integrated delivery system, physician group practice, a consortium of such entities, or any other legal entity that the Secretary determines appropriate to carry out a chronic care improvement program under this section.
(C) Care management plan
The term "care management plan" means a plan established under subsection (d) for a participant in a chronic care improvement program.
(D) Threshold condition
The term "threshold condition" means a chronic condition, such as congestive heart failure, diabetes, chronic obstructive pulmonary disease (COPD), or other diseases or conditions, as selected by the Secretary as appropriate for the establishment of a chronic care improvement program.
(E) Targeted beneficiary
The term "targeted beneficiary" means, with respect to a chronic care improvement program, an individual who—
(i) is entitled to benefits under part A and enrolled under part B, but not enrolled in a plan under part C;
(ii) has one or more threshold conditions covered under such program; and
(iii) has been identified under subsection (d)(1) as a potential participant in such program.
(3) Construction
Nothing in this section shall be construed as—
(A) expanding the amount, duration, or scope of benefits under this subchapter;
(B) providing an entitlement to participate in a chronic care improvement program under this section;
(C) providing for any hearing or appeal rights under
(D) providing benefits under a chronic care improvement program for which a claim may be submitted to the Secretary by any provider of services or supplier (as defined in
(b) Developmental phase (Phase I)
(1) In general
In carrying out this section, the Secretary shall enter into agreements consistent with subsection (f) with chronic care improvement organizations for the development, testing, and evaluation of chronic care improvement programs using randomized controlled trials. The first such agreement shall be entered into not later than 12 months after December 8, 2003.
(2) Agreement period
The period of an agreement under this subsection shall be for 3 years.
(3) Minimum participation
(A) In general
The Secretary shall enter into agreements under this subsection in a manner so that chronic care improvement programs offered under this section are offered in geographic areas that, in the aggregate, consist of areas in which at least 10 percent of the aggregate number of medicare beneficiaries reside.
(B) Medicare beneficiary defined
In this paragraph, the term "medicare beneficiary" means an individual who is entitled to benefits under part A, enrolled under part B, or both, and who resides in the United States.
(4) Site selection
In selecting geographic areas in which agreements are entered into under this subsection, the Secretary shall ensure that each chronic care improvement program is conducted in a geographic area in which at least 10,000 targeted beneficiaries reside among other individuals entitled to benefits under part A, enrolled under part B, or both to serve as a control population.
(5) Independent evaluations of Phase I programs
The Secretary shall contract for an independent evaluation of the programs conducted under this subsection. Such evaluation shall be done by a contractor with knowledge of chronic care management programs and demonstrated experience in the evaluation of such programs. Each evaluation shall include an assessment of the following factors of the programs:
(A) Quality improvement measures, such as adherence to evidence-based guidelines and rehospitalization rates.
(B) Beneficiary and provider satisfaction.
(C) Health outcomes.
(D) Financial outcomes, including any cost savings to the program under this subchapter.
(c) Expanded implementation phase (Phase II)
(1) In general
With respect to chronic care improvement programs conducted under subsection (b), if the Secretary finds that the results of the independent evaluation conducted under subsection (b)(6) indicate that the conditions specified in paragraph (2) have been met by a program (or components of such program), the Secretary shall enter into agreements consistent with subsection (f) to expand the implementation of the program (or components) to additional geographic areas not covered under the program as conducted under subsection (b), which may include the implementation of the program on a national basis. Such expansion shall begin not earlier than 2 years after the program is implemented under subsection (b) and not later than 6 months after the date of completion of such program.
(2) Conditions for expansion of programs
The conditions specified in this paragraph are, with respect to a chronic care improvement program conducted under subsection (b) for a threshold condition, that the program is expected to—
(A) improve the clinical quality of care;
(B) improve beneficiary satisfaction; and
(C) achieve targets for savings to the program under this subchapter specified by the Secretary in the agreement within a range determined to be appropriate by the Secretary, subject to the application of budget neutrality with respect to the program and not taking into account any payments by the organization under the agreement under the program for risk under subsection (f)(3)(B).
(3) Independent evaluations of Phase II programs
The Secretary shall carry out evaluations of programs expanded under this subsection as the Secretary determines appropriate. Such evaluations shall be carried out in the similar manner as is provided under subsection (b)(5).
(d) Identification and enrollment of prospective program participants
(1) Identification of prospective program participants
The Secretary shall establish a method for identifying targeted beneficiaries who may benefit from participation in a chronic care improvement program.
(2) Initial contact by Secretary
The Secretary shall communicate with each targeted beneficiary concerning participation in a chronic care improvement program. Such communication may be made by the Secretary and shall include information on the following:
(A) A description of the advantages to the beneficiary in participating in a program.
(B) Notification that the organization offering a program may contact the beneficiary directly concerning such participation.
(C) Notification that participation in a program is voluntary.
(D) A description of the method for the beneficiary to participate or for declining to participate and the method for obtaining additional information concerning such participation.
(3) Voluntary participation
A targeted beneficiary may participate in a chronic care improvement program on a voluntary basis and may terminate participation at any time.
(e) Chronic care improvement programs
(1) In general
Each chronic care improvement program shall—
(A) have a process to screen each targeted beneficiary for conditions other than threshold conditions, such as impaired cognitive ability and co-morbidities, for the purposes of developing an individualized, goal-oriented care management plan under paragraph (2);
(B) provide each targeted beneficiary participating in the program with such plan; and
(C) carry out such plan and other chronic care improvement activities in accordance with paragraph (3).
(2) Elements of care management plans
A care management plan for a targeted beneficiary shall be developed with the beneficiary and shall, to the extent appropriate, include the following:
(A) A designated point of contact responsible for communications with the beneficiary and for facilitating communications with other health care providers under the plan.
(B) Self-care education for the beneficiary (through approaches such as disease management or medical nutrition therapy) and education for primary caregivers and family members.
(C) Education for physicians and other providers and collaboration to enhance communication of relevant clinical information.
(D) The use of monitoring technologies that enable patient guidance through the exchange of pertinent clinical information, such as vital signs, symptomatic information, and health self-assessment.
(E) The provision of information about hospice care, pain and palliative care, and end-of-life care.
(3) Conduct of programs
In carrying out paragraph (1)(C) with respect to a participant, the chronic care improvement organization shall—
(A) guide the participant in managing the participant's health (including all co-morbidities, relevant health care services, and pharmaceutical needs) and in performing activities as specified under the elements of the care management plan of the participant;
(B) use decision-support tools such as evidence-based practice guidelines or other criteria as determined by the Secretary; and
(C) develop a clinical information database to track and monitor each participant across settings and to evaluate outcomes.
(4) Additional responsibilities
(A) Outcomes report
Each chronic care improvement organization offering a chronic care improvement program shall monitor and report to the Secretary, in a manner specified by the Secretary, on health care quality, cost, and outcomes.
(B) Additional requirements
Each such organization and program shall comply with such additional requirements as the Secretary may specify.
(5) Accreditation
The Secretary may provide that chronic care improvement programs and chronic care improvement organizations that are accredited by qualified organizations (as defined by the Secretary) may be deemed to meet such requirements under this section as the Secretary may specify.
(f) Terms of agreements
(1) Terms and conditions
(A) In general
An agreement under this section with a chronic care improvement organization shall contain such terms and conditions as the Secretary may specify consistent with this section.
(B) Clinical, quality improvement, and financial requirements
The Secretary may not enter into an agreement with such an organization under this section for the operation of a chronic care improvement program unless—
(i) the program and organization meet the requirements of subsection (e) and such clinical, quality improvement, financial, and other requirements as the Secretary deems to be appropriate for the targeted beneficiaries to be served; and
(ii) the organization demonstrates to the satisfaction of the Secretary that the organization is able to assume financial risk for performance under the agreement (as applied under paragraph (3)(B)) with respect to payments made to the organization under such agreement through available reserves, reinsurance, withholds, or such other means as the Secretary determines appropriate.
(2) Manner of payment
Subject to paragraph (3)(B), the payment under an agreement under—
(A) subsection (b) shall be computed on a per-member per-month basis; or
(B) subsection (c) may be on a per-member per-month basis or such other basis as the Secretary and organization may agree.
(3) Application of performance standards
(A) Specification of performance standards
Each agreement under this section with a chronic care improvement organization shall specify performance standards for each of the factors specified in subsection (c)(2), including clinical quality and spending targets under this subchapter, against which the performance of the chronic care improvement organization under the agreement is measured.
(B) Adjustment of payment based on performance
(i) In general
Each such agreement shall provide for adjustments in payment rates to an organization under the agreement insofar as the Secretary determines that the organization failed to meet the performance standards specified in the agreement under subparagraph (A).
(ii) Financial risk for performance
In the case of an agreement under subsection (b) or (c), the agreement shall provide for a full recovery for any amount by which the fees paid to the organization under the agreement exceed the estimated savings to the programs under this subchapter attributable to implementation of such agreement.
(4) Budget neutral payment condition
Under this section, the Secretary shall ensure that the aggregate sum of medicare program benefit expenditures for beneficiaries participating in chronic care improvement programs and funds paid to chronic care improvement organizations under this section, shall not exceed the medicare program benefit expenditures that the Secretary estimates would have been made for such targeted beneficiaries in the absence of such programs.
(g) Funding
(1) Subject to paragraph (2), there are appropriated to the Secretary, in appropriate part from the Federal Hospital Insurance Trust Fund and the Federal Supplementary Medical Insurance Trust Fund, such sums as may be necessary to provide for agreements with chronic care improvement programs under this section.
(2) In no case shall the funding under this section exceed $100,000,000 in aggregate increased expenditures under this subchapter (after taking into account any savings attributable to the operation of this section) over the 3-fiscal-year period beginning on October 1, 2003.
(Aug. 14, 1935, ch. 531, title XVIII, §1807, as added
Editorial Notes
References in Text
Parts A, B, and C, referred to in subsecs. (a)(2)(E)(i) and (b)(3)(B), (4), are classified to sections 1395c et seq., 1395j et seq., and 1395w–21 et seq., respectively, of this title.
Statutory Notes and Related Subsidiaries
Demonstration Project for Consumer-Directed Chronic Outpatient Services
"(a)
"(1)
"(2)
"(b)
"(1)
"(A)
"(B)
"(2)
"(c)
"(d)
"(e)
"(1)
"(2)
"(A) An analysis of the patient outcomes and costs of furnishing care to the individuals with chronic conditions participating in the projects as compared to such outcomes and costs to other individuals for the same health conditions.
"(B) Evaluation of patient satisfaction under the demonstration projects.
"(C) Such recommendations regarding the extension, expansion, or termination of the projects as the Secretary determines appropriate.
"(f)
"(g)
"(2) There are authorized to be appropriated from such Trust Fund such sums as may be necessary for the Secretary to enter into contracts with appropriate organizations for the deign [sic], implementation, and evaluation of the demonstration project.
"(3) In no case may expenditures under this section exceed the aggregate expenditures that would otherwise have been made for the provision of personal care services."
Reports
"(1) Not later than 2 years after the date of the implementation of such section, the Secretary shall submit to Congress an interim report on the scope of implementation of the programs under subsection (b) of such section, the design of the programs, and preliminary cost and quality findings with respect to those programs based on the following measures of the programs:
"(A) Quality improvement measures, such as adherence to evidence-based guidelines and rehospitalization rates.
"(B) Beneficiary and provider satisfaction.
"(C) Health outcomes.
"(D) Financial outcomes.
"(2) Not later than 3 years and 6 months after the date of the implementation of such section the Secretary shall submit to Congress an update to the report required under paragraph (1) on the results of such programs.
"(3) The Secretary shall submit to Congress 2 additional biennial reports on the chronic care improvement programs conducted under such section. The first such report shall be submitted not later than 2 years after the report is submitted under paragraph (2). Each such report shall include information on—
"(A) the scope of implementation (in terms of both regions and chronic conditions) of the chronic care improvement programs;
"(B) the design of the programs; and
"(C) the improvements in health outcomes and financial efficiencies that result from such implementation."
Chronically Ill Medicare Beneficiary Research, Data, Demonstration Strategy
"(a)
"(b)
"(1) integrate existing data sets including, the Medicare Current Beneficiary Survey (MCBS), Minimum Data Set (MDS), Outcome and Assessment Information Set (OASIS), data from Quality Improvement Organizations (QIO), and claims data;
"(2) identify any new data needs and a methodology to address new data needs;
"(3) plan for the collection of such data in a data warehouse; and
"(4) develop a research agenda using such data.
"(c)
"(d)
"(e)
§1395b–9. Provisions relating to administration
(a) Coordinated administration of medicare prescription drug and Medicare Advantage programs
(1) In general
There is within the Centers for Medicare & Medicaid Services a center to carry out the duties described in paragraph (3).
(2) Director
Such center shall be headed by a director who shall report directly to the Administrator of the Centers for Medicare & Medicaid Services.
(3) Duties
The duties described in this paragraph are the following:
(A) The administration of parts C and D.
(B) The provision of notice and information under
(C) Such other duties as the Secretary may specify.
(4) Deadline
The Secretary shall ensure that the center is carrying out the duties described in paragraph (3) by not later than January 1, 2008.
(b) Employment of management staff
(1) In general
The Secretary may employ, within the Centers for Medicare & Medicaid Services, such individuals as management staff as the Secretary determines to be appropriate. With respect to the administration of parts C and D, such individuals shall include individuals with private sector expertise in negotiations with health benefits plans.
(2) Eligibility
To be eligible for employment under paragraph (1) an individual shall be required to have demonstrated, by their education and experience (either in the public or private sector), superior expertise in at least one of the following areas:
(A) The review, negotiation, and administration of health care contracts.
(B) The design of health care benefit plans.
(C) Actuarial sciences.
(D) Compliance with health plan contracts.
(E) Consumer education and decision making.
(F) Any other area specified by the Secretary that requires specialized management or other expertise.
(3) Rates of payment
(A) Performance-related pay
Subject to subparagraph (B), the Secretary shall establish the rate of pay for an individual employed under paragraph (1). Such rate shall take into account expertise, experience, and performance.
(B) Limitation
In no case may the rate of compensation determined under subparagraph (A) exceed the highest rate of basic pay for the Senior Executive Service under
(c) Medicare Beneficiary Ombudsman
(1) In general
The Secretary shall appoint within the Department of Health and Human Services a Medicare Beneficiary Ombudsman who shall have expertise and experience in the fields of health care and education of (and assistance to) individuals entitled to benefits under this subchapter.
(2) Duties
The Medicare Beneficiary Ombudsman shall—
(A) receive complaints, grievances, and requests for information submitted by individuals entitled to benefits under part A or enrolled under part B, or both, with respect to any aspect of the medicare program;
(B) provide assistance with respect to complaints, grievances, and requests referred to in subparagraph (A), including—
(i) assistance in collecting relevant information for such individuals, to seek an appeal of a decision or determination made by a fiscal intermediary, carrier, MA organization, or the Secretary;
(ii) assistance to such individuals with any problems arising from disenrollment from an MA plan under part C; and
(iii) assistance to such individuals in presenting information under
(C) submit annual reports to Congress and the Secretary that describe the activities of the Office and that include such recommendations for improvement in the administration of this subchapter as the Ombudsman determines appropriate.
The Ombudsman shall not serve as an advocate for any increases in payments or new coverage of services, but may identify issues and problems in payment or coverage policies.
(3) Working with health insurance counseling programs
To the extent possible, the Ombudsman shall work with health insurance counseling programs (receiving funding under
(d) Pharmaceutical and technology ombudsman
(1) In general
Not later than 12 months after December 13, 2016, the Secretary shall provide for a pharmaceutical and technology ombudsman within the Centers for Medicare & Medicaid Services who shall receive and respond to complaints, grievances, and requests that—
(A) are from entities that manufacture pharmaceutical, biotechnology, medical device, or diagnostic products that are covered or for which coverage is being sought under this subchapter; and
(B) are with respect to coverage, coding, or payment under this subchapter for such products.
(2) Application
The second sentence of subsection (c)(2) shall apply to the ombudsman under subparagraph (A) in the same manner as such sentence applies to the Medicare Beneficiary Ombudsman under subsection (c).
(e) Funding for implementation of beneficiary enrollment simplification
For purposes of carrying out the provisions of and the amendments made by section 120 of division CC of the Consolidated Appropriations Act, 2021, the Secretary shall provide for the transfer, from the Federal Hospital Insurance Trust Fund under
(Aug. 14, 1935, ch. 531, title XVIII, §1808, as added and amended
Editorial Notes
References in Text
Section 120 of division CC of the Consolidated Appropriations Act, 2021, referred to in subsec. (e), is section 120 of div. CC of
Amendments
2020—Subsec. (e).
2016—Subsec. (d).
2003—Subsec. (b).
Subsec. (c).
Statutory Notes and Related Subsidiaries
Deadline for Appointment
1 So in original. A closing parenthesis probably should precede the semicolon.
§1395b–10. Addressing health care disparities
(a) Evaluating data collection approaches
The Secretary shall evaluate approaches for the collection of data under this subchapter, to be performed in conjunction with existing quality reporting requirements and programs under this subchapter, that allow for the ongoing, accurate, and timely collection and evaluation of data on disparities in health care services and performance on the basis of race, ethnicity, and gender. In conducting such evaluation, the Secretary shall consider the following objectives:
(1) Protecting patient privacy.
(2) Minimizing the administrative burdens of data collection and reporting on providers and health plans participating under this subchapter.
(3) Improving Medicare program data on race, ethnicity, and gender.
(b) Reports to Congress
(1) Report on evaluation
Not later than 18 months after July 15, 2008, the Secretary shall submit to Congress a report on the evaluation conducted under subsection (a). Such report shall, taking into consideration the results of such evaluation—
(A) identify approaches (including defining methodologies) for identifying and collecting and evaluating data on health care disparities on the basis of race, ethnicity, and gender for the original Medicare fee-for-service program under parts A and B, the Medicare Advantage program under part C, and the Medicare prescription drug program under part D; and
(B) include recommendations on the most effective strategies and approaches to reporting HEDIS quality measures as required under
(2) Reports on data analyses
Not later than 4 years after July 15, 2008, and 4 years thereafter, the Secretary shall submit to Congress a report that includes recommendations for improving the identification of health care disparities for Medicare beneficiaries based on analyses of the data collected under subsection (c).
(c) Implementing effective approaches
Not later than 24 months after July 15, 2008, the Secretary shall implement the approaches identified in the report submitted under subsection (b)(1) for the ongoing, accurate, and timely collection and evaluation of data on health care disparities on the basis of race, ethnicity, and gender.
(Aug. 14, 1935, ch. 531, title XVIII, §1809, as added
Part A—Hospital Insurance Benefits for Aged and Disabled
§1395c. Description of program
The insurance program for which entitlement is established by
(Aug. 14, 1935, ch. 531, title XVIII, §1811, as added
Editorial Notes
Amendments
1989—
1988—
1986—
1982—
1980—
1978—
1972—
Statutory Notes and Related Subsidiaries
Effective Date of 1989 Amendment
Effective Date of 1988 Amendment
Amendment by
Effective Date of 1986 Amendment
Amendment by
Effective Date of 1982 Amendment
Amendment by section 278(b)(3) of
Effective Date of 1980 Amendment
Amendment by
Amendment by
Amendment by
Effective Date of 1978 Amendment
Amendment by
Developing Guidance on Pain Management and Opioid Use Disorder Prevention for Hospitals Receiving Payment Under Part A of the Medicare Program
"(a)
"(b)
"(1) medical professional organizations;
"(2) providers and suppliers of services (as such terms are defined in section 1861 of the Social Security Act (
"(3) health care consumers or groups representing such consumers; and
"(4) other entities determined appropriate by the Secretary.
"(c)
"(1) Best practices regarding evidence-based screening and practitioner education initiatives relating to screening and treatment protocols for opioid use disorder, including—
"(A) methods to identify such individuals at-risk of opioid use disorder, including risk stratification;
"(B) ways to prevent, recognize, and treat opioid overdoses; and
"(C) resources available to such individuals, such as opioid treatment programs, peer support groups, and other recovery programs.
"(2) Best practices for such hospitals to educate practitioners furnishing items and services at such hospital with respect to pain management and substance use disorders, including education on—
"(A) the adverse effects of prolonged opioid use;
"(B) non-opioid, evidence-based, non-pharmacological pain management treatments;
"(C) monitoring programs for individuals who have been prescribed opioids; and
"(D) the prescribing of naloxone along with an initial opioid prescription.
"(3) Best practices for such hospitals to make such individuals aware of the risks associated with opioid use (which may include use of the notification template described in paragraph (4)).
"(4) A notification template developed by the Secretary, for use as appropriate, for such individuals who are prescribed an opioid that—
"(A) explains the risks and side effects associated with opioid use (including the risks of addiction and overdose) and the importance of adhering to the prescribed treatment regimen, avoiding medications that may have an adverse interaction with such opioid, and storing such opioid safely and securely;
"(B) highlights multimodal and evidence-based non-opioid alternatives for pain management;
"(C) encourages such individuals to talk to their health care providers about such alternatives;
"(D) provides for a method (through signature or otherwise) for such an individual, or person acting on such individual's behalf, to acknowledge receipt of such notification template;
"(E) is worded in an easily understandable manner and made available in multiple languages determined appropriate by the Secretary; and
"(F) includes any other information determined appropriate by the Secretary.
"(5) Best practices for such hospital to track opioid prescribing trends by practitioners furnishing items and services at such hospital, including—
"(A) ways for such hospital to establish target levels, taking into account the specialties of such practitioners and the geographic area in which such hospital is located, with respect to opioids prescribed by such practitioners;
"(B) guidance on checking the medical records of such individuals against information included in prescription drug monitoring programs;
"(C) strategies to reduce long-term opioid prescriptions; and
"(D) methods to identify such practitioners who may be over-prescribing opioids.
"(6) Other information the Secretary determines appropriate, including any such information from the Opioid Safety Initiative established by the Department of Veterans Affairs or the Opioid Overdose Prevention Toolkit published by the Substance Abuse and Mental Health Services Administration."
Advisory Council To Study Coverage of Disabled Under This Subchapter
Reimbursement of Charges Under Part A for Services to Patients Admitted Prior to 1968 to Certain Hospitals
"(a) Notwithstanding any provision of title XVIII of the Social Security Act [
"(1) the hospital did not have an agreement in effect under section 1866 of such Act [
"(2) the hospital (A) meets the requirements of paragraphs (5) and (7) of section 1861(e) of such Act [
"(3) the hospital did not meet the requirements that must be met to permit payment to the hospital under part A of title XVIII of such Act [
"(4) an application is filed (submitted in such form and manner and by such person, and containing and supported by such information, as the Secretary shall by regulations prescribe) for reimbursement before January 1, 1969.
"(b) Payments under this section may not be made for inpatient hospital services (as described in subsection (a)) furnished to an individual—
"(1) prior to July 1, 1966,
"(2) after December 31, 1967, unless furnished with respect to an admission to the hospital prior to January 1, 1968, and
"(3) for more than—
"(A) 90 days in any spell of illness, but only if (i) prior to January 1, 1969, the hospital furnishing such services entered into an agreement under section 1866 of the Social Security Act [
"(B) 20 days in any spell of illness, if the hospital did not meet the conditions of clauses (i) and (ii) of subparagraph (A).
"(c)(1) The amounts payable in accordance with subsection (a) with respect to inpatient hospital services shall, subject to paragraph (2) of this subsection, be paid from the Federal Hospital Insurance Trust Fund in amounts equal to 60 percent of the hospital's reasonable charges for routine services furnished in the accommodations occupied by the individual or in semi-private accommodations (as defined in section 1861(v)(4) of the Social Security Act [
"(2) Before applying paragraph (1), payments made under this section shall be reduced to the extent provided for under section 1813 of the Social Security Act [
"(d) For the purposes of this section—
"(1) the 90-day period, referred to in subsection (b)(3)(A), shall be reduced by the number of days of inpatient hospital services furnished to such individual during the spell of illness, referred to therein, and with respect to which he was entitled to have payment made under part A of title XVIII of the Social Security Act [
"(2) the 20-day period, referred to in subsection (b)(3)(B) shall be reduced by the number of days in excess of 70 days of inpatient hospital services furnished during the spell of illness, referred to therein, and with respect to which such individual was entitled to have payment made under such part A [
"(3) the term 'spell of illness' shall have the meaning assigned to it by subsection (a) of section 1861 of such Act [
§1395d. Scope of benefits
(a) Entitlement to payment for inpatient hospital services, post-hospital extended care services, home health services, and hospice care
The benefits provided to an individual by the insurance program under this part shall consist of entitlement to have payment made on his behalf or, in the case of payments referred to in
(1) inpatient hospital services or inpatient critical access hospital services for up to 150 days during any spell of illness minus 1 day for each day of such services in excess of 90 received during any preceding spell of illness (if such individual was entitled to have payment for such services made under this part unless he specifies in accordance with regulations of the Secretary that he does not desire to have such payment made);
(2)(A) post-hospital extended care services for up to 100 days during any spell of illness, and (B) to the extent provided in subsection (f), extended care services that are not post-hospital extended care services;
(3) in the case of individuals not enrolled in part B, home health services, and in the case of individuals so enrolled, post-institutional home health services furnished during a home health spell of illness for up to 100 visits during such spell of illness;
(4) in lieu of certain other benefits, hospice care with respect to the individual during up to two periods of 90 days each and an unlimited number of subsequent periods of 60 days each with respect to which the individual makes an election under subsection (d)(1); and
(5) for individuals who are terminally ill, have not made an election under subsection (d)(1), and have not previously received services under this paragraph, services that are furnished by a physician (as defined in
(A) consist of—
(i) an evaluation of the individual's need for pain and symptom management, including the individual's need for hospice care; and
(ii) counseling the individual with respect to hospice care and other care options; and
(B) may include advising the individual regarding advanced care planning.
(b) Services not covered
Payment under this part for services furnished an individual during a spell of illness may not (subject to subsection (c)) be made for—
(1) inpatient hospital services furnished to him during such spell after such services have been furnished to him for 150 days during such spell minus 1 day for each day of inpatient hospital services in excess of 90 received during any preceding spell of illness (if such individual was entitled to have payment for such services made under this part unless he specifies in accordance with regulations of the Secretary that he does not desire to have such payment made);
(2) post-hospital extended care services furnished to him during such spell after such services have been furnished to him for 100 days during such spell; or
(3) inpatient psychiatric hospital services furnished to him after such services have been furnished to him for a total of 190 days during his lifetime.
Payment under this part for post-institutional home health services furnished an individual during a home health spell of illness may not be made for such services beginning after such services have been furnished for a total of 100 visits during such spell.
(c) Inpatients of psychiatric hospitals
If an individual is an inpatient of a psychiatric hospital on the first day of the first month for which he is entitled to benefits under this part, the days on which he was an inpatient of such a hospital in the 150-day period immediately before such first day shall be included in determining the number of days limit under subsection (b)(1) insofar as such limit applies to (1) inpatient psychiatric hospital services, or (2) inpatient hospital services for an individual who is an inpatient primarily for the diagnosis or treatment of mental illness (but shall not be included in determining such number of days limit insofar as it applies to other inpatient hospital services or in determining the 190-day limit under subsection (b)(3)).
(d) Hospice care; election; waiver of rights; revocation; change of election
(1) Payment under this part may be made for hospice care provided with respect to an individual only during two periods of 90 days each and an unlimited number of subsequent periods of 60 days each during the individual's lifetime and only, with respect to each such period, if the individual makes an election under this paragraph to receive hospice care under this part provided by, or under arrangements made by, a particular hospice program instead of certain other benefits under this subchapter.
(2)(A) Except as provided in subparagraphs (B) and (C) and except in such exceptional and unusual circumstances as the Secretary may provide, if an individual makes such an election for a period with respect to a particular hospice program, the individual shall be deemed to have waived all rights to have payment made under this subchapter with respect to—
(i) hospice care provided by another hospice program (other than under arrangements made by the particular hospice program) during the period, and
(ii) services furnished during the period that are determined (in accordance with guidelines of the Secretary) to be—
(I) related to the treatment of the individual's condition with respect to which a diagnosis of terminal illness has been made or
(II) equivalent to (or duplicative of) hospice care;
except that clause (ii) shall not apply to physicians' services furnished by the individual's attending physician (if not an employee of the hospice program) or to services provided by (or under arrangements made by) the hospice program.
(B) After an individual makes such an election with respect to a 90-day period or a subsequent 60-day period, the individual may revoke the election during the period, in which case—
(i) the revocation shall act as a waiver of the right to have payment made under this part for any hospice care benefits for the remaining time in such period and (for purposes of subsection (a)(4) and subparagraph (A)) the individual shall be deemed to have been provided such benefits during such entire period, and
(ii) the individual may at any time after the revocation execute a new election for a subsequent period, if the individual otherwise is entitled to hospice care benefits with respect to such a period.
(C) An individual may, once in each such period, change the hospice program with respect to which the election is made and such change shall not be considered a revocation of an election under subparagraph (B).
(D) For purposes of this subchapter, an individual's election with respect to a hospice program shall no longer be considered to be in effect with respect to that hospice program after the date the individual's revocation or change of election with respect to that election takes effect.
(e) Services taken into account
For purposes of subsections (b) and (c), inpatient hospital services, inpatient psychiatric hospital services, and post-hospital extended care services shall be taken into account only if payment is or would be, except for this section or the failure to comply with the request and certification requirements of or under
(f) Coverage of extended care services without regard to three-day prior hospitalization requirement
(1) The Secretary shall provide for coverage, under clause (B) of subsection (a)(2), of extended care services which are not post-hospital extended care services at such time and for so long as the Secretary determines, and under such terms and conditions (described in paragraph (2)) as the Secretary finds appropriate, that the inclusion of such services will not result in any increase in the total of payments made under this subchapter and will not alter the acute care nature of the benefit described in subsection (a)(2).
(2) The Secretary may provide—
(A) for such limitations on the scope and extent of services described in subsection (a)(2)(B) and on the categories of individuals who may be eligible to receive such services, and
(B) notwithstanding
as may be necessary to carry out paragraph (1).
(g) "Spell of illness" defined
For definitions of "spell of illness", and for definitions of other terms used in this part, see
(Aug. 14, 1935, ch. 531, title XVIII, §1812, as added
Editorial Notes
Amendments
2003—Subsec. (a)(3).
Subsec. (a)(5).
1999—Subsec. (b).
1997—Subsec. (a)(1).
Subsec. (a)(3).
Subsec. (a)(4).
Subsec. (b).
Subsec. (d)(1).
Subsec. (d)(2)(B).
1994—Subsec. (a)(1).
1990—Subsec. (a)(4).
Subsec. (d)(1).
Subsec. (d)(2)(B).
1989—Subsec. (a).
Subsec. (a)(1).
Subsecs. (b) to (d)(1), (2)(B), (e) to (g).
1988—Subsec. (a).
"(1) inpatient hospital services;
"(2) extended care services for up to 150 days during any calendar year;
"(3) home health services; and
"(4) in lieu of certain other benefits, hospice care with respect to the individual during up to two periods of 90 days each, a subsequent period of 30 days, and a subsequent extension period with respect to which the individual makes an election under subsection (d)(1) of this section."
Subsec. (b).
Subsec. (c).
Subsec. (d)(1).
Subsec. (d)(2)(B).
Subsec. (e).
Subsec. (f).
Subsec. (g).
1983—Subsec. (d)(2)(A).
1982—Subsec. (a)(2).
Subsec. (a)(4).
Subsec. (d).
Subsecs. (f), (g).
1981—Subsec. (a).
1980—Subsec. (a)(3).
Subsec. (a)(4).
Subsec. (d).
Subsec. (e).
1968—Subsec. (a).
Subsec. (a)(1).
Subsec. (a)(4).
Subsec. (b)(1).
Subsec. (c).
Statutory Notes and Related Subsidiaries
Effective Date of 2003 Amendment
Effective Date of 1999 Amendment
Effective Date of 1997 Amendment
Amendment by section 4201(c)(1) of
Effective Date of 1994 Amendment
Effective Date of 1990 Amendment
Effective Date of 1989 Amendment
Amendment by
Effective Date of 1988 Amendment
"(1)
"(A) to the inpatient hospital deductible for 1989 and succeeding years,
"(B) to care and services furnished on or after January 1, 1989,
"(C) to premiums for January 1989 and succeeding months, and
"(D) to blood or blood cells furnished on or after January 1, 1989.
"(2)
Effective Date of 1983 Amendment
Amendment by
Effective Date of 1982 Amendment
Amendment by section 122(b) of
Effective Date of 1981 Amendment
Effective Date of 1980 Amendment
Amendment by section 930(b)–(d) of
Effective Date of 1968 Amendment
Medicare Hospice Concurrent Care Demonstration Program
"(a)
"(1)
"(2)
"(3)
"(b)
"(1)
"(2)
"(c)
Protecting Home Health Benefits
Rural Hospice Demonstration Project
"(a)
"(b)
"(c)
"(1) the hospice program shall comply with otherwise applicable requirements, except that it shall not be required to offer services outside of the home or to meet the requirements of section 1861(dd)(2)(A)(iii) of the Social Security Act [
"(2) payments for hospice care shall be made at the rates otherwise applicable to such care under title XVIII of such Act [
The Secretary may require the program to comply with such additional quality assurance standards for its provision of services in its facility as the Secretary deems appropriate.
"(d)
OIG Report on Notices Relating to Use of Hospital Lifetime Reserve Days
"(1) the extent to which hospitals provide notice to medicare beneficiaries in accordance with applicable requirements before they use the 60 lifetime reserve days described in section 1812(a)(1) of the Social Security Act (
"(2) the appropriateness and feasibility of hospitals providing a notice to such beneficiaries before they completely exhaust such lifetime reserve days."
MedPAC Report on Access to, and Use of, Hospice Benefit
Transition
"(1)
"(2)
"(A) 1998 is 1/6,
"(B) 1999 is 1/3,
"(C) 2000 is ½,
"(D) 2001 is 2/3, and
"(E) 2002 is 5/6.
"(3)
"(A)
"(i) For 1998, 1/7.
"(ii) For 1999, 2/7.
"(iii) For 2000, 3/7.
"(iv) For 2001, 4/7.
"(v) For 2002, 5/7.
"(vi) For 2003, 6/7.
"(B)
Repeal of 1988 Expansion of Medicare Part A Benefits
For provisions repealing amendment by section 101 of
§1395e. Deductibles and coinsurance
(a) Inpatient hospital services; outpatient hospital diagnostic services; blood; post-hospital extended care services
(1) The amount payable for inpatient hospital services or inpatient critical access hospital services furnished an individual during any spell of illness shall be reduced by a deduction equal to the inpatient hospital deductible or, if less, the charges imposed with respect to such individual for such services, except that, if the customary charges for such services are greater than the charges so imposed, such customary charges shall be considered to be the charges so imposed. Such amount shall be further reduced by a coinsurance amount equal to—
(A) one-fourth of the inpatient hospital deductible for each day (before the 91st day) on which such individual is furnished such services during such spell of illness after such services have been furnished to him for 60 days during such spell; and
(B) one-half of the inpatient hospital deductible for each day (before the day following the last day for which such individual is entitled under
except that the reduction under this sentence for any day shall not exceed the charges imposed for that day with respect to such individual for such services (and for this purpose, if the customary charges for such services are greater than the charges so imposed, such customary charges shall be considered to be the charges so imposed).
(2)(A) The amount payable to any provider of services under this part for services furnished an individual shall be further reduced by a deduction equal to the expenses incurred for the first three pints of whole blood (or equivalent quantities of packed red blood cells, as defined under regulations) furnished to the individual during each calendar year, except that such deductible for such blood shall in accordance with regulations be appropriately reduced to the extent that there has been a replacement of such blood (or equivalent quantities of packed red blood cells, as so defined); and for such purposes blood (or equivalent quantities of packed red blood cells, as so defined) furnished such individual shall be deemed replaced when the institution or other person furnishing such blood (or such equivalent quantities of packed red blood cells, as so defined) is given one pint of blood for each pint of blood (or equivalent quantities of packed red blood cells, as so defined) furnished such individual with respect to which a deduction is made under this sentence.
(B) The deductible under subparagraph (A) for blood or blood cells furnished an individual in a year shall be reduced to the extent that a deductible has been imposed under
(3) The amount payable for post-hospital extended care services furnished an individual during any spell of illness shall be reduced by a coinsurance amount equal to one-eighth of the inpatient hospital deductible for each day (before the 101st day) on which he is furnished such services after such services have been furnished to him for 20 days during such spell.
(4)(A) The amount payable for hospice care shall be reduced—
(i) in the case of drugs and biologicals provided on an outpatient basis by (or under arrangements made by) the hospice program, by a coinsurance amount equal to an amount (not to exceed $5 per prescription) determined in accordance with a drug copayment schedule (established by the hospice program) which is related to, and approximates 5 percent of, the cost of the drug or biological to the program, and
(ii) in the case of respite care provided by (or under arrangements made by) the hospice program, by a coinsurance amount equal to 5 percent of the amount estimated by the hospice program (in accordance with regulations of the Secretary) to be equal to the amount of payment under
except that the total of the coinsurance required under clause (ii) for an individual may not exceed for a hospice coinsurance period the inpatient hospital deductible applicable for the year in which the period began. For purposes of this subparagraph, the term "hospice coinsurance period" means, for an individual, a period of consecutive days beginning with the first day for which an election under
(B) During the period of an election by an individual under
(b) Inpatient hospital deductible; application
(1) The inpatient hospital deductible for 1987 shall be $520. The inpatient hospital deductible for any succeeding year shall be an amount equal to the inpatient hospital deductible for the preceding calendar year, changed by the Secretary's best estimate of the payment-weighted average of the applicable percentage increases (as defined in
(2) The Secretary shall promulgate the inpatient hospital deductible and all coinsurance amounts under this section between September 1 and September 15 of the year preceding the year to which they will apply.
(3) The inpatient hospital deductible for a year shall apply to—
(A) the deduction under the first sentence of subsection (a)(1) for the year in which the first day of inpatient hospital services or inpatient critical access hospital services occurs in a spell of illness, and
(B) to the coinsurance amounts under subsection (a) for inpatient hospital services, inpatient critical access hospital services and post-hospital extended care services furnished in that year.
(Aug. 14, 1935, ch. 531, title XVIII, §1813, as added
Editorial Notes
Amendments
1997—
1994—Subsec. (a)(1).
Subsec. (b)(3)(A).
Subsec. (b)(3)(B).
1989—Subsecs. (a)(1) to (3), (b)(3).
1988—Subsec. (a)(1) to (3).
Subsec. (b)(1).
Subsec. (b)(3).
1987—Subsec. (b)(1).
1986—Subsec. (b).
"(1) The inpatient hospital deductible which shall be applicable for the purposes of subsection (a) of this section shall be $40 in the case of any spell of illness beginning before 1969.
"(2) The Secretary shall, between July 1 and September 15 of 1968, and of each year thereafter, determine and promulgate the inpatient hospital deductible which shall be applicable for the purposes of subsection (a) of this section in the case of any inpatient hospital services or post-hospital extended care services furnished during the succeeding calendar year. Such inpatient hospital deductible shall be equal to $45 multiplied by the ratio of (A) the current average per diem rate for inpatient hospital services for the calendar year preceding the promulgation, to (B) the current average per diem rate for such services for 1966. Any amount determined under the preceding sentence which is not a multiple of $4 shall be rounded to the nearest multiple of $4 (or, if it is midway between two multiplies of $4, to the next higher multiple of $4). The current average per diem rate for any year shall be determined by the Secretary on the basis of the best information available to him (at the time the determination is made) as to the amounts paid under this part on account of inpatient hospital services furnished during such year, by hospitals which have agreements in effect under
Subsec. (b)(2).
1982—Subsec. (a)(4).
1981—Subsec. (b)(2).
1968—Subsec. (a)(1).
Subsec. (a)(2).
Subsec. (a)(2) to (4).
Subsec. (b)(1), (2).
Statutory Notes and Related Subsidiaries
Effective Date of 1997 Amendment
Amendment by
Effective Date of 1989 Amendment
Amendment by
Effective Date of 1988 Amendment
Amendment by section 102 of
Effective Date of 1986 Amendment
Effective Date of 1982 Amendment
Amendment by
Effective Date of 1981 Amendment
Effective Date of 1968 Amendment
Amendment by section 129(c)(3), (4) of
Amendment by section 137(b) of
Repeal of 1988 Expansion of Medicare Part A Benefits
"(a)
"(1)
"(2)
"(b)
"(1)
"(A) no day before January 1, 1990, shall be counted in determining the beginning (or period) of a spell of illness;
"(B) with respect to the limitation (other than the limitation under section 1812(c) of such Act [
"(C) the limitation of coverage of extended care services to post-hospital extended care services shall not apply to an individual receiving such services from a skilled nursing facility during a continuous period beginning before (and including) January 1, 1990, until the end of the period of 30 consecutive days in which the individual is not provided inpatient hospital services or extended care services; and
"(D) the inpatient hospital deductible under section 1813(a)(1) of such Act [
"(i) in the case of an individual who is receiving inpatient hospital services during a continuous period beginning before (and including) January 1, 1990, with respect to the spell of illness beginning on such date, if such a deductible was imposed on the individual for a period of hospitalization during 1989;
"(ii) for a spell of illness beginning during January 1990, if such a deductible was imposed on the individual for a period of hospitalization that began in December 1989; and
"(iii) in the case of a spell of illness of an individual that began before January 1, 1990.
"(2)
[
Hold Harmless Provisions; Application of Subsection (a)(1) and (2)
"(1)(A) section 1813(a)(1) of such Act [subsec. (a)(1) of this section] (as amended by this subtitle [subtitle A (§§101–104) of title I of
"(B) if that individual begins a period of hospitalization (as defined in such section) during 1989 after the end of that spell of illness, the first period of hospitalization during 1989 that begins after that spell of illness shall be considered to be (for purposes of such section) the first period of hospitalization that begins during that year; and
"(2) the amount of any deductible under section 1813(a)(2) of such Act (as amended by this subtitle) shall be reduced during that spell of illness during 1989 to the extent the deductible under such section was applied during the spell of illness."
Promulgation of New Deductible
§1395f. Conditions of and limitations on payment for services
(a) Requirement of requests and certifications
Except as provided in subsections (d) and (g) and in
(1) written request, signed by such individual, except in cases in which the Secretary finds it impracticable for the individual to do so, is filed for such payment in such form, in such manner, and by such person or persons as the Secretary may by regulation prescribe, no later than the close of the period ending 1 calendar year after the date of service;
(2) a physician, or, in the case of services described in subparagraph (B), a physician, or a nurse practitioner, a clinical nurse specialist, or a physician assistant (as those terms are defined in
(A) in the case of inpatient psychiatric hospital services, such services are or were required to be given on an inpatient basis, by or under the supervision of a physician, for the psychiatric treatment of an individual; and (i) such treatment can or could reasonably be expected to improve the condition for which such treatment is or was necessary or (ii) inpatient diagnostic study is or was medically required and such services are or were necessary for such purposes;
(B) in the case of post-hospital extended care services, such services are or were required to be given because the individual needs or needed on a daily basis skilled nursing care (provided directly by or requiring the supervision of skilled nursing personnel) or other skilled rehabilitation services, which as a practical matter can only be provided in a skilled nursing facility on an inpatient basis, for any of the conditions with respect to which he was receiving inpatient hospital services (or services which would constitute inpatient hospital services if the institution met the requirements of paragraphs (6) and (9) of
(C) in the case of home health services, such services are or were required because the individual is or was confined to his home (except when receiving items and services referred to in
(D) in the case of inpatient hospital services in connection with the care, treatment, filling, removal, or replacement of teeth or structures directly supporting teeth, the individual, because of his underlying medical condition and clinical status or because of the severity of the dental procedure, requires hospitalization in connection with the provision of such services;
(3) with respect to inpatient hospital services (other than inpatient psychiatric hospital services) which are furnished over a period of time, a physician certifies that such services are required to be given on an inpatient basis for such individual's medical treatment, or that inpatient diagnostic study is medically required and such services are necessary for such purpose, except that (A) such certification shall be furnished only in such cases, with such frequency, and accompanied by such supporting material, appropriate to the cases involved, as may be provided by regulations, and (B) the first such certification required in accordance with clause (A) shall be furnished no later than the 20th day of such period;
(4) in the case of inpatient psychiatric hospital services, the services are those which the records of the hospital indicate were furnished to the individual during periods when he was receiving (A) intensive treatment services, (B) admission and related services necessary for a diagnostic study, or (C) equivalent services;
(5) with respect to inpatient hospital services furnished such individual after the 20th day of a continuous period of such services, there was not in effect, at the time of admission of such individual to the hospital, a decision under
(6) with respect to inpatient hospital services or post-hospital extended care services furnished such individual during a continuous period, a finding has not been made (by the physician members of the committee or group, as described in
(7) in the case of hospice care provided an individual—
(A)(i) in the first 90-day period—
(I) the individual's attending physician (as defined in
(II) the medical director (or physician member of the interdisciplinary group described in
each certify in writing at the beginning of the period, that the individual is terminally ill (as defined in
(ii) in a subsequent 90- or 60-day period, the medical director or physician described in clause (i)(II) recertifies at the beginning of the period that the individual is terminally ill based on such clinical judgment;
(B) a written plan for providing hospice care with respect to such individual has been established (before such care is provided by, or under arrangements made by, that hospice program) and is periodically reviewed by the individual's attending physician and by the medical director (and the interdisciplinary group described in
(C) such care is being or was provided pursuant to such plan of care;
(D) on and after January 1, 2011 (and, in the case of clause (ii), before October 6, 2014)—
(i)(I) subject to subclause (II), a hospice physician or nurse practitioner has a face-to-face encounter with the individual to determine continued eligibility of the individual for hospice care prior to the 180th-day recertification and each subsequent recertification under subparagraph (A)(ii) and attests that such visit took place (in accordance with procedures established by the Secretary); and
(II) during the emergency period described in
(ii) in the case of hospice care provided an individual for more than 180 days by a hospice program for which the number of such cases for such program comprises more than a percent (specified by the Secretary) of the total number of such cases for all programs under this subchapter, the hospice care provided to such individual is medically reviewed (in accordance with procedures established by the Secretary); and
(E) on and after October 6, 2014, in the case of hospice care provided an individual for more than 180 days by a hospice program for which the number of such cases for such program comprises more than a percent (specified by the Secretary) of the total number of all cases of individuals provided hospice care by the program under this subchapter, the hospice care provided to such individual is medically reviewed (in accordance with procedures established by the Secretary); and
(8) in the case of inpatient critical access hospital services, a physician certifies that the individual may reasonably be expected to be discharged or transferred to a hospital within 96 hours after admission to the critical access hospital.
To the extent provided by regulations, the certification and recertification requirements of paragraph (2) shall be deemed satisfied where, at a later date, a physician, nurse practitioner, clinical nurse specialist, or physician assistant (as the case may be) makes certification of the kind provided in subparagraph (A), (B), (C), or (D) of paragraph (2) (whichever would have applied), but only where such certification is accompanied by such medical and other evidence as may be required by such regulations. With respect to the certification required by paragraph (2) for home health services furnished to any individual by a home health agency (other than an agency which is a governmental entity) and with respect to the establishment and review of a plan for such services, the Secretary shall prescribe regulations which shall become effective no later than July 1, 1981 (or in the case of regulations to implement the amendments made by section 3708 of the CARES Act, the Secretary shall prescribe regulations, which shall become effective no later than 6 months after March 27, 2020), and which prohibit a physician, nurse practitioner, clinical nurse specialist, or physician assistant who has a significant ownership interest in, or a significant financial or contractual relationship with, such home health agency from performing such certification and from establishing or reviewing such plan, except that such prohibition shall not apply with respect to a home health agency which is a sole community home health agency (as determined by the Secretary). For purposes of the preceding sentence, service by a physician, nurse practitioner, clinical nurse specialist, or physician assistant as an uncompensated officer or director of a home health agency shall not constitute having a significant ownership interest in, or a significant financial or contractual relationship with, such agency. For purposes of documentation for physician certification and recertification made under paragraph (2) on or after January 1, 2019 or no later than 6 months after March 27, 2020, for purposes of documentation for certification and recertification made under paragraph (2) by a nurse practitioner, clinical nurse specialist, or physician assistant,,1 and made with respect to home health services furnished by a home health agency, in addition to using documentation in the medical record of the physician, nurse practitioner, clinical nurse specialist, or physician assistant who so certifies or the medical record of the acute or post-acute care facility (in the case that home health services were furnished to an individual who was directly admitted to the home health agency from such a facility), the Secretary may use documentation in the medical record of the home health agency as supporting material, as appropriate to the case involved. For purposes of paragraph (2)(C), an individual shall be considered to be "confined to his home" if the individual has a condition, due to an illness or injury, that restricts the ability of the individual to leave his or her home except with the assistance of another individual or the aid of a supportive device (such as crutches, a cane, a wheelchair, or a walker), or if the individual has a condition such that leaving his or her home is medically contraindicated. While an individual does not have to be bedridden to be considered "confined to his home", the condition of the individual should be such that there exists a normal inability to leave home and that leaving home requires a considerable and taxing effort by the individual. Any absence of an individual from the home attributable to the need to receive health care treatment, including regular absences for the purpose of participating in therapeutic, psychosocial, or medical treatment in an adult day-care program that is licensed or certified by a State, or accredited, to furnish adult day-care services in the State shall not disqualify an individual from being considered to be "confined to his home". Any other absence of an individual from the home shall not so disqualify an individual if the absence is of infrequent or of relatively short duration. For purposes of the preceding sentence, any absence for the purpose of attending a religious service shall be deemed to be an absence of infrequent or short duration. In applying paragraph (1), the Secretary may specify exceptions to the 1 calendar year period specified in such paragraph.
(b) Amount paid to provider of services
The amount paid to any provider of services (other than a hospice program providing hospice care, other than a critical access hospital providing inpatient critical access hospital services, and other than a home health agency with respect to durable medical equipment) with respect to services for which payment may be made under this part shall, subject to the provisions of
(1) except as provided in paragraph (3), the lesser of (A) the reasonable cost of such services, as determined under
(2) if such services are furnished by a public provider of services, or by another provider which demonstrates to the satisfaction of the Secretary that a significant portion of its patients are low-income (and requests that payment be made under this paragraph), free of charge or at nominal charges to the public, the amount determined on the basis of those items (specified in regulations prescribed by the Secretary) included in the determination of such reasonable cost which the Secretary finds will provide fair compensation to such provider for such services; or
(3) if some or all of the hospitals in a State have been reimbursed for services (for which payment may be made under this part) pursuant to a reimbursement system approved as a demonstration project under section 402 of the Social Security Amendments of 1967 or section 222 of the Social Security Amendments of 1972, if the rate of increase in such hospitals in their costs per hospital inpatient admission of individuals entitled to benefits under this part over the duration of such project was equal to or less than such rate of increase for admissions of such individuals with respect to all hospitals in the United States during such period, and if either the State has legislative authority to operate such system and the State elects to have reimbursement to such hospitals made in accordance with this paragraph or the system is operated through a voluntary agreement of hospitals and such hospitals elect to have reimbursement to those hospitals made in accordance with this paragraph, then, subject to section 1395ww(d)(3)(B)(ix)(III) 2 of this title, the Secretary may provide for continuation of reimbursement to such hospitals under such system until the Secretary determines that—
(A) a third-party payor reimburses such a hospital on a basis other than under such system, or
(B) the aggregate rate of increase from January 1, 1981, to the most recent date for which annual data are available in such hospitals in costs per hospital inpatient admission of individuals entitled to benefits under this part is greater than such rate of increase for admissions of such individuals with respect to all hospitals in the United States for such period.
In the case of any State which has had such a demonstration project reimbursement system in continuous operation since July 1, 1977, the Secretary shall provide under paragraph (3) for continuation of reimbursement to hospitals in the State under such system until the first day of the 37th month beginning after the date the Secretary determines and notifies the Governor of the State that either of the conditions described in subparagraph (A) or (B) of such paragraph has occurred. If, by the end of such 36-month period, the Secretary determines, based on evidence submitted by the Governor of the State, that neither of the conditions described in subparagraph (A) or (B) of paragraph (3) continues to apply, the Secretary shall continue without interruption payment to hospitals in the State under the State's system. If, by the end of such 36-month period, the Secretary determines, based on such evidence, that either of the conditions described in subparagraph (A) or (B) of such paragraph continues to apply, the Secretary shall (i) collect any net excess reimbursement to hospitals in the State during such 36-month period (basing such net excess reimbursement on the net difference, if any, in the rate of increase in costs per hospital inpatient admission under the State system compared to the rate of increase in such costs with respect to all hospitals in the United States over the 36-month period, as measured by including the cumulative savings under the State system based on the difference in the rate of increase in costs per hospital inpatient admission under the State system as compared to the rate of increase in such costs with respect to all hospitals in the United States between January 1, 1981, and the date of the Secretary's initial notice), and (ii) provide a reasonable period, not to exceed 2 years, for transition from the State system to the national payment system. For purposes of applying paragraph (3), there shall be taken into account incentive payments, and payment adjustments under subsection (b)(3)(B)(ix) or (n) of
(c) No payments to Federal providers of services
Subject to
(d) Payments for emergency hospital services
(1) Payments shall also be made to any hospital for inpatient hospital services furnished in a calendar year, by the hospital or under arrangements (as defined in
(2) Payment may be made on the basis of an itemized bill to an individual entitled to hospital insurance benefits under
(3) The amounts payable under the preceding paragraph with respect to services described therein shall, subject to the provisions of
(e) Payment for inpatient hospital services prior to notification of noneligibility
Notwithstanding that an individual is not entitled to have payment made under this part for inpatient hospital services furnished by any hospital, payment shall be made to such hospital (unless it elects not to receive such payment or, if payment has already been made by or on behalf of such individual, fails to refund such payment within the time specified by the Secretary) for such services which are furnished to the individual prior to notification to such hospital from the Secretary of his lack of entitlement, if such payments are precluded only by reason of
(f) Payment for certain inpatient hospital services furnished outside United States
(1) Payment shall be made for inpatient hospital services furnished to an individual entitled to hospital insurance benefits under
(A) such individual is a resident of the United States, and
(B) such hospital was closer to, or substantially more accessible from, the residence of such individual than the nearest hospital within the United States which was adequately equipped to deal with, and was available for the treatment of, such individual's illness or injury.
(2) Payment may also be made for emergency inpatient hospital services furnished to an individual entitled to hospital insurance benefits under
(A) such individual was physically present—
(i) in a place within the United States; or
(ii) at a place within Canada while traveling without unreasonable delay by the most direct route (as determined by the Secretary) between Alaska and another State;
at the time the emergency which necessitated such inpatient hospital services occurred, and
(B) such hospital was closer to, or substantially more accessible from, such place than the nearest hospital within the United States which was adequately equipped to deal with, and was available for the treatment of, such individual's illness or injury.
(3) Payment shall be made in the amount provided under subsection (b) to any hospital for the inpatient hospital services described in paragraph (1) or (2) furnished to an individual by the hospital or under arrangements (as defined in
(4) Payment for the inpatient hospital services described in paragraph (1) or (2) furnished to an individual entitled to hospital insurance benefits under
(g) Payments to physicians for services rendered in teaching hospitals
For purposes of services for which the reasonable cost thereof is determined under
(1) such hospital has an agreement with the Secretary under
(2) the Secretary has received written assurances that (A) such payment will be used by such fund solely for the improvement of care of hospital patients or for educational or charitable purposes and (B) the individuals who were furnished such services or any other persons will not be charged for such services (or if charged, provision will be made for return of any moneys incorrectly collected).
(h) Payment for specified hospital services provided in Department of Veterans Affairs hospitals; amount of payment
(1) Payments shall also be made to any hospital operated by the Department of Veterans Affairs for inpatient hospital services furnished in a calendar year by the hospital, or under arrangements (as defined in
(2) Payment for services described in paragraph (1) shall be in an amount equal to the charge imposed by the Secretary of Veterans Affairs for such services, or (if less) the amount that would be payable for such services under subsection (b) and
(i) Payment for hospice care
(1)(A) Subject to the limitation under paragraph (2) and the provisions of
(B) Notwithstanding subparagraph (A), for hospice care furnished on or after April 1, 1986, the daily rate of payment per day for routine home care shall be $63.17 and the daily rate of payment for other services included in hospice care shall be the daily rate of payment recognized under subparagraph (A) as of July 1, 1985, increased by $10.
(C)(i) With respect to routine home care and other services included in hospice care furnished on or after January 1, 1990, and on or before September 30, 1990, the payment rates for such care and services shall be 120 percent of such rates in effect as of September 30, 1989.
(ii) With respect to routine home care and other services included in hospice care furnished during a subsequent fiscal year (before the first fiscal year in which the payment revisions described in paragraph (6)(D) are implemented), the payment rates for such care and services shall be the payment rates in effect under this subparagraph during the previous fiscal year increased by—
(I) for a fiscal year ending on or before September 30, 1993, the market basket percentage increase (as defined in
(II) for fiscal year 1994, the market basket percentage increase for the fiscal year minus 2.0 percentage points;
(III) for fiscal year 1995, the market basket percentage increase for the fiscal year minus 1.5 percentage points;
(IV) for fiscal year 1996, the market basket percentage increase for the fiscal year minus 1.5 percentage points;
(V) for fiscal year 1997, the market basket percentage increase for the fiscal year minus 0.5 percentage point;
(VI) for each of fiscal years 1998 through 2002, the market basket percentage increase for the fiscal year involved minus 1.0 percentage points, plus, in the case of fiscal year 2001, 5.0 percentage points; and
(VII) for a subsequent fiscal year (before the first fiscal year in which the payment revisions described in paragraph (6)(D) are implemented), subject to clauses (iv) and (vi), the market basket percentage increase for the fiscal year.
(iii) With respect to routine home care and other services included in hospice care furnished during fiscal years subsequent to the first fiscal year in which payment revisions described in paragraph (6)(D) are implemented, the payment rates for such care and services shall be the payment rates in effect under this clause during the preceding fiscal year increased by, subject to clauses (iv) and (vi), the market basket percentage increase (as defined in
(iv) Subject to clause (vi), after determining the market basket percentage increase under clause (ii)(VII) or (iii), as applicable, with respect to fiscal year 2013 and each subsequent fiscal year, the Secretary shall reduce such percentage—
(I) for 2013 and each subsequent fiscal year, by the productivity adjustment described in
(II) subject to clause (v), for each of fiscal years 2013 through 2019, by 0.3 percentage point.
The application of this clause may result in the market basket percentage increase under clause (ii)(VII) or (iii), as applicable, being less than 0.0 for a fiscal year, and may result in payment rates under this subsection for a fiscal year being less than such payment rates for the preceding fiscal year.
(v) Clause (iv)(II) shall be applied with respect to any of fiscal years 2014 through 2019 by substituting "0.0 percentage points" for "0.3 percentage point", if for such fiscal year—
(I) the excess (if any) of—
(aa) the total percentage of the non-elderly insured population for the preceding fiscal year (based on the most recent estimates available from the Director of the Congressional Budget Office before a vote in either House on the Patient Protection and Affordable Care Act that, if determined in the affirmative, would clear such Act for enrollment); over
(bb) the total percentage of the non-elderly insured population for such preceding fiscal year (as estimated by the Secretary); exceeds
(II) 5 percentage points.
(vi) For fiscal year 2018, the market basket percentage increase under clause (ii)(VII) or (iii), as applicable, after application of clause (iv), shall be 1 percent.
(2)(A) The amount of payment made under this part for hospice care provided by (or under arrangements made by) a hospice program for an accounting year may not exceed the "cap amount" for the year (computed under subparagraph (B)) multiplied by the number of medicare beneficiaries in the hospice program in that year (determined under subparagraph (C)).
(B)(i) Except as provided in clause (ii), for purposes of subparagraph (A), the "cap amount" for a year is $6,500, increased or decreased, for accounting years that end after October 1, 1984, by the same percentage as the percentage increase or decrease, respectively, in the medical care expenditure category of the Consumer Price Index for All Urban Consumers (United States city average), published by the Bureau of Labor Statistics, from March 1984 to the fifth month of the accounting year.
(ii) For purposes of subparagraph (A) for accounting years that end after September 30, 2016, and before October 1, 2033, the "cap amount" is the cap amount under this subparagraph for the preceding accounting year updated by the percentage update to payment rates for hospice care under paragraph (1)(C) for services furnished during the fiscal year beginning on the October 1 preceding the beginning of the accounting year (including the application of any productivity or other adjustment under clause (iv) of that paragraph).
(iii) For accounting years that end after September 30, 2033, the cap amount shall be computed under clause (i) as if clause (ii) had never applied.
(C) For purposes of subparagraph (A), the "number of medicare beneficiaries" in a hospice program in an accounting year is equal to the number of individuals who have made an election under subsection (d) with respect to the hospice program and have been provided hospice care by (or under arrangements made by) the hospice program under this part in the accounting year, such number reduced to reflect the proportion of hospice care that each such individual was provided in a previous or subsequent accounting year or under a plan of care established by another hospice program.
(D) A hospice program shall submit claims for payment for hospice care furnished in an individual's home under this subchapter only on the basis of the geographic location at which the service is furnished, as determined by the Secretary.
(3) Hospice programs providing hospice care for which payment is made under this subsection shall submit to the Secretary such data with respect to the costs for providing such care for each fiscal year, beginning with fiscal year 1999, as the Secretary determines necessary.
(4) The amount paid to a hospice program with respect to the services under
(5)
(A)
(i)
(ii)
(B)
(C)
(D)
(i)
(ii)
(iii)
(E)
(6)(A) The Secretary shall collect additional data and information as the Secretary determines appropriate to revise payments for hospice care under this subsection pursuant to subparagraph (D) and for other purposes as determined appropriate by the Secretary. The Secretary shall begin to collect such data by not later than January 1, 2011.
(B) The additional data and information to be collected under subparagraph (A) may include data and information on—
(i) charges and payments;
(ii) the number of days of hospice care which are attributable to individuals who are entitled to, or enrolled for, benefits under this part; and
(iii) with respect to each type of service included in hospice care—
(I) the number of days of hospice care attributable to the type of service;
(II) the cost of the type of service; and
(III) the amount of payment for the type of service;
(iv) charitable contributions and other revenue of the hospice program;
(v) the number of hospice visits;
(vi) the type of practitioner providing the visit; and
(vii) the length of the visit and other basic information with respect to the visit.
(C) The Secretary may collect the additional data and information under subparagraph (A) on cost reports, claims, or other mechanisms as the Secretary determines to be appropriate.
(D)(i) Notwithstanding the preceding paragraphs of this subsection, not earlier than October 1, 2013, the Secretary shall, by regulation, implement revisions to the methodology for determining the payment rates for routine home care and other services included in hospice care under this part, as the Secretary determines to be appropriate. Such revisions may be based on an analysis of data and information collected under subparagraph (A). Such revisions may include adjustments to per diem payments that reflect changes in resource intensity in providing such care and services during the course of the entire episode of hospice care.
(ii) Revisions in payment implemented pursuant to clause (i) shall result in the same estimated amount of aggregate expenditures under this subchapter for hospice care furnished in the fiscal year in which such revisions in payment are implemented as would have been made under this subchapter for such care in such fiscal year if such revisions had not been implemented.
(E) The Secretary shall consult with hospice programs and the Medicare Payment Advisory Commission regarding the additional data and information to be collected under subparagraph (A) and the payment revisions under subparagraph (D).
(7) In the case of hospice care provided by a hospice program under arrangements under
(j) Elimination of lesser-of-cost-or-charges provision
(1) The lesser-of-cost-or-charges provisions (described in paragraph (2)) will not apply in the case of services provided by a class of provider of services if the Secretary determines and certifies to Congress that the failure of such provisions to apply to the services provided by that class of providers will not result in any increase in the amount of payments made for those services under this subchapter. Such change will take effect with respect to services furnished, or cost reporting periods of providers, on or after such date as the Secretary shall provide in the certification. Such change for a class of provider shall be discontinued if the Secretary determines and notifies Congress that such change has resulted in an increase in the amount of payments made under this subchapter for services provided by that class of provider.
(2) The lesser-of-cost-or-charges provisions referred to in paragraph (1) are as follows:
(A) Clause (B) of paragraph (1) and paragraph (2) of subsection (b).
(B)
(C) So much of subparagraph (A) of
(D) Subclause (II) of clause (i) and clause (ii) of
(k) Payments to home health agencies for durable medical equipment
The amount paid to any home health agency with respect to durable medical equipment for which payment may be made under this part shall be the amount described in
(l) Payment for inpatient critical access hospital services
(1) Except as provided in the subsequent paragraphs of this subsection, the amount of payment under this part for inpatient critical access hospital services is equal to 101 percent of the reasonable costs of the critical access hospital in providing such services.
(2) In the case of a distinct part psychiatric or rehabilitation unit of a critical access hospital described in
(3)(A) The following rules shall apply in determining payment and reasonable costs under paragraph (1) for costs described in subparagraph (C) for a critical access hospital that would be a meaningful EHR user (as would be determined under paragraph (3) of
(i) The Secretary shall compute reasonable costs by expensing such costs in a single payment year and not depreciating such costs over a period of years (and shall include as costs with respect to cost reporting periods beginning during a payment year costs from previous cost reporting periods to the extent they have not been fully depreciated as of the period involved).
(ii) There shall be substituted for the Medicare share that would otherwise be applied under paragraph (1) a percent (not to exceed 100 percent) equal to the sum of—
(I) the Medicare share (as would be specified under paragraph (2)(D) of
(II) 20 percentage points.
(B) The payment under this paragraph with respect to a critical access hospital shall be paid through a prompt interim payment (subject to reconciliation) after submission and review of such information (as specified by the Secretary) necessary to make such payment, including information necessary to apply this paragraph. In no case may payment under this paragraph be made with respect to a cost reporting period beginning during a payment year after 2015 and in no case may a critical access hospital receive payment under this paragraph with respect to more than 4 consecutive payment years.
(C) The costs described in this subparagraph are costs for the purchase of certified EHR technology to which purchase depreciation (excluding interest) would apply if payment was made under paragraph (1) and not under this paragraph.
(D) For purposes of this paragraph, paragraph (4), and paragraph (5), the terms "certified EHR technology", "eligible hospital", "EHR reporting period", and "payment year" have the meanings given such terms in
(4)(A) Subject to subparagraph (C), for cost reporting periods beginning in fiscal year 2015 or a subsequent fiscal year, in the case of a critical access hospital that is not a meaningful EHR user (as would be determined under paragraph (3) of
(B) The percent described in this subparagraph is—
(i) for fiscal year 2015, 100.66 percent;
(ii) for fiscal year 2016, 100.33 percent; and
(iii) for fiscal year 2017 and each subsequent fiscal year, 100 percent.
(C) The provisions of subclause (II) of
(5) There shall be no administrative or judicial review under
(A) the methodology and standards for determining the amount of payment and reasonable cost under paragraph (3) and payment adjustments under paragraph (4), including selection of periods under
(B) the methodology and standards for determining a meaningful EHR user under
(C) the specification of EHR reporting periods under section 1395ww(n)(6)(B) 4 of this title as applied under paragraphs (3) and (4); and
(D) the identification of costs for purposes of paragraph (3)(C).
(Aug. 14, 1935, ch. 531, title XVIII, §1814, as added
Editorial Notes
References in Text
The amendments made by section 3708 of the CARES Act, referred to in subsec. (a), are the amendments made by section 3708 of
Section 402 of the Social Security Amendments of 1967, referred to in subsec. (b)(3), means section 402 of
Section 222 of the Social Security Amendments of 1972, referred to in subsec. (b)(3), means section 222 of
The Patient Protection and Affordable Care Act, referred to in subsec. (i)(1)(C)(v)(I)(aa), is
The matter following clause (v) of
Amendments
2025—Subsec. (a)(7)(D)(i)(II).
2024—Subsec. (a)(7)(D)(i)(II).
Subsec. (i)(2)(B)(ii), (iii).
2022—Subsec. (a)(7)(D)(i)(II).
Subsec. (i)(2)(B)(ii), (iii).
2020—Subsec. (a).
Subsec. (a)(2).
Subsec. (a)(2)(C).
Subsec. (a)(7)(D)(i).
Subsec. (i)(2)(B)(ii), (iii).
Subsec. (i)(5)(A)(i).
2018—Subsec. (a).
Subsec. (a)(7)(A)(i)(I).
2015—Subsec. (i)(1)(C)(ii)(VII).
Subsec. (i)(1)(C)(iii).
Subsec. (i)(1)(C)(iv).
Subsec. (i)(1)(C)(vi).
Subsec. (i)(5)(A)(i).
2014—Subsec. (a)(7)(D).
Subsec. (a)(7)(E).
Subsec. (i)(2)(B).
2010—Subsec. (a).
Subsec. (a)(1).
Subsec. (a)(2).
Subsec. (a)(2)(C).
Subsec. (a)(7)(D).
Subsec. (i)(1)(C)(ii).
Subsec. (i)(1)(C)(ii)(VII).
Subsec. (i)(1)(C)(iii).
Subsec. (i)(1)(C)(iv).
Subsec. (i)(1)(C)(iv)(II).
Subsec. (i)(1)(C)(v).
Subsec. (i)(5).
Subsec. (i)(6).
Subsec. (i)(7).
2009—Subsec. (b).
Subsec. (b)(3).
Subsec. (l)(1).
Subsec. (l)(3) to (5).
2003—Subsec. (a).
Subsec. (a)(7)(A)(i).
Subsec. (a)(7)(A)(i)(I).
Subsec. (a)(7)(A)(ii).
Subsec. (b).
Subsec. (i)(4).
Subsec. (i)(5).
Subsec. (l).
2000—Subsec. (a).
Subsec. (a)(7)(A)(ii).
Subsec. (i)(1)(C)(ii)(VI).
1997—Subsec. (a)(2)(C).
Subsec. (a)(7)(A)(i).
Subsec. (a)(7)(A)(ii).
Subsec. (a)(7)(A)(iii).
Subsec. (a)(8).
Subsec. (b).
Subsec. (i)(1)(C)(ii)(V) to (VII).
Subsec. (i)(2)(D).
Subsec. (i)(3).
Subsec. (l).
"(1) The amount of payment under this part for inpatient rural primary care hospital services—
"(A) in the case of the first 12-month cost reporting period for which the facility operates as such a hospital, is the reasonable costs of the facility in providing inpatient rural primary care hospital services during such period, as such costs are determined on a per diem basis, and
"(B) in the case of a later reporting period, is the per diem payment amount established under this paragraph for the preceding 12-month cost reporting period, increased by the applicable percentage increase under
The payment amounts otherwise determined under this paragraph shall be reduced, to the extent necessary, to avoid duplication of any payment made under
"(2) The Secretary shall develop a prospective payment system for determining payment amounts for inpatient rural primary care hospital services under this part furnished on or after January 1, 1996."
1994—Subsec. (a)(5).
Subsec. (a)(8).
Subsec. (i)(1)(C)(i).
Subsec. (l)(2).
1993—Subsec. (i)(1)(C)(ii).
1991—Subsec. (h).
1990—Subsec. (a)(7)(A)(iii).
Subsec. (b)(3).
Subsec. (i)(1)(C)(i).
1989—Subsec. (a).
Subsec. (a)(2).
Subsec. (a)(2)(B), (6).
Subsec. (a)(7)(A)(i).
Subsec. (a)(7)(A)(iii).
Subsec. (a)(8).
Subsec. (b).
Subsec. (d)(3).
Subsec. (i)(1)(A).
Subsec. (i)(1)(C).
Subsec. (l).
1988—Subsec. (a)(2)(B).
Subsec. (a)(6).
Subsec. (a)(7)(A)(iii).
Subsec. (d)(3).
1987—Subsec. (a).
Subsec. (b)(3)(B).
Subsec. (j)(2)(B).
Subsec. (k).
"(1) the lesser of—
"(A) the reasonable cost of such equipment, as determined under
"(B) the customary charges with respect to such equipment,
less the amount the home health agency may charge as described in
"(2) if such equipment is furnished by a public home health agency, or by another home health agency which demonstrates to the satisfaction of the Secretary that a significant portion of its patients are low-income (and requests that payment be made under this paragraph), free of charge or at nominal charge to the public, 80 percent of the amount which the Secretary finds will provide fair compensation to the home health agency."
1986—Subsec. (i)(1)(B).
Subsec. (i)(1)(C).
1984—Subsec. (a).
Subsec. (a)(2)(B) to (E).
Subsec. (a)(3).
Subsec. (a)(5) to (8).
Subsec. (b).
Subsec. (b)(2).
Subsec. (b)(3).
Subsec. (i)(1).
Subsec. (j)(2)(B) to (D).
Subsec. (k).
Subsec. (k)(2).
1983—Subsec. (g).
Subsec. (h)(2).
Subsec. (i)(1).
Subsec. (i)(2)(A).
Subsec. (i)(2)(B).
Subsec. (j).
Subsec. (j)(2)(A).
1982—Subsec. (a)(8).
Subsec. (b).
Subsec. (i).
1981—Subsec. (a)(2)(D).
Subsec. (a)(2)(F).
1980—Subsec. (a).
Subsec. (a)(2)(D).
Subsec. (a)(2)(E).
Subsec. (a)(2)(F).
Subsec. (b)(1).
Subsec. (b)(3).
Subsec. (c).
Subsecs. (h) to (j).
1978—Subsec. (b)(1).
1977—Subsec. (c).
Subsec. (j).
1976—Subsec. (c).
1973—Subsec. (a)(2)(E).
Subsec. (a), last sentence.
1972—Subsec. (a).
Subsec. (a)(1).
Subsec. (a)(2)(C).
Subsec. (a)(2)(D).
Subsec. (a)(2)(E).
Subsec. (a)(6).
Subsec. (a)(7).
Subsec. (b).
Subsec. (f).
Subsec. (g).
Subsec. (h).
Subsec. (i).
1968—Subsec. (a).
Subsec. (a)(2)(A) to (E).
Subsec. (a)(2)(F).
Subsec. (a)(3) to (7).
Subsec. (d).
Subsec. (d)(1) to (3).
Statutory Notes and Related Subsidiaries
Effective Date of 2020 Amendment
Effective Date of 2018 Amendment
Effective Date of 2010 Amendment
"(1)
"(2)
Effective Date of 2003 Amendment
Amendment by section 512(b) of
Effective Date of 2000 Amendment
Effective Date of 1997 Amendment
Amendment by sections 4441, 4443(b)(2), and 4448 of
Amendment by section 4603(c)(1) of
Effective Date of 1994 Amendment
Amendment by section 106(b)(1)(A) of
Effective Date of 1990 Amendment
Amendment by section 4006(b) of
Effective Date of 1989 Amendment
Amendment by
Effective Date of 1988 Amendment
Amendment by
Effective Date of 1987 Amendment
[
Effective Date of 1984 Amendment
Amendment by section 2354(b)(1) of
Amendment by section 2354(c)(1)(A) of
Effective Date of 1983 Amendment
Amendment by
Amendment by
Effective Date of 1982 Amendment
Amendment by section 122(c)(1), (2) of
Effective Date of 1981 Amendment
Amendment by section 2121(b) of
Effective Date of 1980 Amendment
Amendment by section 930(e), (f) of
Amendment by section 931(b) of
Effective Date of 1978 Amendment
Amendment by
Effective Date of 1977 Amendment
Effective Date of 1973 Amendment
Effective Date of 1972 Amendment
Amendment by section 226(c)(1) of
Amendment by section 227(b) of
Amendment by section 234(g)(1) of
Amendment by section 281(e) of
Effective Date of 1968 Amendment
Amendment by section 129(c)(5), (6)(A) of
Amendment by section 143(c) of
Revision of Regulations Regarding Access to Home Health Services
Promulgation of Regulations
Section 122(h)(2) of
"(A) a description of the care included in 'hospice care' and the standards for qualification of a 'hospice program', under section 1861(dd) of the Social Security Act [
"(B) the standards for payment for hospice care under part A of title XVIII of such Act [
Implementation of 2022 Amendment
Application to Medicaid
Application of 2010 Amendment
Study and Report on Effect of 2000 Amendment
"(1)
"(2)
Study and Report on Physician Certification Requirement for Hospice Benefits
"(1)
"(2)
Temporary Increase in Payment for Hospice Care
"(a)
"(1) fiscal year 2001, by 0.5 percent, and
"(2) fiscal year 2002, by 0.75 percent.
"(b)
Study and Report to Congress Regarding Modification of Payment Rates for Hospice Care
Study of Methods To Compensate Hospices for High-Cost Care
Continuation of Bad Debt Recognition for Hospital Services
[
[
Providers of Services To Calculate and Report Lesser-of-Cost-or-Charges Determinations Separately With Respect to Payments Under Parts A and B of This Subchapter; Issuance of Regulations
Determination of Nominal Charges for Applying Nominality Test
Study and Report Relating to the Reimbursement Method and Benefit Structure for Hospice Care; Supervision of Report by Comptroller General
Waiver of Limitations To Allow Pre-Existing Hospices To Participate as a Hospice Program
Medicare Payment Basis for Services Provided by Agencies and Providers; Effective Date
2 So in original. Probably should be "1395ww(b)(3)(B)(ix)(III)".
3 See References in Text note below.
4 So in original. Probably should be "1395ww(n)(3)(B)".
§1395g. Payments to providers of services
(a) Determination of amount
The Secretary shall periodically determine the amount which should be paid under this part to each provider of services with respect to the services furnished by it, and the provider of services shall be paid, at such time or times as the Secretary believes appropriate (but not less often than monthly) and prior to audit or settlement by the Government Accountability Office, from the Federal Hospital Insurance Trust Fund, the amounts so determined, with necessary adjustments on account of previously made overpayments or underpayments; except that no such payments shall be made to any provider unless it has furnished such information as the Secretary may request in order to determine the amounts due such provider under this part for the period with respect to which the amounts are being paid or any prior period.
(b) Conditions
No payment shall be made to a provider of services which is a hospital for or with respect to services furnished by it for any period with respect to which it is deemed, under
(c) Payments under assignment or power of attorney
No payment which may be made to a provider of services under this subchapter for any service furnished to an individual shall be made to any other person under an assignment or power of attorney; but nothing in this subsection shall be construed (1) to prevent the making of such a payment in accordance with an assignment from the provider if such assignment is made to a governmental agency or entity or is established by or pursuant to the order of a court of competent jurisdiction, or (2) to preclude an agent of the provider of services from receiving any such payment if (but only if) such agent does so pursuant to an agency agreement under which the compensation to be paid to the agent for his services for or in connection with the billing or collection of payments due such provider under this subchapter is unrelated (directly or indirectly) to the amount of such payments or the billings therefor, and is not dependent upon the actual collection of any such payment.
(d) Accrual of interest on balance of excess or deficit not paid
Whenever a final determination is made that the amount of payment made under this part to a provider of services was in excess of or less than the amount of payment that is due, and payment of such excess or deficit is not made (or effected by offset) within 30 days of the date of the determination, interest shall accrue on the balance of such excess or deficit not paid or offset (to the extent that the balance is owed by or owing to the provider) at a rate determined in accordance with the regulations of the Secretary of the Treasury applicable to charges for late payments (or, in the case of such a determination made with respect to a payment made on or after March 27, 2020, and during the emergency period described in
(e) Periodic interim payments
(1) The Secretary shall provide payment under this part for inpatient hospital services furnished by a subsection (d) hospital (as defined in
(A) Upon the request of a hospital which is paid through an agency or organization with an agreement with the Secretary under
(B) In the case of a hospital that—
(i) has a disproportionate share adjustment percentage (as established in clause (iv) of such section) of at least 5.1 percent (as computed for purposes of establishing the average standardized amounts for discharges occurring during fiscal year 1987), and
(ii) requests payment on such basis,
but only if the hospital was being paid for inpatient hospital services on such a periodic interim payment basis as of June 30, 1987, and continues to meet the requirements (in effect as of October 1, 1986) applicable to payment on such a basis.
(C) In the case of a hospital that—
(i) is located in a rural area,
(ii) has 100 or fewer beds, and
(iii) requests payment on such basis,
but only if the hospital was being paid for inpatient hospital services on such a periodic interim payment basis as of June 30, 1987, and continues to meet the requirements (in effect as of October 1, 1986) applicable to payment on such a basis.
(2) The Secretary shall provide (or continue to provide) for payment on a periodic interim payment basis (under the standards established under section 405.454(j) of title 42, Code of Federal Regulations, as in effect on October 1, 1986, in the cases described in subparagraphs (A) through (D)) with respect to—
(A) inpatient hospital services of a hospital that is not a subsection (d) hospital (as defined in
(B) a hospital which is receiving payment under a State hospital reimbursement system under
(C) extended care services;
(D) hospice care; and
(E) inpatient critical access hospital services;
if the provider of such services elects to receive, and qualifies for, such payments.
(3) Subject to subsection (f), in the case of a subsection (d) hospital or a subsection (d) Puerto Rico hospital (as defined for purposes of
(4) A hospital created by the merger or consolidation of 2 or more hospitals or hospital campuses shall be eligible to receive periodic interim payment on the basis described in paragraph (1)(B) if—
(A) at least one of the hospitals or campuses received periodic interim payment on such basis prior to the merger or consolidation; and
(B) the merging or consolidating hospitals or campuses would each meet the requirement of paragraph (1)(B)(i) if such hospitals or campuses were treated as independent hospitals for purposes of this subchapter.
(f) Expansion of accelerated payment program during COVID–19 public health emergency
(1) During the emergency period described in
(2) In expanding the program under subsection (e)(3), the following shall apply:
(A)(i) In addition to the hospitals described in subsection (e)(3), the following hospitals shall be eligible to participate in the program:
(I) Hospitals described in clause (iii) of
(II) Hospitals described in clause (v) of such section.
(III) Critical access hospitals (as defined in
(ii) Subject to appropriate safeguards against fraud, waste, and abuse, upon a request of a hospital described in clause (i), the Secretary shall (or, with respect to requests submitted to the Secretary after April 26, 2020, may) provide accelerated payments under the program to such hospital.
(B) Upon the request of the hospital, the Secretary may do any of the following:
(i) Make accelerated payments on a periodic or lump sum basis.
(ii) Increase the amount of payment that would otherwise be made to hospitals under the program up to 100 percent (or, in the case of critical access hospitals, up to 125 percent).
(iii) Extend the period that accelerated payments cover so that it covers up to a 6-month period.
(C) In the case of a payment made under the terms of the program under subsection (e)(3), including such program as expanded pursuant to this subsection, on or after March 27, 2020, and so made during the emergency period described in
(i) provide 1 year before payments for items and services furnished by the hospital are offset to recoup payments under such program;
(ii) provide that any such offset be an amount equal to—
(I) during the first 11 months in which any such offsets are made with respect to payment for items and services furnished by the hospital, 25 percent of the amount of such payment for such items and services; and
(II) during the succeeding 6 months, 50 percent of the amount of such payment for such items and services; and
(iii) allow 29 months from the date of the first payment under such program to such provider before requiring that the outstanding balance be paid in full.
(3) Nothing in this subsection shall preclude the Secretary from carrying out the provisions described in clauses (i), (ii), and (iii) of paragraph (2)(B) and clauses (i) and (ii) of paragraph (2)(C) under the program under subsection (e)(3) after the period for which this subsection applies.
(4) Notwithstanding any other provision of law, the Secretary may implement the provisions of this subsection by program instruction or otherwise.
(Aug. 14, 1935, ch. 531, title XVIII, §1815, as added
Editorial Notes
Amendments
2020—Subsec. (d).
Subsec. (e)(3).
Subsec. (f).
Subsec. (f)(2)(A)(ii).
Subsec. (f)(2)(C).
"(i) Provide up to 120 days before claims are offset to recoup the accelerated payment.
"(ii) Allow not less than 12 months from the date of the first accelerated payment before requiring that the outstanding balance be paid in full."
2011—Subsec. (b).
2004—Subsec. (a).
2003—Subsec. (e)(1)(B).
Subsec. (e)(2).
Subsec. (e)(2)(E).
1997—Subsec. (e)(2)(C) to (E).
1989—Subsec. (e)(4).
1986—Subsec. (e).
1982—Subsec. (b).
Subsec. (d).
1980—Subsec. (c).
1977—Subsec. (c).
1975—
Statutory Notes and Related Subsidiaries
Effective Date of 2011 Amendment
Amendment by
Effective Date of 2003 Amendment
Effective Date of 1997 Amendment
Amendment by
Effective Date of 1989 Amendment
Effective Date of 1986 Amendment
Effective Date of 1982 Amendment
Amendment by section 148(b) of
Effective Date of 1977 Amendment
Effective Date of 1975 Amendment
Amendment by
Application to Other Part A Providers
"(i)
"(ii)
"(I) the programs under sections 413.64(g), 412.541(f), 412.632(e), 412.116(f), 413.350(d), or 418.307 of title 42, Code of Federal Regulations (or any successor regulations); and
"(II) any other comparable program under part A of title XVIII of the Social Security Act [
"(iii)
Publication of Data
"(1)
"(A)
"(i) The total amount of such payments made under each applicable payment program (as defined in paragraph (3)(A)), including a specification of the percentage of such payments so made from the Federal Hospital Insurance Trust Fund established under section 1817 of the Social Security Act (
"(ii) The amount of specified payments made under each such program by type of provider of services or supplier receiving such payments.
"(iii) The Centers for Medicare & Medicaid Services certification number or other appropriate number of, and the amount of such payments received by, each provider of services and supplier receiving such payments.
"(B)
"(2)
"(A) The total amount of all specified payments not recouped or repaid under each applicable payment program.
"(B) The amount of payments made under each such program and not recouped or repaid by type of provider of services or supplier.
"(C) The total amount of specified payments that have been recouped or repaid under each such program, including a specification of the percentage of such payments so recouped or repaid that have been deposited into the Federal Hospital Insurance Trust Fund and the percentage of such payments so recouped or repaid that have been deposited into the Federal Supplementary Insurance Trust Fund under each such program.
"(D) The dollar amount of interest that has been collected with respect to all specified payments under each such program.
"(3)
"(A)
"(i) the program under subsection (e)(3) of section 1815 of the Social Security Act (
"(ii) an applicable program (as defined in subsection (a)(1)(C)(ii) of this section [set out as a note above]); and
"(iii) the program described in section 421.214 of title 42, Code of Federal Regulations (or any successor regulation).
"(B)
"(C)
"(D)
"(E)
Development of Alternative Timing Methods of Periodic Interim Payments
Transition
"(A) as of June 30, 1987, is receiving payments under part A of title XVIII of such Act [
"(B) requests continuation of payment on such basis, and
"(C) is paid through an agency or organization with an agreement under section 1816 of such Act [
the Secretary of Health and Human Services shall continue payment on such a basis until not earlier than the end of the first period of three consecutive calendar months (beginning no earlier than April 1987) during all of which the agency or organization has met the requirements of section 1816(c)(2) of such Act (relating to prompt payment of claims)."
Delay in Periodic Interim Payments
"(1) with respect to the last 21 days for which such payments would otherwise be made during fiscal year 1983, such payments shall be deferred until fiscal year 1984; and
"(2) with respect to the last 21 days for which such payments would otherwise be made during fiscal year 1984, such payments shall be deferred until fiscal year 1985."
§1395h. Provisions relating to the administration of part A
(a) In general
The administration of this part shall be conducted through contracts with medicare administrative contractors under
(b) Repealed. Pub. L. 108–173, title IX, §911(b)(3), Dec. 8, 2003, 117 Stat. 2383
(c) Prompt payment of claims
(1) Repealed.
(2)(A) Each contract under
(i) which are clean claims, and
(ii) for which payment is not made on a periodic interim payment basis,
within the applicable number of calendar days after the date on which the claim is received.
(B) In this paragraph:
(i) The term "clean claim" means a claim that has no defect or impropriety (including any lack of any required substantiating documentation) or particular circumstance requiring special treatment that prevents timely payment from being made on the claim under this subchapter.
(ii) The term "applicable number of calendar days" means—
(I) with respect to claims received in the 12-month period beginning October 1, 1986, 30 calendar days,
(II) with respect to claims received in the 12-month period beginning October 1, 1987, 26 calendar days,
(III) with respect to claims received in the 12-month period beginning October 1, 1988, 25 calendar days,
(IV) with respect to claims received in the 12-month period beginning October 1, 1989, and claims received in any succeeding 12-month period ending on or before September 30, 1993, 24 calendar days, and
(V) with respect to claims received in the 12-month period beginning October 1, 1993, and claims received in any succeeding 12-month period, 30 calendar days.
(C) If payment is not issued, mailed, or otherwise transmitted within the applicable number of calendar days (as defined in clause (ii) of subparagraph (B)) after a clean claim (as defined in clause (i) of such subparagraph) is received from a hospital, critical access hospital, skilled nursing facility, home health agency, hospice program, comprehensive outpatient rehabilitation facility, or rehabilitation agency that is not receiving payments on a periodic interim payment basis with respect to such services, interest shall be paid at the rate used for purposes of
(3)(A) Each contract under
(B) In this paragraph, the term "applicable number of calendar days" means—
(i) with respect to claims submitted electronically as prescribed by the Secretary, 13 days, and
(ii) with respect to claims submitted otherwise, 28 days.
(d) to (i). Repealed. Pub. L. 108–173, title IX, §911(b)(5), Dec. 8, 2003, 117 Stat. 2383
(j) Denial of claim; notification and reconsideration
A contract with a medicare administrative contractor under
(1) furnish the provider and the individual with respect to whom the claim is made with a written explanation of the denial and of the statutory or regulatory basis for the denial; and
(2) in the case of a request for reconsideration of a denial, promptly notify such individual and the provider of the disposition of such reconsideration.
(k) Annual reporting requirement on erroneous payment recovery
A contract with a medicare administrative contractor under
(l) Repealed. Pub. L. 108–173, title IX, §911(b)(7), Dec. 8, 2003, 117 Stat. 2383
(Aug. 14, 1935, ch. 531, title XVIII, §1816, as added
Editorial Notes
Amendments
2006—Subsec. (c)(3)(B)(ii).
2003—
Subsec. (a).
Subsec. (b).
Subsec. (c)(1).
Subsec. (c)(2)(A).
Subsec. (c)(2)(B)(ii)(III).
Subsec. (c)(2)(B)(ii)(IV).
Subsec. (c)(3)(A).
Subsecs. (d) to (i).
Subsec. (j).
Subsec. (k).
Subsec. (l).
1997—Subsec. (c)(2)(C).
1996—Subsec. (l).
1994—Subsec. (f)(1)(A).
Subsec. (f)(2)(A)(ii).
Subsec. (k).
1993—Subsec. (c)(2)(B)(ii)(IV), (V).
Subsec. (c)(3)(B).
"(i) with respect to claims received in the 3-month period beginning July 1, 1988, 10 days, and
"(ii) with respect to claims received in the 12-month period beginning October 1, 1988, 14 days."
1990—Subsec. (f).
1989—Subsec. (c)(1).
Subsec. (c)(2)(C).
Subsec. (k).
1988—Subsec. (j)(2).
Subsec. (k).
1987—Subsec. (c)(1).
Subsec. (c)(2)(C).
Subsec. (c)(3).
Subsec. (f).
Subsec. (j).
1986—Subsec. (a).
Subsec. (c).
1984—Subsec. (c).
Subsec. (e)(4).
Subsec. (f).
1982—Subsec. (e)(5).
1980—Subsec. (e)(2).
Subsec. (e)(4).
1977—Subsec. (a).
Subsec. (b).
Subsecs. (e), (f).
Subsec. (g).
Subsecs. (h), (i).
1972—Subsec. (a).
Statutory Notes and Related Subsidiaries
Effective Date of 2006 Amendment
Effective Date of 2003 Amendment
Amendment by section 911(b) of
Effective Date of 1997 Amendment
Amendment by
Effective Date of 1994 Amendment
Effective Date of 1993 Amendment
Effective Date of 1989 Amendment
Amendment by
Effective Date of 1988 Amendment
Amendment by section 203(f) of
Except as specifically provided in section 411 of
Effective Date of 1987 Amendment
"(A) The amendment made by subsection (a) [amending this section] shall apply with respect to claims received on or after January 1, 1988.
"(B) The amendment made by subsection (b) [amending this section] shall apply with respect to reconsiderations requested on or after October 1, 1988."
"(A) The amendment made by paragraph (1) [amending this section] shall apply to claims received on or after the date of enactment of this Act [Dec. 22, 1987].
"(B) The Secretary of Health and Human Services shall provide for such timely amendments to agreements under section 1816 [
Effective Date of 1986 Amendment
"(1) Except as provided in paragraph (2), the amendments made by subsections (b) and (c) [amending this section and
"(2) Sections 1816(c)(2)(C)) [sic] and 1842(c)(2)(C) of the Social Security Act [
"(3) The Secretary of Health and Human Services shall provide for such timely amendments to agreements under section 1816 of the Social Security Act [
Amendment by section 9352(a)(2) of
Effective Date of 1984 Amendment
Effective Date of 1982 Amendment
Amendment by
Effective Date of 1980 Amendment
Amendment by
Effective Date of 1977 Amendment
"(c) The amendment made by paragraphs (2) and (3) of subsection (a) [amending this section] to the extent that they require application of standards, criteria, and procedures developed under section 1816(f) of the Social Security Act [
"(d) Except as provided in subsection (c), the amendment made by subsection (a)(2) [amending this section] shall apply to agreements entered into or renewed on or after the date of enactment of this Act [Oct. 25, 1977]."
Effective Date of 1972 Amendment
Amendment by
Advisory Committee on Medicare Home Health Claims
Amendments to Agreements and Contracts Necessary To Implement Section 4031(a) of Pub. L. 100–203
Prohibition of Policies Other Than as Provided by Section 4031 of Pub. L. 100–203 Intended To Slow Down Medicare Payments; Budget Considerations
Amendments to Agreements and Contracts Necessary To Implement Section 4032(a), (b) of Pub. L. 100–203
Replacement of Agency, Organization, or Carrier Processing Medicare Claims; Number of Agreements and Contracts Authorized for Fiscal Years 1985 Through 1993
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Audit and Medical Claims Review
Developmental Date for Standards, Criteria, and Procedures Pursuant to Subsec. (f) of This Section
§1395i. Federal Hospital Insurance Trust Fund
(a) Creation; deposits; transfers from Treasury
There is hereby created on the books of the Treasury of the United States a trust fund to be known as the "Federal Hospital Insurance Trust Fund" (hereinafter in this section referred to as the "Trust Fund"). The Trust Fund shall consist of such gifts and bequests as may be made as provided in
(1) the taxes imposed by sections 3101(b) and 3111(b) of the Internal Revenue Code of 1986 with respect to wages reported to the Secretary of the Treasury or his delegate pursuant to subtitle F of such Code after December 31, 1965, as determined by the Secretary of the Treasury by applying the applicable rates of tax under such sections to such wages, which wages shall be certified by the Commissioner of Social Security on the basis of records of wages established and maintained by the Commissioner of Social Security in accordance with such reports; and
(2) the taxes imposed by section 1401(b) of the Internal Revenue Code of 1986 with respect to self-employment income reported to the Secretary of the Treasury or his delegate on tax returns under subtitle F of such Code, as determined by the Secretary of the Treasury by applying the applicable rate of tax under such section to such self-employment income, which self-employment income shall be certified by the Commissioner of Social Security on the basis of records of self-employment established and maintained by the Commissioner of Social Security in accordance with such returns.
The amounts appropriated by the preceding sentence shall be transferred from time to time from the general fund in the Treasury to the Trust Fund, such amounts to be determined on the basis of estimates by the Secretary of the Treasury of the taxes, specified in the preceding sentence, paid to or deposited into the Treasury; and proper adjustments shall be made in amounts subsequently transferred to the extent prior estimates were in excess of or were less than the taxes specified in such sentence.
(b) Board of Trustees; composition; meetings; duties
With respect to the Trust Fund, there is hereby created a body to be known as the Board of Trustees of the Trust Fund (hereinafter in this section referred to as the "Board of Trustees") composed of the Commissioner of Social Security, the Secretary of the Treasury, the Secretary of Labor, and the Secretary of Health and Human Services, all ex officio, and of two members of the public (both of whom may not be from the same political party), who shall be nominated by the President for a term of four years and subject to confirmation by the Senate. A member of the Board of Trustees serving as a member of the public and nominated and confirmed to fill a vacancy occurring during a term shall be nominated and confirmed only for the remainder of such term. An individual nominated and confirmed as a member of the public may serve in such position after the expiration of such member's term until the earlier of the time at which the member's successor takes office or the time at which a report of the Board is first issued under paragraph (2) after the expiration of the member's term. The Secretary of the Treasury shall be the Managing Trustee of the Board of Trustees (hereinafter in this section referred to as the "Managing Trustee"). The Administrator of the Centers for Medicare & Medicaid Services shall serve as the Secretary of the Board of Trustees. The Board of Trustees shall meet not less frequently than once each calendar year. It shall be the duty of the Board of Trustees to—
(1) Hold the Trust Fund;
(2) Report to the Congress not later than the first day of April of each year on the operation and status of the Trust Fund during the preceding fiscal year and on its expected operation and status during the current fiscal year and the next 2 fiscal years; Each report provided under paragraph (2) beginning with the report in 2005 shall include the information specified in section 801(a) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.1
(3) Report immediately to the Congress whenever the Board is of the opinion that the amount of the Trust Fund is unduly small; and
(4) Review the general policies followed in managing the Trust Fund, and recommend changes in such policies, including necessary changes in the provisions of law which govern the way in which the Trust Fund is to be managed.
The report provided for in paragraph (2) shall include a statement of the assets of, and the disbursements made from, the Trust Fund during the preceding fiscal year, an estimate of the expected income to, and disbursements to be made from, the Trust Fund during the current fiscal year and each of the next 2 fiscal years, and a statement of the actuarial status of the Trust Fund. Such report shall also include an actuarial opinion by the Chief Actuary of the Centers for Medicare & Medicaid Services certifying that the techniques and methodologies used are generally accepted within the actuarial profession and that the assumptions and cost estimates used are reasonable. Such report shall be printed as a House document of the session of the Congress to which the report is made. A person serving on the Board of Trustees shall not be considered to be a fiduciary and shall not be personally liable for actions taken in such capacity with respect to the Trust Fund.
(c) Investment of Trust Fund by Managing Trustee
It shall be the duty of the Managing Trustee to invest such portion of the Trust Fund as is not, in his judgment, required to meet current withdrawals. Such investments may be made only in interest-bearing obligations of the United States or in obligations guaranteed as to both principal and interest by the United States. For such purpose such obligations may be acquired (1) on original issue at the issue price, or (2) by purchase of outstanding obligations at the market price. The purposes for which obligations of the United States may be issued under
(d) Authority of Managing Trustee to sell obligations
Any obligations acquired by the Trust Fund (except public-debt obligations issued exclusively to the Trust Fund) may be sold by the Managing Trustee at the market price, and such public-debt obligations may be redeemed at par plus accrued interest.
(e) Interest on and proceeds from sale or redemption of obligations
The interest on, and the proceeds from the sale or redemption of, any obligations held in the Trust Fund shall be credited to and form a part of the Trust Fund.
(f) Payment of estimated taxes
(1) The Managing Trustee is directed to pay from time to time from the Trust Fund into the Treasury the amount estimated by him as taxes imposed under section 3101(b) which are subject to refund under section 6413(c) of the Internal Revenue Code of 1986 with respect to wages paid after December 31, 1965. Such taxes shall be determined on the basis of the records of wages established and maintained by the Commissioner of Social Security in accordance with the wages reported to the Secretary of the Treasury or his delegate pursuant to subtitle F of the Internal Revenue Code of 1986, and the Commissioner of Social Security shall furnish the Managing Trustee such information as may be required by the Managing Trustee for such purpose. The payments by the Managing Trustee shall be covered into the Treasury as repayments to the account for refunding internal revenue collections.
(2) Repayments made under paragraph (1) shall not be available for expenditures but shall be carried to the surplus fund of the Treasury. If it subsequently appears that the estimates under such paragraph in any particular period were too high or too low, appropriate adjustments shall be made by the Managing Trustee in future payments.
(g) Transfers from other Funds
There shall be transferred periodically (but not less often than once each fiscal year) to the Trust Fund from the Federal Old-Age and Survivors Insurance Trust Fund and from the Federal Disability Insurance Trust Fund amounts equivalent to the amounts not previously so transferred which the Secretary of Health and Human Services shall have certified as overpayments (other than amounts so certified to the Railroad Retirement Board) pursuant to
(h) Payments from Trust Fund amounts certified by Secretary
The Managing Trustee shall also pay from time to time from the Trust Fund such amounts as the Secretary of Health and Human Services certifies are necessary to make the payments provided for by this part, and the payments with respect to administrative expenses in accordance with
(i) Payment of travel expenses for travel within United States; reconsideration interviews and proceedings before administrative law judges
There are authorized to be made available for expenditure out of the Trust Fund such amounts as are required to pay travel expenses, either on an actual cost or commuted basis, to parties, their representatives, and all reasonably necessary witnesses for travel within the United States (as defined in
(j) Loans from other Funds; interest; repayment; report to Congress
(1) If at any time prior to January 1988 the Managing Trustee determines that borrowing authorized under this subsection is appropriate in order to best meet the need for financing the benefit payments from the Federal Hospital Insurance Trust Fund, the Managing Trustee may, subject to paragraph (5), borrow such amounts as he determines to be appropriate from either the Federal Old-Age and Survivors Insurance Trust Fund or the Federal Disability Insurance Trust Fund for transfer to and deposit in the Federal Hospital Insurance Trust Fund.
(2) In any case where a loan has been made to the Federal Hospital Insurance Trust Fund under paragraph (1), there shall be transferred on the last day of each month after such loan is made, from such Trust Fund to the lending Trust Fund, the total interest accrued to such day with respect to the unrepaid balance of such loan at a rate equal to the rate which the lending Trust Fund would earn on the amount involved if the loan were an investment under subsection (c) (even if such an investment would earn interest at a rate different than the rate earned by investments redeemed by the lending fund in order to make the loan).
(3)(A) If in any month after a loan has been made to the Federal Hospital Insurance Trust Fund under paragraph (1), the Managing Trustee determines that the assets of such Trust Fund are sufficient to permit repayment of all or part of any loans made to such Fund under paragraph (1), he shall make such repayments as he determines to be appropriate.
(B)(i) If on the last day of any year after a loan has been made under paragraph (1) by the Federal Old-Age and Survivors Insurance Trust Fund or the Federal Disability Insurance Trust Fund to the Federal Hospital Insurance Trust Fund, the Managing Trustee determines that the Hospital Insurance Trust Fund ratio exceeds 15 percent, he shall transfer from such Trust Fund to the lending trust fund an amount that—
(I) together with any amounts transferred to another lending trust fund under this paragraph for such year, will reduce the Hospital Insurance Trust Fund ratio to 15 percent; and
(II) does not exceed the outstanding balance of such loan.
(ii) Amounts required to be transferred under clause (i) shall be transferred on the last day of the first month of the year succeeding the year in which the determination described in clause (i) is made.
(iii) For purposes of this subparagraph, the term "Hospital Insurance Trust Fund ratio" means, with respect to any calendar year, the ratio of—
(I) the balance in the Federal Hospital Insurance Trust Fund, as of the last day of such calendar year; to
(II) the amount estimated by the Secretary to be the total amount to be paid from the Federal Hospital Insurance Trust Fund during the calendar year following such calendar year (other than payments of interest on, and repayments of, loans from the Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund under paragraph (1)), and reducing the amount of any transfer to the Railroad Retirement Account by the amount of any transfers into such Trust Fund from the Railroad Retirement Account.
(C)(i) The full amount of all loans made under paragraph (1) (whether made before or after January 1, 1983) shall be repaid at the earliest feasible date and in any event no later than December 31, 1989.
(ii) For the period after December 31, 1987 and before January 1, 1990, the Managing Trustee shall transfer each month from the Federal Hospital Insurance Trust Fund to any Trust Fund that is owed any amount by the Federal Hospital Insurance Trust Fund on a loan made under paragraph (1), an amount not less than an amount equal to (I) the amount owed to such Trust Fund by the Federal Hospital Insurance Trust Fund at the beginning of such month (plus the interest accrued on the outstanding balance of such loan during such month), divided by (II) the number of months elapsing after the preceding month and before January 1990. The Managing Trustee may, during this period, transfer larger amounts than prescribed by the preceding sentence.
(4) The Board of Trustees shall make a timely report to the Congress of any amounts transferred (including interest payments) under this subsection.
(5)(A) No amounts may be loaned by the Federal Old-Age and Survivors Insurance Trust Fund or the Federal Disability Insurance Trust Fund under paragraph (1) during any month if the OASDI trust fund ratio for such month is less than 10 percent.
(B) For purposes of this paragraph, the term "OASDI trust fund ratio" means, with respect to any month, the ratio of—
(i) the combined balance in the Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund, reduced by the outstanding amount of any loan (including interest thereon) theretofore made to either such Trust Fund from the Federal Hospital Insurance Trust Fund under
(ii) the amount obtained by multiplying by twelve the total amount which (as estimated by the Secretary) will be paid from the Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund during the month for which such ratio is to be determined for all purposes authorized by
(k) Health Care Fraud and Abuse Control Account
(1) Establishment
There is hereby established in the Trust Fund an expenditure account to be known as the "Health Care Fraud and Abuse Control Account" (in this subsection referred to as the "Account").
(2) Appropriated amounts to Trust Fund
(A) In general
There are hereby appropriated to the Trust Fund—
(i) such gifts and bequests as may be made as provided in subparagraph (B);
(ii) such amounts as may be deposited in the Trust Fund as provided in sections 242(b) and 249(c) of the Health Insurance Portability and Accountability Act of 1996, and subchapter XI; and
(iii) such amounts as are transferred to the Trust Fund under subparagraph (C).
(B) Authorization to accept gifts
The Trust Fund is authorized to accept on behalf of the United States money gifts and bequests made unconditionally to the Trust Fund, for the benefit of the Account or any activity financed through the Account.
(C) Transfer of amounts
The Managing Trustee shall transfer to the Trust Fund, under rules similar to the rules in section 9601 of the Internal Revenue Code of 1986, an amount equal to the sum of the following:
(i) Criminal fines recovered in cases involving a Federal health care offense (as defined in
(ii) Civil monetary penalties and assessments imposed in health care cases, including amounts recovered under this subchapter and subchapters XI and XIX, and
(iii) Amounts resulting from the forfeiture of property by reason of a Federal health care offense.
(iv) Penalties and damages obtained and otherwise creditable to miscellaneous receipts of the general fund of the Treasury obtained under
(D) Application
Nothing in subparagraph (C)(iii) shall be construed to limit the availability of recoveries and forfeitures obtained under title I of the Employee Retirement Income Security Act of 1974 [
(3) Appropriated amounts to Account for fraud and abuse control program, etc.
(A) Departments of Health and Human Services and Justice
(i) In general
There are hereby appropriated to the Account from the Trust Fund such sums as the Secretary and the Attorney General certify are necessary to carry out the purposes described in subparagraph (C), to be available without further appropriation until expended, in an amount not to exceed—
(I) for fiscal year 1997, $104,000,000;
(II) for each of the fiscal years 1998 through 2003, the limit for the preceding fiscal year, increased by 15 percent;
(III) for each of fiscal years 2004, 2005, and 2006, the limit for fiscal year 2003; and
(IV) for each fiscal year after fiscal year 2006, the limit under this clause for the preceding fiscal year, increased by the percentage increase in the consumer price index for all urban consumers (all items; United States city average) over the previous year.
(ii) Medicare and medicaid activities
For each fiscal year, of the amount appropriated in clause (i), the following amounts shall be available only for the purposes of the activities of the Office of the Inspector General of the Department of Health and Human Services with respect to the programs under this subchapter and subchapter XIX—
(I) for fiscal year 1997, not less than $60,000,000 and not more than $70,000,000;
(II) for fiscal year 1998, not less than $80,000,000 and not more than $90,000,000;
(III) for fiscal year 1999, not less than $90,000,000 and not more than $100,000,000;
(IV) for fiscal year 2000, not less than $110,000,000 and not more than $120,000,000;
(V) for fiscal year 2001, not less than $120,000,000 and not more than $130,000,000;
(VI) for fiscal year 2002, not less than $140,000,000 and not more than $150,000,000;
(VII) for each of fiscal years 2003, 2004, 2005, and 2006, not less than $150,000,000 and not more than $160,000,000;
(VIII) for fiscal year 2007, not less than $160,000,000, increased by the percentage increase in the consumer price index for all urban consumers (all items; United States city average) over the previous year; and
(IX) for each fiscal year after fiscal year 2007, not less than the amount required under this clause for the preceding fiscal year, increased by the percentage increase in the consumer price index for all urban consumers (all items; United States city average) over the previous year.
(B) Federal Bureau of Investigation
There are hereby appropriated from the general fund of the United States Treasury and hereby appropriated to the Account for transfer to the Federal Bureau of Investigation to carry out the purposes described in subparagraph (C), to be available without further appropriation until expended—
(i) for fiscal year 1997, $47,000,000;
(ii) for fiscal year 1998, $56,000,000;
(iii) for fiscal year 1999, $66,000,000;
(iv) for fiscal year 2000, $76,000,000;
(v) for fiscal year 2001, $88,000,000;
(vi) for fiscal year 2002, $101,000,000;
(vii) for each of fiscal years 2003, 2004, 2005, and 2006, $114,000,000; and
(viii) for each fiscal year after fiscal year 2006, the amount to be appropriated under this subparagraph for the preceding fiscal year, increased by the percentage increase in the consumer price index for all urban consumers (all items; United States city average) over the previous year.
(C) Use of funds
The purposes described in this subparagraph are to cover the costs (including equipment, salaries and benefits, and travel and training) of the administration and operation of the health care fraud and abuse control program established under
(i) prosecuting health care matters (through criminal, civil, and administrative proceedings);
(ii) investigations;
(iii) financial and performance audits of health care programs and operations;
(iv) inspections and other evaluations; and
(v) provider and consumer education regarding compliance with the provisions of subchapter XI.
(4) Appropriated amounts to Account for Medicare Integrity Program
(A) In general
There are hereby appropriated to the Account from the Trust Fund for each fiscal year such amounts as are necessary for activities described in paragraph (3)(C) and to carry out the Medicare Integrity Program under
(B) Amounts specified
Subject to subparagraph (C), the amount appropriated under subparagraph (A) for a fiscal year is as follows:
(i) For fiscal year 1997, such amount shall be not less than $430,000,000 and not more than $440,000,000.
(ii) For fiscal year 1998, such amount shall be not less than $490,000,000 and not more than $500,000,000.
(iii) For fiscal year 1999, such amount shall be not less than $550,000,000 and not more than $560,000,000.
(iv) For fiscal year 2000, such amount shall be not less than $620,000,000 and not more than $630,000,000.
(v) For fiscal year 2001, such amount shall be not less than $670,000,000 and not more than $680,000,000.
(vi) For fiscal year 2002, such amount shall be not less than $690,000,000 and not more than $700,000,000.
(vii) For each fiscal year after fiscal year 2002, such amount shall be not less than $710,000,000 and not more than $720,000,000.
(C) Adjustments
The amount appropriated under subparagraph (A) for a fiscal year is increased as follows:
(i) For fiscal year 2006, $100,000,000.
(ii) For each fiscal year after 2010, by the percentage increase in the consumer price index for all urban consumers (all items; United States city average) over the previous year.
(D) Expansion of the Medicare-Medicaid Data Match Program
The amount appropriated under subparagraph (A) for a fiscal year is further increased as follows for purposes of carrying out
(i) $12,000,000 for fiscal year 2006.
(ii) $24,000,000 for fiscal year 2007.
(iii) $36,000,000 for fiscal year 2008.
(iv) $48,000,000 for fiscal year 2009.
(v) $60,000,000 for fiscal year 2010 and each fiscal year thereafter.
(5) Annual report
Not later than January 1, the Secretary and the Attorney General shall submit jointly a report to Congress which identifies—
(A) the amounts appropriated to the Trust Fund for the previous fiscal year under paragraph (2)(A) and the source of such amounts; and
(B) the amounts appropriated from the Trust Fund for such year under paragraph (3) and the justification for the expenditure of such amounts.
(6) GAO report
Not later than June 1, 1998, and January 1 of 2000, 2002, and 2004, the Comptroller General of the United States shall submit a report to Congress which—
(A) identifies—
(i) the amounts appropriated to the Trust Fund for the previous two fiscal years under paragraph (2)(A) and the source of such amounts; and
(ii) the amounts appropriated from the Trust Fund for such fiscal years under paragraph (3) and the justification for the expenditure of such amounts;
(B) identifies any expenditures from the Trust Fund with respect to activities not involving the program under this subchapter;
(C) identifies any savings to the Trust Fund, and any other savings, resulting from expenditures from the Trust Fund; and
(D) analyzes such other aspects of the operation of the Trust Fund as the Comptroller General of the United States considers appropriate.
(7) Additional funding
In addition to the funds otherwise appropriated to the Account from the Trust Fund under paragraphs (3) and (4) and for purposes described in paragraphs (3)(C) and (4)(A), there are hereby appropriated an additional $10,000,000 to such Account from such Trust Fund for each of fiscal years 2011 through 2020. The funds appropriated under this paragraph shall be allocated in the same proportion as the total funding appropriated with respect to paragraphs (3)(A) and (4)(A) was allocated with respect to fiscal year 2010, and shall be available without further appropriation until expended.
(8) Additional funding
(A) In general
In addition to the funds otherwise appropriated to the Account from the Trust Fund under paragraphs (3)(C) and (4)(A) and for purposes described in paragraphs (3)(C) and (4)(A), there are hereby appropriated to such Account from such Trust Fund the following additional amounts:
(i) For fiscal year 2011, $95,000,000.
(ii) For fiscal year 2012, $55,000,000.
(iii) For each of fiscal years 2013 and 2014, $30,000,000.
(iv) For each of fiscal years 2015 and 2016, $20,000,000.
(B) Allocation
The funds appropriated under this paragraph shall be allocated in the same proportion as the total funding appropriated with respect to paragraphs (3)(A) and (4)(A) was allocated with respect to fiscal year 2010, and shall be available without further appropriation until expended.
(Aug. 14, 1935, ch. 531, title XVIII, §1817, as added
Editorial Notes
References in Text
The Internal Revenue Code of 1986, referred to in subsecs. (a)(1), (2), (f)(1), and (k)(2)(C), is classified generally to Title 26, Internal Revenue Code. Subtitle F of such Code appears at
Section 801(a) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, referred to in subsec. (b)(2), is section 801(a) of
Sections 242(b) and 249(b) of the Health Insurance Portability and Accountability Act of 1996, referred to in subsec. (k)(2)(A)(ii), are sections 242(b) and 249(b) of
The Employee Retirement Income Security Act of 1974, referred to in subsec. (k)(2)(D), is
Amendments
2010—Subsec. (k)(3)(A)(i)(III).
Subsec. (k)(3)(A)(i)(IV).
Subsec. (k)(3)(A)(i)(V).
Subsec. (k)(3)(A)(ii)(VIII).
Subsec. (k)(3)(A)(ii)(IX).
Subsec. (k)(3)(A)(ii)(X).
Subsec. (k)(3)(B)(vii).
Subsec. (k)(3)(B)(viii).
Subsec. (k)(3)(B)(ix).
Subsec. (k)(4)(A).
Subsec. (k)(4)(C)(ii).
Subsec. (k)(7).
Subsec. (k)(8).
2006—Subsec. (k)(3)(A)(i).
Subsec. (k)(3)(A)(ii)(VI) to (X).
Subsec. (k)(3)(B).
Subsec. (k)(4)(A).
Subsec. (k)(4)(B).
Subsec. (k)(4)(C).
Subsec. (k)(4)(D).
2003—Subsec. (b).
Subsec. (b)(2).
Subsec. (k)(3)(A)(i)(I).
Subsec. (k)(3)(A)(ii).
Subsec. (k)(6)(B).
1999—Subsec. (k)(2)(C)(i).
1997—Subsec. (k)(6).
1996—Subsec. (k).
1994—Subsec. (a).
Subsec. (b).
Subsec. (f)(1).
1990—Subsec. (i).
1989—Subsec. (b).
1988—Subsec. (b).
1986—Subsec. (a)(1), (2).
Subsec. (b).
Subsec. (f)(1).
1984—Subsec. (a).
Subsec. (a)(1), (2).
Subsec. (c).
Subsecs. (f)(1), (g), (h).
1983—Subsec. (a).
Subsec. (b).
Subsec. (j)(1).
Subsec. (j)(2).
Subsec. (j)(3)(A).
Subsec. (j)(5).
1981—Subsec. (j).
1980—Subsec. (i).
1978—Subsec. (b).
1972—Subsec. (a).
1968—Subsec. (b)(2).
Statutory Notes and Related Subsidiaries
Effective Date of 1999 Amendment
Effective Date of 1994 Amendment
Amendment by
Effective Date of 1990 Amendment
Amendment by
Effective Date of 1989 Amendment
Amendment by
Effective Date of 1988 Amendment
Amendment by
Effective Date of 1984 Amendment
Amendment by section 2354(b)(2) of
Amendment by section 2663(j)(2)(F)(i) of
Effective Date of 1983 Amendment
Amendment by section 141(b) of
Amendment by sections 154(b) and 341(b) of
Effective Date of 1981 Amendment
Amendment by
Effective Date of 1978 Amendment
Amendment by
Effective Date of 1972 Amendment
Amendment by
Restoration of Medicare Trust Funds
"(a)
"(1)
"(2)
"(b)
"(1)
"(2)
"(A) issue to the Trust Fund obligations under
"(i) would have been issued to the Trust Fund if the clerical error involved had not occurred; or
"(ii) were issued to the Trust Fund and were redeemed by reason of the clerical error involved; and
"(B) redeem from the Trust Fund obligations that would have been redeemed from the Trust Fund if the clerical error involved had not occurred.
"(c)
"(d)
"(e)
"(1) the Secretary of the Treasury shall take the actions under subsection (b)(1); and
"(2) the appropriation under subsection (c) shall be made."
Inclusion in Annual Report of Medicare Trustees of Information on Status of Medicare Trust Funds
"(a)
"(1)
"(A) the information described in subsection (b); and
"(B) a determination as to whether there is projected to be excess general revenue medicare funding (as defined in subsection (c)) for the fiscal year in which the report is submitted or for any of the succeeding 6 fiscal years.
"(2)
"(3) 7-
"(b)
"(1)
"(A) Each fiscal year within the 7-fiscal-year reporting period.
"(B) Previous fiscal years and as of 10, 50, and 75 years after such year.
"(2)
"(A) The gross domestic product.
"(B) Private health costs.
"(C) National health expenditures.
"(D) Other appropriate measures.
"(3)
"(4)
"(c)
"(1)
"(A) general revenue medicare funding (as defined in paragraph (2)), expressed as a percentage of total medicare outlays (as defined in paragraph (4)) for the fiscal year; exceeds
"(B) 45 percent.
"(2)
"(A) the total medicare outlays (as defined in paragraph (4)) for the year; minus
"(B) the dedicated medicare financing sources (as defined in paragraph (3)) for the year.
"(3)
"(A)
"(B)
"(C)
"(D)
"(i)
"(ii)
"(iii)
Premiums under clauses (ii) and (iii) shall be determined without regard to any reduction in such premiums attributable to a beneficiary rebate under section 1854(b)(1)(C) of such title [
"(E)
"(4)
"(A) include payments made to plans under part C of title XVIII of the Social Security Act [
"(B) include administrative expenditures made in carrying out title XVIII of such Act [
"(C) offset outlays by the amount of fraud and abuse collections insofar as they are applied or deposited into a medicare trust fund.
"(5)
"(A) the Federal Hospital Insurance Trust Fund established under section 1817 of the Social Security Act (
"(B) the Federal Supplementary Medical Insurance Trust Fund established under section 1841 of such Act (
"(d)
"(1)
"(2)
"(e)
Criminal Fines Deposited in Federal Hospital Insurance Trust Fund
Property Forfeited Deposited in Federal Hospital Insurance Trust Fund
"(1)
"(2)
"(A) the payment, at the discretion of the Attorney General, of any expenses necessary to seize, detain, inventory, safeguard, maintain, advertise, sell, or dispose of property under seizure, detention, or forfeited, or of any other necessary expenses incident to the seizure, detention, forfeiture, or disposal of such property, including payment for—
"(i) contract services;
"(ii) the employment of outside contractors to operate and manage properties or provide other specialized services necessary to dispose of such properties in an effort to maximize the return from such properties; and
"(iii) reimbursement of any Federal, State, or local agency for any expenditures made to perform the functions described in this subparagraph;
"(B) at the discretion of the Attorney General, the payment of awards for information or assistance leading to a civil or criminal forfeiture involving any Federal agency participating in the Health Care Fraud and Abuse Control Account;
"(C) the compromise and payment of valid liens and mortgages against property that has been forfeited, subject to the discretion of the Attorney General to determine the validity of any such lien or mortgage and the amount of payment to be made, and the employment of attorneys and other personnel skilled in State real estate law as necessary;
"(D) payment authorized in connection with remission or mitigation procedures relating to property forfeited; and
"(E) the payment of State and local property taxes on forfeited real property that accrued between the date of the violation giving rise to the forfeiture and the date of the forfeiture order.
"(3)
Due Date for 1983 Report on Operation and Status of Trust Fund
Notwithstanding subsec. (b)(2) of this section, the annual report of the Board of Trustees of the Trust Fund required for calendar year 1983 under this section may be filed at any time not later than forty-five days after Apr. 20, 1983, see section 154(d) of
1 So in original. See 2003 Amendment note below.
§1395i–1. Authorization of appropriations
There are authorized to be appropriated to the Federal Hospital Insurance Trust Fund (established by
(1) payments made or to be made during such fiscal year from such Trust Fund under this part with respect to individuals who are qualified railroad retirement beneficiaries (as defined in section 426(c) 1 of this title) and who are not, and upon filing application for monthly insurance benefits under
(2) the additional administrative expenses resulting or expected to result therefrom, and
(3) any loss of interest to such Trust Fund resulting from the payment of such amounts,
in order to place such Trust Fund in the same position at the end of such fiscal year in which it would have been if the individuals described in paragraph (1) had not been entitled to benefits under this part.
(
Editorial Notes
References in Text
The Railroad Retirement Act of 1937, referred to in par. (1), is act Aug. 29, 1935, ch. 812,
Codification
Section was enacted as part of the Social Security Amendments of 1965 and also as part of the Health Insurance for the Aged Act, and not as part of the Social Security Act which comprises this chapter.
Statutory Notes and Related Subsidiaries
Effective Date
"(1) The amendments made by the preceding provisions of this section [enacting this section and
"(2) The requirement referred to in paragraph (1) shall be deemed to have been met with respect to any calendar year if, as of the October 1 immediately preceding such calendar year, the Railroad Retirement Tax Act [
1 See References in Text note below.
§1395i–1a. Repealed. Pub. L. 101–234, title I, §102(a), Dec. 13, 1989, 103 Stat. 1980
Section, act Aug. 14, 1935, ch. 531, title XVIII, §1817A, as added July 1, 1988,
Statutory Notes and Related Subsidiaries
Effective Date of Repeal
Repeal effective Jan. 1, 1990, see section 102(d)(1) of
Adjustments for Interest Lost Due to Delay of Transfers to Reserve Fund During 1989
§1395i–2. Hospital insurance benefits for uninsured elderly individuals not otherwise eligible
(a) Individuals eligible to enroll
Every individual who—
(1) has attained the age of 65,
(2) is enrolled under part B of this subchapter,
(3) is a resident of the United States, and is either (A) a citizen or (B) an alien lawfully admitted for permanent residence who has resided in the United States continuously during the 5 years immediately preceding the month in which he applies for enrollment under this section, and
(4) is not otherwise entitled to benefits under this part,
shall be eligible to enroll in the insurance program established by this part. Except as otherwise provided, any reference to an individual entitled to benefits under this part includes an individual entitled to benefits under this part pursuant to an enrollment under this section or
(b) Time, manner, and form of enrollment
An individual may enroll under this section only in such manner and form as may be prescribed in regulations, and only during an enrollment period prescribed in or under this section.
(c) Period of enrollment; scope of coverage
The provisions of
(1) individuals who meet the conditions of subsection (a)(1), (3), and (4) on or before the last day of the seventh month after October 1972 may enroll under this part and (if not already so enrolled) may also enroll under part B during an initial general enrollment period which shall begin on the first day of the second month which begins after October 30, 1972, and shall end on the last day of the tenth month after October 1972;
(2) in the case of an individual who first meets the conditions of eligibility under this section on or after the first day of the eighth month after October 1972, the initial enrollment period shall begin on the first day of the third month before the month in which he first becomes eligible and shall end 7 months later;
(3) in the case of an individual who enrolls pursuant to paragraph (1) of this subsection, entitlement to benefits shall begin on—
(A) the first day of the second month after the month in which he enrolls,
(B) July 1, 1973, or
(C) the first day of the first month in which he meets the requirements of subsection (a),
whichever is the latest;
(4) an individual's entitlement under this section shall terminate with the month before the first month in which he becomes eligible for hospital insurance benefits under
(5) termination of coverage for supplementary medical insurance shall result in simultaneous termination of hospital insurance benefits for uninsured individuals who are not otherwise entitled to benefits under this chapter;
(6) any percent increase effected under
(7) an individual who meets the conditions of subsection (a) may enroll under this part during a special enrollment period that includes any month during any part of which the individual is enrolled under
(8) in the case of an individual who enrolls during a special enrollment period under paragraph (7)—
(A) in any month of the special enrollment period in which the individual is at any time enrolled under
(B) in any other month of the special enrollment period, the coverage period shall begin on the first day of the month following the month in which the individual so enrolls; and
(9) in applying the provisions of
(d) Monthly premiums
(1) The Secretary shall, during September of each year (beginning with 1988), estimate the monthly actuarial rate for months in the succeeding year. Such actuarial rate shall be one-twelfth of the amount which the Secretary estimates (on an average, per capita basis) is equal to 100 percent of the benefits and administrative costs which will be payable from the Federal Hospital Insurance Trust Fund for services performed and related administrative costs incurred in the succeeding year with respect to individuals age 65 and over who will be entitled to benefits under this part during that year.
(2) The Secretary shall, during September of each year 1 determine and promulgate the dollar amount which shall be applicable for premiums for months occurring in the following year. Subject to paragraphs (4) and (5), the amount of an individual's monthly premium under this section shall be equal to the monthly actuarial rate determined under paragraph (1) for that following year. Any amount determined under the preceding sentence which is not a multiple of $1 shall be rounded to the nearest multiple of $1 (or, if it is a multiple of 50 cents but not a multiple of $1, to the next higher multiple of $1).
(3) Whenever the Secretary promulgates the dollar amount which shall be applicable as the monthly premium under this section, he shall, at the time such promulgation is announced, issue a public statement setting forth the actuarial assumptions and bases employed by him in arriving at the amount of an adequate actuarial rate for individuals 65 and older as provided in paragraph (1).
(4)(A) In the case of an individual described in subparagraph (B), the monthly premium for a month shall be reduced by the applicable reduction percent specified in the following table:
| For a month in: | The applicable reduction percent is: |
|---|---|
| 1994 | 25 percent |
| 1995 | 30 percent |
| 1996 | 35 percent |
| 1997 | 40 percent |
| 1998 or subsequent year | 45 percent. |
(B) An individual described in this subparagraph with respect to a month is an individual who establishes to the satisfaction of the Secretary that, as of the last day of the previous month, the individual—
(i) had at least 30 quarters of coverage under subchapter II;
(ii) was married (and had been married for the previous 1-year period) to an individual who had at least 30 quarters of coverage under such subchapter;
(iii) had been married to an individual for a period of at least 1 year (at the time of such individual's death) if at such time the individual had at least 30 quarters of coverage under such subchapter; or
(iv) is divorced from an individual and had been married to the individual for a period of at least 10 years (at the time of the divorce) if at such time the individual had at least 30 quarters of coverage under such subchapter.
(5)(A) The amount of the monthly premium shall be zero in the case of an individual who is a person described in subparagraph (B) for a month, if—
(i) the individual's premium under this section for the month is not (and will not be) paid for, in whole or in part, by a State (under subchapter XIX or otherwise), a political subdivision of a State, or an agency or instrumentality of one or more States or political subdivisions thereof; and
(ii) in each of 84 months before such month, the individual was enrolled in this part under this section and the payment of the individual's premium under this section for the month was not paid for, in whole or in part, by a State (under subchapter XIX or otherwise), a political subdivision of a State, or an agency or instrumentality of one or more States or political subdivisions thereof.
(B) A person described in this subparagraph for a month is a person who establishes to the satisfaction of the Secretary that, as of the last day of the previous month—
(i)(I) the person was receiving cash benefits under a qualified State or local government retirement system (as defined in subparagraph (C)) on the basis of the person's employment in one or more positions covered under any such system, and (II) the person would have at least 40 quarters of coverage under subchapter II if remuneration for medicare qualified government employment (as defined in paragraph (1) of
(ii)(I) the person was married (and had been married for the previous 1-year period) to an individual who is described in clause (i), or (II) the person met the requirement of clause (i)(II) and was married (and had been married for the previous 1-year period) to an individual described in clause (i)(I);
(iii) the person had been married to an individual for a period of at least 1 year (at the time of such individual's death) if (I) the individual was described in clause (i) at the time of the individual's death, or (II) the person met the requirement of clause (i)(II) and the individual was described in clause (i)(I) at the time of the individual's death; or
(iv) the person is divorced from an individual and had been married to the individual for a period of at least 10 years (at the time of the divorce) if (I) the individual was described in clause (i) at the time of the divorce, or (II) the person met the requirement of clause (i)(II) and the individual was described in clause (i)(I) at the time of the divorce.
(C) For purposes of subparagraph (B)(i)(I), the term "qualified State or local government retirement system" means a retirement system that—
(i) is established or maintained by a State or political subdivision thereof, or an agency or instrumentality of one or more States or political subdivisions thereof;
(ii) covers positions of some or all employees of such a State, subdivision, agency, or instrumentality; and
(iii) does not adjust cash retirement benefits based on eligibility for a reduction in premium under this paragraph.
(6)(A) In the case where a State, a political subdivision of a State, or an agency or instrumentality of a State or political subdivision thereof determines to pay, for the life of each individual, the monthly premiums due under paragraph (1) on behalf of each of the individuals in a qualified State or local government retiree group who meets the conditions of subsection (a), the amount of any increase otherwise applicable under
(B) For purposes of this paragraph, the term "qualified State or local government retiree group" means all of the individuals who retire prior to a specified date that is before January 1, 2002, from employment in one or more occupations or other broad classes of employees of—
(i) the State;
(ii) a political subdivision of the State; or
(iii) an agency or instrumentality of the State or political subdivision of the State.
(e) Contract or other arrangement for payment of monthly premiums
Payment of the monthly premiums on behalf of any individual who meets the conditions of subsection (a) may be made by any public or private agency or organization under a contract or other arrangement entered into between it and the Secretary if the Secretary determines that payment of such premiums under such contract or arrangement is administratively feasible.
(f) Deposit of amounts into Treasury
Amounts paid to the Secretary for coverage under this section shall be deposited in the Treasury to the credit of the Federal Hospital Insurance Trust Fund.
(g) Buy-in under this part for qualified medicare beneficiaries
(1) The Secretary shall, at the request of a State made after 1989, enter into a modification of an agreement entered into with the State pursuant to
(2)(A) Except as provided in subparagraph (B), the provisions of subsections (c), (d), (e), and (f) of
(B) For purposes of this subsection,
(Aug. 14, 1935, ch. 531, title XVIII, §1818, as added
Editorial Notes
References in Text
The Internal Revenue Code of 1986, referred to in subsec. (d)(6)(A), is classified generally to Title 26, Internal Revenue Code.
Amendments
2022—Subsec. (c).
2003—Subsec. (a).
Subsec. (d)(6)(A).
Subsec. (g)(2)(B).
2000—Subsec. (c)(6).
Subsec. (d)(6).
1997—Subsec. (d)(2).
Subsec. (d)(5).
1993—Subsec. (d)(2).
Subsec. (d)(4).
1990—Subsec. (c)(7) to (9).
Subsec. (g)(2)(B).
1989—
Subsec. (g).
1988—Subsec. (c)(4) to (7).
Subsec. (d).
"(1) The monthly premium of each individual for each month in his coverage period before July 1974 shall be $33.
"(2) The Secretary shall, during the next to last calendar quarter of each year determine and promulgate the dollar amount (whether or not such dollar amount was applicable for premiums for any prior month) which shall be applicable for premiums for months occurring in the following calendar year. Such amount shall be equal to $33, multiplied by the ratio of (A) the inpatient hospital deductible for that following calendar year, as promulgated under
Subsec. (d)(1).
1987—Subsec. (c)(4) to (7).
1986—Subsec. (c)(7).
1984—Subsec. (c).
Subsec. (c)(1).
Subsec. (d)(2).
1983—Subsec. (c).
Subsec. (d)(2).
Statutory Notes and Related Subsidiaries
Effective Date of 2000 Amendment
Effective Date of 1997 Amendment
Effective Date of 1993 Amendment
Effective Date of 1990 Amendment
Effective Date of 1989 Amendment
Amendment by section 6012(a)(1) of
Effective Date of 1988 Amendment
Amendment by
Amendment by section 103 of
Except as specifically provided in section 411 of
Effective Date of 1986 Amendment
"(1) The amendment made by subsection (a)(3) [amending this section] shall apply to premiums paid for months beginning with July 1986.
"(2) In applying that amendment, months (before, during, or after April 1986) in which an individual was required to pay a premium increased under the section that was so amended shall be taken into account in determining the month in which the premium will no longer be subject to an increase under that section as so amended."
Effective Date of 1984 Amendment
Amendment by section 2315(e) of
Amendment by section 2354(b)(3), (4) of
Effective Date of 1983 Amendment; Transitional Rule
Amendment by
Special Enrollment Provisions for Merchant Seamen
"(a) Any individual who—
"(1) was entitled to medical, surgical, and dental treatment and hospitalization under section 322(a) of the Public Health Service Act [
"(2) as of September 30, 1981, was eligible under section 1818(a) or section 1836 of the Social Security Act [
may enroll (if not otherwise enrolled) in the respective program during the period beginning on the first day of the first month beginning at least 20 days after the date of the enactment of this Act [Sept. 3, 1982] and ending on December 31, 1982.
"(b)(1) The coverage period under the respective program of an individual who enrolls under subsection (a) shall begin—
"(A) on the first day of the month following the month in which the individual enrolls, or
"(B) on October 1, 1981, if the individual files a request for this subparagraph to apply and pays the monthly premiums for the months so covered.
"(2) The coverage period under the respective program of an individual described in subsection (a) who enrolled in the respective program before the enrollment period described in that subsection shall be retroactively extended to October 1, 1981, if the individual files a request before January 1, 1983, for such retroactive extension and pays the monthly premiums for the months so covered.
"(c)(1) For purposes of section 1839(d) of the Social Security Act [
"(2) Paragraph (1) shall not apply to an individual—
"(A) if the individual has enrolled in the insurance program before March 10, 1981, unless the enrollment was terminated solely because the individual lost eligibility to be so enrolled, or
"(B) unless the individual applies for the benefit of such paragraph before January 1, 1983.
"(d)(1) The Secretary of Health and Human Services, beginning as soon as possible but not later than 30 days after the date of the enactment of this Act [Sept. 3, 1982], shall provide for the dissemination of information—
"(A) to unions and other associations representing or assisting seamen,
"(B) to offices enrolling individuals under the respective programs, and
"(C) to such other entities and in such a manner as will effectively inform individuals eligible for benefits under this section,
concerning the special benefits provided under this section.
"(2) An individual may establish that the individual was entitled at a date to medical, surgical, and dental treatment and hospitalization under section 322(a) of the Public Health Service Act [
"(A) documentation relating to the status under which the individual was provided care in (or under arrangements with) a Public Health Service facility on that date,
"(B) the individual's seamen's papers covering that date, or
"(C) such other reasonable documentation as the Secretary may require."
1 So in original. Probably should be followed by a comma.
§1395i–2a. Hospital insurance benefits for disabled individuals who have exhausted other entitlement
(a) Eligibility
Every individual who—
(1) has not attained the age of 65;
(2)(A) has been entitled to benefits under this part under
(B)(i) continues to have the disabling physical or mental impairment on the basis of which the individual was found to be under a disability or to be a disabled qualified railroad retirement beneficiary, or (ii) is blind (within the meaning of
(C) whose entitlement under
(3) is not otherwise entitled to benefits under this part,
shall be eligible to enroll in the insurance program established by this part.
(b) Enrollment
(1) An individual may enroll under this section only in such manner and form as may be prescribed in regulations, and only during an enrollment period prescribed in or under this section.
(2) The individual's initial enrollment period shall begin with the month in which the individual receives notice that the individual's entitlement to benefits under
(3) There shall be a general enrollment period during the period beginning on January 1 and ending on March 31 of each year (beginning with 1990).
(c) Coverage period
(1) The period (in this subsection referred to as a "coverage period") during which an individual is entitled to benefits under the insurance program under this part shall begin on whichever of the following is the latest:
(A) In the case of an individual who enrolls under subsection (b)(2) before the month in which the individual first satisfies subsection (a), the first day of such month.
(B) In the case of an individual who enrolls under subsection (b)(2) in the month in which the individual first satisfies subsection (a), the first day of the month following the month in which the individual so enrolls.
(C) In the case of an individual who enrolls under subsection (b)(2) in the month following the month in which the individual first satisfies subsection (a), the first day of the second month following the month in which the individual so enrolls.
(D) In the case of an individual who enrolls under subsection (b)(2) more than one month following the month in which the individual first satisfies subsection (a), the first day of the third month following the month in which the individual so enrolls.
(E) In the case of an individual who enrolls under subsection (b)(3), the July 1 following the month in which the individual so enrolls.
(2) An individual's coverage period under this section shall continue until the individual's enrollment is terminated as follows:
(A) As of the month following the month in which the Secretary provides notice to the individual that the individual no longer meets the condition described in subsection (a)(2)(B).
(B) As of the month following the month in which the individual files notice that the individual no longer wishes to participate in the insurance program established by this part.
(C) As of the month before the first month in which the individual becomes eligible for hospital insurance benefits under
(D) As of a date, determined under regulations of the Secretary, for nonpayment of premiums.
The regulations under subparagraph (D) may provide a grace period of not longer than 90 days, which may be extended to not to exceed 180 days in any case where the Secretary determines that there was good cause for failure to pay the overdue premiums within such 90-day period. Termination of coverage under this section shall result in simultaneous termination of any coverage affected under any other part of this subchapter.
(3) The provisions of subsections (h), (i), and (m) of
(d) Payment of premiums
(1)(A) Premiums for enrollment under this section shall be paid to the Secretary at such times, and in such manner, as the Secretary shall by regulations prescribe, and shall be deposited in the Treasury to the credit of the Federal Hospital Insurance Trust Fund.
(B)(i) Subject to clause (ii), such premiums shall be payable for the period commencing with the first month of an individual's coverage period and ending with the month in which the individual dies or, if earlier, in which the individual's coverage period terminates.
(ii) Such premiums shall not be payable for any month in which the individual is eligible for benefits under this part pursuant to
(2) The provisions of subsections (d) through (f) of
(Aug. 14, 1935, ch. 531, title XVIII, §1818A, as added
Editorial Notes
Amendments
2020—Subsec. (c)(3).
1990—Subsec. (d)(1)(A).
Subsec. (d)(1)(C).
Statutory Notes and Related Subsidiaries
Effective Date
§1395i–3. Requirements for, and assuring quality of care in, skilled nursing facilities
(a) "Skilled nursing facility" defined
In this subchapter, the term "skilled nursing facility" means an institution (or a distinct part of an institution) which—
(1) is primarily engaged in providing to residents—
(A) skilled nursing care and related services for residents who require medical or nursing care, or
(B) rehabilitation services for the rehabilitation of injured, disabled, or sick persons,
and is not primarily for the care and treatment of mental diseases;
(2) has in effect a transfer agreement (meeting the requirements of
(3) meets the requirements for a skilled nursing facility described in subsections (b), (c), and (d) of this section.
(b) Requirements relating to provision of services
(1) Quality of life
(A) In general
A skilled nursing facility must care for its residents in such a manner and in such an environment as will promote maintenance or enhancement of the quality of life of each resident.
(B) Quality assessment and assurance
A skilled nursing facility must maintain a quality assessment and assurance committee, consisting of the director of nursing services, a physician designated by the facility, and at least 3 other members of the facility's staff, which (i) meets at least quarterly to identify issues with respect to which quality assessment and assurance activities are necessary and (ii) develops and implements appropriate plans of action to correct identified quality deficiencies. A State or the Secretary may not require disclosure of the records of such committee except insofar as such disclosure is related to the compliance of such committee with the requirements of this subparagraph.
(2) Scope of services and activities under plan of care
A skilled nursing facility must provide services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, in accordance with a written plan of care which—
(A) describes the medical, nursing, and psychosocial needs of the resident and how such needs will be met;
(B) is initially prepared, with the participation to the extent practicable of the resident or the resident's family or legal representative, by a team which includes the resident's attending physician and a registered professional nurse with responsibility for the resident; and
(C) is periodically reviewed and revised by such team after each assessment under paragraph (3).
(3) Residents' assessment
(A) Requirement
A skilled nursing facility must conduct a comprehensive, accurate, standardized, reproducible assessment of each resident's functional capacity, which assessment—
(i) describes the resident's capability to perform daily life functions and significant impairments in functional capacity;
(ii) is based on a uniform minimum data set specified by the Secretary under subsection (f)(6)(A);
(iii) uses an instrument which is specified by the State under subsection (e)(5); and
(iv) includes the identification of medical problems.
(B) Certification
(i) In general
Each such assessment must be conducted or coordinated (with the appropriate participation of health professionals) by a registered professional nurse who signs and certifies the completion of the assessment. Each individual who completes a portion of such an assessment shall sign and certify as to the accuracy of that portion of the assessment.
(ii) Penalty for falsification
(I) An individual who willfully and knowingly certifies under clause (i) a material and false statement in a resident assessment is subject to a civil money penalty of not more than $1,000 with respect to each assessment.
(II) An individual who willfully and knowingly causes another individual to certify under clause (i) a material and false statement in a resident assessment is subject to a civil money penalty of not more than $5,000 with respect to each assessment.
(III) The provisions of
(iii) Use of independent assessors
If a State determines, under a survey under subsection (g) or otherwise, that there has been a knowing and willful certification of false assessments under this paragraph, the State may require (for a period specified by the State) that resident assessments under this paragraph be conducted and certified by individuals who are independent of the facility and who are approved by the State.
(C) Frequency
(i) In general
Subject to the timeframes prescribed by the Secretary under
(I) promptly upon (but no later than 14 days after the date of) admission for each individual admitted on or after October 1, 1990, and by not later than January 1, 1991, for each resident of the facility on that date;
(II) promptly after a significant change in the resident's physical or mental condition; and
(III) in no case less often than once every 12 months.
(ii) Resident review
The skilled nursing facility must examine each resident no less frequently than once every 3 months and, as appropriate, revise the resident's assessment to assure the continuing accuracy of the assessment.
(D) Use
The results of such an assessment shall be used in developing, reviewing, and revising the resident's plan of care under paragraph (2).
(E) Coordination
Such assessments shall be coordinated with any State-required preadmission screening program to the maximum extent practicable in order to avoid duplicative testing and effort.
(4) Provision of services and activities
(A) In general
To the extent needed to fulfill all plans of care described in paragraph (2), a skilled nursing facility must provide, directly or under arrangements (or, with respect to dental services, under agreements) with others for the provision of—
(i) nursing services and specialized rehabilitative services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident;
(ii) medically-related social services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident;
(iii) pharmaceutical services (including procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals) to meet the needs of each resident;
(iv) dietary services that assure that the meals meet the daily nutritional and special dietary needs of each resident;
(v) an on-going program, directed by a qualified professional, of activities designed to meet the interests and the physical, mental, and psychosocial well-being of each resident;
(vi) routine and emergency dental services to meet the needs of each resident; and
(vii) treatment and services required by mentally ill and mentally retarded residents not otherwise provided or arranged for (or required to be provided or arranged for) by the State.
The services provided or arranged by the facility must meet professional standards of quality. Nothing in clause (vi) shall be construed as requiring a facility to provide or arrange for dental services described in that clause without additional charge.
(B) Qualified persons providing services
Services described in clauses (i), (ii), (iii), (iv), and (vi) of subparagraph (A) must be provided by qualified persons in accordance with each resident's written plan of care.
(C) Required nursing care
(i) In general
Except as provided in clause (ii), a skilled nursing facility must provide 24-hour licensed nursing service which is sufficient to meet nursing needs of its residents and must use the services of a registered professional nurse at least 8 consecutive hours a day, 7 days a week.
(ii) Exception
To the extent that clause (i) may be deemed to require that a skilled nursing facility engage the services of a registered professional nurse for more than 40 hours a week, the Secretary is authorized to waive such requirement if the Secretary finds that—
(I) the facility is located in a rural area and the supply of skilled nursing facility services in such area is not sufficient to meet the needs of individuals residing therein,
(II) the facility has one full-time registered professional nurse who is regularly on duty at such facility 40 hours a week,
(III) the facility either has only patients whose physicians have indicated (through physicians' orders or admission notes) that each such patient does not require the services of a registered nurse or a physician for a 48-hour period, or has made arrangements for a registered professional nurse or a physician to spend such time at such facility as may be indicated as necessary by the physician to provide necessary skilled nursing services on days when the regular full-time registered professional nurse is not on duty,
(IV) the Secretary provides notice of the waiver to the State long-term care ombudsman (established under section 307(a)(12) 1 of the Older Americans Act of 1965) and the protection and advocacy system in the State for the mentally ill and the mentally retarded, and
(V) the facility that is granted such a waiver notifies residents of the facility (or, where appropriate, the guardians or legal representatives of such residents) and members of their immediate families of the waiver.
A waiver under this subparagraph shall be subject to annual renewal.
(5) Required training of nurse aides
(A) In general
(i) Except as provided in clause (ii), a skilled nursing facility must not use on a full-time basis any individual as a nurse aide in the facility on or after October 1, 1990 for more than 4 months unless the individual—
(I) has completed a training and competency evaluation program, or a competency evaluation program, approved by the State under subsection (e)(1)(A), and
(II) is competent to provide nursing or nursing-related services.
(ii) A skilled nursing facility must not use on a temporary, per diem, leased, or on any basis other than as a permanent employee any individual as a nurse aide in the facility on or after January 1, 1991, unless the individual meets the requirements described in clause (i).
(B) Offering competency evaluation programs for current employees
A skilled nursing facility must provide, for individuals used as a nurse aide 2 by the facility as of January 1, 1990, for a competency evaluation program approved by the State under subsection (e)(1) and such preparation as may be necessary for the individual to complete such a program by October 1, 1990.
(C) Competency
The skilled nursing facility must not permit an individual, other than in a training and competency evaluation program approved by the State, to serve as a nurse aide or provide services of a type for which the individual has not demonstrated competency and must not use such an individual as a nurse aide unless the facility has inquired of any State registry established under subsection (e)(2)(A) that the facility believes will include information concerning the individual.
(D) Re-training required
For purposes of subparagraph (A), if, since an individual's most recent completion of a training and competency evaluation program, there has been a continuous period of 24 consecutive months during none of which the individual performed nursing or nursing-related services for monetary compensation, such individual shall complete a new training and competency evaluation program or a new competency evaluation program.
(E) Regular in-service education
The skilled nursing facility must provide such regular performance review and regular in-service education as assures that individuals used as nurse aides are competent to perform services as nurse aides, including training for individuals providing nursing and nursing-related services to residents with cognitive impairments.
(F) "Nurse aide" defined
In this paragraph, the term "nurse aide" means any individual providing nursing or nursing-related services to residents in a skilled nursing facility, but does not include an individual—
(i) who is a licensed health professional (as defined in subparagraph (G)) or a registered dietician, or
(ii) who volunteers to provide such services without monetary compensation.
Such term includes an individual who provides such services through an agency or under a contract with the facility.
(G) "Licensed health professional" defined
In this paragraph, the term "licensed health professional" means a physician, physician assistant, nurse practitioner, physical, speech, or occupational therapist, physical or occupational therapy assistant, registered professional nurse, licensed practical nurse, licensed or certified social worker, registered respiratory therapist, or certified respiratory therapy technician.
(6) Physician supervision and clinical records
A skilled nursing facility must—
(A) require that the medical care of every resident be provided under the supervision of a physician;
(B) provide for having a physician available to furnish necessary medical care in case of emergency; and
(C) maintain clinical records on all residents, which records include the plans of care (described in paragraph (2)) and the residents' assessments (described in paragraph (3)).
(7) Required social services
In the case of a skilled nursing facility with more than 120 beds, the facility must have at least one social worker (with at least a bachelor's degree in social work or similar professional qualifications) employed full-time to provide or assure the provision of social services.
(8) Information on nurse staffing
(A) In general
A skilled nursing facility shall post daily for each shift the current number of licensed and unlicensed nursing staff directly responsible for resident care in the facility. The information shall be displayed in a uniform manner (as specified by the Secretary) and in a clearly visible place.
(B) Publication of data
A skilled nursing facility shall, upon request, make available to the public the nursing staff data described in subparagraph (A).
(c) Requirements relating to residents' rights
(1) General rights
(A) Specified rights
A skilled nursing facility must protect and promote the rights of each resident, including each of the following rights:
(i) Free choice
The right to choose a personal attending physician, to be fully informed in advance about care and treatment, to be fully informed in advance of any changes in care or treatment that may affect the resident's well-being, and (except with respect to a resident adjudged incompetent) to participate in planning care and treatment or changes in care and treatment.
(ii) Free from restraints
The right to be free from physical or mental abuse, corporal punishment, involuntary seclusion, and any physical or chemical restraints imposed for purposes of discipline or convenience and not required to treat the resident's medical symptoms. Restraints may only be imposed—
(I) to ensure the physical safety of the resident or other residents, and
(II) only upon the written order of a physician that specifies the duration and circumstances under which the restraints are to be used (except in emergency circumstances specified by the Secretary until such an order could reasonably be obtained).
(iii) Privacy
The right to privacy with regard to accommodations, medical treatment, written and telephonic communications, visits, and meetings of family and of resident groups.
(iv) Confidentiality
The right to confidentiality of personal and clinical records and to access to current clinical records of the resident upon request by the resident or the resident's legal representative, within 24 hours (excluding hours occurring during a weekend or holiday) after making such a request.
(v) Accommodation of needs
The right—
(I) to reside and receive services with reasonable accommodation of individual needs and preferences, except where the health or safety of the individual or other residents would be endangered, and
(II) to receive notice before the room or roommate of the resident in the facility is changed.
(vi) Grievances
The right to voice grievances with respect to treatment or care that is (or fails to be) furnished, without discrimination or reprisal for voicing the grievances and the right to prompt efforts by the facility to resolve grievances the resident may have, including those with respect to the behavior of other residents.
(vii) Participation in resident and family groups
The right of the resident to organize and participate in resident groups in the facility and the right of the resident's family to meet in the facility with the families of other residents in the facility.
(viii) Participation in other activities
The right of the resident to participate in social, religious, and community activities that do not interfere with the rights of other residents in the facility.
(ix) Examination of survey results
The right to examine, upon reasonable request, the results of the most recent survey of the facility conducted by the Secretary or a State with respect to the facility and any plan of correction in effect with respect to the facility.
(x) Refusal of certain transfers
The right to refuse a transfer to another room within the facility, if a purpose of the transfer is to relocate the resident from a portion of the facility that is a skilled nursing facility (for purposes of this subchapter) to a portion of the facility that is not such a skilled nursing facility.
(xi) Other rights
Any other right established by the Secretary.
Clause (iii) shall not be construed as requiring the provision of a private room. A resident's exercise of a right to refuse transfer under clause (x) shall not affect the resident's eligibility or entitlement to benefits under this subchapter or to medical assistance under subchapter XIX of this chapter.
(B) Notice of rights and services
A skilled nursing facility must—
(i) inform each resident, orally and in writing at the time of admission to the facility, of the resident's legal rights during the stay at the facility;
(ii) make available to each resident, upon reasonable request, a written statement of such rights (which statement is updated upon changes in such rights) including the notice (if any) of the State developed under
(iii) inform each other resident, in writing before or at the time of admission and periodically during the resident's stay, of services available in the facility and of related charges for such services, including any charges for services not covered under this subchapter or by the facility's basic per diem charge.
The written description of legal rights under this subparagraph shall include a description of the protection of personal funds under paragraph (6) and a statement that a resident may file a complaint with a State survey and certification agency respecting resident abuse and neglect and misappropriation of resident property in the facility.
(C) Rights of incompetent residents
In the case of a resident adjudged incompetent under the laws of a State, the rights of the resident under this subchapter shall devolve upon, and, to the extent judged necessary by a court of competent jurisdiction, be exercised by, the person appointed under State law to act on the resident's behalf.
(D) Use of psychopharmacologic drugs
Psychopharmacologic drugs may be administered only on the orders of a physician and only as part of a plan (included in the written plan of care described in paragraph (2)) designed to eliminate or modify the symptoms for which the drugs are prescribed and only if, at least annually, an independent, external consultant reviews the appropriateness of the drug plan of each resident receiving such drugs. In determining whether such a consultant is qualified to conduct reviews under the preceding sentence, the Secretary shall take into account the needs of nursing facilities under this subchapter to have access to the services of such a consultant on a timely basis.
(E) Information respecting advance directives
A skilled nursing facility must comply with the requirement of
(2) Transfer and discharge rights
(A) In general
A skilled nursing facility must permit each resident to remain in the facility and must not transfer or discharge the resident from the facility unless—
(i) the transfer or discharge is necessary to meet the resident's welfare and the resident's welfare cannot be met in the facility;
(ii) the transfer or discharge is appropriate because the resident's health has improved sufficiently so the resident no longer needs the services provided by the facility;
(iii) the safety of individuals in the facility is endangered;
(iv) the health of individuals in the facility would otherwise be endangered;
(v) the resident has failed, after reasonable and appropriate notice, to pay (or to have paid under this subchapter or subchapter XIX on the resident's behalf) for a stay at the facility; or
(vi) the facility ceases to operate.
In each of the cases described in clauses (i) through (v), the basis for the transfer or discharge must be documented in the resident's clinical record. In the cases described in clauses (i) and (ii), the documentation must be made by the resident's physician, and in the cases described in clauses (iii) and (iv) the documentation must be made by a physician.
(B) Pre-transfer and pre-discharge notice
(i) In general
Before effecting a transfer or discharge of a resident, a skilled nursing facility must—
(I) notify the resident (and, if known, a family member of the resident or legal representative) of the transfer or discharge and the reasons therefor,
(II) record the reasons in the resident's clinical record (including any documentation required under subparagraph (A)), and
(III) include in the notice the items described in clause (iii).
(ii) Timing of notice
The notice under clause (i)(I) must be made at least 30 days in advance of the resident's transfer or discharge except—
(I) in a case described in clause (iii) or (iv) of subparagraph (A);
(II) in a case described in clause (ii) of subparagraph (A), where the resident's health improves sufficiently to allow a more immediate transfer or discharge;
(III) in a case described in clause (i) of subparagraph (A), where a more immediate transfer or discharge is necessitated by the resident's urgent medical needs; or
(IV) in a case where a resident has not resided in the facility for 30 days.
In the case of such exceptions, notice must be given as many days before the date of the transfer or discharge as is practicable.
(iii) Items included in notice
Each notice under clause (i) must include—
(I) for transfers or discharges effected on or after October 1, 1990, notice of the resident's right to appeal the transfer or discharge under the State process established under subsection (e)(3); and
(II) the name, mailing address, and telephone number of the State long-term care ombudsman (established under title III or VII of the Older Americans Act of 1965 [
(C) Orientation
A skilled nursing facility must provide sufficient preparation and orientation to residents to ensure safe and orderly transfer or discharge from the facility.
(3) Access and visitation rights
A skilled nursing facility must—
(A) permit immediate access to any resident by any representative of the Secretary, by any representative of the State, by an ombudsman described in paragraph (2)(B)(iii)(II), or by the resident's individual physician;
(B) permit immediate access to a resident, subject to the resident's right to deny or withdraw consent at any time, by immediate family or other relatives of the resident;
(C) permit immediate access to a resident, subject to reasonable restrictions and the resident's right to deny or withdraw consent at any time, by others who are visiting with the consent of the resident;
(D) permit reasonable access to a resident by any entity or individual that provides health, social, legal, or other services to the resident, subject to the resident's right to deny or withdraw consent at any time; and
(E) permit representatives of the State ombudsman (described in paragraph (2)(B)(iii)(II)), with the permission of the resident (or the resident's legal representative) and consistent with State law, to examine a resident's clinical records.
(4) Equal access to quality care
A skilled nursing facility must establish and maintain identical policies and practices regarding transfer, discharge, and covered services under this subchapter for all individuals regardless of source of payment.
(5) Admissions policy
(A) Admissions
With respect to admissions practices, a skilled nursing facility must—
(i)(I) not require individuals applying to reside or residing in the facility to waive their rights to benefits under this subchapter or under a State plan under subchapter XIX, (II) not require oral or written assurance that such individuals are not eligible for, or will not apply for, benefits under this subchapter or such a State plan, and (III) prominently display in the facility and provide to such individuals written information about how to apply for and use such benefits and how to receive refunds for previous payments covered by such benefits; and
(ii) not require a third party guarantee of payment to the facility as a condition of admission (or expedited admission) to, or continued stay in, the facility.
(B) Construction
(i) No preemption of stricter standards
Subparagraph (A) shall not be construed as preventing States or political subdivisions therein from prohibiting, under State or local law, the discrimination against individuals who are entitled to medical assistance under this subchapter with respect to admissions practices of skilled nursing facilities.
(ii) Contracts with legal representatives
Subparagraph (A)(ii) shall not be construed as preventing a facility from requiring an individual, who has legal access to a resident's income or resources available to pay for care in the facility, to sign a contract (without incurring personal financial liability) to provide payment from the resident's income or resources for such care.
(6) Protection of resident funds
(A) In general
The skilled nursing facility—
(i) may not require residents to deposit their personal funds with the facility, and
(ii) upon the written authorization of the resident, must hold, safeguard, and account for such personal funds under a system established and maintained by the facility in accordance with this paragraph.
(B) Management of personal funds
Upon written authorization of a resident under subparagraph (A)(ii), the facility must manage and account for the personal funds of the resident deposited with the facility as follows:
(i) Deposit
The facility must deposit any amount of personal funds in excess of $100 with respect to a resident in an interest bearing account (or accounts) that is separate from any of the facility's operating accounts and credits 3 all interest earned on such separate account to such account. With respect to any other personal funds, the facility must maintain such funds in a non-interest bearing account or petty cash fund.
(ii) Accounting and records
The facility must assure a full and complete separate accounting of each such resident's personal funds, maintain a written record of all financial transactions involving the personal funds of a resident deposited with the facility, and afford the resident (or a legal representative of the resident) reasonable access to such record.
(iii) Conveyance upon death
Upon the death of a resident with such an account, the facility must convey promptly the resident's personal funds (and a final accounting of such funds) to the individual administering the resident's estate.
(C) Assurance of financial security
The facility must purchase a surety bond, or otherwise provide assurance satisfactory to the Secretary, to assure the security of all personal funds of residents deposited with the facility.
(D) Limitation on charges to personal funds
The facility may not impose a charge against the personal funds of a resident for any item or service for which payment is made under this subchapter or subchapter XIX.
(d) Requirements relating to administration and other matters
(1) Administration
(A) In general
A skilled nursing facility must be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident (consistent with requirements established under subsection (f)(5)).
(B) Skilled nursing facility administrator
The administrator of a skilled nursing facility must meet standards established by the Secretary under subsection (f)(4).
(C) Availability of survey, certification, and complaint investigation reports
A skilled nursing facility must—
(i) have reports with respect to any surveys, certifications, and complaint investigations made respecting the facility during the 3 preceding years available for any individual to review upon request; and
(ii) post notice of the availability of such reports in areas of the facility that are prominent and accessible to the public.
The facility shall not make available under clause (i) identifying information about complainants or residents.
(2) Licensing and Life Safety Code
(A) Licensing
A skilled nursing facility must be licensed under applicable State and local law.
(B) Life Safety Code
A skilled nursing facility must meet such provisions of such edition (as specified by the Secretary in regulation) of the Life Safety Code of the National Fire Protection Association as are applicable to nursing homes; except that—
(i) the Secretary may waive, for such periods as he deems appropriate, specific provisions of such Code which if rigidly applied would result in unreasonable hardship upon a facility, but only if such waiver would not adversely affect the health and safety of residents or personnel, and
(ii) the provisions of such Code shall not apply in any State if the Secretary finds that in such State there is in effect a fire and safety code, imposed by State law, which adequately protects residents of and personnel in skilled nursing facilities.
(3) Sanitary and infection control and physical environment
A skilled nursing facility must—
(A) establish and maintain an infection control program designed to provide a safe, sanitary, and comfortable environment in which residents reside and to help prevent the development and transmission of disease and infection, and
(B) be designed, constructed, equipped, and maintained in a manner to protect the health and safety of residents, personnel, and the general public.
(4) Miscellaneous
(A) Compliance with Federal, State, and local laws and professional standards
A skilled nursing facility must operate and provide services in compliance with all applicable Federal, State, and local laws and regulations (including the requirements of
(B) Other
A skilled nursing facility must meet such other requirements relating to the health, safety, and well-being of residents or relating to the physical facilities thereof as the Secretary may find necessary.
(e) State requirements relating to skilled nursing facility requirements
The requirements, referred to in
(1) Specification and review of nurse aide training and competency evaluation programs and of nurse aide competency evaluation programs
The State must—
(A) by not later than January 1, 1989, specify those training and competency evaluation programs, and those competency evaluation programs, that the State approves for purposes of subsection (b)(5) and that meet the requirements established under subsection (f)(2), and
(B) by not later than January 1, 1990, provide for the review and reapproval of such programs, at a frequency and using a methodology consistent with the requirements established under subsection (f)(2)(A)(iii).
The failure of the Secretary to establish requirements under subsection (f)(2) shall not relieve any State of its responsibility under this paragraph.
(2) Nurse aide registry
(A) In general
By not later than January 1, 1989, the State shall establish and maintain a registry of all individuals who have satisfactorily completed a nurse aide training and competency evaluation program, or a nurse aide competency evaluation program, approved under paragraph (1) in the State, or any individual described in subsection (f)(2)(B)(ii) or in subparagraph (B), (C), or (D) of section 6901(b)(4) of the Omnibus Budget Reconciliation Act of 1989.
(B) Information in registry
The registry under subparagraph (A) shall provide (in accordance with regulations of the Secretary) for the inclusion of specific documented findings by a State under subsection (g)(1)(C) of resident neglect or abuse or misappropriation of resident property involving an individual listed in the registry, as well as any brief statement of the individual disputing the findings, but shall not include any allegations of resident abuse or neglect or misappropriation of resident property that are not specifically documented by the State under such subsection. The State shall make available to the public information in the registry. In the case of inquiries to the registry concerning an individual listed in the registry, any information disclosed concerning such a finding shall also include disclosure of any such statement in the registry relating to the finding or a clear and accurate summary of such a statement.
(C) Prohibition against charges
A State may not impose any charges on a nurse aide relating to the registry established and maintained under subparagraph (A).
(3) State appeals process for transfers and discharges
The State, for transfers and discharges from skilled nursing facilities effected on or after October 1, 1989, must provide for a fair mechanism for hearing appeals on transfers and discharges of residents of such facilities. Such mechanism must meet the guidelines established by the Secretary under subsection (f)(3); but the failure of the Secretary to establish such guidelines shall not relieve any State of its responsibility to provide for such a fair mechanism.
(4) Skilled nursing facility administrator standards
By not later than January 1, 1990, the State must have implemented and enforced the skilled nursing facility administrator standards developed under subsection (f)(4) respecting the qualification of administrators of skilled nursing facilities.
(5) Specification of resident assessment instrument
Effective July 1, 1990, the State shall specify the instrument to be used by nursing facilities in the State in complying with the requirement of subsection (b)(3)(A)(iii). Such instrument shall be—
(A) one of the instruments designated under subsection (f)(6)(B), or
(B) an instrument which the Secretary has approved as being consistent with the minimum data set of core elements, common definitions, and utilization guidelines specified by the Secretary under subsection (f)(6)(A).
(f) Responsibilities of Secretary relating to skilled nursing facility requirements
(1) General responsibility
It is the duty and responsibility of the Secretary to assure that requirements which govern the provision of care in skilled nursing facilities under this subchapter, and the enforcement of such requirements, are adequate to protect the health, safety, welfare, and rights of residents and to promote the effective and efficient use of public moneys.
(2) Requirements for nurse aide training and competency evaluation programs and for nurse aide competency evaluation programs
(A) In general
For purposes of subsections (b)(5) and (e)(1)(A), the Secretary shall establish, by not later than September 1, 1988—
(i) requirements for the approval of nurse aide training and competency evaluation programs, including requirements relating to (I) the areas to be covered in such a program (including at least basic nursing skills, personal care skills, recognition of mental health and social service needs, care of cognitively impaired residents, basic restorative services, and residents' rights) and content of the curriculum (including, in the case of initial training and, if the Secretary determines appropriate, in the case of ongoing training, dementia management training, and patient abuse prevention training,4 (II) minimum hours of initial and ongoing training and retraining (including not less than 75 hours in the case of initial training), (III) qualifications of instructors, and (IV) procedures for determination of competency;
(ii) requirements for the approval of nurse aide competency evaluation programs, including requirement relating to the areas to be covered in such a program, including at least basic nursing skills, personal care skills, recognition of mental health and social service needs, care of cognitively impaired residents, basic restorative services, residents' rights, and procedures for determination of competency;
(iii) requirements respecting the minimum frequency and methodology to be used by a State in reviewing such programs' compliance with the requirements for such programs; and
(iv) requirements, under both such programs, that—
(I) provide procedures for determining competency that permit a nurse aide, at the nurse aide's option, to establish competency through procedures or methods other than the passing of a written examination and to have the competency evaluation conducted at the nursing facility at which the aide is (or will be) employed (unless the facility is described in subparagraph (B)(iii)(I)),
(II) prohibit the imposition on a nurse aide who is employed by (or who has received an offer of employment from) a facility on the date on which the aide begins either such program of any charges (including any charges for textbooks and other required course materials and any charges for the competency evaluation) for either such program, and
(III) in the case of a nurse aide not described in subclause (II) who is employed by (or who has received an offer of employment from) a facility not later than 12 months after completing either such program, the State shall provide for the reimbursement of costs incurred in completing such program on a prorata 5 basis during the period in which the nurse aide is so employed.
(B) Approval of certain programs
Such requirements—
(i) may permit approval of programs offered by or in facilities (subject to clause (iii)), as well as outside facilities (including employee organizations), and of programs in effect on December 22, 1987;
(ii) shall permit a State to find that an individual who has completed (before July 1, 1989) a nurse aide training and competency evaluation program shall be deemed to have completed such a program approved under subsection (b)(5) if the State determines that, at the time the program was offered, the program met the requirements for approval under such paragraph; and
(iii) subject to subparagraphs (C) and (D), shall prohibit approval of such a program—
(I) offered by or in a skilled nursing facility which, within the previous 2 years—
(a) has operated under a waiver under subsection (b)(4)(C)(ii)(II);
(b) has been subject to an extended (or partial extended) survey under subsection (g)(2)(B)(i) or
(c) has been assessed a civil money penalty described in subsection (h)(2)(B)(ii) or
(II) offered by or in a skilled nursing facility unless the State makes the determination, upon an individual's completion of the program, that the individual is competent to provide nursing and nursing-related services in skilled nursing facilities.
A State may not delegate (through subcontract or otherwise) its responsibility under clause (iii)(II) to the skilled nursing facility.
(C) Waiver authorized
Clause (iii)(I) of subparagraph (B) shall not apply to a program offered in (but not by) a nursing facility (or skilled nursing facility for purposes of this subchapter) in a State if the State—
(i) determines that there is no other such program offered within a reasonable distance of the facility,
(ii) assures, through an oversight effort, that an adequate environment exists for operating the program in the facility, and
(iii) provides notice of such determination and assurances to the State long-term care ombudsman.
(D) Waiver of disapproval of nurse-aide training programs
Upon application of a nursing facility, the Secretary may waive the application of subparagraph (B)(iii)(I)(c) if the imposition of the civil monetary penalty was not related to the quality of care provided to residents of the facility. Nothing in this subparagraph shall be construed as eliminating any requirement upon a facility to pay a civil monetary penalty described in the preceding sentence.
(3) Federal guidelines for State appeals process for transfers and discharges
For purposes of subsections (c)(2)(B)(iii)(I) and (e)(3), by not later than October 1, 1988, the Secretary shall establish guidelines for minimum standards which State appeals processes under subsection (e)(3) must meet to provide a fair mechanism for hearing appeals on transfers and discharges of residents from skilled nursing facilities.
(4) Secretarial standards for qualification of administrators
For purposes of subsections (d)(1)(C) and (e)(4), the Secretary shall develop, by not later than March 1, 1989, standards to be applied in assuring the qualifications of administrators of skilled nursing facilities.
(5) Criteria for administration
The Secretary shall establish criteria for assessing a skilled nursing facility's compliance with the requirement of subsection (d)(1) with respect to—
(A) its governing body and management,
(B) agreements with hospitals regarding transfers of residents to and from the hospitals and to and from other skilled nursing facilities,
(C) disaster preparedness,
(D) direction of medical care by a physician,
(E) laboratory and radiological services,
(F) clinical records, and
(G) resident and advocate participation.
(6) Specification of resident assessment data set and instruments
The Secretary shall—
(A) not later than January 1, 1989, specify a minimum data set of core elements and common definitions for use by nursing facilities in conducting the assessments required under subsection (b)(3), and establish guidelines for utilization of the data set; and
(B) by not later than April 1, 1990, designate one or more instruments which are consistent with the specification made under subparagraph (A) and which a State may specify under subsection (e)(5)(A) for use by nursing facilities in complying with the requirements of subsection (b)(3)(A)(iii).
(7) List of items and services furnished in skilled nursing facilities not chargeable to the personal funds of a resident
(A) Regulations required
Pursuant to the requirement of section 21(b) of the Medicare-Medicaid Anti-Fraud and Abuse Amendments of 1977, the Secretary shall issue regulations, on or before the first day of the seventh month to begin after December 22, 1987, that define those costs which may be charged to the personal funds of residents in skilled nursing facilities who are individuals receiving benefits under this part and those costs which are to be included in the reasonable cost (or other payment amount) under this subchapter for extended care services.
(B) Rule if failure to publish regulations
If the Secretary does not issue the regulations under subparagraph (A) on or before the date required in such subparagraph, in the case of a resident of a skilled nursing facility who is eligible to receive benefits under this part, the costs which may not be charged to the personal funds of such resident (and for which payment is considered to be made under this subchapter) shall include, at a minimum, the costs for routine personal hygiene items and services furnished by the facility.
(8) Special focus facility program
(A) In general
The Secretary shall conduct a special focus facility program for enforcement of requirements for skilled nursing facilities that the Secretary has identified as having substantially failed to meet applicable requirement 6 of this chapter.
(B) Periodic surveys
Under such program the Secretary shall conduct surveys of each facility in the program not less than once every 6 months.
(g) Survey and certification process
(1) State and Federal responsibility
(A) In general
Pursuant to an agreement under
(B) Educational program
Each State shall conduct periodic educational programs for the staff and residents (and their representatives) of skilled nursing facilities in order to present current regulations, procedures, and policies under this section.
(C) Investigation of allegations of resident neglect and abuse and misappropriation of resident property
The State shall provide, through the agency responsible for surveys and certification of nursing facilities under this subsection, for a process for the receipt and timely review and investigation of allegations of neglect and abuse and misappropriation of resident property by a nurse aide of a resident in a nursing facility or by another individual used by the facility in providing services to such a resident. The State shall, after providing the individual involved with a written notice of the allegations (including a statement of the availability of a hearing for the individual to rebut the allegations) and the opportunity for a hearing on the record, make a written finding as to the accuracy of the allegations. If the State finds that a nurse aide has neglected or abused a resident or misappropriated resident property in a facility, the State shall notify the nurse aide and the registry of such finding. If the State finds that any other individual used by the facility has neglected or abused a resident or misappropriated resident property in a facility, the State shall notify the appropriate licensure authority. A State shall not make a finding that an individual has neglected a resident if the individual demonstrates that such neglect was caused by factors beyond the control of the individual.
(D) Removal of name from nurse aide registry
(i) In general
In the case of a finding of neglect under subparagraph (C), the State shall establish a procedure to permit a nurse aide to petition the State to have his or her name removed from the registry upon a determination by the State that—
(I) the employment and personal history of the nurse aide does not reflect a pattern of abusive behavior or neglect; and
(II) the neglect involved in the original finding was a singular occurrence.
(ii) Timing of determination
In no case shall a determination on a petition submitted under clause (i) be made prior to the expiration of the 1-year period beginning on the date on which the name of the petitioner was added to the registry under subparagraph (C).
(E) Construction
The failure of the Secretary to issue regulations to carry out this subsection shall not relieve a State of its responsibility under this subsection.
(2) Surveys
(A) Standard survey
(i) In general
Each skilled nursing facility shall be subject to a standard survey, to be conducted without any prior notice to the facility. Any individual who notifies (or causes to be notified) a skilled nursing facility of the time or date on which such a survey is scheduled to be conducted is subject to a civil money penalty of not to exceed $2,000. The provisions of
(ii) Contents
Each standard survey shall include, for a case-mix stratified sample of residents—
(I) a survey of the quality of care furnished, as measured by indicators of medical, nursing, and rehabilitative care, dietary and nutrition services, activities and social participation, and sanitation, infection control, and the physical environment,
(II) written plans of care provided under subsection (b)(2) and an audit of the residents' assessments under subsection (b)(3) to determine the accuracy of such assessments and the adequacy of such plans of care, and
(III) a review of compliance with residents' rights under subsection (c).
(iii) Frequency
(I) In general
Each skilled nursing facility shall be subject to a standard survey not later than 15 months after the date of the previous standard survey conducted under this subparagraph. The Statewide average interval between standard surveys of skilled nursing facilities under this subsection shall not exceed 12 months.
(II) Special surveys
If not otherwise conducted under subclause (I), a standard survey (or an abbreviated standard survey) may be conducted within 2 months of any change of ownership, administration, management of a skilled nursing facility, or the director of nursing in order to determine whether the change has resulted in any decline in the quality of care furnished in the facility.
(B) Extended surveys
(i) In general
Each skilled nursing facility which is found, under a standard survey, to have provided substandard quality of care shall be subject to an extended survey. Any other facility may, at the Secretary's or State's discretion, be subject to such an extended survey (or a partial extended survey).
(ii) Timing
The extended survey shall be conducted immediately after the standard survey (or, if not practicable, not later than 2 weeks after the date of completion of the standard survey).
(iii) Contents
In such an extended survey, the survey team shall review and identify the policies and procedures which produced such substandard quality of care and shall determine whether the facility has complied with all the requirements described in subsections (b), (c), and (d). Such review shall include an expansion of the size of the sample of residents' assessments reviewed and a review of the staffing, of in-service training, and, if appropriate, of contracts with consultants.
(iv) Construction
Nothing in this paragraph shall be construed as requiring an extended or partial extended survey as a prerequisite to imposing a sanction against a facility under subsection (h) on the basis of findings in a standard survey.
(C) Survey protocol
Standard and extended surveys shall be conducted—
(i) based upon a protocol which the Secretary has developed, tested, and validated by not later than January 1, 1990, and
(ii) by individuals, of a survey team, who meet such minimum qualifications as the Secretary establishes by not later than such date.
The failure of the Secretary to develop, test, or validate such protocols or to establish such minimum qualifications shall not relieve any State of its responsibility (or the Secretary of the Secretary's responsibility) to conduct surveys under this subsection.
(D) Consistency of surveys
Each State and the Secretary shall implement programs to measure and reduce inconsistency in the application of survey results among surveyors.
(E) Survey teams
(i) In general
Surveys under this subsection shall be conducted by a multidisciplinary team of professionals (including a registered professional nurse).
(ii) Prohibition of conflicts of interest
A State may not use as a member of a survey team under this subsection an individual who is serving (or has served within the previous 2 years) as a member of the staff of, or as a consultant to, the facility surveyed respecting compliance with the requirements of subsections (b), (c), and (d), or who has a personal or familial financial interest in the facility being surveyed.
(iii) Training
The Secretary shall provide for the comprehensive training of State and Federal surveyors in the conduct of standard and extended surveys under this subsection, including the auditing of resident assessments and plans of care. No individual shall serve as a member of a survey team unless the individual has successfully completed a training and testing program in survey and certification techniques that has been approved by the Secretary.
(3) Validation surveys
(A) In general
The Secretary shall conduct onsite surveys of a representative sample of skilled nursing facilities in each State, within 2 months of the date of surveys conducted under paragraph (2) by the State, in a sufficient number to allow inferences about the adequacies of each State's surveys conducted under paragraph (2). In conducting such surveys, the Secretary shall use the same survey protocols as the State is required to use under paragraph (2). If the State has determined that an individual skilled nursing facility meets the requirements of subsections (b), (c), and (d), but the Secretary determines that the facility does not meet such requirements, the Secretary's determination as to the facility's noncompliance with such requirements is binding and supersedes that of the State survey.
(B) Scope
With respect to each State, the Secretary shall conduct surveys under subparagraph (A) each year with respect to at least 5 percent of the number of skilled nursing facilities surveyed by the State in the year, but in no case less than 5 skilled nursing facilities in the State.
(C) Remedies for substandard performance
If the Secretary finds, on the basis of such surveys, that a State has failed to perform surveys as required under paragraph (2) or that a State's survey and certification performance otherwise is not adequate, the Secretary shall provide for an appropriate remedy, which may include the training of survey teams in the State.
(D) Special surveys of compliance
Where the Secretary has reason to question the compliance of a skilled nursing facility with any of the requirements of subsections (b), (c), and (d), the Secretary may conduct a survey of the facility and, on the basis of that survey, make independent and binding determinations concerning the extent to which the skilled nursing facility meets such requirements.
(4) Investigation of complaints and monitoring compliance
Each State shall maintain procedures and adequate staff to—
(A) investigate complaints of violations of requirements by skilled nursing facilities, and
(B) monitor, on-site, on a regular, as needed basis, a skilled nursing facility's compliance with the requirements of subsections (b), (c), and (d), if—
(i) the facility has been found not to be in compliance with such requirements and is in the process of correcting deficiencies to achieve such compliance;
(ii) the facility was previously found not to be in compliance with such requirements, has corrected deficiencies to achieve such compliance, and verification of continued compliance is indicated; or
(iii) the State has reason to question the compliance of the facility with such requirements.
A State may maintain and utilize a specialized team (including an attorney, an auditor, and appropriate health care professionals) for the purpose of identifying, surveying, gathering and preserving evidence, and carrying out appropriate enforcement actions against substandard skilled nursing facilities.
(5) Disclosure of results of inspections and activities
(A) Public information
Each State, and the Secretary, shall make available to the public—
(i) information respecting all surveys and certifications made respecting skilled nursing facilities, including statements of deficiencies, within 14 calendar days after such information is made available to those facilities, and approved plans of correction,
(ii) copies of cost reports of such facilities filed under this subchapter or subchapter XIX,
(iii) copies of statements of ownership under
(iv) information disclosed under
(B) Notice to ombudsman
Each State shall notify the State long-term care ombudsman (established under title III or VII of the Older Americans Act of 1965 [
(C) Notice to physicians and skilled nursing facility administrator licensing board
If a State finds that a skilled nursing facility has provided substandard quality of care, the State shall notify—
(i) the attending physician of each resident with respect to which such finding is made, and
(ii) the State board responsible for the licensing of the skilled nursing facility administrator at the facility.
(D) Access to fraud control units
Each State shall provide its State medicaid fraud and abuse control unit (established under
(E) Submission of survey and certification information to the Secretary
In order to improve the timeliness of information made available to the public under subparagraph (A) and provided on the Nursing Home Compare Medicare website under subsection (i), each State shall submit information respecting any survey or certification made respecting a skilled nursing facility (including any enforcement actions taken by the State) to the Secretary not later than the date on which the State sends such information to the facility. The Secretary shall use the information submitted under the preceding sentence to update the information provided on the Nursing Home Compare Medicare website as expeditiously as practicable but not less frequently than quarterly.
(h) Enforcement process
(1) In general
If a State finds, on the basis of a standard, extended, or partial extended survey under subsection (g)(2) or otherwise, that a skilled nursing facility no longer meets a requirement of subsection (b), (c), or (d), and further finds that the facility's deficiencies—
(A) immediately jeopardize the health or safety of its residents, the State shall recommend to the Secretary that the Secretary take such action as described in paragraph (2)(A)(i); or
(B) do not immediately jeopardize the health or safety of its residents, the State may recommend to the Secretary that the Secretary take such action as described in paragraph (2)(A)(ii).
If a State finds that a skilled nursing facility meets the requirements of subsections (b), (c), and (d), but, as of a previous period, did not meet such requirements, the State may recommend a civil money penalty under paragraph (2)(B)(ii) for the days in which it finds that the facility was not in compliance with such requirements.
(2) Secretarial authority
(A) In general
With respect to any skilled nursing facility in a State, if the Secretary finds, or pursuant to a recommendation of the State under paragraph (1) finds, that a skilled nursing facility no longer meets a requirement of subsection (b), (c), (d), or (e), and further finds that the facility's deficiencies—
(i) immediately jeopardize the health or safety of its residents, the Secretary shall take immediate action to remove the jeopardy and correct the deficiencies through the remedy specified in subparagraph (B)(iii), or terminate the facility's participation under this subchapter and may provide, in addition, for one or more of the other remedies described in subparagraph (B); or
(ii) do not immediately jeopardize the health or safety of its residents, the Secretary may impose any of the remedies described in subparagraph (B).
Nothing in this subparagraph shall be construed as restricting the remedies available to the Secretary to remedy a skilled nursing facility's deficiencies. If the Secretary finds, or pursuant to the recommendation of the State under paragraph (1) finds, that a skilled nursing facility meets such requirements but, as of a previous period, did not meet such requirements, the Secretary may provide for a civil money penalty under subparagraph (B)(ii) for the days on which he finds that the facility was not in compliance with such requirements.
(B) Specified remedies
The Secretary may take the following actions with respect to a finding that a facility has not met an applicable requirement:
(i) Denial of payment
The Secretary may deny any further payments under this subchapter with respect to all individuals entitled to benefits under this subchapter in the facility or with respect to such individuals admitted to the facility after the effective date of the finding.
(ii) Authority with respect to civil money penalties
(I) In general
Subject to subclause (II), the Secretary may impose a civil money penalty in an amount not to exceed $10,000 for each day of noncompliance. The provisions of
(II) Reduction of civil money penalties in certain circumstances
Subject to subclause (III), in the case where a facility self-reports and promptly corrects a deficiency for which a penalty was imposed under this clause not later than 10 calendar days after the date of such imposition, the Secretary may reduce the amount of the penalty imposed by not more than 50 percent.
(III) Prohibitions on reduction for certain deficiencies
(aa) Repeat deficiencies
The Secretary may not reduce the amount of a penalty under subclause (II) if the Secretary had reduced a penalty imposed on the facility in the preceding year under such subclause with respect to a repeat deficiency.
(bb) Certain other deficiencies
The Secretary may not reduce the amount of a penalty under subclause (II) if the penalty is imposed on the facility for a deficiency that is found to result in a pattern of harm or widespread harm, immediately jeopardizes the health or safety of a resident or residents of the facility, or results in the death of a resident of the facility.
(IV) Collection of civil money penalties
In the case of a civil money penalty imposed under this clause, the Secretary shall issue regulations that—
(aa) subject to item (cc), not later than 30 days after the imposition of the penalty, provide for the facility to have the opportunity to participate in an independent informal dispute resolution process which generates a written record prior to the collection of such penalty;
(bb) in the case where the penalty is imposed for each day of noncompliance, provide that a penalty may not be imposed for any day during the period beginning on the initial day of the imposition of the penalty and ending on the day on which the informal dispute resolution process under item (aa) is completed;
(cc) may provide for the collection of such civil money penalty and the placement of such amounts collected in an escrow account under the direction of the Secretary on the earlier of the date on which the informal dispute resolution process under item (aa) is completed or the date that is 90 days after the date of the imposition of the penalty;
(dd) may provide that such amounts collected are kept in such account pending the resolution of any subsequent appeals;
(ee) in the case where the facility successfully appeals the penalty, may provide for the return of such amounts collected (plus interest) to the facility; and
(ff) in the case where all such appeals are unsuccessful, may provide that some portion of such amounts collected may be used to support activities that benefit residents, including assistance to support and protect residents of a facility that closes (voluntarily or involuntarily) or is decertified (including offsetting costs of relocating residents to home and community-based settings or another facility), projects that support resident and family councils and other consumer involvement in assuring quality care in facilities, and facility improvement initiatives approved by the Secretary (including joint training of facility staff and surveyors, technical assistance for facilities implementing quality assurance programs, the appointment of temporary management firms, and other activities approved by the Secretary).
(iii) Appointment of temporary management
In consultation with the State, the Secretary may appoint temporary management to oversee the operation of the facility and to assure the health and safety of the facility's residents, where there is a need for temporary management while—
(I) there is an orderly closure of the facility, or
(II) improvements are made in order to bring the facility into compliance with all the requirements of subsections (b), (c), and (d).
The temporary management under this clause shall not be terminated under subclause (II) until the Secretary has determined that the facility has the management capability to ensure continued compliance with all the requirements of subsections (b), (c), and (d).
The Secretary shall specify criteria, as to when and how each of such remedies is to be applied, the amounts of any fines, and the severity of each of these remedies, to be used in the imposition of such remedies. Such criteria shall be designed so as to minimize the time between the identification of violations and final imposition of the remedies and shall provide for the imposition of incrementally more severe fines for repeated or uncorrected deficiencies. In addition, the Secretary may provide for other specified remedies, such as directed plans of correction.
(C) Continuation of payments pending remediation
The Secretary may continue payments, over a period of not longer than 6 months after the effective date of the findings, under this subchapter with respect to a skilled nursing facility not in compliance with a requirement of subsection (b), (c), or (d), if—
(i) the State survey agency finds that it is more appropriate to take alternative action to assure compliance of the facility with the requirements than to terminate the certification of the facility,
(ii) the State has submitted a plan and timetable for corrective action to the Secretary for approval and the Secretary approves the plan of corrective action, and
(iii) the facility agrees to repay to the Federal Government payments received under this subparagraph if the corrective action is not taken in accordance with the approved plan and timetable.
The Secretary shall establish guidelines for approval of corrective actions requested by States under this subparagraph.
(D) Assuring prompt compliance
If a skilled nursing facility has not complied with any of the requirements of subsections (b), (c), and (d), within 3 months after the date the facility is found to be out of compliance with such requirements, the Secretary shall impose the remedy described in subparagraph (B)(i) for all individuals who are admitted to the facility after such date.
(E) Repeated noncompliance
In the case of a skilled nursing facility which, on 3 consecutive standard surveys conducted under subsection (g)(2), has been found to have provided substandard quality of care, the Secretary shall (regardless of what other remedies are provided)—
(i) impose the remedy described in subparagraph (B)(i), and
(ii) monitor the facility under subsection (g)(4)(B),
until the facility has demonstrated, to the satisfaction of the Secretary, that it is in compliance with the requirements of subsections (b), (c), and (d), and that it will remain in compliance with such requirements.
(3) Effective period of denial of payment
A finding to deny payment under this subsection shall terminate when the Secretary finds that the facility is in substantial compliance with all the requirements of subsections (b), (c), and (d).
(4) Immediate termination of participation for facility where Secretary finds noncompliance and immediate jeopardy
If the Secretary finds that a skilled nursing facility has not met a requirement of subsection (b), (c), or (d), and finds that the failure immediately jeopardizes the health or safety of its residents, the Secretary shall take immediate action to remove the jeopardy and correct the deficiencies through the remedy specified in paragraph (2)(B)(iii), or the Secretary, subject to
(5) Construction
The remedies provided under this subsection are in addition to those otherwise available under State or Federal law and shall not be construed as limiting such other remedies, including any remedy available to an individual at common law. The remedies described in clauses (i), (ii)(IV), and (iii) of paragraph (2)(B) may be imposed during the pendency of any hearing.
(6) Sharing of information
Notwithstanding any other provision of law, all information concerning skilled nursing facilities required by this section to be filed with the Secretary or a State agency shall be made available by such facilities to Federal or State employees for purposes consistent with the effective administration of programs established under this subchapter and subchapter XIX, including investigations by State medicaid fraud control units.
(i) Nursing Home Compare website
(1) Inclusion of additional information
(A) In general
The Secretary shall ensure that the Department of Health and Human Services includes, as part of the information provided for comparison of nursing homes on the official Internet website of the Federal Government for Medicare beneficiaries (commonly referred to as the "Nursing Home Compare" Medicare website) (or a successor website), the following information in a manner that is prominent, updated on a timely basis, easily accessible, readily understandable to consumers of long-term care services, and searchable:
(i) Staffing data for each facility (including resident census data and data on the hours of care provided per resident per day) based on data submitted under
(I) concise explanations of how to interpret the data (such as a plain English explanation of data reflecting "nursing home staff hours per resident day");
(II) differences in types of staff (such as training associated with different categories of staff);
(III) the relationship between nurse staffing levels and quality of care; and
(IV) an explanation that appropriate staffing levels vary based on patient case mix.
(ii) Links to State Internet websites with information regarding State survey and certification programs, links to Form 2567 State inspection reports (or a successor form) on such websites, information to guide consumers in how to interpret and understand such reports, and the facility plan of correction or other response to such report. Any such links shall be posted on a timely basis.
(iii) The standardized complaint form developed under
(iv) Summary information on the number, type, severity, and outcome of substantiated complaints.
(v) The number of adjudicated instances of criminal violations by a facility or the employees of a facility—
(I) that were committed inside the facility;
(II) with respect to such instances of violations or crimes committed inside of the facility that were the violations or crimes of abuse, neglect, and exploitation, criminal sexual abuse, or other violations or crimes that resulted in serious bodily injury; and
(III) 7 the number of civil monetary penalties levied against the facility, employees, contractors, and other agents.
(B) Deadline for provision of information
(i) In general
Except as provided in clause (ii), the Secretary shall ensure that the information described in subparagraph (A) is included on such website (or a successor website) not later than 1 year after March 23, 2010.
(ii) Exception
The Secretary shall ensure that the information described in subparagraph (A)(i) is included on such website (or a successor website) not later than the date on which the requirements under
(2) Review and modification of website
(A) In general
The Secretary shall establish a process—
(i) to review the accuracy, clarity of presentation, timeliness, and comprehensiveness of information reported on such website as of the day before March 23, 2010; and
(ii) not later than 1 year after March 23, 2010, to modify or revamp such website in accordance with the review conducted under clause (i).
(B) Consultation
In conducting the review under subparagraph (A)(i), the Secretary shall consult with—
(i) State long-term care ombudsman programs;
(ii) consumer advocacy groups;
(iii) provider stakeholder groups; and
(iv) any other representatives of programs or groups the Secretary determines appropriate.
(3) Funding
The Secretary shall transfer to the Centers for Medicare & Medicaid Services Program Management Account, from the Federal Hospital Insurance Trust Fund under
(j) Construction
Where requirements or obligations under this section are identical to those provided under
(k) Funding for strike teams
In addition to amounts otherwise available, there is appropriated to the Secretary, out of any monies in the Treasury not otherwise appropriated, $250,000,000, to remain available until expended, for purposes of allocating such amount among the States (including the District of Columbia and each territory of the United States) for such a State to establish and implement a strike team that will be deployed to a skilled nursing facility in the State with diagnosed or suspected cases of COVID–19 among residents or staff for the purposes of assisting with clinical care, infection control, or staffing during the emergency period described in section 1320b–5(g)(1)(B) of this section and the 1-year period immediately following the end of such emergency period.
(Aug. 14, 1935, ch. 531, title XVIII, §1819, as added and amended
Editorial Notes
References in Text
The Older Americans Act of 1965, referred to in subsecs. (b)(4)(C)(ii)(IV), (c)(2)(B)(iii)(II), and (g)(5)(B), is
Subparagraphs (B), (C), and (D) of section 6901(b)(4) of the Omnibus Budget Reconciliation Act of 1989 [
Section 21(b) of the Medicare-Medicaid Anti-Fraud and Abuse Amendments of 1977, referred to in subsec. (f)(7)(A), probably means section 21(b) of the Medicare-Medicaid Anti-Fraud and Abuse Amendments,
Amendments
2021—Subsec. (k).
2014—Subsec. (i)(3).
2010—Subsec. (b)(5)(F).
Subsec. (d)(1)(B).
Subsec. (d)(1)(C).
Subsec. (f)(2)(A)(i)(I).
Subsec. (f)(8).
Subsec. (g)(5)(E).
Subsec. (h)(2)(B)(ii).
Subsec. (h)(4).
Subsec. (h)(5).
Subsecs. (i), (j).
2003—Subsec. (b)(4)(C)(i).
Subsec. (d)(1)(A).
Subsec. (f)(2)(B)(iii).
Subsec. (f)(2)(D).
2000–Subsec. (b)(8).
1997—Subsec. (b)(3)(C)(i).
Subsec. (f)(2)(B)(iii).
Subsec. (f)(2)(C).
Subsec. (g)(1)(D), (E).
1994—Subsec. (b)(3)(C)(i)(I).
Subsec. (b)(5)(D).
Subsec. (b)(5)(G).
Subsec. (c)(1)(D).
Subsec. (c)(6)(B)(i).
Subsec. (e)(2)(B).
Subsec. (f)(2)(B)(i).
Subsec. (f)(2)(B)(iii)(I)(b).
Subsec. (f)(2)(B)(iii)(I)(c).
Subsec. (g)(1)(C).
Subsec. (g)(5)(B).
1992—Subsecs. (c)(2)(B)(iii)(II), (g)(5)(B).
1990—Subsec. (b)(1)(B).
Subsec. (b)(3)(C)(i)(I).
Subsec. (b)(4)(A)(vii).
Subsec. (b)(4)(C)(ii)(IV), (V).
Subsec. (b)(5)(A).
Subsec. (b)(5)(C).
Subsec. (b)(5)(D).
Subsec. (b)(5)(F)(i).
Subsec. (c)(1)(A).
Subsec. (c)(1)(A)(iv).
Subsec. (c)(1)(A)(x), (xi).
Subsec. (c)(1)(B)(ii).
Subsec. (c)(1)(E).
Subsec. (e)(1)(A).
Subsec. (e)(2)(A).
Subsec. (e)(2)(C).
Subsec. (f)(2)(A)(ii).
Subsec. (f)(2)(A)(iv).
Subsec. (f)(2)(B).
Subsec. (f)(2)(B)(iii)(I).
Subsec. (g)(1)(C).
Subsec. (g)(5)(A)(i).
Subsec. (g)(5)(B).
1989—Subsec. (b)(5)(A).
Subsec. (b)(5)(B).
Subsec. (c)(1)(A)(ii)(II).
Subsec. (c)(1)(A)(v)(I).
Subsec. (f)(2)(A)(i)(I).
Subsec. (f)(2)(A)(ii).
Subsec. (f)(2)(A)(iv).
Subsec. (h)(2)(C).
1988—Subsec. (b)(3)(A)(iii).
Subsec. (b)(3)(A)(iv).
Subsec. (b)(3)(B)(ii)(III).
Subsec. (b)(3)(C)(i)(I).
Subsec. (b)(4)(C)(i).
Subsec. (b)(5)(A).
Subsec. (b)(5)(A)(ii).
Subsec. (b)(5)(G).
Subsec. (c)(1)(D).
Subsec. (c)(2)(A)(v).
Subsec. (c)(6).
Subsec. (e)(1)(A).
Subsec. (e)(1)(B).
Subsec. (e)(2)(A).
Subsec. (e)(2)(B).
Subsec. (e)(3).
Subsec. (e)(5).
Subsec. (f)(2)(A)(i)(I).
Subsec. (f)(3).
Subsec. (f)(6)(A).
Subsec. (f)(6)(B).
Subsec. (f)(7)(A).
Subsec. (f)(7)(B).
Subsec. (g)(1)(C).
Subsec. (g)(1)(D).
Subsec. (g)(2)(A)(i).
Subsec. (g)(2)(B)(ii).
Subsec. (g)(2)(C)(i).
Subsec. (g)(3)(D).
Subsec. (g)(4).
Subsec. (h)(2)(B)(ii).
Subsec. (h)(5).
Subsec. (h)(6).
1987—Subsecs. (g) to (i).
Statutory Notes and Related Subsidiaries
Effective Date of 2010 Amendment
Amendment by section 6113(b) of
Effective Date of 2003 Amendment
Effective Date of 2000 Amendment
Effective Date of 1997 Amendment
Effective Date of 1994 Amendment
Effective Date of 1992 Amendment
Amendment by
Amendment by
Effective Date of 1990 Amendment
"(I) The amendments made by clause (i) [amending this section] shall take effect as if included in the enactment of the Omnibus Budget Reconciliation Act of 1987 [
"(aa) had its participation terminated under title XVIII of the Social Security Act [
"(bb) was subject to a denial of payment under either such title;
"(cc) was assessed a civil money penalty not less than $5,000 for deficiencies in skilled nursing facility standards;
"(dd) operated under a temporary management appointed to oversee the operation of the facility and to ensure the health and safety of the facility's residents; or
"(ee) pursuant to State action, was closed or had its residents transferred.
"(II) Notwithstanding subclause (I) and subject to section 1819(f)(2)(B)(iii)(I) of the Social Security Act [
Effective Date of 1989 Amendment
"(A)
"(B)
"(A)
"(B)
Effective Date of 1988 Amendment
Amendment by
Except as specifically provided in section 411 of
Effective Date
"(a)
"(b)
"(2) In applying the amendments made by section 4203 of this Act for services furnished by a skilled nursing facility before October 1, 1990, any reference to a requirement of subsection (b), (c), or (d), of section 1819 of the Social Security Act is deemed a reference to the provisions of section 1861(j) of such Act [
"(c)
Guidance to States on Form 2567 State Inspection Reports and Complaint Investigation Reports
"(1)
"(3)
"(A)
"(B)
"(C)
Development of Consumer Rights Information Page on Nursing Home Compare Website
"(1) The documentation on nursing facilities that is available to the public.
"(2) General information and tips on choosing a nursing facility that meets the needs of the individual.
"(3) General information on consumer rights with respect to nursing facilities.
"(4) The nursing facility survey process (on a national and State-specific basis).
"(5) On a State-specific basis, the services available through the State long-term care ombudsman for such State."
National Demonstration Projects on Culture Change and Use of Information Technology in Nursing Homes
"(a)
"(b)
"(1)
"(2)
"(c)
"(1)
"(2)
"(d)
"(1)
"(2)
"(3)
"(e)
"(f)
Review and Report on Current Standards of Practice for Pharmacy Services Provided to Patients in Nursing Facilities
"(1)
"(A)
"(B)
"(i) assess the current standards of practice, clinical services, and other service requirements generally used for pharmacy services in long-term care settings; and
"(ii) evaluate the impact of those standards with respect to patient safety, reduction of medication errors and quality of care.
"(2)
"(A)
"(B)
"(i) a description of the plans of the Secretary to implement the provisions of this Act [see Tables for classification] in a manner consistent with applicable State and Federal laws designed to protect the safety and quality of care of nursing facility patients; and
"(ii) recommendations regarding necessary actions and appropriate reimbursement to ensure the provision of prescription drugs to medicare beneficiaries residing in nursing facilities in a manner consistent with existing patient safety and quality of care standards under applicable State and Federal laws."
Study and Report Regarding State Licensure and Certification Standards and Respiratory Therapy Competency Examinations
Retroactive Review
Study and Report on Deeming for Nursing Facilities and Renal Dialysis Facilities
"(1)
"(A) a study concerning the effectiveness and appropriateness of the current mechanisms for surveying and certifying skilled nursing facilities for compliance with the conditions and requirements of sections 1819 and 1861(j) of the Social Security Act [
"(B) a study concerning the effectiveness and appropriateness of the current mechanisms for surveying and certifying renal dialysis facilities for compliance with the conditions and requirements of section 1881(b) of the Social Security Act [
"(2)
Maintaining Regulatory Standards for Certain Services
Nurse Aide Training and Competency Evaluation Programs; Publication of Proposed Regulations
Nurse Aide Training and Competency Evaluation; Satisfaction of Requirements; Waiver
"(B) A nurse aide shall be considered to satisfy the requirement of sections 1819(b)(5)(A) and 1919(b)(5)(A) of the Social Security Act [
"(C) A nurse aide shall be considered to satisfy the requirement of sections 1819(b)(5)(A) and 1919(b)(5)(A) of the Social Security Act (of having completed a training and competency evaluation program approved by a State under section 1819(e)(1)(A) or 1919(e)(1)(A) of such Act), if such aide was found competent (whether or not by the State), before July 1, 1989, after the completion of a course of nurse aide training of at least 100 hours duration.
"(D) With respect to the nurse aide competency evaluation requirements described in sections 1819(b)(5)(A) and 1919(b)(5)(A) of the Social Security Act, a State may waive such requirements with respect to an individual who can demonstrate to the satisfaction of the State that such individual has served as a nurse aide at one or more facilities of the same employer in the State for at least 24 consecutive months before the date of the enactment of this Act [Dec. 19, 1989]."
Evaluation and Report on Implementation of Resident Assessment Process
Annual Report on Statutory Compliance and Enforcement Actions
1 See References in Text note below.
2 So in original. Probably should be "as nurse aides".
3 So in original. Probably should be "credit".
4 So in original. A closing parenthesis probably should appear before the comma.
5 So in original. Probably should be "pro rata".
6 So in original. Probably should be "requirements".
7 So in original. Probably should be cl. (vi).
§1395i–3a. Protecting residents of long-term care facilities
(1) National Training Institute for surveyors
(A) In general
The Secretary of Health and Human Services shall enter into a contract with an entity for the purpose of establishing and operating a National Training Institute for Federal and State surveyors. Such Institute shall provide and improve the training of surveyors with respect to investigating allegations of abuse, neglect, and misappropriation of property in programs and long-term care facilities that receive payments under title XVIII or XIX of the Social Security Act [
(B) Activities carried out by the Institute
The contract entered into under subparagraph (A) shall require the Institute established and operated under such contract to carry out the following activities:
(i) Assess the extent to which State agencies use specialized surveyors for the investigation of reported allegations of abuse, neglect, and misappropriation of property in such programs and long-term care facilities.
(ii) Evaluate how the competencies of surveyors may be improved to more effectively investigate reported allegations of such abuse, neglect, and misappropriation of property, and provide feedback to Federal and State agencies on the evaluations conducted.
(iii) Provide a national program of training, tools, and technical assistance to Federal and State surveyors on investigating reports of such abuse, neglect, and misappropriation of property.
(iv) Develop and disseminate information on best practices for the investigation of such abuse, neglect, and misappropriation of property.
(v) Assess the performance of State complaint intake systems, in order to ensure that the intake of complaints occurs 24 hours per day, 7 days a week (including holidays).
(vi) To the extent approved by the Secretary of Health and Human Services, provide a national 24 hours per day, 7 days a week (including holidays), back-up system to State complaint intake systems in order to ensure optimum national responsiveness to complaints of such abuse, neglect, and misappropriation of property.
(vii) Analyze and report annually on the following:
(I) The total number and sources of complaints of such abuse, neglect, and misappropriation of property.
(II) The extent to which such complaints are referred to law enforcement agencies.
(III) General results of Federal and State investigations of such complaints.
(viii) Conduct a national study of the cost to State agencies of conducting complaint investigations of skilled nursing facilities and nursing facilities under sections 1819 and 1919, respectively, of the Social Security Act (
(C) Authorization
There are authorized to be appropriated to carry out this paragraph, for the period of fiscal years 2011 through 2014, $12,000,000.
(2) Grants to State survey agencies
(A) In general
The Secretary of Health and Human Services shall make grants to State agencies that perform surveys of skilled nursing facilities or nursing facilities under sections 1819 or 1919, respectively, of the Social Security Act (
(B) Use of funds
A grant awarded under subparagraph (A) shall be used for the purpose of designing and implementing complaint investigations systems that—
(i) promptly prioritize complaints in order to ensure a rapid response to the most serious and urgent complaints;
(ii) respond to complaints with optimum effectiveness and timeliness; and
(iii) optimize the collaboration between local authorities, consumers, and providers, including—
(I) such State agency;
(II) the State Long-Term Care Ombudsman;
(III) local law enforcement agencies;
(IV) advocacy and consumer organizations;
(V) State aging units;
(VI) Area Agencies on Aging; and
(VII) other appropriate entities.
(C) Authorization
There are authorized to be appropriated to carry out this paragraph, for each of fiscal years 2011 through 2014, $5,000,000.
(
Editorial Notes
References in Text
The Social Security Act, referred to in par. (1)(A), is act Aug. 14, 1935, ch. 531,
Codification
Section was enacted as part of the Elder Justice Act of 2009 and also as part of the Patient Protection and Affordable Care Act, and not as part of the Social Security Act which comprises this chapter.
Statutory Notes and Related Subsidiaries
Definitions
§1395i–4. Medicare rural hospital flexibility program
(a) Establishment
Any State that submits an application in accordance with subsection (b) may establish a medicare rural hospital flexibility program described in subsection (c).
(b) Application
A State may establish a medicare rural hospital flexibility program described in subsection (c) if the State submits to the Secretary at such time and in such form as the Secretary may require an application containing—
(1) assurances that the State—
(A) has developed, or is in the process of developing, a State rural health care plan that—
(i) provides for the creation of 1 or more rural health networks (as defined in subsection (d)) in the State;
(ii) promotes regionalization of rural health services in the State; and
(iii) improves access to hospital and other health services for rural residents of the State; and
(B) has developed the rural health care plan described in subparagraph (A) in consultation with the hospital association of the State, rural hospitals located in the State, and the State Office of Rural Health (or, in the case of a State in the process of developing such plan, that assures the Secretary that the State will consult with its State hospital association, rural hospitals located in the State, and the State Office of Rural Health in developing such plan);
(2) assurances that the State has designated (consistent with the rural health care plan described in paragraph (1)(A)), or is in the process of so designating, rural nonprofit or public hospitals or facilities located in the State as critical access hospitals; and
(3) such other information and assurances as the Secretary may require.
(c) Medicare rural hospital flexibility program described
(1) In general
A State that has submitted an application in accordance with subsection (b), may establish a medicare rural hospital flexibility program that provides that—
(A) the State shall develop at least 1 rural health network (as defined in subsection (d)) in the State; and
(B) at least 1 facility in the State shall be designated as a critical access hospital in accordance with paragraph (2).
(2) State designation of facilities
(A) In general
A State may designate 1 or more facilities as a critical access hospital in accordance with subparagraphs (B), (C), and (D).
(B) Criteria for designation as critical access hospital
A State may designate a facility as a critical access hospital if the facility—
(i) is a hospital that is located in a county (or equivalent unit of local government) in a rural area (as defined in
(I) is located more than a 35-mile drive (or, in the case of mountainous terrain or in areas with only secondary roads available, a 15-mile drive) from a hospital, or another facility described in this subsection; or
(II) is certified before January 1, 2006, by the State as being a necessary provider of health care services to residents in the area;
(ii) makes available 24-hour emergency care services that a State determines are necessary for ensuring access to emergency care services in each area served by a critical access hospital;
(iii) provides not more than 25 acute care inpatient beds (meeting such standards as the Secretary may establish) for providing inpatient care for a period that does not exceed, as determined on an annual, average basis, 96 hours per patient;
(iv) meets such staffing requirements as would apply under
(I) the facility need not meet hospital standards relating to the number of hours during a day, or days during a week, in which the facility must be open and fully staffed, except insofar as the facility is required to make available emergency care services as determined under clause (ii) and must have nursing services available on a 24-hour basis, but need not otherwise staff the facility except when an inpatient is present;
(II) the facility may provide any services otherwise required to be provided by a full-time, on site dietitian, pharmacist, laboratory technician, medical technologist, and radiological technologist on a part-time, off site basis under arrangements as defined in
(III) the inpatient care described in clause (iii) may be provided by a physician assistant, nurse practitioner, or clinical nurse specialist subject to the oversight of a physician who need not be present in the facility; and
(v) meets the requirements of
(C) Recently closed facilities
A State may designate a facility as a critical access hospital if the facility—
(i) was a hospital that ceased operations on or after the date that is 10 years before November 29, 1999; and
(ii) as of the effective date of such designation, meets the criteria for designation under subparagraph (B).
(D) Downsized facilities
A State may designate a health clinic or a health center (as defined by the State) as a critical access hospital if such clinic or center—
(i) is licensed by the State as a health clinic or a health center;
(ii) was a hospital that was downsized to a health clinic or health center; and
(iii) as of the effective date of such designation, meets the criteria for designation under subparagraph (B).
(E) Authority to establish psychiatric and rehabilitation distinct part units
(i) In general
Subject to the succeeding provisions of this subparagraph, a critical access hospital may establish—
(I) a psychiatric unit of the hospital that is a distinct part of the hospital; and
(II) a rehabilitation unit of the hospital that is a distinct part of the hospital,
if the distinct part meets the requirements (including conditions of participation) that would otherwise apply to the distinct part if the distinct part were established by a subsection (d) hospital in accordance with the matter following clause (v) 1 of
(ii) Limitation on number of beds
The total number of beds that may be established under clause (i) for a distinct part unit may not exceed 10.
(iii) Exclusion of beds from bed count
In determining the number of beds of a critical access hospital for purposes of applying the bed limitations referred to in subparagraph (B)(iii) and subsection (f), the Secretary shall not take into account any bed established under clause (i).
(iv) Effect of failure to meet requirements
If a psychiatric or rehabilitation unit established under clause (i) does not meet the requirements described in such clause with respect to a cost reporting period, no payment may be made under this subchapter to the hospital for services furnished in such unit during such period. Payment to the hospital for services furnished in the unit may resume only after the hospital has demonstrated to the Secretary that the unit meets such requirements.
(d) "Rural health network" defined
(1) In general
In this section, the term "rural health network" means, with respect to a State, an organization consisting of—
(A) at least 1 facility that the State has designated or plans to designate as a critical access hospital; and
(B) at least 1 hospital that furnishes acute care services.
(2) Agreements
(A) In general
Each critical access hospital that is a member of a rural health network shall have an agreement with respect to each item described in subparagraph (B) with at least 1 hospital that is a member of the network.
(B) Items described
The items described in this subparagraph are the following:
(i) Patient referral and transfer.
(ii) The development and use of communications systems including (where feasible)—
(I) telemetry systems; and
(II) systems for electronic sharing of patient data.
(iii) The provision of emergency and non-emergency transportation among the facility and the hospital.
(C) Credentialing and quality assurance
Each critical access hospital that is a member of a rural health network shall have an agreement with respect to credentialing and quality assurance with at least—
(i) 1 hospital that is a member of the network;
(ii) 1 peer review organization or equivalent entity; or
(iii) 1 other appropriate and qualified entity identified in the State rural health care plan.
(e) Certification by Secretary
The Secretary shall certify a facility as a critical access hospital if the facility—
(1) is located in a State that has established a medicare rural hospital flexibility program in accordance with subsection (c);
(2) is designated as a critical access hospital by the State in which it is located; and
(3) meets such other criteria as the Secretary may require.
(f) Permitting maintenance of swing beds
Nothing in this section shall be construed to prohibit a State from designating or the Secretary from certifying a facility as a critical access hospital solely because, at the time the facility applies to the State for designation as a critical access hospital, there is in effect an agreement between the facility and the Secretary under
(g) Grants
(1) Medicare rural hospital flexibility program
The Secretary may award grants to States that have submitted applications in accordance with subsection (b) for—
(A) engaging in activities relating to planning and implementing a rural health care plan;
(B) engaging in activities relating to planning and implementing rural health networks;
(C) designating facilities as critical access hospitals; and
(D) providing support for critical access hospitals for quality improvement, quality reporting, performance improvements, and benchmarking.
(2) Rural emergency medical services
(A) In general
The Secretary may award grants to States that have submitted applications in accordance with subparagraph (B) for the establishment or expansion of a program for the provision of rural emergency medical services.
(B) Application
An application is in accordance with this subparagraph if the State submits to the Secretary at such time and in such form as the Secretary may require an application containing the assurances described in subparagraphs (A)(ii), (A)(iii), and (B) of subsection (b)(1) and paragraph (3) of that subsection.
(3) Upgrading data systems
(A) Grants to hospitals
The Secretary may award grants to hospitals that have submitted applications in accordance with subparagraph (C) to assist eligible small rural hospitals in meeting the costs of implementing data systems required to meet requirements established under the medicare program pursuant to amendments made by the Balanced Budget Act of 1997 and to assist such hospitals in participating in delivery system reforms under the provisions of and amendments made by the Patient Protection and Affordable Care Act, such as value-based purchasing programs, accountable care organizations under
(B) Eligible small rural hospital defined
For purposes of this paragraph, the term "eligible small rural hospital" means a non-Federal, short-term general acute care hospital that—
(i) is located in a rural area (as defined for purposes of
(ii) has less than 50 beds.
(C) Application
A hospital seeking a grant under this paragraph shall submit an application to the Secretary on or before such date and in such form and manner as the Secretary specifies.
(D) Amount of grant
A grant to a hospital under this paragraph may not exceed $50,000.
(E) Use of funds
A hospital receiving a grant under this paragraph may use the funds for the purchase of computer software and hardware, the education and training of hospital staff on computer information systems, to offset costs related to the implementation of prospective payment systems and to participate in delivery system reforms under the provisions of and amendments made by the Patient Protection and Affordable Care Act, such as value-based purchasing programs, accountable care organizations under
(F) Reports
(i) Information
A hospital receiving a grant under this section shall furnish the Secretary with such information as the Secretary may require to evaluate the project for which the grant is made and to ensure that the grant is expended for the purposes for which it is made.
(ii) Timing of submission
(I) Interim reports
The Secretary shall report to the Committee on Ways and Means of the House of Representatives and the Committee on Finance of the Senate at least annually on the grant program established under this section, including in such report information on the number of grants made, the nature of the projects involved, the geographic distribution of grant recipients, and such other matters as the Secretary deems appropriate.
(II) Final report
The Secretary shall submit a final report to such committees not later than 180 days after the completion of all of the projects for which a grant is made under this section.
(4) Additional requirements with respect to FLEX grants
With respect to grants awarded under paragraph (1) or (2) from funds appropriated for fiscal year 2005 and subsequent fiscal years—
(A) Consultation with the state hospital association and rural hospitals on the most appropriate ways to use grants
A State shall consult with the hospital association of such State and rural hospitals located in such State on the most appropriate ways to use the funds under such grant.
(B) Limitation on use of grant funds for administrative expenses
A State may not expend more than the lesser of—
(i) 15 percent of the amount of the grant for administrative expenses; or
(ii) the State's federally negotiated indirect rate for administering the grant.
(5) Use of funds for Federal administrative expenses
Of the total amount appropriated for grants under paragraphs (1) and (2) for a fiscal year (for each of fiscal years 2005 through 2008) and, of the total amount appropriated for grants under paragraphs (1), (2), and (6) for a fiscal year (beginning with fiscal year 2009), up to 5 percent of such amount shall be available to the Health Resources and Services Administration for purposes of administering such grants.
(6) Providing mental health services and other health services to veterans and other residents of rural areas
(A) Grants to States
The Secretary may award grants to States that have submitted applications in accordance with subparagraph (B) for increasing the delivery of mental health services or other health care services deemed necessary to meet the needs of veterans of Operation Iraqi Freedom and Operation Enduring Freedom living in rural areas (as defined for purposes of
(B) Application
(i) In general
An application is in accordance with this subparagraph if the State submits to the Secretary at such time and in such form as the Secretary may require an application containing the assurances described in subparagraphs (A)(ii) and (A)(iii) of subsection (b)(1).
(ii) Consideration of regional approaches, networks, or technology
The Secretary may, as appropriate in awarding grants to States under subparagraph (A), consider whether the application submitted by a State under this subparagraph includes 1 or more proposals that utilize regional approaches, networks, health information technology, telehealth, or telemedicine to deliver services described in subparagraph (A) to individuals described in that subparagraph. For purposes of this clause, a network may, as the Secretary determines appropriate, include Federally qualified health centers (as defined in
(iii) Coordination at local level
The Secretary shall require, as appropriate, a State to demonstrate consultation with the hospital association of such State, rural hospitals located in such State, providers of mental health services, or other appropriate stakeholders for the provision of services under a grant awarded under this paragraph.
(iv) Special consideration of certain applications
In awarding grants to States under subparagraph (A), the Secretary shall give special consideration to applications submitted by States in which veterans make up a high percentage (as determined by the Secretary) of the total population of the State. Such consideration shall be given without regard to the number of veterans of Operation Iraqi Freedom and Operation Enduring Freedom living in the areas in which mental health services and other health care services would be delivered under the application.
(C) Coordination with VA
The Secretary shall, as appropriate, consult with the Director of the Office of Rural Health of the Department of Veterans Affairs in awarding and administering grants to States under subparagraph (A).
(D) Use of funds
A State awarded a grant under this paragraph may, as appropriate, use the funds to reimburse providers of services described in subparagraph (A) to individuals described in that subparagraph.
(E) Limitation on use of grant funds for administrative expenses
A State awarded a grant under this paragraph may not expend more than 15 percent of the amount of the grant for administrative expenses.
(F) Independent evaluation and final report
The Secretary shall provide for an independent evaluation of the grants awarded under subparagraph (A). Not later than 1 year after the date on which the last grant is awarded to a State under such subparagraph, the Secretary shall submit a report to Congress on such evaluation. Such report shall include an assessment of the impact of such grants on increasing the delivery of mental health services and other health services to veterans of the United States Armed Forces living in rural areas (as so defined and including such areas that are rural census tracks), with particular emphasis on the impact of such grants on the delivery of such services to veterans of Operation Enduring Freedom and Operation Iraqi Freedom, and to other individuals living in such rural areas.
(7) Critical access hospitals transitioning to skilled nursing facilities and assisted living facilities
(A) Grants
The Secretary may award grants to eligible critical access hospitals that have submitted applications in accordance with subparagraph (B) for assisting such hospitals in the transition to skilled nursing facilities and assisted living facilities.
(B) Application
An applicable critical access hospital seeking a grant under this paragraph shall submit an application to the Secretary on or before such date and in such form and manner as the Secretary specifies.
(C) Additional requirements
The Secretary may not award a grant under this paragraph to an eligible critical access hospital unless—
(i) local organizations or the State in which the hospital is located provides matching funds; and
(ii) the hospital provides assurances that it will surrender critical access hospital status under this subchapter within 180 days of receiving the grant.
(D) Amount of grant
A grant to an eligible critical access hospital under this paragraph may not exceed $1,000,000.
(E) Funding
There are appropriated from the Federal Hospital Insurance Trust Fund under
(F) Eligible critical access hospital defined
For purposes of this paragraph, the term "eligible critical access hospital" means a critical access hospital that has an average daily acute census of less than 0.5 and an average daily swing bed census of greater than 10.0.
(h) Grandfathering provisions
(1) In general
Any medical assistance facility operating in Montana and any rural primary care hospital designated by the Secretary under this section prior to August 5, 1997, shall be deemed to have been certified by the Secretary under subsection (e) as a critical access hospital if such facility or hospital is otherwise eligible to be designated by the State as a critical access hospital under subsection (c).
(2) Continuation of medical assistance facility and rural primary care hospital terms
Notwithstanding any other provision of this subchapter, with respect to any medical assistance facility or rural primary care hospital described in paragraph (1), any reference in this subchapter to a "critical access hospital" shall be deemed to be a reference to a "medical assistance facility" or "rural primary care hospital".
(3) State authority to waive 35-mile rule
In the case of a facility that was designated as a critical access hospital before January 1, 2006, and was certified by the State as being a necessary provider of health care services to residents in the area under subsection (c)(2)(B)(i)(II), as in effect before such date, the authority under such subsection with respect to any redesignation of such facility shall continue to apply notwithstanding the amendment made by section 405(h)(1) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.
(i) Waiver of conflicting part A provisions
The Secretary is authorized to waive such provisions of this part and part E as are necessary to conduct the program established under this section.
(j) Authorization of appropriations
There are authorized to be appropriated from the Federal Hospital Insurance Trust Fund for making grants to all States under subsection (g), $25,000,000 in each of the fiscal years 1998 through 2002, for making grants to all States under paragraphs (1) and (2) of subsection (g), $35,000,000 in each of fiscal years 2005 through 2008, for making grants to all States under paragraphs (1) and (2) of subsection (g), $55,000,000 in each of fiscal years 2009 and 2010, for making grants to all States under paragraph (6) of subsection (g), $50,000,000 in each of fiscal years 2009 and 2010, to remain available until expended and for making grants to all States under subsection (g), such sums as may be necessary in each of fiscal years 2011 and 2012, to remain available until expended.
(Aug. 14, 1935, ch. 531, title XVIII, §1820, as added
Editorial Notes
References in Text
The matter following clause (v) of
The Balanced Budget Act of 1997, referred to in subsec. (g)(3)(A), is
The Patient Protection and Affordable Care Act, referred to in subsec. (g)(3)(A), (E), is
Section 405(h)(1) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, referred to in subsec. (h)(3), is section 405(h)(1) of
Amendments
2010—Subsec. (g)(3)(A).
Subsec. (g)(3)(E).
Subsec. (j).
2008—Subsec. (g)(1)(D).
Subsec. (g)(5).
Subsec. (g)(6).
Subsec. (g)(7).
Subsec. (j).
2003—Subsec. (c)(2)(B)(i)(II).
Subsec. (c)(2)(B)(iii).
Subsec. (c)(2)(E).
Subsec. (f).
Subsec. (g)(4), (5).
Subsec. (h).
Subsec. (h)(3).
Subsec. (i).
Subsec. (j).
1999—Subsec. (c)(2)(A).
Subsec. (c)(2)(B)(i).
Subsec. (c)(2)(B)(iii).
Subsec. (c)(2)(C), (D).
Subsec. (g)(3).
1997—
Subsec. (j).
1994—Subsec. (c)(1).
Subsec. (e)(1).
Subsec. (e)(1)(A).
Subsec. (e)(2) to (6).
Subsec. (f)(1)(F).
Subsec. (f)(1)(H).
Subsec. (f)(3).
Subsec. (f)(4).
Subsec. (i)(1)(A).
Subsec. (i)(1)(B).
Subsec. (i)(2)(A).
Subsec. (k).
Subsec. (l).
1990—Subsec. (d)(1).
Subsec. (f)(1)(A).
Subsec. (f)(1)(B).
Subsec. (g)(1)(A)(ii).
Subsec. (i)(2)(C).
Subsec. (j).
Statutory Notes and Related Subsidiaries
Effective Date of 2010 Amendment
Effective Date of 2003 Amendment
Amendment by section 405(g)(1) of
Effective Date of 1999 Amendment
Amendment by section 1000(a)(6) [title III, §321(a)] of
Effective Date of 1997 Amendment
Amendment by section 4201(a) of
Effective Date of 1990 Amendment
Demonstration Project on Community Health Integration Models in Certain Rural Counties
"(a)
"(b)
"(1) explore ways to increase access to, and improve the adequacy of, payments for acute care, extended care, and other essential health care services provided under the Medicare and Medicaid programs in eligible counties; and
"(2) evaluate regulatory challenges facing such providers and the communities they serve.
"(c)
"(1) Health care providers in eligible counties selected to participate in the demonstration project under subsection (d)(3) shall (when determined appropriate by the Secretary), instead of the payment rates otherwise applicable under the Medicare program, be reimbursed at a rate that covers at least the reasonable costs of the provider in furnishing acute care, extended care, and other essential health care services to Medicare beneficiaries.
"(2) Methods to coordinate the survey and certification process under the Medicare program and the Medicaid program across all health service categories included in the demonstration project shall be tested with the goal of assuring quality and safety while reducing administrative burdens, as appropriate, related to completing such survey and certification process.
"(3) Health care providers in eligible counties selected to participate in the demonstration project under subsection (d)(3) and the Secretary shall work with the State to explore ways to revise reimbursement policies under the Medicaid program to improve access to the range of health care services available in such eligible counties.
"(4) The Secretary shall identify regulatory requirements that may be revised appropriately to improve access to care in eligible counties.
"(5) Other essential health care services necessary to ensure access to the range of health care services in eligible counties selected to participate in the demonstration project under subsection (d)(3) shall be identified. Ways to ensure adequate funding for such services shall also be explored.
"(d)
"(1)
"(A)
"(B)
"(i) is a Rural Hospital Flexibility Program grantee under section 1820(g) of the Social Security Act (
"(ii) is located in a State in which at least 65 percent of the counties in the State are counties that have 6 or less residents per square mile.
"(C)
"(2)
"(A)
"(B)
"(3)
"(4)
"(A) The county has 6 or less residents per square mile.
"(B) As of the date of the enactment of this Act [July 15, 2008], a facility designated as a critical access hospital which meets the following requirements was located in the county:
"(i) As of the date of the enactment of this Act, the critical access hospital furnished 1 or more of the following:
"(I) Home health services.
"(II) Hospice care.
"(ii) As of the date of the enactment of this Act, the critical access hospital has an average daily inpatient census of 5 or less.
"(C) As of the date of the enactment of this Act, skilled nursing facility services were available in the county in—
"(i) a critical access hospital using swing beds; or
"(ii) a local nursing home.
"(e)
"(1)
"(2) HRSA
"(A) award grants to the eligible entities selected to participate in the demonstration project; and
"(B) work with such entities to provide technical assistance related to the requirements under the project.
"(3) CMS
"(f)
"(1)
"(2)
"(A)
"(B)
"(3)
"(g)
"(1) CMS.—
"(A)
"(B)
"(C)
"(2) HRSA.—There are authorized to be appropriated to the Office of Rural Health Policy of the Health Resources and Services Administration $800,000 for each of fiscal years 2010, 2011, and 2012 for the purpose of carrying out the duties of such Office under the demonstration project under this section, to remain available for the duration of the demonstration project.
"(h)
"(1)
"(2)
"(i)
"(j)
"(1)
"(A) Home health services.
"(B) Covered skilled nursing facility services.
"(C) Hospice care.
"(2)
"(3)
"(4)
"(5)
"(6)
"(7)
"(8)
"(A) Ambulance services (as described in section 1861(s)(7) of the Social Security Act (
"(B) Physicians' services (as defined in section 1861(q) of the Social Security Act (
"(C) Public health services (as defined by the Secretary).
"(D) Other health care services determined appropriate by the Secretary.
"(9)
[
GAO Study on Certain Eligibility Requirements for Critical Access Hospitals
"(a)
"(1) the feasibility of having a distinct part unit as part of a critical access hospital for purposes of the medicare program under title XVIII of such Act [this subchapter]; and
"(2) the effect of seasonal variations in patient admissions on critical access hospital eligibility requirements with respect to limitations on average annual length of stay and number of beds.
"(b)
"(1) whether distinct part units should be permitted as part of a critical access hospital under the medicare program;
"(2) if so permitted, the payment methodologies that should apply with respect to services provided by such units;
"(3) whether, and to what extent, such units should be included in or excluded from the bed limits applicable to critical access hospitals under the medicare program; and
"(4) any adjustments to such eligibility requirements to account for seasonal variations in patient admissions."
Transition for MAF
"(A)
"(B)
"(i)
"(ii)
GAO Reports
1 See References in Text note below.
§1395i–5. Conditions for coverage of religious nonmedical health care institutional services
(a) In general
Subject to subsections (c) and (d), payment under this part may be made for inpatient hospital services or post-hospital extended care services furnished an individual in a religious nonmedical health care institution and for home health services furnished an individual by a religious nonmedical health care institution only if—
(1) the individual has an election in effect for such benefits under subsection (b); and
(2) the individual has a condition such that the individual would qualify for benefits under this part for inpatient hospital services, extended care services, or home health services, respectively, if the individual were an inpatient or resident in a hospital or skilled nursing facility, or receiving services from a home health agency, that was not such an institution.
(b) Election
(1) In general
An individual may make an election under this subsection in a form and manner specified by the Secretary consistent with this subsection. Unless otherwise provided, such an election shall take effect immediately upon its execution. Such an election, once made, shall continue in effect until revoked.
(2) Form
The election form under this subsection shall include the following:
(A) A written statement, signed by the individual (or such individual's legal representative), that—
(i) the individual is conscientiously opposed to acceptance of nonexcepted medical treatment; and
(ii) the individual's acceptance of nonexcepted medical treatment would be inconsistent with the individual's sincere religious beliefs.
(B) A statement that the receipt of nonexcepted medical services shall constitute a revocation of the election and may limit further receipt of services described in subsection (a).
(3) Revocation
An election under this subsection by an individual may be revoked by voluntarily notifying the Secretary in writing of such revocation and shall be deemed to be revoked if the individual receives nonexcepted medical treatment for which reimbursement is made under this subchapter.
(4) Limitation on subsequent elections
Once an individual's election under this subsection has been made and revoked twice—
(A) the next election may not become effective until the date that is 1 year after the date of most recent previous revocation, and
(B) any succeeding election may not become effective until the date that is 5 years after the date of the most recent previous revocation.
(5) Excepted medical treatment
For purposes of this subsection:
(A) Excepted medical treatment
The term "excepted medical treatment" means medical care or treatment (including medical and other health services)—
(i) received involuntarily,
(ii) required under Federal or State law or law of a political subdivision of a State, or
(iii) effective beginning on December 29, 2022, that is a COVID–19 vaccine and its administration described in
(B) Nonexcepted medical treatment
The term "nonexcepted medical treatment" means medical care or treatment (including medical and other health services) other than excepted medical treatment.
(c) Monitoring and safeguard against excessive expenditures
(1) Estimate of expenditures
Before the beginning of each fiscal year (beginning with fiscal year 2000), the Secretary shall estimate the level of expenditures under this part for services described in subsection (a) for that fiscal year.
(2) Adjustment in payments
(A) Proportional adjustment
If the Secretary determines that the level estimated under paragraph (1) for a fiscal year will exceed the trigger level (as defined in subparagraph (C)) for that fiscal year, the Secretary shall, subject to subparagraph (B), provide for such a proportional reduction in payment amounts under this part for services described in subsection (a) for the fiscal year involved as will assure that such level (taking into account any adjustment under subparagraph (B)) does not exceed the trigger level for that fiscal year.
(B) Alternative adjustments
The Secretary may, instead of making some or all of the reduction described in subparagraph (A), impose such other conditions or limitations with respect to the coverage of covered services (including limitations on new elections of coverage and new facilities) as may be appropriate to reduce the level of expenditures described in paragraph (1) to the trigger level.
(C) Trigger level
For purposes of this subsection—
(i) In general
Subject to adjustment under paragraph (3)(B), the "trigger level" for a year is the unadjusted trigger level described in clause (ii).
(ii) Unadjusted trigger level
The "unadjusted trigger level" for—
(I) fiscal year 1998, is $20,000,000, or
(II) a succeeding fiscal year is the amount specified under this clause for the previous fiscal year increased by the percentage increase in the consumer price index for all urban consumers (all items; United States city average) for the 12-month period ending with July preceding the beginning of the fiscal year.
(D) Prohibition of administrative and judicial review
There shall be no administrative or judicial review under
(E) Effect on billing
Notwithstanding any other provision of this subchapter, in the case of a reduction in payment provided under this subsection for services of a religious nonmedical health care institution provided to an individual, the amount that the institution is otherwise permitted to charge the individual for such services is increased by the amount of such reduction.
(3) Monitoring expenditure level
(A) In general
The Secretary shall monitor the expenditure level described in paragraph (2)(A) for each fiscal year (beginning with fiscal year 1999).
(B) Adjustment in trigger level
(i) In general
If the Secretary determines that such level for a fiscal year exceeded, or was less than, the trigger level for that fiscal year, then, subject to clause (ii), the trigger level for the succeeding fiscal year shall be reduced, or increased, respectively, by the amount of such excess or deficit.
(ii) Limitation on carryforward
In no case may the increase effected under clause (i) for a fiscal year exceed $50,000,000.
(d) Sunset
If the Secretary determines that the level of expenditures described in subsection (c)(1) for 3 consecutive fiscal years (with the first such year being not earlier than fiscal year 2002) exceeds the trigger level for such expenditures for such years (as determined under subsection (c)(2)), benefits shall be paid under this part for services described in subsection (a) and furnished on or after the first January 1 that occurs after such 3 consecutive years only with respect to an individual who has an election in effect under subsection (b) as of such January 1 and only during the duration of such election.
(e) Annual report
At the beginning of each fiscal year (beginning with fiscal year 1999), the Secretary shall submit to the Committee on Ways and Means of the House of Representatives and the Committee on Finance of the Senate an annual report on coverage and expenditures for services described in subsection (a) under this part and under State plans under subchapter XIX. Such report shall include—
(1) level of expenditures described in subsection (c)(1) for the previous fiscal year and estimated for the fiscal year involved;
(2) trends in such level; and
(3) facts and circumstances of any significant change in such level from the level in previous fiscal years.
(Aug. 14, 1935, ch. 531, title XVIII, §1821, as added
Editorial Notes
Amendments
2022—Subsec. (b)(5)(A)(iii).
2003—Subsec. (a).
Subsec. (a)(2).
Statutory Notes and Related Subsidiaries
Effective Date
Special Rules for COVID–19 Vaccines Relating to Revocation of Election
"(1) Beginning on such date of enactment, such individual may make an election under such section, which shall take effect immediately upon its execution, if such individual would be eligible to make such an election if they had not received such COVID–19 vaccine and its administration.
"(2) Such revoked election shall not be taken into account for purposes of determining the effective date for an election described in subparagraph (A) or (B) of such paragraph (4)."
§1395i–6. Hospice program survey and enforcement procedures
(a) Surveys
(1) Frequency
Any entity that is certified as a hospice program (as defined in
(2) Public transparency of survey and certification information
(A) Submission of information to the Secretary
(i) In general
Each State or local survey agency, and each national accreditation body with respect to which the Secretary has made a finding under
(ii) Required inclusion of specified form
With respect to a survey under this subsection carried out by a national accreditation body described in clause (i) on or after October 1, 2021, information described in such clause shall include Form CMS-2567 (or a successor form), along with such additional information determined appropriate by such body.
(B) Public disclosure of information
Beginning not later than October 1, 2022, the Secretary shall publish the information submitted under subparagraph (A) on the public website of the Centers for Medicare & Medicaid Services in a manner that is prominent, easily accessible, readily understandable, and searchable. The Secretary shall provide for the timely update of such information so published.
(3) Consistency of surveys
Each State and the Secretary shall implement programs to measure and reduce inconsistency in the application of survey results among surveyors.
(4) Survey teams
(A) In general
In the case of a survey conducted under this subsection on or after October 1, 2021, by more than 1 individual, such survey shall be conducted by a multidisciplinary team of professionals (including a registered professional nurse).
(B) Prohibition of conflicts of interest
Beginning October 1, 2021, a State may not use as a member of a survey team under this subsection an individual who is serving (or has served within the previous 2 years) as a member of the staff of, or as a consultant to, the program surveyed respecting compliance with the requirements of
(C) Training
The Secretary shall provide, not later than October 1, 2021, for the comprehensive training of State and Federal surveyors, and any surveyor employed by a national accreditation body described in paragraph (2)(A)(i), in the conduct of surveys under this subsection, including training with respect to the review of written plans for providing hospice care (as described in
(5) Funding
The Secretary shall provide for the transfer, from the Federal Hospital Insurance Trust Fund under
(b) Special focus program
(1) In general
The Secretary shall conduct a special focus program for enforcement of requirements for hospice programs that the Secretary has identified as having substantially failed to meet applicable requirements of this chapter.
(2) Periodic surveys
Under such special focus program, the Secretary shall conduct surveys of each hospice program in the special focus program not less than once every 6 months.
(c) Enforcement
(1) Situations involving immediate jeopardy
If the Secretary determines on the basis of a standard survey or otherwise that a hospice program that is certified for participation under this subchapter is no longer in compliance with the requirements specified in
(2) Situations not involving immediate jeopardy
If the Secretary determines on the basis of a standard survey or otherwise that a hospice program that is certified for participation under this subchapter is no longer in compliance with the requirements specified in
(3) Penalty for previous noncompliance
If the Secretary determines that a hospice program that is certified for participation under this subchapter is in compliance with the requirements specified in
(4) Option to continue payments for noncompliant hospice programs
The Secretary may continue payments under this subchapter with respect to a hospice program not in compliance with the requirements specified in
(A) the State or local survey agency finds that it is more appropriate to take alternative action to assure compliance of the program with such requirements than to terminate the certification of the program;
(B) the program has submitted a plan and timetable for corrective action to the Secretary for approval and the Secretary approves the plan of corrective action; and
(C) the program agrees to repay to the Federal Government payments received under this subchapter during such period if the corrective action is not taken in accordance with the approved plan and timetable.
The Secretary shall establish guidelines for approval of corrective actions requested by hospice programs under this paragraph.
(5) Remedies
(A) Development
(i) In general
Not later than October 1, 2022, the Secretary shall develop and implement—
(I) a range of remedies to apply to hospice programs under the conditions described in paragraphs (1) through (4); and
(II) appropriate procedures for appealing determinations relating to the imposition of such remedies.
Remedies developed pursuant to the preceding sentence shall include the remedies specified in subparagraph (B).
(ii) Conditions of imposition of remedies
Not later than October 1, 2022, the Secretary shall develop and implement specific procedures with respect to the conditions under which each of the remedies developed under clause (i) is to be applied, including the amount of any fines and the severity of each of these remedies. Such procedures shall be designed so as to minimize the time between identification of deficiencies and imposition of these remedies and shall provide for the imposition of incrementally more severe fines for repeated or uncorrected deficiencies.
(B) Specified remedies
The remedies specified in this subparagraph are the following:
(i) Civil money penalties in an amount not to exceed $10,000 for each day of noncompliance by a hospice program with the requirements specified in
(ii) Suspension of all or part of the payments to which a hospice program would otherwise be entitled under this subchapter with respect to items and services furnished by a hospice program on or after the date on which the Secretary determines that remedies should be imposed pursuant to paragraphs (1) and (2).
(iii) The appointment of temporary management to oversee the operation of the hospice program and to protect and assure the health and safety of the individuals under the care of the program while improvements are made in order to bring the program into compliance with all such requirements.
(C) Procedures
(i) Civil money penalties
(I) In general
Subject to subclause (II), the provisions of
(II) Retention of amounts for hospice program improvements
The Secretary may provide that any portion of civil money penalties collected under this subsection may be used to support activities that benefit individuals receiving hospice care, including education and training programs to ensure hospice program compliance with the requirements of
(ii) Suspension of payment
A finding to suspend payment under subparagraph (B)(ii) shall terminate when the Secretary finds that the program is in substantial compliance with all requirements of
(iii) Temporary management
The temporary management under subparagraph (B)(iii) shall not be terminated until the Secretary has determined that the program has the management capability to ensure continued compliance with all the requirements referred to in such subparagraph.
(D) Relationship to other remedies
The remedies developed under subparagraph (A) are in addition to sanctions otherwise available under State or Federal law and shall not be construed as limiting other remedies, including any remedy available to an individual at common law.
(Aug. 14, 1935, ch. 531, title XVIII, §1822, as added
Editorial Notes
References in Text
Section 3(a)(2) of the Improving Medicare Post-Acute Care Transformation Act of 2014, referred to in subsec. (a)(5), means section 3(a)(2) of
Part B—Supplementary Medical Insurance Benefits for Aged and Disabled
§1395j. Establishment of supplementary medical insurance program for aged and disabled
There is hereby established a voluntary insurance program to provide medical insurance benefits in accordance with the provisions of this part for aged and disabled individuals who elect to enroll under such program, to be financed from premium payments by enrollees together with contributions from funds appropriated by the Federal Government.
(Aug. 14, 1935, ch. 531, title XVIII, §1831, as added
Editorial Notes
Amendments
1972—
Statutory Notes and Related Subsidiaries
Study Regarding Coverage Under Part B of Medicare for Nonreimbursable Services Provided by Optometrists for Prosthetic Lenses for Patients With Aphakia
Study To Determine Feasibility of Inclusion of Certain Additional Services Under Part B
§1395k. Scope of benefits; definitions
(a) Scope of benefits
The benefits provided to an individual by the insurance program established by this part shall consist of—
(1) entitlement to have payment made to him or on his behalf (subject to the provisions of this part) for medical and other health services, except those described in subparagraphs (B) and (D) of paragraph (2) and subparagraphs (E) and (F) of
(2) entitlement to have payment made on his behalf (subject to the provisions of this part) for—
(A) home health services (other than items described in subparagraph (G) or subparagraph (I));
(B) medical and other health services (other than items described in subparagraph (G) or subparagraph (I)) furnished by a provider of services or by others under arrangement with them made by a provider of services, excluding—
(i) physician services except where furnished by—
(I) a resident or intern of a hospital, or
(II) a physician to a patient in a hospital which has a teaching program approved as specified in paragraph (6) of
(ii) services for which payment may be made pursuant to
(iii) services described by
(iv) services of a nurse practitioner or clinical nurse specialist but only if no facility or other provider charges or is paid any amounts with respect to the furnishing of such services; and 2
(C) outpatient physical therapy services (other than services to which the second sentence of
(D)(i) rural health clinic services and (ii) Federally qualified health center services;
(E) comprehensive outpatient rehabilitation facility services;
(F) facility services furnished in connection with surgical procedures specified by the Secretary—
(i) pursuant to
(ii) pursuant to
(I) a quality improvement organization (having a contract with the Secretary under part B of subchapter XI of this chapter) is willing, able, and has agreed to carry out a review (on a sample or other reasonable basis) of the physician's performing such procedures in the physician's office,
(II) the particular physician involved has agreed to make available to such organization such records as the Secretary determines to be necessary to carry out the review, and
(III) the physician is authorized to perform the procedure in a hospital located in the area in which the office is located,
and if the physician agrees to accept the standard overhead amount determined under
(G) covered items (described in
(H) outpatient critical access hospital services (as defined in
(I) prosthetic devices and orthotics and prosthetics (described in
(J) partial hospitalization services and intensive outpatient services provided by a community mental health center (as described in
(b) Definitions
For definitions of "spell of illness", "medical and other health services", and other terms used in this part, see
(Aug. 14, 1935, ch. 531, title XVIII, §1832, as added
Editorial Notes
Amendments
2022—Subsec. (a)(2)(J).
2011—Subsec. (a)(2)(F)(ii)(I).
2008—Subsec. (a)(2)(C).
2000—Subsecs. (b), (c).
1999—Subsecs. (b), (c).
1997—Subsec. (a)(1).
Subsec. (a)(2)(B)(iv).
Subsec. (a)(2)(H).
1990—Subsec. (a)(2)(A), (B).
Subsec. (a)(2)(B)(iii).
Subsec. (a)(2)(B)(iv).
Subsec. (a)(2)(D).
Subsec. (a)(2)(I).
Subsec. (a)(2)(J).
1989—Subsec. (a).
Subsec. (a)(2)(H).
Subsec. (b).
1988—Subsec. (a).
Subsec. (a)(2)(A).
Subsec. (a)(2)(B)(iv).
Subsec. (a)(2)(F)(i).
Subsec. (a)(2)(F)(ii).
Subsec. (b).
1987—Subsec. (a)(2)(A).
Subsec. (a)(2)(B).
Subsec. (a)(2)(B)(iv).
Subsec. (a)(2)(F)(i).
Subsec. (a)(2)(F)(ii).
Subsec. (a)(2)(G).
1986—Subsec. (a)(2)(B)(iii).
Subsec. (a)(2)(C).
Subsec. (a)(2)(F).
1984—Subsec. (a)(2)(F)(ii).
Subsec. (a)(2)(F)(ii)(II).
1982—Subsec. (a)(2)(F)(ii)(I).
1980—Subsec. (a)(2)(A).
Subsec. (a)(2)(B)(i)(II).
Subsec. (a)(2)(E).
Subsec. (a)(2)(F).
1977—Subsec. (a)(1).
Subsec. (a)(2)(D).
1972—Subsec. (a)(2)(B).
Subsec. (a)(2)(C).
1968—Subsec. (a)(2)(B).
Subsec. (a)(2)(C).
Statutory Notes and Related Subsidiaries
Effective Date of 2022 Amendment
Effective Date of 2011 Amendment
Amendment by
Effective Date of 2008 Amendment
Effective Date of 1997 Amendment
Amendment by section 4201(c)(1) of
Amendment by section 4432(b)(5)(B) of
Amendment by section 4603(c)(2)(B)(ii) of
Effective Date of 1990 Amendment
"(A) Subject to subparagraphs (B) and (C), the amendments made by this section [probably means this subsection, which amended this section and
"(B) In the case of a Federally qualified health care center that has elected, as of January 1, 1990, under part B of title XVIII of the Social Security Act [this part], to have the amount of payments for services under such part determined on a reasonable-charge basis, the amendment made by paragraph (3)(A) [amending this section] shall only apply on and after such date (not earlier than October 1, 1991) as the center may elect.
"(C) The amendment made by paragraph (6) [amending
Effective Date of 1989 Amendment
Amendment by section 101(a) of
Amendment by section 201(a) of
Effective Date of 1988 Amendment
Amendment by section 104(d)(3) of
Amendment by section 203(a) of
Except as specifically provided in section 411 of
Effective Date of 1987 Amendment
Amendment by section 4062(d)(2) of
Effective Date of 1986 Amendment
Effective Date of 1984 Amendment
Amendment by section 2354(b)(6) of
Effective Date of 1982 Amendment
Amendment by
Effective Date of 1980 Amendment
Amendment by section 930(g) of
Amendment by section 948(a)(2) of
Effective Date of 1977 Amendment
Effective Date of 1972 Amendment
Amendment by section 227(e)(1) of
Amendment by section 251(a)(4) of
Effective Date of 1968 Amendment
Amendment by section 129(c)(6)(B) of
Construction of 2008 Amendment
Construction of 1986 Amendment
Report on Immunosuppressive Drug Benefit
Quality and Utilization of In-Home Care for Chronically Dependent Individuals
Study of Alternative Out-of-Home Services
Continuation of Cost Pass-Through for Certified Registered Nurse Anesthetists
"(1) Subject to paragraph (2), the amendments made by this section [amending this section and
"(A) as of January 1, 1988, the hospital employed or contracted with a certified registered nurse anesthetist (but not more than one full-time equivalent certified registered nurse anesthetist),
"(B) in 1987 the hospital had a volume of surgical procedures (including inpatient and outpatient procedures) requiring anesthesia services that did not exceed 500 (or such higher number as the Secretary determines to be appropriate), and
"(C) each certified registered nurse anesthetist employed by, or under contract with, the hospital has agreed not to bill under part B of title XVIII of such Act [
"(2) Paragraph (1) shall not apply in a year (after 1989) to a hospital unless the hospital establishes, before the beginning of the year, that the hospital has had a volume of surgical procedures (including inpatient and outpatient procedures) requiring anesthesia services in the previous year that did not exceed 500 (or such higher number as the Secretary determines to be appropriate)."
[
Payment for Services of Physicians Rendered in a Teaching Hospital for Accounting Periods Beginning After June 30, 1975, and Prior to October 1, 1978; Studies, Reports, etc.; Effective Dates
1 So in original. The semicolon probably should be a comma.
2 So in original. The word "and" probably should not appear.
§1395l. Payment of benefits
(a) Amounts
Except as provided in
(1) in the case of services described in
(2) in the case of services described in
(A) with respect to home health services (other than a covered osteoporosis drug) (as defined in
(B) with respect to other items and services (except those described in subparagraph (C), (D), or (E) of this paragraph and except as may be provided in
(i) furnished before January 1, 1999, the lesser of—
(I) the reasonable cost of such services, as determined under
(II) the customary charges with respect to such services,
less the amount a provider may charge as described in clause (ii) of
(ii) if such services are furnished before January 1, 1999, by a public provider of services, or by another provider which demonstrates to the satisfaction of the Secretary that a significant portion of its patients are low-income (and requests that payment be made under this clause), free of charge or at nominal charges to the public, 80 percent of the amount determined in accordance with
(iii) if such services are furnished on or after January 1, 1999, the amount determined under subsection (t), or
(iv) if (and for so long as) the conditions described in
(C) with respect to services described in the second sentence of
(D) with respect to clinical diagnostic laboratory tests for which payment is made under this part (i)(I) on the basis of a fee schedule determined under subsection (h)(1) (for tests furnished before January 1, 2017) or
(E) with respect to—
(i) outpatient hospital radiology services (including diagnostic and therapeutic radiology, nuclear medicine and CAT scan procedures, magnetic resonance imaging, and ultrasound and other imaging services, but excluding screening mammography and, for services furnished on or after January 1, 2005, diagnostic mammography), and
(ii) effective for procedures performed on or after October 1, 1989, diagnostic procedures (as defined by the Secretary) described in
the amount determined under subsection (n) or, for services or procedures performed on or after January 1, 1999, subsection (t);
(F) with respect to a covered osteoporosis drug (as defined in
(G) with respect to items and services described in
(i) the reasonable cost of such services, as determined under
(ii) the customary charges with respect to such services; and
(H) with respect to personalized prevention plan services (as defined in
or,4 if such services are furnished by a public provider of services, or by another provider which demonstrates to the satisfaction of the Secretary that a significant portion of its patients are low-income (and requests that payment be made under this provision), free of charge or at nominal charges to the public, the amount determined in accordance with
(3) in the case of services described in
(A) except as provided in subparagraph (B), the costs which are reasonable and related to the cost of furnishing such services or which are based on such other tests of reasonableness as the Secretary may prescribe in regulations, including those authorized under
(B) with respect to the services described in clause (ii) of
(i) the amount of payment that would have otherwise been provided (I) under subparagraph (A) (calculated as if "100 percent" were substituted for "80 percent" in such subparagraph) for such services if the individual had not been so enrolled, or (II) in the case of such services furnished on or after the implementation date of the prospective payment system under
(ii) the amount of the payments received under such written agreement for such services (not including any financial incentives provided for in such agreement such as risk pool payments, bonuses, or withholds),
less the amount the federally qualified health center may charge as described in
(4) in the case of facility services described in
(5) in the case of covered items (described in
(6) in the case of outpatient critical access hospital services, the amounts described in
(7) in the case of prosthetic devices and orthotics and prosthetics (as described in
(8) in the case of—
(A) outpatient physical therapy services, outpatient speech-language pathology services, and outpatient occupational therapy services furnished—
(i) by a rehabilitation agency, public health agency, clinic, comprehensive outpatient rehabilitation facility, or skilled nursing facility,
(ii) by a home health agency to an individual who is not homebound, or
(iii) by another entity under an arrangement with an entity described in clause (i) or (ii); and
(B) outpatient physical therapy services, outpatient speech-language pathology services, and outpatient occupational therapy services furnished—
(i) by a hospital to an outpatient or to a hospital inpatient who is entitled to benefits under part A but has exhausted benefits for inpatient hospital services during a spell of illness or is not so entitled to benefits under part A, or
(ii) by another entity under an arrangement with a hospital described in clause (i),
the amounts described in
(9) in the case of services described in
(10) with respect to rural emergency hospital services furnished on or after January 1, 2023, the amounts determined under
Paragraph (3)(A) shall not apply to Federally qualified health center services furnished on or after the implementation date of the prospective payment system under
(b) Deductible provision
Before applying subsection (a) with respect to expenses incurred by an individual during any calendar year, the total amount of the expenses incurred by such individual during such year (which would, except for this subsection, constitute incurred expenses from which benefits payable under subsection (a) are determinable) shall be reduced by a deductible of $75 for calendar years before 1991, $100 for 1991 through 2004, $110 for 2005, and for a subsequent year the amount of such deductible for the previous year increased by the annual percentage increase in the monthly actuarial rate under
(c) Mental disorders
(1) Notwithstanding any other provision of this part, with respect to expenses incurred in a calendar year in connection with the treatment of mental, psychoneurotic, and personality disorders of an individual who is not an inpatient of a hospital at the time such expenses are incurred, there shall be considered as incurred expenses for purposes of subsections (a) and (b)—
(A) for expenses incurred in years prior to 2010, only 62½ percent of such expenses;
(B) for expenses incurred in 2010 or 2011, only 68¾ percent of such expenses;
(C) for expenses incurred in 2012, only 75 percent of such expenses;
(D) for expenses incurred in 2013, only 81¼ percent of such expenses; and
(E) for expenses incurred in 2014 or any subsequent calendar year, 100 percent of such expenses.
(2) For purposes of subparagraphs (A) through (D) of paragraph (1), the term "treatment" does not include brief office visits (as defined by the Secretary) for the sole purpose of monitoring or changing drug prescriptions used in the treatment of such disorders or partial hospitalization services or intensive outpatient services that are not directly provided by a physician.
(d) Nonduplication of payments
No payment may be made under this part with respect to any services furnished an individual to the extent that such individual is entitled (or would be entitled except for
(e) Information for determination of amounts due
No payment shall be made to any provider of services or other person under this part unless there has been furnished such information as may be necessary in order to determine the amounts due such provider or other person under this part for the period with respect to which the amounts are being paid or for any prior period.
(f) Maximum rate of payment per visit for independent rural health clinics
(1) In establishing limits under subsection (a) on payment for rural health clinic services provided by rural health clinics (other than such clinics in hospitals with less than 50 beds), the Secretary shall establish such limit, for services provided prior to April 1, 2021—
(A) in 1988, after March 31, at $46 per visit, and
(B) in a subsequent year (before April 1, 2021), at the limit established under this paragraph for the previous year increased by the percentage increase in the MEI (as defined in
(2) In establishing limits under subsection (a) on payment for rural health clinic services furnished on or after April 1, 2021, by a rural health clinic (other than a rural health clinic described in paragraph (3)(B)), the Secretary shall establish such limit, for services provided—
(A) in 2021, after March 31, at $100 per visit;
(B) in 2022, at $113 per visit;
(C) in 2023, at $126 per visit;
(D) in 2024, at $139 per visit;
(E) in 2025, at $152 per visit;
(F) in 2026, at $165 per visit;
(G) in 2027, at $178 per visit;
(H) in 2028, at $190 per visit; and
(I) in a subsequent year, at the limit established under this paragraph for the previous year increased by the percentage increase in the MEI applicable to primary care services furnished as of the first day of such subsequent year.
(3)(A) In establishing limits under subsection (a) on payment for rural health clinic services furnished on or after April 1, 2021, by a rural health clinic described in subparagraph (B), the Secretary shall establish such limit, with respect to each such rural health clinic, for services provided—
(i) in 2021, after March 31, at an amount equal to the greater of—
(I) with respect to a rural health clinic that had a per visit payment amount established for services furnished in 2020—
(aa) the per visit payment amount applicable to such rural health clinic for rural health clinic services furnished in 2020, increased by the percentage increase in the MEI applicable to primary care services furnished as of the first day of 2021; or
(bb) the limit described in paragraph (2)(A); and
(II) with respect to a rural health clinic that did not have a per visit payment amount established for services furnished in 2020—
(aa) the per visit payment amount applicable to such rural health clinic for rural health clinic services furnished in 2021; or
(bb) the limit described in paragraph (2)(A); and
(ii) in a subsequent year, at an amount equal to the greater of—
(I) the amount established under subclause (I) or (II) of clause (i), as applicable, or this subclause for the previous year with respect to such rural health clinic, increased by the percentage increase in the MEI applicable to primary care services furnished as of the first day of such subsequent year; or
(II) the limit established under paragraph (2) for such subsequent year.
(B) A rural health clinic described in this subparagraph is a rural health clinic that—
(i) as of December 31, 2020, was in a hospital with less than 50 beds and after such date such hospital continues to have less than 50 beds (not taking into account any increase in the number of beds pursuant to a waiver under subsection (b)(1)(A) of
(ii)(I) as of December 31, 2020, was enrolled under
(II) submitted an application for enrollment under
(g) Physical therapy services
(1)(A) Subject to paragraphs (4) and (5), in the case of physical therapy services of the type described in
(B) With respect to services furnished during 2018 or a subsequent year, in the case of physical therapy services of the type described in
(2) The amount specified in this paragraph—
(A) for 1999, 2000, and 2001, is $1,500, and
(B) for a subsequent year is the amount specified in this paragraph for the preceding year increased by the percentage increase in the MEI (as defined in
except that if an increase under subparagraph (B) for a year is not a multiple of $10, it shall be rounded to the nearest multiple of $10.
(3)(A) Subject to paragraphs (4) and (5), in the case of occupational therapy services (of the type that are described in
(B) With respect to services furnished during 2018 or a subsequent year, in the case of occupational therapy services (of the type that are described in
(4) This subsection shall not apply to expenses incurred with respect to services furnished during 2000, 2001, 2002, 2004, and 2005.
(5)(A) With respect to expenses incurred during the period beginning on January 1, 2006, and ending on December 31, 2017, for services, the Secretary shall implement a process under which an individual enrolled under this part may, upon request of the individual or a person on behalf of the individual, obtain an exception from the uniform dollar limitation specified in paragraph (2), for services described in paragraphs (1) and (3) if the provision of such services is determined to be medically necessary and if the requirement of subparagraph (B) is met. Under such process, if the Secretary does not make a decision on such a request for an exception within 10 business days of the date of the Secretary's receipt of the request made in accordance with such requirement, the Secretary shall be deemed to have found the services to be medically necessary.
(B) In the case of outpatient therapy services for which an exception is requested under the first sentence of subparagraph (A), the claim for such services shall contain an appropriate modifier (such as the KX modifier used as of February 22, 2012) indicating that such services are medically necessary as justified by appropriate documentation in the medical record involved.
(C)(i) In applying this paragraph with respect to a request for an exception with respect to expenses that would be incurred for outpatient therapy services (including services described in subsection (a)(8)(B)) that would exceed the threshold described in clause (ii) for a year, the request for such an exception, for services furnished on or after October 1, 2012, shall be subject to a manual medical review process that, subject to subparagraph (E), is similar to the manual medical review process used for certain exceptions under this paragraph in 2006.
(ii) The threshold under this clause for a year is $3,700. Such threshold shall be applied separately—
(I) for physical therapy services and speech-language pathology services; and
(II) for occupational therapy services.
(E)(i) 6 In place of the manual medical review process under subparagraph (C)(i), the Secretary shall implement a process for medical review under this subparagraph under which the Secretary shall identify and conduct medical review for services described in subparagraph (C)(i) furnished by a provider of services or supplier (in this subparagraph referred to as a "therapy provider") using such factors as the Secretary determines to be appropriate.
(ii) Such factors may include the following:
(I) The therapy provider has had a high claims denial percentage for therapy services under this part or is less compliant with applicable requirements under this subchapter.
(II) The therapy provider has a pattern of billing for therapy services under this part that is aberrant compared to peers or otherwise has questionable billing practices for such services, such as billing medically unlikely units of services in a day.
(III) The therapy provider is newly enrolled under this subchapter or has not previously furnished therapy services under this part.
(IV) The services are furnished to treat a type of medical condition.
(V) The therapy provider is part of group 7 that includes another therapy provider identified using the factors determined under this subparagraph.
(iii) For purposes of carrying out this subparagraph, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under
(iv) The targeted review process under this subparagraph shall not apply to services for which expenses are incurred beyond the period for which the exceptions process under subparagraph (A) is implemented, except as such process is applied under paragraph (7)(B).
(6)(A) In applying paragraphs (1) and (3) to services furnished during the period beginning not later than October 1, 2012, and ending on December 31, 2017, the exclusion of services described in subsection (a)(8)(B) from the uniform dollar limitation specified in paragraph (2) shall not apply to such services furnished during 2012 through 2017.
(B)(i) With respect to outpatient therapy services furnished beginning on or after January 1, 2013, and before January 1, 2014, for which payment is made under
(ii) Nothing in clause (i) shall be construed as changing the method of payment for outpatient therapy services under
(7) For purposes of paragraphs (1)(B) and (3)(B), with respect to services described in such paragraphs, the requirements described in this paragraph are as follows:
(A) Inclusion of appropriate modifier
The claim for such services contains an appropriate modifier (such as the KX modifier described in paragraph (5)(B)) indicating that such services are medically necessary as justified by appropriate documentation in the medical record involved.
(B) Targeted medical review for certain services above threshold
(i) In general
In the case where expenses that would be incurred for such services would exceed the threshold described in clause (ii) for the year, such services shall be subject to the process for medical review implemented under paragraph (5)(E).
(ii) Threshold
The threshold under this clause for—
(I) a year before 2028, is $3,000;
(II) 2028, is the amount specified in subclause (I) increased by the percentage increase in the MEI (as defined in
(III) a subsequent year, is the amount specified in this clause for the preceding year increased by the percentage increase in the MEI (as defined in
except that if an increase under subclause (II) or (III) for a year is not a multiple of $10, it shall be rounded to the nearest multiple of $10.
(iii) Application
The threshold under clause (ii) shall be applied separately—
(I) for physical therapy services and speech-language pathology services; and
(II) for occupational therapy services.
(iv) Funding
For purposes of carrying out this subparagraph, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under
(8) With respect to services furnished on or after January 1, 2013, where payment may not be made as a result of application of paragraphs (1) and (3),
(h) Fee schedules for clinical diagnostic laboratory tests; percentage of prevailing charge level; nominal fee for samples; adjustments; recipients of payments; negotiated payment rate
(1)(A) Subject to
(B) In the case of clinical diagnostic laboratory tests performed by a physician or by a laboratory (other than tests performed by a qualified hospital laboratory (as defined in subparagraph (D)) for outpatients of such hospital), the fee schedules established under subparagraph (A) shall be established on a regional, statewide, or carrier service area basis (as the Secretary may determine to be appropriate) for tests furnished on or after July 1, 1984.
(C) In the case of clinical diagnostic laboratory tests performed by a qualified hospital laboratory (as defined in subparagraph (D)) for outpatients of such hospital, the fee schedules established under subparagraph (A) shall be established on a regional, statewide, or carrier service area basis (as the Secretary may determine to be appropriate) for tests furnished on or after July 1, 1984.
(D) In this subsection, the term "qualified hospital laboratory" means a hospital laboratory, in a sole community hospital (as defined in
(2)(A)(i) Except as provided in clause (v), subparagraph (B), and paragraph (4), the Secretary shall set the fee schedules at 60 percent (or, in the case of a test performed by a qualified hospital laboratory (as defined in paragraph (1)(D)) for outpatients of such hospital, 62 percent) of the prevailing charge level determined pursuant to the third and fourth sentences of
(ii) Notwithstanding clause (i)—
(I) any change in the fee schedules which would have become effective under this subsection for tests furnished on or after January 1, 1988, shall not be effective for tests furnished during the 3-month period beginning on January 1, 1988,
(II) the Secretary shall not adjust the fee schedules under clause (i) to take into account any increase in the consumer price index for 1988,
(III) the annual adjustment in the fee schedules determined under clause (i) for each of the years 1991, 1992, and 1993 shall be 2 percent, and
(IV) the annual adjustment in the fee schedules determined under clause (i) for each of the years 1994 and 1995, 1998 through 2002, and 2004 through 2008 shall be 0 percent.
(iii) In establishing fee schedules under clause (i) with respect to automated tests and tests (other than cytopathology tests) which before July 1, 1984, the Secretary made subject to a limit based on lowest charge levels under the sixth sentence of
(iv) After determining the adjustment to the fee schedules under clause (i), the Secretary shall reduce such adjustment—
(I) for 2011 and each subsequent year, by the productivity adjustment described in
(II) for each of 2011 through 2015, by 1.75 percentage points.
Subclause (I) shall not apply in a year where the adjustment to the fee schedules determined under clause (i) is 0.0 or a percentage decrease for a year. The application of the productivity adjustment under subclause (I) shall not result in an adjustment to the fee schedules under clause (i) being less than 0.0 for a year. The application of subclause (II) may result in an adjustment to the fee schedules under clause (i) being less than 0.0 for a year, and may result in payment rates for a year being less than such payment rates for the preceding year.
(v) The Secretary shall reduce by 2 percent the fee schedules otherwise determined under clause (i) for 2013, and such reduced fee schedules shall serve as the base for 2014 and subsequent years.
(B) The Secretary may make further adjustments or exceptions to the fee schedules to assure adequate reimbursement of (i) emergency laboratory tests needed for the provision of bona fide emergency services, and (ii) certain low volume high-cost tests where highly sophisticated equipment or extremely skilled personnel are necessary to assure quality.
(3) In addition to the amounts provided under the fee schedules (for tests furnished before January 1, 2017) or under
(4)(A) In establishing any fee schedule under this subsection, the Secretary may provide for an adjustment to take into account, with respect to the portion of the expenses of clinical diagnostic laboratory tests attributable to wages, the relative difference between a region's or local area's wage rates and the wage rate presumed in the data on which the schedule is based.
(B) For purposes of subsections (a)(1)(D)(i) and (a)(2)(D)(i), the limitation amount for a clinical diagnostic laboratory test performed—
(i) on or after July 1, 1986, and before April 1, 1988, is equal to 115 percent of the median of all the fee schedules established for that test for that laboratory setting under paragraph (1),
(ii) after March 31, 1988, and before January 1, 1990, is equal to the median of all the fee schedules established for that test for that laboratory setting under paragraph (1),
(iii) after December 31, 1989, and before January 1, 1991, is equal to 93 percent of the median of all the fee schedules established for that test for that laboratory setting under paragraph (1),
(iv) after December 31, 1990, and before January 1, 1994, is equal to 88 percent of such median,
(v) after December 31, 1993, and before January 1, 1995, is equal to 84 percent of such median,
(vi) after December 31, 1994, and before January 1, 1996, is equal to 80 percent of such median,
(vii) after December 31, 1995, and before January 1, 1998, is equal to 76 percent of such median, and
(viii) after December 31, 1997, is equal to 74 percent of such median (or 100 percent of such median in the case of a clinical diagnostic laboratory test performed on or after January 1, 2001, that the Secretary determines is a new test for which no limitation amount has previously been established under this subparagraph).
(5)(A) In the case of a bill or request for payment for a clinical diagnostic laboratory test for which payment may otherwise be made under this part on an assignment-related basis or under a provider agreement under
(i) if a physician performed or supervised the performance of such test, payment may be made to another physician with whom he shares his practice,
(ii) in the case of a test performed at the request of a laboratory by another laboratory, payment may be made to the referring laboratory but only if—
(I) the referring laboratory is located in, or is part of, a rural hospital,
(II) the referring laboratory is wholly owned by the entity performing such test, the referring laboratory wholly owns the entity performing such test, or both the referring laboratory and the entity performing such test are wholly-owned by a third entity, or
(III) not more than 30 percent of the clinical diagnostic laboratory tests for which such referring laboratory (but not including a laboratory described in subclause (II)),8 receives requests for testing during the year in which the test is performed 8 are performed by another laboratory, and
(iii) in the case of a clinical diagnostic laboratory test provided under an arrangement (as defined in
(B) In the case of such a bill or request for payment for a clinical diagnostic laboratory test for which payment may otherwise be made under this part, and which is not described in subparagraph (A), payment may be made to the beneficiary only on the basis of the itemized bill of the person or entity which performed or supervised the performance of the test.
(C) Payment for a clinical diagnostic laboratory test, including a test performed in a physician's office but excluding a test performed by a rural health clinic may only be made on an assignment-related basis or to a provider of services with an agreement in effect under
(D) A person may not bill for a clinical diagnostic laboratory test, including a test performed in a physician's office but excluding a test performed by a rural health clinic, other than on an assignment-related basis. If a person knowingly and willfully and on a repeated basis bills for a clinical diagnostic laboratory test in violation of the previous sentence, the Secretary may apply sanctions against the person in the same manner as the Secretary may apply sanctions against a physician in accordance with paragraph (2) of
(6) For tests furnished before January 1, 2017, in the case of any diagnostic laboratory test payment for which is not made on the basis of a fee schedule under paragraph (1), the Secretary may establish a payment rate which is acceptable to the person or entity performing the test and which would be considered the full charge for such tests. Such negotiated rate shall be limited to an amount not in excess of the total payment that would have been made for the services in the absence of such rate.
(7) Notwithstanding paragraphs (1) and (4) and
(8)(A) The Secretary shall establish by regulation procedures for determining the basis for, and amount of, payment under this subsection for any clinical diagnostic laboratory test with respect to which a new or substantially revised HCPCS code is assigned on or after January 1, 2005 (in this paragraph referred to as "new tests").
(B) Determinations under subparagraph (A) shall be made only after the Secretary—
(i) makes available to the public (through an Internet website and other appropriate mechanisms) a list that includes any such test for which establishment of a payment amount under this subsection is being considered for a year;
(ii) on the same day such list is made available, causes to have published in the Federal Register notice of a meeting to receive comments and recommendations (and data on which recommendations are based) from the public on the appropriate basis under this subsection for establishing payment amounts for the tests on such list;
(iii) not less than 30 days after publication of such notice convenes a meeting, that includes representatives of officials of the Centers for Medicare & Medicaid Services involved in determining payment amounts, to receive such comments and recommendations (and data on which the recommendations are based);
(iv) taking into account the comments and recommendations (and accompanying data) received at such meeting, develops and makes available to the public (through an Internet website and other appropriate mechanisms) a list of proposed determinations with respect to the appropriate basis for establishing a payment amount under this subsection for each such code, together with an explanation of the reasons for each such determination, the data on which the determinations are based, and a request for public written comments on the proposed determination; and
(v) taking into account the comments received during the public comment period, develops and makes available to the public (through an Internet website and other appropriate mechanisms) a list of final determinations of the payment amounts for such tests under this subsection, together with the rationale for each such determination, the data on which the determinations are based, and responses to comments and suggestions received from the public.
(C) Under the procedures established pursuant to subparagraph (A), the Secretary shall—
(i) set forth the criteria for making determinations under subparagraph (A); and
(ii) make available to the public the data (other than proprietary data) considered in making such determinations.
(D) The Secretary may convene such further public meetings to receive public comments on payment amounts for new tests under this subsection as the Secretary deems appropriate.
(E) For purposes of this paragraph:
(i) The term "HCPCS" refers to the Health Care Procedure Coding System.
(ii) A code shall be considered to be "substantially revised" if there is a substantive change to the definition of the test or procedure to which the code applies (such as a new analyte or a new methodology for measuring an existing analyte-specific test).
(9) Notwithstanding any other provision in this part, in the case of any diagnostic laboratory test for HbA1c that is labeled by the Food and Drug Administration for home use and is furnished on or after April 1, 2008, the payment rate for such test shall be the payment rate established under this part for a glycated hemoglobin test (identified as of October 1, 2007, by HCPCS code 83036 (and any succeeding codes)).
(i) Outpatient surgery
(1) The Secretary shall, in consultation with appropriate medical organizations—
(A) specify those surgical procedures which are appropriately (when considered in terms of the proper utilization of hospital inpatient facilities) performed on an inpatient basis in a hospital but which also can be performed safely on an ambulatory basis in an ambulatory surgical center (meeting the standards specified under
(B) specify those surgical procedures which are appropriately (when considered in terms of the proper utilization of hospital inpatient facilities) performed on an inpatient basis in a hospital but which also can be performed safely on an ambulatory basis in a physician's office.
The lists of procedures established under subparagraphs (A) and (B) shall be reviewed and updated not less often than every 2 years, in consultation with appropriate trade and professional organizations.
(2)(A) For services furnished prior to the implementation of the system described in subparagraph (D), subject to subparagraph (E), the amount of payment to be made for facility services furnished in connection with a surgical procedure specified pursuant to paragraph (1)(A) and furnished to an individual in an ambulatory surgical center described in such paragraph shall be equal to 80 percent of a standard overhead amount established by the Secretary (with respect to each such procedure) on the basis of the Secretary's estimate of a fair fee which—
(i) takes into account the costs incurred by such centers, or classes of centers, generally in providing services furnished in connection with the performance of such procedure, as determined in accordance with a survey (based upon a representative sample of procedures and facilities) of the actual audited costs incurred by such centers in providing such services,
(ii) takes such costs into account in such a manner as will assure that the performance of the procedure in such a center will result in substantially less amounts paid under this subchapter than would have been paid if the procedure had been performed on an inpatient basis in a hospital, and
(iii) in the case of insertion of an intraocular lens during or subsequent to cataract surgery includes payment which is reasonable and related to the cost of acquiring the class of lens involved.
Each amount so established shall be reviewed and updated not later than July 1, 1987, and annually thereafter to take account of varying conditions in different areas.
(B) The amount of payment to be made under this part for facility services furnished, in connection with a surgical procedure specified pursuant to paragraph (1)(B), in a physician's office shall be equal to 80 percent of a standard overhead amount established by the Secretary (with respect to each such procedure) on the basis of the Secretary's estimate of a fair fee which—
(i) takes into account additional costs, not usually included in the professional fee, incurred by physicians in securing, maintaining, and staffing the facilities and ancillary services appropriate for the performance of such procedure in the physician's office, and
(ii) takes such items into account in such a manner which will assure that the performance of such procedure in the physician's office will result in substantially less amounts paid under this subchapter than would have been paid if the services had been furnished on an inpatient basis in a hospital.
Each amount so established shall be reviewed and updated not later than July 1, 1987, and annually thereafter to take account of varying conditions in different areas.
(C)(i) Notwithstanding the second sentence of each of subparagraphs (A) and (B), except as otherwise specified in clauses (ii), (iii), and (iv), if the Secretary has not updated amounts established under such subparagraphs or under subparagraph (D), with respect to facility services furnished during a fiscal year (beginning with fiscal year 1986 or a calendar year (beginning with 2006)), such amounts shall be increased by the percentage increase in the Consumer Price Index for all urban consumers (U.S. city average) as estimated by the Secretary for the 12-month period ending with the midpoint of the year involved.
(ii) In each of the fiscal years 1998 through 2002, the increase under this subparagraph shall be reduced (but not below zero) by 2.0 percentage points.
(iii) In fiscal year 2004, beginning with April 1, 2004, the increase under this subparagraph shall be the Consumer Price Index for all urban consumers (U.S. city average) as estimated by the Secretary for the 12-month period ending with March 31, 2003, minus 3.0 percentage points.
(iv) In fiscal year 2005, the last quarter of calendar year 2005, and each of calendar years 2006 through 2009, the increase under this subparagraph shall be 0 percent.
(D)(i) Taking into account the recommendations in the report under section 626(d) of Medicare Prescription Drug, Improvement, and Modernization Act of 2003, the Secretary shall implement a revised payment system for payment of surgical services furnished in ambulatory surgical centers.
(ii) In the year the system described in clause (i) is implemented, such system shall be designed to result in the same aggregate amount of expenditures for such services as would be made if this subparagraph did not apply, as estimated by the Secretary and taking into account reduced expenditures that would apply if subparagraph (E) were to continue to apply, as estimated by the Secretary.
(iii) The Secretary shall implement the system described in clause (i) for periods in a manner so that it is first effective beginning on or after January 1, 2006, and not later than January 1, 2008.
(iv) The Secretary may implement such system in a manner so as to provide for a reduction in any annual update for failure to report on quality measures in accordance with paragraph (7).
(v) In implementing the system described in clause (i) for 2011 and each subsequent year, any annual update under such system for the year, after application of clause (iv), shall be reduced by the productivity adjustment described in
(vi) There shall be no administrative or judicial review under
(E) With respect to surgical procedures furnished on or after January 1, 2007, and before the effective date of the implementation of a revised payment system under subparagraph (D), if—
(i) the standard overhead amount under subparagraph (A) for a facility service for such procedure, without the application of any geographic adjustment, exceeds
(ii) the Medicare OPD fee schedule amount established under the prospective payment system for hospital outpatient department services under paragraph (3)(D) of subsection (t) for such service for such year, determined without regard to geographic adjustment under paragraph (2)(D) of such subsection,
the Secretary shall substitute under subparagraph (A) the amount described in clause (ii) for the standard overhead amount for such service referred to in clause (i).
(3)(A) The aggregate amount of the payments to be made under this part for outpatient hospital facility services or critical access hospital services furnished before January 1, 1999, in connection with surgical procedures specified under paragraph (1)(A) shall be equal to the lesser of—
(i) the amount determined with respect to such services under subsection (a)(2)(B); or
(ii) the blend amount (described in subparagraph (B)).
(B)(i) The blend amount for a cost reporting period is the sum of—
(I) the cost proportion (as defined in clause (ii)(I)) of the amount described in subparagraph (A)(i), and
(II) the ASC proportion (as defined in clause (ii)(II)) of the standard overhead amount payable with respect to the same surgical procedure as if it were provided in an ambulatory surgical center in the same area, as determined under paragraph (2)(A), less the amount a provider may charge as described in clause (ii) of
(ii) Subject to paragraph (4), in this paragraph:
(I) The term "cost proportion" means 75 percent for cost reporting periods beginning in fiscal year 1988, 50 percent for portions of cost reporting periods beginning on or after October 1, 1988, and ending on or before December 31, 1990, and 42 percent for portions of cost reporting periods beginning on or after January 1, 1991.
(II) The term "ASC proportion" means 25 percent for cost reporting periods beginning in fiscal year 1988, 50 percent for portions of cost reporting periods beginning on or after October 1, 1988, and ending on or before December 31, 1990, and 58 percent for portions of cost reporting periods beginning on or after January 1, 1991.
(4)(A) In the case of a hospital that—
(i) makes application to the Secretary and demonstrates that it specializes in eye services or eye and ear services (as determined by the Secretary),
(ii) receives more than 30 percent of its total revenues from outpatient services, and
(iii) on October 1, 1987—
(I) was an eye specialty hospital or an eye and ear specialty hospital, or
(II) was operated as an eye or eye and ear unit (as defined in subparagraph (B)) of a general acute care hospital which, on the date of the application described in clause (i), operates less than 20 percent of the beds that the hospital operated on October 1, 1987, and has sold or otherwise disposed of a substantial portion of the hospital's other acute care operations,
the cost proportion and ASC proportion in effect under subclauses (I) and (II) of paragraph (3)(B)(ii) for cost reporting periods beginning in fiscal year 1988 shall remain in effect for cost reporting periods beginning on or after October 1, 1988, and before January 1, 1995.
(B) For purposes of this 10 subparagraph (A)(iii)(II), the term "eye or eye and ear unit" means a physically separate or distinct unit containing separate surgical suites devoted solely to eye or eye and ear services.
(5)(A) The Secretary is authorized to provide by regulations that in the case of a surgical procedure, specified by the Secretary pursuant to paragraph (1)(A), performed in an ambulatory surgical center described in such paragraph, there shall be paid (in lieu of any amounts otherwise payable under this part) with respect to the facility services furnished by such center and with respect to all related services (including physicians' services, laboratory, X-ray, and diagnostic services) a single all-inclusive fee established pursuant to subparagraph (B), if all parties furnishing all such services agree to accept such fee (to be divided among the parties involved in such manner as they shall have previously agreed upon) as full payment for the services furnished.
(B) In implementing this paragraph, the Secretary shall establish with respect to each surgical procedure specified pursuant to paragraph (1)(A) the amount of the all-inclusive fee for such procedure, taking into account such factors as may be appropriate. The amount so established with respect to any surgical procedure shall be reviewed periodically and may be adjusted by the Secretary, when appropriate, to take account of varying conditions in different areas.
(6) Any person, including a facility having an agreement under
(7)(A) For purposes of paragraph (2)(D)(iv), the Secretary may provide, in the case of an ambulatory surgical center that does not submit, to the Secretary in accordance with this paragraph, data required to be submitted on measures selected under this paragraph with respect to a year, any annual increase provided under the system established under paragraph (2)(D) for such year shall be reduced by 2.0 percentage points. A reduction under this subparagraph shall apply only with respect to the year involved and the Secretary shall not take into account such reduction in computing any annual increase factor for a subsequent year.
(B) Except as the Secretary may otherwise provide, the provisions of subparagraphs (B), (C), (D), and (E) of paragraph (17) of subsection (t) shall apply with respect to services of ambulatory surgical centers under this paragraph in a similar manner to the manner in which they apply under such paragraph and, for purposes of this subparagraph, any reference to a hospital, outpatient setting, or outpatient hospital services is deemed a reference to an ambulatory surgical center, the setting of such a center, or services of such a center, respectively.
(8) The Secretary shall conduct a similar type of review as required under paragraph (22) of
(9) In the case of a part B rebatable drug (as defined in paragraph (2) of
(10)
(A)
(B)
(j) Accrual of interest on balance of excess or deficit not paid
Whenever a final determination is made that the amount of payment made under this part either to a provider of services or to another person pursuant to an assignment under
(k) Hepatitis B vaccine
With respect to services described in
(l) Fee schedule for services of certified registered nurse anesthetists
(1)(A) The Secretary shall establish a fee schedule for services of certified registered nurse anesthetists under
(B) In establishing the fee schedule under this paragraph the Secretary may utilize a system of time units, a system of base and time units, or any appropriate methodology.
(C) The provisions of this subsection shall not apply to certain services furnished in certain hospitals in rural areas under the provisions of section 9320(k) of the Omnibus Budget Reconciliation Act of 1986, as amended by section 6132 of the Omnibus Budget Reconciliation Act of 1989.
(2) Except as provided in paragraph (3), the fee schedule established under paragraph (1) shall be initially based on audited data from cost reporting periods ending in fiscal year 1985 and such other data as the Secretary determines necessary.
(3)(A) In establishing the initial fee schedule for those services, the Secretary shall adjust the fee schedule to the extent necessary to ensure that the estimated total amount which will be paid under this subchapter for those services plus applicable coinsurance in 1989 will equal the estimated total amount which would be paid under this subchapter for those services in 1989 if the services were included as inpatient hospital services and payment for such services was made under part A in the same manner as payment was made in fiscal year 1987, adjusted to take into account changes in prices and technology relating to the administration of anesthesia.
(B) The Secretary shall also reduce the prevailing charge of physicians for medical direction of a certified registered nurse anesthetist, or the fee schedule for services of certified registered nurse anesthetists, or both, to the extent necessary to ensure that the estimated total amount which will be paid under this subchapter plus applicable coinsurance for such medical direction and such services in 1989 and 1990 will not exceed the estimated total amount which would have been paid plus applicable coinsurance but for the enactment of the amendments made by section 9320 of the Omnibus Budget Reconciliation Act of 1986. A reduced prevailing charge under this subparagraph shall become the prevailing charge but for subsequent years for purposes of applying the economic index under the fourth sentence of
(4)(A) Except as provided in subparagraphs (C) and (D), in determining the amount paid under the fee schedule under this subsection for services furnished on or after January 1, 1991, by a certified registered nurse anesthetist who is not medically directed—
(i) the conversion factor shall be—
(I) for services furnished in 1991, $15.50,
(II) for services furnished in 1992, $15.75,
(III) for services furnished in 1993, $16.00,
(IV) for services furnished in 1994, $16.25,
(V) for services furnished in 1995, $16.50,
(VI) for services furnished in 1996, $16.75, and
(VII) for services furnished in calendar years after 1996, the previous year's conversion factor increased by the update determined under
(ii) the payment areas to be used shall be the fee schedule areas used under
(iii) the geographic adjustment factors to be applied to the conversion factor under clause (i) for services in a fee schedule area or locality is— 12
(I) in the case of services furnished in 1991, the geographic work index value and the geographic practice cost index value specified in
(II) in the case of services furnished after 1991, the geographic work index value, the geographic practice cost index value, and the geographic malpractice index value used for determining payments for physicians' services that are anesthesia services under
with 70 percent of the conversion factor treated as attributable to work and 30 percent as attributable to overhead for services furnished in 1991 (and the portions attributable to work, practice expenses, and malpractice expenses in 1992 and thereafter being the same as is applied under
(B)(i) Except as provided in clause (ii) and subparagraph (D), in determining the amount paid under the fee schedule under this subsection for services furnished on or after January 1, 1991, and before January 1, 1994, by a certified registered nurse anesthetist who is medically directed, the Secretary shall apply the same methodology specified in subparagraph (A).
(ii) The conversion factor used under clause (i) shall be—
(I) for services furnished in 1991, $10.50,
(II) for services furnished in 1992, $10.75, and
(III) for services furnished in 1993, $11.00.
(iii) In the case of services of a certified registered nurse anesthetist who is medically directed or medically supervised by a physician which are furnished on or after January 1, 1994, the fee schedule amount shall be one-half of the amount described in
(C) Notwithstanding subclauses (I) through (V) of subparagraph (A)(i)—
(i) in the case of a 1990 conversion factor that is greater than $16.50, the conversion factor for a calendar year after 1990 and before 1996 shall be the 1990 conversion factor reduced by the product of the last digit of the calendar year and one-fifth of the amount by which the 1990 conversion factor exceeds $16.50; and
(ii) in the case of a 1990 conversion factor that is greater than $15.49 but less than $16.51, the conversion factor for a calendar year after 1990 and before 1996 shall be the greater of—
(I) the 1990 conversion factor, or
(II) the conversion factor specified in subparagraph (A)(i) for the year involved.
(D) Notwithstanding subparagraph (C), in no case may the conversion factor used to determine payment for services in a fee schedule area or locality under this subsection, as adjusted by the adjustment factors specified in subparagraphs 13 (A)(iii), exceed the conversion factor used to determine the amount paid for physicians' services that are anesthesia services in the area or locality.
(5)(A) Payment for the services of a certified registered nurse anesthetist (for which payment may otherwise be made under this part) may be made on the basis of a claim or request for payment presented by the certified registered nurse anesthetist furnishing such services, or by a hospital, critical access hospital, physician, group practice, or ambulatory surgical center with which the certified registered nurse anesthetist furnishing such services has an employment or contractual relationship that provides for payment to be made under this part for such services to such hospital, critical access hospital, physician, group practice, or ambulatory surgical center.
(B) No hospital or critical access hospital that presents a claim or request for payment for services of a certified nurse anesthetist under this part may treat any uncollected coinsurance amount imposed under this part with respect to such services as a bad debt of such hospital or critical access hospital for purposes of this subchapter.
(6) If an adjustment under paragraph (3)(B) results in a reduction in the reasonable charge for a physicians' service and a nonparticipating physician furnishes the service to an individual entitled to benefits under this part after the effective date of the reduction, the physician's actual charge is subject to a limit under
(m) Incentive payments for physicians' services furnished in underserved areas
(1) In the case of physicians' services furnished in a year to an individual, who is covered under the insurance program established by this part and who incurs expenses for such services, in an area that is designated (under
(2) For each health professional shortage area identified in paragraph (1) that consists of an entire county, the Secretary shall provide for the additional payment under paragraph (1) without any requirement on the physician to identify the health professional shortage area involved. The Secretary may implement the previous sentence using the method specified in subsection (u)(4)(C).
(3) The Secretary shall post on the Internet website of the Centers for Medicare & Medicaid Services a list of the health professional shortage areas identified in paragraph (1) that consist of a partial county to facilitate the additional payment under paragraph (1) in such areas.
(4) There shall be no administrative or judicial review under
(A) the identification of a county or area;
(B) the assignment of a specialty of any physician under this paragraph;
(C) the assignment of a physician to a county under this subsection; or
(D) the assignment of a postal ZIP Code to a county or other area under this subsection.
(n) Payments to hospital outpatient departments for radiology; amount; definitions
(1)(A) 14 The aggregate amount of the payments to be made for all or part of a cost reporting period for services described in subsection (a)(2)(E)(i) furnished under this part on or after October 1, 1988, and before January 1, 1999, and for services described in subsection (a)(2)(E)(ii) furnished under this part on or after October 1, 1989, and before January 1, 1999, shall be equal to the lesser of—
(i) the amount determined with respect to such services under subsection (a)(2)(B), or
(ii) the blend amount for radiology services and diagnostic procedures determined in accordance with subparagraph (B).
(B)(i) The blend amount for radiology services and diagnostic procedures for a cost reporting period is the sum of—
(I) the cost proportion (as defined in clause (ii)) of the amount described in subparagraph (A)(i); and
(II) the charge proportion (as defined in clause (ii)(II)) of 62 percent (for services described in subsection (a)(2)(E)(i)), or (for procedures described in subsection (a)(2)(E)(ii)), 42 percent or such other percent established by the Secretary (or carriers acting pursuant to guidelines issued by the Secretary) based on prevailing charges established with actual charge data, of the prevailing charge or (for services described in subsection (a)(2)(E)(i) furnished on or after April 1, 1989 and for services described in subsection (a)(2)(E)(ii) furnished on or after January 1, 1992) the fee schedule amount established for participating physicians for the same services as if they were furnished in a physician's office in the same locality as determined under
(ii) In this subparagraph:
(I) The term "cost proportion" means 50 percent, except that such term means 65 percent in the case of outpatient radiology services for portions of cost reporting periods which occur in fiscal year 1989 and in the case of diagnostic procedures described in subsection (a)(2)(E)(ii) for portions of cost reporting periods which occur in fiscal year 1990, and such term means 42 percent in the case of outpatient radiology services for portions of cost reporting periods beginning on or after January 1, 1991.
(II) The term "charge proportion" means 100 percent minus the cost proportion.
(o) Limitation on benefit for payment for therapeutic shoes for individuals with severe diabetic foot disease
(1) In the case of shoes described in
(A) no payment may be made under this part, with respect to any individual for any year, for the furnishing of—
(i) more than one pair of custom molded shoes (including inserts provided with such shoes) and 2 additional pairs of inserts for such shoes, or
(ii) more than one pair of extra-depth shoes (not including inserts provided with such shoes) and 3 pairs of inserts for such shoes, and
(B) with respect to expenses incurred in any calendar year, no more than the amount of payment applicable under paragraph (2) shall be considered as incurred expenses for purposes of subsections (a) and (b).
Payment for shoes (or inserts) under this part shall be considered to include payment for any expenses for the fitting of such shoes (or inserts).
(2)(A) Except as provided by the Secretary under subparagraphs (B) and (C), the amount of payment under this paragraph for custom molded shoes, extra-depth shoes, and inserts shall be the amount determined for such items by the Secretary under
(B) The Secretary may establish payment amounts for shoes and inserts that are lower than the amount established under
(C) In accordance with procedures established by the Secretary, an individual entitled to benefits with respect to shoes described in
(3) In this subchapter, the term "shoes" includes, except for purposes of subparagraphs (A)(ii) and (B) of paragraph (2), inserts for extra-depth shoes.
(p) Repealed. Pub. L. 103–432, title I, §123(b)(2)(A)(ii), Oct. 31, 1994, 108 Stat. 4411
(q) Requests for payment to include information on referring physician
(1) Each request for payment, or bill submitted, for an item or service furnished by an entity for which payment may be made under this part and for which the entity knows or has reason to believe there has been a referral by a referring physician (within the meaning of
(2)(A) In the case of a request for payment for an item or service furnished by an entity under this part on an assignment-related basis and for which information is required to be provided under paragraph (1) but not included, payment may be denied under this part.
(B) In the case of a request for payment for an item or service furnished by an entity under this part not submitted on an assignment-related basis and for which information is required to be provided under paragraph (1) but not included—
(i) if the entity knowingly and willfully fails to provide such information promptly upon request of the Secretary or a carrier, the entity may be subject to a civil money penalty in an amount not to exceed $2,000, and
(ii) if the entity knowingly, willfully, and in repeated cases fails, after being notified by the Secretary of the obligations and requirements of this subsection to provide the information required under paragraph (1), the entity may be subject to exclusion from participation in the programs under this chapter for a period not to exceed 5 years, in accordance with the procedures of subsections (c), (f), and (g) of
The provisions of
(r) Cap on prevailing charge; billing on assignment-related basis
(1) With respect to services described in
(2) No hospital or critical access hospital that presents a claim or request for payment under this part for services described in
(s) Other prepaid organizations
The Secretary may not provide for payment under subsection (a)(1)(A) with respect to an organization unless the organization provides assurances satisfactory to the Secretary that the organization meets the requirement of
(t) Prospective payment system for hospital outpatient department services
(1) Amount of payment
(A) In general
With respect to covered OPD services (as defined in subparagraph (B)) furnished during a year beginning with 1999, the amount of payment under this part shall be determined under a prospective payment system established by the Secretary in accordance with this subsection.
(B) Definition of covered OPD services
For purposes of this subsection, the term "covered OPD services"—
(i) means hospital outpatient services designated by the Secretary;
(ii) subject to clause (iv), includes inpatient hospital services designated by the Secretary that are covered under this part and furnished to a hospital inpatient who (I) is entitled to benefits under part A but has exhausted benefits for inpatient hospital services during a spell of illness, or (II) is not so entitled;
(iii) includes implantable items described in paragraph (3), (6), or (8) of
(iv) does not include any therapy services described in subsection (a)(8) or ambulance services, for which payment is made under a fee schedule described in
(v) does not include applicable items and services (as defined in subparagraph (A) of paragraph (21)) that are furnished on or after January 1, 2017, by an off-campus outpatient department of a provider (as defined in subparagraph (B) of such paragraph).
(2) System requirements
Under the payment system—
(A) the Secretary shall develop a classification system for covered OPD services;
(B) the Secretary may establish groups of covered OPD services, within the classification system described in subparagraph (A), so that services classified within each group are comparable clinically and with respect to the use of resources and so that an implantable item is classified to the group that includes the service to which the item relates;
(C) the Secretary shall, using data on claims from 1996 and using data from the most recent available cost reports, establish relative payment weights for covered OPD services (and any groups of such services described in subparagraph (B)) based on median (or, at the election of the Secretary, mean) hospital costs and shall determine projections of the frequency of utilization of each such service (or group of services) in 1999;
(D) subject to paragraph (19), the Secretary shall determine a wage adjustment factor to adjust the portion of payment and coinsurance attributable to labor-related costs for relative differences in labor and labor-related costs across geographic regions in a budget neutral manner;
(E) the Secretary shall establish, in a budget neutral manner, outlier adjustments under paragraph (5) and transitional pass-through payments under paragraph (6) and temporary additional payments for non-opioid treatments for pain relief under paragraph (16)(G), and other adjustments as determined to be necessary to ensure equitable payments, such as adjustments for certain classes of hospitals;
(F) the Secretary shall develop a method for controlling unnecessary increases in the volume of covered OPD services;
(G) the Secretary shall create additional groups of covered OPD services that classify separately those procedures that utilize contrast agents from those that do not; and
(H) with respect to devices of brachytherapy consisting of a seed or seeds (or radioactive source), the Secretary shall create additional groups of covered OPD services that classify such devices separately from the other services (or group of services) paid for under this subsection in a manner reflecting the number, isotope, and radioactive intensity of such devices furnished, including separate groups for palladium-103 and iodine-125 devices and for stranded and non-stranded devices furnished on or after July 1, 2007.
For purposes of subparagraph (B), items and services within a group shall not be treated as "comparable with respect to the use of resources" if the highest median cost (or mean cost, if elected by the Secretary under subparagraph (C)) for an item or service within the group is more than 2 times greater than the lowest median cost (or mean cost, if so elected) for an item or service within the group; except that the Secretary may make exceptions in unusual cases, such as low volume items and services, but may not make such an exception in the case of a drug or biological that has been designated as an orphan drug under
(3) Calculation of base amounts
(A) Aggregate amounts that would be payable if deductibles were disregarded
The Secretary shall estimate the sum of—
(i) the total amounts that would be payable from the Trust Fund under this part for covered OPD services in 1999, determined without regard to this subsection, as though the deductible under subsection (b) did not apply, and
(ii) the total amounts of copayments estimated to be paid under this subsection by beneficiaries to hospitals for covered OPD services in 1999, as though the deductible under subsection (b) did not apply.
(B) Unadjusted copayment amount
(i) In general
For purposes of this subsection, subject to clause (ii), the "unadjusted copayment amount" applicable to a covered OPD service (or group of such services) is 20 percent of the national median of the charges for the service (or services within the group) furnished during 1996, updated to 1999 using the Secretary's estimate of charge growth during the period.
(ii) Adjusted to be 20 percent when fully phased in
If the pre-deductible payment percentage for a covered OPD service (or group of such services) furnished in a year would be equal to or exceed 80 percent, then the unadjusted copayment amount shall be 20 percent of amount determined under subparagraph (D).
(iii) Rules for new services
The Secretary shall establish rules for establishment of an unadjusted copayment amount for a covered OPD service not furnished during 1996, based upon its classification within a group of such services.
(C) Calculation of conversion factors
(i) For 1999
(I) In general
The Secretary shall establish a 1999 conversion factor for determining the medicare OPD fee schedule amounts for each covered OPD service (or group of such services) furnished in 1999. Such conversion factor shall be established on the basis of the weights and frequencies described in paragraph (2)(C) and in such a manner that the sum for all services and groups of the products (described in subclause (II) for each such service or group) equals the total projected amount described in subparagraph (A).
(II) Product described
The Secretary shall determine for each service or group the product of the medicare OPD fee schedule amounts (taking into account appropriate adjustments described in paragraphs (2)(D) and (2)(E)) and the estimated frequencies for such service or group.
(ii) Subsequent years
Subject to paragraph (8)(B), the Secretary shall establish a conversion factor for covered OPD services furnished in subsequent years in an amount equal to the conversion factor established under this subparagraph and applicable to such services furnished in the previous year increased by the OPD fee schedule increase factor specified under clause (iv) for the year involved.
(iii) Adjustment for service mix changes
Insofar as the Secretary determines that the adjustments for service mix under paragraph (2) for a previous year (or estimates that such adjustments for a future year) did (or are likely to) result in a change in aggregate payments under this subsection during the year that are a result of changes in the coding or classification of covered OPD services that do not reflect real changes in service mix, the Secretary may adjust the conversion factor computed under this subparagraph for subsequent years so as to eliminate the effect of such coding or classification changes.
(iv) OPD fee schedule increase factor
For purposes of this subparagraph, subject to paragraph (17) and subparagraph (F) of this paragraph, the "OPD fee schedule increase factor" for services furnished in a year is equal to the market basket percentage increase applicable under
(D) Calculation of medicare OPD fee schedule amounts
The Secretary shall compute a medicare OPD fee schedule amount for each covered OPD service (or group of such services) furnished in a year, in an amount equal to the product of—
(i) the conversion factor computed under subparagraph (C) for the year, and
(ii) the relative payment weight (determined under paragraph (2)(C)) for the service or group.
(E) Pre-deductible payment percentage
The pre-deductible payment percentage for a covered OPD service (or group of such services) furnished in a year is equal to the ratio of—
(i) the medicare OPD fee schedule amount established under subparagraph (D) for the year, minus the unadjusted copayment amount determined under subparagraph (B) for the service or group, to
(ii) the medicare OPD fee schedule amount determined under subparagraph (D) for the year for such service or group.
(F) Productivity and other adjustment
After determining the OPD fee schedule increase factor under subparagraph (C)(iv), the Secretary shall reduce such increase factor—
(i) for 2012 and subsequent years, by the productivity adjustment described in
(ii) for each of 2010 through 2019, by the adjustment described in subparagraph (G).
The application of this subparagraph may result in the increase factor under subparagraph (C)(iv) being less than 0.0 for a year, and may result in payment rates under the payment system under this subsection for a year being less than such payment rates for the preceding year.
(G) Other adjustment
For purposes of subparagraph (F)(ii), the adjustment described in this subparagraph is—
(i) for each of 2010 and 2011, 0.25 percentage point;
(ii) for each of 2012 and 2013, 0.1 percentage point;
(iii) for 2014, 0.3 percentage point;
(iv) for each of 2015 and 2016, 0.2 percentage point; and
(v) for each of 2017, 2018, and 2019, 0.75 percentage point.
(4) Medicare payment amount
The amount of payment made from the Trust Fund under this part for a covered OPD service (and such services classified within a group) furnished in a year is determined, subject to paragraph (7), as follows:
(A) Fee schedule adjustments
The medicare OPD fee schedule amount (computed under paragraph (3)(D)) for the service or group and year is adjusted for relative differences in the cost of labor and other factors determined by the Secretary, as computed under paragraphs (2)(D) and (2)(E).
(B) Subtract applicable deductible
Reduce the adjusted amount determined under subparagraph (A) by the amount of the deductible under subsection (b), to the extent applicable.
(C) Apply payment proportion to remainder
The amount of payment is the amount so determined under subparagraph (B) multiplied by the pre-deductible payment percentage (as determined under paragraph (3)(E)) for the service or group and year involved, plus the amount of any reduction in the copayment amount attributable to paragraph (8)(C).
(5) Outlier adjustment
(A) In general
Subject to subparagraph (D), the Secretary shall provide for an additional payment for each covered OPD service (or group of services) for which a hospital's charges, adjusted to cost, exceed—
(i) a fixed multiple of the sum of—
(I) the applicable medicare OPD fee schedule amount determined under paragraph (3)(D), as adjusted under paragraph (4)(A) (other than for adjustments under this paragraph or paragraph (6)); and
(II) any transitional pass-through payment under paragraph (6); and
(ii) at the option of the Secretary, such fixed dollar amount as the Secretary may establish.
(B) Amount of adjustment
The amount of the additional payment under subparagraph (A) shall be determined by the Secretary and shall approximate the marginal cost of care beyond the applicable cutoff point under such subparagraph.
(C) Limit on aggregate outlier adjustments
(i) In general
The total of the additional payments made under this paragraph for covered OPD services furnished in a year (as estimated by the Secretary before the beginning of the year) may not exceed the applicable percentage (specified in clause (ii)) of the total program payments estimated to be made under this subsection for all covered OPD services furnished in that year. If this paragraph is first applied to less than a full year, the previous sentence shall apply only to the portion of such year.
(ii) Applicable percentage
For purposes of clause (i), the term "applicable percentage" means a percentage specified by the Secretary up to (but not to exceed)—
(I) for a year (or portion of a year) before 2004, 2.5 percent; and
(II) for 2004 and thereafter, 3.0 percent.
(D) Transitional authority
In applying subparagraph (A) for covered OPD services furnished before January 1, 2002, the Secretary may—
(i) apply such subparagraph to a bill for such services related to an outpatient encounter (rather than for a specific service or group of services) using OPD fee schedule amounts and transitional pass-through payments covered under the bill; and
(ii) use an appropriate cost-to-charge ratio for the hospital involved (as determined by the Secretary), rather than for specific departments within the hospital.
(E) Exclusion of separate drug and biological APCS from outlier payments
No additional payment shall be made under subparagraph (A) in the case of ambulatory payment classification groups established separately for drugs or biologicals.
(6) Transitional pass-through for additional costs of innovative medical devices, drugs, and biologicals
(A) In general
The Secretary shall provide for an additional payment under this paragraph for any of the following that are provided as part of a covered OPD service (or group of services):
(i) Current orphan drugs
A drug or biological that is used for a rare disease or condition with respect to which the drug or biological has been designated as an orphan drug under
(ii) Current cancer therapy drugs and biologicals and brachytherapy
A drug or biological that is used in cancer therapy, including (but not limited to) a chemotherapeutic agent, an antiemetic, a hematopoietic growth factor, a colony stimulating factor, a biological response modifier, a bisphosphonate, and a device of brachytherapy or temperature monitored cryoablation, if payment for such drug, biological, or device as an outpatient hospital service under this part was being made on such first date.
(iii) Current radiopharmaceutical drugs and biological products
A radiopharmaceutical drug or biological product used in diagnostic, monitoring, and therapeutic nuclear medicine procedures if payment for the drug or biological as an outpatient hospital service under this part was being made on such first date.
(iv) New medical devices, drugs, and biologicals
A medical device, drug, or biological not described in clause (i), (ii), or (iii) if—
(I) payment for the device, drug, or biological as an outpatient hospital service under this part was not being made as of December 31, 1996; and
(II) the cost of the drug or biological or the average cost of the category of devices is not insignificant in relation to the OPD fee schedule amount (as calculated under paragraph (3)(D)) payable for the service (or group of services) involved.
(B) Use of categories in determining eligibility of a device for pass-through payments
The following provisions apply for purposes of determining whether a medical device qualifies for additional payments under clause (ii) or (iv) of subparagraph (A):
(i) Establishment of initial categories
(I) In general
The Secretary shall initially establish under this clause categories of medical devices based on type of device by April 1, 2001. Such categories shall be established in a manner such that each medical device that meets the requirements of clause (ii) or (iv) of subparagraph (A) as of January 1, 2001, is included in such a category and no such device is included in more than one category. For purposes of the preceding sentence, whether a medical device meets such requirements as of such date shall be determined on the basis of the program memoranda issued before such date.
(II) Authorization of implementation other than through regulations
The categories may be established under this clause by program memorandum or otherwise, after consultation with groups representing hospitals, manufacturers of medical devices, and other affected parties.
(ii) Establishing criteria for additional categories
(I) In general
The Secretary shall establish criteria that will be used for creation of additional categories (other than those established under clause (i)) through rulemaking (which may include use of an interim final rule with comment period).
(II) Standard
Such categories shall be established under this clause in a manner such that no medical device is described by more than one category. Such criteria shall include a test of whether the average cost of devices that would be included in a category and are in use at the time the category is established is not insignificant, as described in subparagraph (A)(iv)(II).
(III) Deadline
Criteria shall first be established under this clause by July 1, 2001. The Secretary may establish in compelling circumstances categories under this clause before the date such criteria are established.
(IV) Adding categories
The Secretary shall promptly establish a new category of medical devices under this clause for any medical device that meets the requirements of subparagraph (A)(iv) and for which none of the categories in effect (or that were previously in effect) is appropriate.
(iii) Period for which category is in effect
Subject to subparagraph (K), a category of medical devices established under clause (i) or (ii) shall be in effect for a period of at least 2 years, but not more than 3 years, that begins—
(I) in the case of a category established under clause (i), on the first date on which payment was made under this paragraph for any device described by such category (including payments made during the period before April 1, 2001); and
(II) in the case of any other category, on the first date on which payment is made under this paragraph for any medical device that is described by such category.
(iv) Requirements treated as met
A medical device shall be treated as meeting the requirements of subparagraph (A)(iv), regardless of whether the device meets the requirement of subclause (I) of such subparagraph, if—
(I) the device is described by a category established and in effect under clause (i); or
(II) the device is described by a category established and in effect under clause (ii) and an application under
Nothing in this clause shall be construed as requiring an application or prior approval (other than that described in subclause (II)) in order for a covered device described by a category to qualify for payment under this paragraph.
(C) Limited period of payment
(i) Drugs and biologicals
Subject to subparagraph (G), the payment under this paragraph with respect to a drug or biological shall only apply during a period of at least 2 years, but not more than 3 years, that begins—
(I) on the first date this subsection is implemented in the case of a drug or biological described in clause (i), (ii), or (iii) of subparagraph (A) and in the case of a drug or biological described in subparagraph (A)(iv) and for which payment under this part is made as an outpatient hospital service before such first date; or
(II) in the case of a drug or biological described in subparagraph (A)(iv) not described in subclause (I), on the first date on which payment is made under this part for the drug or biological as an outpatient hospital service.
(ii) Medical devices
Payment shall be made under this paragraph with respect to a medical device only if such device—
(I) is described by a category of medical devices established and in effect under subparagraph (B); and
(II) is provided as part of a service (or group of services) paid for under this subsection and provided during the period for which such category is in effect under such subparagraph.
(D) Amount of additional payment
Subject to subparagraph (E)(iii), the amount of the payment under this paragraph with respect to a device, drug, or biological provided as part of a covered OPD service is—
(i) subject to subparagraph (H), in the case of a drug or biological, the amount by which the amount determined under
(ii) in the case of a medical device, the amount by which the hospital's charges for the device, adjusted to cost, exceeds the portion of the otherwise applicable medicare OPD fee schedule that the Secretary determines is associated with the device.
(E) Limit on aggregate annual adjustment
(i) In general
The total of the additional payments made under this paragraph for covered OPD services furnished in a year (as estimated by the Secretary before the beginning of the year) may not exceed the applicable percentage (specified in clause (ii)) of the total program payments estimated to be made under this subsection for all covered OPD services furnished in that year. If this paragraph is first applied to less than a full year, the previous sentence shall apply only to the portion of such year. This clause shall not apply for 2018 or 2020.
(ii) Applicable percentage
For purposes of clause (i), the term "applicable percentage" means—
(I) for a year (or portion of a year) before 2004, 2.5 percent; and
(II) for 2004 and thereafter, a percentage specified by the Secretary up to (but not to exceed) 2.0 percent.
(iii) Uniform prospective reduction if aggregate limit projected to be exceeded
If the Secretary estimates before the beginning of a year that the amount of the additional payments under this paragraph for the year (or portion thereof) as determined under clause (i) without regard to this clause will exceed the limit established under such clause, the Secretary shall reduce pro rata the amount of each of the additional payments under this paragraph for that year (or portion thereof) in order to ensure that the aggregate additional payments under this paragraph (as so estimated) do not exceed such limit.
(F) Limitation of application of functional equivalence standard
(i) In general
The Secretary may not publish regulations that apply a functional equivalence standard to a drug or biological under this paragraph.
(ii) Application
Clause (i) shall apply to the application of a functional equivalence standard to a drug or biological on or after December 8, 2003, unless—
(I) such application was being made to such drug or biological prior to December 8, 2003; and
(II) the Secretary applies such standard to such drug or biological only for the purpose of determining eligibility of such drug or biological for additional payments under this paragraph and not for the purpose of any other payments under this subchapter.
(iii) Rule of construction
Nothing in this subparagraph shall be construed to effect the Secretary's authority to deem a particular drug to be identical to another drug if the 2 products are pharmaceutically equivalent and bioequivalent, as determined by the Commissioner of Food and Drugs.
(G) Pass-through extension for certain drugs and biologicals
In the case of a drug or biological whose period of pass-through status under this paragraph ended on December 31, 2017, and for which payment under this subsection was packaged into a payment for a covered OPD service (or group of services) furnished beginning January 1, 2018, such pass-through status shall be extended for a 2-year period beginning on October 1, 2018.
(H) Temporary payment rule for certain drugs and biologicals
In the case of a drug or biological whose period of pass-through status under this paragraph ended on December 31, 2017, and for which payment under this subsection was packaged into a payment for a covered OPD service (or group of services) furnished beginning January 1, 2018, the payment amount for such drug or biological under this subsection that is furnished during the period beginning on October 1, 2018, and ending on March 31, 2019, shall be the greater of—
(i) the payment amount that would otherwise apply under subparagraph (D)(i) for such drug or biological during such period; or
(ii) the payment amount that applied under such subparagraph (D)(i) for such drug or biological on December 31, 2017.
(I) Special payment adjustment rules for last quarter of 2018
In the case of a drug or biological whose period of pass-through status under this paragraph ended on December 31, 2017, and for which payment under this subsection was packaged into a payment amount for a covered OPD service (or group of services) beginning January 1, 2018, the following rules shall apply with respect to payment amounts under this subsection for covered a OPD 15 service (or group of services) furnished during the period beginning on October 1, 2018, and ending on December 31, 2018:
(i) The Secretary shall remove the packaged costs of such drug or biological (as determined by the Secretary) from the payment amount under this subsection for the covered OPD service (or group of services) with which it is packaged.
(ii) The Secretary shall not make any adjustments to payment amounts under this subsection for a covered OPD service (or group of services) for which no costs were removed under clause (i).
(J) Additional pass-through extension and special payment adjustment rule for certain diagnostic radiopharmaceuticals
In the case of a drug or biological furnished in the context of a clinical study on diagnostic imaging tests approved under a coverage with evidence development determination whose period of pass-through status under this paragraph concluded on December 31, 2018, and for which payment under this subsection was packaged into a payment for a covered OPD service (or group of services) furnished beginning January 1, 2019, the Secretary shall—
(i) extend such pass-through status for such drug or biological for the 9-month period beginning on January 1, 2020;
(ii) remove, during such period, the packaged costs of such drug or biological (as determined by the Secretary) from the payment amount under this subsection for the covered OPD service (or group of services) with which it is packaged; and
(iii) not make any adjustments to payment amounts under this subsection for a covered OPD service (or group of services) for which no costs were removed under clause (ii).
(K) Pass-through extension for certain devices
(i) In general
In the case of a device whose period of pass-through status under this paragraph will end on December 31, 2022, such pass-through status shall be extended for a 1–year period beginning on January 1, 2023.
(ii) No adjustment for packaged costs
For purposes of the 1–year period described in clause (i), the Secretary shall not remove the packaged costs of such device (as determined by the Secretary) from the payment amount under this subsection for a covered OPD service (or group of services) with which it is packaged.
(iii) No application of aggregate limit or budget neutrality
Notwithstanding any other provision of this subsection, this subparagraph shall not be taken into account—
(I) in applying the limit on annual aggregate adjustments under subparagraph (E) for 2023; or
(II) in making any budget neutrality adjustments under this subsection for 2023.
(7) Transitional adjustment to limit decline in payment
(A) Before 2002
Subject to subparagraph (D), for covered OPD services furnished before January 1, 2002, for which the PPS amount (as defined in subparagraph (E)) is—
(i) at least 90 percent, but less than 100 percent, of the pre-BBA amount (as defined in subparagraph (F)), the amount of payment under this subsection shall be increased by 80 percent of the amount of such difference;
(ii) at least 80 percent, but less than 90 percent, of the pre-BBA amount, the amount of payment under this subsection shall be increased by the amount by which (I) the product of 0.71 and the pre-BBA amount, exceeds (II) the product of 0.70 and the PPS amount;
(iii) at least 70 percent, but less than 80 percent, of the pre-BBA amount, the amount of payment under this subsection shall be increased by the amount by which (I) the product of 0.63 and the pre-BBA amount, exceeds (II) the product of 0.60 and the PPS amount; or
(iv) less than 70 percent of the pre-BBA amount, the amount of payment under this subsection shall be increased by 21 percent of the pre-BBA amount.
(B) 2002
Subject to subparagraph (D), for covered OPD services furnished during 2002, for which the PPS amount is—
(i) at least 90 percent, but less than 100 percent, of the pre-BBA amount, the amount of payment under this subsection shall be increased by 70 percent of the amount of such difference;
(ii) at least 80 percent, but less than 90 percent, of the pre-BBA amount, the amount of payment under this subsection shall be increased by the amount by which (I) the product of 0.61 and the pre-BBA amount, exceeds (II) the product of 0.60 and the PPS amount; or
(iii) less than 80 percent of the pre-BBA amount, the amount of payment under this subsection shall be increased by 13 percent of the pre-BBA amount.
(C) 2003
Subject to subparagraph (D), for covered OPD services furnished during 2003, for which the PPS amount is—
(i) at least 90 percent, but less than 100 percent, of the pre-BBA amount, the amount of payment under this subsection shall be increased by 60 percent of the amount of such difference; or
(ii) less than 90 percent of the pre-BBA amount, the amount of payment under this subsection shall be increased by 6 percent of the pre-BBA amount.
(D) Hold harmless provisions
(i) Temporary treatment for certain rural hospitals
(I) In the case of a hospital located in a rural area and that has not more than 100 beds or a sole community hospital (as defined in
(II) In the case of a hospital located in a rural area and that has not more than 100 beds and that is not a sole community hospital (as defined in
(III) In the case of a sole community hospital (as defined in
(ii) Permanent treatment for cancer hospitals and children's hospitals
In the case of a hospital described in clause (iii) or (v) of
(E) PPS amount defined
In this paragraph, the term "PPS amount" means, with respect to covered OPD services, the amount payable under this subchapter for such services (determined without regard to this paragraph), including amounts payable as copayment under paragraph (8), coinsurance under
(F) Pre-BBA amount defined
(i) In general
In this paragraph, the "pre-BBA amount" means, with respect to covered OPD services furnished by a hospital in a year, an amount equal to the product of the reasonable cost of the hospital for such services for the portions of the hospital's cost reporting period (or periods) occurring in the year and the base OPD payment-to-cost ratio for the hospital (as defined in clause (ii)).
(ii) Base payment-to-cost ratio defined
For purposes of this subparagraph, the "base payment-to-cost ratio" for a hospital means the ratio of—
(I) the hospital's reimbursement under this part for covered OPD services furnished during the cost reporting period ending in 1996 (or in the case of a hospital that did not submit a cost report for such period, during the first subsequent cost reporting period ending before 2001 for which the hospital submitted a cost report), including any reimbursement for such services through cost-sharing described in subparagraph (E), to
(II) the reasonable cost of such services for such period.
The Secretary shall determine such ratios as if the amendments made by section 4521 of the Balanced Budget Act of 1997 were in effect in 1996.
(G) Interim payments
The Secretary shall make payments under this paragraph to hospitals on an interim basis, subject to retrospective adjustments based on settled cost reports.
(H) No effect on copayments
Nothing in this paragraph shall be construed to affect the unadjusted copayment amount described in paragraph (3)(B) or the copayment amount under paragraph (8).
(I) Application without regard to budget neutrality
The additional payments made under this paragraph—
(i) shall not be considered an adjustment under paragraph (2)(E); and
(ii) shall not be implemented in a budget neutral manner.
(8) Copayment amount
(A) In general
Except as provided in subparagraphs (B) and (C), the copayment amount under this subsection is the amount by which the amount described in paragraph (4)(B) exceeds the amount of payment determined under paragraph (4)(C).
(B) Election to offer reduced copayment amount
The Secretary shall establish a procedure under which a hospital, before the beginning of a year (beginning with 1999), may elect to reduce the copayment amount otherwise established under subparagraph (A) for some or all covered OPD services to an amount that is not less than 20 percent of the medicare OPD fee schedule amount (computed under paragraph (3)(D)) for the service involved. Under such procedures, such reduced copayment amount may not be further reduced or increased during the year involved and the hospital may disseminate information on the reduction of copayment amount effected under this subparagraph.
(C) Limitation on copayment amount
(i) To inpatient hospital deductible amount
In no case shall the copayment amount for a procedure performed in a year exceed the amount of the inpatient hospital deductible established under
(ii) To specified percentage
The Secretary shall reduce the national unadjusted copayment amount for a covered OPD service (or group of such services) furnished in a year in a manner so that the effective copayment rate (determined on a national unadjusted basis) for that service in the year does not exceed the following percentage:
(I) For procedures performed in 2001, on or after April 1, 2001, 57 percent.
(II) For procedures performed in 2002 or 2003, 55 percent.
(III) For procedures performed in 2004, 50 percent.
(IV) For procedures performed in 2005, 45 percent.
(V) For procedures performed in 2006 and thereafter, 40 percent.
(D) No impact on deductibles
Nothing in this paragraph shall be construed as affecting a hospital's authority to waive the charging of a deductible under subsection (b).
(E) Computation ignoring outlier and pass-through adjustments
The copayment amount shall be computed under subparagraph (A) as if the adjustments under paragraphs (5) and (6) (and any adjustment made under paragraph (2)(E) in relation to such adjustments) had not occurred.
(F) Part B rebatable drugs
In the case of a part B rebatable drug (as defined in paragraph (2) of
(9) Periodic review and adjustments components of prospective payment system
(A) Periodic review
The Secretary shall review not less often than annually and revise the groups, the relative payment weights, and the wage and other adjustments described in paragraph (2) to take into account changes in medical practice, changes in technology, the addition of new services, new cost data, and other relevant information and factors. The Secretary shall consult with an expert outside advisory panel composed of an appropriate selection of representatives of providers to review (and advise the Secretary concerning) the clinical integrity of the groups and weights. Such panel may use data collected or developed by entities and organizations (other than the Department of Health and Human Services) in conducting such review.
(B) Budget neutrality adjustment
If the Secretary makes adjustments under subparagraph (A), then the adjustments for a year may not cause the estimated amount of expenditures under this part for the year to increase or decrease from the estimated amount of expenditures under this part that would have been made if the adjustments had not been made. In determining adjustments under the preceding sentence for 2004 and 2005, the Secretary shall not take into account under this subparagraph or paragraph (2)(E) any expenditures that would not have been made but for the application of paragraph (14).
(C) Update factor
If the Secretary determines under methodologies described in paragraph (2)(F) that the volume of services paid for under this subsection increased beyond amounts established through those methodologies, the Secretary may appropriately adjust the update to the conversion factor otherwise applicable in a subsequent year.
(10) Special rule for ambulance services
The Secretary shall pay for hospital outpatient services that are ambulance services on the basis described in
(11) Special rules for certain hospitals
In the case of hospitals described in clause (iii) or (v) of
(A) the system under this subsection shall not apply to covered OPD services furnished before January 1, 2000; and
(B) the Secretary may establish a separate conversion factor for such services in a manner that specifically takes into account the unique costs incurred by such hospitals by virtue of their patient population and service intensity.
(12) Limitation on review
There shall be no administrative or judicial review under
(A) the development of the classification system under paragraph (2), including the establishment of groups and relative payment weights for covered OPD services, of wage adjustment factors, other adjustments, and methods described in paragraph (2)(F);
(B) the calculation of base amounts under paragraph (3);
(C) periodic adjustments made under paragraph (6);
(D) the establishment of a separate conversion factor under paragraph (8)(B); and
(E) the determination of the fixed multiple, or a fixed dollar cutoff amount, the marginal cost of care, or applicable percentage under paragraph (5) or the determination of insignificance of cost, the duration of the additional payments, the determination and deletion of initial and new categories (consistent with subparagraphs (B) and (C) of paragraph (6)), the portion of the medicare OPD fee schedule amount associated with particular devices, drugs, or biologicals, and the application of any pro rata reduction under paragraph (6).
(13) Authorization of adjustment for rural hospitals
(A) Study
The Secretary shall conduct a study to determine if, under the system under this subsection, costs incurred by hospitals located in rural areas by ambulatory payment classification groups (APCs) exceed those costs incurred by hospitals located in urban areas.
(B) Authorization of adjustment
Insofar as the Secretary determines under subparagraph (A) that costs incurred by hospitals located in rural areas exceed those costs incurred by hospitals located in urban areas, the Secretary shall provide for an appropriate adjustment under paragraph (2)(E) to reflect those higher costs by January 1, 2006.
(14) Drug APC payment rates
(A) In general
The amount of payment under this subsection for a specified covered outpatient drug (defined in subparagraph (B)) that is furnished as part of a covered OPD service (or group of services)—
(i) in 2004, in the case of—
(I) a sole source drug shall in no case be less than 88 percent, or exceed 95 percent, of the reference average wholesale price for the drug;
(II) an innovator multiple source drug shall in no case exceed 68 percent of the reference average wholesale price for the drug; or
(III) a noninnovator multiple source drug shall in no case exceed 46 percent of the reference average wholesale price for the drug;
(ii) in 2005, in the case of—
(I) a sole source drug shall in no case be less than 83 percent, or exceed 95 percent, of the reference average wholesale price for the drug;
(II) an innovator multiple source drug shall in no case exceed 68 percent of the reference average wholesale price for the drug; or
(III) a noninnovator multiple source drug shall in no case exceed 46 percent of the reference average wholesale price for the drug; or
(iii) in a subsequent year, shall be equal, subject to subparagraph (E)—
(I) to the average acquisition cost for the drug for that year (which, at the option of the Secretary, may vary by hospital group (as defined by the Secretary based on volume of covered OPD services or other relevant characteristics)), as determined by the Secretary taking into account the hospital acquisition cost survey data under subparagraph (D); or
(II) if hospital acquisition cost data are not available, the average price for the drug in the year established under
(B) Specified covered outpatient drug defined
(i) In general
In this paragraph, the term "specified covered outpatient drug" means, subject to clause (ii), a covered outpatient drug (as defined in
(I) a radiopharmaceutical; or
(II) a drug or biological for which payment was made under paragraph (6) (relating to pass-through payments) on or before December 31, 2002.
(ii) Exception
Such term does not include—
(I) a drug or biological for which payment is first made on or after January 1, 2003, under paragraph (6);
(II) a drug or biological for which a temporary HCPCS code has not been assigned; or
(III) during 2004 and 2005, an orphan drug (as designated by the Secretary).
(C) Payment for designated orphan drugs during 2004 and 2005
The amount of payment under this subsection for an orphan drug designated by the Secretary under subparagraph (B)(ii)(III) that is furnished as part of a covered OPD service (or group of services) during 2004 and 2005 shall equal such amount as the Secretary may specify.
(D) Acquisition cost survey for hospital outpatient drugs
(i) Annual GAO surveys in 2004 and 2005
(I) In general
The Comptroller General of the United States shall conduct a survey in each of 2004 and 2005 to determine the hospital acquisition cost for each specified covered outpatient drug. Not later than April 1, 2005, the Comptroller General shall furnish data from such surveys to the Secretary for use in setting the payment rates under subparagraph (A) for 2006.
(II) Recommendations
Upon the completion of such surveys, the Comptroller General shall recommend to the Secretary the frequency and methodology of subsequent surveys to be conducted by the Secretary under clause (ii).
(ii) Subsequent secretarial surveys
The Secretary, taking into account such recommendations, shall conduct periodic subsequent surveys to determine the hospital acquisition cost for each specified covered outpatient drug for use in setting the payment rates under subparagraph (A).
(iii) Survey requirements
The surveys conducted under clauses (i) and (ii) shall have a large sample of hospitals that is sufficient to generate a statistically significant estimate of the average hospital acquisition cost for each specified covered outpatient drug. With respect to the surveys conducted under clause (i), the Comptroller General shall report to Congress on the justification for the size of the sample used in order to assure the validity of such estimates.
(iv) Differentiation in cost
In conducting surveys under clause (i), the Comptroller General shall determine and report to Congress if there is (and the extent of any) variation in hospital acquisition costs for drugs among hospitals based on the volume of covered OPD services performed by such hospitals or other relevant characteristics of such hospitals (as defined by the Comptroller General).
(v) Comment on proposed rates
Not later than 30 days after the date the Secretary promulgated proposed rules setting forth the payment rates under subparagraph (A) for 2006, the Comptroller General shall evaluate such proposed rates and submit to Congress a report regarding the appropriateness of such rates based on the surveys the Comptroller General has conducted under clause (i).
(E) Adjustment in payment rates for overhead costs
(i) MedPAC report on drug APC design
The Medicare Payment Advisory Commission shall submit to the Secretary, not later than July 1, 2005, a report on adjustment of payment for ambulatory payment classifications for specified covered outpatient drugs to take into account overhead and related expenses, such as pharmacy services and handling costs. Such report shall include—
(I) a description and analysis of the data available with regard to such expenses;
(II) a recommendation as to whether such a payment adjustment should be made; and
(III) if such adjustment should be made, a recommendation regarding the methodology for making such an adjustment.
(ii) Adjustment authorized
The Secretary may adjust the weights for ambulatory payment classifications for specified covered outpatient drugs to take into account the recommendations contained in the report submitted under clause (i).
(F) Classes of drugs
For purposes of this paragraph:
(i) Sole source drugs
The term "sole source drug" means—
(I) a biological product (as defined under
(II) a single source drug (as defined in
(ii) Innovator multiple source drugs
The term "innovator multiple source drug" has the meaning given such term in
(iii) Noninnovator multiple source drugs
The term "noninnovator multiple source drug" has the meaning given such term in
(G) Reference average wholesale price
The term "reference average wholesale price" means, with respect to a specified covered outpatient drug, the average wholesale price for the drug as determined under
(H) Inapplicability of expenditures in determining conversion, weighting, and other adjustment factors
Additional expenditures resulting from this paragraph shall not be taken into account in establishing the conversion, weighting, and other adjustment factors for 2004 and 2005 under paragraph (9), but shall be taken into account for subsequent years.
(15) Payment for new drugs and biologicals until HCPCS code assigned
With respect to payment under this part for an outpatient drug or biological that is covered under this part and is furnished as part of covered OPD services for which a HCPCS code has not been assigned, the amount provided for payment for such drug or biological under this part shall be equal to 95 percent of the average wholesale price for the drug or biological.
(16) Miscellaneous provisions
(A) Application of reclassification of certain hospitals
If a hospital is being treated as being located in a rural area under
(B) Threshold for establishment of separate APCS for drugs
The Secretary shall reduce the threshold for the establishment of separate ambulatory payment classification groups (APCs) with respect to drugs or biologicals to $50 per administration for drugs and biologicals furnished in 2005 and 2006.
(C) Payment for devices of brachytherapy and therapeutic radiopharmaceuticals at charges adjusted to cost
Notwithstanding the preceding provisions of this subsection, for a device of brachytherapy consisting of a seed or seeds (or radioactive source) furnished on or after January 1, 2004, and before January 1, 2010, and for therapeutic radiopharmaceuticals furnished on or after January 1, 2008, and before January 1, 2010, the payment basis for the device or therapeutic radiopharmaceutical under this subsection shall be equal to the hospital's charges for each device or therapeutic radiopharmaceutical furnished, adjusted to cost. Charges for such devices or therapeutic radiopharmaceuticals shall not be included in determining any outlier payment under this subsection.
(D) Special payment rule
(i) In general
In the case of covered OPD services furnished on or after April 1, 2013, in a hospital described in clause (ii), if—
(I) the payment rate that would otherwise apply under this subsection for stereotactic radiosurgery, complete course of treatment of cranial lesion(s) consisting of 1 session that is multi-source Cobalt 60 based (identified as of January 1, 2013, by HCPCS code 77371 (and any succeeding code) and reimbursed as of such date under APC 0127 (and any succeeding classification group)); exceeds
(II) the payment rate that would otherwise apply under this subsection for linear accelerator based stereotactic radiosurgery, complete course of therapy in one session (identified as of January 1, 2013, by HCPCS code G0173 (and any succeeding code) and reimbursed as of such date under APC 0067 (and any succeeding classification group)),
the payment rate for the service described in subclause (I) shall be reduced to an amount equal to the payment rate for the service described in subclause (II).
(ii) Hospital described
A hospital described in this clause is a hospital that is not—
(I) located in a rural area (as defined in
(II) classified as a rural referral center under
(III) a sole community hospital (as defined in
(iii) Not budget neutral
In making any budget neutrality adjustments under this subsection for 2013 (with respect to covered OPD services furnished on or after April 1, 2013, and before January 1, 2014) or a subsequent year, the Secretary shall not take into account the reduced expenditures that result from the application of this subparagraph.
(E) Application of appropriate use criteria for certain imaging services
For provisions relating to the application of appropriate use criteria for certain imaging services, see
(F) Payment incentive for the transition from traditional X-ray imaging to digital radiography
Notwithstanding the previous provisions of this subsection:
(i) Limitation on payment for film X-ray imaging services
In the case of an imaging service that is an X-ray taken using film and that is furnished during 2017 or a subsequent year, the payment amount for such service (including the X-ray component of a packaged service) that would otherwise be determined under this section (without application of this paragraph and before application of any other adjustment under this subsection) for such year shall be reduced by 20 percent.
(ii) Phased-in limitation on payment for computed radiography imaging services
In the case of an imaging service that is an X-ray taken using computed radiography technology (as defined in
(I) in the case of such a service furnished during 2018, 2019, 2020, 2021, or 2022, the payment amount for such service (including the X-ray component of a packaged service) that would otherwise be determined under this section (without application of this paragraph and before application of any other adjustment under this subsection) for such year shall be reduced by 7 percent; and
(II) in the case of such a service furnished during 2023 or a subsequent year, the payment amount for such service (including the X-ray component of a packaged service) that would otherwise be determined under this section (without application of this paragraph and before application of any other adjustment under this subsection) for such year shall be reduced by 10 percent.
(iii) Application without regard to budget neutrality
The reductions made under this subparagraph—
(I) shall not be considered an adjustment under paragraph (2)(E); and
(II) shall not be implemented in a budget neutral manner.
(iv) Implementation
In order to implement this subparagraph, the Secretary shall adopt appropriate mechanisms which may include use of modifiers.
(G) Temporary additional payments for non-opioid treatments for pain relief
(i) In general
Notwithstanding any other provision of this subsection, with respect to a non-opioid treatment for pain relief (as defined in clause (iv)) furnished on or after January 1, 2025, and before January 1, 2028, the Secretary shall not package payment for such non-opioid treatment for pain relief into a payment for a covered OPD service (or group of services), and shall make an additional payment as specified in clause (ii) for such non-opioid treatment for pain relief.
(ii) Amount of payment
Subject to the limitation under clause (iii), the amount of the payment specified in this clause is, with respect to a non-opioid treatment for pain relief that is—
(I) a drug or biological product, the amount of payment for such drug or biological determined under
(II) a medical device, the amount of the hospital's charges for the device, adjusted to cost, that exceeds the portion of the otherwise applicable Medicare OPD fee schedule that the Secretary determines is associated with the device.
(iii) Limitation
The additional payment amount specified in clause (ii) shall not exceed the estimated average of 18 percent of the OPD fee schedule amount for the OPD service (or group of services) with which the non-opioid treatment for pain relief is furnished, as determined by the Secretary.
(iv) Definition of non-opioid treatment for pain relief
In this subparagraph, the term "non-opioid treatment for pain relief" means a drug, biological product, or medical device that—
(I) in the case of a drug or biological product, has a label indication approved by the Food and Drug Administration to reduce postoperative pain, or produce postsurgical or regional analgesia, without acting upon the body's opioid receptors;
(II) in case of a medical device, is used to deliver a therapy to reduce postoperative pain, or produce postsurgical or regional analgesia, and has—
(aa) an application under
(bb) demonstrated the ability to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer-reviewed journal;
(III) does not receive transitional pass-through payment under paragraph (6); and
(IV) has payment that is packaged into a payment for a covered OPD service (or group of services).
(17) Quality reporting
(A) Reduction in update for failure to report
(i) In general
For purposes of paragraph (3)(C)(iv) for 2009 and each subsequent year, in the case of a subsection (d) hospital (as defined in
(ii) Non-cumulative application
A reduction under this subparagraph shall apply only with respect to the year involved and the Secretary shall not take into account such reduction in computing the OPD fee schedule increase factor for a subsequent year.
(B) Form and manner of submission
Each subsection (d) hospital shall submit data on measures selected under this paragraph to the Secretary in a form and manner, and at a time, specified by the Secretary for purposes of this paragraph.
(C) Development of outpatient measures
(i) In general
The Secretary shall develop measures that the Secretary determines to be appropriate for the measurement of the quality of care (including medication errors) furnished by hospitals in outpatient settings and that reflect consensus among affected parties and, to the extent feasible and practicable, shall include measures set forth by one or more national consensus building entities.
(ii) Construction
Nothing in this paragraph shall be construed as preventing the Secretary from selecting measures that are the same as (or a subset of) the measures for which data are required to be submitted under
(D) Replacement of measures
For purposes of this paragraph, the Secretary may replace any measures or indicators in appropriate cases, such as where all hospitals are effectively in compliance or the measures or indicators have been subsequently shown not to represent the best clinical practice.
(E) Availability of data
The Secretary shall establish procedures for making data submitted under this paragraph available to the public. Such procedures shall ensure that a hospital has the opportunity to review the data that are to be made public with respect to the hospital prior to such data being made public. The Secretary shall report quality measures of process, structure, outcome, patients' perspectives on care, efficiency, and costs of care that relate to services furnished in outpatient settings in hospitals on the Internet website of the Centers for Medicare & Medicaid Services.
(18) Authorization of adjustment for cancer hospitals
(A) Study
The Secretary shall conduct a study to determine if, under the system under this subsection, costs incurred by hospitals described in
(B) Authorization of adjustment
Insofar as the Secretary determines under subparagraph (A) that costs incurred by hospitals described in
(C) Target PCR adjustment
In applying section 419.43(i) of title 42 of the Code of Federal Regulations to implement the appropriate adjustment under this paragraph for services furnished on or after January 1, 2018, the Secretary shall use a target PCR that is 1.0 percentage points less than the target PCR that would otherwise apply. In addition to the percentage point reduction under the previous sentence, the Secretary may consider making an additional percentage point reduction to such target PCR that takes into account payment rates for applicable items and services described in paragraph (21)(C) other than for services furnished by hospitals described in
(19) Floor on area wage adjustment factor for hospital outpatient department services in frontier States
(A) In general
Subject to subparagraph (B), with respect to covered OPD services furnished on or after January 1, 2011, the area wage adjustment factor applicable under the payment system established under this subsection to any hospital outpatient department which is located in a frontier State (as defined in
(B) Limitation
This paragraph shall not apply to any hospital outpatient department located in a State that receives a non-labor related share adjustment under
(20) Not budget neutral application of reduced expenditures resulting from quality incentives for computed tomography
The Secretary shall not take into account the reduced expenditures that result from the application of
(21) Services furnished by an off-campus outpatient department of a provider
(A) Applicable items and services
For purposes of paragraph (1)(B)(v) and this paragraph, the term "applicable items and services" means items and services other than items and services furnished by a dedicated emergency department (as defined in section 489.24(b) of title 42 of the Code of Federal Regulations).
(B) Off-campus outpatient department of a provider
(i) In general
For purposes of paragraph (1)(B)(v) and this paragraph, subject to the subsequent provisions of this subparagraph, the term "off-campus outpatient department of a provider" means a department of a provider (as defined in section 413.65(a)(2) of title 42 of the Code of Federal Regulations, as in effect as of November 2, 2015) that is not located—
(I) on the campus (as defined in such section 413.65(a)(2)) of such provider; or
(II) within the distance (described in such definition of campus) from a remote location of a hospital facility (as defined in such section 413.65(a)(2)).
(ii) Exception
For purposes of paragraph (1)(B)(v) and this paragraph, the term "off-campus outpatient department of a provider" shall not include a department of a provider (as so defined) that was billing under this subsection with respect to covered OPD services furnished prior to November 2, 2015.
(iii) Deemed treatment for 2017
For purposes of applying clause (ii) with respect to applicable items and services furnished during 2017, a department of a provider (as so defined) not described in such clause is deemed to be billing under this subsection with respect to covered OPD services furnished prior to November 2, 2015, if the Secretary received from the provider prior to December 2, 2015, an attestation (pursuant to section 413.65(b)(3) of title 42 of the Code of Federal Regulations) that such department was a department of a provider (as so defined).
(iv) Alternative exception beginning with 2018
For purposes of paragraph (1)(B)(v) and this paragraph with respect to applicable items and services furnished during 2018 or a subsequent year, the term "off-campus outpatient department of a provider" also shall not include a department of a provider (as so defined) that is not described in clause (ii) if—
(I) the Secretary receives from the provider an attestation (pursuant to such section 413.65(b)(3)) not later than December 31, 2016 (or, if later, 60 days after December 13, 2016), that such department met the requirements of a department of a provider specified in section 413.65 of title 42 of the Code of Federal Regulations;
(II) the provider includes such department as part of the provider on its enrollment form in accordance with the enrollment process under
(III) the department met the mid-build requirement of clause (v) and the Secretary receives, not later than 60 days after December 13, 2016, from the chief executive officer or chief operating officer of the provider a written certification that the department met such requirement.
(v) Mid-build requirement described
The mid-build requirement of this clause is, with respect to a department of a provider, that before November 2, 2015, the provider had a binding written agreement with an outside unrelated party for the actual construction of such department.
(vi) Exclusion for certain cancer hospitals
For purposes of paragraph (1)(B)(v) and this paragraph with respect to applicable items and services furnished during 2017 or a subsequent year, the term "off-campus outpatient department of a provider" also shall not include a department of a provider (as so defined) that is not described in clause (ii) if the provider is a hospital described in
(I) in the case of a department that met the requirements of section 413.65 of title 42 of the Code of Federal Regulations after November 1, 2015, and before December 13, 2016, the Secretary receives from the provider an attestation that such department met such requirements not later than 60 days after such date; or
(II) in the case of a department that meets such requirements after such date, the Secretary receives from the provider an attestation that such department meets such requirements not later than 60 days after the date such requirements are first met with respect to such department.
(vii) Audit
Not later than December 31, 2018, the Secretary shall audit the compliance with requirements of clause (iv) with respect to each department of a provider to which such clause applies. Not later than 2 years after the date the Secretary receives an attestation under clause (vi) relating to compliance of a department of a provider with requirements referred to in such clause, the Secretary shall audit the compliance with such requirements with respect to the department. If the Secretary finds as a result of an audit under this clause that the applicable requirements were not met with respect to such department, the department shall not be excluded from the term "off-campus outpatient department of a provider" under such clause.
(viii) Implementation
For purposes of implementing clauses (iii) through (vii):
(I) Notwithstanding any other provision of law, the Secretary may implement such clauses by program instruction or otherwise.
(II) Subchapter I of
(III) For purposes of carrying out this subparagraph with respect to clauses (iii) and (iv) (and clause (vii) insofar as it relates to clause (iv)), $10,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under
(C) Availability of payment under other payment systems
Payments for applicable items and services furnished by an off-campus outpatient department of a provider that are described in paragraph (1)(B)(v) shall be made under the applicable payment system under this part (other than under this subsection) if the requirements for such payment are otherwise met.
(D) Information needed for implementation
Each hospital shall provide to the Secretary such information as the Secretary determines appropriate to implement this paragraph and paragraph (1)(B)(v) (which may include reporting of information on a hospital claim using a code or modifier and reporting information about off-campus outpatient departments of a provider on the enrollment form described in
(E) Limitations
There shall be no administrative or judicial review under
(i) The determination of the applicable items and services under subparagraph (A) and applicable payment systems under subparagraph (C).
(ii) The determination of whether a department of a provider meets the term described in subparagraph (B).
(iii) Any information that hospitals are required to report pursuant to subparagraph (D).
(iv) The determination of an audit under subparagraph (B)(vii).
(22) Review and revisions of payments for non-opioid alternative treatments
(A) In general
With respect to payments made under this subsection for covered OPD services (or groups of services), including covered OPD services assigned to a comprehensive ambulatory payment classification, the Secretary—
(i) shall, as soon as practicable, conduct a review (part of which may include a request for information) of payments for opioids and evidence-based non-opioid alternatives for pain management (including drugs and devices, nerve blocks, surgical injections, and neuromodulation) with a goal of ensuring that there are not financial incentives to use opioids instead of non-opioid alternatives;
(ii) may, as the Secretary determines appropriate, conduct subsequent reviews of such payments; and
(iii) shall consider the extent to which revisions under this subsection to such payments (such as the creation of additional groups of covered OPD services to classify separately those procedures that utilize opioids and non-opioid alternatives for pain management) would reduce payment incentives to use opioids instead of non-opioid alternatives for pain management.
(B) Priority
In conducting the review under clause (i) of subparagraph (A) and considering revisions under clause (iii) of such subparagraph, the Secretary shall focus on covered OPD services (or groups of services) assigned to a comprehensive ambulatory payment classification, ambulatory payment classifications that primarily include surgical services, and other services determined by the Secretary which generally involve treatment for pain management.
(C) Revisions
If the Secretary identifies revisions to payments pursuant to subparagraph (A)(iii), the Secretary shall, as determined appropriate, begin making such revisions for services furnished on or after January 1, 2020. Revisions under the previous sentence shall be treated as adjustments for purposes of application of paragraph (9)(B).
(D) Rules of construction
Nothing in this paragraph shall be construed to preclude the Secretary—
(i) from conducting a demonstration before making the revisions described in subparagraph (C); or
(ii) prior to implementation of this paragraph, from changing payments under this subsection for covered OPD services (or groups of services) which include opioids or non-opioid alternatives for pain management.
(u) Incentive payments for physician scarcity areas
(1) In general
In the case of physicians' services furnished on or after January 1, 2005, and before July 1, 2008—
(A) by a primary care physician in a primary care scarcity county (identified under paragraph (4)); or
(B) by a physician who is not a primary care physician in a specialist care scarcity county (as so identified),
in addition to the amount of payment that would otherwise be made for such services under this part, there also shall be paid an amount equal to 5 percent of the payment amount for the service under this part.
(2) Determination of ratios of physicians to medicare beneficiaries in area
Based upon available data, the Secretary shall establish for each county or equivalent area in the United States, the following:
(A) Number of physicians practicing in the area
The number of physicians who furnish physicians' services in the active practice of medicine or osteopathy in that county or area, other than physicians whose practice is exclusively for the Federal Government, physicians who are retired, or physicians who only provide administrative services. Of such number, the number of such physicians who are—
(i) primary care physicians; or
(ii) physicians who are not primary care physicians.
(B) Number of medicare beneficiaries residing in the area
The number of individuals who are residing in the county and are entitled to benefits under part A or enrolled under this part, or both (in this subsection referred to as "individuals").
(C) Determination of ratios
(i) Primary care ratio
The ratio (in this paragraph referred to as the "primary care ratio") of the number of primary care physicians (determined under subparagraph (A)(i)), to the number of individuals determined under subparagraph (B).
(ii) Specialist care ratio
The ratio (in this paragraph referred to as the "specialist care ratio") of the number of other physicians (determined under subparagraph (A)(ii)), to the number of individuals determined under subparagraph (B).
(3) Ranking of counties
The Secretary shall rank each such county or area based separately on its primary care ratio and its specialist care ratio.
(4) Identification of counties
(A) In general
The Secretary shall identify—
(i) those counties and areas (in this paragraph referred to as "primary care scarcity counties") with the lowest primary care ratios that represent, if each such county or area were weighted by the number of individuals determined under paragraph (2)(B), an aggregate total of 20 percent of the total of the individuals determined under such paragraph; and
(ii) those counties and areas (in this subsection referred to as "specialist care scarcity counties") with the lowest specialist care ratios that represent, if each such county or area were weighted by the number of individuals determined under paragraph (2)(B), an aggregate total of 20 percent of the total of the individuals determined under such paragraph.
(B) Periodic revisions
The Secretary shall periodically revise the counties or areas identified in subparagraph (A) (but not less often than once every three years) unless the Secretary determines that there is no new data available on the number of physicians practicing in the county or area or the number of individuals residing in the county or area, as identified in paragraph (2).
(C) Identification of counties where service is furnished
For purposes of paying the additional amount specified in paragraph (1), if the Secretary uses the 5-digit postal ZIP Code where the service is furnished, the dominant county of the postal ZIP Code (as determined by the United States Postal Service, or otherwise) shall be used to determine whether the postal ZIP Code is in a scarcity county identified in subparagraph (A) or revised in subparagraph (B).
(D) Special rule
With respect to physicians' services furnished on or after January 1, 2008, and before July 1, 2008, for purposes of this subsection, the Secretary shall use the primary care scarcity counties and the specialty care scarcity counties (as identified under the preceding provisions of this paragraph) that the Secretary was using under this subsection with respect to physicians' services furnished on December 31, 2007.
(E) Judicial review
There shall be no administrative or judicial review under
(i) the identification of a county or area;
(ii) the assignment of a specialty of any physician under this paragraph;
(iii) the assignment of a physician to a county under paragraph (2); or
(iv) the assignment of a postal ZIP Code to a county or other area under this subsection.
(5) Rural census tracts
To the extent feasible, the Secretary shall treat a rural census tract of a metropolitan statistical area (as determined under the most recent modification of the Goldsmith Modification, originally published in the Federal Register on February 27, 1992 (57 Fed. Reg. 6725)), as an equivalent area for purposes of qualifying as a primary care scarcity county or specialist care scarcity county under this subsection.
(6) Physician defined
For purposes of this paragraph, the term "physician" means a physician described in
(7) Publication of list of counties; posting on website
With respect to a year for which a county or area is identified or revised under paragraph (4), the Secretary shall identify such counties or areas as part of the proposed and final rule to implement the physician fee schedule under
(v) Increase of FQHC payment limits
In the case of services furnished by Federally qualified health centers (as defined in
(1) in 2010, at the limits otherwise established under this part for such year increased by $5; and
(2) in a subsequent year, at the limits established under this subsection for the previous year increased by the percentage increase in the MEI (as defined in
(w) Methods of payment
The Secretary may develop alternative methods of payment for items and services provided under clinical trials and comparative effectiveness studies sponsored or supported by an agency of the Department of Health and Human Services, as determined by the Secretary, to those that would otherwise apply under this section, to the extent such alternative methods are necessary to preserve the scientific validity of such trials or studies, such as in the case where masking the identity of interventions from patients and investigators is necessary to comply with the particular trial or study design.
(x) Incentive payments for primary care services
(1) In general
In the case of primary care services furnished on or after January 1, 2011, and before January 1, 2016, by a primary care practitioner, in addition to the amount of payment that would otherwise be made for such services under this part, there also shall be paid (on a monthly or quarterly basis) an amount equal to 10 percent of the payment amount for the service under this part.
(2) Definitions
In this subsection:
(A) Primary care practitioner
The term "primary care practitioner" means an individual—
(i) who—
(I) is a physician (as described in
(II) is a nurse practitioner, clinical nurse specialist, or physician assistant (as those terms are defined in
(ii) for whom primary care services accounted for at least 60 percent of the allowed charges under this part for such physician or practitioner in a prior period as determined appropriate by the Secretary.
(B) Primary care services
The term "primary care services" means services identified, as of January 1, 2009, by the following HCPCS codes (and as subsequently modified by the Secretary):
(i) 99201 through 99215.
(ii) 99304 through 99340.
(iii) 99341 through 99350.
(3) Coordination with other payments
The amount of the additional payment for a service under this subsection and subsection (m) shall be determined without regard to any additional payment for the service under subsection (m) and this subsection, respectively. The amount of the additional payment for a service under this subsection and subsection (z) shall be determined without regard to any additional payment for the service under subsection (z) and this subsection, respectively.
(4) Limitation on review
There shall be no administrative or judicial review under
(y) Incentive payments for major surgical procedures furnished in health professional shortage areas
(1) In general
In the case of major surgical procedures furnished on or after January 1, 2011, and before January 1, 2016, by a general surgeon in an area that is designated (under
(2) Definitions
In this subsection:
(A) General surgeon
In this subsection, the term "general surgeon" means a physician (as described in
(B) Major surgical procedures
The term "major surgical procedures" means physicians' services which are surgical procedures for which a 10-day or 90-day global period is used for payment under the fee schedule under
(3) Coordination with other payments
The amount of the additional payment for a service under this subsection and subsection (m) shall be determined without regard to any additional payment for the service under subsection (m) and this subsection, respectively. The amount of the additional payment for a service under this subsection and subsection (z) shall be determined without regard to any additional payment for the service under subsection (z) and this subsection, respectively.
(4) Application
The provisions of paragraph 17 (2) and (4) of subsection (m) shall apply to the determination of additional payments under this subsection in the same manner as such provisions apply to the determination of additional payments under subsection (m).
(z) Incentive payments for participation in eligible alternative payment models
(1) Payment incentive
(A) In general
In the case of covered professional services furnished by an eligible professional during a year that is in the period beginning with 2019 and ending with 2026 and for which the professional is a qualifying APM participant with respect to such year, in addition to the amount of payment that would otherwise be made for such covered professional services under this part for such year, there also shall be paid to such professional an amount equal to 5 percent (or, with respect to 2025, 3.5 percent, or, with respect to 2026, 1.88 percent) of the estimated aggregate payment amounts for such covered professional services under this part for the preceding year. For purposes of the previous sentence, the payment amount for the preceding year may be an estimation for the full preceding year based on a period of such preceding year that is less than the full year. The Secretary shall establish policies to implement this subparagraph in cases in which payment for covered professional services furnished by a qualifying APM participant in an alternative payment model—
(i) is made to an eligible alternative payment entity rather than directly to the qualifying APM participant; or
(ii) is made on a basis other than a fee-for-service basis (such as payment on a capitated basis).
(B) Form of payment
Payments under this subsection shall be made in a lump sum, on an annual basis, as soon as practicable.
(C) Treatment of payment incentive
Payments under this subsection shall not be taken into account for purposes of determining actual expenditures under an alternative payment model and for purposes of determining or rebasing any benchmarks used under the alternative payment model.
(D) Coordination
The amount of the additional payment under this subsection or subsection (m) shall be determined without regard to any additional payment under subsection (m) and this subsection, respectively. The amount of the additional payment under this subsection or subsection (x) shall be determined without regard to any additional payment under subsection (x) and this subsection, respectively. The amount of the additional payment under this subsection or subsection (y) shall be determined without regard to any additional payment under subsection (y) and this subsection, respectively.
(2) Qualifying APM participant
For purposes of this subsection, the term "qualifying APM participant" means the following:
(A) 2019 and 2020
With respect to 2019 and 2020, an eligible professional for whom the Secretary determines that at least 25 percent of payments under this part for covered professional services furnished by such professional during the most recent period for which data are available (which may be less than a year) were attributable to such services furnished under this part through an eligible alternative payment entity.
(B) 2021 through 2026
With respect to each of 2021 through 2026, an eligible professional described in either of the following clauses:
(i) Medicare payment threshold option
An eligible professional for whom the Secretary determines that at least 50 percent of payments under this part for covered professional services furnished by such professional during the most recent period for which data are available (which may be less than a year) were attributable to such services furnished under this part through an eligible alternative payment entity.
(ii) Combination all-payer and medicare payment threshold option
An eligible professional—
(I) for whom the Secretary determines, with respect to items and services furnished by such professional during the most recent period for which data are available (which may be less than a year), that at least 50 percent of the sum of—
(aa) payments described in clause (i); and
(bb) all other payments, regardless of payer (other than payments made by the Secretary of Defense or the Secretary of Veterans Affairs and other than payments made under subchapter XIX in a State in which no medical home or alternative payment model is available under the State program under that subchapter),
meet the requirement described in clause (iii)(I) with respect to payments described in item (aa) and meet the requirement described in clause (iii)(II) with respect to payments described in item (bb);
(II) for whom the Secretary determines at least 25 percent of payments under this part for covered professional services furnished by such professional during the most recent period for which data are available (which may be less than a year) were attributable to such services furnished under this part through an eligible alternative payment entity; and
(III) who provides to the Secretary such information as is necessary for the Secretary to make a determination under subclause (I), with respect to such professional.
(iii) Requirement
For purposes of clause (ii)(I)—
(I) the requirement described in this subclause, with respect to payments described in item (aa) of such clause, is that such payments are made to an eligible alternative payment entity; and
(II) the requirement described in this subclause, with respect to payments described in item (bb) of such clause, is that such payments are made under arrangements in which—
(aa) quality measures comparable to measures under the performance category described in
(bb) certified EHR technology is used; and
(cc) the eligible professional participates in an entity that—
(AA) bears more than nominal financial risk if actual aggregate expenditures exceeds 18 expected aggregate expenditures; or
(BB) with respect to beneficiaries under subchapter XIX, is a medical home that meets criteria comparable to medical homes expanded under
(C) Beginning in 2027
With respect to 2027 and each subsequent year, an eligible professional described in either of the following clauses:
(i) Medicare payment threshold option
An eligible professional for whom the Secretary determines that at least 75 percent of payments under this part for covered professional services furnished by such professional during the most recent period for which data are available (which may be less than a year) were attributable to such services furnished under this part through an eligible alternative payment entity.
(ii) Combination all-payer and medicare payment threshold option
An eligible professional—
(I) for whom the Secretary determines, with respect to items and services furnished by such professional during the most recent period for which data are available (which may be less than a year), that at least 75 percent of the sum of—
(aa) payments described in clause (i); and
(bb) all other payments, regardless of payer (other than payments made by the Secretary of Defense or the Secretary of Veterans Affairs and other than payments made under subchapter XIX in a State in which no medical home or alternative payment model is available under the State program under that subchapter),
meet the requirement described in clause (iii)(I) with respect to payments described in item (aa) and meet the requirement described in clause (iii)(II) with respect to payments described in item (bb);
(II) for whom the Secretary determines at least 25 percent of payments under this part for covered professional services furnished by such professional during the most recent period for which data are available (which may be less than a year) were attributable to such services furnished under this part through an eligible alternative payment entity; and
(III) who provides to the Secretary such information as is necessary for the Secretary to make a determination under subclause (I), with respect to such professional.
(iii) Requirement
For purposes of clause (ii)(I)—
(I) the requirement described in this subclause, with respect to payments described in item (aa) of such clause, is that such payments are made to an eligible alternative payment entity; and
(II) the requirement described in this subclause, with respect to payments described in item (bb) of such clause, is that such payments are made under arrangements in which—
(aa) quality measures comparable to measures under the performance category described in
(bb) certified EHR technology is used; and
(cc) the eligible professional participates in an entity that—
(AA) bears more than nominal financial risk if actual aggregate expenditures exceeds 18 expected aggregate expenditures; or
(BB) with respect to beneficiaries under subchapter XIX, is a medical home that meets criteria comparable to medical homes expanded under
(D) Use of patient approach
The Secretary may base the determination of whether an eligible professional is a qualifying APM participant under this subsection and the determination of whether an eligible professional is a partial qualifying APM participant under
(3) Additional definitions
In this subsection:
(A) Covered professional services
The term "covered professional services" has the meaning given that term in
(B) Eligible professional
The term "eligible professional" has the meaning given that term in
(C) Alternative payment model (APM)
The term "alternative payment model" means, other than for purposes of subparagraphs (B)(ii)(I)(bb) and (C)(ii)(I)(bb) of paragraph (2), any of the following:
(i) A model under
(ii) The shared savings program under
(iii) A demonstration under
(iv) A demonstration required by Federal law.
(D) Eligible alternative payment entity
The term "eligible alternative payment entity" means, with respect to a year, an entity that—
(i) participates in an alternative payment model that—
(I) requires participants in such model to use certified EHR technology (as defined in subsection (o)(4)); and
(II) provides for payment for covered professional services based on quality measures comparable to measures under the performance category described in
(ii)(I) bears financial risk for monetary losses under such alternative payment model that are in excess of a nominal amount; or
(II) is a medical home expanded under
(4) Limitation
There shall be no administrative or judicial review under
(A) The determination that an eligible professional is a qualifying APM participant under paragraph (2) and the determination that an entity is an eligible alternative payment entity under paragraph (3)(D).
(B) The determination of the amount of the 5 percent (or, with respect to 2025, 3.5 percent, or, with respect to 2026, 1.88 percent) payment incentive under paragraph (1)(A), including any estimation as part of such determination.
(aa) Medical review of spinal subluxation services
(1) In general
The Secretary shall implement a process for the medical review (as described in paragraph (2)) of treatment by a chiropractor described in
(A) services furnished by a such a 1 chiropractor whose pattern of billing is aberrant compared to peers; and
(B) services furnished by such a chiropractor who, in a prior period, has a services denial percentage in the 85th percentile or greater, taking into consideration the extent that service denials are overturned on appeal.
(2) Medical review
(A) Prior authorization medical review
(i) In general
Subject to clause (ii), the Secretary shall use prior authorization medical review for services described in paragraph (1) that are furnished to an individual by a chiropractor described in
(ii) Ending application of prior authorization medical review
The Secretary shall end the application of prior authorization medical review under clause (i) to services described in paragraph (1) by such a chiropractor if the Secretary determines that the chiropractor has a low denial rate under such prior authorization medical review. The Secretary may subsequently reapply prior authorization medical review to such chiropractor if the Secretary determines it to be appropriate and the chiropractor has, in the time period subsequent to the determination by the Secretary of a low denial rate with respect to the chiropractor, furnished such services described in paragraph (1).
(iii) Early request for prior authorization review permitted
Nothing in this subsection shall be construed to prevent such a chiropractor from requesting prior authorization for services described in paragraph (1) that are to be furnished to an individual before the chiropractor furnishes the twelfth such service to such individual for an episode of treatment.
(B) Type of review
The Secretary may use pre-payment review or post-payment review of services described in
(C) Relationship to law enforcement activities
The Secretary may determine that medical review under this subsection does not apply in the case where potential fraud may be involved.
(3) No payment without prior authorization
With respect to a service described in paragraph (1) for which prior authorization medical review under this subsection applies, the following shall apply:
(A) Prior authorization determination
The Secretary shall make a determination, prior to the service being furnished, of whether the service would or would not meet the applicable requirements of
(B) Denial of payment
Subject to paragraph (5), no payment may be made under this part for the service unless the Secretary determines pursuant to subparagraph (A) that the service would meet the applicable requirements of such
(4) Submission of information
A chiropractor described in
(5) Timeliness
If the Secretary does not make a prior authorization determination under paragraph (3)(A) within 14 business days of the date of the receipt of medical documentation needed to make such determination, paragraph (3)(B) shall not apply.
(6) Application of limitation on beneficiary liability
Where payment may not be made as a result of the application of paragraph (2)(B),
(7) Review by contractors
The medical review described in paragraph (2) may be conducted by medicare administrative contractors pursuant to
(8) Multiple services
The Secretary shall, where practicable, apply the medical review under this subsection in a manner so as to allow an individual described in paragraph (1) to obtain, at a single time rather than on a service-by-service basis, an authorization in accordance with paragraph (3)(A) for multiple services.
(9) Construction
With respect to a service described in paragraph (1) that has been affirmed by medical review under this subsection, nothing in this subsection shall be construed to preclude the subsequent denial of a claim for such service that does not meet other applicable requirements under this chapter.
(10) Implementation
(A) Authority
The Secretary may implement the provisions of this subsection by interim final rule with comment period.
(B) Administration
(bb) Additional payments for certain rural health clinics with physicians or practitioners receiving data 2000 waivers
(1) In general
In the case of a rural health clinic with respect to which, beginning on or after January 1, 2019, rural health clinic services (as defined in
(2) Application
In order to receive a payment described in paragraph (1), a rural health clinic shall submit to the Secretary an application for such a payment at such time, in such manner, and containing such information as specified by the Secretary. A rural health clinic may apply for such a payment for each physician or practitioner described in paragraph (1) furnishing services described in such paragraph at such clinic.
(3) Requirements
For purposes of paragraph (1), the requirements described in this paragraph, with respect to a physician or practitioner, are the following:
(A) The physician or practitioner is employed by or working under contract with a rural health clinic described in paragraph (1) that submits an application under paragraph (2).
(B) The physician or practitioner first begins prescribing narcotic drugs in schedule III, IV, or V of
(4) Funding
For purposes of making payments under this subsection, there are appropriated, out of amounts in the Treasury not otherwise appropriated, $2,000,000, which shall remain available until expended.
(cc) Specified COVID–19 testing-related services
For purposes of subsection (a)(1)(DD):
(1) Description
(A) In general
A specified COVID–19 testing-related service described in this paragraph is a medical visit that—
(i) is in any of the categories of HCPCS evaluation and management service codes described in subparagraph (B);
(ii) is furnished during any portion of the emergency period (as defined in
(iii) results in an order for or administration of a clinical diagnostic laboratory test described in
(iv) relates to the furnishing or administration of such test or to the evaluation of such individual for purposes of determining the need of such individual for such test.
(B) Categories of HCPCS codes
For purposes of subparagraph (A), the categories of HCPCS evaluation and management services codes are the following:
(i) Office and other outpatient services.
(ii) Hospital observation services.
(iii) Emergency department services.
(iv) Nursing facility services.
(v) Domiciliary, rest home, or custodial care services.
(vi) Home services.
(vii) Online digital evaluation and management services.
(2) Specified outpatient payment provision
A specified outpatient payment provision described in this paragraph is any of the following:
(A) The hospital outpatient prospective payment system under subsection (t).
(B) The physician fee schedule under
(C) The prospective payment system developed under
(D)
(E) The payment basis determined in regulations pursuant to subsection (a)(3) for rural health clinic services.
(dd) Special coinsurance rule for certain colorectal cancer screening tests
(1) In general
In the case of a colorectal cancer screening test to which paragraph (1)(Y) of subsection (a) would not apply but for the third sentence of such subsection that is furnished during a year beginning on or after January 1, 2022, and before January 1, 2030, the amount paid shall be equal to the specified percent (as defined in paragraph (2)) for such year of the lesser of the actual charge for the service or the amount determined under the fee schedule that applies to such test under this part (or, in the case such test is a covered OPD service (as defined in subsection (t)(1)(B)), the amount determined under subsection (t)).
(2) Specified percent defined
For purposes of paragraph (1), the term "specified percent" means—
(A) for 2022, 80 percent;
(B) for 2023 through 2026, 85 percent; and
(C) for 2027 through 2029, 90 percent.
(Aug. 14, 1935, ch. 531, title XVIII, §1833, as added
Editorial Notes
References in Text
Section 626(d) of Medicare Prescription Drug, Improvement, and Modernization Act of 2003, referred to in subsec. (i)(2)(D)(i), is section 626(d) of
Section 9320(k) of the Omnibus Budget Reconciliation Act of 1986, as amended by section 6132 of the Omnibus Budget Reconciliation Act of 1989, referred to in subsec. (l)(1)(C), is section 9320(k) of
The amendments made by section 9320 of the Omnibus Budget Reconciliation Act of 1986, referred to in subsec. (l)(3)(B), are amendments made by section 9320 of
Section 4521 of The Balanced Budget Act of 1997, referred to in subsec. (t)(7)(F), is section 4521 of
Codification
Amendments
2024—Subsec. (z)(1)(A).
Subsec. (z)(2)(B).
Subsec. (z)(2)(C).
Subsec. (z)(2)(D).
Subsec. (z)(4)(B).
2022—Subsec. (a).
Subsec. (a)(1)(G).
Subsec. (a)(1)(S).
.
Subsec. (a)(1)(EE).
Subsec. (a)(1)(FF).
Subsec. (a)(1)(GG).
Subsec. (a)(1)(HH).
Subsec. (b)(13).
Subsec. (c)(2).
Subsec. (i)(9).
Subsec. (i)(10).
Subsec. (t)(2)(E).
Subsec. (t)(6)(B)(iii).
Subsec. (t)(6)(K).
Subsec. (t)(8)(F).
Subsec. (t)(16)(G).
Subsec. (z)(1)(A).
Subsec. (z)(2)(B).
Subsec. (z)(2)(C).
Subsec. (z)(2)(D).
Subsec. (z)(4)(B).
Subsec. (bb)(3)(B).
2021—Subsec. (f)(3)(A)(i).
"(I) the per visit payment amount applicable to such rural health clinic for rural health clinic services furnished in 2020, increased by the percentage increase in the MEI applicable to primary care services furnished as of the first day of 2021; or
"(II) the limit described in paragraph (2)(A); and".
Subsec. (f)(3)(A)(ii)(I).
Subsec. (f)(3)(B).
"(B) A rural health clinic described in this subparagraph is a rural health clinic that, as of December 31, 2019, was—
"(i) in a hospital with less than 50 beds; and
"(ii) enrolled under
2020—Subsec. (a).
Subsec. (a)(1)(Y).
Subsec. (a)(1)(DD).
Subsec. (a)(10).
Subsec. (b)(11).
Subsec. (b)(12).
Subsec. (f).
Subsec. (f)(1).
Subsec. (f)(2).
Subsec. (j).
Subsec. (z)(2)(B).
Subsec. (z)(2)(C).
Subsec. (z)(2)(D).
Subsec. (cc).
Subsec. (dd).
2019—Subsec. (t)(6)(E)(i).
Subsec. (t)(6)(J).
2018—Subsec. (a)(1)(CC).
Subsec. (g)(1).
Subsec. (g)(3).
Subsec. (g)(5)(D).
Subsec. (g)(5)(E)(iv).
Subsec. (g)(7).
Subsec. (g)(8).
Subsec. (i)(8).
Subsec. (t)(6)(C)(i).
Subsec. (t)(6)(D)(i).
Subsec. (t)(6)(E)(i).
Subsec. (t)(6)(G) to (I).
Subsec. (t)(22).
Subsecs. (z), (aa).
Subsec. (bb).
2016—Subsec. (a)(1)(BB).
Subsec. (t)(18)(B).
Subsec. (t)(18)(C).
Subsec. (t)(21)(B)(i).
Subsec. (t)(21)(B)(iii) to (v).
Subsec. (t)(21)(B)(vi).
Subsec. (t)(21)(B)(vii).
Subsec. (t)(21)(B)(viii).
Subsec. (t)(21)(B)(viii)(III).
Subsec. (t)(21)(E)(iv).
2015—Subsec. (a)(1)(AA).
Subsec. (g)(5)(A).
Subsec. (g)(5)(C)(i).
Subsec. (g)(5)(E).
Subsec. (g)(6)(A).
Subsec. (t)(1)(B)(v).
Subsec. (t)(16)(F).
Subsec. (t)(21).
Subsec. (x)(3).
Subsec. (y)(3).
Subsec. (z).
2014—Subsec. (a)(1)(D)(i).
Subsec. (a)(1)(D)(ii).
Subsec. (a)(2)(D)(i).
Subsec. (a)(2)(D)(ii).
Subsec. (b)(3)(B).
Subsec. (g)(5)(A).
Subsec. (g)(6)(A).
Subsec. (h)(2)(A)(i).
Subsec. (h)(3).
Subsec. (h)(6).
Subsec. (h)(7).
Subsec. (t)(16)(E).
Subsec. (t)(20).
2013—Subsec. (g)(5)(A).
Subsec. (g)(5)(D).
Subsec. (g)(6).
Subsec. (g)(6)(A).
Subsec. (t)(16)(D).
2012—Subsec. (g)(1), (3).
Subsec. (g)(5).
Subsec. (g)(6).
Subsec. (h)(2)(A)(i).
Subsec. (h)(2)(A)(iv).
Subsec. (h)(2)(A)(v).
Subsec. (t)(7)(D)(i)(II).
Subsec. (t)(7)(D)(i)(III).
2011—Subsec. (g)(5).
Subsec. (t)(7)(D)(i)(II).
Subsec. (t)(7)(D)(i)(III).
2010—Subsec. (a).
Subsec. (a)(1)(K).
Subsec. (a)(1)(N).
Subsec. (a)(1)(T).
Subsec. (a)(1)(W).
Subsec. (a)(1)(X).
Subsec. (a)(1)(Y).
Subsec. (a)(1)(Z).
Subsec. (a)(2)(F) to (H).
Subsec. (a)(3)(B)(i).
Subsec. (b).
Subsec. (b)(1).
Subsec. (b)(10).
Subsec. (g)(5).
Subsec. (h)(2)(A)(i).
Subsec. (h)(2)(A)(iv).
Subsec. (i)(2)(D)(v), (vi).
Subsec. (t)(1)(B)(iv).
Subsec. (t)(2)(D).
Subsec. (t)(3)(C)(iv).
Subsec. (t)(3)(F).
Subsec. (t)(3)(G).
Subsec. (t)(3)(G)(i)(I).
Subsec. (t)(3)(G)(i)(II).
Subsec. (t)(3)(G)(i)(III).
Subsec. (t)(3)(G)(i)(IV), (V).
Subsec. (t)(3)(G)(ii).
"(I) the excess (if any) of—
"(aa) the total percentage of the non-elderly insured population for the preceding year (based on the most recent estimates available from the Director of the Congressional Budget Office before a vote in either House on the Patient Protection and Affordable Care Act that, if determined in the affirmative, would clear such Act for enrollment); over
"(bb) the total percentage of the non-elderly insured population for such preceding year (as estimated by the Secretary); exceeds
"(II) 5 percentage points."
Subsec. (t)(7)(D)(i)(II).
Subsec. (t)(7)(D)(i)(III).
Subsec. (t)(18), (19).
Subsecs. (x), (y).
2008—Subsec. (a)(1)(D)(iii).
Subsec. (a)(1)(W).
Subsec. (a)(8)(A), (B).
Subsec. (b)(9).
Subsec. (c).
Subsec. (g)(1).
Subsec. (g)(5).
Subsec. (h)(2)(A)(i).
Subsec. (t)(7)(D)(i)(II).
Subsec. (t)(7)(D)(i)(III).
Subsec. (t)(16)(C).
Subsec. (v).
Subsec. (w).
2007—Subsec. (g)(5).
Subsec. (h)(9).
Subsec. (t)(16)(C).
Subsec. (u)(1).
Subsec. (u)(4)(D), (E).
2006—Subsec. (b)(7).
Subsec. (b)(8).
Subsec. (g)(1), (3).
Subsec. (g)(5).
Subsec. (i)(2)(A).
Subsec. (i)(2)(D)(ii).
Subsec. (i)(2)(D)(iv), (v).
Subsec. (i)(2)(E).
Subsec. (i)(7).
Subsec. (t)(2)(H).
Subsec. (t)(3)(C)(iv).
Subsec. (t)(7)(D)(i).
Subsec. (t)(16)(C).
Subsec. (t)(17).
2003—Subsec. (a)(1)(D)(iii).
Subsec. (a)(1)(G).
Subsec. (a)(1)(S).
Subsec. (a)(1)(V).
Subsec. (a)(2)(E)(i).
Subsec. (a)(3).
Subsec. (b).
Subsec. (g)(4).
Subsec. (h)(2)(A)(ii)(IV).
Subsec. (h)(5)(D).
Subsec. (h)(8).
Subsec. (i)(2)(A).
Subsec. (i)(2)(A)(i).
Subsec. (i)(2)(C).
Subsec. (i)(2)(D).
Subsec. (m).
Subsec. (o)(1)(B).
Subsec. (o)(2).
Subsec. (t)(1)(B)(iv).
Subsec. (t)(2)(H).
Subsec. (t)(3)(C)(ii).
Subsec. (t)(5)(E).
Subsec. (t)(6)(D)(i).
Subsec. (t)(6)(F).
Subsec. (t)(7)(D)(i).
Subsec. (t)(9)(B).
Subsec. (t)(13).
Subsec. (t)(14), (15).
Subsec. (t)(16).
Subsec. (t)(16)(B).
Subsec. (t)(16)(C).
Subsec. (u).
2000—Subsec. (a)(1)(D)(i).
Subsec. (a)(1)(R).
Subsec. (a)(1)(T).
Subsec. (a)(1)(U).
Subsec. (a)(2)(D)(i).
Subsec. (f).
Subsec. (g)(4).
Subsec. (h)(4)(B)(viii).
Subsec. (t)(2)(G).
Subsec. (t)(3)(C)(iii).
Subsec. (t)(3)(C)(iv).
Subsec. (t)(6)(A)(ii).
Subsec. (t)(6)(A)(iv)(II).
Subsec. (t)(6)(B).
"(i) on the first date this subsection is implemented in the case of a drug, biological, or device described in clause (i), (ii), or (iii) of subparagraph (A) and in the case of a device, drug, or biological described in subparagraph (A)(iv) and for which payment under this part is made as an outpatient hospital service before such first date; or
"(ii) in the case of a device, drug, or biological described in subparagraph (A)(iv) not described in clause (i), on the first date on which payment is made under this part for the device, drug, or biological as an outpatient hospital service."
Subsec. (t)(6)(C).
Subsec. (t)(6)(D).
Subsec. (t)(6)(E).
Subsec. (t)(7)(D)(ii).
Subsec. (t)(7)(F)(ii)(I).
Subsec. (t)(8)(C).
Subsec. (t)(11).
Subsec. (t)(12)(E).
1999—Subsec. (a)(1)(D)(i).
Subsec. (a)(1)(O).
Subsec. (a)(2)(D)(i).
Subsec. (g)(1), (3).
Subsec. (g)(4).
Subsec. (h)(5)(A)(iii).
Subsec. (h)(7).
Subsec. (l)(4)(A)(i)(VII).
Subsec. (t)(1)(B)(ii).
Subsec. (t)(1)(B)(iii), (iv).
Subsec. (t)(2).
Subsec. (t)(2)(B).
Subsec. (t)(2)(C).
Subsec. (t)(2)(E).
Subsec. (t)(4).
Subsec. (t)(4)(C).
Subsec. (t)(5).
Subsec. (t)(6).
Subsec. (t)(7).
Subsec. (t)(7)(D).
Subsec. (t)(8).
Subsec. (t)(8)(A).
Subsec. (t)(8)(C) to (E).
Subsec. (t)(9).
Subsec. (t)(10).
Subsec. (t)(11).
Subsec. (t)(11)(E).
Subsec. (t)(12).
Subsec. (t)(13).
1997—Subsec. (a)(1)(A).
Subsec. (a)(1)(D).
Subsec. (a)(1)(O).
Subsec. (a)(1)(Q).
Subsec. (a)(1)(R).
Subsec. (a)(1)(S).
Subsec. (a)(2).
Subsec. (a)(2)(A).
"(i) the reasonable cost of such services, as determined under
"(ii) the customary charges with respect to such services,
or, if such services are furnished by a public provider of services, or by another provider which demonstrates to the satisfaction of the Secretary that a significant portion of its patients are low-income (and requests that payment be made under this provision), free of charge or at nominal charges to the public, the amount determined in accordance with
Subsec. (a)(2)(B).
Subsec. (a)(2)(D).
Subsec. (a)(2)(E).
Subsec. (a)(2)(G).
Subsec. (a)(3).
Subsec. (a)(4).
Subsec. (a)(6).
Subsec. (a)(8), (9).
Subsec. (b)(5).
Subsec. (b)(6).
Subsec. (f).
Subsec. (f)(1).
Subsec. (g).
Subsec. (h)(1)(A).
Subsec. (h)(2)(A)(ii)(IV).
Subsec. (h)(4)(B)(vii).
Subsec. (h)(4)(B)(viii).
Subsec. (h)(5)(A)(iii).
Subsec. (i)(1)(A).
Subsec. (i)(2)(C).
Subsec. (i)(3)(A).
Subsec. (i)(3)(B)(i)(II).
Subsec. (l)(5).
Subsec. (n)(1)(A).
Subsec. (n)(1)(B)(i)(II).
Subsec. (r)(1).
Subsec. (r)(2).
"(2)(A) For purposes of subsection (a)(1)(O) of this section, the prevailing charge for services described in
"(B) In subparagraph (A), the term 'applicable percentage' means—
"(i) 75 percent in the case of services performed in a hospital, and
"(ii) 85 percent in the case of other services."
Subsec. (r)(3).
Subsec. (t).
1994—Subsec. (a)(1)(D)(i).
Subsec. (a)(1)(G).
Subsec. (a)(2)(A).
Subsec. (a)(2)(D)(i).
Subsec. (a)(2)(F).
Subsec. (a)(3).
Subsec. (b)(2).
Subsec. (b)(4), (5).
Subsec. (h)(5)(D).
Subsec. (i)(1).
Subsec. (i)(2)(A).
Subsec. (i)(2)(A)(i).
Subsec. (i)(2)(B).
Subsec. (i)(2)(C).
Subsec. (i)(3)(B)(ii).
Subsec. (l)(5)(B), (C).
"(B)(i) Payment for the services of a certified registered nurse anesthetist under this part may be made only on an assignment-related basis, and any such assignment agreed to by a certified registered nurse anesthetist shall be binding upon any other person presenting a claim or request for payment for such services.
"(ii) Except for deductible and coinsurance amounts applicable under this section, any person who knowingly and willfully presents, or causes to be presented, to an individual enrolled under this part a bill or request for payment for services of a certified registered nurse anesthetist for which payment may be made under this part only on an assignment-related basis is subject to a civil money penalty of not to exceed $2,000 for each such bill or request. The provisions of
Subsec. (n)(1)(B)(i)(II).
Subsec. (p).
Subsec. (q)(1).
Subsec. (r).
Subsec. (r)(1).
Subsec. (r)(2)(A).
Subsec. (r)(3), (4).
"(3)(A) Payment under this part for services described in
"(B) Except for deductible and coinsurance amounts applicable under this section, any person who knowingly and willfully presents, or causes to be presented, to an individual enrolled under this part a bill or request for payment for services described in
Subsec. (s).
1993—Subsec. (a)(1).
Subsec. (g).
Subsec. (h)(2)(A)(ii)(IV).
Subsec. (h)(4)(B)(iv) to (vii).
Subsec. (i)(3)(B)(ii).
Subsec. (i)(4).
Subsec. (l)(4)(B)(i).
Subsec. (l)(4)(B)(ii).
"(IV) for services furnished in 1994, $11.25,
"(V) for services furnished in 1995, $11.50,
"(VI) for services furnished in 1996, $11.70, and
"(VII) for services furnished in calendar years after 1997, the previous year's conversion factor increased by the update determined under
Subsec. (l)(4)(B)(iii).
1990—Subsec. (a)(1)(H).
Subsec. (a)(1)(J).
Subsec. (a)(1)(K).
Subsec. (a)(1)(L).
Subsec. (a)(1)(M).
Subsec. (a)(2).
Subsec. (a)(2)(E)(i).
Subsec. (a)(7).
Subsec. (b).
Subsec. (b)(5).
Subsec. (h)(2)(A)(ii).
Subsec. (h)(2)(A)(ii)(III).
Subsec. (h)(4)(B).
Subsec. (h)(5)(A)(ii)(II).
Subsec. (h)(5)(A)(ii)(III).
Subsec. (h)(5)(A)(iii).
Subsec. (h)(5)(C).
Subsec. (h)(5)(D).
Subsec. (i)(3)(B)(ii).
Subsec. (i)(3)(B)(ii)(I).
Subsec. (i)(3)(B)(ii)(II).
Subsec. (l)(1).
Subsec. (l)(2).
Subsec. (l)(4).
Subsec. (m).
Subsec. (n)(1)(B)(ii)(I).
Subsec. (r).
1989—Subsec. (a).
Subsec. (a)(1)(F).
Subsec. (a)(1)(H).
Subsec. (a)(1)(J).
Subsec. (a)(1)(K).
Subsec. (a)(1)(M).
Subsec. (a)(1)(N).
Subsec. (a)(2).
Subsec. (a)(3).
Subsec. (a)(6).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsec. (d)(1).
"(A) $1375.00, or
"(B) 62½ percent of such expenses."
Subsec. (g).
Subsec. (h)(1)(B), (C).
Subsec. (h)(1)(D).
Subsec. (h)(4)(B)(ii).
Subsec. (h)(4)(B)(iii).
Subsec. (h)(5)(A)(ii).
Subsec. (h)(5)(A)(iii).
Subsec. (i)(1)(A).
Subsec. (i)(3)(A).
Subsec. (l)(5)(A).
Subsec. (l)(5)(C).
Subsec. (m).
Subsec. (o)(1).
Subsec. (o)(1)(A).
Subsec. (o)(1)(B), (2)(A).
Subsec. (o)(2)(A)(i).
Subsec. (o)(2)(A)(ii)(II).
Subsec. (o)(2)(D).
Subsec. (p).
Subsec. (q).
1988—Subsec. (a).
Subsec. (a)(1)(D)(i).
Subsec. (a)(1)(F).
Subsec. (a)(1)(G).
Subsec. (a)(1)(H).
Subsec. (a)(1)(J).
Subsec. (a)(1)(K).
Subsec. (a)(1)(L).
Subsec. (a)(1)(M).
Subsec. (a)(2).
Subsec. (a)(2)(B).
Subsec. (a)(2)(D)(i).
Subsec. (a)(2)(E)(i).
Subsec. (a)(2)(F).
Subsec. (a)(3).
Subsec. (b).
Subsec. (b)(1).
Subsec. (b)(2).
Subsec. (b)(3) to (5).
Subsec. (c).
Subsec. (d)(1).
Subsec. (d)(2).
Subsec. (f).
Subsec. (g).
Subsec. (h)(1)(D).
Subsec. (h)(2)(A)(i).
Subsec. (h)(2)(A)(ii).
Subsec. (h)(2)(A)(iii).
Subsec. (h)(2)(B).
Subsec. (h)(3).
Subsec. (h)(4)(B)(ii).
Subsec. (h)(5)(A).
Subsec. (h)(5)(C).
Subsec. (h)(5)(D).
Subsec. (i)(2)(A)(iii).
Subsec. (i)(4).
Subsec. (i)(6).
Subsec. (l)(2).
Subsec. (l)(3)(B).
Subsec. (l)(5)(B)(ii).
Subsec. (n)(1)(A).
Subsec. (n)(1)(B)(i)(II).
Subsec. (n)(1)(B)(ii).
"(I) The term 'cost proportion' means 65 percent for all or any part of cost reporting periods which occur in fiscal year 1989 and 50 percent for other cost reporting periods.
"(II) The term 'charge proportion' means 35 percent for all or any parts of cost reporting periods which occur in fiscal year 1989 and 50 percent for other cost reporting periods."
Subsec. (o).
Subsec. (p).
1987—Subsec. (a)(1)(D)(i).
Subsec. (a)(1)(F).
Subsec. (a)(1)(G).
Subsec. (a)(1)(H).
Subsec. (a)(1)(I).
Subsec. (a)(1)(J).
Subsec. (a)(1)(K).
Subsec. (a)(1)(L).
Subsec. (a)(2).
Subsec. (a)(2)(A).
Subsec. (a)(2)(B).
Subsec. (a)(2)(D)(i).
Subsec. (a)(2)(E).
Subsec. (a)(5).
Subsec. (b)(3).
Subsec. (b)(4).
Subsec. (b)(4)(A).
Subsec. (b)(5).
Subsec. (c).
Subsec. (c)(1).
Subsec. (f).
Subsec. (h)(1)(C).
Subsec. (h)(1)(D).
Subsec. (h)(2).
Subsec. (h)(2)(A)(i).
Subsec. (h)(2)(A)(ii).
Subsec. (h)(2)(A)(iii).
Subsec. (h)(2)(B).
Subsec. (h)(4)(B)(i).
Subsec. (h)(4)(B)(ii).
Subsec. (h)(5)(A).
Subsec. (h)(5)(A)(iii).
Subsec. (h)(5)(C).
Subsec. (h)(5)(D).
Subsec. (i)(2)(A)(iii).
Subsec. (i)(3)(B)(ii).
Subsec. (i)(4).
Subsec. (i)(6).
Subsec. (l)(2).
Subsec. (l)(5)(A).
Subsec. (l)(5)(B)(ii).
Subsec. (l)(6).
"(B) In subparagraph (A), the term 'limiting charge' means, with respect to a service, 125 percent of the prevailing charge for the service after the reduction referred to in subparagraph (A).
"(C) If a physician knowingly and willfully imposes charges in violation of subparagraph (A), the Secretary may apply sanctions against such physician in accordance with subsection (j)(2) of this section.
"(D) This paragraph shall not apply to services furnished after the earlier of (i) December 31, 1990, or (ii) one-year after the date the Secretary reports to Congress, under
Subsec. (m).
Subsec. (n).
Subsec. (o).
Subsec. (p).
1986—Subsec. (a)(1)(D).
Subsec. (a)(1)(D)(i).
Subsec. (a)(1)(F).
Subsec. (a)(1)(G).
Subsec. (a)(1)(H).
Subsec. (a)(2)(A).
Subsec. (a)(2)(D).
Subsec. (a)(2)(D)(i).
Subsec. (a)(3).
Subsec. (a)(4).
Subsec. (b)(3).
Subsec. (b)(5).
Subsec. (g).
Subsec. (h)(1)(B).
Subsec. (h)(1)(C).
Subsec. (h)(1)(D).
Subsec. (h)(2).
Subsec. (h)(3).
Subsec. (h)(4).
Subsec. (h)(5)(C).
Subsec. (i)(1).
Subsec. (i)(2).
Subsec. (i)(3) to (5).
Subsec. (l).
1984—Subsec. (a)(1).
Subsec. (a)(1)(B).
Subsec. (a)(1)(D).
Subsec. (a)(1)(F), (G).
Subsec. (a)(2).
Subsec. (a)(2)(A).
Subsec. (a)(2)(B).
Subsec. (a)(2)(B)(ii).
Subsec. (a)(2)(D).
Subsec. (a)(3).
Subsec. (a)(5).
Subsec. (b)(1).
Subsec. (b)(3).
Subsec. (b)(4).
Subsec. (f).
Subsec. (h).
Subsec. (h)(5)(C).
Subsec. (i)(3).
Subsec. (k).
1982—Subsec. (a)(1)(B).
Subsec. (a)(1)(H).
Subsec. (a)(2)(B).
Subsec. (b)(1).
Subsec. (i)(1).
Subsec. (j).
1981—Subsec. (a)(2)(A).
Subsec. (a)(2)(B).
Subsec. (b).
1980—Subsec. (a)(1)(B).
Subsec. (a)(1)(D).
Subsec. (a)(1)(F).
Subsec. (a)(1)(G).
Subsec. (a)(1)(H).
Subsec. (a)(2).
Subsec. (a)(3).
Subsec. (a)(4), (5).
Subsec. (b)(2).
Subsec. (b)(3).
Subsec. (b)(4).
Subsec. (g).
Subsec. (h).
Subsec. (i).
1978—Subsec. (a)(1)(E).
Subsec. (a)(2).
1977—Subsec. (a)(2).
Subsec. (a)(3).
Subsec. (f)(1).
Subsec. (f)(2).
Subsec. (f)(3), (4).
1972—Subsec. (a).
Subsec. (a)(1).
Subsec. (a)(2).
Subsec. (b).
Subsec. (f).
Subsec. (g).
Subsec. (h).
1968—Subsec. (a)(1).
Subsec. (b).
Subsec. (d).
Subsec. (f).
Statutory Notes and Related Subsidiaries
Effective Date of 2022 Amendment
Amendment by section 4124(b)(3) of
Effective Date of 2021 Amendment
Effective Date of 2020 Amendment
Effective Date of 2016 Amendment
Effective Date of 2015 Amendment
Effective Date of 2012 Amendment
Effective Date of 2010 Amendment
Effective Date of 2008 Amendment
Amendment by section 143(b)(2), (3), of
Effective Date of 2006 Amendment
Effective Date of 2003 Amendment
Amendment by section 237(a) of
"(1) in the case of screening mammography, to services furnished on or after the date of the enactment of this Act [Dec. 8, 2003]; and
"(2) in the case of diagnostic mammography, to services furnished on or after January 1, 2005."
Effective Date of 2000 Amendment
"(1) by subsection (a) [amending
"(2) by subsection (b)(1) [amending this section] shall apply as if included in the enactment of section 403(e)(1) of BBRA (
"(3) by subsection (b)(2) [amending provisions set out as a note under
Effective Date of 1999 Amendment
Amendment by section 1000(a)(6) [title III, §321(g)(2), (k)(2)] of
Amendment by section 1000(a)(6) [title IV, §401(b)(1)] of
Effective Date of 1997 Amendment
Amendment by section 4201(c)(1) of
Amendment by section 4432(b)(5)(C) of
Amendment by section 4511(b) of
"(1) The amendments made by subsections (a)(1), (a)(2), and (b) [amending this section and
"(2) The amendments made by subsections (a)(3) and (c) [amending this section and
"(3) The amendments made by subsection (d)(1) [amending this section] apply to expenses incurred on or after January 1, 1999."
Amendment by section 4603(c)(2)(A) of
Effective Date of 1994 Amendment
"(1)
"(2)
Amendment by section 147(a), (e)(2), (3), (f)(6)(C), (D) of
Amendment by section 156(a)(2)(B) of
Effective Date of 1993 Amendment
Effective Date of 1990 Amendment
Amendment by section 4153(a)(2)(B), (C) of
Amendment by section 4155(b)(2), (3) of
Amendment by section 4161(a)(3)(B) of
Effective Date of 1989 Amendment
"(1) The amendments made by this section [amending this section and
"(2) In applying the amendments made by this section, the increase under subparagraph (C) of section 1833(o)(2) of the Social Security Act [
Amendment by section 6204(b) of
Amendment by section 201(a) of
Amendment by section 202(a) of
Effective Date of 1988 Amendment
Amendment by
Amendment by section 202(b)(1)–(3) of
Amendment by section 203(c)(1)(A)–(E) of
Amendment by section 204(d)(1) of
Amendment by section 205(c) of
Except as specifically provided in section 411 of
Effective Date of 1987 Amendment
Amendment by section 4045(c)(2)(A) of
Amendment by section 4049(a)(1) of
Amendment by section 4062(d)(3) of
For effective date of amendment by section 4072(b) of
Amendment by section 4073(b) of
Amendment by section 4077(b)(2), (3) of
Effective Date of 1986 Amendment
Amendment by section 9320(e)(1), (2) of
Amendment by section 9337(b) of
"(1) The amendments made by subsection (a)(1) [amending this section] shall apply to cost reporting periods beginning on or after October 1, 1987.
"(2) The amendments made by subsections (b)(1) and (c) [amending this section and
"(3) The Secretary of Health and Human Services shall first provide, under the amendment made by subsection (b)(2) [amending this section], for the review and update of procedure lists within 6 months after the date of the enactment of this Act [Oct. 21, 1986].
"(4) The amendments made by subsection (d) [amending
"(A) The amendments made by paragraphs (1) and (2) [amending this section] shall apply to clinical diagnostic laboratory tests performed on or after July 1, 1986.
"(B) The amendment made by paragraph (3) [amending this section] shall apply to clinical diagnostic laboratory tests performed on or after January 1, 1987."
Effective Date of 1984 Amendment
Amendment by
"(1) Except as provided in paragraphs (2) and (3), the amendments made by this section [amending this section and
"(2) The amendments made by subsection (g)(2) [amending
"(3) The amendments made by this section shall not apply to clinical diagnostic laboratory tests furnished to inpatients of a provider operating under a waiver granted pursuant to section 602(k) of the Social Security Amendments of 1983 [section 602(k) of
Amendment by section 2321(b), (d)(4)(A) of
Amendment by section 2354(b)(5), (7) of
Effective Date of 1982 Amendment
Amendment by section 117(a)(2) of
Amendment by section 148(d) of
Effective Date of 1981 Amendment
Effective Date of 1980 Amendment
Amendment by section 930(h) of
Effective Date of 1978 Amendment
Amendment by
Effective Date of 1977 Amendment
Amendment by
Effective Date of 1972 Amendment
Amendment by section 211(c)(4) of
Amendment by section 226(c)(2) of
Amendment by section 233(b) of
Amendment by section 251(a)(2), (3) of
Effective Date of 1968 Amendment
Amendment by section 129(c)(7), (8) of
Amendment by section 135(c) of
Construction of 2008 Amendment
Construction Regarding Limiting Increases in Cost-Sharing
Implementation of 2022 Amendment
Provider Outreach and Reporting on Certain Behavioral Health Integration Services
"(a)
"(b)
"(1)
"(2)
Outreach and Reporting on Opioid Use Disorder Treatment Services Furnished by Opioid Treatment Programs
"(a)
"(1)
"(2)
"(b)
"(1)
"(2)
Centers for Medicare & Medicaid Services Provider Outreach and Reporting on Cognitive Assessment and Care Plan Services
"(a)
"(b)
"(1)
"(2)
Implementation of 2020 Amendment
Claims Modifier
Implementation of Provisions of Pub. L. 116–127
Implementation of 2019 Amendment
Implementation of 2018 Amendment
Improving Documentation of Services
"(1)
"(2)
"(3)
Medicare Patient IVIG Access Demonstration Project
"(a)
"(b)
"(1)
"(A) if the date of enactment of the Disaster Tax Relief and Airport and Airway Extension Act of 2017 is on or before September 30, 2017 [
"(B) if the date of enactment of such Act is after September 30, 2017, for the period beginning on the date of enactment of such Act and ending on December 31, 2020.
"(2)
"(c)
"(d)
"(e)
"(f)
"(1)
"(2)
"(A) The total number of beneficiaries enrolled in the demonstration project during the updated report period.
"(B) The total number of claims submitted for services during the updated report period, disaggregated by month.
"(C) An analysis of the impact of the demonstration on beneficiary access to the in-home administration of intravenous immune globin, including the impact on beneficiary health.
"(D) An analysis of the impact of in-home administration of intravenous immune globin on overall costs to Medicare, including the cost differential between in-home administration of intravenous immune globin and administration of intravenous immune globin in a healthcare facility.
"(E) To the extent practicable, a survey of providers and enrolled beneficiaries that participated in the demonstration project that identifies barriers to accessing services, including reimbursement for items and services.
"(F) Recommendations to Congress on the appropriateness of establishing a permanent bundled services payment for the in-home administration of intravenous immune globin for Medicare beneficiaries.
"(3)
"(A) A final evaluation of the impact of the demonstration project on access for Medicare beneficiaries to items and services needed for the in-home administration of intravenous immune globin.
"(B) An analysis of the appropriateness of implementing a new methodology for payment for intravenous immune globulins in all care settings under part B of title XVIII of the Social Security Act (
"(C) An update to the report entitled 'Analysis of Supply, Distribution, Demand, and Access Issues Associated with Immune Globulin Intravenous (IGIV)', issued in February 2007 by the Office of the Assistant Secretary for Planning and Evaluation of the Department of Health and Human Services.
"(g)
"(h)
"(1)
"(2)
"(3)
"(4)
[
Implementation of 2013 Amendment
Implementation of 2012 Amendment
Collection of Additional Data
"(1)
"(2)
Treatment of Certain Complex Diagnostic Laboratory Tests
"(a)
"(1)
"(2)
"(A) that is an analysis of gene protein expression, topographic genotyping, or a cancer chemotherapy sensitivity assay;
"(B) that is determined by the Secretary to be a laboratory test for which there is not an alternative test having equivalent performance characteristics;
"(C) which is billed using a Health Care Procedure Coding System (HCPCS) code other than a not otherwise classified code under such Coding System;
"(D) which is approved or cleared by the Food and Drug Administration or is covered under title XVIII of the Social Security Act [
"(E) is described in section 1861(s)(3) of the Social Security Act (
"(3)
"(b)
"(c)
"(1) be made from the Federal Supplemental [probably should be "Supplementary"] Medical Insurance Trust Fund under section 1841 of the Social Security Act (
"(2) may not exceed $100,000,000.
"(d)
"(1) an assessment of the impact of the demonstration project on access to care, quality of care, health outcomes, and expenditures under title XVIII of the Social Security Act [
"(2) such recommendations as the Secretary determines appropriate.
"(e)
Treatment of Certified Registered Nurse Anesthetists
"(1) is consistent with the adjustments made by the special rule for teaching anesthesiologists under section 1848(a)(6) of the Social Security Act [
"(2) maintains the existing payment differences between teaching anesthesiologists and teaching certified registered nurse anesthetists."
Implementation of 2006 Amendment
Implementation of Clinically Appropriate Code Edits In Order To Identify and Eliminate Improper Payments for Therapy Services
Application of 2003 Amendment to Physician Specialties
Amendment by section 303 of
Notwithstanding section 303(j) of
GAO Study of Medicare Payment for Inhalation Therapy
Treatment of Certain Clinical Diagnostic Laboratory Tests Furnished to Hospital Outpatients in Certain Rural Areas
"(a)
"(b)
"(c)
[
GAO Report on Payments for Brachytherapy Devices
Moratorium on Physical Therapy Services Caps in 2003
Prompt Submission of Overdue Reports on Payment and Utilization of Outpatient Therapy Services
GAO Study of Ambulatory Surgical Center Payments
"(1)
"(A)
"(B)
"(2)
"(A)
"(B)
"(i) The appropriateness of using the groups of covered services and relative weights established under the outpatient prospective payment system as the basis of payment for ambulatory surgical centers.
"(ii) If the relative weights under such hospital outpatient prospective payment system are appropriate for such purpose—
"(I) whether the payment rates for ambulatory surgical centers should be based on a uniform percentage of the payment rates or weights under such outpatient system; or
"(II) whether the payment rates for ambulatory surgical centers should vary, or the weights should be revised, based on specific procedures or types of services (such as ophthalmology and pain management services).
"(iii) Whether a geographic adjustment should be used for payment of services furnished in ambulatory surgical centers, and if so, the labor and nonlabor shares of such payment."
Demonstration Project for Coverage of Certain Prescription Drugs and Biologicals
"(a)
"(b)
"(c)
"(d)
"(1) coverage for more than 50,000 patients; and
"(2) more than $500,000,000 in funding.
"(e)
Payment for Pancreatic Islet Cell Investigational Transplants for Medicare Beneficiaries in Clinical Trials
"(a)
"(1)
"(2)
"(b)
"(c)
"(1) The term 'routine costs' means reasonable and necessary routine patient care costs (as defined in the Centers for Medicare & Medicaid Services Coverage Issues Manual, section 30–1), including immunosuppressive drugs and other followup care.
"(2) The term 'transplantation and appropriate related items and services' means items and services related to the acquisition and delivery of the pancreatic islet cell transplantation, notwithstanding any national noncoverage determination contained in the Centers for Medicare & Medicaid Services Coverage Issues Manual.
"(3) The term 'medicare beneficiary' means an individual who is entitled to benefits under part A of title XVIII of the Social Security Act [
"(d)
"(1) to permit payment for partial pancreatic tissue or islet cell transplantation under title XVIII of the Social Security Act [
"(2) as authorizing or requiring coverage or payment conveying—
"(A) benefits under part A of such title [
"(B) benefits under part B of such title [
GAO Study of Reduction in Medigap Premium Levels Resulting From Reductions in Coinsurance
MedPAC Study on Low-Volume, Isolated Rural Health Care Providers
"(a)
"(b)
"(1) whether low-volume, isolated rural health care providers are having, or may have, significantly decreased medicare margins or other financial difficulties resulting from any of the payment methodologies described in subsection (c);
"(2) whether the status as a low-volume, isolated rural health care provider should be designated under the medicare program and any criteria that should be used to qualify for such a status; and
"(3) any changes in the payment methodologies described in subsection (c) that are necessary to provide appropriate reimbursement under the medicare program to low-volume, isolated rural health care providers (as designated pursuant to paragraph (2)).
"(c)
"(1) The prospective payment system for hospital outpatient department services under section 1833(t) of the Social Security Act (
"(2) The fee schedule for ambulance services under section 1834(l) of such Act (
"(3) The prospective payment system for inpatient hospital services under section 1886 of such Act (
"(4) The prospective payment system for routine service costs of skilled nursing facilities under section 1888(e) of such Act (
"(5) The prospective payment system for home health services under section 1895 of such Act (
Special Rule for Payment for 2001
"(1) for services furnished on or after January 1, 2001, and before April 1, 2001, shall be the medicare OPD fee schedule amount for 2001 as determined under the provisions of law in effect on the day before the date of the enactment of this Act [Dec. 21, 2000]; and
"(2) for services furnished on or after April 1, 2001, and before January 1, 2002, shall be the fee schedule amount (as determined taking into account the amendment made by subsection (a)), increased by a transitional percentage allowance equal to 0.32 percent (to account for the timing of implementation of the full market basket update)."
Transition Provisions Applicable to Subsection (t)(6)(B)
"(1)
"(2)
"(A) with respect to which an application was submitted (pursuant to such process) on or before such date; and
"(B) that meets the requirements of clause (ii) or (iv) of subparagraph (A) of such paragraph (as determined pursuant to such process),
shall be treated as a device with respect to which an initial category is required to be established under subparagraph (B)(i) of such paragraph (as amended by subsection (a)(2))."
Study on Standards for Supervision of Physical Therapist Assistants
Delay in Implementation of Prospective Payment System for Ambulatory Surgical Centers
MedPAC Study and Report on Medicare Reimbursement for Services Provided by Certain Providers
"(a)
"(1) certified nurse-midwife (as defined in subsection (gg)(2) of section 1861 of such Act (
"(2) physician assistant (as defined in subsection (aa)(5)(A) of such section);
"(3) nurse practitioner (as defined in such subsection); and
"(4) clinical nurse specialist (as defined in subsection (aa)(5)(B) of such section).
The study shall separately examine the appropriateness of such payment rates for orthopedic physician assistants, taking into consideration the requirements for accreditation, training, and education.
"(b)
MedPAC Study on Access to Outpatient Pain Management Services
"(a)
"(1) the specific barriers imposed under the medicare program on the provision of pain management procedures in hospital outpatient departments, ambulatory surgery centers, and physicians' offices; and
"(2) the consistency of medicare payment policies for pain management procedures in those different settings.
"(b)
Establishment of Coding and Payment Procedures for New Clinical Diagnostic Laboratory Tests and Other Items on a Fee Schedule
Report on Procedures Used for Advanced, Improved Technologies
Congressional Intention Regarding Base Amounts in Applying HOPD PPS
Study and Report to Congress Regarding Special Treatment of Rural and Cancer Hospitals in Prospective Payment System for Hospital Outpatient Department Services
"(a)
"(1)
"(2)
"(A) A medicare-dependent, small rural hospital (as defined in section 1886(d)(5)(G)(iv) of the Social Security Act (
"(B) A sole community hospital (as defined in section 1886(d)(5)(D)(iii) of such Act (
"(C) Rural health clinics (as defined in section 1861(aa)(2) of such Act (
"(D) Rural referral centers (as so classified under section 1886(d)(5)(C) of such Act (
"(E) Any other rural hospital with not more than 100 beds.
"(F) Any other rural hospital that the Secretary determines appropriate.
"(G) A hospital described in section 1886(d)(1)(B)(v) of such Act (
"(b)
"(c)
GAO Study on Resources Required To Provide Safe and Effective Outpatient Cancer Therapy
"(a)
"(1) determine the adequacy of practice expense relative value units associated with the utilization of those clinical resources;
"(2) determine the adequacy of work units in the practice expense formula; and
"(3) assess various standards to assure the provision of safe outpatient cancer therapy services.
"(b)
Focused Medical Reviews of Claims During Moratorium Period
Study and Report on Utilization
"(1)
"(A)
"(i) utilization patterns (including nationwide patterns, and patterns by region, types of settings, and diagnosis or condition) of outpatient physical therapy services, outpatient occupational therapy services, and speech-language pathology services that are covered under the medicare program under title XVIII of the Social Security Act (
"(ii) such patterns for such services that were provided in 1998 and 1999.
"(B)
"(2)
Phase-in of PPS for Ambulatory Surgical Centers
"(1) in the first year of its implementation, only a proportion (specified by the Secretary and not to exceed one-fourth) of the payment for such services shall be made in accordance with such system and the remainder shall be made in accordance with current regulations; and
"(2) in each of the following 2 years a proportion (specified by the Secretary and not to exceed one-half and three-fourths, respectively) of the payment for such services shall be made under such system and the remainder shall be made in accordance with current regulations.
By not later than January 1, 2003, the Secretary shall incorporate data from a 1999 medicare cost survey or a subsequent cost survey for purposes of implementing or revising such system."
MedPAC Study on Postsurgical Recovery Care Center Services
"(1)
"(2)
Medicare Reimbursement for Telehealth Services
"(a)
"(b)
"(1) The payment shall [be] shared between the referring physician or practitioner and the consulting physician or practitioner. The amount of such payment shall not be greater than the current fee schedule of the consulting physician or practitioner for the health care services provided.
"(2) The payment shall not include any reimbursement for any telephone line charges or any facility fees, and a beneficiary may not be billed for any such charges or fees.
"(3) The payment shall be made subject to the coinsurance and deductible requirements under subsections (a)(1) and (b) of section 1833 of the Social Security Act (
"(4) The payment differential of section 1848(a)(3) of such Act (
"(c)
"(1) how telemedicine and telehealth systems are expanding access to health care services;
"(2) the clinical efficacy and cost-effectiveness of telemedicine and telehealth applications;
"(3) the quality of telemedicine and telehealth services delivered; and
"(4) the reasonable cost of telecommunications charges incurred in practicing telemedicine and telehealth in rural, frontier, and underserved areas.
"(d)
"(1)
"(2)
"(3)
Report on Coverage of Outpatient Occupational Therapy Services
"(A) the establishment of a mechanism for assuring appropriate utilization of outpatient physical therapy services, outpatient occupational therapy services, and speech-language pathology services that are covered under the medicare program under title XVIII of the Social Security Act (
"(B) the establishment of an alternative payment policy for such services based on classification of individuals by diagnostic category, functional status, prior use of services (in both inpatient and outpatient settings), and such other criteria as the Secretary determines appropriate, in place of the uniform dollar limitations specified in section 1833(g) of such Act [
The recommendations shall include how such a mechanism or policy might be implemented in a budget-neutral manner."
[
Study and Report on Clinical Laboratory Tests
Adjustments to Payment Amounts for New Technology Intraocular Lenses
"(1)
"(2)
"(3)
"(4)
Study of Medicare Coverage of Patient Care Costs Associated With Clinical Trials of New Cancer Therapies
Study of Annual Cap on Amount of Medicare Payment for Outpatient Physical Therapy and Occupational Therapy Services
Ambulatory Surgical Center Services; Inflation Update
Freeze in Allowance for Intraocular Lenses
[
Reduction in Payments Under Part B During Final Two Months of 1990
"(a)
"(b)
"(1)
"(2)
"(3)
Effect on State Law
Conscientious objections of health care provider under State law unaffected by enactment of subsecs. (a)(1)(Q) and (f) of this section, see section 4206(c) of
Development of Criteria Regarding Consultation With a Physician
[
Study of Reimbursement for Ambulance Services
PROPAC Study of Payments for Services in Hospital Outpatient Departments
Budget Neutrality
Adjustment of Contracts With Prepaid Health Plans
For requirement that Secretary of Health and Human Services modify contracts under subsection (a)(1)(A) of this section to take into account amendments made by
Study and Report to Congress Respecting Incentive Payments for Physicians' Services Furnished in Underserved Areas
Fee Schedules for Physician Pathology Services
Applying Copayment and Deductible to Certain Outpatient Physicians' Services
Other Physician Payment Studies
Study of Payment for Chemotherapy in Physicians' Offices
Clinical Diagnostic Laboratory Tests; Limitation on Changes in Fee Schedules
GAO Study of Fee Schedules
Amounts Paid for Independent Rural Health Clinic Services
Report on Establishment of National Fee Schedules for Payment of Clinical Diagnostic Laboratory Tests
State Standards for Directors of Clinical Laboratories
"(1)
"(2)
Transitional Provisions for Payment of Fees for Clinical Diagnostic Laboratory Tests
"(A) shall take effect on January 1, 1987,
"(B) shall apply for the 12-month period beginning on that date, and
"(C) shall take into account the percentage increase or decrease in the Consumer Price Index for all urban consumers (United States city average) occurring over an 18-month period, rather than over a 12-month period."
Extension of Medicare Physician Payment Provisions
Amount of payment under this part for physicians' services furnished between Oct. 1, 1985, and Mar. 14, 1986, to be determined on the same basis as the amount of such services furnished on Sept. 30, 1985, see section 5(b) of
Fee Schedules for Diagnostic Laboratory Tests and Feasibility of Direct Payments to Physicians; Report to Congress
"(1) The Comptroller General shall report to the Congress on—
"(A) the appropriateness of the fee schedules under section 1833(h) of the Social Security Act [
"(B) the potential impact of the adoption of a national fee schedule; and
"(C) the potential impact of applying a national fee schedule to clinical diagnostic laboratory tests provided by hospitals to their outpatients.
"(2) The Secretary of Health and Human Services shall report to the Congress with respect to the advisability and feasibility of a system of direct payment to any physician for all clinical diagnostic laboratory tests ordered by such physician.
"(3) The reports required by paragraphs (1) and (2) shall be submitted not later than January 1, 1987."
Pacemaker Reimbursement Review and Reform
"(1) The Secretary of Health and Human Services shall issue revisions to the current guidelines for the payment under part B of title XVIII of the Social Security Act [
"(2)(A) Except as provided in subparagraph (B), if the guidelines required by paragraph (1) have not been issued and put into effect by October 1, 1984, and until such guidelines have been issued and put into effect, payment may not be made under part B of title XVIII of the Social Security Act for transtelephonic monitoring procedures, with respect to a single-chamber cardiac pacemaker powered by lithium batteries, conducted more frequently than—
"(i) weekly during the first month after implantation,
"(ii) once every two months during the period representing 80 percent of the estimated life of the implanted device, and
"(iii) monthly thereafter.
"(B) Subparagraph (A) shall not apply in cases where the Secretary determines that special medical factors (including possible evidence of pacemaker or lead malfunction) justify more frequent transtelephonic monitoring procedures."
Payment for Preadmission Diagnostic Testing Performed in Physician's Office
Providers of Services To Calculate and Report Lesser-of-Cost-or-Charges Determinations Separately With Respect to Payments Under Parts A and B of This Subchapter; Issuance of Regulations
For provision directing the Secretary to issue regulations requiring providers of services to calculate and report the lesser-of-cost-or-charges determinations separately with respect to payments for services under parts A and B of this subchapter other than diagnostic tests under subsec. (h) of this section, see section 2308(a) of
Determination of Nominal Charges for Applying Nominality Test
For provision directing the Secretary to provide, in addition to other rules deemed appropriate, that charges representing 60 percent or less of costs be considered nominal for purposes of applying the nominality test under subsec. (a)(2)(B)(ii) of this section, see section 2308(b)(1) of
Study of Medicare Part B Payments; Compilation of Centralized Charge Data Base; Report to Congress
Monitoring Provision of Hepatitis B Vaccine; Review of Changes in Medical Technology
Report on Preadmission Diagnostic Testing Expenses
Study of Feasibility and Desirability of Imposing Copayment Requirement on Rural Health Clinic Visits; Report Not Later Than December 13, 1978
Prohibition Against Payments in Cases of Nonentitlement to Monthly Benefits Under Subchapter II or Suspension of Benefits of Aliens Outside the United States
2 So in original. The word "and" probably should not appear.
3 So in original. Probably should be followed by a comma.
4 See 2010 Amendment note for subsec. (a)(2)(F) to (H) below.
5 So in original. Probably should be followed by "to".
6 So in original. There is no subpar. (D).
7 So in original. Probably should be preceded by "a".
8 So in original. The comma after "subclause (II))" probably should follow "is performed".
9 So in original. Probably should be "such paragraph applies".
10 So in original. The word "this" probably should not appear.
11 So in original. The closing parenthesis preceding the comma probably should not appear.
12 So in original. Probably should be "are—".
13 So in original. Probably should be "subparagraph".
14 So in original. No par. (2) has been enacted.
15 So in original. Probably should be "a covered OPD".
16 So in original. Probably should be preceded by "under".
17 So in original. Probably should be "paragraphs".
18 So in original. Probably should be "exceed".
19 So in original. Probably should be preceded by "section".
§1395m. Special payment rules for particular items and services
(a) Payment for durable medical equipment
(1) General rule for payment
(A) In general
With respect to a covered item (as defined in paragraph (13)) for which payment is determined under this subsection, payment shall be made in the frequency specified in paragraphs (2) through (7) and in an amount equal to 80 percent of the payment basis described in subparagraph (B).
(B) Payment basis
Subject to subparagraph (F)(i), the payment basis described in this subparagraph is the lesser of—
(i) the actual charge for the item, or
(ii) the payment amount recognized under paragraphs (2) through (7) of this subsection for the item;
except that clause (i) shall not apply if the covered item is furnished by a public home health agency (or by another home health agency which demonstrates to the satisfaction of the Secretary that a significant portion of its patients are low income) free of charge or at nominal charges to the public.
(C) Exclusive payment rule
Subject to subparagraph (F)(ii), this subsection shall constitute the exclusive provision of this subchapter for payment for covered items under this part or under part A to a home health agency.
(D) Reduction in fee schedules for certain items
With respect to a seat-lift chair or transcutaneous electrical nerve stimulator furnished on or after April 1, 1990, the Secretary shall reduce the payment amount applied under subparagraph (B)(ii) for such an item by 15 percent, and, in the case of a transcutaneous electrical nerve stimulator furnished on or after January 1, 1991, the Secretary shall further reduce such payment amount (as previously reduced) by 45 percent.
(E) Clinical conditions for coverage
(i) In general
The Secretary shall establish standards for clinical conditions for payment for covered items under this subsection.
(ii) Requirements
The standards established under clause (i) shall include the specification of types or classes of covered items that require, as a condition of payment under this subsection, a face-to-face examination of the individual by a physician (as defined in
(iii) Priority of establishment of standards
In establishing the standards under this subparagraph, the Secretary shall first establish standards for those covered items for which the Secretary determines there has been a proliferation of use, consistent findings of charges for covered items that are not delivered, or consistent findings of falsification of documentation to provide for payment of such covered items under this part.
(iv) Standards for power wheelchairs
Effective on December 8, 2003, in the case of a covered item consisting of a motorized or power wheelchair for an individual, payment may not be made for such covered item unless a physician (as defined in
(v) Limitation on payment for covered items
Payment may not be made for a covered item under this subsection unless the item meets any standards established under this subparagraph for clinical condition of coverage.
(F) Application of competitive acquisition; limitation of inherent reasonableness authority
In the case of covered items furnished on or after January 1, 2011, subject to subparagraphs (G) and (H), that are included in a competitive acquisition program in a competitive acquisition area under
(i) the payment basis under this subsection for such items and services furnished in such area shall be the payment basis determined under such competitive acquisition program;
(ii) the Secretary may (and, in the case of covered items furnished on or after January 1, 2016, subject to clause (iii), shall) use information on the payment determined under such competitive acquisition programs to adjust the payment amount otherwise recognized under subparagraph (B)(ii) for an area that is not a competitive acquisition area under
(iii) in the case of covered items furnished on or after January 1, 2016, the Secretary shall continue to make such adjustments described in clause (ii) as, under such competitive acquisition programs, additional covered items are phased in or information is updated as contracts under
(G) Use of information on competitive bid rates
The Secretary shall specify by regulation the methodology to be used in applying the provisions of subparagraph (F)(ii) and subsection (h)(1)(H)(ii). In promulgating such regulation, the Secretary shall consider the costs of items and services in areas in which such provisions would be applied compared to the payment rates for such items and services in competitive acquisition areas. In the case of items and services furnished on or after January 1, 2019, in making any adjustments under clause (ii) or (iii) of subparagraph (F), under subsection (h)(1)(H)(ii), or under
(i) solicit and take into account stakeholder input; and
(ii) take into account the highest amount bid by a winning supplier in a competitive acquisition area and a comparison of each of the following with respect to non-competitive acquisition areas and competitive acquisition areas:
(I) The average travel distance and cost associated with furnishing items and services in the area.
(II) The average volume of items and services furnished by suppliers in the area.
(III) The number of suppliers in the area.
(H) Diabetic supplies
(i) In general
On or after the date described in clause (ii), the payment amount under this part for diabetic supplies, including testing strips, that are non-mail order items (as defined by the Secretary) shall be equal to the single payment amounts established under the national mail order competition for diabetic supplies under
(ii) Date described
The date described in this clause is the date of the implementation of the single payment amounts under the national mail order competition for diabetic supplies under
(I) Treatment of vacuum erection systems
Effective for items and services furnished on and after July 1, 2015, vacuum erection systems described as prosthetic devices described in
(2) Payment for inexpensive and other routinely purchased durable medical equipment
(A) In general
Payment for an item of durable medical equipment (as defined in paragraph (13))—
(i) the purchase price of which does not exceed $150,
(ii) which the Secretary determines is acquired at least 75 percent of the time by purchase,
(iii) which is an accessory used in conjunction with a nebulizer, aspirator, or a ventilator excluded under paragraph (3)(A), or
(iv) in the case of devices furnished on or after October 1, 2015, which serves as a speech generating device or which is an accessory that is needed for the individual to effectively utilize such a device,
shall be made on a rental basis or in a lump-sum amount for the purchase of the item. The payment amount recognized for purchase or rental of such equipment is the amount specified in subparagraph (B) for purchase or rental, except that the total amount of payments with respect to an item may not exceed the payment amount specified in subparagraph (B) with respect to the purchase of the item.
(B) Payment amount
For purposes of subparagraph (A), the amount specified in this subparagraph, with respect to the purchase or rental of an item furnished in a carrier service area—
(i) in 1989 and in 1990 is the average reasonable charge in the area for the purchase or rental, respectively, of the item for the 12-month period ending on June 30, 1987, increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 6-month period ending with December 1987;
(ii) in 1991 is the sum of (I) 67 percent of the local payment amount for the item or device computed under subparagraph (C)(i)(I) for 1991, and (II) 33 percent of the national limited payment amount for the item or device computed under subparagraph (C)(ii) for 1991;
(iii) in 1992 is the sum of (I) 33 percent of the local payment amount for the item or device computed under subparagraph (C)(i)(II) for 1992, and (II) 67 percent of the national limited payment amount for the item or device computed under subparagraph (C)(ii) for 1992; and
(iv) in 1993 and each subsequent year is the national limited payment amount for the item or device computed under subparagraph (C)(ii) for that year (reduced by 10 percent, in the case of a blood glucose testing strip furnished after 1997 for an individual with diabetes).
(C) Computation of local payment amount and national limited payment amount
For purposes of subparagraph (B)—
(i) the local payment amount for an item or device for a year is equal to—
(I) for 1991, the amount specified in subparagraph (B)(i) for 1990 increased by the covered item update for 1991, and
(II) for 1992, 1993, and 1994, the amount determined under this clause for the preceding year increased by the covered item update for the year; and
(ii) the national limited payment amount for an item or device for a year is equal to—
(I) for 1991, the local payment amount determined under clause (i) for such item or device for that year, except that the national limited payment amount may not exceed 100 percent of the weighted average of all local payment amounts determined under such clause for such item for that year and may not be less than 85 percent of the weighted average of all local payment amounts determined under such clause for such item,
(II) for 1992 and 1993, the amount determined under this clause for the preceding year increased by the covered item update for such subsequent year,
(III) for 1994, the local payment amount determined under clause (i) for such item or device for that year, except that the national limited payment amount may not exceed 100 percent of the median of all local payment amounts determined under such clause for such item for that year and may not be less than 85 percent of the median of all local payment amounts determined under such clause for such item or device for that year, and
(IV) for each subsequent year, the amount determined under this clause for the preceding year increased by the covered item update for such subsequent year.
(3) Payment for items requiring frequent and substantial servicing
(A) In general
Payment for a covered item (such as IPPB machines and ventilators, excluding ventilators that are either continuous airway pressure devices or intermittent assist devices with continuous airway pressure devices) for which there must be frequent and substantial servicing in order to avoid risk to the patient's health shall be made on a monthly basis for the rental of the item and the amount recognized is the amount specified in subparagraph (B).
(B) Payment amount
For purposes of subparagraph (A), the amount specified in this subparagraph, with respect to an item or device furnished in a carrier service area—
(i) in 1989 and in 1990 is the average reasonable charge in the area for the rental of the item or device for the 12-month period ending with June 1987, increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 6-month period ending with December 1987;
(ii) in 1991 is the sum of (I) 67 percent of the local payment amount for the item or device computed under subparagraph (C)(i)(I) for 1991, and (II) 33 percent of the national limited payment amount for the item or device computed under subparagraph (C)(ii) for 1991;
(iii) in 1992 is the sum of (I) 33 percent of the local payment amount for the item or device computed under subparagraph (C)(i)(II) for 1992, and (II) 67 percent of the national limited payment amount for the item or device computed under subparagraph (C)(ii) for 1992; and
(iv) in 1993 and each subsequent year is the national limited payment amount for the item or device computed under subparagraph (C)(ii) for that year.
(C) Computation of local payment amount and national limited payment amount
For purposes of subparagraph (B)—
(i) the local payment amount for an item or device for a year is equal to—
(I) for 1991, the amount specified in subparagraph (B)(i) for 1990 increased by the covered item update for 1991, and
(II) for 1992, 1993, and 1994, the amount determined under this clause for the preceding year increased by the covered item update for the year; and
(ii) the national limited payment amount for an item or device for a year is equal to—
(I) for 1991, the local payment amount determined under clause (i) for such item or device for that year, except that the national limited payment amount may not exceed 100 percent of the weighted average of all local payment amounts determined under such clause for such item for that year and may not be less than 85 percent of the weighted average of all local payment amounts determined under such clause for such item,
(II) for 1992 and 1993, the amount determined under this clause for the preceding year increased by the covered item update for such subsequent year,
(III) for 1994, the local payment amount determined under clause (i) for such item or device for that year, except that the national limited payment amount may not exceed 100 percent of the median of all local payment amounts determined under such clause for such item for that year and may not be less than 85 percent of the median of all local payment amounts determined under such clause for such item or device for that year, and
(IV) for each subsequent year, the amount determined under this clause for the preceding year increased by the covered item update for such subsequent year.
(4) Payment for certain customized items
Payment with respect to a covered item that is uniquely constructed or substantially modified to meet the specific needs of an individual patient, and for that reason cannot be grouped with similar items for purposes of payment under this subchapter, shall be made in a lump-sum amount (A) for the purchase of the item in a payment amount based upon the carrier's individual consideration for that item, and (B) for the reasonable and necessary maintenance and servicing for parts and labor not covered by the supplier's or manufacturer's warranty, when necessary during the period of medical need, and the amount recognized for such maintenance and servicing shall be paid on a lump-sum, as needed basis based upon the carrier's individual consideration for that item.
(5) Payment for oxygen and oxygen equipment
(A) In general
Payment for oxygen and oxygen equipment shall be made on a monthly basis in the monthly payment amount recognized under paragraph (9) for oxygen and oxygen equipment (other than portable oxygen equipment), subject to subparagraphs (B), (C), (E), and (F).
(B) Add-on for portable oxygen equipment
When portable oxygen equipment is used, but subject to subparagraph (D), the payment amount recognized under subparagraph (A) shall be increased by the monthly payment amount recognized under paragraph (9) for portable oxygen equipment.
(C) Volume adjustment
When the attending physician prescribes an oxygen flow rate—
(i) exceeding 4 liters per minute, the payment amount recognized under subparagraph (A), subject to subparagraph (D), shall be increased by 50 percent, or
(ii) of less than 1 liter per minute, the payment amount recognized under subparagraph (A) shall be decreased by 50 percent.
(D) Limit on adjustment
When portable oxygen equipment is used and the attending physician prescribes an oxygen flow rate exceeding 4 liters per minute, there shall only be an increase under either subparagraph (B) or (C), whichever increase is larger, and not under both such subparagraphs.
(E) Recertification for patients receiving home oxygen therapy
In the case of a patient receiving home oxygen therapy services who, at the time such services are initiated, has an initial arterial blood gas value at or above a partial pressure of 56 or an arterial oxygen saturation at or above 89 percent (or such other values, pressures, or criteria as the Secretary may specify) no payment may be made under this part for such services after the expiration of the 90-day period that begins on the date the patient first receives such services unless the patient's attending physician certifies that, on the basis of a follow-up test of the patient's arterial blood gas value or arterial oxygen saturation conducted during the final 30 days of such 90-day period, there is a medical need for the patient to continue to receive such services.
(F) Rental cap
(i) In general
Payment for oxygen equipment (including portable oxygen equipment) under this paragraph may not extend over a period of continuous use (as determined by the Secretary) of longer than 36 months.
(ii) Payments and rules after rental cap
After the 36th continuous month during which payment is made for the equipment under this paragraph—
(I) the supplier furnishing such equipment under this subsection shall continue to furnish the equipment during any period of medical need for the remainder of the reasonable useful lifetime of the equipment, as determined by the Secretary;
(II) payments for oxygen shall continue to be made in the amount recognized for oxygen under paragraph (9) for the period of medical need; and
(III) maintenance and servicing payments shall, if the Secretary determines such payments are reasonable and necessary, be made (for parts and labor not covered by the supplier's or manufacturer's warranty, as determined by the Secretary to be appropriate for the equipment), and such payments shall be in an amount determined to be appropriate by the Secretary.
(6) Payment for other covered items (other than durable medical equipment)
Payment for other covered items (other than durable medical equipment and other covered items described in paragraph (3), (4), or (5)) shall be made in a lump-sum amount for the purchase of the item in the amount of the purchase price recognized under paragraph (8).
(7) Payment for other items of durable medical equipment
(A) Payment
In the case of an item of durable medical equipment not described in paragraphs (2) through (6), the following rules shall apply:
(i) Rental
(I) In general
Except as provided in clause (iii), payment for the item shall be made on a monthly basis for the rental of the item during the period of medical need (but payments under this clause may not extend over a period of continuous use (as determined by the Secretary) of longer than 13 months).
(II) Payment amount
Subject to subclause (III) and subparagraph (B), the amount recognized for the item, for each of the first 3 months of such period, is 10 percent of the purchase price recognized under paragraph (8) with respect to the item, and, for each of the remaining months of such period, is 7.5 percent of such purchase price.
(III) Special rule for power-driven wheelchairs
For purposes of payment for power-driven wheelchairs, subclause (II) shall be applied by substituting "15 percent" and "6 percent" for "10 percent" and "7.5 percent", respectively.
(ii) Ownership after rental
On the first day that begins after the 13th continuous month during which payment is made for the rental of an item under clause (i), the supplier of the item shall transfer title to the item to the individual.
(iii) Purchase agreement option for complex, rehabilitative power-driven wheelchairs
In the case of a complex, rehabilitative power-driven wheelchair, at the time the supplier furnishes the item, the supplier shall offer the individual the option to purchase the item, and payment for such item shall be made on a lump-sum basis if the individual exercises such option.
(iv) Maintenance and servicing
After the supplier transfers title to the item under clause (ii) or in the case of a power-driven wheelchair for which a purchase agreement has been entered into under clause (iii), maintenance and servicing payments shall, if the Secretary determines such payments are reasonable and necessary, be made (for parts and labor not covered by the supplier's or manufacturer's warranty, as determined by the Secretary to be appropriate for the particular type of durable medical equipment), and such payments shall be in an amount determined to be appropriate by the Secretary.
(B) Range for rental amounts
(i) For 1989
For items furnished during 1989, the payment amount recognized under subparagraph (A)(i) shall not be more than 115 percent, and shall not be less than 85 percent, of the prevailing charge established for rental of the item in January 1987, increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 6-month period ending with December 1987.
(ii) For 1990
For items furnished during 1990, clause (i) shall apply in the same manner as it applies to items furnished during 1989.
(C) Replacement of items
(i) Establishment of reasonable useful lifetime
In accordance with clause (iii), the Secretary shall determine and establish a reasonable useful lifetime for items of durable medical equipment for which payment may be made under this paragraph.
(ii) Payment for replacement items
If the reasonable lifetime of such an item, as so established, has been reached during a continuous period of medical need, or the carrier determines that the item is lost or irreparably damaged, the patient may elect to have payment for an item serving as a replacement for such item made—
(I) on a monthly basis for the rental of the replacement item in accordance with subparagraph (A); or
(II) in the case of an item for which a purchase agreement has been entered into under subparagraph (A)(iii), in a lump-sum amount for the purchase of the item.
(iii) Length of reasonable useful lifetime
The reasonable useful lifetime of an item of durable medical equipment under this subparagraph shall be equal to 5 years, except that, if the Secretary determines that, on the basis of prior experience in making payments for such an item under this subchapter, a reasonable useful lifetime of 5 years is not appropriate with respect to a particular item, the Secretary shall establish an alternative reasonable lifetime for such item.
(8) Purchase price recognized for miscellaneous devices and items
For purposes of paragraphs (6) and (7), the amount that is recognized under this paragraph as the purchase price for a covered item is the amount described in subparagraph (C) of this paragraph, determined as follows:
(A) Computation of local purchase price
Each carrier under
(i) The carrier shall compute a base local purchase price, for each item described—
(I) in paragraph (6) equal to the average reasonable charge in the locality for the purchase of the item for the 12-month period ending with June 1987, or
(II) in paragraph (7) equal to the average of the purchase prices on the claims submitted on an assignment-related basis for the unused item supplied during the 6-month period ending with December 1986.
(ii) The carrier shall compute a local purchase price, with respect to the furnishing of each particular item—
(I) in 1989 and 1990, equal to the base local purchase price computed under clause (i) increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 6-month period ending with December 1987,
(II) in 1991, equal to the local purchase price computed under this clause for the previous year, increased by the covered item update for 1991, and decreased by the percentage by which the average of the reasonable charges for claims paid for all items described in paragraph (7) is lower than the average of the purchase prices submitted for such items during the final 9 months of 1988; 1 or
(III) in 1992, 1993, and 1994, equal to the local purchase price computed under this clause for the previous year increased by the covered item update for the year.
(B) Computation of national limited purchase price
With respect to the furnishing of a particular item in a year, the Secretary shall compute a national limited purchase price—
(i) for 1991, equal to the local purchase price computed under subparagraph (A)(ii) for the item for the year, except that such national limited purchase price may not exceed 100 percent of the weighted average of all local purchase prices for the item computed under such subparagraph for the year, and may not be less than 85 percent of the weighted average of all local purchase prices for the item computed under such subparagraph for the year;
(ii) for 1992 and 1993, the amount determined under this subparagraph for the preceding year increased by the covered item update for such subsequent year;
(iii) for 1994, the local purchase price computed under subparagraph (A)(ii) for the item for the year, except that such national limited purchase price may not exceed 100 percent of the median of all local purchase prices computed for the item under such subparagraph for the year and may not be less than 85 percent of the median of all local purchase prices computed under such subparagraph for the item for the year; and
(iv) for each subsequent year, equal to the amount determined under this subparagraph for the preceding year increased by the covered item update for such subsequent year.
(C) Purchase price recognized
For purposes of paragraphs (6) and (7), the amount that is recognized under this paragraph as the purchase price for each item furnished—
(i) in 1989 or 1990, is 100 percent of the local purchase price computed under subparagraph (A)(ii)(I);
(ii) in 1991, is the sum of (I) 67 percent of the local purchase price computed under subparagraph (A)(ii)(II) for 1991, and (II) 33 percent of the national limited purchase price computed under subparagraph (B) for 1991;
(iii) in 1992, is the sum of (I) 33 percent of the local purchase price computed under subparagraph (A)(ii)(III) for 1992, and (II) 67 percent of the national limited purchase price computed under subparagraph (B) for 1992; and
(iv) in 1993 or a subsequent year, is the national limited purchase price computed under subparagraph (B) for that year.
(9) Monthly payment amount recognized with respect to oxygen and oxygen equipment
For purposes of paragraph (5), the amount that is recognized under this paragraph for payment for oxygen and oxygen equipment is the monthly payment amount described in subparagraph (C) of this paragraph. Such amount shall be computed separately (i) for all items of oxygen and oxygen equipment (other than portable oxygen equipment) and (ii) for portable oxygen equipment (each such group referred to in this paragraph as an "item").
(A) Computation of local monthly payment rate
Each carrier under this section shall compute a base local payment rate for each item as follows:
(i) The carrier shall compute a base local average monthly payment rate per beneficiary as an amount equal to (I) the total reasonable charges for the item during the 12-month period ending with December 1986, divided by (II) the total number of months for all beneficiaries receiving the item in the area during the 12-month period for which the carrier made payment for the item under this subchapter.
(ii) The carrier shall compute a local average monthly payment rate for the item applicable—
(I) to 1989 and 1990, equal to 95 percent of the base local average monthly payment rate computed under clause (i) for the item increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 6-month period ending with December 1987, or
(II) to 1991, 1992, 1993, and 1994, equal to the local average monthly payment rate computed under this clause for the item for the previous year increased by the covered item increase for the year.
(B) Computation of national limited monthly payment rate
With respect to the furnishing of an item in a year, the Secretary shall compute a national limited monthly payment rate equal to—
(i) for 1991, the local monthly payment rate computed under subparagraph (A)(ii)(II) for the item for the year, except that such national limited monthly payment rate may not exceed 100 percent of the weighted average of all local monthly payment rates computed for the item under such subparagraph for the year, and may not be less than 85 percent of the weighted average of all local monthly payment rates computed for the item under such subparagraph for the year;
(ii) for 1992 and 1993, the amount determined under this subparagraph for the preceding year increased by the covered item update for such subsequent year;
(iii) for 1994, the local monthly payment rate computed under subparagraph (A)(ii) for the item for the year, except that such national limited monthly payment rate may not exceed 100 percent of the median of all local monthly payment rates computed for the item under such subparagraph for the year and may not be less than 85 percent of the median of all local monthly payment rates computed for the item under such subparagraph for the year;
(iv) for 1995, 1996, and 1997, equal to the amount determined under this subparagraph for the preceding year increased by the covered item update for such subsequent year;
(v) for 1998, 75 percent of the amount determined under this subparagraph for 1997; and
(vi) for 1999 and each subsequent year, 70 percent of the amount determined under this subparagraph for 1997.
(C) Monthly payment amount recognized
For purposes of paragraph (5), the amount that is recognized under this paragraph as the base monthly payment amount for each item furnished—
(i) in 1989 and in 1990, is 100 percent of the local average monthly payment rate computed under subparagraph (A)(ii) for the item;
(ii) in 1991, is the sum of (I) 67 percent of the local average monthly payment rate computed under subparagraph (A)(ii)(II) for the item for 1991, and (II) 33 percent of the national limited monthly payment rate computed under subparagraph (B)(i) for the item for 1991;
(iii) in 1992, is the sum of (I) 33 percent of the local average monthly payment rate computed under subparagraph (A)(ii)(II) for the item for 1992, and (II) 67 percent of the national limited monthly payment rate computed under subparagraph (B)(ii) for the item for 1992; and
(iv) in a subsequent year, is the national limited monthly payment rate computed under subparagraph (B) for the item for that year.
(D) Authority to create classes
(i) In general
Subject to clause (ii), the Secretary may establish separate classes for any item of oxygen and oxygen equipment and separate national limited monthly payment rates for each of such classes.
(ii) Budget neutrality
The Secretary may take actions under clause (i) only to the extent such actions do not result in expenditures for any year to be more or less than the expenditures which would have been made if such actions had not been taken. The requirement of the preceding sentence shall not apply beginning with the second calendar quarter beginning on or after December 27, 2020.
(10) Exceptions and adjustments
(A) Areas outside continental United States
Exceptions to the amounts recognized under the previous provisions of this subsection shall be made to take into account the unique circumstances of covered items furnished in Alaska, Hawaii, or Puerto Rico.
(B) Adjustment for inherent reasonableness
The Secretary is authorized to apply the provisions of paragraphs (8) and (9) of
(C) Transcutaneous electrical nerve stimulator (TENS)
In order to permit an attending physician time to determine whether the purchase of a transcutaneous electrical nerve stimulator is medically appropriate for a particular patient, the Secretary may determine an appropriate payment amount for the initial rental of such item for a period of not more than 2 months. If such item is subsequently purchased, the payment amount with respect to such purchase is the payment amount determined under paragraph (2).
(11) Improper billing and requirement of physician order
(A) Improper billing for certain rental items
Notwithstanding any other provision of this subchapter, a supplier of a covered item for which payment is made under this subsection and which is furnished on a rental basis shall continue to supply the item without charge (other than a charge provided under this subsection for the maintenance and servicing of the item) after rental payments may no longer be made under this subsection. If a supplier knowingly and willfully violates the previous sentence, the Secretary may apply sanctions against the supplier under
(B) Requirement of physician order
(i) In general
The Secretary is authorized to require, for specified covered items, that payment may be made under this subsection with respect to the item only if a physician enrolled under
(ii) Requirement for face to face encounter
The Secretary shall require that such an order be written pursuant to a physician, a physician assistant, a nurse practitioner, or a clinical nurse specialist (as those terms are defined in
(12) Regional carriers
The Secretary may designate, by regulation under
(13) "Covered item" defined
In this subsection, the term "covered item" means durable medical equipment (as defined in
(14) Covered item update
In this subsection, the term "covered item update" means, with respect to a year—
(A) for 1991 and 1992, the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June of the previous year reduced by 1 percentage point;
(B) for 1993, 1994, 1995, 1996, and 1997, the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June of the previous year;
(C) for each of the years 1998 through 2000, 0 percentage points;
(D) for 2001, the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June 2000;
(E) for 2002, 0 percentage points;
(F) for 2003, the percentage increase in the consumer price index for all urban consumers (U.S. urban average) for the 12-month period ending with June of 2002;
(G) for 2004 through 2006—
(i) subject to clause (ii), in the case of class III medical devices described in
(ii) in the case of covered items not described in clause (i), 0 percentage points;
(H) for 2007—
(i) subject to clause (ii), in the case of class III medical devices described in
(ii) in the case of covered items not described in clause (i), 0 percentage points;
(I) for 2008—
(i) subject to clause (ii), in the case of class III medical devices described in
(ii) in the case of covered items not described in clause (i), 0 percentage points;
(J) for 2009—
(i) in the case of items and services furnished in any geographic area, if such items or services were selected for competitive acquisition in any area under the competitive acquisition program under
(ii) in the case of other items and services, the percentage increase in the consumer price index for all urban consumers (U.S. urban average) for the 12-month period ending with June 2008;
(K) for 2010, the percentage increase in the consumer price index for all urban consumers (U.S. urban average) for the 12-month period ending with June of the previous year; and
(L) for 2011 and each subsequent year—
(i) the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12-month period ending with June of the previous year, reduced by—
(ii) the productivity adjustment described in
The application of subparagraph (L)(ii) may result in the covered item update under this paragraph being less than 0.0 for a year, and may result in payment rates under this subsection for a year being less than such payment rates for the preceding year.
(15) Advance determinations of coverage for certain items
(A) Development of lists of items by Secretary
The Secretary may develop and periodically update a list of items for which payment may be made under this subsection that the Secretary determines, on the basis of prior payment experience, are frequently subject to unnecessary utilization throughout a carrier's entire service area or a portion of such area.
(B) Development of lists of suppliers by Secretary
The Secretary may develop and periodically update a list of suppliers of items for which payment may be made under this subsection with respect to whom—
(i) the Secretary has found that a substantial number of claims for payment under this part for items furnished by the supplier have been denied on the basis of the application of
(ii) the Secretary has identified a pattern of overutilization resulting from the business practice of the supplier.
(C) Determinations of coverage in advance
A carrier shall determine in advance of delivery of an item whether payment for the item may not be made because the item is not covered or because of the application of
(i) the item is included on the list developed by the Secretary under subparagraph (A);
(ii) the item is furnished by a supplier included on the list developed by the Secretary under subparagraph (B); or
(iii) the item is a customized item (other than inexpensive items specified by the Secretary) and the patient to whom the item is to be furnished or the supplier requests that such advance determination be made.
(16) Disclosure of information and surety bond
The Secretary shall not provide for the issuance (or renewal) of a provider number for a supplier of durable medical equipment, for purposes of payment under this part for durable medical equipment furnished by the supplier, unless the supplier provides the Secretary on a continuing basis—
(A) with—
(i) full and complete information as to the identity of each person with an ownership or control interest (as defined in
(ii) to the extent determined to be feasible under regulations of the Secretary, the name of any disclosing entity (as defined in
(B) with a surety bond in a form specified by the Secretary and in an amount that is not less than $50,000 that the Secretary determines is commensurate with the volume of the billing of the supplier.
The Secretary may waive the requirement of a bond under subparagraph (B) in the case of a supplier that provides a comparable surety bond under State law. The Secretary, at the Secretary's discretion, may impose the requirements of the first sentence with respect to some or all providers of items or services under part A or some or all suppliers or other persons (other than physicians or other practitioners, as defined in
(17) Prohibition against unsolicited telephone contacts by suppliers
(A) In general
A supplier of a covered item under this subsection may not contact an individual enrolled under this part by telephone regarding the furnishing of a covered item to the individual unless 1 of the following applies:
(i) The individual has given written permission to the supplier to make contact by telephone regarding the furnishing of a covered item.
(ii) The supplier has furnished a covered item to the individual and the supplier is contacting the individual only regarding the furnishing of such covered item.
(iii) If the contact is regarding the furnishing of a covered item other than a covered item already furnished to the individual, the supplier has furnished at least 1 covered item to the individual during the 15-month period preceding the date on which the supplier makes such contact.
(B) Prohibiting payment for items furnished subsequent to unsolicited contacts
If a supplier knowingly contacts an individual in violation of subparagraph (A), no payment may be made under this part for any item subsequently furnished to the individual by the supplier.
(C) Exclusion from program for suppliers engaging in pattern of unsolicited contacts
If a supplier knowingly contacts individuals in violation of subparagraph (A) to such an extent that the supplier's conduct establishes a pattern of contacts in violation of such subparagraph, the Secretary shall exclude the supplier from participation in the programs under this chapter, in accordance with the procedures set forth in subsections (c), (f), and (g) of
(18) Refund of amounts collected for certain disallowed items
(A) In general
If a nonparticipating supplier furnishes to an individual enrolled under this part a covered item for which no payment may be made under this part by reason of paragraph (17)(B), the supplier shall refund on a timely basis to the patient (and shall be liable to the patient for) any amounts collected from the patient for the item, unless—
(i) the supplier establishes that the supplier did not know and could not reasonably have been expected to know that payment may not be made for the item by reason of paragraph (17)(B), or
(ii) before the item was furnished, the patient was informed that payment under this part may not be made for that item and the patient has agreed to pay for that item.
(B) Sanctions
If a supplier knowingly and willfully fails to make refunds in violation of subparagraph (A), the Secretary may apply sanctions against the supplier in accordance with
(C) Notice
Each carrier with a contract in effect under this part with respect to suppliers of covered items shall send any notice of denial of payment for covered items by reason of paragraph (17)(B) and for which payment is not requested on an assignment-related basis to the supplier and the patient involved.
(D) Timely basis defined
A refund under subparagraph (A) is considered to be on a timely basis only if—
(i) in the case of a supplier who does not request reconsideration or seek appeal on a timely basis, the refund is made within 30 days after the date the supplier receives a denial notice under subparagraph (C), or
(ii) in the case in which such a reconsideration or appeal is taken, the refund is made within 15 days after the date the supplier receives notice of an adverse determination on reconsideration or appeal.
(19) Certain upgraded items
(A) Individual's right to choose upgraded item
Notwithstanding any other provision of this subchapter, the Secretary may issue regulations under which an individual may purchase or rent from a supplier an item of upgraded durable medical equipment for which payment would be made under this subsection if the item were a standard item.
(B) Payments to supplier
In the case of the purchase or rental of an upgraded item under subparagraph (A)—
(i) the supplier shall receive payment under this subsection with respect to such item as if such item were a standard item; and
(ii) the individual purchasing or renting the item shall pay the supplier an amount equal to the difference between the supplier's charge and the amount under clause (i).
In no event may the supplier's charge for an upgraded item exceed the applicable fee schedule amount (if any) for such item.
(C) Consumer protection safeguards
Any regulations under subparagraph (A) shall provide for consumer protection standards with respect to the furnishing of upgraded equipment under subparagraph (A). Such regulations shall provide for—
(i) determination of fair market prices with respect to an upgraded item;
(ii) full disclosure of the availability and price of standard items and proof of receipt of such disclosure information by the beneficiary before the furnishing of the upgraded item;
(iii) conditions of participation for suppliers in the billing arrangement;
(iv) sanctions of suppliers who are determined to engage in coercive or abusive practices, including exclusion; and
(v) such other safeguards as the Secretary determines are necessary.
(20) Identification of quality standards
(A) In general
Subject to subparagraph (C), the Secretary shall establish and implement quality standards for suppliers of items and services described in subparagraph (D) to be applied by recognized independent accreditation organizations (as designated under subparagraph (B)) and with which such suppliers shall be required to comply in order to—
(i) furnish any such item or service for which payment is made under this part; and
(ii) receive or retain a provider or supplier number used to submit claims for reimbursement for any such item or service for which payment may be made under this subchapter.
(B) Designation of independent accreditation organizations
Not later than the date that is 1 year after the date on which the Secretary implements the quality standards under subparagraph (A), notwithstanding
(C) Quality standards
The quality standards described in subparagraph (A) may not be less stringent than the quality standards that would otherwise apply if this paragraph did not apply and shall include consumer services standards.
(D) Items and services described
The items and services described in this subparagraph are the following items and services, as the Secretary determines appropriate:
(i) Covered items (as defined in paragraph (13)) for which payment may otherwise be made under this subsection.
(ii) Prosthetic devices and orthotics and prosthetics described in subsection (h)(4).
(iii) Items and services described in
(iv) Lymphedema compression treatment items (as defined in
(E) Implementation
The Secretary may establish by program instruction or otherwise the quality standards under this paragraph, including subparagraph (F), after consultation with representatives of relevant parties. Such standards shall be applied prospectively and shall be published on the Internet website of the Centers for Medicare & Medicaid Services.
(F) Application of accreditation requirement
In implementing quality standards under this paragraph—
(i) subject to clause (ii) and subparagraph (G), the Secretary shall require suppliers furnishing items and services described in subparagraph (D) on or after October 1, 2009, directly or as a subcontractor for another entity, to have submitted to the Secretary evidence of accreditation by an accreditation organization designated under subparagraph (B) as meeting applicable quality standards, except that the Secretary shall not require under this clause pharmacies to obtain such accreditation before January 1, 2010, except that the Secretary shall not require a pharmacy to have submitted to the Secretary such evidence of accreditation prior to January 1, 2011; and
(ii) in applying such standards and the accreditation requirement of clause (i) with respect to eligible professionals (as defined in
(I) such standards and accreditation requirement shall not apply to such professionals and persons unless the Secretary determines that the standards being applied are designed specifically to be applied to such professionals and persons; and
(II) the Secretary may exempt such professionals and persons from such standards and requirement if the Secretary determines that licensing, accreditation, or other mandatory quality requirements apply to such professionals and persons with respect to the furnishing of such items and services.
(G) Application of accreditation requirement to certain pharmacies
(i) In general
With respect to items and services furnished on or after January 1, 2011, in implementing quality standards under this paragraph—
(I) subject to subclause (II), in applying such standards and the accreditation requirement of subparagraph (F)(i) with respect to pharmacies described in clause (ii) furnishing such items and services, such standards and accreditation requirement shall not apply to such pharmacies; and
(II) the Secretary may apply to such pharmacies an alternative accreditation requirement established by the Secretary if the Secretary determines such alternative accreditation requirement is more appropriate for such pharmacies.
(ii) Pharmacies described
A pharmacy described in this clause is a pharmacy that meets each of the following criteria:
(I) The total billings by the pharmacy for such items and services under this subchapter are less than 5 percent of total pharmacy sales, as determined based on the average total pharmacy sales for the previous 3 calendar years, 3 fiscal years, or other yearly period specified by the Secretary.
(II) The pharmacy has been enrolled under
(III) The pharmacy submits to the Secretary an attestation, in a form and manner, and at a time, specified by the Secretary, that the pharmacy meets the criteria described in subclauses (I) and (II). Such attestation shall be subject to
(IV) The pharmacy agrees to submit materials as requested by the Secretary, or during the course of an audit conducted on a random sample of pharmacies selected annually, to verify that the pharmacy meets the criteria described in subclauses (I) and (II). Materials submitted under the preceding sentence shall include a certification by an accountant on behalf of the pharmacy or the submission of tax returns filed by the pharmacy during the relevant periods, as requested by the Secretary.
(21) Special payment rule for specified items and supplies
(A) In general
Notwithstanding the preceding provisions of this subsection, for specified items and supplies (described in subparagraph (B)) furnished during 2005, the payment amount otherwise determined under this subsection for such specified items and supplies shall be reduced by the percentage difference between—
(i) the amount of payment otherwise determined for the specified item or supply under this subsection for 2002, and
(ii) the amount of payment for the specified item or supply under
(B) Specified item or supply described
For purposes of subparagraph (A), a specified item or supply means oxygen and oxygen equipment, standard wheelchairs (including standard power wheelchairs), nebulizers, diabetic supplies consisting of lancets and testing strips, hospital beds, and air mattresses, but only if the HCPCS code for the item or supply is identified in a table referred to in subparagraph (A)(ii).
(C) Application of update to special payment amount
The covered item update under paragraph (14) for specified items and supplies for 2006 and each subsequent year shall be applied to the payment amount under subparagraph (A) unless payment is made for such items and supplies under
(22) Special payment rule for diabetic supplies
Notwithstanding the preceding provisions of this subsection, for purposes of determining the payment amount under this subsection for diabetic supplies furnished on or after the first day of the calendar quarter during 2013 that is at least 30 days after January 2, 2013, and before the date described in paragraph (1)(H)(ii), the Secretary shall recalculate and apply the covered item update under paragraph (14) as if subparagraph (J)(i) of such paragraph was amended by striking "but only if furnished through mail order".
(b) Fee schedules for radiologist services
(1) Development
The Secretary shall develop—
(A) a relative value scale to serve as the basis for the payment for radiologist services under this part, and
(B) using such scale and appropriate conversion factors and subject to subsection (c)(1)(A), fee schedules (on a regional, statewide, locality, or carrier service area basis) for payment for radiologist services under this part, to be implemented for such services furnished during 1989.
(2) Consultation
In carrying out paragraph (1), the Secretary shall regularly consult closely with the Physician Payment Review Commission, the American College of Radiology, and other organizations representing physicians or suppliers who furnish radiologist services and shall share with them the data and data analysis being used to make the determinations under paragraph (1), including data on variations in current medicare payments by geographic area, and by service and physician specialty.
(3) Considerations
In developing the relative value scale and fee schedules under paragraph (1), the Secretary—
(A) shall take into consideration variations in the cost of furnishing such services among geographic areas and among different sites where services are furnished, and
(B) may also take into consideration such other factors respecting the manner in which physicians in different specialties furnish such services as may be appropriate to assure that payment amounts are equitable and designed to promote effective and efficient provision of radiologist services by physicians in the different specialties.
(4) Savings
(A) Budget neutral fee schedules
The Secretary shall develop preliminary fee schedules for 1989, which are designed to result in the same amount of aggregate payments (net of any coinsurance and deductibles under
(B) Initial savings
The fee schedules established for payment purposes under this subsection for services furnished in 1989 shall be 97 percent of the amounts permitted under the preliminary fee schedules developed under subparagraph (A).
(C) 1990 fee schedules
For radiologist services (other than portable X-ray services) furnished under this part during 1990, after March 31 of such year, the conversion factors used under this subsection shall be 96 percent of the conversion factors that applied under this subsection as of December 31, 1989.
(D) 1991 fee schedules
For radiologist services (other than portable X-ray services) furnished under this part during 1991, the conversion factors used in a locality under this subsection shall, subject to clause (vii), be reduced to the adjusted conversion factor for the locality determined as follows:
(i) National weighted average conversion factor
The Secretary shall estimate the national weighted average of the conversion factors used under this subsection for services furnished during 1990 beginning on April 1, using the best available data.
(ii) Reduced national weighted average
The national weighted average estimated under clause (i) shall be reduced by 13 percent.
(iii) Computation of 1990 locality index relative to national average
The Secretary shall establish an index which reflects, for each locality, the ratio of the conversion factor used in the locality under this subsection to the national weighted average estimated under clause (i).
(iv) Adjusted conversion factor
The adjusted conversion factor for the professional or technical component of a service in a locality is the sum of ½ of the locally-adjusted amount determined under clause (v) and ½ of the GPCI-adjusted amount determined under clause (vi).
(v) Locally-adjusted amount
For purposes of clause (iv), the locally adjusted amount determined under this clause is the product of (I) the national weighted average conversion factor computed under clause (ii), and (II) the index value established under clause (iii) for the locality.
(vi) GPCI-adjusted amount
For purposes of clause (iv), the GPCI-adjusted amount determined under this clause is the sum of—
(I) the product of (a) the portion of the reduced national weighted average conversion factor computed under clause (ii) which is attributable to physician work and (b) the geographic work index value for the locality (specified in Addendum C to the Model Fee Schedule for Physician Services (published on September 4, 1990, 55 Federal Register pp. 36238–36243)); and
(II) the product of (a) the remaining portion of the reduced national weighted average conversion factor computed under clause (ii), and (b) the geographic practice cost index value specified in
In applying this clause with respect to the professional component of a service, 80 percent of the conversion factor shall be considered to be attributable to physician work and with respect to the technical component of the service, 0 percent shall be considered to be attributable to physician work.
(vii) Limits on conversion factor
The conversion factor to be applied to a locality to the professional or technical component of a service shall not be reduced under this subparagraph by more than 9.5 percent below the conversion factor applied in the locality under subparagraph (C) to such component, but in no case shall the conversion factor be less than 60 percent of the national weighted average of the conversion factors (computed under clause (i)).
(E) Rule for certain scanning services
In the case of the technical components of magnetic resonance imaging (MRI) services and computer assisted tomography (CAT) services furnished after December 31, 1990, the amount otherwise payable shall be reduced by 10 percent.
(F) Subsequent updating
For radiologist services furnished in subsequent years, the fee schedules shall be the schedules for the previous year updated by the percentage increase in the MEI (as defined in
(G) Nonparticipating physicians and suppliers
Each fee schedule so established shall provide that the payment rate recognized for nonparticipating physicians and suppliers is equal to the appropriate percent (as defined in
(5) Limiting charges of nonparticipating physicians and suppliers
(A) In general
In the case of radiologist services furnished after January 1, 1989, for which payment is made under a fee schedule under this subsection, if a nonparticipating physician or supplier furnishes the service to an individual entitled to benefits under this part, the physician or supplier may not charge the individual more than the limiting charge (as defined in subparagraph (B)).
(B) "Limiting charge" defined
In subparagraph (A), the term "limiting charge" means, with respect to a service furnished—
(i) in 1989, 125 percent of the amount specified for the service in the appropriate fee schedule established under paragraph (1),
(ii) in 1990, 120 percent of the amount specified for the service in the appropriate fee schedule established under paragraph (1), and
(iii) after 1990, 115 percent of the amount specified for the service in the appropriate fee schedule established under paragraph (1).
(C) Enforcement
If a physician or supplier knowingly and willfully bills in violation of subparagraph (A), the Secretary may apply sanctions against such physician or supplier in accordance with
(6) "Radiologist services" defined
For the purposes of this subsection and
(A) who is certified, or eligible to be certified, by the American Board of Radiology, or
(B) for whom radiology services account for at least 50 percent of the total amount of charges made under this part.
(c) Payment and standards for screening mammography
(1) In general
With respect to expenses incurred for screening mammography (as defined in
(A) for screening mammography conducted consistent with the frequency permitted under paragraph (2); and
(B) if the screening mammography is conducted by a facility that has a certificate (or provisional certificate) issued under
(2) Frequency covered
(A) In general
Subject to revision by the Secretary under subparagraph (B)—
(i) no payment may be made under this part for screening mammography performed on a woman under 35 years of age;
(ii) payment may be made under this part for only one screening mammography performed on a woman over 34 years of age, but under 40 years of age; and
(iii) in the case of a woman over 39 years of age, payment may not be made under this part for screening mammography performed within 11 months following the month in which a previous screening mammography was performed.
(B) Revision of frequency
(i) Review
The Secretary, in consultation with the Director of the National Cancer Institute, shall review periodically the appropriate frequency for performing screening mammography, based on age and such other factors as the Secretary believes to be pertinent.
(ii) Revision of frequency
The Secretary, taking into consideration the review made under clause (i), may revise from time to time the frequency with which screening mammography may be paid for under this subsection.
(d) Frequency limits and payment for colorectal cancer screening tests
(1) Screening fecal-occult blood tests
(A) Payment amount
The payment amount for colorectal cancer screening tests consisting of screening fecal-occult blood tests is equal to the payment amount established for diagnostic fecal-occult blood tests under
(B) Frequency limit
No payment may be made under this part for a colorectal cancer screening test consisting of a screening fecal-occult blood test—
(i) if the individual is under 50 years of age; or
(ii) if the test is performed within the 11 months after a previous screening fecal-occult blood test.
(2) Screening flexible sigmoidoscopies
(A) Fee schedule
With respect to colorectal cancer screening tests consisting of screening flexible sigmoidoscopies, payment under
(B) Payment limit
In the case of screening flexible sigmoidoscopy services, payment under this part shall not exceed such amount as the Secretary specifies, based upon the rates recognized for diagnostic flexible sigmoidoscopy services.
(C) Facility payment limit
(i) In general
Notwithstanding subsections (i)(2)(A) and (t) of
(I) in accordance with regulations, may be performed in an ambulatory surgical center and for which the Secretary permits ambulatory surgical center payments under this part, and
(II) are performed in an ambulatory surgical center or hospital outpatient department,
payment under this part shall be based on the lesser of the amount under the fee schedule that would apply to such services if they were performed in a hospital outpatient department in an area or the amount under the fee schedule that would apply to such services if they were performed in an ambulatory surgical center in the same area.
(ii) Limitation on coinsurance
Subject to
(I) in computing the amount of any applicable copayment, the computation of such coinsurance shall be based upon the fee schedule under which payment is made for the services, and
(II) the amount of such coinsurance is equal to 25 percent of the payment amount under the fee schedule described in subclause (I).
(D) Special rule for detected lesions
Subject to
(E) Frequency limit
No payment may be made under this part for a colorectal cancer screening test consisting of a screening flexible sigmoidoscopy—
(i) if the individual is under 50 years of age; or
(ii) if the procedure is performed within the 47 months after a previous screening flexible sigmoidoscopy or, in the case of an individual who is not at high risk for colorectal cancer, if the procedure is performed within the 119 months after a previous screening colonoscopy.
(3) Screening colonoscopy
(A) Fee schedule
With respect to colorectal cancer screening test consisting of a screening colonoscopy, payment under
(B) Payment limit
In the case of screening colonoscopy services, payment under this part shall not exceed such amount as the Secretary specifies, based upon the rates recognized for diagnostic colonoscopy services.
(C) Facility payment limit
(i) In general
Notwithstanding subsections (i)(2)(A) and (t) of
(ii) Limitation on coinsurance
Subject to
(I) in computing the amount of any applicable coinsurance, the computation of such coinsurance shall be based upon the fee schedule under which payment is made for the services, and
(II) the amount of such coinsurance is equal to 25 percent of the payment amount under the fee schedule described in subclause (I).
(D) Special rule for detected lesions
Subject to
(E) Frequency limit
No payment may be made under this part for a colorectal cancer screening test consisting of a screening colonoscopy for individuals at high risk for colorectal cancer if the procedure is performed within the 23 months after a previous screening colonoscopy or for other individuals if the procedure is performed within the 119 months after a previous screening colonoscopy or within 47 months after a previous screening flexible sigmoidoscopy.
(e) Accreditation requirement for advanced diagnostic imaging services
(1) In general
(A) In general
Beginning with January 1, 2012, with respect to the technical component of advanced diagnostic imaging services for which payment is made under the fee schedule established under
(B) Advanced diagnostic imaging services defined
In this subsection, the term "advanced diagnostic imaging services" includes—
(i) diagnostic magnetic resonance imaging, computed tomography, and nuclear medicine (including positron emission tomography); and
(ii) such other diagnostic imaging services, including services described in
(C) Supplier defined
In this subsection, the term "supplier" has the meaning given such term in
(2) Accreditation organizations
(A) Factors for designation of accreditation organizations
The Secretary shall consider the following factors in designating accreditation organizations under subparagraph (B)(i) 2 and in reviewing and modifying the list of accreditation organizations designated pursuant to subparagraph (C):
(i) The ability of the organization to conduct timely reviews of accreditation applications.
(ii) Whether the organization has established a process for the timely integration of new advanced diagnostic imaging services into the organization's accreditation program.
(iii) Whether the organization uses random site visits, site audits, or other strategies for ensuring accredited suppliers maintain adherence to the criteria described in paragraph (3).
(iv) The ability of the organization to take into account the capacities of suppliers located in a rural area (as defined in
(v) Whether the organization has established reasonable fees to be charged to suppliers applying for accreditation.
(vi) Such other factors as the Secretary determines appropriate.
(B) Designation
Not later than January 1, 2010, the Secretary shall designate organizations to accredit suppliers furnishing the technical component of advanced diagnostic imaging services. The list of accreditation organizations so designated may be modified pursuant to subparagraph (C).
(C) Review and modification of list of accreditation organizations
(i) In general
The Secretary shall review the list of accreditation organizations designated under subparagraph (B) taking into account the factors under subparagraph (A). Taking into account the results of such review, the Secretary may, by regulation, modify the list of accreditation organizations designated under subparagraph (B).
(ii) Special rule for accreditations done prior to removal from list of designated accreditation organizations
In the case where the Secretary removes an organization from the list of accreditation organizations designated under subparagraph (B), any supplier that is accredited by the organization during the period beginning on the date on which the organization is designated as an accreditation organization under subparagraph (B) and ending on the date on which the organization is removed from such list shall be considered to have been accredited by an organization designated by the Secretary under subparagraph (B) for the remaining period such accreditation is in effect.
(3) Criteria for accreditation
The Secretary shall establish procedures to ensure that the criteria used by an accreditation organization designated under paragraph (2)(B) to evaluate a supplier that furnishes the technical component of advanced diagnostic imaging services for the purpose of accreditation of such supplier is specific to each imaging modality. Such criteria shall include—
(A) standards for qualifications of medical personnel who are not physicians and who furnish the technical component of advanced diagnostic imaging services;
(B) standards for qualifications and responsibilities of medical directors and supervising physicians, including standards that recognize the considerations described in paragraph (4);
(C) procedures to ensure that equipment used in furnishing the technical component of advanced diagnostic imaging services meets performance specifications;
(D) standards that require the supplier have procedures in place to ensure the safety of persons who furnish the technical component of advanced diagnostic imaging services and individuals to whom such services are furnished;
(E) standards that require the establishment and maintenance of a quality assurance and quality control program by the supplier that is adequate and appropriate to ensure the reliability, clarity, and accuracy of the technical quality of diagnostic images produced by such supplier; and
(F) any other standards or procedures the Secretary determines appropriate.
(4) Recognition in standards for the evaluation of medical directors and supervising physicians
The standards described in paragraph (3)(B) shall recognize whether a medical director or supervising physician—
(A) in a particular specialty receives training in advanced diagnostic imaging services in a residency program;
(B) has attained, through experience, the necessary expertise to be a medical director or a supervising physician;
(C) has completed any continuing medical education courses relating to such services; or
(D) has met such other standards as the Secretary determines appropriate.
(5) Rule for accreditations made prior to designation
In the case of a supplier that is accredited before January 1, 2010, by an accreditation organization designated by the Secretary under paragraph (2)(B) as of January 1, 2010, such supplier shall be considered to have been accredited by an organization designated by the Secretary under such paragraph as of January 1, 2012, for the remaining period such accreditation is in effect.
(f) Reduction in payments for physician pathology services during 1991
(1) In general
For physician pathology services furnished under this part during 1991, the prevailing charges used in a locality under this part shall be 7 percent below the prevailing charges used in the locality under this part in 1990 after March 31.
(2) Limitation
The prevailing charge for the technical and professional components of an 3 physician pathology service furnished by a physician through an independent laboratory shall not be reduced pursuant to paragraph (1) to the extent that such reduction would reduce such prevailing charge below 115 percent of the prevailing charge for the professional component of such service when furnished by a hospital-based physician in the same locality. For purposes of the preceding sentence, an independent laboratory is a laboratory that is independent of a hospital and separate from the attending or consulting physicians' office.
(g) Payment for outpatient critical access hospital services
(1) In general
The amount of payment for outpatient critical access hospital services of a critical access hospital is equal to 101 percent of the reasonable costs of the hospital in providing such services, unless the hospital makes the election under paragraph (2).
(2) Election of cost-based hospital outpatient service payment plus fee schedule for professional services
A critical access hospital may elect to be paid for outpatient critical access hospital services amounts equal to the sum of the following, less the amount that such hospital may charge as described in
(A) Facility fee
With respect to facility services, not including any services for which payment may be made under subparagraph (B), 101 percent of the reasonable costs of the critical access hospital in providing such services.
(B) Fee schedule for professional services
With respect to professional services otherwise included within outpatient critical access hospital services, 115 percent of such amounts as would otherwise be paid under this part if such services were not included in outpatient critical access hospital services. Subsections (x) and (y) of
The Secretary may not require, as a condition for applying subparagraph (B) with respect to a critical access hospital, that each physician or other practitioner providing professional services in the hospital must assign billing rights with respect to such services, except that such subparagraph shall not apply to those physicians and practitioners who have not assigned such billing rights.
(3) Disregarding charges
The payment amounts under this subsection shall be determined without regard to the amount of the customary or other charge.
(4) Treatment of clinical diagnostic laboratory services
No coinsurance, deductible, copayment, or other cost-sharing otherwise applicable under this part shall apply with respect to clinical diagnostic laboratory services furnished as an outpatient critical access hospital service. Nothing in this subchapter shall be construed as providing for payment for clinical diagnostic laboratory services furnished as part of outpatient critical access hospital services, other than on the basis described in this subsection. For purposes of the preceding sentence and
(5) Coverage of costs for certain emergency room on-call providers
In determining the reasonable costs of outpatient critical access hospital services under paragraphs (1) and (2)(A), the Secretary shall recognize as allowable costs, amounts (as defined by the Secretary) for reasonable compensation and related costs for physicians, physician assistants, nurse practitioners, and clinical nurse specialists who are on-call (as defined by the Secretary) to provide emergency services but who are not present on the premises of the critical access hospital involved, and are not otherwise furnishing services covered under this subchapter and are not on-call at any other provider or facility.
(h) Payment for prosthetic devices and orthotics and prosthetics
(1) General rule for payment
(A) In general
Payment under this subsection for prosthetic devices and orthotics and prosthetics shall be made in a lump-sum amount for the purchase of the item in an amount equal to 80 percent of the payment basis described in subparagraph (B).
(B) Payment basis
Except as provided in subparagraphs (C), (E), and (H)(i), the payment basis described in this subparagraph is the lesser of—
(i) the actual charge for the item; or
(ii) the amount recognized under paragraph (2) as the purchase price for the item.
(C) Exception for certain public home health agencies
Subparagraph (B)(i) shall not apply to an item furnished by a public home health agency (or by another home health agency which demonstrates to the satisfaction of the Secretary that a significant portion of its patients are low income) free of charge or at nominal charges to the public.
(D) Exclusive payment rule
Subject to subparagraph (H)(ii), this subsection shall constitute the exclusive provision of this subchapter for payment for prosthetic devices, orthotics, and prosthetics under this part or under part A to a home health agency.
(E) Exception for certain items
Payment for ostomy supplies, tracheostomy supplies, and urologicals shall be made in accordance with subparagraphs (B) and (C) of subsection (a)(2).
(F) Special payment rules for certain prosthetics and custom-fabricated orthotics
(i) In general
No payment shall be made under this subsection for an item of custom-fabricated orthotics described in clause (ii) or for an item of prosthetics unless such item is—
(I) furnished by a qualified practitioner; and
(II) fabricated by a qualified practitioner or a qualified supplier at a facility that meets such criteria as the Secretary determines appropriate.
(ii) Description of custom-fabricated item
(I) In general
An item described in this clause is an item of custom-fabricated orthotics that requires education, training, and experience to custom-fabricate and that is included in a list established by the Secretary in subclause (II). Such an item does not include shoes and shoe inserts.
(II) List of items
The Secretary, in consultation with appropriate experts in orthotics (including national organizations representing manufacturers of orthotics), shall establish and update as appropriate a list of items to which this subparagraph applies. No item may be included in such list unless the item is individually fabricated for the patient over a positive model of the patient.
(iii) Qualified practitioner defined
In this subparagraph, the term "qualified practitioner" means a physician or other individual who—
(I) is a qualified physical therapist or a qualified occupational therapist;
(II) in the case of a State that provides for the licensing of orthotics and prosthetics, is licensed in orthotics or prosthetics by the State in which the item is supplied; or
(III) in the case of a State that does not provide for the licensing of orthotics and prosthetics, is specifically trained and educated to provide or manage the provision of prosthetics and custom-designed or -fabricated orthotics, and is certified by the American Board for Certification in Orthotics and Prosthetics, Inc. or by the Board for Orthotist/Prosthetist Certification, or is credentialed and approved by a program that the Secretary determines, in consultation with appropriate experts in orthotics and prosthetics, has training and education standards that are necessary to provide such prosthetics and orthotics.
(iv) Qualified supplier defined
In this subparagraph, the term "qualified supplier" means any entity that is accredited by the American Board for Certification in Orthotics and Prosthetics, Inc. or by the Board for Orthotist/Prosthetist Certification, or accredited and approved by a program that the Secretary determines has accreditation and approval standards that are essentially equivalent to those of such Board.
(G) Replacement of prosthetic devices and parts
(i) In general
Payment shall be made for the replacement of prosthetic devices which are artificial limbs, or for the replacement of any part of such devices, without regard to continuous use or useful lifetime restrictions if an ordering physician determines that the provision of a replacement device, or a replacement part of such a device, is necessary because of any of the following:
(I) A change in the physiological condition of the patient.
(II) An irreparable change in the condition of the device, or in a part of the device.
(III) The condition of the device, or the part of the device, requires repairs and the cost of such repairs would be more than 60 percent of the cost of a replacement device, or, as the case may be, of the part being replaced.
(ii) Confirmation may be required if device or part being replaced is less than 3 years old
If a physician determines that a replacement device, or a replacement part, is necessary pursuant to clause (i)—
(I) such determination shall be controlling; and
(II) such replacement device or part shall be deemed to be reasonable and necessary for purposes of
except that if the device, or part, being replaced is less than 3 years old (calculated from the date on which the beneficiary began to use the device or part), the Secretary may also require confirmation of necessity of the replacement device or replacement part, as the case may be.
(H) Application of competitive acquisition to orthotics; limitation of inherent reasonableness authority
In the case of orthotics described in paragraph (2)(C) of
(i) the payment basis under this subsection for such orthotics furnished in such area shall be the payment basis determined under such competitive acquisition program; and
(ii) subject to subsection (a)(1)(G), the Secretary may use information on the payment determined under such competitive acquisition programs to adjust the payment amount otherwise recognized under subparagraph (B)(ii) for an area that is not a competitive acquisition area under
(2) Purchase price recognized
For purposes of paragraph (1), the amount that is recognized under this paragraph as the purchase price for prosthetic devices, orthotics, and prosthetics is the amount described in subparagraph (C) of this paragraph, determined as follows:
(A) Computation of local purchase price
Each carrier under
(i) The carrier shall compute a base local purchase price for each item equal to the average reasonable charge in the locality for the purchase of the item for the 12-month period ending with June 1987.
(ii) The carrier shall compute a local purchase price, with respect to the furnishing of each particular item—
(I) in 1989 and 1990, equal to the base local purchase price computed under clause (i) increased by the percentage increase in the consumer price index for all urban consumers (United States city average) for the 6-month period ending with December 1987, or
(II) in 1991, 1992 or 1993, equal to the local purchase price computed under this clause for the previous year increased by the applicable percentage increase for the year.
(B) Computation of regional purchase price
With respect to the furnishing of a particular item in each region (as defined by the Secretary), the Secretary shall compute a regional purchase price—
(i) for 1992, equal to the average (weighted by relative volume of all claims among carriers) of the local purchase prices for the carriers in the region computed under subparagraph (A)(ii)(II) for the year, and
(ii) for each subsequent year, equal to the regional purchase price computed under this subparagraph for the previous year increased by the applicable percentage increase for the year.
(C) Purchase price recognized
For purposes of paragraph (1) and subject to subparagraph (D), the amount that is recognized under this paragraph as the purchase price for each item furnished—
(i) in 1989, 1990, or 1991, is 100 percent of the local purchase price computed under subparagraph (A)(ii);
(ii) in 1992, is the sum of (I) 75 percent of the local purchase price computed under subparagraph (A)(ii)(II) for 1992, and (II) 25 percent of the regional purchase price computed under subparagraph (B) for 1992;
(iii) in 1993, is the sum of (I) 50 percent of the local purchase price computed under subparagraph (A)(ii)(II) for 1993, and (II) 50 percent of the regional purchase price computed under subparagraph (B) for 1993; and
(iv) in 1994 or a subsequent year, is the regional purchase price computed under subparagraph (B) for that year.
(D) Range on amount recognized
The amount that is recognized under subparagraph (C) as the purchase price for an item furnished—
(i) in 1992, may not exceed 125 percent, and may not be lower than 85 percent, of the average of the purchase prices recognized under such subparagraph for all the carrier service areas in the United States in that year; and
(ii) in a subsequent year, may not exceed 120 percent, and may not be lower than 90 percent, of the average of the purchase prices recognized under such subparagraph for all the carrier service areas in the United States in that year.
(3) Applicability of certain provisions relating to durable medical equipment
Paragraphs (12), (15), and (17) and subparagraphs (A) and (B) of paragraph (10) and paragraph (11) of subsection (a) shall apply to prosthetic devices, orthotics, and prosthetics in the same manner as such provisions apply to covered items under such subsection.
(4) Definitions
In this subsection—
(A) the term "applicable percentage increase" means—
(i) for 1991, 0 percent;
(ii) for 1992 and 1993, the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12-month period ending with June of the previous year;
(iii) for 1994 and 1995, 0 percent;
(iv) for 1996 and 1997, the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12-month period ending with June of the previous year;
(v) for each of the years 1998 through 2000, 1 percent;
(vi) for 2001, the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June 2000;
(vii) for 2002, 1 percent;
(viii) for 2003, the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12-month period ending with June of the previous year;
(ix) for 2004, 2005, and 2006, 0 percent;
(x) for for 4 each of 2007 through 2010, the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12-month period ending with June of the previous year; and
(xi) for 2011 and each subsequent year—
(I) the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12-month period ending with June of the previous year, reduced by—
(II) the productivity adjustment described in
The application of subparagraph (A)(xi)(II) may result in the applicable percentage increase under subparagraph (A) being less than 0.0 for a year, and may result in payment rates under this subsection for a year being less than such payment rates for the preceding year.
(B) the term "prosthetic devices" has the meaning given such term in
(C) the term "orthotics and prosthetics" has the meaning given such term in
(5) Documentation created by orthotists and prosthetists
For purposes of determining the reasonableness and medical necessity of orthotics and prosthetics, documentation created by an orthotist or prosthetist shall be considered part of the individual's medical record to support documentation created by eligible professionals described in
(i) Payment for surgical dressings
(1) In general
Payment under this subsection for surgical dressings (described in
(A) the actual charge for the item; or
(B) a payment amount determined in accordance with the methodology described in subparagraphs (B) and (C) of subsection (a)(2) (except that in applying such methodology, the national limited payment amount referred to in such subparagraphs shall be initially computed based on local payment amounts using average reasonable charges for the 12-month period ending December 31, 1992, increased by the covered item updates described in such subsection for 1993 and 1994).
(2) Exceptions
Paragraph (1) shall not apply to surgical dressings that are—
(A) furnished as an incident to a physician's professional service; or
(B) furnished by a home health agency.
(j) Requirements for suppliers of medical equipment and supplies
(1) Issuance and renewal of supplier number
(A) Payment
Except as provided in subparagraph (C), no payment may be made under this part after October 31, 1994, for items furnished by a supplier of medical equipment and supplies unless such supplier obtains (and renews at such intervals as the Secretary may require) a supplier number.
(B) Standards for possessing a supplier number
A supplier may not obtain a supplier number unless—
(i) for medical equipment and supplies furnished on or after October 31, 1994, and before January 1, 1996, the supplier meets standards prescribed by the Secretary in regulations issued on June 18, 1992; and
(ii) for medical equipment and supplies furnished on or after January 1, 1996, the supplier meets revised standards prescribed by the Secretary (in consultation with representatives of suppliers of medical equipment and supplies, carriers, and consumers) that shall include requirements that the supplier—
(I) comply with all applicable State and Federal licensure and regulatory requirements;
(II) maintain a physical facility on an appropriate site;
(III) have proof of appropriate liability insurance; and
(IV) meet such other requirements as the Secretary may specify.
(C) Exception for items furnished as incident to a physician's service
Subparagraph (A) shall not apply with respect to medical equipment and supplies furnished incident to a physician's service.
(D) Prohibition against multiple supplier numbers
The Secretary may not issue more than one supplier number to any supplier of medical equipment and supplies unless the issuance of more than one number is appropriate to identify subsidiary or regional entities under the supplier's ownership or control.
(E) Prohibition against delegation of supplier determinations
The Secretary may not delegate (other than by contract under
(2) Certificates of medical necessity
(A) Limitation on information provided by suppliers on certificates of medical necessity
(i) In general
Effective 60 days after October 31, 1994, a supplier of medical equipment and supplies may distribute to physicians, or to individuals entitled to benefits under this part, a certificate of medical necessity for commercial purposes which contains no more than the following information completed by the supplier:
(I) An identification of the supplier and the beneficiary to whom such medical equipment and supplies are furnished.
(II) A description of such medical equipment and supplies.
(III) Any product code identifying such medical equipment and supplies.
(IV) Any other administrative information (other than information relating to the beneficiary's medical condition) identified by the Secretary.
(ii) Information on payment amount and charges
If a supplier distributes a certificate of medical necessity containing any of the information permitted to be supplied under clause (i), the supplier shall also list on the certificate of medical necessity the fee schedule amount and the supplier's charge for the medical equipment or supplies being furnished prior to distribution of such certificate to the physician.
(iii) Penalty
Any supplier of medical equipment and supplies who knowingly and willfully distributes a certificate of medical necessity in violation of clause (i) or fails to provide the information required under clause (ii) is subject to a civil money penalty in an amount not to exceed $1,000 for each such certificate of medical necessity so distributed. The provisions of
(B) "Certificate of medical necessity" defined
For purposes of this paragraph, the term "certificate of medical necessity" means a form or other document containing information required by the carrier to be submitted to show that an item is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.
(3) Coverage and review criteria
The Secretary shall annually review the coverage and utilization of items of medical equipment and supplies to determine whether such items should be made subject to coverage and utilization review criteria, and if appropriate, shall develop and apply such criteria to such items.
(4) Limitation on patient liability
If a supplier of medical equipment and supplies (as defined in paragraph (5))—
(A) furnishes an item or service to a beneficiary for which no payment may be made by reason of paragraph (1);
(B) furnishes an item or service to a beneficiary for which payment is denied in advance under subsection (a)(15); or
(C) furnishes an item or service to a beneficiary for which payment is denied under
any expenses incurred for items and services furnished to an individual by such a supplier not on an assigned basis shall be the responsibility of such supplier. The individual shall have no financial responsibility for such expenses and the supplier shall refund on a timely basis to the individual (and shall be liable to the individual for) any amounts collected from the individual for such items or services. The provisions of subsection (a)(18) shall apply to refunds required under the previous sentence in the same manner as such provisions apply to refunds under such subsection.
(5) "Medical equipment and supplies" defined
The term "medical equipment and supplies" means—
(A) durable medical equipment (as defined in
(B) prosthetic devices (as described in
(C) orthotics and prosthetics (as described in
(D) surgical dressings (as described in
(E) items and services related to the administration of intravenous immune globulin furnished on or after January 1, 2024, as described in
(F) lymphedema compression treatment items (as defined in
(G) 5 such other items as the Secretary may determine; and
(G) 5 for purposes of paragraphs (1) and (3)—
(i) home dialysis supplies and equipment (as described in
(ii) immunosuppressive drugs (as described in
(iii) therapeutic shoes for diabetics (as described in
(iv) oral drugs prescribed for use as an anticancer therapeutic agent (as described in
(v) self-administered erythropoetin (as described in
(k) Payment for outpatient therapy services and comprehensive outpatient rehabilitation services
(1) In general
With respect to services described in
(A) for services furnished during 1998, the amount determined under paragraph (2); or
(B) for services furnished during a subsequent year, 80 percent of the lesser of—
(i) the actual charge for the services, or
(ii) the applicable fee schedule amount (as defined in paragraph (3)) for the services.
(2) Payment in 1998 based upon adjusted reasonable costs
The amount under this paragraph for services is the lesser of—
(A) the charges imposed for the services, or
(B) the adjusted reasonable costs (as defined in paragraph (4)) for the services,
less 20 percent of the amount of the charges imposed for such services.
(3) Applicable fee schedule amount
In this subsection, the term "applicable fee schedule amount" means, with respect to services furnished in a year, the amount determined under the fee schedule established under
(4) Adjusted reasonable costs
In paragraph (2), the term "adjusted reasonable costs" means, with respect to any services, reasonable costs determined for such services, reduced by 10 percent. The 10-percent reduction shall not apply to services described in
(5) Uniform coding
For claims for services submitted on or after April 1, 1998, for which the amount of payment is determined under this subsection, the claim shall include a code (or codes) under a uniform coding system specified by the Secretary that identifies the services furnished.
(6) Restraint on billing
The provisions of subparagraphs (A) and (B) of
(7) Adjustment in discount for certain multiple therapy services
In the case of therapy services furnished on or after April 1, 2013, and for which payment is made under this subsection pursuant to the applicable fee schedule amount (as defined in paragraph (3)), instead of the 25 percent multiple procedure payment reduction specified in the final rule published by the Secretary in the Federal Register on November 29, 2010, the reduction percentage shall be 50 percent.
(l) Establishment of fee schedule for ambulance services
(1) In general
The Secretary shall establish a fee schedule for payment for ambulance services whether provided directly by a supplier or provider or under arrangement with a provider under this part through a negotiated rulemaking process described in title 5 and in accordance with the requirements of this subsection.
(2) Considerations
In establishing such fee schedule, the Secretary shall—
(A) establish mechanisms to control increases in expenditures for ambulance services under this part;
(B) establish definitions for ambulance services which link payments to the type of services provided;
(C) consider appropriate regional and operational differences;
(D) consider adjustments to payment rates to account for inflation and other relevant factors; and
(E) phase in the application of the payment rates under the fee schedule in an efficient and fair manner consistent with paragraph (11), except that such phase-in shall provide for full payment of any national mileage rate for ambulance services provided by suppliers that are paid by carriers in any of the 50 States where payment by a carrier for such services for all such suppliers in such State did not, prior to the implementation of the fee schedule, include a separate amount for all mileage within the county from which the beneficiary is transported.
(3) Savings
In establishing such fee schedule, the Secretary shall—
(A) ensure that the aggregate amount of payments made for ambulance services under this part during 2000 does not exceed the aggregate amount of payments which would have been made for such services under this part during such year if the amendments made by section 4531(a) of the Balanced Budget Act of 1997 continued in effect, except that in making such determination the Secretary shall assume an update in such payments for 2002 equal to percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June of the previous year reduced in the case of 2002 by 1.0 percentage points;
(B) set the payment amounts provided under the fee schedule for services furnished in 2001 and each subsequent year at amounts equal to the payment amounts under the fee schedule for services furnished during the previous year, increased, subject to subparagraph (C) and the succeeding sentence of this paragraph, by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June of the previous year reduced in the case of 2002 by 1.0 percentage points; and
(C) for 2011 and each subsequent year, after determining the percentage increase under subparagraph (B) for the year, reduce such percentage increase by the productivity adjustment described in
The application of subparagraph (C) may result in the percentage increase under subparagraph (B) being less than 0.0 for a year, and may result in payment rates under the fee schedule under this subsection for a year being less than such payment rates for the preceding year.
(4) Consultation
In establishing the fee schedule for ambulance services under this subsection, the Secretary shall consult with various national organizations representing individuals and entities who furnish and regulate ambulance services and share with such organizations relevant data in establishing such schedule.
(5) Limitation on review
There shall be no administrative or judicial review under
(6) Restraint on billing
The provisions of subparagraphs (A) and (B) of
(7) Coding system
The Secretary may require the claim for any services for which the amount of payment is determined under this subsection to include a code (or codes) under a uniform coding system specified by the Secretary that identifies the services furnished.
(8) Services furnished by critical access hospitals
Notwithstanding any other provision of this subsection, the Secretary shall pay 101 percent of the reasonable costs incurred in furnishing ambulance services if such services are furnished—
(A) by a critical access hospital (as defined in
(B) by an entity that is owned and operated by a critical access hospital,
but only if the critical access hospital or entity is the only provider or supplier of ambulance services that is located within a 35-mile drive of such critical access hospital.
(9) Transitional assistance for rural providers
In the case of ground ambulance services furnished on or after July 1, 2001, and before January 1, 2004, for which the transportation originates in a rural area (as defined in
(10) Phase-in providing floor using blend of fee schedule and regional fee schedules
In carrying out the phase-in under paragraph (2)(E) for each level of ground service furnished in a year, the portion of the payment amount that is based on the fee schedule shall be the greater of the amount determined under such fee schedule (without regard to this paragraph) or the following blended rate of the fee schedule under paragraph (1) and of a regional fee schedule for the region involved:
(A) For 2004 (for services furnished on or after July 1, 2004), the blended rate shall be based 20 percent on the fee schedule under paragraph (1) and 80 percent on the regional fee schedule.
(B) For 2005, the blended rate shall be based 40 percent on the fee schedule under paragraph (1) and 60 percent on the regional fee schedule.
(C) For 2006, the blended rate shall be based 60 percent on the fee schedule under paragraph (1) and 40 percent on the regional fee schedule.
(D) For 2007, 2008, and 2009, the blended rate shall be based 80 percent on the fee schedule under paragraph (1) and 20 percent on the regional fee schedule.
(E) For 2010 and each succeeding year, the blended rate shall be based 100 percent on the fee schedule under paragraph (1).
For purposes of this paragraph, the Secretary shall establish a regional fee schedule for each of the nine census divisions (referred to in
(11) Adjustment in payment for certain long trips
In the case of ground ambulance services furnished on or after July 1, 2004, and before January 1, 2009, regardless of where the transportation originates, the fee schedule established under this subsection shall provide that, with respect to the payment rate for mileage for a trip above 50 miles the per mile rate otherwise established shall be increased by ¼ of the payment per mile otherwise applicable to miles in excess of 50 miles in such trip.
(12) Assistance for rural providers furnishing services in low population density areas
(A) In general
In the case of ground ambulance services furnished on or after July 1, 2004, and before October 1, 2025, for which the transportation originates in a qualified rural area (identified under subparagraph (B)(iii)), the Secretary shall provide for a percent increase in the base rate of the fee schedule for a trip established under this subsection. In establishing such percent increase, the Secretary shall estimate the average cost per trip for such services (not taking into account mileage) in the lowest quartile as compared to the average cost per trip for such services (not taking into account mileage) in the highest quartile of all rural county populations.
(B) Identification of qualified rural areas
(i) Determination of population density in area
Based upon data from the United States decennial census for the year 2000, the Secretary shall determine, for each rural area, the population density for that area.
(ii) Ranking of areas
The Secretary shall rank each such area based on such population density.
(iii) Identification of qualified rural areas
The Secretary shall identify those areas (in subparagraph (A) referred to as "qualified rural areas") with the lowest population densities that represent, if each such area were weighted by the population of such area (as used in computing such population densities), an aggregate total of 25 percent of the total of the population of all such areas.
(iv) Rural area
For purposes of this paragraph, the term "rural area" has the meaning given such term in
(v) Judicial review
There shall be no administrative or judicial review under
(13) Temporary increase for ground ambulance services
(A) In general
After computing the rates with respect to ground ambulance services under the other applicable provisions of this subsection, in the case of such services furnished on or after July 1, 2004, and before January 1, 2007, and for such services furnished on or after July 1, 2008, and before October 1, 2025,,4 for which the transportation originates in—
(i) a rural area described in paragraph (9) or in a rural census tract described in such paragraph, the fee schedule established under this section shall provide that the rate for the service otherwise established, after the application of any increase under paragraphs (11) and (12), shall be increased by 2 percent (or 3 percent if such service is furnished on or after July 1, 2008, and before October 1, 2025); and
(ii) an area not described in clause (i), the fee schedule established under this subsection shall provide that the rate for the service otherwise established, after the application of any increase under paragraph (11), shall be increased by 1 percent (or 2 percent if such service is furnished on or after July 1, 2008, and before October 1, 2025).
(B) Application of increased payments after applicable period
The increased payments under subparagraph (A) shall not be taken into account in calculating payments for services furnished after the applicable period specified in such subparagraph.
(14) Providing appropriate coverage of rural air ambulance services
(A) In general
The regulations described in
(i) is reasonable and necessary based on the health condition of the individual being transported at or immediately prior to the time of the transport; and
(ii) complies with equipment and crew requirements established by the Secretary.
(B) Satisfaction of requirement of medically necessary
The requirement of subparagraph (A)(i) is deemed to be met for a rural air ambulance service if—
(i) subject to subparagraph (D), such service is requested by a physician or other qualified medical personnel (as specified by the Secretary) who certifies or reasonably determines that the individual's condition is such that the time needed to transport the individual by land or the instability of transportation by land poses a threat to the individual's survival or seriously endangers the individual's health; or
(ii) such service is furnished pursuant to a protocol that is established by a State or regional emergency medical service (EMS) agency and recognized or approved by the Secretary under which the use of an air ambulance is recommended, if such agency does not have an ownership interest in the entity furnishing such service.
(C) Rural air ambulance service defined
For purposes of this paragraph, the term "rural air ambulance service" means fixed wing and rotary wing air ambulance service in which the point of pick up of the individual occurs in a rural area (as defined in
(D) Limitation
(i) In general
Subparagraph (B)(i) shall not apply if there is a financial or employment relationship between the person requesting the rural air ambulance service and the entity furnishing the ambulance service, or an entity under common ownership with the entity furnishing the air ambulance service, or a financial relationship between an immediate family member of such requester and such an entity.
(ii) Exception
Where a hospital and the entity furnishing rural air ambulance services are under common ownership, clause (i) shall not apply to remuneration (through employment or other relationship) by the hospital of the requester or immediate family member if the remuneration is for provider-based physician services furnished in a hospital (as described in
(15) Payment adjustment for non-emergency ambulance transports for ESRD beneficiaries
The fee schedule amount otherwise applicable under the preceding provisions of this subsection shall be reduced by 10 percent for ambulance services furnished during the period beginning on October 1, 2013, and ending on September 30, 2018, and by 23 percent for such services furnished on or after October 1, 2018, consisting of non-emergency basic life support services involving transport of an individual with end-stage renal disease for renal dialysis services (as described in
(16) Prior authorization for repetitive scheduled non-emergent ambulance transports
(A) In general
Beginning January 1, 2017, if the expansion to all States of the model of prior authorization described in paragraph (2) of section 515(a) of the Medicare Access and CHIP Reauthorization Act of 2015 meets the requirements described in paragraphs (1) through (3) of
(B) Funding
The Secretary shall use funds made available under
(C) Clarification regarding budget neutrality
Nothing in this paragraph may be construed to limit or modify the application of
(17) Submission of cost and other information
(A) Development of data collection system
The Secretary shall develop a data collection system (which may include use of a cost survey) to collect cost, revenue, utilization, and other information determined appropriate by the Secretary with respect to providers of services (in this paragraph referred to as "providers") and suppliers of ground ambulance services. Such system shall be designed to collect information—
(i) needed to evaluate the extent to which reported costs relate to payment rates under this subsection;
(ii) on the utilization of capital equipment and ambulance capacity, including information consistent with the type of information described in
(iii) on different types of ground ambulance services furnished in different geographic locations, including rural areas and low population density areas described in paragraph (12).
(B) Specification of data collection system
(i) In general
The Secretary shall—
(I) not later than December 31, 2019, specify the data collection system under subparagraph (A); and
(II) identify the providers and suppliers of ground ambulance services that would be required to submit information under such data collection system, including the representative sample described in clause (ii).
(ii) Determination of representative sample
(I) In general
Not later than December 31, 2019, with respect to the data collection for the first year under such system, and for each subsequent year through 2024, the Secretary shall determine a representative sample to submit information under the data collection system.
(II) Requirements
The sample under subclause (I) shall be representative of the different types of providers and suppliers of ground ambulance services (such as those providers and suppliers that are part of an emergency service or part of a government organization) and the geographic locations in which ground ambulance services are furnished (such as urban, rural, and low population density areas).
(III) Limitation
The Secretary shall not include an individual provider or supplier of ground ambulance services in the sample under subclause (I) in 2 consecutive years, to the extent practicable.
(C) Reporting of cost information
For each year, a provider or supplier of ground ambulance services identified by the Secretary under subparagraph (B)(i)(II) as being required to submit information under the data collection system with respect to a period for the year shall submit to the Secretary information specified under the system. Such information shall be submitted in a form and manner, and at a time, specified by the Secretary for purposes of this subparagraph.
(D) Payment reduction for failure to report
(i) In general
Beginning January 1, 2022, subject to clause (ii), a 10 percent reduction to payments under this subsection shall be made for the applicable period (as defined in clause (ii)) to a provider or supplier of ground ambulance services that—
(I) is required to submit information under the data collection system with respect to a period under subparagraph (C); and
(II) does not sufficiently submit such information, as determined by the Secretary.
(ii) Applicable period defined
For purposes of clause (i), the term "applicable period" means, with respect to a provider or supplier of ground ambulance services, a year specified by the Secretary not more than 2 years after the end of the period with respect to which the Secretary has made a determination under clause (i)(II) that the provider or supplier of ground ambulance services failed to sufficiently submit information under the data collection system.
(iii) Hardship exemption
The Secretary may exempt a provider or supplier from the payment reduction under clause (i) with respect to an applicable period in the event of significant hardship, such as a natural disaster, bankruptcy, or other similar situation that the Secretary determines interfered with the ability of the provider or supplier of ground ambulance services to submit such information in a timely manner for the specified period.
(iv) Informal review
The Secretary shall establish a process under which a provider or supplier of ground ambulance services may seek an informal review of a determination that the provider or supplier is subject to the payment reduction under clause (i).
(E) Ongoing data collection
(i) Revision of data collection system
The Secretary may, as the Secretary determines appropriate and, if available, taking into consideration the report (or reports) under subparagraph (F), revise the data collection system under subparagraph (A).
(ii) Subsequent data collection
In order to continue to evaluate the extent to which reported costs relate to payment rates under this subsection and for other purposes the Secretary deems appropriate, the Secretary shall require providers and suppliers of ground ambulance services to submit information for years after 2024 as the Secretary determines appropriate, but in no case less often than once every 3 years.
(F) Ground ambulance data collection system study
(i) In general
Not later than the second June 15th following the date on which the Secretary transmits data for the first representative sample of providers and suppliers of ground ambulance services to the Medicare Payment Advisory Commission, and as determined necessary by such Commission thereafter,,4 such Commission shall assess, and submit to Congress a report on, information submitted by providers and suppliers of ground ambulance services through the data collection system under subparagraph (A), the adequacy of payments for ground ambulance services under this subsection, and geographic variations in the cost of furnishing such services.
(ii) Contents
A report under clause (i) shall contain the following:
(I) An analysis of information submitted through the data collection system.
(II) An analysis of any burden on providers and suppliers of ground ambulance services associated with the data collection system.
(III) A recommendation as to whether information should continue to be submitted through such data collection system or if such system should be revised under subparagraph (E)(i).
(IV) Other information determined appropriate by the Commission.
(G) Public availability
The Secretary shall post information on the results of the data collection under this paragraph on the Internet website of the Centers for Medicare & Medicaid Services, as determined appropriate by the Secretary.
(H) Implementation
The Secretary shall implement this paragraph through notice and comment rulemaking.
(I) Administration
(J) Limitations on review
There shall be no administrative or judicial review under
(K) Funding for implementation
For purposes of carrying out subparagraph (A), the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under
(m) Payment for telehealth services
(1) In general
Subject to paragraphs (8) and (9), the Secretary shall pay for telehealth services that are furnished via a telecommunications system by a physician (as defined in
(2) Payment amount
(A) Distant site
Subject to paragraph (8), the Secretary shall pay to a physician or practitioner located at a distant site that furnishes a telehealth service to an eligible telehealth individual an amount equal to the amount that such physician or practitioner would have been paid under this subchapter had such service been furnished without the use of a telecommunications system.
(B) Facility fee for originating site
(i) In general
Subject to clauses (ii) and (iii) and paragraph (6)(C), with respect to a telehealth service, subject to
(I) for the period beginning on October 1, 2001, and ending on December 31, 2001, and for 2002, $20; and
(II) for a subsequent year, the facility fee specified in subclause (I) or this subclause for the preceding year increased by the percentage increase in the MEI (as defined in
(ii) No facility fee if originating site is the home
No facility fee shall be paid under this subparagraph to an originating site described in paragraph (4)(C)(ii)(X).
(iii) No facility fee for new sites
In the case that the emergency period described in
(C) Telepresenter not required
Nothing in this subsection shall be construed as requiring an eligible telehealth individual to be presented by a physician or practitioner at the originating site for the furnishing of a service via a telecommunications system, unless it is medically necessary (as determined by the physician or practitioner at the distant site).
(3) Limitation on beneficiary charges
(A) Physician and practitioner
The provisions of
(B) Originating site
The provisions of
(4) Definitions
For purposes of this subsection:
(A) Distant site
Subject to paragraph (8), the term "distant site" means the site at which the physician or practitioner is located at the time the service is provided via a telecommunications system.
(B) Eligible telehealth individual
The term "eligible telehealth individual" means an individual enrolled under this part who receives a telehealth service furnished at an originating site.
(C) Originating site
(i) In general
Except as provided in clause (iii) and paragraphs (5), (6), and (7), the term "originating site" means only those sites described in clause (ii) at which the eligible telehealth individual is located at the time the service is furnished via a telecommunications system and only if such site is located—
(I) in an area that is designated as a rural health professional shortage area under
(II) in a county that is not included in a Metropolitan Statistical Area; or
(III) from an entity that participates in a Federal telemedicine demonstration project that has been approved by (or receives funding from) the Secretary of Health and Human Services as of December 31, 2000.
(ii) Sites described
The sites referred to in clause (i) are the following sites:
(I) The office of a physician or practitioner.
(II) A critical access hospital (as defined in
(III) A rural health clinic (as defined in
(IV) A Federally qualified health center (as defined in
(V) A hospital (as defined in
(VI) A hospital-based or critical access hospital-based renal dialysis center (including satellites).
(VII) A skilled nursing facility (as defined in
(VIII) A community mental health center (as defined in
(IX) A renal dialysis facility, but only for purposes of
(X) The home of an individual, but only for purposes of
(XI) A rural emergency hospital (as defined in
(iii) Expanding access to telehealth services
In the case that the emergency period described in
(D) Physician
The term "physician" has the meaning given that term in
(E) Practitioner
The term "practitioner" has the meaning given that term in
(F) Telehealth service
(i) In general
Subject to paragraph (8), the term "telehealth service" means professional consultations, office visits, and office psychiatry services (identified as of July 1, 2000, by HCPCS codes 99241–99275, 99201–99215, 90804–90809, and 90862 (and as subsequently modified by the Secretary)), and any additional service specified by the Secretary.
(ii) Yearly update
The Secretary shall establish a process that provides, on an annual basis, for the addition or deletion of services (and HCPCS codes), as appropriate, to those specified in clause (i) for authorized payment under paragraph (1).
(5) Treatment of home dialysis monthly ESRD-related visit
The geographic requirements described in paragraph (4)(C)(i) shall not apply with respect to telehealth services furnished on or after January 1, 2019, for purposes of
(6) Treatment of stroke telehealth services
(A) Non-application of originating site requirements
The requirements described in paragraph (4)(C) shall not apply with respect to telehealth services furnished on or after January 1, 2019, for purposes of diagnosis, evaluation, or treatment of symptoms of an acute stroke, as determined by the Secretary.
(B) Inclusion of certain sites
With respect to telehealth services described in subparagraph (A), the term "originating site" shall include any hospital (as defined in
(C) No originating site facility fee for new sites
No facility fee shall be paid under paragraph (2)(B) to an originating site with respect to a telehealth service described in subparagraph (A) if the originating site does not otherwise meet the requirements for an originating site under paragraph (4)(C).
(7) Treatment of substance use disorder services and mental health services furnished through telehealth
(A) In general
The geographic requirements described in paragraph (4)(C)(i) shall not apply with respect to telehealth services furnished on or after July 1, 2019, to an eligible telehealth individual with a substance use disorder diagnosis for purposes of treatment of such disorder or co-occurring mental health disorder, as determined by the Secretary, or, on or after the first day after the end of the emergency period described in
(B) Requirements for mental health services furnished through telehealth
(i) In general
Payment may not be made under this paragraph for telehealth services furnished on or after October 1, 2025, by a physician or practitioner to an eligible telehealth individual for purposes of diagnosis, evaluation, or treatment of a mental health disorder unless such physician or practitioner furnishes an item or service in person, without the use of telehealth, for which payment is made under this subchapter (or would have been made under this subchapter if such individual were entitled to, or enrolled for, benefits under this subchapter at the time such item or service is furnished)—
(I) within the 6-month period prior to the first time such physician or practitioner furnishes such a telehealth service to the eligible telehealth individual; and
(II) during subsequent periods in which such physician or practitioner furnishes such telehealth services to the eligible telehealth individual, at such times as the Secretary determines appropriate.
(ii) Clarification
This subparagraph shall not apply if payment would otherwise be allowed—
(I) under this paragraph (with respect to telehealth services furnished to an eligible telehealth individual with a substance use disorder diagnosis for purposes of treatment of such disorder or co-occurring mental health disorder); or
(II) under this subsection without application of this paragraph.
(8) Enhancing telehealth services for Federally qualified health centers and rural health clinics
(A) In general
During the emergency period described in
(i) the Secretary shall pay for telehealth services that are furnished via a telecommunications system by a Federally qualified health center or a rural health clinic to an eligible telehealth individual enrolled under this part notwithstanding that the Federally qualified health center or rural clinic providing the telehealth service is not at the same location as the beneficiary;
(ii) the amount of payment to a Federally qualified health center or rural health clinic that serves as a distant site for such a telehealth service shall be determined under subparagraph (B); and
(iii) for purposes of this subsection—
(I) the term "distant site" includes a Federally qualified health center or rural health clinic that furnishes a telehealth service to an eligible telehealth individual; and
(II) the term "telehealth services" includes a rural health clinic service or Federally qualified health center service that is furnished using telehealth to the extent that payment codes corresponding to services identified by the Secretary under clause (i) or (ii) of paragraph (4)(F) are listed on the corresponding claim for such rural health clinic service or Federally qualified health center service.
(B) Special payment rule
(i) In general
The Secretary shall develop and implement payment methods that apply under this subsection to a Federally qualified health center or rural health clinic that serves as a distant site that furnishes a telehealth service to an eligible telehealth individual during the periods for which subparagraph (A) applies. Such payment methods shall be based on payment rates that are similar to the national average payment rates for comparable telehealth services under the physician fee schedule under
(ii) Exclusion from FQHC PPS calculation and RHC air calculation
Costs associated with telehealth services shall not be used to determine the amount of payment for Federally qualified health center services under the prospective payment system under subsection (o) or for rural health clinic services under the methodology for all-inclusive rates (established by the Secretary) under
(9) Treatment of telehealth services furnished using audio-only telecommunications technology
In the case that the emergency period described in
(n) Authority to modify or eliminate coverage of certain preventive services
Notwithstanding any other provision of this subchapter, effective beginning on January 1, 2010, if the Secretary determines appropriate, the Secretary may—
(1) modify—
(A) the coverage of any preventive service described in subparagraph (A) of
(B) the services included in the initial preventive physical examination described in subparagraph (B) of such section; and
(2) provide that no payment shall be made under this subchapter for a preventive service described in subparagraph (A) of such section that has not received a grade of A, B, C, or I by such Task Force.
(o) Development and implementation of prospective payment system
(1) Development
(A) In general
The Secretary shall develop a prospective payment system for payment for Federally qualified health center services furnished by Federally qualified health centers under this subchapter. Such system shall include a process for appropriately describing the services furnished by Federally qualified health centers and shall establish payment rates for specific payment codes based on such appropriate descriptions of services. Such system shall be established to take into account the type, intensity, and duration of services furnished by Federally qualified health centers. Such system may include adjustments, including geographic adjustments, determined appropriate by the Secretary.
(B) Collection of data and evaluation
By not later than January 1, 2011, the Secretary shall require Federally qualified health centers to submit to the Secretary such information as the Secretary may require in order to develop and implement the prospective payment system under this subsection, including the reporting of services using HCPCS codes.
(2) Implementation
(A) In general
Notwithstanding
(B) Payments
(i) Initial payments
The Secretary shall implement such prospective payment system so that the estimated aggregate amount of prospective payment rates (determined prior to the application of
(ii) Payments in subsequent years
Payment rates in years after the year of implementation of such system shall be the payment rates in the previous year increased—
(I) in the first year after implementation of such system, by the percentage increase in the MEI (as defined in
(II) in subsequent years, by the percentage increase in a market basket of Federally qualified health center goods and services as promulgated through regulations, or if such an index is not available, by the percentage increase in the MEI (as defined in
(C) Preparation for PPS implementation
Notwithstanding any other provision of law, the Secretary may establish and implement by program instruction or otherwise the payment codes to be used under the prospective payment system under this section.
(3) Additional payments for certain FQHCS with physicians or other practitioners receiving data 2000 waivers
(A) In general
In the case of a Federally qualified health center with respect to which, beginning on or after January 1, 2019, Federally qualified health center services (as defined in
(B) Application
In order to receive a payment described in subparagraph (A), a Federally qualified health center shall submit to the Secretary an application for such a payment at such time, in such manner, and containing such information as specified by the Secretary. A Federally qualified health center may apply for such a payment for each physician or practitioner described in subparagraph (A) furnishing services described in such subparagraph at such center.
(C) Requirements
For purposes of subparagraph (A), the requirements described in this subparagraph, with respect to a physician or practitioner, are the following:
(i) The physician or practitioner is employed by or working under contract with a Federally qualified health center described in subparagraph (A) that submits an application under subparagraph (B).
(ii) The physician or practitioner first begins prescribing narcotic drugs in schedule III, IV, or V of
(D) Funding
For purposes of making payments under this paragraph, there are appropriated, out of amounts in the Treasury not otherwise appropriated, $6,000,000, which shall remain available until expended.
(4) Payment for certain services furnished by federally qualified health centers
(A) Attending physician services for hospice patients
In the case of services described in
(B) Mental health visits furnished via telecommunications technology
In the case of mental health visits furnished via interactive, real-time, audio and video telecommunications technology or audio-only interactions, the in-person mental health visit requirements established under section 405.2463(b)(3) of title 42 of the Code of Federal Regulations (or a successor regulation) shall not apply prior to October 1, 2025.
(5) Special payment rule for intensive outpatient services
(A) In general
In the case of intensive outpatient services furnished by a Federally qualified health center, the payment amount for such services shall be equal to the amount that would have been paid under this subchapter for such services had such services been covered OPD services furnished by a hospital.
(B) Exclusion
Costs associated with intensive outpatient services shall not be used to determine the amount of payment for Federally qualified health center services under the prospective payment system under this subsection.
(p) Quality incentives to promote patient safety and public health in computed tomography
(1) Quality incentives
In the case of an applicable computed tomography service (as defined in paragraph (2)) for which payment is made under an applicable payment system (as defined in paragraph (3)) and that is furnished on or after January 1, 2016, using equipment that is not consistent with the CT equipment standard (described in paragraph (4)), the payment amount for such service shall be reduced by the applicable percentage (as defined in paragraph (5)).
(2) Applicable computed tomography services defined
In this subsection, the term "applicable computed tomography service" means a service billed using diagnostic radiological imaging codes for computed tomography (identified as of January 1, 2014, by HCPCS codes 70450–70498, 71250–71275, 72125–72133, 72191–72194, 73200–73206, 73700–73706, 74150–74178, 74261–74263, and 75571–75574 (and any succeeding codes).6
(3) Applicable payment system defined
In this subsection, the term "applicable payment system" means the following:
(A) The technical component and the technical component of the global fee under the fee schedule established under
(B) The prospective payment system for hospital outpatient department services under
(4) Consistency with CT equipment standard
In this subsection, the term "not consistent with the CT equipment standard" means, with respect to an applicable computed tomography service, that the service was furnished using equipment that does not meet each of the attributes of the National Electrical Manufacturers Association (NEMA) Standard XR–29–2013, entitled "Standard Attributes on CT Equipment Related to Dose Optimization and Management". Through rulemaking, the Secretary may apply successor standards.
(5) Applicable percentage defined
In this subsection, the term "applicable percentage" means—
(A) for 2016, 5 percent; and
(B) for 2017 and subsequent years, 15 percent.
(6) Implementation
(A) Information
The Secretary shall require that information be provided and attested to by a supplier and a hospital outpatient department that indicates whether an applicable computed tomography service was furnished that was not consistent with the CT equipment standard (described in paragraph (4)). Such information may be included on a claim and may be a modifier. Such information shall be verified, as appropriate, as part of the periodic accreditation of suppliers under subsection (e) and hospitals under
(B) Administration
(q) Recognizing appropriate use criteria for certain imaging services
(1) Program established
(A) In general
The Secretary shall establish a program to promote the use of appropriate use criteria (as defined in subparagraph (B)) for applicable imaging services (as defined in subparagraph (C)) furnished in an applicable setting (as defined in subparagraph (D)) by ordering professionals and furnishing professionals (as defined in subparagraphs (E) and (F), respectively).
(B) Appropriate use criteria defined
In this subsection, the term "appropriate use criteria" means criteria, only developed or endorsed by national professional medical specialty societies or other provider-led entities, to assist ordering professionals and furnishing professionals in making the most appropriate treatment decision for a specific clinical condition for an individual. To the extent feasible, such criteria shall be evidence-based.
(C) Applicable imaging service defined
In this subsection, the term "applicable imaging service" means an advanced diagnostic imaging service (as defined in subsection (e)(1)(B)) for which the Secretary determines—
(i) one or more applicable appropriate use criteria specified under paragraph (2) apply;
(ii) there are one or more qualified clinical decision support mechanisms listed under paragraph (3)(C); and
(iii) one or more of such mechanisms is available free of charge.
(D) Applicable setting defined
In this subsection, the term "applicable setting" means a physician's office, a hospital outpatient department (including an emergency department), an ambulatory surgical center, and any other provider-led outpatient setting determined appropriate by the Secretary.
(E) Ordering professional defined
In this subsection, the term "ordering professional" means a physician (as defined in
(F) Furnishing professional defined
In this subsection, the term "furnishing professional" means a physician (as defined in
(2) Establishment of applicable appropriate use criteria
(A) In general
Not later than November 15, 2015, the Secretary shall through rulemaking, and in consultation with physicians, practitioners, and other stakeholders, specify applicable appropriate use criteria for applicable imaging services only from among appropriate use criteria developed or endorsed by national professional medical specialty societies or other provider-led entities.
(B) Considerations
In specifying applicable appropriate use criteria under subparagraph (A), the Secretary shall take into account whether the criteria—
(i) have stakeholder consensus;
(ii) are scientifically valid and evidence based; and
(iii) are based on studies that are published and reviewable by stakeholders.
(C) Revisions
The Secretary shall review, on an annual basis, the specified applicable appropriate use criteria to determine if there is a need to update or revise (as appropriate) such specification of applicable appropriate use criteria and make such updates or revisions through rulemaking.
(D) Treatment of multiple applicable appropriate use criteria
In the case where the Secretary determines that more than one appropriate use criterion applies with respect to an applicable imaging service, the Secretary shall apply one or more applicable appropriate use criteria under this paragraph for the service.
(3) Mechanisms for consultation with applicable appropriate use criteria
(A) Identification of mechanisms to consult with applicable appropriate use criteria
(i) In general
The Secretary shall specify qualified clinical decision support mechanisms that could be used by ordering professionals to consult with applicable appropriate use criteria for applicable imaging services.
(ii) Consultation
The Secretary shall consult with physicians, practitioners, health care technology experts, and other stakeholders in specifying mechanisms under this paragraph.
(iii) Inclusion of certain mechanisms
Mechanisms specified under this paragraph may include any or all of the following that meet the requirements described in subparagraph (B)(ii):
(I) Use of clinical decision support modules in certified EHR technology (as defined in
(II) Use of private sector clinical decision support mechanisms that are independent from certified EHR technology, which may include use of clinical decision support mechanisms available from medical specialty organizations.
(III) Use of a clinical decision support mechanism established by the Secretary.
(B) Qualified clinical decision support mechanisms
(i) In general
For purposes of this subsection, a qualified clinical decision support mechanism is a mechanism that the Secretary determines meets the requirements described in clause (ii).
(ii) Requirements
The requirements described in this clause are the following:
(I) The mechanism makes available to the ordering professional applicable appropriate use criteria specified under paragraph (2) and the supporting documentation for the applicable imaging service ordered.
(II) In the case where there is more than one applicable appropriate use criterion specified under such paragraph for an applicable imaging service, the mechanism indicates the criteria that it uses for the service.
(III) The mechanism determines the extent to which an applicable imaging service ordered is consistent with the applicable appropriate use criteria so specified.
(IV) The mechanism generates and provides to the ordering professional a certification or documentation that documents that the qualified clinical decision support mechanism was consulted by the ordering professional.
(V) The mechanism is updated on a timely basis to reflect revisions to the specification of applicable appropriate use criteria under such paragraph.
(VI) The mechanism meets privacy and security standards under applicable provisions of law.
(VII) The mechanism performs such other functions as specified by the Secretary, which may include a requirement to provide aggregate feedback to the ordering professional.
(C) List of mechanisms for consultation with applicable appropriate use criteria
(i) Initial list
Not later than April 1, 2016, the Secretary shall publish a list of mechanisms specified under this paragraph.
(ii) Periodic updating of list
The Secretary shall identify on an annual basis the list of qualified clinical decision support mechanisms specified under this paragraph.
(4) Consultation with applicable appropriate use criteria
(A) Consultation by ordering professional
Beginning with January 1, 2017, subject to subparagraph (C), with respect to an applicable imaging service ordered by an ordering professional that would be furnished in an applicable setting and paid for under an applicable payment system (as defined in subparagraph (D)), an ordering professional shall—
(i) consult with a qualified decision support mechanism listed under paragraph (3)(C); and
(ii) provide to the furnishing professional the information described in clauses (i) through (iii) of subparagraph (B).
(B) Reporting by furnishing professional
Beginning with January 1, 2017, subject to subparagraph (C), with respect to an applicable imaging service furnished in an applicable setting and paid for under an applicable payment system (as defined in subparagraph (D)), payment for such service may only be made if the claim for the service includes the following:
(i) Information about which qualified clinical decision support mechanism was consulted by the ordering professional for the service.
(ii) Information regarding—
(I) whether the service ordered would adhere to the applicable appropriate use criteria specified under paragraph (2);
(II) whether the service ordered would not adhere to such criteria; or
(III) whether such criteria was not applicable to the service ordered.
(iii) The national provider identifier of the ordering professional (if different from the furnishing professional).
(C) Exceptions
The provisions of subparagraphs (A) and (B) and paragraph (6)(A) shall not apply to the following:
(i) Emergency services
An applicable imaging service ordered for an individual with an emergency medical condition (as defined in
(ii) Inpatient services
An applicable imaging service ordered for an inpatient and for which payment is made under part A.
(iii) Significant hardship
An applicable imaging service ordered by an ordering professional who the Secretary may, on a case-by-case basis, exempt from the application of such provisions if the Secretary determines, subject to annual renewal, that consultation with applicable appropriate use criteria would result in a significant hardship, such as in the case of a professional who practices in a rural area without sufficient Internet access.
(D) Applicable payment system defined
In this subsection, the term "applicable payment system" means the following:
(i) The physician fee schedule established under
(ii) The prospective payment system for hospital outpatient department services under
(iii) The ambulatory surgical center payment systems under
(5) Identification of outlier ordering professionals
(A) In general
With respect to applicable imaging services furnished beginning with 2017, the Secretary shall determine, on an annual basis, no more than five percent of the total number of ordering professionals who are outlier ordering professionals.
(B) Outlier ordering professionals
The determination of an outlier ordering professional shall—
(i) be based on low adherence to applicable appropriate use criteria specified under paragraph (2), which may be based on comparison to other ordering professionals; and
(ii) include data for ordering professionals for whom prior authorization under paragraph (6)(A) applies.
(C) Use of two years of data
The Secretary shall use two years of data to identify outlier ordering professionals under this paragraph.
(D) Process
The Secretary shall establish a process for determining when an outlier ordering professional is no longer an outlier ordering professional.
(E) Consultation with stakeholders
The Secretary shall consult with physicians, practitioners and other stakeholders in developing methods to identify outlier ordering professionals under this paragraph.
(6) Prior authorization for ordering professionals who are outliers
(A) In general
Beginning January 1, 2020, subject to paragraph (4)(C), with respect to services furnished during a year, the Secretary shall, for a period determined appropriate by the Secretary, apply prior authorization for applicable imaging services that are ordered by an outlier ordering professional identified under paragraph (5).
(B) Appropriate use criteria in prior authorization
In applying prior authorization under subparagraph (A), the Secretary shall utilize only the applicable appropriate use criteria specified under this subsection.
(C) Funding
For purposes of carrying out this paragraph, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under
(7) Construction
Nothing in this subsection shall be construed as granting the Secretary the authority to develop or initiate the development of clinical practice guidelines or appropriate use criteria.
(r) Payment for renal dialysis services for individuals with acute kidney injury
(1) Payment rate
In the case of renal dialysis services (as defined in subparagraph (B) of
(2) Individual with acute kidney injury defined
In this subsection, the term "individual with acute kidney injury" means an individual who has acute loss of renal function and does not receive renal dialysis services for which payment is made under
(s) Payment for applicable disposable devices
(1) Separate payment
The Secretary shall make a payment (separate from the payments otherwise made under
(2) Applicable disposable device
In this subsection, the term applicable disposable device means a disposable device that, as determined by the Secretary, is—
(A) a disposable negative pressure wound therapy device that is an integrated system comprised of a non-manual vacuum pump, a receptacle for collecting exudate, and dressings for the purposes of wound therapy; and
(B) a substitute for, and used in lieu of, a negative pressure wound therapy durable medical equipment item that is an integrated system of a negative pressure vacuum pump, a separate exudate collection canister, and dressings that would otherwise be covered for individuals for such wound therapy.
(3) Payment
(A) In general
The separate payment amount established under this paragraph for an applicable disposable device for a year shall be equal to—
(i) for a year before 2024, the amount of the payment that would be made under
(ii) for 2024, the supply price used to determine the relative value for the service under the fee schedule under
(iii) for 2025 and each subsequent year, the payment amount established under this paragraph for such device for the previous year, updated by the specified adjustment described in subparagraph (B) for such year.
(B) Specified adjustment
(i) In general
For purposes of subparagraph (A), the specified adjustment described in this subparagraph for a year is equal to—
(I) the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12-month period ending in June of the previous year; minus
(II) the productivity adjustment described in
(ii) Clarification on application of the productivity adjustment
The application of clause (i)(II) may result in a specified adjustment of less than 0.0 for a year, and may result in the separate payment amount under this subsection for an applicable device for a year being less than such separate payment amount for such device for the preceding year.
(C) Exclusion of nursing and therapy services from separate payment
With respect to applicable devices furnished on or after January 1, 2024, the separate payment amount determined under this paragraph shall not include payment for nursing or therapy services described in
(4) Implementation
As part of submitting claims for the separate payment established under this subsection, beginning with 2024, the Secretary shall accept and process claims submitted using the type of bill that is most commonly used by home health agencies to bill services under a home health plan of care.
(t) Site-of-service price transparency
(1) In general
In order to facilitate price transparency with respect to items and services for which payment may be made either to a hospital outpatient department or to an ambulatory surgical center under this subchapter, the Secretary shall, for 2018 and each year thereafter, make available to the public via a searchable Internet website, with respect to an appropriate number of such items and services—
(A) the estimated payment amount for the item or service under the outpatient department fee schedule under subsection (t) of
(B) the estimated amount of beneficiary liability applicable to the item or service.
(2) Calculation of estimated beneficiary liability
For purposes of paragraph (1)(B), the estimated amount of beneficiary liability, with respect to an item or service, is the amount for such item or service for which an individual who does not have coverage under a Medicare supplemental policy certified under
(3) Implementation
In carrying out this subsection, the Secretary—
(A) shall include in the notice described in
(B) may utilize mechanisms in existence on December 13, 2016, such as the portion of the Internet website of the Centers for Medicare & Medicaid Services on which information comparing physician performance is posted (commonly referred to as the Physician Compare Internet website), to make available such estimated amounts under such paragraph.
(4) Funding
For purposes of implementing this subsection, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under
(u) Payment and related requirements for home infusion therapy
(1) Payment
(A) Single payment
(i) In general
Subject to clause (iii) and subparagraphs (B) and (C), the Secretary shall implement a payment system under which a single payment is made under this subchapter to a qualified home infusion therapy supplier for items and services described in subparagraphs (A) and (B) of section 1395x(iii)(2)) 7 of this title furnished by a qualified home infusion therapy supplier (as defined in
(ii) Unit of single payment
A unit of single payment under the payment system implemented under this subparagraph is for each infusion drug administration calendar day in the individual's home. The Secretary shall, as appropriate, establish single payment amounts for types of infusion therapy, including to take into account variation in utilization of nursing services by therapy type.
(iii) Limitation
The single payment amount determined under this subparagraph after application of subparagraph (B) and paragraph (3) shall not exceed the amount determined under the fee schedule under
(B) Required adjustments
The Secretary shall adjust the single payment amount determined under subparagraph (A) for home infusion therapy services under
(i) a geographic wage index and other costs that may vary by region; and
(ii) patient acuity and complexity of drug administration.
(C) Discretionary adjustments
(i) In general
Subject to clause (ii), the Secretary may adjust the single payment amount determined under subparagraph (A) (after application of subparagraph (B)) to reflect outlier situations and other factors as the Secretary determines appropriate.
(ii) Requirement of budget neutrality
Any adjustment under this subparagraph shall be made in a budget neutral manner.
(2) Considerations
In developing the payment system under this subsection, the Secretary may consider the costs of furnishing infusion therapy in the home, consult with home infusion therapy suppliers, consider payment amounts for similar items and services under this part and part A, and consider payment amounts established by Medicare Advantage plans under part C and in the private insurance market for home infusion therapy (including average per treatment day payment amounts by type of home infusion therapy).
(3) Annual updates
(A) In general
Subject to subparagraph (B), the Secretary shall update the single payment amount under this subsection from year to year beginning in 2022 by increasing the single payment amount from the prior year by the percentage increase in the Consumer Price Index for all urban consumers (United States city average) for the 12-month period ending with June of the preceding year.
(B) Adjustment
For each year, the Secretary shall reduce the percentage increase described in subparagraph (A) by the productivity adjustment described in
(4) Authority to apply prior authorization
The Secretary may, as determined appropriate by the Secretary, apply prior authorization for home infusion therapy services under
(5) Accreditation of qualified home infusion therapy suppliers
(A) Factors for designation of accreditation organizations
The Secretary shall consider the following factors in designating accreditation organizations under subparagraph (B) and in reviewing and modifying the list of accreditation organizations designated pursuant to subparagraph (C):
(i) The ability of the organization to conduct timely reviews of accreditation applications.
(ii) The ability of the organization to take into account the capacities of suppliers located in a rural area (as defined in
(iii) Whether the organization has established reasonable fees to be charged to suppliers applying for accreditation.
(iv) Such other factors as the Secretary determines appropriate.
(B) Designation
Not later than January 1, 2021, the Secretary shall designate organizations to accredit suppliers furnishing home infusion therapy. The list of accreditation organizations so designated may be modified pursuant to subparagraph (C).
(C) Review and modification of list of accreditation organizations
(i) In general
The Secretary shall review the list of accreditation organizations designated under subparagraph (B) taking into account the factors under subparagraph (A). Taking into account the results of such review, the Secretary may, by regulation, modify the list of accreditation organizations designated under subparagraph (B).
(ii) Special rule for accreditations done prior to removal from list of designated accreditation organizations
In the case where the Secretary removes an organization from the list of accreditation organizations designated under subparagraph (B), any supplier that is accredited by the organization during the period beginning on the date on which the organization is designated as an accreditation organization under subparagraph (B) and ending on the date on which the organization is removed from such list shall be considered to have been accredited by an organization designated by the Secretary under subparagraph (B) for the remaining period such accreditation is in effect.
(D) Rule for accreditations made prior to designation
In the case of a supplier that is accredited before January 1, 2021, by an accreditation organization designated by the Secretary under subparagraph (B) as of January 1, 2019, such supplier shall be considered to have been accredited by an organization designated by the Secretary under such paragraph as of January 1, 2023, for the remaining period such accreditation is in effect.
(6) Notification of infusion therapy options available prior to furnishing home infusion therapy
Prior to the furnishing of home infusion therapy to an individual, the physician who establishes the plan described in
(7) Home infusion therapy services temporary transitional payment
(A) Temporary transitional payment
(i) In general
The Secretary shall, in accordance with the payment methodology described in subparagraph (B) and subject to the provisions of this paragraph, provide a home infusion therapy services temporary transitional payment under this part to an eligible home infusion supplier (as defined in subparagraph (F)) for items and services described in subparagraphs (A) and (B) of section 1395x(iii)(2)) 7 of this title furnished during the period specified in clause (ii) by such supplier in coordination with the furnishing of transitional home infusion drugs (as defined in clause (iii)).
(ii) Period specified
For purposes of clause (i), the period specified in this clause is the period beginning on January 1, 2019, and ending on the day before the date of the implementation of the payment system under paragraph (1)(A).
(iii) Transitional home infusion drug defined
For purposes of this paragraph, the term "transitional home infusion drug" has the meaning given to the term "home infusion drug" under section 1395x(iii)(3)(C)) 7 of this title, except that clause (ii) of such section shall not apply if a drug described in such clause is identified in clauses (i), (ii), (iii) or (iv) of subparagraph (C) as of February 9, 2018.
(B) Payment methodology
For purposes of this paragraph, the Secretary shall establish a payment methodology, with respect to items and services described in subparagraph (A)(i). Under such payment methodology the Secretary shall—
(i) create the three payment categories described in clauses (i), (ii), and (iii) of subparagraph (C);
(ii) assign drugs to such categories, in accordance with such clauses;
(iii) assign appropriate Healthcare Common Procedure Coding System (HCPCS) codes to each payment category; and
(iv) establish a single payment amount for each such payment category, in accordance with subparagraph (D), for each infusion drug administration calendar day in the individual's home for drugs assigned to such category.
(C) Payment categories
(i) Payment category 1
The Secretary shall create a payment category 1 and assign to such category drugs which are covered under the Local Coverage Determination on External Infusion Pumps (LCD number L33794) and billed with the following HCPCS codes (as identified as of January 1, 2018, and as subsequently modified by the Secretary): J0133, J0285, J0287, J0288, J0289, J0895, J1170, J1250, J1265, J1325, J1455, J1457, J1570, J2175, J2260, J2270, J2274, J2278, J3010, or J3285.
(ii) Payment category 2
The Secretary shall create a payment category 2 and assign to such category drugs which are covered under such local coverage determination and billed with the following HCPCS codes (as identified as of January 1, 2018, and as subsequently modified by the Secretary): J1555 JB, J1559 JB, J1561 JB, J1562 JB, J1569 JB, or J1575 JB.
(iii) Payment category 3
The Secretary shall create a payment category 3 and assign to such category drugs which are covered under such local coverage determination and billed with the following HCPCS codes (as identified as of January 1, 2018, and as subsequently modified by the Secretary): J9000, J9039, J9040, J9065, J9100, J9190, J9200, J9360, or J9370.
(iv) Infusion drugs not otherwise included
With respect to drugs that are not included in payment category 1, 2, or 3 under clause (i), (ii), or (iii), respectively, the Secretary shall assign to the most appropriate of such categories, as determined by the Secretary, drugs which are—
(I) covered under such local coverage determination and billed under HCPCS codes J7799 or J7999 (as identified as of July 1, 2017, and as subsequently modified by the Secretary); or
(II) billed under any code that is implemented after February 9, 2018, and included in such local coverage determination or included in subregulatory guidance as a home infusion drug described in subparagraph (A)(i).
(D) Payment amounts
(i) In general
Under the payment methodology, the Secretary shall pay eligible home infusion suppliers, with respect to items and services described in subparagraph (A)(i) furnished during the period described in subparagraph (A)(ii) by such supplier to an individual, at amounts equal to the amounts determined under the physician fee schedule established under
(ii) Payment amount for category 1
For purposes of clause (i), the codes and units described in this clause, with respect to drugs included in payment category 1 described in subparagraph (C)(i), are one unit of HCPCS code 96365 plus three units of HCPCS code 96366 (as identified as of January 1, 2018, and as subsequently modified by the Secretary).
(iii) Payment amount for category 2
For purposes of clause (i), the codes and units described in this clause, with respect to drugs included in payment category 2 described in subparagraph (C)(i), are one unit of HCPCS code 96369 plus three units of HCPCS code 96370 (as identified as of January 1, 2018, and as subsequently modified by the Secretary).
(iv) Payment amount for category 3
For purposes of clause (i), the codes and units described in this clause, with respect to drugs included in payment category 3 described in subparagraph (C)(i), are one unit of HCPCS code 96413 plus three units of HCPCS code 96415 (as identified as of January 1, 2018, and as subsequently modified by the Secretary).
(E) Clarifications
(i) Infusion drug administration day
For purposes of this subsection, with respect to the furnishing of transitional home infusion drugs or home infusion drugs to an individual by an eligible home infusion supplier or a qualified home infusion therapy supplier, a reference to payment to such supplier for an infusion drug administration calendar day in the individual's home shall refer to payment only for the date on which professional services (as described in
(ii) Treatment of multiple drugs administered on same infusion drug administration day
In the case that an eligible home infusion supplier, with respect to an infusion drug administration calendar day in an individual's home, furnishes to such individual transitional home infusion drugs which are not all assigned to the same payment category under subparagraph (C), payment to such supplier for such infusion drug administration calendar day in the individual's home shall be a single payment equal to the amount of payment under this paragraph for the drug, among all such drugs so furnished to such individual during such calendar day, for which the highest payment would be made under this paragraph.
(F) Eligible home infusion suppliers
In this paragraph, the term "eligible home infusion supplier" means a supplier that is enrolled under this part as a pharmacy that provides external infusion pumps and external infusion pump supplies and that maintains all pharmacy licensure requirements in the State in which the applicable infusion drugs are administered.
(G) Implementation
Notwithstanding any other provision of law, the Secretary may implement this paragraph by program instruction or otherwise.
(v) Payment for outpatient physical therapy services and outpatient occupational therapy services furnished by a therapy assistant
(1) In general
In the case of an outpatient physical therapy service or outpatient occupational therapy service furnished on or after January 1, 2022, for which payment is made under
(2) Use of modifier
(A) Establishment
Not later than January 1, 2019, the Secretary shall establish a modifier to indicate (in a form and manner specified by the Secretary), in the case of an outpatient physical therapy service or outpatient occupational therapy service furnished in whole or in part by a therapy assistant (as so defined), that the service was furnished by a therapy assistant.
(B) Required use
Each request for payment, or bill submitted, for an outpatient physical therapy service or outpatient occupational therapy service furnished in whole or in part by a therapy assistant (as so defined) on or after January 1, 2020, shall include the modifier established under subparagraph (A) for each such service.
(3) Implementation
The Secretary shall implement this subsection through notice and comment rulemaking.
(w) Opioid use disorder treatment services
(1) In general
The Secretary shall pay to an opioid treatment program (as defined in paragraph (2) of
(2) Considerations
The Secretary may implement this subsection through one or more bundles based on the type of medication provided (such as buprenorphine, methadone, naltrexone, or a new innovative drug), the frequency of services, the scope of services furnished, characteristics of the individuals furnished such services, or other factors as the Secretary determine 8 appropriate. In developing such bundles, the Secretary may consider payment rates paid to opioid treatment programs for comparable services under State plans under subchapter XIX or under the TRICARE program under
(3) Annual updates
The Secretary shall provide an update each year to the bundled payment amounts under this subsection.
(x) Payment rules relating to rural emergency hospitals
(1) Payment for rural emergency hospital services
In the case of rural emergency hospital services (as defined in
(2) Additional facility payment
(A) In general
The Secretary shall make monthly payments to a rural emergency hospital in an amount that is equal to 1/12 of the annual additional facility payment specified in subparagraph (B).
(B) Annual additional facility payment amount
The annual additional facility payment amount specified in this subparagraph is—
(i) for 2023, a Medicare subsidy amount determined under subparagraph (C); and
(ii) for 2024 and each subsequent year, the amount determined under this subparagraph for the preceding year, increased by the hospital market basket percentage increase.
(C) Determination of medicare subsidy amount
For purposes of subparagraph (B)(i), the Medicare subsidy amount determined under this subparagraph is an amount equal to—
(i) the excess (if any) of—
(I) the total amount that the Secretary determines was paid under this subchapter to all critical access hospitals in 2019; over
(II) the estimated total amount that the Secretary determines would have been paid under this subchapter to such hospitals in 2019 if payment were made for inpatient hospital, outpatient hospital, and skilled nursing facility services under the applicable prospective payment systems for such services during such year; divided by
(ii) the total number of such hospitals in 2019.
(D) Reporting on use of the additional facility payment
A rural emergency hospital receiving the additional facility payment under this paragraph shall maintain detailed information as specified by the Secretary as to how the facility has used the additional facility payments. Such information shall be made available to the Secretary upon request.
(3) Payment for ambulance services
For provisions relating to payment for ambulance services furnished by an entity owned and operated by a rural emergency hospital, see subsection (l).
(4) Payment for post-hospital extended care services
For provisions relating to payment for post-hospital extended care services furnished by a rural emergency hospital that has a unit that is a distinct part licensed as a skilled nursing facility, see
(5) Source of payments
(A) In general
Except as provided in subparagraph (B), payments under this subsection shall be made from the Federal Supplementary Medical Insurance Trust Fund under
(B) Additional facility payment and post-hospital extended care services
Payments under paragraph (2) shall be made from the Federal Hospital Insurance Trust Fund under
(y) Payment for certain services furnished by rural health clinics
(1) Attending physician services for hospice patients
In the case of services described in
(2) Mental health visits furnished via telecommunications technology
In the case of mental health visits furnished via interactive, real-time, audio and video telecommunications technology or audio-only interactions, the in-person mental health visit requirements established under section 405.2463(b)(3) of title 42 of the Code of Federal Regulations (or a successor regulation) shall not apply prior to October 1, 2025.
(3) Special payment rule for intensive outpatient services
(A) In general
In the case of intensive outpatient services furnished by a rural health clinic, the payment amount for such services shall be equal to the amount that would have been paid under this subchapter for such services had such services been covered OPD services furnished by a hospital.
(B) Exclusion
Costs associated with intensive outpatient services shall not be used to determine the amount of payment for rural health clinic services under the methodology for all-inclusive rates (established by the Secretary) under
(z) Payment for lymphedema compression treatment items
(1) In general
The Secretary shall determine an appropriate payment basis for lymphedema compression treatment items (as defined in
(2) Frequency limitation
No payment may be made under this part for lymphedema compression treatment items furnished other than at such frequency as the Secretary may establish.
(3) Application of competitive acquisition
In the case of lymphedema compression treatment items that are included in a competitive acquisition program in a competitive acquisition area under
(A) the payment basis under this subsection for such items furnished in such area shall be the payment basis determined under such competitive acquisition program; and
(B) the Secretary may use information on the payment determined under such competitive acquisition programs to adjust the payment amount otherwise determined under this subsection for an area that is not a competitive acquisition area under
(Aug. 14, 1935, ch. 531, title XVIII, §1834, as added and amended
Editorial Notes
References in Text
Section 302(c)(1)(B) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, referred to in subsec. (a)(14)(H)(i), is section 302(c)(1)(B) of
Section 4531(a) of the Balanced Budget Act of 1997, referred to in subsec. (l)(3)(A), is section 4531(a) of
Section 515(a) of the Medicare Access and CHIP Reauthorization Act of 2015, referred to in subsec. (l)(16)(A), is section 515(a) of
Codification
Amendment of subsec. (a)(4) by
Prior Provisions
A prior section 1395m, act Aug. 14, 1935, ch. 531, title XVIII, §1834, as added July 30, 1965,
Amendments
2025—Subsec. (l)(12)(A).
Subsec. (l)(13)(A).
Subsec. (m)(2)(B)(iii).
Subsec. (m)(4)(C)(iii).
Subsec. (m)(4)(E).
Subsec. (m)(7)(B)(i).
Subsec. (m)(8)(A).
Subsec. (m)(9).
Subsec. (o)(4)(B).
Subsec. (y)(2).
2024—Subsec. (l)(12)(A).
Subsec. (l)(13)(A).
Subsec. (m)(2)(B)(iii).
Subsec. (m)(4)(C)(iii).
Subsec. (m)(4)(E).
Subsec. (m)(7)(B)(i).
Subsec. (m)(8)(A).
Subsec. (m)(9).
Subsec. (o)(4)(B).
Subsec. (y)(2).
2022—Subsec. (a)(20)(D)(iv).
Subsec. (j)(5)(E).
Subsec. (j)(5)(F).
Subpar. (j)(5)(G).
Subsec. (l)(12)(A).
Subsec. (l)(13)(A).
Subsec. (l)(17)(F)(i).
Subsec. (m)(1).
Subsec. (m)(2)(B)(i).
Subsec. (m)(2)(B)(iii).
Subsec. (m)(4)(C)(i).
Subsec. (m)(4)(C)(iii).
Subsec. (m)(4)(E).
Subsec. (m)(7)(A).
Subsec. (m)(7)(B)(i).
Subsec. (m)(8).
Subsec. (m)(8)(A).
Subsec. (m)(8)(B)(i).
Subsec. (m)(9).
Subsec. (o)(3)(C)(ii).
Subsec. (o)(4).
Subsec. (o)(4)(B).
Subsec. (o)(5).
Subsec. (s)(3).
Subsec. (s)(4).
Subsec. (y).
Subsec. (y)(2).
Subsec. (y)(3).
Subsec. (z).
2020—Subsec. (a)(9)(D).
Subsec. (a)(9)(D)(ii).
Subsec. (d)(2)(C)(ii), (3)(C)(ii).
Subsec. (d)(2)(D), (3)(D).
Subsec. (m)(1).
Subsec. (m)(2)(A).
Subsec. (m)(4)(A).
Subsec. (m)(4)(C)(ii)(XI).
Subsec. (m)(4)(F)(i).
Subsec. (m)(7).
Subsec. (m)(8).
Subsec. (o)(4).
Subsec. (x).
Subsec. (y).
2018—Subsec. (a)(2)(A)(iv).
Subsec. (h)(5).
Subsec. (l)(12)(A).
Subsec. (l)(13)(A).
Subsec. (l)(15).
Subsec. (l)(17).
Subsec. (m)(2)(B).
Subsec. (m)(2)(B)(i).
Subsec. (m)(2)(B)(ii).
Subsec. (m)(4)(C)(i).
Subsec. (m)(4)(C)(ii)(IX).
Subsec. (m)(4)(C)(ii)(X).
Subsec. (m)(5).
Subsec. (m)(6).
Subsec. (m)(7).
Subsec. (o)(3).
Subsec. (u)(7).
Subsec. (v).
Subsec. (w).
2016—Subsec. (a)(1)(G).
Subsec. (h)(1)(H)(ii).
Subsec. (t).
Subsec. (u).
2015—Subsec. (a)(2)(A)(iv).
Subsec. (a)(11)(B)(ii).
Subsec. (l)(12)(A).
Subsec. (l)(13)(A).
Subsec. (l)(16).
Subsec. (r).
Subsec. (s).
2014—Subsec. (a)(1)(I).
Subsec. (l)(12)(A).
Subsec. (l)(13)(A).
Subsec. (p).
Subsec. (q).
2013—Subsec. (a)(1)(F).
Subsec. (a)(1)(H).
Subsec. (a)(22).
Subsec. (k)(7).
Subsec. (l)(12)(A).
Subsec. (l)(13)(A).
Subsec. (l)(15).
2012—Subsec. (l)(12)(A).
Subsec. (l)(13)(A).
2011—Subsec. (l)(12)(A).
Subsec. (l)(13)(A).
2010—Subsec. (a)(1)(F)(ii).
Subsec. (a)(1)(F)(iii).
Subsec. (a)(7)(A)(i)(II).
Subsec. (a)(7)(A)(i)(III).
Subsec. (a)(7)(A)(iii).
Subsec. (a)(7)(C)(ii)(II).
Subsec. (a)(11)(B).
Subsec. (a)(11)(B)(ii).
Subsec. (a)(14).
Subsec. (a)(14)(K).
Subsec. (a)(14)(L), (M).
"(L) for 2014—
"(i) in the case of items and services described in subparagraph (J)(i) for which a payment adjustment has not been made under subsection (a)(1)(F)(ii) in any previous year, the percentage increase in the consumer price index for all urban consumers (U.S. urban average) for the 12-month period ending with June 2013, plus 2.0 percentage points; or
"(ii) in the case of other items and services, the percentage increase in the consumer price index for all urban consumers (U.S. urban average) for the 12-month period ending with June 2013; and
"(M) for a subsequent year, the percentage increase in the consumer price index for all urban consumers (U.S. urban average) for the 12-month period ending with June of the previous year."
Subsec. (a)(16)(B).
Subsec. (a)(20)(F)(i).
Subsec. (a)(20)(G).
Subsec. (g)(2)(A).
Subsec. (g)(2)(B).
Subsec. (h)(4)(A).
Subsec. (h)(4)(A)(x).
Subsec. (h)(4)(A)(xi).
Subsec. (l)(3).
Subsec. (l)(3)(B).
Subsec. (l)(3)(C).
Subsec. (l)(8).
Subsec. (l)(12)(A).
Subsec. (l)(13)(A).
Subsec. (l)(13)(A)(i), (ii).
Subsec. (n).
Subsec. (o).
2009—Subsec. (a)(20)(F)(i).
2008—Subsec. (a)(1)(E)(ii).
Subsec. (a)(1)(F).
Subsec. (a)(1)(G).
Subsec. (a)(5)(F).
Subsec. (a)(14)(J) to (M).
Subsec. (a)(20)(B).
Subsec. (a)(20)(E).
Subsec. (a)(20)(F).
Subsec. (e).
Subsec. (g)(4).
Subsec. (h)(1)(H).
Subsec. (l)(13)(A).
Subsec. (l)(13)(B).
Subsec. (l)(14)(B)(i).
Subsec. (m)(4)(C)(ii)(VI) to (VIII).
2006—Subsec. (a)(5)(A).
Subsec. (a)(5)(F).
Subsec. (a)(7)(A).
Subsec. (d)(2)(C)(ii).
Subsec. (d)(3)(C)(ii).
2003—Subsec. (a)(1)(B).
Subsec. (a)(1)(C).
Subsec. (a)(1)(E).
Subsec. (a)(1)(F).
Subsec. (a)(10)(B).
Subsec. (a)(14)(F).
Subsec. (a)(14)(G) to (J).
Subsec. (a)(17), (19).
Subsec. (a)(20).
Subsec. (a)(21).
Subsec. (b)(4)(D)(iv).
Subsec. (g)(1).
Subsec. (g)(2).
Subsec. (g)(5).
Subsec. (h)(1)(B).
Subsec. (h)(1)(D).
Subsec. (h)(1)(H).
Subsec. (h)(4)(A)(viii).
Subsec. (h)(4)(A)(ix), (x).
Subsec. (h)(4)(C).
Subsec. (l)(2)(E).
Subsec. (l)(8), (9).
Subsec. (l)(10).
Subsec. (l)(11).
Subsec. (l)(12).
Subsec. (l)(13).
Subsec. (l)(14).
Subsec. (m)(4)(C)(ii)(III).
2000—Subsec. (a)(14)(C).
Subsec. (a)(14)(D) to (F).
Subsec. (c).
Subsec. (d)(2)(E)(ii).
Subsec. (d)(3).
Subsec. (d)(3)(A).
Subsec. (d)(3)(E).
Subsec. (g)(2)(B).
Subsec. (g)(4).
Subsec. (g)(5).
Subsec. (h)(1)(F).
Subsec. (h)(1)(G).
Subsec. (h)(4)(A)(v).
Subsec. (h)(4)(A)(vi) to (viii).
Subsec. (l)(2)(E).
Subsec. (l)(3)(A), (B).
Subsec. (l)(8).
Subsec. (m).
1999—Subsec. (a)(13).
Subsec. (g).
Subsec. (h)(4)(A)(i).
Subsec. (h)(4)(A)(v).
Subsec. (h)(4)(B).
1997—Subsec. (a)(2)(B)(iv).
Subsec. (a)(9)(B)(iv).
Subsec. (a)(9)(B)(v), (vi).
Subsec. (a)(9)(D).
Subsec. (a)(10)(B).
Subsec. (a)(14)(B).
Subsec. (a)(14)(C), (D).
Subsec. (a)(16).
Subsec. (a)(17).
Subsec. (c)(1)(C).
Subsec. (c)(2)(A)(iii).
"(I) is at a high risk of developing breast cancer (as determined pursuant to factors identified by the Secretary), payment may not be made under this part for a screening mammography performed within the 11 months following the month in which a previous screening mammography was performed, or
"(II) is not at a high risk of developing breast cancer, payment may not be made under this part for a screening mammography performed within the 23 months following the month in which a previous screening mammography was performed."
Subsec. (c)(2)(A)(iv), (v).
"(iv) In the case of a woman over 49 years of age, but under 65 years of age, payment may not be made under this part for screening mammography performed within 11 months following the month in which a previous screening mammography was performed.
"(v) In the case of a woman over 64 years of age, payment may not be made for screening mammography performed within 23 months following the month in which a previous screening mammography was performed."
Subsec. (d).
Subsec. (g).
Subsec. (h)(4)(A)(iv).
Subsec. (h)(4)(A)(v), (vi).
Subsec. (k).
Subsec. (l).
1994—Subsec. (a)(3)(D).
Subsec. (a)(5)(E).
Subsec. (a)(7).
Subsec. (a)(7)(A)(iii)(II).
Subsec. (a)(7)(C)(i).
Subsec. (a)(10)(B).
Subsec. (a)(14)(A).
Subsec. (a)(15).
"(A)
"(B)
Subsec. (a)(16).
"(A)
"(B)
Subsec. (a)(17), (18).
Subsec. (b)(4)(D).
Subsec. (b)(4)(D)(iv).
Subsec. (b)(4)(D)(vii).
Subsec. (b)(4)(E).
Subsec. (b)(4)(F), (G).
Subsec. (c)(1)(B).
Subsec. (c)(1)(C)(iii).
Subsec. (c)(3) to (5).
Subsec. (f).
Subsec. (g)(1).
Subsec. (g)(1)(B).
Subsec. (g)(2).
Subsec. (h)(3).
Subsec. (j).
Subsec. (j)(4), (5).
1993—Subsec. (a)(1)(D).
Subsec. (a)(2)(A)(iii).
Subsec. (a)(2)(C).
Subsec. (a)(3)(A).
Subsec. (a)(3)(C).
Subsec. (a)(8)(A)(ii)(III).
Subsec. (a)(8)(B)(ii) to (iv).
Subsec. (a)(9)(A)(ii)(II).
Subsec. (a)(9)(B)(ii) to (iv).
Subsec. (h)(1)(B).
Subsec. (h)(1)(E).
Subsec. (h)(4)(A).
Subsec. (i).
1990—Subsec. (a).
Subsec. (a)(1)(D).
Subsec. (a)(2)(A).
Subsec. (a)(2)(B).
Subsec. (a)(2)(C).
Subsec. (a)(3)(B).
Subsec. (a)(3)(C).
Subsec. (a)(3)(D).
Subsec. (a)(4).
Subsec. (a)(5)(A).
Subsec. (a)(5)(E).
Subsec. (a)(7)(A)(i).
Subsec. (a)(7)(A)(ii), (iii).
Subsec. (a)(7)(A)(iv).
Subsec. (a)(7)(A)(v).
Subsec. (a)(7)(A)(vi).
Subsec. (a)(7)(C).
Subsec. (a)(8)(A)(ii).
Subsec. (a)(8)(B).
"(i) for 1991 and for 1992, equal to the average (weighted by relative volume of all claims among carriers) of the local purchase prices for the carriers in the region computed under subparagraph (A)(ii)(II) for the year, and
"(ii) for each subsequent year, equal to the regional purchase price computed under this subparagraph for the previous year increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June of the previous year."
Subsec. (a)(8)(C).
Subsec. (a)(8)(C)(ii).
Subsec. (a)(8)(C)(iii).
Subsec. (a)(8)(C)(iv).
Subsec. (a)(8)(D).
"(i) in 1991, may not exceed 125 percent, and may not be lower than 85 percent, of the average of the purchase prices recognized under such subparagraph for all the carrier service areas in the United States in that year; and
"(ii) in a subsequent year, may not exceed 120 percent, and may not be lower than 90 percent, of the average of the purchase prices recognized under such subparagraph for all the carrier service areas in the United States in that year."
Subsec. (a)(9)(A)(ii)(II).
Subsec. (a)(9)(B).
"(i) for 1991 and 1992, equal to the average (weighted by relative volume of all claims among carriers) of the local monthly payment rates for the carriers in the region computed under subparagraph (A)(ii)(II) for the year, and
"(ii) for each subsequent year, equal to the regional monthly payment rates computed under this subparagraph for the previous year increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June of the previous year."
Subsec. (a)(9)(C)(ii).
Subsec. (a)(9)(C)(iii).
Subsec. (a)(9)(C)(iv).
Subsec. (a)(9)(D).
"(i) in 1991, may not exceed 125 percent, and may not be lower than 85 percent, of the average of the base monthly payment amounts recognized under such subparagraph for all the carrier service areas in the United States in that year; and
"(ii) in a subsequent year, may not exceed 120 percent, and may not be lower than 90 percent, of the average of the base monthly payment amounts recognized under such subparagraph for all the carrier service areas in the United States in that year."
Subsec. (a)(12).
Subsec. (a)(13).
"(A) durable medical equipment (as defined in
"(B) prosthetic devices (described in
"(C) orthotics and prosthetics (described in
but does not include intraocular lenses or medical supplies (including catheters, catheter supplies, ostomy bags, and supplies related to ostomy care) furnished by a home health agency under
Subsec. (a)(14).
Subsec. (a)(15).
Subsec. (a)(16).
Subsec. (b)(1)(B).
Subsec. (b)(4)(D).
Subsec. (b)(4)(E).
Subsec. (b)(4)(F).
Subsec. (c).
Subsec. (f).
Subsec. (h).
1989—Subsec. (a)(1)(D).
Subsec. (a)(2)(A)(iii).
Subsec. (a)(2)(B)(i), (3)(B)(i).
Subsec. (a)(7)(A)(i).
Subsec. (a)(7)(B)(i).
Subsec. (a)(7)(B)(ii).
Subsec. (a)(8)(A)(ii)(I).
Subsec. (a)(8)(A)(ii)(II).
Subsec. (a)(8)(D)(i).
Subsec. (a)(8)(D)(ii).
Subsec. (a)(9)(A)(ii)(I).
Subsec. (a)(9)(A)(ii)(II).
Subsec. (a)(9)(D)(i).
Subsec. (a)(9)(D)(ii).
Subsec. (a)(13).
Subsec. (b)(1)(B).
Subsec. (b)(4)(A).
Subsec. (b)(4)(C) to (E).
Subsecs. (c) to (e).
Subsec. (f).
Subsec. (g).
1988—
Subsec. (a)(1)(C).
Subsec. (a)(2)(A).
Subsec. (a)(2)(B)(i).
Subsec. (a)(3)(A).
Subsec. (a)(3)(B)(i).
Subsec. (a)(4).
Subsec. (a)(7)(A)(ii).
Subsec. (a)(7)(A)(iii).
Subsec. (a)(7)(B)(i).
Subsec. (a)(8)(A)(i)(I).
Subsec. (a)(8)(B).
Subsec. (a)(9)(A)(ii)(I).
Subsec. (a)(9)(A)(ii)(II).
Subsec. (a)(9)(B).
Subsec. (a)(9)(C)(i).
Subsec. (a)(10)(B).
Subsec. (a)(11)(A).
Subsec. (a)(12).
Subsec. (a)(14).
Subsec. (b).
Subsec. (b)(1)(B).
Subsec. (b)(4)(C).
Subsec. (b)(4)(D), (5).
Subsec. (b)(5)(C).
Subsec. (b)(6).
Subsec. (b)(6)(B).
Subsec. (c).
Subsec. (d).
Subsec. (e).
1987—Subsec. (b).
Statutory Notes and Related Subsidiaries
Effective Date of 2022 Amendment
Amendment by section 4124(c) of
Effective Date of 2020 Amendment
Amendment by section 125(a)(2)(B), (c) of
Effective Date of 2016 Amendment
Amendment by section 5012(b) of
Effective Date of 2015 Amendment
Amendment by
Effective Date of 2010 Amendment
"(1)
"(2)
Amendment by section 6405(a) of
Effective Date of 2008 Amendment
Amendment by section 125(b)(5) of
Effective Date of 2006 Amendment
"(A)
"(B)
Amendment by section 5113(b) of
Effective Date of 2003 Amendment
Amendment by section 405(a)(1) of
"(A)
"(B)
Amendment by section 627(b)(1) of
Effective Date of 2000 Amendment
Amendment by section 1(a)(6) [title II, §201(a)] of
Amendment by section 1(a)(6) [title II, §205(a)] of
Amendment by section 1(a)(6) [title II, §223(b)] of
Effective Date of 1999 Amendment
Amendment by section 1000(a)(6) [title II, §201(e)(2)] of
Amendment by section 1000(a)(6) [title III, §321(k)(3)] of
Effective Date of 1997 Amendment
Amendment by section 4101(a), (c) of
Amendment by section 4104(b)(1) of
"(1)
"(2)
Amendment by section 4201(c)(5) of
Amendment by section 4531(b)(2) of
Amendment by section 4541(a)(2) of
"(1)
"(2)
Effective Date of 1994 Amendment
Amendment by section 156(a)(2)(C) of
Effective Date of 1993 Amendment
Amendment by section 13544(b)(1) of
Effective Date of 1990 Amendment
"(1) Except as otherwise provided, the amendments made by this section [amending this section,
"(2) The amendment made by subsection (f) [amending this section] shall be effective as if included in the enactment of the Omnibus Budget Reconciliation Act of 1987 [
Amendment by section 4104(a) of
Amendment by section 4153(a)(1), (2)(D) of
Amendment by section 4163(b) of
Effective Date of 1989 Amendment
Amendment by section 6102(f)(1) of
Amendment by section 201(a) of
Effective Date of 1988 Amendment
Amendment by
Amendment by section 202(b)(4) of
Amendment by section 203(c)(1)(F) of
Except as specifically provided in section 411 of
Effective Date of 1987 Amendment
[
Effective Date
Subsection (a) of this section applicable to covered items (other than oxygen and oxygen equipment) furnished on or after Jan. 1, 1989, and to oxygen and oxygen equipment furnished on or after June 1, 1989, see section 4062(e) of
Regulations
Construction of 2010 Amendment
Construction of 2009 Amendment
Construction of 2008 Amendment
Transfer of Functions
Physician Payment Review Commission (PPRC) was terminated and its assets and staff transferred to the Medicare Payment Advisory Commission (MedPAC) by section 4022(c)(2), (3) of
Implementation of 2025 Amendment
Implementation of 2024 Amendment
Payment Rates for Durable Medical Equipment Under the Medicare Program
"(a)
"(b)
"(c)
Publication of Data
Implementation of 2022 Amendment
Implementation of 2020 Amendment
Encouraging Use of Telecommunications Systems for Home Health Services Furnished During Emergency Period
Revising Payment Rates for Durable Medical Equipment Under the Medicare Program Through Duration of Emergency Period
"(a)
"(b)
Implementation of 2018 Amendment
Implementation of 2015 Amendment
Implementation of 2010 Amendment
Demonstration Project To Assess the Appropriate Use of Imaging Services
"(1)
"(A)
"(B)
"(C)
"(2)
"(A)
"(i)
"(ii)
"(B)
"(i)
"(ii)
"(I) represent a wide range of geographic areas, demographic characteristics (such as urban, rural, and suburban), and practice settings (such as private and academic practices); and
"(II) have the capability to submit data to the Secretary (or an entity under a subcontract with the Secretary) in an electronic format in accordance with standards established by the Secretary.
"(C)
"(i) reimburse physicians for reasonable administrative costs incurred in participating in the demonstration project under this subsection; and
"(ii) provide reasonable incentives to physicians to encourage participation in the demonstration project under this subsection.
"(D)
"(i)
"(ii)
"(I) be developed or endorsed by a medical specialty society; and
"(II) be developed in adherence to appropriateness principles developed by a consensus organization, such as the AQA alliance.
"(E)
"(i) A model described in subparagraph (F).
"(ii) A model described in subparagraph (G).
"(iii) Any other model that the Secretary determines to be useful in evaluating the use of appropriateness criteria for advanced diagnostic imaging services.
"(F)
"(i) uses an electronic or paper intake form that—
"(I) contains a certification by the physician furnishing the imaging service that the data on the intake form was confirmed with the Medicare beneficiary before the service was furnished;
"(II) contains standardized data elements for diagnosis, service ordered, service furnished, and such other information determined by the Secretary, in consultation with medical specialty societies and other stakeholders, to be germane to evaluating the effectiveness of the use of appropriateness criteria selected under subparagraph (D); and
"(III) is accessible to physicians participating in the demonstration project under this subsection in a format that allows for the electronic submission of such form; and
"(ii) provides for feedback reports in accordance with paragraph (3)(B).
"(G)
"(i) uses a computerized order-entry system that requires the transmittal of relevant supporting information at the time of referral for advanced diagnostic imaging services and provides automated decision-support feedback to the referring physician regarding the appropriateness of furnishing such imaging services; and
"(ii) provides for feedback reports in accordance with paragraph (3)(B).
"(H)
"(i) as a model for collecting data regarding physician compliance with appropriateness criteria selected under subparagraph (D) under the demonstration project under this subsection; or
"(ii) under any model used for collecting such data under the demonstration project.
"(I)
"(i)
"(ii)
"(I) the satisfaction of Medicare beneficiaries who are furnished advanced diagnostic imaging services by a physician participating in the demonstration project;
"(II) the satisfaction of physicians participating in the demonstration project;
"(III) if applicable, timelines for the provision of feedback reports under paragraph (3)(B); and
"(IV) any other areas determined appropriate by the Secretary.
"(3)
"(A)
"(i) the appropriateness criteria selected under paragraph (2)(D); and
"(ii) to the extent feasible, the utilization of such services by physicians not participating in the demonstration project.
"(B)
"(i) a profile of the rate of compliance by the physician with appropriateness criteria selected under paragraph (2)(D), including a comparison of—
"(I) the rate of compliance by the physician with such criteria; and
"(II) the rate of compliance by the physician's peers (as defined by the Secretary) with such criteria; and
"(ii) to the extent feasible, a comparison of—
"(I) the rate of utilization of advanced diagnostic imaging services by the physician; and
"(II) the rate of utilization of such services by the physician's peers (as defined by the Secretary) who are not participating in the demonstration project.
"(4)
"(A)
"(B)
"(5)
"(A)
"(i) assess the timeliness and efficacy of the demonstration project;
"(ii) assess the performance of entities under a contract entered into under paragraph (2)(I)(i);
"(iii) analyze data—
"(I) on the rates of appropriate, uncertain, and inappropriate advanced diagnostic imaging services furnished by physicians participating in the demonstration project;
"(II) on patterns and trends in the appropriateness and inappropriateness of such services furnished by such physicians;
"(III) on patterns and trends in national and regional variations of care with respect to the furnishing of such services; and
"(IV) on the correlation between the appropriateness of the services furnished and image results; and
"(iv) address—
"(I) the thresholds used under the demonstration project to identify acceptable and outlier levels of performance with respect to the appropriateness of advanced diagnostic imaging services furnished;
"(II) whether prospective use of appropriateness criteria could have an effect on the volume of such services furnished;
"(III) whether expansion of the use of appropriateness criteria with respect to such services to a broader population of Medicare beneficiaries would be advisable;
"(IV) whether, under such an expansion, physicians who demonstrate consistent compliance with such appropriateness criteria should be exempted from certain requirements;
"(V) the use of incident-specific versus practice-specific outlier information in formulating future recommendations with respect to the use of appropriateness criteria for such services under the Medicare program; and
"(VI) the potential for using methods (including financial incentives), in addition to those used under the models under the demonstration project, to ensure compliance with such criteria.
"(B)
"(6)
Air Ambulance Payment Improvements
Evaluation of Certain Code
GAO Report on Class III Medical Devices
Use of Data
Implementation of 2003 Amendment
GAO Report on Costs and Access
Report on Demonstration Project Permitting Skilled Nursing Facilities To Be Originating Telehealth Sites; Authority To Implement
"(a)
"(b)
"(c)
Payment for New Technologies
"(1)
"(A)
"(i) In the case of a technology which directly takes a digital image (without involving film), in an amount equal to 150 percent of the amount of payment under section 1848 of such Act (
"(ii) In the case of a technology which allows conversion of a standard film mammogram into a digital image and subsequently analyzes such resulting image with software to identify possible problem areas, in an amount equal to the limit that would otherwise be applied under section 1834(c)(3) of such Act (
"(B)
"(C)
"(D)
"(2)
"(3)
"(A) A significant increase or decrease in the resources used in the test or in the manufacture of the equipment.
"(B) A significant improvement in the performance of the test or equipment.
"(C) A significant advance in medical technology that is expected to significantly improve the treatment of medicare beneficiaries.
"(4)
MedPAC Study and Report on Medicare Coverage of Cardiac and Pulmonary Rehabilitation Therapy Services
"(a)
"(1)
"(2)
"(A) qualifying diagnoses required for coverage of cardiac and pulmonary rehabilitation therapy services;
"(B) level of physician direct involvement and supervision in furnishing such services; and
"(C) level of reimbursement for such services.
"(b)
GAO Studies on Costs of Ambulance Services Furnished in Rural Areas
"(1)
"(2)
"(A) The cost of efficiently providing ambulance services for trips originating in rural areas, with special emphasis on collection of cost data from rural providers.
"(B) The means by which rural areas with low population densities can be identified for the purpose of designating areas in which the cost of providing ambulance services would be expected to be higher than similar services provided in more heavily populated areas because of low usage. Such study shall also include an analysis of the additional costs of providing ambulance services in areas designated under the previous sentence.
"(3)
Adjustment in Rural Rates
Study and Report on Additional Coverage for Telehealth Services
"(1)
"(A) settings and sites for the provision of telehealth services that are in addition to those permitted under section 1834(m) of the Social Security Act [
"(B) practitioners that may be reimbursed under such section for furnishing telehealth services that are in addition to the practitioners that may be reimbursed for such services under such section; and
"(C) geographic areas in which telehealth services may be reimbursed that are in addition to the geographic areas where such services may be reimbursed under such section.
"(2)
Special Rules for Payments for 2001
"(A) for services furnished on or after January 1, 2001, and before July 1, 2001, shall be the percentage increase for 2001 as determined under the provisions of law in effect on the day before the date of the enactment of this Act [Dec. 21, 2000]; and
"(B) for services furnished on or after July 1, 2001, and before January 1, 2002, shall be equal to 4.7 percent."
"(1) for items furnished on or after January 1, 2001, and before July 1, 2001, shall be the payment basis for 2001 as determined under the provisions of law in effect on the day before the date of the enactment of this Act [Dec. 21, 2000] (including the application of section 228(a)(1) of BBRA [
"(2) for items furnished on or after July 1, 2001, and before January 1, 2002, shall be the payment basis that is determined under such section 1834(a) if such section 228(a)(1) did not apply and taking into account the amendment made by subsection (a), increased by a transitional percentage allowance equal to 3.28 percent (to account for the timing of implementation of the CPI update)."
"(1) for items furnished on or after January 1, 2001, and before July 1, 2001, shall be the payment basis for 2001 as determined under the provisions of law in effect on the day before the date of the enactment of this Act [Dec. 21, 2000]; and
"(2) for items furnished on or after July 1, 2001, and before January 1, 2002, shall be the payment basis that is determined under such section taking into account the amendments made by subsection (a), increased by a transitional percentage allowance equal to 2.6 percent (to account for the timing of implementation of the CPI update)."
Preemption of Rule
GAO Study and Report on Costs of Emergency and Medical Transportation Services
"(a)
"(b)
Treatment of Temporary Payment Increases After Calendar Year 2001
"(1) Section 401(c)(2) [set out as a note under
"(2) Section 422(e)(2) [set out as a note under
"(3) Section 423(a)(2)(B) [set out above] (relating to ambulance services).
"(4) Section 425(b)(2) [set out above] (relating to durable medical equipment).
"(5) Section 426(b)(2) [set out above] (relating to prosthetic devices and orthotics and prosthetics)."
Study of Delivery of Intravenous Immune Globulin (IVIG) Outside Hospitals and Physicians' Offices
Temporary Increase in Payment Rates for Durable Medical Equipment and Oxygen
"(a)
"(1) 2001 by 0.3 percent, and
"(2) 2002 by 0.6 percent.
"(b)
"(1) under subsection (a)(1) shall not apply after 2001 and shall not be taken into account in calculating the payment amounts applicable for covered items furnished after such year; and
"(2) under subsection (a)(2) shall not apply after 2002 and shall not be taken into account in calculating the payment amounts applicable for covered items furnished after such year."
Demonstration of Coverage of Ambulance Services Under Medicare Through Contracts With Units of Local Government
"(a)
"(1) the unit of local government furnishes (or arranges for the furnishing of) ambulance services for which payment may be made under part B of title XVIII of the Social Security Act [
"(2) any individual or entity furnishing ambulance services under the contract meets the requirements otherwise applicable to individuals and entities furnishing such services under such part; and
"(3) for each month during which the contract is in effect, the Secretary makes a capitated payment to the unit of local government in accordance with subsection (b).
The projects may extend over a period of not to exceed 3 years each. Not later than July 1, 2000, the Secretary shall publish a request for proposals for such projects.
"(b)
"(1)
"(A) the Secretary's estimate of the number of individuals covered under the contract for the month; and
"(B) 1/12 of the capitated payment rate for the year established under paragraph (2).
"(2)
"(A) in its first year, a rate established for the project by the Secretary, using the most current available data, in a manner that ensures that aggregate payments under the project will not exceed the aggregate payment that would have been made for ambulance services under part B of title XVIII of the Social Security Act [
"(B) in a subsequent year, the capitated payment rate established for the previous year increased by an appropriate inflation adjustment factor.
"(c)
"(1) covering individuals residing in additional units of local government (under arrangements entered into between such units and the unit of local government involved);
"(2) permitting the unit of local government to transport individuals to non-hospital providers if such providers are able to furnish quality services at a lower cost than hospital providers; or
"(3) implementing such other innovations as the unit of local government may propose to improve the quality of ambulance services and control the costs of such services.
"(d)
"(e)
"(1)
"(2)
[References to Medicare+Choice deemed to refer to Medicare Advantage, see section 201(b) of
[
Payment Freeze for Parenteral and Enteral Nutrients, Supplies, and Equipment
Service Standards for Providers of Oxygen and Oxygen Equipment
Access to Home Oxygen Equipment
"(1)
"(2)
Use of Covered Items by Disabled Beneficiaries
"(1)
"(2)
Criteria for Treatment of Items as Prosthetic Devices or Orthotics and Prosthetics
Adjustment Required for Certain Items
"(1)
"(2)
Limitation on Prevailing Charge for Physicians' Radiology Services Furnished During 1991; Exceptions
"(1)
"(2)
Limitation on Carrier Adjustments for Radiologist Services Furnished During 1991
"(1) a carrier may not make any adjustment, under section 1842(b)(3)(B) of such Act [
"(2) no payment adjustment may be made under section 1842(b)(8) of such Act, and
"(3) section 1842(b)(9) of such Act shall not apply."
Study of Payments for Prosthetic Devices, Orthotics, and Prosthetics
Special Rule for Nuclear Medicine Physicians
Special Rule for Interventional Radiologists; "Split Billing"
Rental Payments for Enteral and Parenteral Pumps
"(1)
"(2)
"(A) monthly rental payments shall not be made under part B of title XVIII of the Social Security Act for more than 15 months during such period, and
"(B) after monthly rental payments have been made for 15 months during such period, payment under such part shall be made for maintenance and servicing of the pump in such amounts as the Secretary of Health and Human Services determines to be reasonable and necessary to ensure the proper operation of the pump."
Treatment of Power-Driven Wheelchairs as Customized Items
Study of Payment for Portable X-Ray Services
GAO Study of Standards for Use of and Payment for Items of Durable Medical Equipment
Reports on Medicare Beneficiary Drug Expenses
Additional Studies by Secretary or Comptroller General
Development of Standard Medicare Claims Forms
Studies and Reports on Screening Mammography
Deadline for Establishment of Fee Schedules for Radiologist Services; Report to Congress
Study and Evaluation
"(1) The Secretary of Health and Human Services shall monitor the impact of the amendments made by this section [enacting this section, amending
"(2) Before January 1, 1991, the Secretary may not conduct any demonstration project respecting alternative methods of payment for covered items under title XVIII of the Social Security Act [
"(3) In this subsection, the term 'covered item' has the meaning given such term in section 1834(a)(13) of the Social Security Act [
"(4) The Secretary shall, upon written request and payment of a reasonable copying fee which the Secretary may establish, provide the data and information used in determining the payment amounts for covered items under section 1834(a) of the Social Security Act [
"(5) The Comptroller General shall conduct a study on the appropriateness of the level of payments allowed for covered items under the medicare program, and shall report to Congress on the results of such study (including recommendations on the transition to regional or national rates) by not later than January 1, 1991. Entities furnishing such items which fail to provide the Comptroller General with reasonable access to necessary records to carry out the study under this paragraph are subject to exclusion from the medicare program under section 1128(a) of the Social Security Act [
1 So in original. The semicolon probably should be a comma.
2 So in original. Subpar. (B) of par. (2) does not contain clauses.
3 So in original. Probably should be "a".
5 So in original. Two subpars. (G) have been enacted.
6 So in original. The period probably should be preceded by another closing parenthesis.
7 So in original. The second closing parenthesis probably should not appear.
8 So in original. Probably should be "determines".
§1395m–1. Improving policies for clinical diagnostic laboratory tests
(a) Reporting of private sector payment rates for establishment of medicare payment rates
(1) In general
(A) General reporting requirements
Subject to subparagraph (B), beginning January 1, 2016, and every 3 years thereafter (or, annually, in the case of reporting with respect to an advanced diagnostic laboratory test, as defined in subsection (d)(5)), an applicable laboratory (as defined in paragraph (2)) shall report to the Secretary, at a time specified by the Secretary (referred to in this subsection as the "reporting period"), applicable information (as defined in paragraph (3)) for a data collection period (as defined in paragraph (4)) for each clinical diagnostic laboratory test that the laboratory furnishes during such period for which payment is made under this part.
(B) Revised reporting period
In the case of reporting with respect to clinical diagnostic laboratory tests that are not advanced diagnostic laboratory tests, the Secretary shall revise the reporting period under subparagraph (A) such that—
(i) no reporting is required during the period beginning January 1, 2020, and ending December 31, 2025;
(ii) reporting is required during the period beginning January 1, 2026, and ending March 31, 2026; and
(iii) reporting is required every three years after the period described in clause (ii).
(2) Definition of applicable laboratory
In this section, the term "applicable laboratory" means a laboratory that, with respect to its revenues under this subchapter, a majority of such revenues are from this section,
(3) Applicable information defined
(A) In general
In this section, subject to subparagraph (B), the term "applicable information" means, with respect to a laboratory test for a data collection period, the following:
(i) The payment rate (as determined in accordance with paragraph (5)) that was paid by each private payor for the test during the period.
(ii) The volume of such tests for each such payor for the period.
(B) Exception for certain contractual arrangements
Such term shall not include information with respect to a laboratory test for which payment is made on a capitated basis or other similar payment basis during the data collection period.
(4) Data collection period defined
(A) In general
Subject to subparagraph (B), in this section, the term "data collection period" means a period of time, such as a previous 12 month period, specified by the Secretary.
(B) Exception
In the case of the reporting period described in paragraph (1)(B)(ii) with respect to clinical diagnostic laboratory tests that are not advanced diagnostic laboratory tests, the term "data collection period" means the period beginning January 1, 2019, and ending June 30, 2019.
(5) Treatment of discounts
The payment rate reported by a laboratory under this subsection shall reflect all discounts, rebates, coupons, and other price concessions, including those described in
(6) Ensuring complete reporting
In the case where an applicable laboratory has more than one payment rate for the same payor for the same test or more than one payment rate for different payors for the same test, the applicable laboratory shall report each such payment rate and the volume for the test at each such rate under this subsection. Beginning with January 1, 2019, the Secretary may establish rules to aggregate reporting with respect to the situations described in the preceding sentence.
(7) Certification
An officer of the laboratory shall certify the accuracy and completeness of the information reported under this subsection.
(8) Private payor defined
In this section, the term "private payor" means the following:
(A) A health insurance issuer and a group health plan (as such terms are defined in
(B) A Medicare Advantage plan under part C.
(C) A medicaid managed care organization (as defined in
(9) Civil money penalty
(A) In general
If the Secretary determines that an applicable laboratory has failed to report or made a misrepresentation or omission in reporting information under this subsection with respect to a clinical diagnostic laboratory test, the Secretary may apply a civil money penalty in an amount of up to $10,000 per day for each failure to report or each such misrepresentation or omission.
(B) Application
The provisions of
(10) Confidentiality of information
Notwithstanding any other provision of law, information disclosed by a laboratory under this subsection is confidential and shall not be disclosed by the Secretary or a Medicare contractor in a form that discloses the identity of a specific payor or laboratory, or prices charged or payments made to any such laboratory, except—
(A) as the Secretary determines to be necessary to carry out this section;
(B) to permit the Comptroller General to review the information provided;
(C) to permit the Director of the Congressional Budget Office to review the information provided; and
(D) to permit the Medicare Payment Advisory Commission to review the information provided.
(11) Protection from public disclosure
A payor shall not be identified on information reported under this subsection. The name of an applicable laboratory under this subsection shall be exempt from disclosure under
(12) Regulations
Not later than June 30, 2015, the Secretary shall establish through notice and comment rulemaking parameters for data collection under this subsection.
(b) Payment for clinical diagnostic laboratory tests
(1) Use of private payor rate information to determine medicare payment rates
(A) In general
Subject to paragraph (3) and subsections (c) and (d), in the case of a clinical diagnostic laboratory test furnished on or after January 1, 2017, the payment amount under this section shall be equal to the weighted median determined for the test under paragraph (2) for the most recent data collection period.
(B) Application of payment amounts to hospital laboratories
The payment amounts established under this section shall apply to a clinical diagnostic laboratory test furnished by a hospital laboratory if such test is paid for separately, and not as part of a bundled payment under
(2) Calculation of weighted median
For each laboratory test with respect to which information is reported under subsection (a) for a data collection period, the Secretary shall calculate a weighted median for the test for the period, by arraying the distribution of all payment rates reported for the period for each test weighted by volume for each payor and each laboratory.
(3) Phase-in of reductions from private payor rate implementation
(A) In general
Payment amounts determined under this subsection for a clinical diagnostic laboratory test for each of 2017 through 2028 shall not result in a reduction in payments for a clinical diagnostic laboratory test for the year of greater than the applicable percent (as defined in subparagraph (B)) of the amount of payment for the test for the preceding year.
(B) Applicable percent defined
In this paragraph, the term "applicable percent" means—
(i) for each of 2017 through 2020, 10 percent;
(ii) for each of 2021 through 2025, 0 percent; and
(iii) for each of 2026 through 2028, 15 percent.
(C) No application to new tests
This paragraph shall not apply to payment amounts determined under this section for either of the following.
(i) A new test under subsection (c).
(ii) A new advanced diagnostic test 1 (as defined in subsection (d)(5)) under subsection (d).
(4) Application of market rates
(A) In general
Subject to paragraph (3), once established for a year following a data collection period, the payment amounts under this subsection shall continue to apply until the year following the next data collection period.
(B) Other adjustments not applicable
The payment amounts under this section shall not be subject to any adjustment (including any geographic adjustment, budget neutrality adjustment, annual update, or other adjustment).
(5) Sample collection fee
In the case of a sample collected from an individual in a skilled nursing facility or by a laboratory on behalf of a home health agency, the nominal fee that would otherwise apply under
(c) Payment for new tests that are not advanced diagnostic laboratory tests
(1) Payment during initial period
In the case of a clinical diagnostic laboratory test that is assigned a new or substantially revised HCPCS code on or after April 1, 2014, and which is not an advanced diagnostic laboratory test (as defined in subsection (d)(5)), during an initial period until payment rates under subsection (b) are established for the test, payment for the test shall be determined—
(A) using cross-walking (as described in section 414.508(a) of title 42, Code of Federal Regulations, or any successor regulation) to the most appropriate existing test under the fee schedule under this section during that period; or
(B) if no existing test is comparable to the new test, according to the gapfilling process described in paragraph (2).
(2) Gapfilling process described
The gapfilling process described in this paragraph shall take into account the following sources of information to determine gapfill amounts, if available:
(A) Charges for the test and routine discounts to charges.
(B) Resources required to perform the test.
(C) Payment amounts determined by other payors.
(D) Charges, payment amounts, and resources required for other tests that may be comparable or otherwise relevant.
(E) Other criteria the Secretary determines appropriate.
(3) Additional consideration
In determining the payment amount under crosswalking or gapfilling processes under this subsection, the Secretary shall consider recommendations from the panel established under subsection (f)(1).
(4) Explanation of payment rates
In the case of a clinical diagnostic laboratory test for which payment is made under this subsection, the Secretary shall make available to the public an explanation of the payment rate for the test, including an explanation of how the criteria described in paragraph (2) and paragraph (3) are applied.
(d) Payment for new advanced diagnostic laboratory tests
(1) Payment during initial period
(A) In general
In the case of an advanced diagnostic laboratory test for which payment has not been made under the fee schedule under
(B) Actual list charge
For purposes of subparagraph (A), the term "actual list charge", with respect to a laboratory test furnished during such period, means the publicly available rate on the first day at which the test is available for purchase by a private payor.
(2) Special rule for timing of initial reporting
With respect to an advanced diagnostic laboratory test described in paragraph (1)(A), an applicable laboratory shall initially be required to report under subsection (a) not later than the last day of the second quarter of the initial period under such paragraph.
(3) Application of market rates after initial period
Subject to paragraph (4), data reported under paragraph (2) shall be used to establish the payment amount for an advanced diagnostic laboratory test after the initial period under paragraph (1)(A) using the methodology described in subsection (b). Such payment amount shall continue to apply until the year following the next data collection period.
(4) Recoupment if actual list charge exceeds market rate
With respect to the initial period described in paragraph (1)(A), if, after such period, the Secretary determines that the payment amount for an advanced diagnostic laboratory test under paragraph (1)(A) that was applicable during the period was greater than 130 percent of the payment amount for the test established using the methodology described in subsection (b) that is applicable after such period, the Secretary shall recoup the difference between such payment amounts for tests furnished during such period.
(5) Advanced diagnostic laboratory test defined
In this subsection, the term "advanced diagnostic laboratory test" means a clinical diagnostic laboratory test covered under this part that is offered and furnished only by a single laboratory and not sold for use by a laboratory other than the original developing laboratory (or a successor owner) and meets one of the following criteria:
(A) The test is an analysis of multiple biomarkers of DNA, RNA, or proteins combined with a unique algorithm to yield a single patient-specific result.
(B) The test is cleared or approved by the Food and Drug Administration.
(C) The test meets other similar criteria established by the Secretary.
(e) Coding
(1) Temporary codes for certain new tests
(A) In general
The Secretary shall adopt temporary HCPCS codes to identify new advanced diagnostic laboratory tests (as defined in subsection (d)(5)) and new laboratory tests that are cleared or approved by the Food and Drug Administration.
(B) Duration
(i) In general
Subject to clause (ii), the temporary code shall be effective until a permanent HCPCS code is established (but not to exceed 2 years).
(ii) Exception
The Secretary may extend the temporary code or establish a permanent HCPCS code, as the Secretary determines appropriate.
(2) Existing tests
Not later than January 1, 2016, for each existing advanced diagnostic laboratory test (as so defined) and each existing clinical diagnostic laboratory test that is cleared or approved by the Food and Drug Administration for which payment is made under this part as of April 1, 2014, if such test has not already been assigned a unique HCPCS code, the Secretary shall—
(A) assign a unique HCPCS code for the test; and
(B) publicly report the payment rate for the test.
(3) Establishment of unique identifier for certain tests
For purposes of tracking and monitoring, if a laboratory or a manufacturer requests a unique identifier for an advanced diagnostic laboratory test (as so defined) or a laboratory test that is cleared or approved by the Food and Drug Administration, the Secretary shall utilize a means to uniquely track such test through a mechanism such as a HCPCS code or modifier.
(f) Input from clinicians and technical experts
(1) In general
The Secretary shall consult with an expert outside advisory panel, established by the Secretary not later than July 1, 2015, composed of an appropriate selection of individuals with expertise, which may include molecular pathologists, researchers, and individuals with expertise in laboratory science or health economics, in issues related to clinical diagnostic laboratory tests, which may include the development, validation, performance, and application of such tests, to provide—
(A) input on—
(i) the establishment of payment rates under this section for new clinical diagnostic laboratory tests, including whether to use crosswalking or gapfilling processes to determine payment for a specific new test; and
(ii) the factors used in determining coverage and payment processes for new clinical diagnostic laboratory tests; and
(B) recommendations to the Secretary under this section.
(2) Compliance with chapter 10 of title 5
The panel shall be subject to
(3) Continuation of annual meeting
The Secretary shall continue to convene the annual meeting described in
(g) Coverage
(1) Issuance of coverage policies
(A) In general
A medicare administrative contractor shall only issue a coverage policy with respect to a clinical diagnostic laboratory test in accordance with the process for making a local coverage determination (as defined in
(B) No effect on national coverage determination process
This paragraph shall not apply to the national coverage determination process (as defined in
(C) Effective date
This paragraph shall apply to coverage policies issued on or after January 1, 2015.
(2) Designation of one or more medicare administrative contractors for clinical diagnostic laboratory tests
The Secretary may designate one or more (not to exceed 4) medicare administrative contractors to either establish coverage policies or establish coverage policies and process claims for payment for clinical diagnostic laboratory tests, as determined appropriate by the Secretary.
(h) Implementation
(1) Implementation
There shall be no administrative or judicial review under
(2) Administration
(3) Funding
For purposes of implementing this section, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under
(i) Transitional rule
During the period beginning on April 1, 2014, and ending on December 31, 2016, with respect to advanced diagnostic laboratory tests under this part, the Secretary shall use the methodologies for pricing, coding, and coverage in effect on the day before April 1, 2014, which may include cross-walking or gapfilling methods.
(Aug. 14, 1935, ch. 531, title XVIII, §1834A, as added
Editorial Notes
Amendments
2024—Subsec. (a)(1)(B)(i).
Subsec. (a)(1)(B)(ii).
Subsec. (b)(3)(A).
Subsec. (b)(3)(B)(ii).
Subsec. (b)(3)(B)(iii).
2023—Subsec. (a)(1)(B)(i).
Subsec. (a)(1)(B)(ii).
Subsec. (b)(3)(A).
Subsec. (b)(3)(B)(ii).
Subsec. (b)(3)(B)(iii).
2022—Subsec. (a)(1)(B)(i).
Subsec. (a)(1)(B)(ii).
Subsec. (b)(3)(A).
Subsec. (b)(3)(B)(ii).
Subsec. (b)(3)(B)(iii).
Subsec. (f)(2).
2021—Subsec. (a)(1)(B)(i).
Subsec. (a)(1)(B)(ii).
Subsec. (b)(3)(A).
Subsec. (b)(3)(B)(ii).
Subsec. (b)(3)(B)(iii).
2020—Subsec. (a)(1)(B)(i).
Subsec. (a)(1)(B)(ii).
Subsec. (b)(3)(A).
Subsec. (b)(3)(B).
2019—Subsec. (a)(1).
Subsec. (a)(4).
Subsec. (b)(3)(A).
Subsec. (b)(3)(B)(i).
Subsec. (b)(3)(B)(ii).
Statutory Notes and Related Subsidiaries
Monitoring of Medicare Expenditures and Implementation of New Payment System for Laboratory Tests
"(A) publicly release an annual analysis of the top 25 laboratory tests by expenditures under title XVIII of the Social Security Act [
"(B) conduct analyses the Inspector General determines appropriate with respect to the implementation and effect of the new payment system for laboratory tests under section 1834A of the Social Security Act [
1 So in original. Probably should be preceded by "laboratory".
§1395n. Procedure for payment of claims of providers of services
(a) Conditions for payment for services described in section 1395k(a)(2) of this title
Except as provided in subsections (b), (c), and (e), payment for services described in
(1) written request, signed by such individual, except in cases in which the Secretary finds it impracticable for the individual to do so, is filed for such payment in such form, in such manner and by such person or persons as the Secretary may by regulation prescribe, no later than the close of the period ending 1 calendar year after the date of service; and
(2) a physician, or, in the case of services described in subparagraph (A), a physician, a nurse practitioner or clinical nurse specialist (as those terms are defined in
(A) in the case of home health services (i) such services are or were required because the individual is or was confined to his home (except when receiving items and services referred to in
(B) in the case of medical and other health services, except services described in subparagraphs (B), (C), and (D) of
(C) in the case of outpatient physical therapy services or outpatient occupational therapy services, (i) such services are or were required because the individual needed physical therapy services or occupational therapy services, respectively, (ii) a plan for furnishing such services has been established by a physician or by the qualified physical therapist or qualified occupational therapist, respectively, providing such services and is periodically reviewed by a physician, and (iii) such services are or were furnished while the individual is or was under the care of a physician;
(D) in the case of outpatient speech pathology services, (i) such services are or were required because the individual needed speech pathology services, (ii) a plan for furnishing such services has been established by a physician or by the speech pathologist providing such services and is periodically reviewed by a physician, and (iii) such services are or were furnished while the individual is or was under the care of a physician;
(E) in the case of comprehensive outpatient rehabilitation facility services, (i) such services are or were required because the individual needed skilled rehabilitation services, (ii) a plan for furnishing such services has been established and is periodically reviewed by a physician, and (iii) such services are or were furnished while the individual is or was under the care of a physician; and
(F) in the case of partial hospitalization services, (i) the individual would require inpatient psychiatric care in the absence of such services, (ii) an individualized, written plan for furnishing such services has been established by a physician and is reviewed periodically by a physician, and (iii) such services are or were furnished while the individual is or was under the care of a physician.
For purposes of this section, the term "provider of services" shall include a clinic, rehabilitation agency, or public health agency if, in the case of a clinic or rehabilitation agency, such clinic or agency meets the requirements of
To the extent provided by regulations, the certification and recertification requirements of paragraph (2) shall be deemed satisfied where, at a later date, a physician, nurse practitioner, clinical nurse specialist, or physician assistant (as the case may be) makes a certification of the kind provided in subparagraph (A) or (B) of paragraph (2) (whichever would have applied), but only where such certification is accompanied by such medical and other evidence as may be required by such regulations. With respect to the certification required by paragraph (2) for home health services furnished to any individual by a home health agency (other than an agency which is a governmental entity) and with respect to the establishment and review of a plan for such services, the Secretary shall prescribe regulations which shall become effective no later than July 1, 1981 (or in the case of regulations to implement the amendments made by section 3708 of the CARES Act the Secretary shall prescribe regulations which shall become effective no later than 6 months after March 27, 2020), and which prohibit a physician, nurse practitioner, clinical nurse specialist, or physician assistant who has a significant ownership interest in, or a significant financial or contractual relationship with, such home health agency from performing such certification and from establishing or reviewing such plan, except that such prohibition shall not apply with respect to a home health agency which is a sole community home health agency (as determined by the Secretary). For purposes of the preceding sentence, service by a physician, nurse practitioner, clinical nurse specialist, or physician assistant as an uncompensated officer or director of a home health agency shall not constitute having a significant ownership interest in, or a significant financial or contractual relationship with, such agency. For purposes of documentation for physician certification and recertification made under paragraph (2) on or after January 1, 2019 or no later than 6 months after March 27, 2020, for purposes of documentation for certification and recertification made under paragraph (2) by a nurse practitioner, clinical nurse specialist, or physician assistant,,1 and made with respect to home health services furnished by a home health agency, in addition to using documentation in the medical record of the physician, nurse practitioner, clinical nurse specialist, or physician assistant who so certifies or the medical record of the acute or post-acute care facility (in the case that home health services were furnished to an individual who was directly admitted to the home health agency from such a facility), the Secretary may use documentation in the medical record of the home health agency as supporting material, as appropriate to the case involved. For purposes of paragraph (2)(A), an individual shall be considered to be "confined to his home" if the individual has a condition, due to an illness or injury, that restricts the ability of the individual to leave his or her home except with the assistance of another individual or the aid of a supportive device (such as crutches, a cane, a wheelchair, or a walker), or if the individual has a condition such that leaving his or her home is medically contraindicated. While an individual does not have to be bedridden to be considered "confined to his home", the condition of the individual should be such that there exists a normal inability to leave home and that leaving home requires a considerable and taxing effort by the individual. Any absence of an individual from the home attributable to the need to receive health care treatment, including regular absences for the purpose of participating in therapeutic, psychosocial, or medical treatment in an adult day-care program that is licensed or certified by a State, or accredited, to furnish adult day-care services in the State shall not disqualify an individual from being considered to be "confined to his home". Any other absence of an individual from the home shall not so disqualify an individual if the absence is of infrequent or of relatively short duration. For purposes of the preceding sentence, any absence for the purpose of attending a religious service shall be deemed to be an absence of infrequent or short duration. In applying paragraph (1), the Secretary may specify exceptions to the 1 calendar year period specified in such paragraph.
(b) Conditions for payment for services described in section 1395x(s) of this title
(1) Payment may also be made to any hospital for services described in
(2) Payment may also be made on the basis of an itemized bill to an individual for services described in paragraph (1) of this subsection if (A) payment cannot be made under such paragraph (1) solely because the hospital does not elect, in accordance with
(c) Collection of charges from individuals for services specified in section 1395x(s) of this title
Notwithstanding the provisions of this section and
(d) Payment to Federal provider of services or other Federal agencies prohibited
Subject to
(e) Payment to fund designated by medical staff or faculty of medical school
For purposes of services (1) which are inpatient hospital services by reason of paragraph (7) of
(A) such hospital has an agreement with the Secretary under
(B) the Secretary has received written assurances that (i) such payment will be used by such fund solely for the improvement of care to patients in such hospital or for educational or charitable purposes and (ii) the individuals who were furnished such services or any other persons will not be charged for such services (or if charged provision will be made for return of any moneys incorrectly collected).
(Aug. 14, 1935, ch. 531, title XVIII, §1835, as added
Editorial Notes
References in Text
The amendments made by section 3708 of the CARES Act, referred to in subsec. (a), are the amendments made by section 3708 of
Amendments
2020—Subsec. (a).
Subsec. (a)(2).
Subsec. (a)(2)(A)(ii), (iii).
Subsec. (a)(2)(A)(iv).
2018—Subsec. (a).
2010—Subsec. (a).
Subsec. (a)(1).
Subsec. (a)(2).
Subsec. (a)(2)(A)(iv).
2008—Subsec. (a).
2003—Subsec. (a).
2000—Subsec. (a).
1997—Subsec. (a)(2)(A).
Subsec. (c).
1990—Subsec. (c).
1989—Subsec. (a)(2)(G), (H).
Subsec. (c).
1988—Subsec. (a)(2)(G).
Subsec. (a)(2)(H).
1987—Subsec. (a).
Subsec. (a)(2)(C)(i).
Subsec. (a)(2)(F).
1986—Subsec. (a).
Subsec. (a)(2)(C).
1984—Subsec. (a).
Subsec. (a)(2)(B), (C).
Subsec. (a)(2)(C)(ii).
Subsec. (a)(2)(D).
Subsec. (e)(2).
1983—Subsec. (e).
1981—Subsec. (a)(2)(A).
Subsec. (a)(2)(D).
Subsec. (a)(2)(E).
1980—Subsec. (a).
Subsec. (a)(2)(A).
Subsec. (a)(2)(D)(ii).
Subsec. (a)(2)(E).
1976—Subsec. (d).
1972—Subsec. (a).
Subsec. (a)(1).
Subsec. (a)(2)(C).
Subsec. (a)(2)(D).
Subsec. (c).
Subsec. (e).
1968—Subsec. (a).
Subsec. (a)(2).
Subsec. (a)(2)(B).
Subsec. (a)(2)(C).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Statutory Notes and Related Subsidiaries
Effective Date of 2020 Amendment
Secretary of Health and Human Services to prescribe regulations to apply the amendments made by
Effective Date of 2010 Amendment
Amendment by section 6404(a)(2)(B) of
Amendment by section 6405(b)(2) of
Effective Date of 2008 Amendment
Amendment by
Effective Date of 2000 Amendment
Amendment by
Effective Date of 1997 Amendment
Amendment by section 4201(c)(1) of
Amendment by section 4615(a) of
Effective Date of 1989 Amendment
Amendment by
Effective Date of 1988 Amendment
Amendment by section 203(d)(1) of
Amendment by section 205(d) of
Effective Date of 1987 Amendment
Amendment by section 4024(b) of
Effective Date of 1986 Amendment
Amendment by
Effective Date of 1984 Amendment
Amendment by
Amendment by section 2336(a) of
Amendment by section 2354(b)(1), (8), (9) of
Effective Date of 1983 Amendment
Amendment by
Effective Date of 1981 Amendment
Amendment by section 2122(a)(1) of
Effective Date of 1980 Amendment
Amendment by section 930(e), (j) of
Amendment by section 933(b) of
Effective Date of 1972 Amendment
Amendment by section 204(b) of
Amendment by section 227(e)(2) of
Amendment by section 251(b)(2) of
Amendment by section 281(f) of
Effective Date of 1968 Amendment
Amendment by section 126(b) of
Amendment by section 129(c)(9)(A), (B) of
Amendment by section 133(e) of
Regulations
Secretary of Health and Human Services required to provide, not later than 90 days after July 18, 1984, for revision of regulations as may be required to reflect amendment to subsec. (a) by section 2336(b) of
MedPAC Study on Direct Access to Physical Therapy Services
"(a)
"(b)
"(c)
"(1) without regard to any requirement that—
"(A) an individual be under the care of (or referred by) a physician; or
"(B) services be provided under the supervision of a physician; and
"(2) by allowing a physician or a qualified physical therapist to satisfy any requirement for—
"(A) certification and recertification; and
"(B) establishment and periodic review of a plan of care."
Home Health Prospective Payment Demonstration Project
§1395o. Eligible individuals
(a) In general
Every individual who—
(1) is entitled to hospital insurance benefits under part A, or
(2) has attained age 65 and is a resident of the United States, and is either (A) a citizen or (B) an alien lawfully admitted for permanent residence who has resided in the United States continuously during the 5 years immediately preceding the month in which he applies for enrollment under this part,
is eligible to enroll in the insurance program established by this part.
(b) Individuals eligible for immunosuppressive drug coverage
(1) In general
Except as provided under paragraph (2), every individual whose entitlement to insurance benefits under part A ends (whether before, on, or after January 1, 2023) by reason of
(2) Exception if other coverage is available
(A) In general
An individual described in paragraph (1) shall not be eligible for enrollment in the program for purposes of coverage described in such paragraph with respect to any period in which the individual, as determined in accordance with subparagraph (B)—
(i) is enrolled in a group health plan or group or individual health insurance coverage, as such terms are defined in
(ii) is enrolled for coverage under the TRICARE for Life program under
(iii) is enrolled under a State plan (or waiver of such plan) under subchapter XIX and is eligible to receive benefits for immunosuppressive drugs described in this subsection under such plan (or such waiver);
(iv) is enrolled under a State child health plan (or waiver of such plan) under subchapter XXI and is eligible to receive benefits for such drugs under such plan (or such waiver); or
(v)(I) is enrolled in the patient enrollment system of the Department of Veterans Affairs established and operated under
(II) is not required to enroll under section 1705 of such title to receive immunosuppressive drugs described in this subsection; or
(III) is otherwise eligible under a provision of title 38, other than section 1710 of such title to receive immunosuppressive drugs described in this subsection.
(B) Eligibility determinations
(i) In general
The Secretary, in coordination with the Commissioner of Social Security, shall establish a process for determining whether an individual described in paragraph (1) who is to be enrolled or deemed to be enrolled in the medical insurance program described in such paragraph meets the requirements for such enrollment under this subsection, including the requirement that the individual not be enrolled in other coverage as described in subparagraph (A).
(ii) Attestation regarding other coverage
The process established under clause (i) shall include, at a minimum, a requirement that—
(I) the individual provide to the Commissioner an attestation that the individual is not enrolled and does not expect to enroll in such other coverage; and
(II) the individual notify the Commissioner within 60 days of enrollment in such other coverage.
(Aug. 14, 1935, ch. 531, title XVIII, §1836, as added
Editorial Notes
Amendments
2020—
1972—
Statutory Notes and Related Subsidiaries
Persons Convicted of Subversive Activities
§1395p. Enrollment periods
(a) Generally; regulations
An individual may enroll in the insurance program established by this part only in such manner and form as may be prescribed by regulations, and only during an enrollment period prescribed in or under this section.
(b) Repealed. Pub. L. 96–499, title IX, §945(a), Dec. 5, 1980, 94 Stat. 2642
(c) Initial general enrollment period; eligible individuals before March 1, 1966
In the case of individuals who first satisfy paragraph (1) or (2) of
(d) Eligible individuals on or after March 1, 1966
In the case of an individual who first satisfies paragraph (1) or (2) of
(e) General enrollment period
There shall be a general enrollment period during the period beginning on January 1 and ending on March 31 of each year.
(f) Individuals deemed enrolled in medical insurance program
Any individual—
(1) who is eligible under
(2) whose initial enrollment period under subsection (d) begins after March 31, 1973, and
(3) who is residing in the United States, exclusive of Puerto Rico,
shall be deemed to have enrolled in the medical insurance program established by this part.
(g) Commencement of enrollment period
All of the provisions of this section shall apply to individuals satisfying subsection (f), except that—
(1) in the case of an individual who satisfies subsection (f) by reason of entitlement to disability insurance benefits described in
(2)(A) in the case of an individual who is entitled to monthly benefits under
(B) in the case of an individual who is not entitled to benefits under
(3) in the case of an individual who would otherwise satisfy subsection (f) but does not establish his entitlement to hospital insurance benefits until after the last day of his initial enrollment period (as defined in subsection (d) of this section), his enrollment shall be deemed to have occurred on the first day of the earlier of the then current or immediately succeeding general enrollment period (as defined in subsection (e) of this section).
(h) Waiver of enrollment period requirements where individual's rights were prejudiced by administrative error or inaction
In any case where the Secretary finds that an individual's enrollment or nonenrollment in the insurance program established by this part or part A pursuant to
(i) Special enrollment periods
(1) In the case of an individual who—
(A) at the time the individual first satisfies paragraph (1) or (2) of
(B) has elected not to enroll (or to be deemed enrolled) under this section during the individual's initial enrollment period,
there shall be a special enrollment period described in paragraph (3). In the case of an individual not described in the previous sentence who has not attained the age of 65, at the time the individual first satisfies paragraph (1) of
(2) In the case of an individual who—
(A)(i) has enrolled (or has been deemed to have enrolled) in the medical insurance program established under this part during the individual's initial enrollment period, or (ii) is an individual described in paragraph (1)(A);
(B) has enrolled in such program during any subsequent special enrollment period under this subsection during which the individual was not enrolled in a group health plan described in
(C) has not terminated enrollment under this section at any time at which the individual is not enrolled in such a group health plan by reason of the individual's (or individual's spouse's) current employment status,
there shall be a special enrollment period described in paragraph (3). In the case of an individual not described in the previous sentence who has not attained the age of 65, has enrolled (or has been deemed to have enrolled) in the medical insurance program established under this part during the individual's initial enrollment period, or is an individual described in the second sentence of paragraph (1), has enrolled in such program during any subsequent special enrollment period under this subsection during which the individual was not enrolled in a large group health plan (as that term is defined in
(3)(A) The special enrollment period referred to in the first sentences of paragraphs (1) and (2) is the period including each month during any part of which the individual is enrolled in a group health plan described in
(B) The special enrollment period referred to in the second sentences of paragraphs (1) and (2) is the period including each month during any part of which the individual is enrolled in a large group health plan (as that term is defined in
(4)(A) In the case of an individual who is entitled to benefits under part A pursuant to
(i) who at the time the individual first satisfies paragraph (1) of
(I) is enrolled in a group health plan described in
(II) has elected not to enroll (or to be deemed enrolled) under this section during the individual's initial enrollment period; and
(ii) whose continuous enrollment under such group health plan is involuntarily terminated at a time when the enrollment under the plan is not by reason of the individual's current employment or by reason of the current employment of a member of the individual's family,
there shall be a special enrollment period described in subparagraph (B).
(B) The special enrollment period referred to in subparagraph (A) is the 6-month period beginning on the first day of the month which includes the date of the enrollment termination described in subparagraph (A)(ii).
(j) Special rules for individuals with ALS
In applying this section in the case of an individual who is entitled to benefits under part A pursuant to the operation of
(1) The initial enrollment period under subsection (d) shall begin on the first day of the first month in which the individual satisfies the requirement of
(2) In applying subsection (g)(1), the initial enrollment period shall begin on the first day of the first month of entitlement to disability insurance benefits referred to in such subsection.
(k) Special enrollment period for certain volunteers serving outside United States
(1) In the case of an individual who—
(A) at the time the individual first satisfies paragraph (1) or (2) of
(B) has terminated enrollment under this section during a month in which the individual is described in paragraph (3),
there shall be a special enrollment period described in paragraph (2).
(2) The special enrollment period described in this paragraph is the 6-month period beginning on the first day of the month which includes the date that the individual is no longer described in paragraph (3).
(3) For purposes of paragraph (1), an individual described in this paragraph is an individual who—
(A) is serving as a volunteer outside of the United States through a program—
(i) that covers at least a 12-month period; and
(ii) that is sponsored by an organization described in section 501(c)(3) of the Internal Revenue Code of 1986 and exempt from taxation under section 501(a) of such Code; and
(B) demonstrates health insurance coverage while serving in the program.
(l) Special enrollment period for disabled TRICARE beneficiaries
(1) In the case of any individual who is a covered beneficiary (as defined in
(2) The special enrollment period described in this paragraph, with respect to an individual, is the 12-month period beginning on the day after the last day of the initial enrollment period of the individual or, if later, the 12-month period beginning with the month the individual is notified of enrollment under this section.
(3) In the case of an individual who enrolls during the special enrollment period provided under paragraph (1), the coverage period under this part shall begin on the first day of the month in which the individual enrolls, or, at the option of the individual, the first month after the end of the individual's initial enrollment period.
(4) An individual may only enroll during the special enrollment period provided under paragraph (1) one time during the individual's lifetime.
(5) The Secretary shall ensure that the materials relating to coverage under this part that are provided to an individual described in paragraph (1) prior to the individual's initial enrollment period contain information concerning the impact of not enrolling under this part, including the impact on health care benefits under the TRICARE program under
(6) The Secretary of Defense shall collaborate with the Secretary of Health and Human Services and the Commissioner of Social Security to provide for the accurate identification of individuals described in paragraph (1). The Secretary of Defense shall provide such individuals with notification with respect to this subsection. The Secretary of Defense shall collaborate with the Secretary of Health and Human Services and the Commissioner of Social Security to ensure appropriate follow up pursuant to any notification provided under the preceding sentence.
(m) Special enrollment periods for exceptional circumstances
Beginning January 1, 2023, the Secretary may establish special enrollment periods in the case of individuals who satisfy paragraph (1) or (2) of
(n) Enrollment for individuals only eligible for coverage of immunosuppressive drugs
(1) Any individual who is eligible for coverage of immunosuppressive drugs under
(2) An individual described in paragraph (1) whose entitlement for hospital insurance benefits under part A ends by reason of
(3) An individual described in paragraph (1) whose entitlement for hospital insurance benefits under part A ends by reason of
(4) The Secretary shall establish a process under which an individual described in paragraph (1) whose other coverage described in
(o) Special enrollment period for certain Postal Service annuitants and family members
(1) In the case of an individual who—
(A) as of January 1, 2024, is—
(i) a Postal Service annuitant who is entitled to benefits under part A of this subchapter, but excluding an individual who is eligible to enroll under such part under
(ii) a member of family (as defined in
(B) is not enrolled under this part, the individual may elect to be enrolled under this part during a special enrollment period during the 6-month period beginning on April 1, 2024.
(2) In this subsection, the term "Postal Service annuitant" means an annuitant enrolled in a health benefits plan under
(Aug. 14, 1935, ch. 531, title XVIII, §1837, as added
Editorial Notes
References in Text
Section 501 of the Internal Revenue Code of 1986, referred to in subsec. (k)(3)(A)(ii), is classified to
Amendments
2022—Subsec. (o).
2020—
Subsec. (j)(1).
Subsec. (m).
Subsec. (n).
2010—Subsec. (l).
2006—Subsec. (k).
2000—Subsec. (j).
1997—Subsec. (i)(1) to (3).
Subsec. (i)(4).
1994—Subsec. (i)(1).
Subsec. (i)(1)(A).
Subsec. (i)(2).
Subsec. (i)(2)(B), (C).
Subsec. (i)(3)(A).
Subsec. (i)(3)(B).
1989—Subsec. (i)(1).
Subsec. (i)(2).
Subsec. (i)(3).
1986—Subsec. (i)(1).
Subsec. (i)(1)(A).
Subsec. (i)(2).
Subsec. (i)(2)(A).
Subsec. (i)(2)(B).
Subsec. (i)(2)(C), (D).
Subsec. (i)(3).
1984—Subsec. (g)(1).
Subsec. (i).
1981—Subsec. (e).
Subsec. (g)(3).
1980—Subsec. (b).
Subsec. (e).
Subsec. (g)(1).
Subsec. (g)(3).
1972—Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsecs. (f), (g).
Subsec. (h).
1968—Subsec. (b)(1).
Subsec. (d).
Subsec. (e).
1966—Subsec. (c).
Subsec. (d).
Statutory Notes and Related Subsidiaries
Effective Date of 2010 Amendment
[
Effective Date of 2006 Amendment
Effective Date of 2000 Amendment
Amendment by
Effective Date of 1997 Amendment
Effective Date of 1994 Amendment
Effective Date of 1989 Amendment
Amendment by section 6202(b)(4)(C) of
Effective Date of 1986 Amendment
Amendment by
Amendment by
"(i) The amendments made by paragraph (2) [amending this section] shall apply to enrollments in months beginning with the first effective month (as defined in clause (ii)), except that in the case of any individual who would have a special enrollment period under section 1837(i) of the Social Security Act [
"(ii) For purposes of clause (i), the term 'first effective month' means the first month that begins more than 90 days after the date of the enactment of this Act [Apr. 7, 1986]."
Effective Date of 1984 Amendment
"(A) The amendments made by subsections (b) and (c) [amending this section and
"(B) For purposes of subparagraph (A), the term 'first effective month' means the first month which begins more than 90 days after the date of the enactment of this Act [July 18, 1984]."
Amendment by section 2354(b)(10) of
Effective Date of 1981 Amendment
Effective Date of 1980 Amendment
Amendment by
Effective Date of 1972 Amendment
Effective Date of 1968 Amendment
Medicare Part B Special Enrollment Period
"(1)
"(2)
Extension Through March 31, 1968 of 1967 General Enrollment Period
Enrollment Before Oct. 1, 1966, of Eligible Individuals Failing for Good Cause To Enroll Before June 1, 1966; Commencement of Coverage Period
"(1) an individual was eligible to enroll under section 1837(c) of the Social Security Act [
"(2) it is shown to the satisfaction of the Secretary of Health, Education, and Welfare [now Health and Human Services] that there was good cause for such failure to enroll before June 1, 1966,
such individual may enroll pursuant to this subsection at any time before October 1, 1966. The determination of what constitutes good cause for purposes of the preceding sentence shall be made in accordance with regulations of the Secretary. In the case of any individual who enrolls pursuant to this subsection, the coverage period (within the meaning of section 1838 of the Social Security Act [
1 So in original. Probably should be "involuntarily".
§1395q. Coverage period
(a) Commencement
The period during which an individual is entitled to benefits under the insurance program established by this part (hereinafter referred to as his "coverage period") shall begin on whichever of the following is the latest:
(1) July 1, 1966, or (in the case of a disabled individual who has not attained age 65) July 1, 1973; or
(2)(A) in the case of an individual who enrolls pursuant to subsection (d) of
(B) in the case of an individual who first satisfies such paragraph in a month beginning before January 2023 and who enrolls pursuant to such subsection (d)—
(i) in such month in which he first satisfies such paragraph, the first day of the month following the month in which he so enrolls,
(ii) in the month following such month in which he first satisfies such paragraph, the first day of the second month following the month in which he so enrolls, or
(iii) more than one month following such month in which he satisfies such paragraph, the first day of the third month following the month in which he so enrolls,
(C) in the case of an individual who first satisfies such paragraph in a month beginning on or after January 1, 2023, and who enrolls pursuant to such subsection (d) in such month in which he first satisfies such paragraph or in any subsequent month of his initial enrollment period, the first day of the month following the month in which he so enrolls, or
(D) in the case of an individual who enrolls pursuant to subsection (e) of
(i) before January 1, 2023, the July 1 following the month in which he so enrolls; or
(ii) on or after January 1, 2023, the first day of the month following the month in which he so enrolls; or
(3) in the case of an individual who is deemed to have enrolled—
(A) on or before the last day of the third month of his initial enrollment period, the first day of the month in which he first meets the applicable requirements of
(B) on or after the first day of the fourth month of his initial enrollment period, and where such month begins—
(i) before January 1, 2023, as prescribed under subparagraphs (B)(i), (B)(ii), (B)(iii), and (D)(i) of paragraph (2), or
(ii) on or after January 1, 2023, as prescribed under subparagraphs (C) and (D)(ii) of paragraph (2).
(b) Continuation
An individual's coverage period shall continue until his enrollment has been terminated—
(1) by the filing of notice that the individual no longer wishes to participate in the insurance program established by this part, or
(2) for nonpayment of premiums.
The termination of a coverage period under paragraph (1) shall (except as otherwise provided in
Where an individual who is deemed to have enrolled for medical insurance pursuant to
(c) Termination
In the case of an individual satisfying paragraph (1) of
(d) Payment of expenses incurred during coverage period
No payments may be made under this part with respect to the expenses of an individual unless such expenses were incurred by such individual during a period which, with respect to him, is a coverage period.
(e) Commencement of coverage for special enrollment periods
Notwithstanding subsection (a), in the case of an individual who enrolls during a special enrollment period pursuant to
(1) in any month of the special enrollment period in which the individual is at any time enrolled in a plan (specified in subparagraph (A) or (B), as applicable, of
(2) in any other month of the special enrollment period, the coverage period shall begin on the first day of the month following the month in which the individual so enrolls.
(f) Commencement of coverage for certain volunteers serving outside United States
Notwithstanding subsection (a), in the case of an individual who enrolls during a special enrollment period pursuant to
(g) Special enrollment periods for exceptional circumstances
Notwithstanding subsection (a), in the case of an individual who enrolls during a special enrollment period pursuant to
(h) Coverage period for individuals only eligible for coverage of immunosuppressive drugs
In the case of an individual described in
(1) In the case of such an individual who is deemed to have enrolled in part B for coverage of immunosuppressive drugs under
(2) In the case of such an individual who enrolls (or reenrolls, if applicable) in part B for coverage of immunosuppressive drugs under paragraph (2) or (4) of
(3) The provisions of subsections (b) and (d) shall apply with respect to an individual described in paragraph (1) or (2).
(4) In addition to the reasons for termination under subsection (b), the coverage period of an individual described in paragraph (1) or (2) shall end when the individual becomes entitled to benefits under this subchapter under subsection (a) or (b) of
(5) The Secretary may conduct public education activities to raise awareness of the availability of more comprehensive, individual health insurance coverage (as defined in
(i) Coverage period for certain Postal Service annuitants and family members
Notwithstanding subsection (a), in the case of an individual who enrolls during the special enrollment period pursuant to
(Aug. 14, 1935, ch. 531, title XVIII, §1838, as added
Editorial Notes
Amendments
2022—Subsec. (i).
2020—Subsec. (a)(2).
Subsec. (a)(3).
"(A) in the case of an individual who is deemed to have enrolled on or before the last day of the third month of his initial enrollment period, the first day of the month in which he first meets the applicable requirements of
"(B) in the case of an individual who is deemed to have enrolled on or after the first day of the fourth month of his initial enrollment period, as prescribed under subparagraphs (B), (C), (D), and (E) of paragraph (2) of this subsection."
Subsec. (b).
Subsec. (c).
Subsec. (g).
Subsec. (h).
2006—Subsec. (f).
2003—Subsec. (a)(1).
1997—Subsec. (e).
1994—Subsec. (e).
"(1) in the first month of the special enrollment period, the coverage period shall begin on the first day of that month, or
"(2) in a month after the first month of the special enrollment period, the coverage period shall begin on the first day of the month following the month in which the individual so enrolls."
1986—Subsec. (b).
Subsec. (e).
"(1) subparagraph (A) of
"(A) before the month in which he attains the age of 70, the coverage period shall begin on the first day of the month in which he has attained the age of 70, or
"(B) in or after the month in which he attains the age of 70, the coverage period shall begin on the first day of the month following the month in which he so enrolls; or
"(2) subparagraph (B) of
"(A) in the first month of the special enrollment period, the coverage period shall begin on the first day of such month, or
"(B) in a month after the first month of the special enrollment period, the coverage period shall begin on the first day of the month following the month in which he so enrolls."
1984—Subsec. (e).
1981—Subsec. (a)(2)(E).
Subsec. (b).
1980—Subsec. (a)(2)(E).
Subsec. (b).
1972—Subsec. (a)(1).
Subsec. (a)(2).
Subsec. (a)(3).
Subsec. (b).
Subsecs. (c), (d).
1968—Subsec. (b).
Statutory Notes and Related Subsidiaries
Effective Date of 2006 Amendment
Amendment by
Effective Date of 1997 Amendment
Amendment by
Effective Date of 1994 Amendment
Amendment by
Effective Date of 1986 Amendment
Amendment by
Effective Date of 1984 Amendment
For effective date of amendment by
Effective Date of 1981 Amendment
Amendment by section 2106(b)(2) of
Amendment by section 2151(a)(3) of
Effective Date of 1980 Amendment
Amendment by section 945(c)(1) of
Amendment by section 947(b) of
Effective Date of 1972 Amendment
Effective Date of 1968 Amendment
Amendment by
Coverage Period; Termination Dates
"(1) shall terminate at the close of December 31, 1967, if he filed his notice of termination before January 1, 1968, or
"(2) shall terminate at the close of March 31, 1968, if he filed his notice of termination after December 31, 1967, and before April 1, 1968.
An individual whose coverage period terminated pursuant to paragraph (1) at the close of December 31, 1967, may, notwithstanding section 1837(b)(2) of such Act [
Extension of 1967 General Enrollment Period Through March 31, 1968
Extension of the general enrollment period under
Coverage Period for Individuals Becoming Eligible in March 1966 Who Enroll in May 1966
Commencement of Coverage Period of Certain Enrollees
Commencement of coverage period upon enrollment before Oct. 1, 1966 of eligible individuals failing for good cause to enroll before June 1, 1966, see section 102(b) of
§1395r. Amount of premiums for individuals enrolled under this part
(a) Determination of monthly actuarial rates and premiums
(1) The Secretary shall, during September of 1983 and of each year thereafter, determine the monthly actuarial rate for enrollees age 65 and over which shall be applicable for the succeeding calendar year. Subject to paragraphs (5), (6), and (7), such actuarial rate shall be the amount the Secretary estimates to be necessary so that the aggregate amount for such calendar year with respect to those enrollees age 65 and older will equal one-half of the total of the benefits and administrative costs which he estimates will be payable from the Federal Supplementary Medical Insurance Trust Fund for services performed and related administrative costs incurred in such calendar year with respect to such enrollees. In calculating the monthly actuarial rate, the Secretary shall include an appropriate amount for a contingency margin. In applying this paragraph there shall not be taken into account additional payments under
(2) The monthly premium of each individual enrolled under this part for each month after December 1983 shall be the amount determined under paragraph (3), adjusted as required in accordance with subsections (b), (c), (f), and (i), and to reflect any credit provided under
(3) The Secretary, during September of each year, shall determine and promulgate a monthly premium rate for the succeeding calendar year that (except as provided in subsection (g)) is equal to 50 percent of the monthly actuarial rate for enrollees age 65 and over, determined according to paragraph (1), for that succeeding calendar year. Whenever the Secretary promulgates the dollar amount which shall be applicable as the monthly premium rate for any period, he shall, at the time such promulgation is announced, issue a public statement setting forth the actuarial assumptions and bases employed by him in arriving at the amount of an adequate actuarial rate for enrollees age 65 and older as provided in paragraph (1).
(4) The Secretary shall also, during September of 1983 and of each year thereafter, determine the monthly actuarial rate for disabled enrollees under age 65 which shall be applicable for the succeeding calendar year. Such actuarial rate shall be the amount the Secretary estimates to be necessary so that the aggregate amount for such calendar year with respect to disabled enrollees under age 65 will equal one-half of the total of the benefits and administrative costs which he estimates will be payable from the Federal Supplementary Medical Insurance Trust Fund for services performed and related administrative costs incurred in such calendar year with respect to such enrollees. In calculating the monthly actuarial rate under this paragraph, the Secretary shall include an appropriate amount for a contingency margin.
(5)(A) In applying this part (including subsection (i) and
(B) Subsection (f) shall continue to be applied to paragraph (6)(A) (during a repayment month, as described in paragraph (6)(B)) and without regard to the application of subparagraph (A).
(6)(A) With respect to a repayment month (as described in subparagraph (B)), the monthly premium otherwise established under paragraph (3) shall be increased by, subject to subparagraph (D), $3.
(B) For purposes of this paragraph, a repayment month is a month during a year, beginning with 2016, for which a balance due amount is computed under subparagraph (C) as greater than zero.
(C) For purposes of this paragraph, the balance due amount computed under this subparagraph, with respect to a month, is the amount estimated by the Chief Actuary of the Centers for Medicare & Medicaid Services to be equal to—
(i) the amount transferred under subsections (d)(1) and (e)(1) of
(ii) the amount that is equal to the aggregate reduction, for all individuals enrolled under this part, in the income related monthly adjustment amount as a result of the application of paragraphs (5) and (7); minus
(iii) the amounts payable under this part as a result of the application of this paragraph for preceding months.
(D) If the balance due amount computed under subparagraph (C), without regard to this subparagraph, for December of a year would be less than zero, the Chief Actuary of the Centers for Medicare & Medicaid Services shall estimate, and the Secretary shall apply, a reduction to the dollar amount increase applied under subparagraph (A) for each month during such year in a manner such that the balance due amount for January of the subsequent year is equal to zero.
(7)(A) In applying this part (including subsection (i) and
(i) the monthly actuarial rate for enrollees age 65 and over for 2020; plus
(ii) 25 percent of the difference between such rate for 2020 and the preliminary monthly actuarial rate for enrollees age 65 and over for 2021 (as estimated under subparagraph (B)).
(B) For purposes of subparagraph (A)(ii), the Secretary shall estimate a preliminary monthly actuarial rate for enrollees age 65 and over for 2021 using the methodology described in paragraph (1) and as if subparagraph (A) of this paragraph did not apply. The Secretary shall make the estimate under the previous sentence as if the transfers described in
(b) Increase in monthly premium
In the case of an individual whose coverage period began pursuant to an enrollment after his initial enrollment period (determined pursuant to subsection (c) or (d) of
(c) Premiums rounded to nearest multiple of ten cents
If any monthly premium determined under the foregoing provisions of this section is not a multiple of 10 cents, such premium shall be rounded to the nearest multiple of 10 cents.
(d) "Continuous period of eligibility" defined
For purposes of subsection (b) (and
(e) State payment of part B late enrollment premium increases
(1) Upon the request of a State (or any appropriate State or local governmental entity specified by the Secretary), the Secretary may enter into an agreement with the State (or such entity) under which the State (or such entity) agrees to pay on a quarterly or other periodic basis to the Secretary (to be deposited in the Treasury to the credit of the Federal Supplementary Medical Insurance Trust Fund) an amount equal to the amount of the part B late enrollment premium increases with respect to the premiums for eligible individuals (as defined in paragraph (3)(A)(i)). The Secretary shall enter into an agreement with the United States Postal Service under which the United States Postal Service agrees to pay on a quarterly or other periodic basis to the Secretary (to be deposited in the Treasury to the credit of the Federal Supplementary Medical Insurance Trust Fund) an amount equal to the amount of the part B late enrollment premium increases with respect to the premiums for eligible individuals (as defined in paragraph (3)(A)(ii))..1
(2) No part B late enrollment premium increase shall apply to an eligible individual for premiums for months for which the amount of such an increase is payable under an agreement under paragraph (1).
(3) In this subsection:
(A) The term "eligible individual" means an individual who is enrolled under this part B 1 and who—
(i) in the case of an agreement entered into under the first sentence of paragraph (1), is within a class of individuals specified in such agreement; and
(ii) in the case of an agreement entered into under the second sentence of paragraph (1), is so enrolled under this part pursuant to the special enrollment period under
(B) The term "part B late enrollment premium increase" means any increase in a premium as a result of the application of subsection (b).
(f) Limitation on increase in monthly premium
For any calendar year after 1988, if an individual is entitled to monthly benefits under
(g) Exclusions from estimate of benefits and administrative costs
In estimating the benefits and administrative costs which will be payable from the Federal Supplementary Medical Insurance Trust Fund for a year for purposes of determining the monthly premium rate under subsection (a)(3), the Secretary shall exclude an estimate of any benefits and administrative costs attributable to—
(1) the application of
(2) the medicare prescription drug discount card and transitional assistance program under
(h) Potential application of comparative cost adjustment in CCA areas
(1) In general
Certain individuals who are residing in a CCA area under section 1395w–29 3 of this title who are not enrolled in an MA plan under part C may be subject to a premium adjustment under subsection (f) of such section for months in which the CCA program under such section is in effect in such area.
(2) No effect on late enrollment penalty or income-related adjustment in subsidies
Nothing in this subsection or section 1395w–29(f) 3 of this title shall be construed as affecting the amount of any premium adjustment under subsection (b) or (i). Subsection (f) shall be applied without regard to any premium adjustment referred to in paragraph (1).
(3) Implementation
In order to carry out a premium adjustment under this subsection and section 1395w–29(f) 3 of this title (insofar as it is effected through the manner of collection of premiums under
(A) at the beginning of each year, the name, social security account number, and the amount of the premium adjustment (if any) for each individual enrolled under this part for each month during the year; and
(B) periodically throughout the year, information to update the information previously transmitted under this paragraph for the year.
(i) Reduction in premium subsidy based on income
(1) In general
In the case of an individual whose modified adjusted gross income exceeds the threshold amount under paragraph (2), the monthly amount of the premium subsidy applicable to the premium under this section for a month after December 2006 shall be reduced (and the monthly premium shall be increased) by the monthly adjustment amount specified in paragraph (3).
(2) Threshold amount
For purposes of this subsection, subject to paragraph (6), the threshold amount is—
(A) except as provided in subparagraph (B), $80,000 (or, beginning with 2018, $85,000), and
(B) in the case of a joint return, twice the amount applicable under subparagraph (A) for the calendar year.
(3) Monthly adjustment amount
(A) In general
Subject to subparagraph (B), the monthly adjustment amount specified in this paragraph for an individual for a month in a year is equal to the product of the following:
(i) Sliding scale percentage
Subject to paragraph (6), the applicable percentage specified in the applicable table in subparagraph (C) for the individual minus 25 percentage points.
(ii) Unsubsidized part B premium amount
(I) 200 percent of the monthly actuarial rate for enrollees age 65 and over (as determined under subsection (a)(1) for the year); plus
(II) 4 times the amount of the increase in the monthly premium under subsection (a)(6) for a month in the year (or, with respect to an individual enrolled under
(B) 3-year phase in
The monthly adjustment amount specified in this paragraph for an individual for a month in a year before 2009 is equal to the following percentage of the monthly adjustment amount specified in subparagraph (A):
(i) For 2007, 33 percent.
(ii) For 2008, 67 percent.
(C) Applicable percentage
(i) In general
(I) Subject to paragraphs (5) and (6), for years before 2018:
| If the modified adjusted gross income is: | The applicable percentage is: |
|---|---|
| More than $80,000 but not more than $100,000 | 35 percent |
| More than $100,000 but not more than $150,000 | 50 percent |
| More than $150,000 but not more than $200,000 | 65 percent |
| More than $200,000 | 80 percent. |
(II) Subject to paragraph (5), for 2018:
| If the modified adjusted gross income is: | The applicable percentage is: |
|---|---|
| More than $85,000 but not more than $107,000 | 35 percent |
| More than $107,000 but not more than $133,500 | 50 percent |
| More than $133,500 but not more than $160,000 | 65 percent |
| More than $160,000 | 80 percent. |
(III) Subject to paragraph (5), for years beginning with 2019:
| If the modified adjusted gross income is: | The applicable percentage is: |
|---|---|
| More than $85,000 but not more than $107,000 | 35 percent |
| More than $107,000 but not more than $133,500 | 50 percent |
| More than $133,500 but not more than $160,000 | 65 percent |
| More than $160,000 but less than $500,000 | 80 percent |
| At least $500,000 | 85 percent. |
(ii) Joint returns
In the case of a joint return, clause (i) shall be applied by substituting dollar amounts which are twice the dollar amounts otherwise applicable under clause (i) for the calendar year except, with respect to the dollar amounts applied in the last row of the table under subclause (III) of such clause (and the second dollar amount specified in the second to last row of such table), clause (i) shall be applied by substituting dollar amounts which are 150 percent of such dollar amounts for the calendar year.
(iii) Married individuals filing separate returns
In the case of an individual who—
(I) is married as of the close of the taxable year (within the meaning of section 7703 of the Internal Revenue Code of 1986) but does not file a joint return for such year, and
(II) does not live apart from such individual's spouse at all times during the taxable year,
clause (i) shall be applied by reducing each of the dollar amounts otherwise applicable under such clause for the calendar year by the threshold amount for such year applicable to an unmarried individual.
(4) Modified adjusted gross income
(A) In general
For purposes of this subsection, the term "modified adjusted gross income" means adjusted gross income (as defined in section 62 of the Internal Revenue Code of 1986)—
(i) determined without regard to sections 135, 911, 931, and 933 of such Code; and
(ii) increased by the amount of interest received or accrued during the taxable year which is exempt from tax under such Code.
In the case of an individual filing a joint return, any reference in this subsection to the modified adjusted gross income of such individual shall be to such return's modified adjusted gross income.
(B) Taxable year to be used in determining modified adjusted gross income
(i) In general
In applying this subsection for an individual's premiums in a month in a year, subject to clause (ii) and subparagraph (C), the individual's modified adjusted gross income shall be such income determined for the individual's last taxable year beginning in the second calendar year preceding the year involved.
(ii) Temporary use of other data
If, as of October 15 before a calendar year, the Secretary of the Treasury does not have adequate data for an individual in appropriate electronic form for the taxable year referred to in clause (i), the individual's modified adjusted gross income shall be determined using the data in such form from the previous taxable year. Except as provided in regulations prescribed by the Commissioner of Social Security in consultation with the Secretary, the preceding sentence shall cease to apply when adequate data in appropriate electronic form are available for the individual for the taxable year referred to in clause (i), and proper adjustments shall be made to the extent that the premium adjustments determined under the preceding sentence were inconsistent with those determined using such taxable year.
(iii) Non-filers
In the case of individuals with respect to whom the Secretary of the Treasury does not have adequate data in appropriate electronic form for either taxable year referred to in clause (i) or clause (ii), the Commissioner of Social Security, in consultation with the Secretary, shall prescribe regulations which provide for the treatment of the premium adjustment with respect to such individual under this subsection, including regulations which provide for—
(I) the application of the highest applicable percentage under paragraph (3)(C) to such individual if the Commissioner has information which indicates that such individual's modified adjusted gross income might exceed the threshold amount for the taxable year referred to in clause (i), and
(II) proper adjustments in the case of the application of an applicable percentage under subclause (I) to such individual which is inconsistent with such individual's modified adjusted gross income for such taxable year.
(C) Use of more recent taxable year
(i) In general
The Commissioner of Social Security in consultation with the Secretary of the Treasury shall establish a procedures under which an individual's modified adjusted gross income shall, at the request of such individual, be determined under this subsection—
(I) for a more recent taxable year than the taxable year otherwise used under subparagraph (B), or
(II) by such methodology as the Commissioner, in consultation with such Secretary, determines to be appropriate, which may include a methodology for aggregating or disaggregating information from tax returns in the case of marriage or divorce.
(ii) Standard for granting requests
A request under clause (i)(I) to use a more recent taxable year may be granted only if—
(I) the individual furnishes to such Commissioner with respect to such year such documentation, such as a copy of a filed Federal income tax return or an equivalent document, as the Commissioner specifies for purposes of determining the premium adjustment (if any) under this subsection; and
(II) the individual's modified adjusted gross income for such year is significantly less than such income for the taxable year determined under subparagraph (B) by reason of the death of such individual's spouse, the marriage or divorce of such individual, or other major life changing events specified in regulations prescribed by the Commissioner in consultation with the Secretary.
(5) Inflation adjustment
(A) In general
Subject to subparagraph (C), in the case of any calendar year beginning after 2007 (other than 2018 and 2019), each dollar amount in paragraph (2) or (3) shall be increased by an amount equal to—
(i) such dollar amount, multiplied by
(ii) the percentage (if any) by which the average of the Consumer Price Index for all urban consumers (United States city average) for the 12-month period ending with August of the preceding calendar year exceeds such average for the 12-month period ending with August 2006 (or, in the case of a calendar year beginning with 2020, August 2018).
(B) Rounding
If any dollar amount after being increased under subparagraph (A) or (C) is not a multiple of $1,000, such dollar amount shall be rounded to the nearest multiple of $1,000.
(C) Treatment of adjustments for certain higher income individuals
(i) In general
Subparagraph (A) shall not apply with respect to each dollar amount in paragraph (3) of $500,000.
(ii) Adjustment beginning 2028
In the case of any calendar year beginning after 2027, each dollar amount in paragraph (3) of $500,000 shall be increased by an amount equal to—
(I) such dollar amount, multiplied by
(II) the percentage (if any) by which the average of the Consumer Price Index for all urban consumers (United States city average) for the 12-month period ending with August of the preceding calendar year exceeds such average for the 12-month period ending with August 2026.
(6) Temporary adjustment to income thresholds
Notwithstanding any other provision of this subsection, during the period beginning on January 1, 2011, and ending on December 31, 2017—
(A) the threshold amount otherwise applicable under paragraph (2) shall be equal to such amount for 2010; and
(B) the dollar amounts otherwise applicable under paragraph (3)(C)(i) shall be equal to such dollar amounts for 2010.
(7) Joint return defined
For purposes of this subsection, the term "joint return" has the meaning given to such term by section 7701(a)(38) of the Internal Revenue Code of 1986.
(j) Determination of premium for individuals only eligible for coverage of immunosuppressive drugs
The Secretary shall, during September of each year (beginning with 2022), determine and promulgate a monthly premium rate for the succeeding calendar year for individuals enrolled only for the purpose of coverage of immunosuppressive drugs under
(Aug. 14, 1935, ch. 531, title XVIII, §1839, as added
Editorial Notes
References in Text
The Railroad Retirement Act of 1974, referred to in subsec. (f), is act Aug. 29, 1935, ch. 812, as amended generally by
The Internal Revenue Code of 1986, referred to in subsec. (i)(3)(C)(iii)(I), (4)(A), (7), is classified generally to Title 26, Internal Revenue Code.
Amendments
2022—Subsec. (e)(1).
Subsec. (e)(3)(A).
2020—Subsec. (a)(1).
Subsec. (a)(6)(C)(i).
Subsec. (a)(6)(C)(ii).
Subsec. (a)(7).
Subsec. (b).
Subsec. (d).
Subsec. (f).
Subsec. (i)(3)(A)(ii)(I).
Subsec. (i)(3)(A)(ii)(II).
Subsec. (j).
2018—Subsec. (i)(3)(C)(i)(II).
Subsec. (i)(3)(C)(i)(III).
Subsec. (i)(3)(C)(ii).
Subsec. (i)(5)(A).
Subsec. (i)(5)(B).
Subsec. (i)(5)(C).
2015—Subsec. (a)(1).
Subsec. (a)(5), (6).
Subsec. (i)(2)(A).
Subsec. (i)(3)(A)(i).
Subsec. (i)(3)(A)(ii).
Subsec. (i)(3)(C)(i).
Subsec. (i)(5)(A).
Subsec. (i)(5)(A)(ii).
Subsec. (i)(6).
2010—Subsec. (b).
Subsec. (i)(2).
Subsec. (i)(3)(A)(i).
Subsec. (i)(6), (7).
2009—Subsec. (a)(1).
2006—Subsec. (b).
Subsec. (i)(3)(B).
Subsec. (i)(3)(B)(i).
Subsec. (i)(3)(B)(ii).
Subsec. (i)(3)(B)(iii), (iv).
"(iii) For 2009, 60 percent.
"(iv) for 2010, 80 percent."
2003—Subsec. (a)(2).
Subsec. (a)(4).
Subsec. (b).
Subsec. (f).
Subsec. (g).
Subsec. (h).
Subsec. (i).
2000—Subsec. (a)(2).
1998—Subsec. (a)(3).
Subsec. (g).
1997—Subsec. (a)(2).
Subsec. (a)(3).
"(A) the monthly actuarial rate for enrollees age 65 and over, determined according to paragraph (1) of this subsection, for that calendar year, or
"(B) the monthly premium rate most recently promulgated by the Secretary under this paragraph, increased by a percentage determined as follows: The Secretary shall ascertain the primary insurance amount computed under
Subsec. (b).
Subsec. (e).
"(1)(A) Notwithstanding the provisions of subsection (a) of this section, the monthly premium for each individual enrolled under this part for each month after after December 1995 and prior to January 1999 shall be an amount equal to 50 percent of the monthly actuarial rate for enrollees age 65 and over, as determined under subsection (a)(1) of this section and applicable to such month.
"(B) Notwithstanding the provisions of subsection (a) of this section, the monthly premium for each individual enrolled under this part for each month in—
"(i) 1991 shall be $29.90,
"(ii) 1992 shall be $31.80,
"(iii) 1993 shall be $36.60,
"(iv) 1994 shall be $41.10, and
"(v) 1995 shall be $46.10.
"(2) Any increases in premium amounts taking effect prior to January 1998 by reason of paragraph (1) shall be taken into account for purposes of determining increases thereafter under subsection (a)(3) of this section."
Subsec. (e)(1).
Subsec. (g).
1994—Subsec. (b).
Subsec. (g).
1993—Subsec. (e)(1)(A).
Subsec. (e)(2).
1990—Subsec. (e)(1).
1989—Subsec. (a).
Subsec. (b).
Subsec. (e).
Subsec. (e)(1).
Subsec. (g).
1988—Subsec. (a)(1).
Subsec. (a)(2).
Subsec. (a)(3).
Subsec. (a)(4).
Subsec. (b).
Subsec. (e)(1).
Subsec. (f).
Subsec. (g).
Subsec. (g)(1)(B)(iii)(I).
Subsec. (g)(1)(B)(iii)(II).
Subsec. (g)(7)(A)(ii).
1987—Subsec. (e).
Subsec. (f)(1).
Subsec. (f)(2).
1986—Subsec. (b).
Subsec. (e).
Subsec. (f)(1).
Subsec. (f)(2).
Subsec. (f)(2)(A).
1984—Subsec. (b).
Subsec. (e).
Subsec. (f).
Subsec. (f)(2)(A).
1983—Subsec. (a).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsec. (e).
Subsec. (e)(1).
Subsec. (e)(2).
Subsecs. (f), (g).
1982—Subsec. (c)(2).
Subsec. (c)(3).
Subsec. (g).
1981—Subsec. (d).
1980—Subsec. (d).
1977—Subsec. (c)(3)(B).
1975—Subsec. (c)(3).
1972—Subsec. (b)(1).
Subsec. (b)(2).
Subsec. (c).
Subsec. (d).
Subsec. (e).
Subsec. (f).
1968—Subsec. (b)(2).
Statutory Notes and Related Subsidiaries
Effective Date of 2006 Amendment
Amendment by section 5115(a)(1) of
Effective Date of 2003 Amendment
Amendment by section 222(l)(2)(A) of
Effective Date of 2000 Amendment
Effective Date of 1997 Amendment
Amendment by section 4581(a) of
Effective Date of 1994 Amendment
Effective Date of 1989 Amendment
Amendment by section 6202(b)(4)(C) of
Amendment by section 6202(c)(2) of
Amendment by
Effective Date of 1988 Amendment
Amendment by
Effective Date of 1986 Amendment
Amendment by section 9001(c) of
Amendment by section 9319(c)(4) of
Effective Date of 1984 Amendment
Amendment by
Effective Date of 1983 Amendment; Transitional Rule
"(1) the monthly premiums under part A and under part B of title XVIII of the Social Security Act [
"(2) the amount of the Government contributions under section 1844(a)(1) of such Act [
Amendment by
Effective Date of 1981 Amendment
Amendment by
Effective Date of 1980 Amendment
Amendment by
Effective Date of 1977 Amendment
Amendment by
Effective Date of 1975 Amendment
Effective Date of 1968 Amendment
Amendment by
Construction Regarding No Authority To Initiate Application to Years After 2017
Conditional Application to 2017 if No Social Security COLA for 2017
"(1) the reference to '2016' in paragraph (5)(A) of section 1839(a) of the Social Security Act (
"(2) the reference to 'a month during a year, beginning with 2016' in paragraph (6)(B) of section 1839 of such Act (
"(3) the reference to '2016' in subsection (d)(1) of section 1844 of such Act (
Any increase in premiums effected under this subsection shall be in addition to the increase effected by the amendments made by subsection (a) [amending this section]."
No Change in Medicare's Defined Benefit Package
Determination of Premium Amounts by Secretary
"(1) the dollar amount applicable for premiums under part B of title XVIII of such Act [
"(2) the Secretary of Health, Education, and Welfare may determine and promulgate such dollar amount for months after March 1968 and before January 1970 at any time on or before December 31, 1967."
Persons Enrolling Before April 1, 1968, Who Did Not Enroll During Their Initial Enrollment Period
2 So in original. Probably should be followed by a period.
3 See References in Text note below.
§1395s. Payment of premiums
(a) Deductions from section 402 or 423 monthly benefits
(1) In the case of an individual who is entitled to monthly benefits under
(2) The Secretary of the Treasury shall, from time to time, transfer from the Federal Old-Age and Survivors Insurance Trust Fund or the Federal Disability Insurance Trust Fund to the Federal Supplementary Medical Insurance Trust Fund the aggregate amount deducted under paragraph (1) for the period to which such transfer relates from benefits under
(b) Deductions from railroad retirement annuities or pensions
(1) In the case of an individual who is entitled to receive for a month an annuity under the Railroad Retirement Act of 1974 [
(2) The Secretary of the Treasury shall, from time to time, transfer from the Railroad Retirement Account to the Federal Supplementary Medical Insurance Trust Fund the aggregate amount deducted under paragraph (1) for the period to which such transfer relates. Such transfers shall be made on the basis of a certification by the Railroad Retirement Board and shall be appropriately adjusted to the extent that prior transfers were too great or too small.
(c) Portion of monthly premium in excess of deducted amount
If an individual to whom subsection (a) or (b) applies estimates that the amount which will be available for deduction under such subsection for any premium payment period will be less than the amount of the monthly premiums for such period, he may (under regulations) pay to the Secretary such portion of the monthly premiums for such period as he desires.
(d) Deductions from civil service retirement annuities
(1) In the case of an individual receiving an annuity under subchapter III of
(2) The Secretary of the Treasury shall, from time to time, but not less often than quarterly, transfer from the Civil Service Retirement and Disability Fund, or the account (if any) applicable in the case of such other law administered by the Director of the Office of Personnel Management, to the Federal Supplementary Medical Insurance Trust Fund the aggregate amount deducted under paragraph (1) for the period to which such transfer relates. Such transfer shall be made on the basis of a certification by the Director of the Office of Personnel Management and shall be appropriately adjusted to the extent that prior transfers were too great or too small.
(e) Manner and time of payment prescribed by Secretary
In the case of an individual who participates in the insurance program established by this part but with respect to whom none of the preceding provisions of this section applies, or with respect to whom subsection (c) applies, the premiums shall be paid to the Secretary at such times, and in such manner, as the Secretary shall by regulations prescribe.
(f) Deposit of amounts in Treasury
Amounts paid to the Secretary under subsection (c) or (e) shall be deposited in the Treasury to the credit of the Federal Supplementary Medical Insurance Trust Fund.
(g) Premium payability period
In the case of an individual who participates in the insurance program established by this part, premiums shall be payable for the period commencing with the first month of his coverage period and ending with the month in which he dies or, if earlier, in which his coverage under such program terminates.
(h) Exempted monthly benefits
In the case of an individual who is enrolled under the program established by this part as a member of a coverage group to which an agreement with a State entered into pursuant to
(i) Adjustments for individuals enrolled in Medicare+Choice plans
In the case of an individual enrolled in a Medicare+Choice plan, the Secretary shall provide for necessary adjustments of the monthly beneficiary premium to reflect 80 percent of any reduction elected under
(Aug. 14, 1935, ch. 531, title XVIII, §1840, as added
Editorial Notes
References in Text
The Railroad Retirement Act of 1974, referred to in subsec. (b)(1), is act Aug. 29, 1935, ch. 812, as amended generally by
Amendments
2003—Subsec. (i).
2000—Subsec. (i).
1994—Subsec. (a)(1).
Subsec. (a)(2).
1989—Subsec. (i).
1988—Subsec. (i).
1985—Subsec. (d)(1).
1984—Subsec. (a)(2).
Subsec. (d)(1).
Subsec. (d)(2).
1974—Subsec. (b)(1).
1972—Subsec. (a)(1).
Subsec. (a)(2).
Subsec. (b)(1).
Subsec. (c).
Subsec. (d).
Subsec. (e).
Subsec. (f).
Subsec. (g).
Subsecs. (h), (i).
1968—Subsec. (e).
1966—Subsec. (i).
Statutory Notes and Related Subsidiaries
Change of Name
References to Medicare+Choice deemed to refer to Medicare Advantage or MA, subject to an appropriate transition provided by the Secretary of Health and Human Services in the use of those terms, see section 201 of
Effective Date of 2003 Amendment
Amendment by
Effective Date of 2000 Amendment
Amendment by
Effective Date of 1994 Amendment
Amendment by
Effective Date of 1989 Amendment
Amendment by
Effective Date of 1988 Amendment
Amendment by
Effective Date of 1984 Amendment
Amendment by section 2354(b)(11) of
Amendment by section 2663(j)(2)(F)(ii) of
Effective Date of 1974 Amendment
Amendment by
Effective Date of 1972 Amendment
1 See References in Text note below.
§1395t. Federal Supplementary Medical Insurance Trust Fund
(a) Creation; deposits; fund transfers
There is hereby created on the books of the Treasury of the United States a trust fund to be known as the "Federal Supplementary Medical Insurance Trust Fund" (hereinafter in this section referred to as the "Trust Fund"). The Trust Fund shall consist of such gifts and bequests as may be made as provided in
(b) Board of Trustees; composition; meetings; duties
With respect to the Trust Fund, there is hereby created a body to be known as the Board of Trustees of the Trust Fund (hereinafter in this section referred to as the "Board of Trustees") composed of the Commissioner of Social Security, the Secretary of the Treasury, the Secretary of Labor, and the Secretary of Health and Human Services, all ex officio, and of two members of the public (both of whom may not be from the same political party), who shall be nominated by the President for a term of four years and subject to confirmation by the Senate. A member of the Board of Trustees serving as a member of the public and nominated and confirmed to fill a vacancy occurring during a term shall be nominated and confirmed only for the remainder of such term. An individual nominated and confirmed as a member of the public may serve in such position after the expiration of such member's term until the earlier of the time at which the member's successor takes office or the time at which a report of the Board is first issued under paragraph (2) after the expiration of the member's term. The Secretary of the Treasury shall be the Managing Trustee of the Board of Trustees (hereinafter in this section referred to as the "Managing Trustee"). The Administrator of the Centers for Medicare & Medicaid Services shall serve as the Secretary of the Board of Trustees. The Board of Trustees shall meet not less frequently than once each calendar year. It shall be the duty of the Board of Trustees to—
(1) Hold the Trust Fund;
(2) Report to the Congress not later than the first day of April of each year on the operation and status of the Trust Fund during the preceding fiscal year and on its expected operation and status during the current fiscal year and the next 2 fiscal years; Each report provided under paragraph (2) beginning with the report in 2005 shall include the information specified in section 801(a) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.2
(3) Report immediately to the Congress whenever the Board is of the opinion that the amount of the Trust Fund is unduly small; and
(4) Review the general policies followed in managing the Trust Fund, and recommend changes in such policies, including necessary changes in the provisions of law which govern the way in which the Trust Fund is to be managed.
The report provided for in paragraph (2) shall include a statement of the assets of, and the disbursements made from, the Trust Fund during the preceding fiscal year, an estimate of the expected income to, and disbursements to be made from, the Trust Fund during the current fiscal year and each of the next 2 fiscal years, and a statement of the actuarial status of the Trust Fund. Such report shall also include an actuarial opinion by the Chief Actuary of the Centers for Medicare & Medicaid Services certifying that the techniques and methodologies used are generally accepted within the actuarial profession and that the assumptions and cost estimates used are reasonable. Such report shall be printed as a House document of the session of the Congress to which the report is made. A person serving on the Board of Trustees shall not be considered to be a fiduciary and shall not be personally liable for actions taken in such capacity with respect to the Trust Fund.
(c) Investment of Trust Fund by Managing Trustee
It shall be the duty of the Managing Trustee to invest such portion of the Trust Fund as is not, in his judgment, required to meet current withdrawals. Such investments may be made only in interest-bearing obligations of the United States or in obligations guaranteed as to both principal and interest by the United States. For such purpose such obligations may be acquired (1) on original issue at the issue price, or (2) by purchase of outstanding obligations at the market price. The purposes for which obligations of the United States may be issued under
(d) Authority of Managing Trustee to sell obligations
Any obligations acquired by the Trust Fund (except public-debt obligations issued exclusively to the Trust Fund) may be sold by the Managing Trustee at the market price, and such public-debt obligations may be redeemed at par plus accrued interest.
(e) Interest on or proceeds from sale or redemption of obligations
The interest on, and the proceeds from the sale or redemption of, any obligations held in the Trust Fund shall be credited to and form a part of the Trust Fund.
(f) Transfers to other Funds
There shall be transferred periodically (but not less often than once each fiscal year) to the Trust Fund from the Federal Old-Age and Survivors Insurance Trust Fund and from the Federal Disability Insurance Trust Fund amounts equivalent to the amounts not previously so transferred which the Secretary of Health and Human Services shall have certified as overpayments (other than amounts so certified to the Railroad Retirement Board) pursuant to
(g) Payments from Trust Fund of amounts provided for by this part or with respect to administrative expenses
The Managing Trustee shall pay from time to time from the Trust Fund such amounts as the Secretary of Health and Human Services certifies are necessary to make the payments provided for by this part, and the payments with respect to administrative expenses in accordance with
(h) Payments from Trust Fund of costs incurred by Director of Office of Personnel Management
The Managing Trustee shall pay from time to time from the Trust Fund such amounts as the Secretary of Health and Human Services certifies are necessary to pay the costs incurred by the Director of the Office of Personnel Management in making deductions pursuant to
(i) Payments from Trust Fund of costs incurred by Railroad Retirement Board
The Managing Trustee shall pay from time to time from the Trust Fund such amounts as the Secretary of Health and Human Services certifies are necessary to pay the costs incurred by the Railroad Retirement Board for services performed pursuant to section 1395s(b)(1) and
(Aug. 14, 1935, ch. 531, title XVIII, §1841, as added
Editorial Notes
References in Text
Section 9008(c) of the Patient Protection and Affordable Care Act of 2009, referred to in subsec. (a), probably means section 9008(c) of
Section 801(a) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, referred to in subsec. (b)(2), is section 801(a) of
Amendments
2010—Subsec. (a).
2003—Subsec. (a).
Subsec. (b).
Subsec. (b)(2).
Subsec. (g).
Subsec. (h).
Subsec. (i).
1994—Subsec. (b).
1989—Subsecs. (a), (b).
1988—Subsec. (a).
Subsec. (b).
1986—Subsec. (b).
1984—Subsec. (c).
Subsecs. (f), (g).
Subsec. (h).
Subsec. (i).
1983—Subsec. (b).
1978—Subsec. (b).
1972—Subsec. (a).
Subsec. (h).
Subsec. (i).
1968—Subsec. (b)(2).
Statutory Notes and Related Subsidiaries
Effective Date of 1994 Amendment
Amendment by
Effective Date of 1989 Amendment
Amendment by
Effective Date of 1988 Amendment
Amendment by
Effective Date of 1984 Amendment
Amendment by section 2354(b)(2), (11), (12) of
Amendment by section 2663(j)(2)(F)(iii) of
Effective Date of 1983 Amendment
Amendment by sections 154(c) and 341(c) of
Effective Date of 1978 Amendment
Amendment by
Effective Date of 1972 Amendment
Amendment by section 132(e) of
Amendment by section 263(d)(4), (e) of
Disposal of Funds in Federal Hospital Insurance Catastrophic Coverage Reserve Fund
Due Date for 1983 Report on Operation and Status of Trust Fund
Notwithstanding subsec. (b)(2) of this section, the annual report of the Board of Trustees of the Trust Fund required for calendar year 1983 under this section may be filed at any time not later than forty-five days after Apr. 20, 1983, see section 154(d) of
1 See References in Text note below.
2 So in original. See 2003 Amendment note below.
§§1395t–1, 1395t–2. Repealed. Pub. L. 101–234, title II, §202(a), Dec. 13, 1989, 103 Stat. 1981
Section 1395t–1, act Aug. 14, 1935, ch. 531, title XVIII, §1841A, as added July 1, 1988,
Section 1395t–2, act Aug. 14, 1935, ch. 531, title XVIII, §1841B, as added July 1, 1988,
Statutory Notes and Related Subsidiaries
Effective Date of Repeal
Repeal effective Jan. 1, 1990, see section 202(b) of
§1395u. Provisions relating to the administration of part B
(a) In general
The administration of this part shall be conducted through contracts with medicare administrative contractors under
(b) Determination of reasonable charges
(1) Repealed.
(2)(A), (B) Repealed.
(C) In the case of residents of nursing facilities who receive services described in clause (i) or (ii) of
(3) The Secretary—
(A) shall take such action as may be necessary to assure that, where payment under this part for a service is on a cost basis, the cost is reasonable cost (as determined under
(B) shall take such action as may be necessary to assure that, where payment under this part for a service is on a charge basis, such charge will be reasonable and not higher than the charge applicable, for a comparable service and under comparable circumstances, to the policyholders and subscribers of the medicare administrative contractor, and such payment will (except as otherwise provided in
(i) on the basis of an itemized bill; or
(ii) on the basis of an assignment under the terms of which (I) the reasonable charge is the full charge for the service, (II) the physician or other person furnishing such service agrees not to charge (and to refund amounts already collected) for services for which payment under this subchapter is denied under
but (in the case of bills submitted, or requests for payment made, after March 1968) only if the bill is submitted, or a written request for payment is made in such other form as may be permitted under regulations, no later than the period ending 1 calendar year after the date of service;
(C) to (E) Repealed.
(F) shall take such action as may be necessary to assure that where payment under this part for a service rendered is on a charge basis, such payment shall be determined on the basis of the charge that is determined in accordance with this section on the basis of customary and prevailing charge levels in effect at the time the service was rendered or, in the case of services rendered more than 12 months before the year in which the bill is submitted or request for payment is made, on the basis of such levels in effect for the 12-month period preceding such year;
(G) shall, for a service that is furnished with respect to an individual enrolled under this part, that is not paid on an assignment-related basis, and that is subject to a limiting charge under
(i) determine, prior to making payment, whether the amount billed for such service exceeds the limiting charge applicable under
(ii) notify the physician, supplier, or other person periodically (but not less often than once every 30 days) of determinations that amounts billed exceeded such applicable limiting charges; and
(iii) provide for prompt response to inquiries of physicians, suppliers, and other persons concerning the accuracy of such limiting charges for their services;
(H) shall implement—
(i) programs to recruit and retain physicians as participating physicians in the area served by the medicare administrative contractor, including educational and outreach activities and the use of professional relations personnel to handle billing and other problems relating to payment of claims of participating physicians; and
(ii) programs to familiarize beneficiaries with the participating physician program and to assist such beneficiaries in locating participating physicians; 1
(I) Repealed.
(J), (K) Repealed.
(L) shall monitor and profile physicians' billing patterns within each area or locality and provide comparative data to physicians whose utilization patterns vary significantly from other physicians in the same payment area or locality.
In determining the reasonable charge for services for purposes of this paragraph, there shall be taken into consideration the customary charges for similar services generally made by the physician or other person furnishing such services, as well as the prevailing charges in the locality for similar services. No charge may be determined to be reasonable in the case of bills submitted or requests for payment made under this part after December 31, 1970, if it exceeds the higher of (i) the prevailing charge recognized by the carrier and found acceptable by the Secretary for similar services in the same locality in administering this part on December 31, 1970, or (ii) the prevailing charge level that, on the basis of statistical data and methodology acceptable to the Secretary, would cover 75 percent of the customary charges made for similar services in the same locality during the 12-month period ending on the June 30 last preceding the start of the calendar year in which the service is rendered. In the case of physicians' services the prevailing charge level determined for purposes of clause (ii) of the preceding sentence for any twelve-month period (beginning after June 30, 1973) specified in clause (ii) of such sentence may not exceed (in the aggregate) the level determined under such clause for the fiscal year ending June 30, 1973, or (with respect to physicians' services furnished in a year after 1987) the level determined under this sentence (or under any other provision of law affecting the prevailing charge level) for the previous year except to the extent that the Secretary finds, on the basis of appropriate economic index data, that such higher level is justified by year-to-year economic changes. With respect to power-operated wheelchairs for which payment may be made in accordance with
(4)(A)(i) In determining the prevailing charge levels under the third and fourth sentences of paragraph (3) for physicians' services furnished during the 15-month period beginning July 1, 1984, the Secretary shall not set any level higher than the same level as was set for the 12-month period beginning July 1, 1983.
(ii)(I) In determining the prevailing charge levels under the third and fourth sentences of paragraph (3) for physicians' services furnished during the 8-month period beginning May 1, 1986, by a physician who is not a participating physician (as defined in subsection (h)(1)) at the time of furnishing the services, the Secretary shall not set any level higher than the same level as was set for the 12-month period beginning July 1, 1983.
(II) In determining the prevailing charge levels under the fourth sentence of paragraph (3) for physicians' services furnished during the 8-month period beginning May 1, 1986, by a physician who is a participating physician (as defined in subsection (h)(1)) at the time of furnishing the services, the Secretary shall permit an additional one percentage point increase in the increase otherwise permitted under that sentence.
(iii) In determining the maximum allowable prevailing charges which may be recognized consistent with the index described in the fourth sentence of paragraph (3) for physicians' services furnished on or after January 1, 1987, by participating physicians, the Secretary shall treat the maximum allowable prevailing charges recognized as of December 31, 1986, under such sentence with respect to participating physicians as having been justified by economic changes.
(iv) The reasonable charge for physicians' services furnished on or after January 1, 1987, and before January 1, 1992, by a nonparticipating physician shall be no greater than the applicable percent of the prevailing charge levels established under the third and fourth sentences of paragraph (3) (or under any other applicable provision of law affecting the prevailing charge level). In the previous sentence, the term "applicable percent" means for services furnished (I) on or after January 1, 1987, and before April 1, 1988, 96 percent, (II) on or after April 1, 1988, and before January 1, 1989, 95.5 percent, and (III) on or after January 1, 1989, 95 percent.
(v) In determining the prevailing charge levels under the third and fourth sentences of paragraph (3) for physicians' services furnished during the 3-month period beginning January 1, 1988, the Secretary shall not set any level higher than the same level as was set for the 12-month period beginning January 1, 1987.
(vi) Before each year (beginning with 1989), the Secretary shall establish a prevailing charge floor for primary care services (as defined in subsection (i)(4)) equal to 60 percent of the estimated average prevailing charge levels based on the best available data (determined, under the third and fourth sentences of paragraph (3) and under paragraph (4), without regard to this clause and without regard to physician specialty) for such service for all localities in the United States (weighted by the relative frequency of the service in each locality) for the year.
(vii) Beginning with 1987, the percentage increase in the MEI (as defined in subsection (i)(3)) for each year shall be the same for nonparticipating physicians as for participating physicians.
(B)(i) In determining the reasonable charge under paragraph (3) for physicians' services furnished during the 15-month period beginning July 1, 1984, the customary charges shall be the same customary charges as were recognized under this section for the 12-month period beginning July 1, 1983.
(ii) In determining the reasonable charge under paragraph (3) for physicians' services furnished during the 8-month period beginning May 1, 1986, by a physician who is not a participating physician (as defined in subsection (h)(1)) at the time of furnishing the services—
(I) if the physician was not a participating physician at any time during the 12-month period beginning on October 1, 1984, the customary charges shall be the same customary charges as were recognized under this section for the 12-month period beginning July 1, 1983, and
(II) if the physician was a participating physician at any time during the 12-month period beginning on October 1, 1984, the physician's customary charges shall be determined based upon the physician's actual charges billed during the 12-month period ending on March 31, 1985.
(iii) In determining the reasonable charge under paragraph (3) for physicians' services furnished during the 3-month period beginning January 1, 1988, the customary charges shall be the same customary charges as were recognized under this section for the 12-month period beginning January 1, 1987.
(iv) In determining the reasonable charge under paragraph (3) for physicians' services (other than primary care services, as defined in subsection (i)(4)) furnished during 1991, the customary charges shall be the same customary charges as were recognized under this section for the 9-month period beginning April 1, 1990. In a case in which subparagraph (F) applies (relating to new physicians) so as to limit the customary charges of a physician during 1990 to a percent of prevailing charges, the previous sentence shall not prevent such limit on customary charges under such subparagraph from increasing in 1991 to a higher percent of such prevailing charges.
(C) In determining the prevailing charge levels under the third and fourth sentences of paragraph (3) for physicians' services furnished during periods beginning after September 30, 1985, the Secretary shall treat the level as set under subparagraph (A)(i) as having fully provided for the economic changes which would have been taken into account but for the limitations contained in subparagraph (A)(i).
(D)(i) In determining the customary charges for physicians' services furnished during the 8-month period beginning May 1, 1986, or the 12-month period beginning January 1, 1987, by a physician who was not a participating physician (as defined in subsection (h)(1)) on September 30, 1985, the Secretary shall not recognize increases in actual charges for services furnished during the 15-month period beginning on July 1, 1984, above the level of the physician's actual charges billed in the 3-month period ending on June 30, 1984.
(ii) In determining the customary charges for physicians' services furnished during the 12-month period beginning January 1, 1987, by a physician who is not a participating physician (as defined in subsection (h)(1)) on April 30, 1986, the Secretary shall not recognize increases in actual charges for services furnished during the 7-month period beginning on October 1, 1985, above the level of the physician's actual charges billed during the 3-month period ending on June 30, 1984.
(iii) In determining the customary charges for physicians' services furnished during the 12-month period beginning January 1, 1987, or January 1, 1988, by a physician who is not a participating physician (as defined in subsection (h)(1)) on December 31, 1986, the Secretary shall not recognize increases in actual charges for services furnished during the 8-month period beginning on May 1, 1986, above the level of the physician's actual charges billed during the 3-month period ending on June 30, 1984.
(iv) In determining the customary charges for a physicians' service furnished on or after January 1, 1988, if a physician was a nonparticipating physician in a previous year (beginning with 1987), the Secretary shall not recognize any amount of such actual charges (for that service furnished during such previous year) that exceeds the maximum allowable actual charge for such service established under subsection (j)(1)(C).
(E)(i) For purposes of this part for physicians' services furnished in 1987, the percentage increase in the MEI is 3.2 percent.
(ii) For purposes of this part for physicians' services furnished in 1988, on or after April 1, the percentage increase in the MEI is—
(I) 3.6 percent for primary care services (as defined in subsection (i)(4)), and
(II) 1 percent for other physicians' services.
(iii) For purposes of this part for physicians' services furnished in 1989, the percentage increase in the MEI is—
(I) 3.0 percent for primary care services, and
(II) 1 percent for other physicians' services.
(iv) For purposes of this part for items and services furnished in 1990, after March 31, 1990, the percentage increase in the MEI is—
(I) 0 percent for radiology services, for anesthesia services, and for other services specified in the list referred to in paragraph (14)(C)(i),
(II) 2 percent for other services (other than primary care services), and
(III) such percentage increase in the MEI (as defined in subsection (i)(3)) as would be otherwise determined for primary care services (as defined in subsection (i)(4)).
(v) For purposes of this part for items and services furnished in 1991, the percentage increase in the MEI is—
(I) 0 percent for services (other than primary care services), and
(II) 2 percent for primary care services (as defined in subsection (i)(4)).
(5) Repealed.
(6) No payment under this part for a service provided to any individual shall (except as provided in
(7)(A) In the case of physicians' services furnished to a patient in a hospital with a teaching program approved as specified in
(i) unless—
(I) the physician renders sufficient personal and identifiable physicians' services to the patient to exercise full, personal control over the management of the portion of the case for which the payment is sought,
(II) the services are of the same character as the services the physician furnishes to patients not entitled to benefits under this subchapter, and
(III) at least 25 percent of the hospital's patients (during a representative past period, as determined by the Secretary) who were not entitled to benefits under this subchapter and who were furnished services described in subclauses (I) and (II) paid all or a substantial part of charges (other than nominal charges) imposed for such services; and
(ii) to the extent that the payment is based upon a reasonable charge for the services in excess of the customary charge as determined in accordance with subparagraph (B).
(B) The customary charge for such services in a hospital shall be determined in accordance with regulations issued by the Secretary and taking into account the following factors:
(i) In the case of a physician who is not a teaching physician (as defined by the Secretary), the Secretary shall take into account the amounts the physician charges for similar services in the physician's practice outside the teaching setting.
(ii) In the case of a teaching physician, if the hospital, its physicians, or other appropriate billing entity has established one or more schedules of charges which are collected for medical and surgical services, the Secretary shall base payment under this subchapter on the greatest of—
(I) the charges (other than nominal charges) which are most frequently collected in full or substantial part with respect to patients who were not entitled to benefits under this subchapter and who were furnished services described in subclauses (I) and (II) of subparagraph (A)(i),
(II) the mean of the charges (other than nominal charges) which were collected in full or substantial part with respect to such patients, or
(III) 85 percent of the prevailing charges paid for similar services in the same locality.
(iii) If all the teaching physicians in a hospital agree to have payment made for all of their physicians' services under this part furnished to patients in such hospital on an assignment-related basis, the customary charge for such services shall be equal to 90 percent of the prevailing charges paid for similar services in the same locality.
(C) In the case of physicians' services furnished to a patient in a hospital with a teaching program approved as specified in
(D)(i) In the case of physicians' services furnished to a patient in a hospital with a teaching program approved as specified in
(I) are required due to exceptional medical circumstances,
(II) are performed by team physicians needed to perform complex medical procedures, or
(III) constitute concurrent medical care relating to a medical condition which requires the presence of, and active care by, a physician of another specialty during surgery,
and under such other circumstances as the Secretary determines by regulation to be appropriate.
(ii) For purposes of this subparagraph, the term "assistant at surgery" means a physician who actively assists the physician in charge of a case in performing a surgical procedure.
(iii) The Secretary shall determine appropriate methods of reimbursement of assistants at surgery where such services are reimbursable under this part.
(8)(A)(i) The Secretary shall by regulation—
(I) describe the factors to be used in determining the cases (of particular items or services) in which the application of this subchapter to payment under this part (other than to physicians' services paid under
(II) provide in those cases for the factors to be considered in determining an amount that is realistic and equitable.
(ii) Notwithstanding the determination made in clause (i), the Secretary may not apply factors that would increase or decrease the payment under this part during any year for any particular item or service by more than 15 percent from such payment during the preceding year except as provided in subparagraph (B).
(B) The Secretary may make a determination under this subparagraph that would result in an increase or decrease under subparagraph (A) of more than 15 percent of the payment amount for a year, but only if—
(i) the Secretary's determination takes into account the factors described in subparagraph (C) and any additional factors the Secretary determines appropriate,
(ii) the Secretary's determination takes into account the potential impacts described in subparagraph (D), and
(iii) the Secretary complies with the procedural requirements of paragraph (9).
(C) The factors described in this subparagraph are as follows:
(i) The programs established under this subchapter and subchapter XIX are the sole or primary sources of payment for an item or service.
(ii) The payment amount does not reflect changing technology, increased facility with that technology, or reductions in acquisition or production costs.
(iii) The payment amount for an item or service under this part is substantially higher or lower than the payment made for the item or service by other purchasers.
(D) The potential impacts of a determination under subparagraph (B) on quality, access, and beneficiary liability, including the likely effects on assignment rates and participation rates.
(9)(A) The Secretary shall consult with representatives of suppliers or other individuals who furnish an item or service before making a determination under paragraph (8)(B) with regard to that item or service.
(B) The Secretary shall publish notice of a proposed determination under paragraph (8)(B) in the Federal Register—
(i) specifying the payment amount proposed to be established with respect to an item or service,
(ii) explaining the factors and data that the Secretary took into account in determining the payment amount so specified, and
(iii) explaining the potential impacts described in paragraph (8)(D).
(C) After publication of the notice required by subparagraph (B), the Secretary shall allow not less than 60 days for public comment on the proposed determination.
(D)(i) Taking into consideration the comments made by the public, the Secretary shall publish in the Federal Register a final determination under paragraph (8)(B) with respect to the payment amount to be established with respect to the item or service.
(ii) A final determination published pursuant to clause (i) shall explain the factors and data that the Secretary took into consideration in making the final determination.
(10)(A)(i) In determining the reasonable charge for procedures described in subparagraph (B) and performed during the 9-month period beginning on April 1, 1988, the prevailing charge for such procedure shall be the prevailing charge otherwise recognized for such procedure for 1987—
(I) subject to clause (iii), reduced by 2.0 percent, and
(II) further reduced by the applicable percentage specified in clause (ii).
(ii) For purposes of clause (i), the applicable percentage specified in this clause is—
(I) 15 percent, in the case of a prevailing charge otherwise recognized (without regard to this paragraph and determined without regard to physician specialty) that is at least 150 percent of the weighted national average (as determined by the Secretary) of such prevailing charges for such procedure for all localities in the United States for 1987;
(II) 0 percent, in the case of a prevailing charge that does not exceed 85 percent of such weighted national average; and
(III) in the case of any other prevailing charge, a percent determined on the basis of a straight-line sliding scale, equal to 3/13 of a percentage point for each percent by which the prevailing charge exceeds 85 percent of such weighted national average.
(iii) In no case shall the reduction under clause (i) for a procedure result in a prevailing charge in a locality for 1988 which is less than 85 percent of the Secretary's estimate of the weighted national average of such prevailing charges for such procedure for all localities in the United States for 1987 (based upon the best available data and determined without regard to physician specialty) after making the reduction described in clause (i)(I).
(B) The procedures described in this subparagraph are as follows: bronchoscopy, carpal tunnel repair, cataract surgery (including subsequent insertion of an intraocular lens), coronary artery bypass surgery, diagnostic and/or therapeutic dilation and curettage, knee arthroscopy, knee arthroplasty, pacemaker implantation surgery, total hip replacement, suprapubic prostatectomy, transurethral resection of the prostate, and upper gastrointestinal endoscopy.
(C) In the case of a reduction in the reasonable charge for a physicians' service under subparagraph (A), if a nonparticipating physician furnishes the service to an individual entitled to benefits under this part, after the effective date of such reduction, the physician's actual charge is subject to a limit under subsection (j)(1)(D).
(D) There shall be no administrative or judicial review under
(11)(A) In providing payment for cataract eyeglasses and cataract contact lenses, and professional services relating to them, under this part, each carrier shall—
(i) provide for separate determinations of the payment amount for the eyeglasses and lenses and of the payment amount for the professional services of a physician (as defined in
(ii) not recognize as reasonable for such eyeglasses and lenses more than such amount as the Secretary establishes in guidelines relating to the inherent reasonableness of charges for such eyeglasses and lenses.
(B)(i) In determining the reasonable charge under paragraph (3) for a cataract surgical procedure, subject to clause (ii), the prevailing charge for such procedure otherwise recognized for participating and nonparticipating physicians shall be reduced by 10 percent with respect to procedures performed in 1987.
(ii) In no case shall the reduction under clause (i) for a surgical procedure result in a prevailing charge in a locality for a year which is less than 75 percent of the weighted national average of such prevailing charges for such procedure for all the localities in the United States for 1986.
(C)(i) The prevailing charge level determined with respect to A-mode ophthalmic ultrasound procedures may not exceed 5 percent of the prevailing charge level established with respect to extracapsular cataract removal with lens insertion.
(ii) The reasonable charge for an intraocular lens inserted during or subsequent to cataract surgery in a physician's office may not exceed the actual acquisition cost for the lens (taking into account any discount) plus a handling fee (not to exceed 5 percent of such actual acquisition cost).
(D) In the case of a reduction in the reasonable charge for a physicians' service or item under subparagraph (B) or (C), if a nonparticipating physician furnishes the service or item to an individual entitled to benefits under this part after the effective date of such reduction, the physician's actual charge is subject to a limit under subsection (j)(1)(D).
(12) Repealed.
(13)(A) In determining payments under
(B) The Secretary shall require claims for physicians' services for medical direction of nurse anesthetists during the periods in which the provisions of subparagraph (A) apply to indicate the number of such anesthetists being medically directed concurrently at any time during the procedure, the name of each nurse anesthetist being directed, and the type of procedure for which the services are provided.
(14)(A)(i) In determining the reasonable charge for a physicians' service specified in subparagraph (C)(i) and furnished during the 9-month period beginning on April 1, 1990, the prevailing charge for such service shall be the prevailing charge otherwise recognized for such service for 1989 reduced by 15 percent or, if less, 1/3 of the percent (if any) by which the prevailing charge otherwise applied in the locality in 1989 exceeds the locally-adjusted reduced prevailing amount (as determined under subparagraph (B)(i)) for the service.
(ii) In determining the reasonable charge for a physicians' service specified in subparagraph (C)(i) and furnished during 1991, the prevailing charge for such service shall be the prevailing charge otherwise recognized for such service for the period during 1990 beginning on April 1, reduced by the same amount as the amount of the reduction effected under this paragraph (as amended by the Omnibus Budget Reconciliation Act of 1990) for such service during such period.
(B) For purposes of this paragraph:
(i) The "locally-adjusted reduced prevailing amount" for a locality for a physicians' service is equal to the product of—
(I) the reduced national weighted average prevailing charge for the service (specified under clause (ii)), and
(II) the adjustment factor (specified under clause (iii)) for the locality.
(ii) The "reduced national weighted average prevailing charge" for a physicians' service is equal to the national weighted average prevailing charge for the service (specified in subparagraph (C)(ii)) reduced by the percentage change (specified in subparagraph (C)(iii)) for the service.
(iii) The "adjustment factor", for a physicians' service for a locality, is the sum of—
(I) the practice expense component (percent), divided by 100, specified in appendix A (pages 187 through 194) of the Report of the Medicare and Medicaid Health Budget Reconciliation Amendments of 1989, prepared by the Subcommittee on Health and the Environment of the Committee on Energy and Commerce, House of Representatives, (Committee Print 101–M, 101st Congress, 1st Session) for the service, multiplied by the geographic practice cost index value (specified in subparagraph (C)(iv)) for the locality, and
(II) 1 minus the practice expense component (percent), divided by 100.
(C) For purposes of this paragraph:
(i) The physicians' services specified in this clause are the procedures specified (by code and description) in the Overvalued Procedures List for Finance Committee, Revised September 20, 1989, prepared by the Physician Payment Review Commission which specification is of physicians' services that have been identified as overvalued by at least 10 percent based on a comparison of payments for such services under a resource-based relative value scale and of the national average prevailing charges under this part.
(ii) The "national weighted average prevailing charge" specified in this clause, for a physicians' service specified in clause (i), is the national weighted average prevailing charge for the service in 1989 as determined by the Secretary using the best data available.
(iii) The "percentage change" specified in this clause, for a physicians' service specified in clause (i), is the percent difference (but expressed as a positive number) specified for the service in the list referred to in clause (i).
(iv) The geographic practice cost index value specified in this clause for a locality is the Geographic Overhead Costs Index specified for the locality in table 1 of the September 1989 Supplement to the Geographic Medicare Economic Index: Alternative Approaches (prepared by the Urban Institute and the Center for Health Economics Research).
(D) In the case of a reduction in the prevailing charge for a physicians' service under subparagraph (A), if a nonparticipating physician furnishes the service to an individual entitled to benefits under this part, after the effective date of such reduction, the physician's actual charge is subject to a limit under subsection (j)(1)(D).
(15)(A) In determining the reasonable charge for surgery, radiology, and diagnostic physicians' services which the Secretary shall designate (based on their high volume of expenditures under this part) and for which the prevailing charge (but for this paragraph) differs by physician specialty, the prevailing charge for such a service may not exceed the prevailing charge or fee schedule amount for that specialty of physicians that furnish the service most frequently nationally.
(B) In the case of a reduction in the prevailing charge for a physician's service under subparagraph (A), if a nonparticipating physician furnishes the service to an individual entitled to benefits under this part, after the effective date of the reduction, the physician's actual charge is subject to a limit under subsection (j)(1)(D).
(16)(A) In determining the reasonable charge for all physicians' services other than physicians' services specified in subparagraph (B) furnished during 1991, the prevailing charge for a locality shall be 6.5 percent below the prevailing charges used in the locality under this part in 1990 after March 31.
(B) For purposes of subparagraph (A), the physicians' services specified in this subparagraph are as follows:
(i) Radiology, anesthesia and physician pathology services, the technical components of diagnostic tests specified in paragraph (17) and physicians' services specified in paragraph (14)(C)(i).
(ii) Primary care services specified in subsection (i)(4), hospital inpatient medical services, consultations, other visits, preventive medicine visits, psychiatric services, emergency care facility services, and critical care services.
(iii) Partial mastectomy; tendon sheath injections and small joint arthrocentesis; femoral fracture and trochanteric fracture treatments; endotracheal intubation; thoracentesis; thoracostomy; aneurysm repair; cystourethroscopy; transurethral fulguration and resection; tympanoplasty with mastoidectomy; and ophthalmoscopy.
(17) With respect to payment under this part for the technical (as distinct from professional) component of diagnostic tests (other than clinical diagnostic laboratory tests, tests specified in paragraph (14)(C)(i), and radiology services, including portable x-ray services) which the Secretary shall designate (based on their high volume of expenditures under this part), the reasonable charge for such technical component (including the applicable portion of a global service) may not exceed the national median of such charges for all localities, as estimated by the Secretary using the best available data.
(18)(A) Payment for any service furnished by a practitioner described in subparagraph (C) and for which payment may be made under this part on a reasonable charge or fee schedule basis may only be made under this part on an assignment-related basis.
(B) A practitioner described in subparagraph (C) or other person may not bill (or collect any amount from) the individual or another person for any service described in subparagraph (A), except for deductible and coinsurance amounts applicable under this part. No person is liable for payment of any amounts billed for such a service in violation of the previous sentence. If a practitioner or other person knowingly and willfully bills (or collects an amount) for such a service in violation of such sentence, the Secretary may apply sanctions against the practitioner or other person in the same manner as the Secretary may apply sanctions against a physician in accordance with subsection (j)(2) in the same manner as such section applies with respect to a physician. Paragraph (4) of subsection (j) shall apply in this subparagraph in the same manner as such paragraph applies to such section.
(C) A practitioner described in this subparagraph is any of the following:
(i) A physician assistant, nurse practitioner, or clinical nurse specialist (as defined in
(ii) A certified registered nurse anesthetist (as defined in
(iii) A certified nurse-midwife (as defined in
(iv) A clinical social worker (as defined in
(v) A clinical psychologist (as defined by the Secretary for purposes of
(vi) A registered dietitian or nutrition professional.
(vii) A marriage and family therapist (as defined in
(viii) A mental health counselor (as defined in
(D) For purposes of this paragraph, a service furnished by a practitioner described in subparagraph (C) includes any services and supplies furnished as incident to the service as would otherwise be covered under this part if furnished by a physician or as incident to a physician's service.
(19) For purposes of
(c) Prompt payment of claims
(1) Repealed.
(2)(A) Each contract under
(i) which are clean claims, and
(ii) for which payment is not made on a periodic interim payment basis,
within the applicable number of calendar days after the date on which the claim is received.
(B) In this paragraph:
(i) The term "clean claim" means a claim that has no defect or impropriety (including any lack of any required substantiating documentation) or particular circumstance requiring special treatment that prevents timely payment from being made on the claim under this part.
(ii) The term "applicable number of calendar days" means—
(I) with respect to claims received in the 12-month period beginning October 1, 1986, 30 calendar days,
(II) with respect to claims received in the 12-month period beginning October 1, 1987, 26 calendar days (or 19 calendar days with respect to claims submitted by participating physicians),
(III) with respect to claims received in the 12-month period beginning October 1, 1988, 25 calendar days (or 18 calendar days with respect to claims submitted by participating physicians),
(IV) with respect to claims received in the 12-month period beginning October 1, 1989, and claims received in any succeeding 12-month period ending on or before September 30, 1993, 24 calendar days (or 17 calendar days with respect to claims submitted by participating physicians), and
(V) with respect to claims received in the 12-month period beginning October 1, 1993, and claims received in any succeeding 12-month period, 30 calendar days.
(C) If payment is not issued, mailed, or otherwise transmitted within the applicable number of calendar days (as defined in clause (ii) of subparagraph (B)) after a clean claim (as defined in clause (i) of such subparagraph) is received, interest shall be paid at the rate used for purposes of
(3)(A) Each contract under this section which provides for the disbursement of funds, as described in
(B) In this paragraph, the term "applicable number of calendar days" means—
(i) with respect to claims submitted electronically as prescribed by the Secretary, 13 days, and
(ii) with respect to claims submitted otherwise, 28 days.
(4) Neither a medicare administrative contractor nor the Secretary may impose a fee under this subchapter—
(A) for the filing of claims related to physicians' services,
(B) for an error in filing a claim relating to physicians' services or for such a claim which is denied,
(C) for any appeal under this subchapter with respect to physicians' services,
(D) for applying for (or obtaining) a unique identifier under subsection (r), or
(E) for responding to inquiries respecting physicians' services or for providing information with respect to medical review of such services.
(d) to (f). Repealed. Pub. L. 108–173, title IX, §911(c)(5), Dec. 8, 2003, 117 Stat. 2384
(g) Authority of Railroad Retirement Board to enter into contracts with medicare administrative contractors
The Railroad Retirement Board shall, in accordance with such regulations as the Secretary may prescribe, contract with a medicare administrative contractor or contractors to perform the functions set out in this section with respect to individuals entitled to benefits as qualified railroad retirement beneficiaries pursuant to
(h) Participating physician or supplier; agreement with Secretary; publication of directories; availability; inclusion of program in explanation of benefits; payment of claims on assignment-related basis
(1) Any physician or supplier may voluntarily enter into an agreement with the Secretary to become a participating physician or supplier. For purposes of this section, the term "participating physician or supplier" means a physician or supplier (excluding any provider of services) who, before the beginning of any year beginning with 1984, enters into an agreement with the Secretary which provides that such physician or supplier will accept payment under this part on an assignment-related basis for all items and services furnished to individuals enrolled under this part during such year. In the case of a newly licensed physician or a physician who begins a practice in a new area, or in the case of a new supplier who begins a new business, or in such similar cases as the Secretary may specify, such physician or supplier may enter into such an agreement after the beginning of a year, for items and services furnished during the remainder of the year.
(2) The Secretary shall maintain a toll-free telephone number or numbers at which individuals enrolled under this part may obtain the names, addresses, specialty, and telephone numbers of participating physicians and suppliers and may request a copy of an appropriate directory published under paragraph (4). The Secretary shall, without charge, mail a copy of such directory upon such a request.
(3)(A) In any case in which 2 medicare administrative contractor having a contract under
(B) The Secretary shall establish a procedure whereby an individual enrolled under this part may assign, in an appropriate manner on the form claiming a benefit under this part for an item or service furnished by a participating physician or supplier, the individual's rights of payment under a medicare supplemental policy (described in
(4) At the beginning of each year the Secretary shall publish directories (for appropriate local geographic areas) containing the name, address, and specialty of all participating physicians and suppliers (as defined in paragraph (1)) for that area for that year. Each directory shall be organized to make the most useful presentation of the information (as determined by the Secretary) for individuals enrolled under this part. Each participating physician directory for an area shall provide an alphabetical listing of all participating physicians practicing in the area and an alphabetical listing by locality and specialty of such physicians.
(5)(A) The Secretary shall promptly notify individuals enrolled under this part through an annual mailing of the participation program under this subsection and the publication and availability of the directories and shall make the appropriate area directory or directories available in each district and branch office of the Social Security Administration, in the offices of medicare administrative contractors, and to senior citizen organizations.
(B) The annual notice provided under subparagraph (A) shall include—
(i) a description of the participation program,
(ii) an explanation of the advantages to beneficiaries of obtaining covered services through a participating physician or supplier,
(iii) an explanation of the assistance offered by medicare administrative contractors in obtaining the names of participating physicians and suppliers, and
(iv) the toll-free telephone number under paragraph (2)(A) for inquiries concerning the program and for requests for free copies of appropriate directories.
(6) The Secretary shall provide that the directories shall be available for purchase by the public. The Secretary shall provide that each appropriate area directory is sent to each participating physician located in that area and that an appropriate number of copies of each such directory is sent to hospitals located in the area. Such copies shall be sent free of charge.
(7) The Secretary shall provide that each explanation of benefits provided under this part for services furnished in the United States, in conjunction with the payment of claims under
(A) a prominent reminder of the participating physician and supplier program established under this subsection (including the limitation on charges that may be imposed by such physicians and suppliers and a clear statement of any amounts charged for the particular items or services on the claim involved above the amount recognized under this part),
(B) the toll-free telephone number or numbers, maintained under paragraph (2), at which an individual enrolled under this part may obtain information on participating physicians and suppliers,
(C)(i) an offer of assistance to such an individual in obtaining the names of participating physicians of appropriate specialty and (ii) an offer to provide a free copy of the appropriate participating physician directory, and
(D) in the case of services for which the billed amount exceeds the limiting charge imposed under
(8) The Secretary may refuse to enter into an agreement with a physician or supplier under this subsection, or may terminate or refuse to renew such agreement, in the event that such physician or supplier has been convicted of a felony under Federal or State law for an offense which the Secretary determines is detrimental to the best interests of the program or program beneficiaries.
(9) The Secretary may revoke enrollment, for a period of not more than one year for each act, for a physician or supplier under
(i) Definitions
For purposes of this subchapter:
(1) A claim is considered to be paid on an "assignment-related basis" if the claim is paid on the basis of an assignment described in subsection (b)(3)(B)(ii), in accordance with subsection (b)(6)(B), or under the procedure described in
(2) The term "participating physician" refers, with respect to the furnishing of services, to a physician who at the time of furnishing the services is a participating physician (under subsection (h)(1)); the term "nonparticipating physician" refers, with respect to the furnishing of services, to a physician who at the time of furnishing the services is not a participating physician; and the term "nonparticipating supplier or other person" means a supplier or other person (excluding a provider of services) that is not a participating physician or supplier (as defined in subsection (h)(1)).
(3) The term "percentage increase in the MEI" means, with respect to physicians' services furnished in a year, the percentage increase in the medicare economic index (referred to in the fourth sentence of subsection (b)(3)) applicable to such services furnished as of the first day of that year.
(4) The term "primary care services" means physicians' services which constitute office medical services, emergency department services, home medical services, skilled nursing, intermediate care, and long-term care medical services, or nursing home, boarding home, domiciliary, or custodial care medical services.
(j) Monitoring of charges of nonparticipating physicians; sanctions; restitution
(1)(A) In the case of a physician who is not a participating physician for items and services furnished during a portion of the 30-month period beginning July 1, 1984, the Secretary shall monitor the physician's actual charges to individuals enrolled under this part for physicians' services during that portion of that period. If such physician knowingly and willfully bills individuals enrolled under this part for actual charges in excess of such physician's actual charges for the calendar quarter beginning on April 1, 1984, the Secretary may apply sanctions against such physician in accordance with paragraph (2).
(B)(i) During any period (on or after January 1, 1987, and before the date specified in clause (ii)), during which a physician is a nonparticipating physician, the Secretary shall monitor the actual charges of each such physician for physicians' services furnished to individuals enrolled under this part. If such physician knowingly and willfully bills on a repeated basis for such a service an actual charge in excess of the maximum allowable actual charge determined under subparagraph (C) for that service, the Secretary may apply sanctions against such physician in accordance with paragraph (2).
(ii) Clause (i) shall not apply to services furnished after December 31, 1990.
(C)(i) For a particular physicians' service furnished by a nonparticipating physician to individuals enrolled under this part during a year, for purposes of subparagraph (B), the maximum allowable actual charge is determined as follows: If the physician's maximum allowable actual charge for that service in the previous year was—
(I) less than 115 percent of the applicable percent (as defined in subsection (b)(4)(A)(iv)) of the prevailing charge for the year and service involved, the maximum allowable actual charge for the year involved is the greater of the maximum allowable actual charge described in subclause (II) or the charge described in clause (ii), or
(II) equal to, or greater than, 115 percent of the applicable percent (as defined in subsection (b)(4)(A)(iv)) of the prevailing charge for the year and service involved, the maximum allowable actual charge is 101 percent of the physician's maximum allowable actual charge for the service for the previous year.
(ii) For purposes of clause (i)(I), the charge described in this clause for a particular physicians' service furnished in a year is the maximum allowable actual charge for the service of the physician for the previous year plus the product of (I) the applicable fraction (as defined in clause (iii)) and (II) the amount by which 115 percent of the prevailing charge for the year involved for such service furnished by nonparticipating physicians, exceeds the physician's maximum allowable actual charge for the service for the previous year.
(iii) In clause (ii), the "applicable fraction" is—
(I) for 1987, ¼,
(II) for 1988, 1/3,
(III) for 1989, ½, and
(IV) for any subsequent year, 1.
(iv) For purposes of determining the maximum allowable actual charge under clauses (i) and (ii) for 1987, in the case of a physicians' service for which the physician has actual charges for the calendar quarter beginning on April 1, 1984, the "maximum allowable actual charge" for 1986 is the physician's actual charge for such service furnished during such quarter.
(v) For purposes of determining the maximum allowable actual charge under clauses (i) and (ii) for a year after 1986, in the case of a physicians' service for which the physician has no actual charges for the calendar quarter beginning on April 1, 1984, and for which a maximum allowable actual charge has not been previously established under this clause, the "maximum allowable actual charge" for the previous year shall be the 50th percentile of the customary charges for the service (weighted by frequency of the service) performed by nonparticipating physicians in the locality during the 12-month period ending June 30 of that previous year.
(vi) For purposes of this subparagraph, a "physician's actual charge" for a physicians' service furnished in a year or other period is the weighted average (or, at the option of the Secretary for a service furnished in the calendar quarter beginning April 1, 1984, the median) of the physician's charges for such service furnished in the year or other period.
(vii) In the case of a nonparticipating physician who was a participating physician during a previous period, for the purpose of computing the physician's maximum allowable actual charge during the physician's period of nonparticipation, the physician shall be deemed to have had a maximum allowable actual charge during the period of participation, and such deemed maximum allowable actual charge shall be determined according to clauses (i) through (vi).
(viii) Notwithstanding any other provision of this subparagraph, the maximum allowable actual charge for a particular physician's service furnished by a nonparticipating physician to individuals enrolled under this part during the 3-month period beginning on January 1, 1988, shall be the amount determined under this subparagraph for 1987. The maximum allowable actual charge for any such service otherwise determined under this subparagraph for 1988 shall take effect on April 1, 1988.
(ix) If there is a reduction under subsection (b)(13) in the reasonable charge for medical direction furnished by a nonparticipating physician, the maximum allowable actual charge otherwise permitted under this subsection for such services shall be reduced in the same manner and in the same percentage as the reduction in such reasonable charge.
(D)(i) If an action described in clause (ii) results in a reduction in a reasonable charge for a physicians' service or item and a nonparticipating physician furnishes the service or item to an individual entitled to benefits under this part after the effective date of such action, the physician may not charge the individual more than 125 percent of the reduced payment allowance (as defined in clause (iii)) plus (for services or items furnished during the 12-month period (or 9-month period in the case of an action described in clause (ii)(II)) beginning on the effective date of the action) ½ of the amount by which the physician's maximum allowable actual charge for the service or item for the previous 12-month period exceeds such 125 percent level.
(ii) The first sentence of clause (i) shall apply to—
(I) an adjustment under subsection (b)(8)(B) (relating to inherent reasonableness),
(II) a reduction under subsection (b)(10)(A) or (b)(14)(A) (relating to certain overpriced procedures),
(III) a reduction under subsection (b)(11)(B) (relating to certain cataract procedures),
(IV) a prevailing charge limit established under subsection (b)(11)(C)(i) or (b)(15)(A),
(V) a reasonable charge limit established under subsection (b)(11)(C)(ii) of this section, and
(VI) an adjustment under
(iii) In clause (i), the term "reduced payment allowance" means, with respect to an action—
(I) under subsection (b)(8)(B), the inherently reasonable charge established under subsection (b)(8);
(II) under subsection (b)(10)(A), (b)(11)(B), (b)(11)(C)(i), (b)(14)(A), or (b)(15)(A) or under
(III) under subsection (b)(11)(C)(ii), the payment allowance established under such subsection.
(iv) If a physician knowingly and willfully bills in violation of clause (i) (whether or not such charge violates subparagraph (B)), the Secretary may apply sanctions against such physician in accordance with paragraph (2).
(v) Clause (i) shall not apply to items and services furnished after December 31, 1990.
(2) Subject to paragraph (3), the sanctions which the Secretary may apply under this paragraph are—
(A) excluding a physician from participation in the programs under this chapter for a period not to exceed 5 years, in accordance with the procedures of subsections (c), (f), and (g) of
(B) civil monetary penalties and assessments, in the same manner as such penalties and assessments are authorized under
or both. The provisions of
(3)(A) The Secretary may not exclude a physician pursuant to paragraph (2)(A) if such physician is a sole community physician or sole source of essential specialized services in a community.
(B) The Secretary shall take into account access of beneficiaries to physicians' services for which payment may be made under this part in determining whether to bar a physician from participation under paragraph (2)(A).
(4) The Secretary may, out of any civil monetary penalty or assessment collected from a physician pursuant to this subsection, make a payment to a beneficiary enrolled under this part in the nature of restitution for amounts paid by such beneficiary to such physician which was determined to be an excess charge under paragraph (1).
(k) Sanctions for billing for services of assistant at cataract operations
(1) If a physician knowingly and willfully presents or causes to be presented a claim or bills an individual enrolled under this part for charges for services as an assistant at surgery for which payment may not be made by reason of
(2) If a physician knowingly and willfully presents or causes to be presented a claim or bills an individual enrolled under this part for charges that includes a charge for an assistant at surgery for which payment may not be made by reason of
(l) Prohibition of unassigned billing of services determined to be medically unnecessary by carrier
(1)(A) Subject to subparagraph (C), if—
(i) a nonparticipating physician furnishes services to an individual enrolled for benefits under this part,
(ii) payment for such services is not accepted on an assignment-related basis,
(iii)(I) a medicare administrative contractor determines under this part or a quality improvement organization determines under part B of subchapter XI that payment may not be made by reason of
(iv) the physician has collected any amounts for such services,
the physician shall refund on a timely basis to the individual (and shall be liable to the individual for) any amounts so collected.
(B) A refund under subparagraph (A) is considered to be on a timely basis only if—
(i) in the case of a physician who does not request reconsideration or seek appeal on a timely basis, the refund is made within 30 days after the date the physician receives a denial notice under paragraph (2), or
(ii) in the case in which such a reconsideration or appeal is taken, the refund is made within 15 days after the date the physician receives notice of an adverse determination on reconsideration or appeal.
(C) Subparagraph (A) shall not apply to the furnishing of a service by a physician to an individual in the case described in subparagraph (A)(iii)(I) if—
(i) the physician establishes that the physician did not know and could not reasonably have been expected to know that payment may not be made for the service by reason of
(ii) before the service was provided, the individual was informed that payment under this part may not be made for the specific service and the individual has agreed to pay for that service.
(2) Each medicare administrative contractor with a contract in effect under this section with respect to physicians and each quality improvement organization with a contract under part B of subchapter XI shall send any notice of denial of payment for physicians' services based on
(3) If a physician knowingly and willfully fails to make refunds in violation of paragraph (1)(A), the Secretary may apply sanctions against such physician in accordance with subsection (j)(2).
(m) Disclosure of information of unassigned claims for certain physicians' services
(1) In the case of a nonparticipating physician who—
(A) performs an elective surgical procedure for an individual enrolled for benefits under this part and for which the physician's actual charge is at least $500, and
(B) does not accept payment for such procedure on an assignment-related basis,
the physician must disclose to the individual, in writing and in a form approved by the Secretary, the physician's estimated actual charge for the procedure, the estimated approved charge under this part for the procedure, the excess of the physician's actual charge over the approved charge, and the coinsurance amount applicable to the procedure. The written estimate may not be used as the basis for, or evidence in, a civil suit.
(2) A physician who fails to make a disclosure required under paragraph (1) with respect to a procedure shall refund on a timely basis to the individual (and shall be liable to the individual for) any amounts collected for the procedure in excess of the charges recognized and approved under this part.
(3) If a physician knowingly and willfully fails to comply with paragraph (2), the Secretary may apply sanctions against such physician in accordance with subsection (j)(2).
(4) The Secretary shall provide for such monitoring of requests for payment for physicians' services to which paragraph (1) applies as is necessary to assure compliance with paragraph (2).
(n) Elimination of markup for certain purchased services
(1) If a physician's bill or a request for payment for services billed by a physician includes a charge for a diagnostic test described in
(A) If the bill or request for payment indicates that the test was performed by a supplier, identifies the supplier, and indicates the amount the supplier charged the billing physician, payment for the test (less the applicable deductible and coinsurance amounts) shall be the actual acquisition costs (net of any discounts) or, if lower, the supplier's reasonable charge (or other applicable limit) for the test.
(B) If the bill or request for payment (i) does not indicate who performed the test, or (ii) indicates that the test was performed by a supplier but does not identify the supplier or include the amount charged by the supplier, no payment shall be made under this part.
(2) A physician may not bill an individual enrolled under this part—
(A) any amount other than the payment amount specified in paragraph (1)(A) and any applicable deductible and coinsurance for a diagnostic test for which payment is made pursuant to paragraph (1)(A), or
(B) any amount for a diagnostic test for which payment may not be made pursuant to paragraph (1)(B).
(3) If a physician knowingly and willfully in repeated cases bills one or more individuals in violation of paragraph (2), the Secretary may apply sanctions against such physician in accordance with subsection (j)(2).
(o) Reimbursement for drugs and biologicals
(1) If a physician's, supplier's, or any other person's bill or request for payment for services includes a charge for a drug or biological for which payment may be made under this part and the drug or biological is not paid on a cost or prospective payment basis as otherwise provided in this part, the amount payable for the drug or biological is equal to the following:
(A) In the case of any of the following drugs or biologicals, 95 percent of the average wholesale price:
(i) A drug or biological furnished before January 1, 2004.
(ii) Blood clotting factors furnished during 2004.
(iii) A drug or biological furnished during 2004 that was not available for payment under this part as of April 1, 2003.
(iv) A vaccine described in subparagraph (A) or (B) of
(v) A drug or biological furnished during 2004 in connection with the furnishing of renal dialysis services if separately billed by renal dialysis facilities.
(B) In the case of a drug or biological furnished during 2004 that is not described in—
(i) clause (ii), (iii), (iv), or (v) of subparagraph (A),
(ii) subparagraph (D)(i), or
(iii) subparagraph (F),
the amount determined under paragraph (4).
(C) In the case of a drug or biological that is not described in subparagraph (A)(iv), (D)(i), or (F) furnished on or after January 1, 2005 (and including a drug or biological described in subparagraph (D)(i) furnished on or after January 1, 2017), the amount provided under
(D)(i) Except as provided in clause (ii), in the case of infusion drugs or biologicals furnished through an item of durable medical equipment covered under
(ii) In the case of such infusion drugs or biologicals furnished in a competitive acquisition area under
(E) In the case of a drug or biological, consisting of intravenous immune globulin, furnished—
(i) in 2004, the amount of payment provided under paragraph (4); and
(ii) in 2005 and subsequent years, the amount of payment provided under
(F) In the case of blood and blood products (other than blood clotting factors), the amount of payment shall be determined in the same manner as such amount of payment was determined on October 1, 2003.
(G) In the case of inhalation drugs or biologicals furnished through durable medical equipment covered under
(i) in 2004, the amount provided under paragraph (4) for the drug or biological; and
(ii) in 2005 and subsequent years, the amount provided under
(2) If payment for a drug or biological is made to a licensed pharmacy approved to dispense drugs or biologicals under this part, the Secretary may pay a dispensing fee (less the applicable deductible and coinsurance amounts) to the pharmacy. This paragraph shall not apply in the case of payment under paragraph (1)(C).
(3)(A) Payment for a charge for any drug or biological for which payment may be made under this part may be made only on an assignment-related basis.
(B) The provisions of subsection (b)(18)(B) shall apply to charges for such drugs or biologicals in the same manner as they apply to services furnished by a practitioner described in subsection (b)(18)(C).
(4)(A) Subject to the succeeding provisions of this paragraph, the amount of payment for a drug or biological under this paragraph furnished in 2004 is equal to 85 percent of the average wholesale price (determined as of April 1, 2003) for the drug or biological.
(B) The Secretary shall substitute for the percentage under subparagraph (A) for a drug or biological the percentage that would apply to the drug or biological under the column entitled "Average of GAO and OIG data (percent)" in the table entitled "Table 3.—Medicare Part B Drugs in the Most Recent GAO and OIG Studies" published on August 20, 2003, in the Federal Register (68 Fed. Reg. 50445).
(C)(i) The Secretary may substitute for the percentage under subparagraph (A) a percentage that is based on data and information submitted by the manufacturer of the drug or biological by October 15, 2003.
(ii) The Secretary may substitute for the percentage under subparagraph (A) with respect to drugs and biologicals furnished during 2004 on or after April 1, 2004, a percentage that is based on data and information submitted by the manufacturer of the drug or biological after October 15, 2003, and before January 1, 2004.
(D) In no case may the percentage substituted under subparagraph (B) or (C) be less than 80 percent.
(5)(A) Subject to subparagraph (B), in the case of clotting factors furnished on or after January 1, 2005, the Secretary shall, after reviewing the January 2003 report to Congress by the Comptroller General of the United States entitled "Payment for Blood Clotting Factor Exceeds Providers Acquisition Cost", provide for a separate payment, to the entity which furnishes to the patient blood clotting factors, for items and services related to the furnishing of such factors in an amount that the Secretary determines to be appropriate. Such payment amount may take into account any or all of the following:
(i) The mixing (if appropriate) and delivery of factors to an individual, including special inventory management and storage requirements.
(ii) Ancillary supplies and patient training necessary for the self-administration of such factors.
(B) In determining the separate payment amount under subparagraph (A) for blood clotting factors furnished in 2005, the Secretary shall ensure that the total amount of payments under this part (as estimated by the Secretary) for such factors under paragraph (1)(C) and such separate payments for such factors does not exceed the total amount of payments that would have been made for such factors under this part (as estimated by the Secretary) if the amendments made by section 303 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 had not been enacted.
(C) The separate payment amount under this subparagraph for blood clotting factors furnished in 2006 or a subsequent year shall be equal to the separate payment amount determined under this paragraph for the previous year increased by the percentage increase in the consumer price index for medical care for the 12-month period ending with June of the previous year.
(6) In the case of an immunosuppressive drug described in subparagraph (J) of
(7) There shall be no administrative or judicial review under
(8) In the case of intravenous immune globulin described in
(p) Requiring submission of diagnostic information
(1) Each request for payment, or bill submitted, for an item or service furnished by a physician or practitioner specified in subsection (b)(18)(C) for which payment may be made under this part shall include the appropriate diagnosis code (or codes) as established by the Secretary for such item or service.
(2) In the case of a request for payment for an item or service furnished by a physician or practitioner specified in subsection (b)(18)(C) on an assignment-related basis which does not include the code (or codes) required under paragraph (1), payment may be denied under this part.
(3) In the case of a request for payment for an item or service furnished by a physician not submitted on an assignment-related basis and which does not include the code (or codes) required under paragraph (1)—
(A) if the physician knowingly and willfully fails to provide the code (or codes) promptly upon request of the Secretary or a medicare administrative contractor, the physician may be subject to a civil money penalty in an amount not to exceed $2,000, and
(B) if the physician knowingly, willfully, and in repeated cases fails, after being notified by the Secretary of the obligations and requirements of this subsection, to include the code (or codes) required under paragraph (1), the physician may be subject to the sanction described in subsection (j)(2)(A).
The provisions of
(4) In the case of an item or service defined in paragraph (3), (6), (8), or (9) of sub
(q) Anesthesia services; counting actual time units
(1)(A) The Secretary, in consultation with groups representing physicians who furnish anesthesia services, shall establish by regulation a relative value guide for use in all localities in making payment for physician anesthesia services furnished under this part. Such guide shall be designed so as to result in expenditures under this subchapter for such services in an amount that would not exceed the amount of such expenditures which would otherwise occur.
(B) For physician anesthesia services furnished under this part during 1991, the prevailing charge conversion factor used in a locality under this subsection shall, subject to clause (iv), be reduced to the adjusted prevailing charge conversion factor for the locality determined as follows:
(i) The Secretary shall estimate the national weighted average of the prevailing charge conversion factors used under this subsection for services furnished during 1990 after March 31, using the best available data.
(ii) The national weighted average estimated under clause (i) shall be reduced by 7 percent.
(iii) The adjusted prevailing charge conversion factor for a locality is the sum of—
(I) the product of (a) the portion of the reduced national weighted average prevailing charge conversion factor computed under clause (ii) which is attributable to physician work and (b) the geographic work index value for the locality (specified in Addendum C to the Model Fee Schedule for Physician Services (published on September 4, 1990, 55 Federal Register pp. 36238–36243)); and
(II) the product of (a) the remaining portion of the reduced national weighted average prevailing charge conversion factor computed under clause (ii) and (b) the geographic practice cost index value specified in subsection (b)(14)(C)(iv) for the locality.
In applying this clause, 70 percent of the prevailing charge conversion factor shall be considered to be attributable to physician work.
(iv) The prevailing charge conversion factor to be applied to a locality under this subparagraph shall not be reduced by more than 15 percent below the prevailing charge conversion factor applied in the locality for the period during 1990 after March 31, but in no case shall the prevailing charge conversion factor be less than 60 percent of the national weighted average of the prevailing charge conversion factors (computed under clause (i)).
(2) For purposes of payment for anesthesia services (whether furnished by physicians or by certified registered nurse anesthetists) under this part, the time units shall be counted based on actual time rather than rounded to full time units.
(r) Establishment of physician identification system
The Secretary shall establish a system which provides for a unique identifier for each physician who furnishes services for which payment may be made under this subchapter. Under such system, the Secretary may impose appropriate fees on such physicians to cover the costs of investigation and recertification activities with respect to the issuance of the identifiers.
(s) Application of fee schedule
(1)(A) Subject to paragraph (3), the Secretary may implement a statewide or other areawide fee schedule to be used for payment of any item or service described in paragraph (2) which is paid on a reasonable charge basis.
(B) Any fee schedule established under this paragraph for such item or service shall be updated—
(i) for years before 2011—
(I) subject to subclause (II), by the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12-month period ending with June of the preceding year; and
(II) for items and services described in paragraph (2)(D) for 2009,
(ii) for 2011 and subsequent years—
(I) the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12-month period ending with June of the previous year, reduced by—
(II) the productivity adjustment described in
The application of subparagraph (B)(ii)(II) may result in the update under this paragraph being less than 0.0 for a year, and may result in payment rates under any fee schedule established under this paragraph for a year being less than such payment rates for the preceding year.
(2) The items and services described in this paragraph are as follows:
(A) Medical supplies.
(B) Home dialysis supplies and equipment (as defined in
(C) Repealed.
(D) Parenteral and enteral nutrients, equipment, and supplies.
(E) Electromyogram devices.
(F) Salivation devices.
(G) Blood products.
(H) Transfusion medicine.
(3) In the case of items and services described in paragraph (2)(D) that are included in a competitive acquisition program in a competitive acquisition area under
(A) the payment basis under this subsection for such items and services furnished in such area shall be the payment basis determined under such competitive acquisition program; and
(B) subject to
(t) Facility provider number required on claims
(1) Each request for payment, or bill submitted, for an item or service furnished to an individual who is a resident of a skilled nursing facility for which payment may be made under this part shall include the facility's medicare provider number.
(2) Each request for payment, or bill submitted, for therapy services described in paragraph (1) or (3) of
(u) Reporting of anemia quality indicators for cancer anti-anemia drugs
Each request for payment, or bill submitted, for a drug furnished to an individual for the treatment of anemia in connection with the treatment of cancer shall include (in a form and manner specified by the Secretary) information on the hemoglobin or hematocrit levels for the individual.
(Aug. 14, 1935, ch. 531, title XVIII, §1842, as added
Editorial Notes
References in Text
The Omnibus Budget Reconciliation Act of 1990, referred to in subsec. (b)(14)(A)(ii), is
Section 303 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, referred to in subsec. (o)(5)(B), is section 303 of
Section 101 of the Medicare IVIG Access and Strengthening Medicare and Repaying Taxpayers Act of 2012, referred to in subsec. (o)(8), is section 101 of
Amendments
2022—Subsec. (b)(18)(C)(vii), (viii).
Subsec. (o)(8).
2020—Subsec. (b)(6)(C).
2018—Subsec. (b)(6)(I).
2016—Subsec. (b)(6)(I).
Subsec. (b)(6)(J).
Subsec. (o)(1)(C).
Subsec. (o)(1)(D)(i).
Subsec. (o)(1)(D)(ii).
Subsec. (s)(3)(B).
2012—Subsec. (t).
2011—Subsec. (l)(1)(A)(iii)(I), (2).
2010—Subsec. (b)(3).
Subsec. (b)(3)(B).
Subsec. (h)(9).
Subsec. (s)(1).
"(A) for 2009
"(B) for 2014, if subparagraph (A) is applied to the items and services and there has not been a payment adjustment under paragraph (3)(B) for the items and services for any previous year, the percentage increase computed under
2008—Subsec. (b)(6)(D)(iii).
Subsec. (s)(1).
2007—Subsec. (b)(6)(D)(iii).
2006—Subsec. (b)(6)(H).
Subsec. (c)(3)(B)(ii).
Subsec. (u).
2003—
Subsec. (a).
Subsec. (b)(1).
Subsec. (b)(2)(A), (B).
Subsec. (b)(2)(C).
Subsec. (b)(2)(D), (E).
Subsec. (b)(3).
Subsec. (b)(3)(A).
Subsec. (b)(3)(B).
Subsec. (b)(3)(C) to (E).
Subsec. (b)(3)(F).
Subsec. (b)(3)(G).
Subsec. (b)(3)(H).
Subsec. (b)(3)(H)(i).
Subsec. (b)(3)(I).
Subsec. (b)(3)(L).
Subsec. (b)(5).
Subsec. (b)(6).
Subsec. (b)(6)(A)(ii).
Subsec. (b)(6)(D)(iv).
Subsec. (b)(7).
Subsec. (c)(1).
Subsec. (c)(2)(A).
Subsec. (c)(2)(B)(ii)(III).
Subsec. (c)(2)(B)(ii)(IV).
Subsec. (c)(3)(A).
Subsec. (c)(4).
Subsec. (c)(5), (6).
Subsec. (d) to (f).
Subsec. (g).
Subsec. (h)(2).
Subsec. (h)(3)(A).
Subsec. (h)(3)(B).
Subsec. (h)(5)(A), (B)(iii).
Subsec. (i)(2).
Subsec. (l)(1)(A)(iii), (2).
Subsec. (o)(1).
Subsec. (o)(1)(G).
Subsec. (o)(2).
Subsec. (o)(4).
Subsec. (o)(5), (6).
Subsec. (o)(7).
Subsec. (p)(3)(A).
Subsec. (q)(1)(A).
Subsec. (s)(1).
Subsec. (s)(2)(C).
Subsec. (s)(3).
2000—Subsec. (b)(6)(C).
Subsec. (b)(6)(E).
Subsec. (b)(6)(G).
Subsec. (b)(18)(C)(vi).
Subsec. (o)(3).
Subsec. (t).
1999—Subsec. (b)(6)(F).
Subsec. (b)(8)(A)(i)(I).
Subsec. (s)(2)(E).
1997—Subsec. (b)(2)(E).
Subsec. (b)(6).
Subsec. (b)(6)(A)(ii).
Subsec. (b)(6)(C).
Subsec. (b)(6)(E).
Subsec. (b)(6)(F).
Subsec. (b)(8), (9).
Subsec. (b)(12).
"(12)(A) With respect to services described in clauses (i), (ii), or (iv) of
"(i) payment under this part may only be made on an assignment-related basis; and
"(ii) the prevailing charges determined under paragraph (3) shall not exceed—
"(I) in the case of services performed as an assistant at surgery, 65 percent of the amount that would otherwise be recognized if performed by a physician who is serving as an assistant at surgery, or
"(II) in other cases, the applicable percentage (as defined in subparagraph (B)) of the prevailing charge rate determined for such services (or, for services furnished on or after January 1, 1992, the fee schedule amount specified in
"(B) In subparagraph (A)(ii)(II), the term 'applicable percentage' means—
"(i) 75 percent in the case of services performed (other than as an assistant at surgery) in a hospital, and
"(ii) 85 percent in the case of other services."
Subsec. (b)(19).
Subsec. (h)(8).
Subsec. (o).
Subsec. (p)(1), (2).
Subsec. (p)(4).
Subsec. (s).
Subsec. (t).
1996—Subsec. (c)(6).
Subsec. (r).
1994—Subsec. (b)(2)(A).
Subsec. (b)(2)(D).
Subsec. (b)(3)(G).
Subsec. (b)(3)(H).
Subsec. (b)(3)(I).
Subsec. (b)(6)(D).
Subsec. (b)(12)(C).
Subsec. (b)(16)(B)(iii).
Subsec. (b)(17).
Subsec. (b)(18).
Subsec. (c)(1).
Subsec. (c)(4).
Subsec. (c)(5).
Subsec. (h)(7)(C).
Subsec. (h)(7)(D).
Subsec. (q)(1).
Subsec. (q)(1)(B).
Subsec. (q)(1)(B)(iii).
1993—Subsec. (b)(4)(F).
Subsec. (b)(13)(A).
"(i) 10 percent, in the case of medical direction of 2 nurse anesthetists concurrently,
"(ii) 25 percent, in the case of medical direction of 3 nurse anesthetists concurrently, and
"(iii) 40 percent, in the case of medical direction of 4 nurse anesthetists concurrently."
Subsec. (b)(13)(B), (C).
Subsec. (c)(2)(B)(ii).
Subsec. (c)(3)(B).
"(i) with respect to claims received in the 3-month period beginning July 1, 1988, 10 days, and
"(ii) with respect to claims received in the 12-month period beginning October 1, 1988, 14 days."
Subsec. (i)(2).
1990—Subsec. (b)(2)(A).
Subsec. (b)(3)(G).
Subsec. (b)(4)(A)(vi).
Subsec. (b)(4)(B)(iv).
Subsec. (b)(4)(E)(iv)(I).
Subsec. (b)(4)(E)(v).
Subsec. (b)(4)(F).
Subsec. (b)(4)(F)(i).
Subsec. (b)(4)(F)(ii)(II).
Subsec. (b)(6)(C).
Subsec. (b)(6)(D).
Subsec. (b)(12)(A).
Subsec. (b)(12)(A)(ii)(II).
Subsec. (b)(12)(C).
Subsec. (b)(13)(A), (B).
Subsec. (b)(14)(A).
Subsec. (b)(14)(B)(iii)(I).
Subsec. (b)(14)(B)(iii)(II).
Subsec. (b)(14)(C)(i).
Subsec. (b)(14)(C)(iii).
Subsec. (b)(14)(C)(iv).
Subsec. (b)(16).
Subsec. (b)(18).
Subsec. (q)(1).
Subsec. (r).
1989—Subsec. (b)(2)(A).
Subsec. (b)(2)(C).
Subsec. (b)(3)(G).
Subsec. (b)(3)(I) to (K).
Subsec. (b)(3)(L).
Subsec. (b)(4)(A)(iv).
Subsec. (b)(4)(E)(iv).
Subsec. (b)(4)(F).
Subsec. (b)(6)(A)(ii).
Subsec. (b)(6)(C).
Subsec. (b)(12)(A).
Subsec. (b)(12)(A)(ii)(II).
Subsec. (b)(14).
Subsec. (b)(15).
Subsecs. (c)(1)(A), (2)(A), (3)(A), (4), (f)(3), (h)(1), (2), (4).
Subsec. (j)(1)(B)(ii).
Subsec. (j)(1)(C)(vii).
Subsec. (j)(1)(D)(ii)(II).
Subsec. (j)(1)(D)(ii)(IV).
Subsec. (j)(1)(D)(iii)(II).
Subsec. (j)(1)(D)(v).
Subsec. (j)(2).
Subsec. (o).
Subsec. (q).
1988—Subsec. (b)(2).
Subsec. (b)(2)(A).
Subsec. (b)(3).
Subsec. (b)(3)(B)(ii).
Subsec. (b)(3)(I).
Subsec. (b)(3)(J).
Subsec. (b)(3)(K).
Subsec. (b)(4)(A)(iv).
Subsec. (b)(4)(A)(iv)(II).
Subsec. (b)(4)(A)(vi).
Subsec. (b)(4)(A)(vii).
Subsec. (b)(4)(E).
Subsec. (b)(4)(F).
Subsec. (b)(4)(F)(ii)(I).
Subsec. (b)(4)(F)(iii).
Subsec. (b)(4)(G).
Subsec. (b)(7)(B)(iii).
Subsec. (b)(10)(A)(i).
Subsec. (b)(10)(A)(iii).
Subsec. (b)(10)(B).
Subsec. (b)(10)(D).
Subsec. (b)(11)(B)(i).
Subsec. (b)(11)(C)(i).
Subsec. (b)(11)(C)(ii).
Subsec. (b)(12)(C).
Subsec. (b)(13), (14).
Subsec. (c)(1)(A).
Subsec. (c)(1)(A)(ii).
Subsec. (c)(2)(A), (3)(A).
Subsec. (c)(4).
Subsec. (f)(3).
Subsec. (h)(1).
Subsec. (h)(2).
Subsec. (h)(3)(B).
Subsec. (h)(4).
Subsec. (h)(5).
Subsec. (h)(7).
Subsec. (h)(8).
Subsec. (i).
Subsec. (i)(2), (3).
Subsec. (i)(3).
Subsec. (i)(4).
Subsec. (j)(1)(C)(i).
Subsec. (j)(1)(C)(viii).
Subsec. (j)(1)(C)(ix).
Subsec. (j)(1)(D)(ii)(IV).
Subsec. (j)(1)(D)(ii)(V).
Subsec. (j)(1)(D)(iii).
Subsec. (j)(1)(D)(iv).
Subsec. (j)(2).
Subsec. (l)(1)(C)(i).
Subsec. (n)(1).
Subsec. (n)(1)(A).
Subsec. (n)(2)(A).
Subsec. (n)(3).
Subsec. (o).
Subsec. (o)(1)(A)(i).
Subsec. (o)(1)(B)(ii).
Subsec. (p).
1987—Subsec. (b)(2).
Subsec. (b)(3).
Subsec. (b)(3)(B)(ii).
Subsec. (b)(3)(C).
Subsec. (b)(4)(A)(iv).
Subsec. (b)(4)(A)(v).
Subsec. (b)(4)(A)(vi).
Subsec. (b)(4)(A)(vii).
Subsec. (b)(4)(B)(iii).
Subsec. (b)(4)(E).
Subsec. (b)(4)(F).
Subsec. (b)(4)(G).
Subsec. (b)(7)(B)(iii).
Subsec. (b)(10).
Subsec. (b)(11)(B)(i).
Subsec. (b)(11)(C).
"(ii) In clause (i), the term 'limiting charge' means, with respect to a service, 125 percent of the prevailing charge for the service after the reduction referred to in clause (i).
"(iii) If a physician knowingly and willfully imposes charges in violation of clause (i), the Secretary may apply sanctions against such physician in accordance with subsection (j)(2) of this section.
"(iv) This subparagraph shall not apply to services furnished after the earlier of (I) December 31, 1990, or (II) one-year after the date the Secretary reports to Congress, under
Subsec. (b)(11)(D).
Subsec. (b)(12)(C).
Subsec. (b)(14).
Subsec. (c)(1).
Subsec. (c)(3).
Subsec. (h)(3).
Subsec. (h)(5).
Subsec. (h)(7).
Subsec. (h)(8).
Subsec. (i).
Subsec. (i)(2), (3).
Subsec. (i)(4).
Subsec. (j)(1)(B)(i).
Subsec. (j)(1)(C)(i).
Subsec. (j)(1)(C)(v).
Subsec. (j)(1)(C)(vi).
Subsec. (j)(1)(C)(vii).
Subsec. (j)(1)(C)(viii).
Subsec. (j)(1)(C)(ix).
Subsec. (j)(1)(D).
Subsec. (j)(1)(D)(ii)(IV).
Subsec. (j)(1)(D)(ii)(V), (VI).
Subsec. (j)(1)(D)(iii).
Subsec. (j)(2).
Subsec. (j)(3)(A).
Subsec. (k)(1), (2).
Subsec. (l)(1)(A)(iii).
Subsec. (l)(1)(C).
Subsec. (l)(1)(C)(i).
Subsec. (n).
1986—Subsec. (b)(3).
Subsec. (b)(3)(C).
Subsec. (b)(3)(F).
Subsec. (b)(3)(G).
Subsec. (b)(3)(H).
Subsec. (b)(4)(A)(i), (ii).
Subsec. (b)(4)(A)(iii).
Subsec. (b)(4)(A)(iv), (v).
Subsec. (b)(4)(B).
Subsec. (b)(4)(C).
Subsec. (b)(4)(D)(i) to (iii).
Subsec. (b)(4)(D)(iv).
Subsec. (b)(4)(E).
Subsec. (b)(6).
Subsec. (b)(7)(B)(ii)(III).
Subsec. (b)(7)(B)(iii).
Subsec. (b)(8).
Subsec. (b)(9).
Subsec. (b)(10).
Subsec. (b)(11).
Subsec. (b)(12).
Subsec. (c).
Subsec. (h)(1).
Subsec. (h)(2).
Subsec. (h)(4).
Subsec. (h)(5).
Subsec. (h)(6).
Subsec. (h)(7), (8).
Subsec. (i)(1).
Subsec. (i)(2).
Subsec. (i)(3).
Subsec. (i)(4).
Subsec. (j)(1).
Subsec. (j)(2).
Subsec. (k).
Subsec. (l).
Subsec. (m).
1984—Subsec. (b)(2).
Subsec. (b)(3).
Subsec. (b)(3)(B)(ii)(II).
Subsec. (b)(3)(F).
Subsec. (b)(4), (5).
Subsec. (b)(6).
Subsec. (b)(7).
Subsec. (b)(7)(A).
Subsec. (b)(7)(A)(ii).
Subsec. (b)(7)(B)(i).
Subsec. (b)(7)(B)(ii).
Subsec. (b)(7)(B)(ii)(III).
Subsec. (b)(7)(B)(iii).
Subsec. (c).
Subsec. (h).
Subsecs. (i), (j).
1982—Subsec. (b)(3)(B)(ii)(II).
Subsec. (b)(3).
Subsec. (b)(6)(D).
1981—Subsec. (b)(3).
1980—Subsec. (b)(3).
Subsec. (b)(3)(F).
Subsec. (b)(6).
Subsec. (h).
1977—Subsec. (b)(3).
Subsec. (b)(5).
1976—Subsec. (b)(3).
1975—Subsec. (b)(3).
1974—Subsec. (g).
1972—Subsec. (a).
Subsec. (b)(3).
Subsec. (b)(3)(B)(ii).
Subsec. (b)(3)(C).
Subsec. (b)(5).
Subsec. (g).
1968—Subsec. (b)(3)(B).
Statutory Notes and Related Subsidiaries
Change of Name
Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of
Effective Date of 2022 Amendment
Amendment by section 4121(a)(5) of
Effective Date of 2016 Amendment
Amendment by section 5012(c)(2) of
"(1)
"(2)
Effective Date of 2011 Amendment
Amendment by
Effective Date of 2010 Amendment
Amendment by section 6404(a)(2)(A) of
Amendment by section 6406(a) of
Effective Date of 2008 Amendment
Amendment by section 154(a)(2)(B) of
Effective Date of 2007 Amendment
Effective Date of 2006 Amendment
Amendment by section 5202(a)(2) of
Effective Date of 2003 Amendment
Amendment by section 627(b)(2) of
Amendment by section 911(c) of
Effective Date of 2000 Amendment
Amendment by section 1(a)(6) [title I, §105(d)] of
Effective Date of 1999 Amendment
Amendment by section 1000(a)(6) [title III, §321(k)(4)] of
Effective Date of 1997 Amendment
Amendment by section 4201(c)(1) of
Amendment by section 4205(d)(3)(B) of
Amendment by section 4315(a) of
Amendment by section 4316(a) of
Amendment by section 4432(b)(2), (4) of
Amendment by section 4512(b)(2), (c) of
Amendment by section 4556(a) of
Amendment by section 4603(c)(2)(B)(i) of
Amendment by section 4611(d) of
Effective Date of 1994 Amendment
Amendment by section 123(b)(1), (2)(B) of
"(3)
"(4)
Amendment by section 126(a)(1), (c), (e), (g)(9) of
Amendment by section 151(b)(1)(B), (2)(B) of
Effective Date of 1993 Amendment
Amendment by section 13568(a), (b) of
Effective Date of 1990 Amendment
"(1) The amendments made by subsection (a) [amending this section and provisions set out below] apply to services furnished after 1990, except that—
"(A) the provisions concerning the third and fourth years of practice apply only to physicians' services furnished after 1990 and 1991, respectively, and
"(B) the provisions concerning the second, third, and fourth years of practice apply only to services of a health care practitioner furnished after 1991, 1992, and 1993, respectively.
"(2) The amendments made by subsection (b) [amending this section and
Amendment by section 4155(c) of
Effective Date of 1989 Amendment
"(A) Subject to subparagraph (B), the amendments made by paragraph (1) [amending this section] apply to services furnished in 1990 or 1991 which were subject to the first sentence of section 1842(b)(4)(F) of the Social Security Act [
"(B) The amendments made by paragraph (1) shall not apply to services furnished in 1990 before April 1, 1990. With respect to physicians' services furnished during 1990 on and after April 1, such amendments shall be applied as though any reference, in the matter inserted by such amendments, to the 'first calendar year during which the preceding sentence no longer applies' were deemed a reference to the remainder of 1990."
Amendment by section 6202(d)(2) of
Amendment by section 201(a) of
"(1) the repeal of section 421 of MCCA [
"(2) the amendments made by subsection (b) [amending this section and
Effective Date of 1988 Amendment
Amendment by
"(1) [Repealed. Prior to repeal by
"(2) [Repealed. Prior to repeal by
"(3) [Repealed. Prior to repeal by
"(4)
"(5) [Repealed. Prior to repeal by
[Amendment of section 202(m) of
"(2) The amendments made by subsection (b) [amending this section] shall apply to annual notices beginning with 1989.
"(3) The amendments made by subsection (c) [amending this section] shall first apply to explanations of benefits provided for items and services furnished on or after January 1, 1989."
Except as specifically provided in section 411 of
Effective Date of 1987 Amendment
Amendment by section 4031(a)(2) of
Amendment by section 4035(a)(2) of
"(1) The amendment made by subsection (a) [amending this section] shall apply to diagnostic tests performed on or after April 1, 1988.
"(2) The Secretary of Health and Human Services shall complete the review and make an appropriate adjustment of prevailing charge levels under subsection (b) [set out below] for items and services furnished no later than January 1, 1989."
Amendment by section 4063(a) of
Amendment by section 4096(a)(1) of
Amendment by
Effective Date of 1986 Amendment
Amendment by section 1895(b)(14)(A), (15) of
Amendment by section 9311(c) of
Amendment by section 9320(e)(3) of
Amendment by section 9338(b), (c) of
Amendment by section 9341(a)(2) of
Amendment by section 9307(c) of
Effective Date of 1984 Amendment
Amendment by
Amendment by section 2303(e) of
Amendment by section 2326(d)(2) of
Amendment by section 2354(b)(13), (14) of
Amendment by section 2663(j)(2)(F)(iv) of
Effective Date of 1982 Amendment
Amendment by section 128(d)(1) of
Effective Date of 1980 Amendment
Effective Date of 1977 Amendment
Amendment by
Amendment by
Effective Date of 1976 Amendment
Effective Date of 1974 Amendment
Amendment by
Effective Date of 1972 Amendment
Amendment by section 211(c)(3) of
Amendment by section 227(e)(3) of
Amendment by section 263(d)(5) of
Amendment by section 281(d) of
Effective Date of 1968 Amendment
Transfer of Functions
Physician Payment Review Commission (PPRC) was terminated and its assets and staff transferred to the Medicare Payment Advisory Commission (MedPAC) by section 4022(c)(2), (3) of
Part B Advance Payments
"(A)
"(i) provide 1 year before payments for items and services furnished by such provider or supplier are offset to recoup payments under such program;
"(ii) provide that any such offset be an amount equal to—
"(I) during the first 11 months in which any such offsets are made with respect to payment for items and services furnished by such provider or supplier, 25 percent of the amount of such payment for such items and services; and
"(II) during the succeeding 6 months, 50 percent of the amount of such payment for such items and services; and
"(iii) allow 29 months from the date of the first payment under such program to such provider or supplier before requiring that the outstanding balance be paid in full.
"(B)
"(i) for the portion of 2020 occurring during such period of the emergency period and for each year, shall not exceed $10,000,000;
"(ii) for each year beginning and ending during such period of the emergency period, shall not exceed $10,000,000; and
"(iii) for the last year beginning during such period of the emergency period, the portion of such last year occurring during such period of the emergency period, shall not exceed $10,000,000."
Linkage of Revised Drug Payments and Increases for Drug Administration
Continuation of Payment Methodology for Radiopharmaceuticals
Implementation of 2003 Amendment
Application of 2003 Amendment to Physician Specialties
Issuance of Temporary National Codes
Revised Part B Payment for Drugs and Biologicals and Related Services
"(a)
"(1)
"(A)
"(i) identify the average prices at which such drugs and biologicals are acquired by physicians and other suppliers;
"(ii) quantify the difference between such average prices and the reimbursement amount under such section; and
"(iii) determine the extent to which (if any) payment under such part is adequate to compensate physicians, providers of services, or other suppliers of such drugs and biologicals for costs incurred in the administration, handling, or storage of such drugs or biologicals.
"(B)
"(2)
"(3)
"(A)
"(i) proposals to make adjustments under subsection (c) of section 1848 of the Social Security Act (
"(ii) proposals for new payments to providers of services or suppliers for such costs, if appropriate.
"(B)
"(C)
"(i) the method and amount of reimbursement for similar drugs and biologicals made by large group health plans;
"(ii) as a result of any revised payment methodology, the potential for patients to receive inpatient or outpatient hospital services in lieu of services in a physician's office; and
"(iii) the effect of any revised payment methodology on the delivery of drug therapies by hospital outpatient departments.
"(D)
"(b)
"(1)
"(2)
"(c)
Implementation of Inherent Reasonableness (IR) Authority
"(a)
"(1) the Comptroller General of the United States releases a report pursuant to the request for such a report made on March 1, 1999, regarding the impact of the Secretary's, fiscal intermediaries', and carriers' use of such authority; and
"(2) the Secretary has published a notice of final rulemaking in the Federal Register that relates to such authority and that responds to such report and to comments received in response to the Secretary's interim final regulation relating to such authority that was published in the Federal Register on January 7, 1998.
"(b)
"(1) reevaluate the appropriateness of the criteria included in such interim final regulation for identifying payments which are excessive or deficient; and
"(2) take appropriate steps to ensure the use of valid and reliable data when exercising such authority."
Initial Budget Neutrality
Improvements in Administration of Laboratory Tests Benefit
"(a)
"(1)
"(A) divide the United States into no more than 5 regions, and
"(B) designate a single carrier for each such region, for the purpose of payment of claims under part B of title XVIII of the Social Security Act [
"(2)
"(A) a carrier's timeliness, quality, and experience in claims processing, and
"(B) a carrier's capacity to conduct electronic data interchange with laboratories and data matches with other carriers.
"(3)
"(4)
"(5)
"(b)
"(1)
"(2)
"(A) Beneficiary information required to be submitted with each claim or order for laboratory tests.
"(B) The medical conditions for which a laboratory test is reasonable and necessary (within the meaning of section 1862(a)(1)(A) of the Social Security Act [
"(C) The appropriate use of procedure codes in billing for a laboratory test, including the unbundling of laboratory services.
"(D) The medical documentation that is required by a medicare contractor at the time a claim is submitted for a laboratory test in accordance with section 1833(e) of the Social Security Act [
"(E) Recordkeeping requirements in addition to any information required to be submitted with a claim, including physicians' obligations regarding such requirements.
"(F) Procedures for filing claims and for providing remittances by electronic media.
"(G) Limitation on frequency of coverage for the same tests performed on the same individual.
"(3)
"(4)
"(5)
"(6)
"(7)
"(c)
Wholesale Price Study and Report
Budget Neutrality Adjustment
"(1) The relative values established under section 1848(c) of such Act [
"(2) The amounts determined under section 1848(a)(2)(B)(ii)(I) of such Act.
"(3) The prevailing charges or fee schedule amounts to be applied under such part for services of a health care practitioner (as defined in section 1842(b)(4)(F)(ii)(I) of such Act [
Procedure Codes
"(A) The codes for the procedures specified in clause (ii) are as follows: Hospital inpatient medical services (HCPCS codes 90200 through 90292), consultations (HCPCS codes 90600 through 90654), other visits (HCPCS code 90699), preventive medicine visits (HCPCS codes 90750 through 90764), psychiatric services (HCPCS codes 90801 through 90862), emergency care facility services (HCPCS codes 99062 through 99065), and critical care services (HCPCS codes 99160 through 99174).
"(B) The codes for the procedures specified in clause (iii) are as follows: Partial mastectomy (HCPCS code 19160); tendon sheath injections and small joint arthrocentesis (HCPCS codes 20550, 20600, 20605, and 20610); femoral fracture and trochanteric fracture treatments (HCPCS codes 27230, 27232, 27234, 27238, 27240, 27242, 27246, and 27248); endotracheal intubation (HCPCS code 31500); thoracentesis (HCPCS code 32000); thoracostomy (HCPCS codes 32020, 32035, and 32036); aneurysm repair (HCPCS codes 35111); cystourethroscopy (HCPCS code 52340); transurethral fulguration and resection (HCPCS codes 52606 and 52620); tympanoplasty with mastoidectomy (HCPCS code 69645); and ophthalmoscopy (HCPCS codes 92250 and 92260)."
Study of Release of Prepayment Medical Review Screen Parameters
Freeze in Charges for Parenteral and Enteral Nutrients, Supplies, and Equipment
Prohibition on Regulations Changing Coverage of Conventional Eyewear
"(A) Notwithstanding any other provision of law (except as provided in subparagraph (B)) the Secretary of Health and Human Services (referred to in this subsection as the 'Secretary') may not issue any regulation that changes the coverage of conventional eyewear furnished to individuals (enrolled under part B of title XVIII of the Social Security Act [
"(B) Paragraph (1) shall not apply to any regulation issued for the sole purpose of implementing the amendments made by paragraph (2)."
Directory of Unique Physician Identifier Numbers
Treatment of Certain Eye Examination Visits as Primary Care Services
Delay in Update Until April 1, 1990, and Reduction in Percentage Increase in Medicare Economic Index
"(1)
"(2)
"(3)
"(A) subject to the last sentence of this paragraph, each participation agreement in effect on December 31, 1989, under section 1842(h)(1) of the Social Security Act [
"(B) the effective period for such agreements under such section entered into for 1990 shall be the 9-month period beginning on April 1, 1990, and the Secretary of Health and Human Services shall provide an opportunity for physicians and suppliers to enroll as participating physicians and suppliers before April 1, 1990;
"(C) instead of publishing, under section 1842(h)(4) of the Social Security Act [
"(D) instead of providing to nonparticipating physicians under section 1842(b)(3)(G) of the Social Security Act [
An agreement with a participating physician or supplier described in subparagraph (A) in effect on December 31, 1989, under section 1842(h)(1) of the Social Security Act shall not remain in effect for the period described in subparagraph (A) if the participating physician or supplier requests on or before December 31, 1989, that the agreement be terminated."
State Demonstration Projects on Application of Limitation on Visits Per Month Per Resident on Aggregate Basis for a Team
Application of Different Performance Standards for Electronic System for Covered Outpatient Drugs
Delay in Application of Coordination of Benefits With Private Health Insurance
Extension of Physician Participation Agreements and Related Provisions
"(A) subject to the last sentence of this paragraph, each agreement with a participating physician in effect on December 31, 1987, under section 1842(h)(1) of the Social Security Act [
"(B) the effective period for agreements under such section entered into for 1988 shall be the nine-month period beginning on April 1, 1988, and the Secretary shall provide an opportunity for physicians to enroll as participating physicians prior to April 1, 1988;
"(C) instead of publishing, under section 1842(h)(4) of the Social Security Act [
"(D) instead of providing to nonparticipating physicians, under section 1842(b)(3)(G) of the Social Security Act [
An agreement with a participating physician in effect on December 31, 1987, under section 1842(h)(1) of the Social Security Act shall not remain in effect for the period described in subparagraph (A) if the participating physician requests on or before December 31, 1987, that the agreement be terminated."
Development of Uniform Relative Value Guide
[
Study of Prevailing Charges for Anesthesia Services
GAO Studies
"(1) The Comptroller General shall conduct a study—
"(A) to determine the average anesthesia times reported for medicare reimbursement purposes,
"(B) to verify those times from patient medical records,
"(C) to compare anesthesia times to average surgical times, and
"(D) to determine whether the current payments for physician supervision of nurse anesthetists are excessive.
The Comptroller General shall report to Congress, by not later than January 1, 1989, on such study and in the report include recommendations regarding the appropriateness of the anesthesia times recognized by medicare for reimbursement purposes and recommendations regarding adjustments of payments for physician supervision of nurse anesthetists.
"(2) The Comptroller General shall conduct a study on the impact of the amendment made by subsection (a) [amending this section], and shall report to Congress on the results of such study by April 1, 1990."
Adjustment in Medicare Prevailing Charges
"(1)
"(2)
Adjustment for Maximum Allowable Actual Charge
Physician Payment Studies; Definitions of Medical and Surgical Procedures
"(1)
"(2)
"(A) ancillary services commonly performed in conjunction with a major procedure would be included with the major procedure;
"(B) pre- and post-procedure services would be included in the procedure; and
"(C) similar procedures would be listed together if the procedures are similar in resource requirements."
Payments for Durable Medical Equipment, Prosthetic Devices, Orthotics, and Prosthetics; 1-Year Freeze on Charge Limitations
"(1)
"(2)
Special Rule With Respect to Payment for Intraocular Lenses
Study on Cost Effectiveness of Hearing Prior to Hearing by Administrative Law Judge on Carrier Determinations; Report to Congress
Capacity To Set Geographic Payment Limits
Utilization Screens for Physician Services Provided to Patients in Rehabilitation Hospitals
"(1) The Secretary of Health and Human Services shall establish (in consultation with appropriate physician groups, including those representing rehabilitative medicine) a separate utilization screen for physician visits to patients in rehabilitation hospitals and rehabilitative units (and patients in long-term care hospitals receiving rehabilitation services) to be used by carriers under section 1842 of the Social Security Act [
"(2) Not later than 12 months after the date of enactment of this Act [Dec. 22, 1987], the Secretary of Health and Human Services shall take appropriate steps to implement the utilization screen established under paragraph (1)."
Plan Amendments Not Required Until January 1, 1989
For provisions directing that if any amendments made by subtitle A or subtitle C of title XI [§§1101–1147 and 1171–1177] or title XVIII [§§1800–1899A] of
Amendments in Contracts and Regulations
The Secretary of Health and Human Services to provide for such timely amendments to contracts under this section, and regulations, to such extent as may be necessary to implement
Medicare Economic Index
"(1)
"(2)
"(4)
"(5)
"(6)
Development and Use of HCFA Common Procedure Coding System
"(1) Not later than July 1, 1989, the Secretary of Health and Human Services (in this subsection referred to as the 'Secretary'), after public notice and opportunity for public comment and after consulation [consultation] with appropriate medical and other experts, shall group the procedure codes contained in any HCFA Common Procedure Coding System for payment purposes to minimize inappropriate increases in the intensity or volume of services provided as a result of coding distinctions which do not reflect substantial differences in the services rendered.
"(2) Not later than January 1, 1990, each carrier with which the Secretary has entered into a contract under section 1842 of the Social Security Act [
Measuring Carrier Performance; Carrier Bonuses for Good Performance
"(B)
"(C)
Review of Procedures
Ratification of Regulations
"(1)
"(2)
Payment for Parenteral and Enteral Nutrition Supplies and Equipment
"(1) for enteral nutrition nutrients, supplies, and equipment and parenteral nutrition supplies and equipment furnished on or after January 1, 1987, and
"(2) for parenteral nutrition nutrients furnished on or after October 1, 1987."
Reporting of OPD Services Using HCPCS
Period for Entering Into Participation Agreements
Transitional Provisions for Medicare Part B Payments
Computation of Customary Charges for Certain Former Hospital-Compensated Physicians
"(1) In applying section 1842(b) of the Social Security Act [
"(A) be based upon the physician's actual charges billed during the 12-month period ending on March 31, 1985, and
"(B) in the case of a physician who was not a participating physician (as defined in section 1842(h)(1) of the Social Security Act [
"(2) In applying section 1842(b) of the Social Security Act [
"(3) In this subsection, the term 'hospital-compensated physician' means, with respect to services furnished to patients of a hospital, a physician who is compensated by the hospital for the furnishing of physicians' services for which payment may be made under this part."
Extension of Medicare Physician Payment Provisions
Period of 15 months referred to in subsec. (j)(1) of this section for monitoring the charges of nonparticipating physicians to be deemed to include the period Oct. 1, 1985, to Mar. 14, 1986, see section 5(b) of
Simplification of Procedures With Respect to Claims and Payments for Clinical Diagnostic Laboratory Tests
Study of Amounts Billed for Physician Services and Paid by Carriers Under Subsection (b)(7) of This Section; Report to Congress
Replacement of Agency, Organization, or Carrier Processing Medicare Claims; Number of Agreements and Contracts Authorized for Fiscal Years 1985 Through 1993
For provision authorizing two agreements under
Rules and Regulations
Report on Reimbursement of Clinical Laboratories
Prevailing Charge Levels for Fiscal Year Beginning July 1, 1975
Report by Health Insurance Benefits Advisory Council on Methods of Reimbursement of Physicians for Their Services
Executive Documents
Executive Order No. 13947
Ex. Ord. No. 13947, July 24, 2020, 85 F.R. 59171, which related to a payment model pursuant to which Medicare would pay, for certain high-cost prescription drugs and biological products covered by Medicare Part B, no more than the most-favored-nation price, was revoked by Ex. Ord. No. 13948, §5, Sept. 13, 2020, 85 F.R. 59650, set out below.
Ex. Ord. No. 13948. Lowering Drug Prices by Putting America First
Ex. Ord. No. 13948, Sept. 13, 2020, 85 F.R. 59649, provided:
By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:
In addition to being unfair, high drug prices in the United States also have serious economic and health consequences for patients in need of treatment. High prices cause Americans to divert too much of their scarce resources to pharmaceutical treatments and away from other productive uses. High prices are also a reason many patients skip doses of their medications, take less than the recommended doses, or abandon treatment altogether. The consequences of these behaviors can be severe. For example, patients may develop acute conditions that result in poor clinical outcomes or that require drastic and expensive medical interventions.
In most markets, the largest buyers pay the lowest prices, but this has not been true for prescription drugs. The Federal Government is the largest payer for prescription drugs in the world, but it pays more than many smaller buyers, including other developed nations. When the Federal Government purchases a drug covered by Medicare—the cost of which is shared by American seniors who take the drug and American taxpayers—it should insist on, at a minimum, the lowest price at which the manufacturer sells that drug to any other developed nation.
(b) The "most-favored-nation price" shall mean the lowest price, after adjusting for volume and differences in national gross domestic product, for a pharmaceutical product that the drug manufacturer sells in a member country of the Organisation for Economic Co-operation and Development (OECD) that has a comparable per-capita gross domestic product.
(i) the authority granted by law to an executive department or agency, or the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
Donald J. Trump.
1 So in original. Probably should be followed by "and".
2 So in original. Probably should be followed by "a".
3 So in original. The period probably should not appear.
§1395v. Agreements with States
(a) Duty of Secretary; enrollment of eligible individuals
The Secretary shall, at the request of a State made before January 1, 1970, or during 1981 or after 1988, enter into an agreement with such State pursuant to which all eligible individuals in either of the coverage groups described in subsection (b) (as specified in the agreement) will be enrolled under the program established by this part.
(b) Coverage of groups to which applicable
An agreement entered into with any State pursuant to subsection (a) may be applicable to either of the following coverage groups:
(1) individuals receiving money payments under the plan of such State approved under subchapter I or subchapter XVI; or
(2) individuals receiving money payments under all of the plans of such State approved under subchapters I, X, XIV, and XVI, and part A of subchapter IV.
Except as provided in subsection (g), there shall be excluded from any coverage group any individual who is entitled to monthly insurance benefits under subchapter II or who is entitled to receive an annuity under the Railroad Retirement Act of 1974 [
(c) Eligible individuals
For purposes of this section, an individual shall be treated as an eligible individual only if he is an eligible individual (within the meaning of
(d) Monthly premiums; coverage periods
In the case of any individual enrolled pursuant to this section—
(1) the monthly premium to be paid by the State shall be determined under
(2) his coverage period shall begin on whichever of the following is the latest:
(A) July 1, 1966;
(B) the first day of the third month following the month in which the State agreement is entered into;
(C) the first day of the first month in which he is both an eligible individual and a member of a coverage group specified in the agreement under this section; or
(D) such date as may be specified in the agreement; and
(3) his coverage period attributable to the agreement with the State under this section shall end on the last day of whichever of the following first occurs:
(A) the month in which he is determined by the State agency to have become ineligible both for money payments of a kind specified in the agreement and (if there is in effect a modification entered into under subsection (h)) for medical assistance, or
(B) the month preceding the first month for which he becomes entitled to monthly benefits under subchapter II or to an annuity or pension under the Railroad Retirement Act of 1974 [
(e) Subsection (d)(3) terminations deemed resulting in section 1395p enrollment
Any individual whose coverage period attributable to the State agreement is terminated pursuant to subsection (d)(3) shall be deemed for purposes of this part (including the continuation of his coverage period under this part) to have enrolled under
(f) "Carrier" as including State agency; provisions facilitating deductions, coinsurance, etc., and leading to economy and efficiency of operation
With respect to eligible individuals receiving money payments under the plan of a State approved under subchapter I, X, XIV, or XVI, or part A of subchapter IV, or eligible to receive medical assistance under the plan of such State approved under subchapter XIX, if the agreement entered into under this section so provides, the term "carrier" as defined in section 1395u(f) 1 of this title also includes the State agency, specified in such agreement, which administers or supervises the administration of the plan of such State approved under subchapter I, XVI, or XIX. The agreement shall also contain such provisions as will facilitate the financial transactions of the State and the carrier with respect to deductions, coinsurance, and otherwise, and as will lead to economy and efficiency of operation, with respect to individuals receiving money payments under plans of the State approved under subchapters I, X, XIV, and XVI, and part A of subchapter IV, and individuals eligible to receive medical assistance under the plan of the State approved under subchapter XIX.
(g) Subsection (b) exclusions from coverage groups
(1) The Secretary shall, at the request of a State made before January 1, 1970, or during 1981 or after 1988, enter into a modification of an agreement entered into with such State pursuant to subsection (a) under which the second sentence of subsection (b) shall not apply with respect to such agreement.
(2) In the case of any individual who would (but for this subsection) be excluded from the applicable coverage group described in subsection (b) by the second sentence of such subsection—
(A) subsections (c) and (d)(2) shall be applied as if such subsections referred to the modification under this subsection (in lieu of the agreement under subsection (a)), and
(B) subsection (d)(3)(B) shall not apply so long as there is in effect a modification entered into by the State under this subsection.
(h) Modifications respecting subsection (b) coverage groups
(1) The Secretary shall, at the request of a State made before January 1, 1970, or during 1981 or after 1988, enter into a modification of an agreement entered into with such State pursuant to subsection (a) under which the coverage group described in subsection (b) and specified in such agreement is broadened to include (A) individuals who are eligible to receive medical assistance under the plan of such State approved under subchapter XIX, or (B) qualified medicare beneficiaries (as defined in
(2) For purposes of this section, an individual shall be treated as eligible to receive medical assistance under the plan of the State approved under subchapter XIX if, for the month in which the modification is entered into under this subsection or for any month thereafter, he has been determined to be eligible to receive medical assistance under such plan. In the case of any individual who would (but for this subsection) be excluded from the agreement, subsections (c) and (d)(2) shall be applied as if they referred to the modification under this subsection (in lieu of the agreement under subsection (a)), and subsection (d)(2)(C) shall be applied (except in the case of qualified medicare beneficiaries, as defined in
(3) In this subsection, the term "qualified medicare beneficiary" also includes an individual described in
(i) Enrollment of qualified medicare beneficiaries
For provisions relating to enrollment of qualified medicare beneficiaries under part A, see
(Aug. 14, 1935, ch. 531, title XVIII, §1843, as added
Editorial Notes
References in Text
The Railroad Retirement Act of 1974, referred to in subsec. (d)(3)(B), is act Aug. 29, 1935, ch. 812, as amended generally by
Amendments
1990—Subsec. (h)(3).
1989—Subsec. (i).
1988—Subsecs. (a), (g)(1).
Subsec. (h)(1).
Subsec. (h)(2).
1984—Subsec. (d)(3)(B).
1983—Subsec. (d)(1).
1980—Subsec. (a).
Subsec. (e).
Subsec. (g)(1).
Subsec. (g)(2)(C).
Subsec. (h)(1).
1974—Subsec. (b).
1973—Subsec. (b).
1968—
Subsec. (a).
Subsec. (b)(2).
Subsec. (c).
Subsec. (d)(2)(D).
Subsec. (d)(3)(A).
Subsec. (f).
Subsec. (g)(1).
Subsec. (h).
1966—Subsec. (b).
Subsec. (g).
Statutory Notes and Related Subsidiaries
Effective Date of 1990 Amendment
Amendment by
Effective Date of 1989 Amendment
Amendment by
Effective Date of 1988 Amendment
Amendment by
Effective Date of 1984 Amendment
Amendment by
Effective Date of 1983 Amendment; Transitional Rule
Amendment by
Effective Date of 1980 Amendment
Effective Date of 1974 Amendment
Amendment by
Effective Date of 1973 Amendment
Amendment by
Termination Period for Certain Individuals Covered Pursuant to State Agreements
District of Columbia; Agreement of Commissioner With Secretary for Supplementary Medical Insurance
1 See References in Text note below.
§1395w. Appropriations to cover Government contributions and contingency reserve
(a) In general
There are authorized to be appropriated from time to time, out of any moneys in the Treasury not otherwise appropriated, to the Federal Supplementary Medical Insurance Trust Fund—
(1)(A) a Government contribution equal to the aggregate premiums payable for a month for enrollees age 65 and over under this part and deposited in the Trust Fund, multiplied by the ratio of—
(i) twice the dollar amount of the actuarially adequate rate per enrollee age 65 and over as determined under
(ii) the dollar amount of the premium per enrollee for such month, plus
(B) a Government contribution equal to the aggregate premiums payable for a month for enrollees under age 65 under this part and deposited in the Trust Fund, multiplied by the ratio of—
(i) twice the dollar amount of the actuarially adequate rate per enrollee under age 65 as determined under
(ii) the dollar amount of the premium per enrollee for such month; minus
(C) the aggregate amount of additional premium payments attributable to the application of
(2) such sums as the Secretary deems necessary to place the Trust Fund, at the end of any fiscal year occurring after June 30, 1967, in the same position in which it would have been at the end of such fiscal year if (A) a Government contribution representing the excess of the premiums deposited in the Trust Fund during the fiscal year ending June 30, 1967, over the Government contribution actually appropriated to the Trust Fund during such fiscal year had been appropriated to it on June 30, 1967, and (B) the Government contribution for premiums deposited in the Trust Fund after June 30, 1967, had been appropriated to it when such premiums were deposited; plus
(3) a Government contribution equal to the amount of payment incentives payable under
(4) a Government contribution equal to the estimated aggregate reduction in premiums payable under part B that results from establishing the premium at 15 percent of the actuarial rate (as would be determined in accordance with
In applying paragraph (1), the amounts transferred under subsection (d)(1) with respect to enrollees described in subparagraphs (A) and (B) of such subsection shall be treated as premiums payable and deposited in the Trust Fund under subparagraphs (A) and (B), respectively, of paragraph (1). In applying paragraph (1), the amounts transferred under subsection (e)(1) with respect to enrollees described in subparagraphs (A) and (B) of such subsection shall be treated as premiums payable and deposited in the Trust Fund under subparagraphs (A) and (B), respectively, of paragraph (1). The Government contribution under paragraph (4) shall be treated as premiums payable and deposited for purposes of subparagraphs (A) and (B) of paragraph (1).
(b) Contingency reserve
In order to assure prompt payment of benefits provided under this part and the administrative expenses thereunder during the early months of the program established by this part, and to provide a contingency reserve, there is also authorized to be appropriated, out of any moneys in the Treasury not otherwise appropriated, to remain available through the calendar year 1969 for repayable advances (without interest) to the Trust Fund, an amount equal to $18 multiplied by the number of individuals (as estimated by the Secretary) who could be covered in July 1966 by the insurance program established by this part if they had theretofore enrolled under this part.
(c) Election under section 1395w–24
The Secretary shall determine the Government contribution under subparagraphs (A) and (B) of subsection (a)(1) without regard to any premium reduction resulting from an election under
(d) Transfer of certain General Fund amounts for 2016
(1) For 2016, there shall be transferred from the General Fund to the Trust Fund an amount, as estimated by the Chief Actuary of the Centers for Medicare & Medicaid Services, equal to the reduction in aggregate premiums payable under this part for a month in such year (excluding any changes in amounts collected under
(A) enrollees age 65 and over; and
(B) enrollees under age 65.
Such amounts shall be transferred from time to time as appropriate.
(2) Premium increases affected under
(3) There shall be transferred from the Trust Fund to the General Fund of the Treasury amounts equivalent to the additional premiums payable as a result of the application of
(e) Transfer of certain General Fund amounts for 2021
(1) For 2021, there shall be transferred from the General Fund to the Trust Fund an amount, as estimated by the Chief Actuary of the Centers for Medicare & Medicaid Services, equal to the reduction in aggregate premiums payable under this part for a month in such year (excluding any changes in amounts collected under
(A) enrollees age 65 and over; and
(B) enrollees under age 65.
Such amounts shall be transferred from time to time as appropriate.
(2) Premium increases affected under
(3) There shall be transferred from the Trust Fund to the General Fund of the Treasury amounts equivalent to the additional premiums payable as a result of the application of
(f) Transfer of certain General Fund amounts for COVID–19 public health emergency period
(1) There shall be transferred from the General Fund of the Treasury to the Trust Fund an amount, as estimated by the Chief Actuary of the Centers for Medicare & Medicaid Services, equal to amounts paid in advance for items and services under this part during the period beginning on the first day of the emergency period described in
(2) There shall be transferred from the Trust Fund to the General Fund of the Treasury amounts equivalent to the sum of—
(A) the amounts by which claims have offset (in whole or in part) the amount of such payments described in paragraph (1); and
(B) the amount of such payments that have been repaid (in whole or in part).
(3) Amounts described in paragraphs (1) and (2) shall be transferred from time to time as appropriate.
(Aug. 14, 1935, ch. 531, title XVIII, §1844, as added
Editorial Notes
References in Text
Amendments
2020—Subsec. (a).
Subsec. (a)(4).
Subsec. (e).
Subsec. (f).
2015—Subsec. (a).
Subsec. (d).
2009—Subsec. (a)(2), (3).
2003—Subsec. (a)(1)(B)(ii).
Subsec. (a)(1)(C).
Subsec. (c).
2000—Subsec. (c).
1997—Subsec. (a)(1)(A)(i), (B)(i).
1989—Subsec. (a).
1988—Subsec. (a).
1984—Subsec. (a)(1)(B)(ii).
1983—Subsec. (a)(1)(A)(i).
Subsec. (a)(1)(B)(i).
1982—Subsec. (a)(1)(A)(i), (B)(i).
1972—Subsec. (a)(1).
1968—Subsec. (a).
Subsec. (b).
Statutory Notes and Related Subsidiaries
Effective Date of 2003 Amendment
Amendment by section 222(l)(2)(C) of
Effective Date of 2000 Amendment
Amendment by
Effective Date of 1989 Amendment
Amendment by
Effective Date of 1988 Amendment
Amendment by
Effective Date of 1984 Amendment
Amendment by
Effective Date of 1983 Amendment; Transitional Rule
Amendment by
Effective Date of 1972 Amendment
Construction of 2015 Amendment; Conditional Application to 2017
For provisions relating to construction and application of amendment by
1 See References in Text note below.
§1395w–1. Repealed. Pub. L. 105–33, title IV, §4022(b)(2)(A), Aug. 5, 1997, 111 Stat. 354
Section, act Aug. 14, 1935, ch. 531, title XVIII, §1845, as added and amended Apr. 7, 1986,
Statutory Notes and Related Subsidiaries
Effective Date of Repeal
Repeal effective Nov. 1, 1997, the date of termination of the Prospective Payment Assessment Commission and the Physician Payment Review Commission, see section 4022(c)(2) of
§1395w–2. Intermediate sanctions for providers or suppliers of clinical diagnostic laboratory tests
(a) If the Secretary determines that any provider or clinical laboratory approved for participation under this subchapter no longer substantially meets the conditions of participation or for coverage specified under this subchapter with respect to the provision of clinical diagnostic laboratory tests under this part, the Secretary may (for a period not to exceed one year) impose intermediate sanctions developed pursuant to subsection (b), in lieu of terminating immediately the provider agreement or cancelling immediately approval of the clinical laboratory.
(b)(1) The Secretary shall develop and implement—
(A) a range of intermediate sanctions to apply to providers or clinical laboratories under the conditions described in subsection (a), and
(B) appropriate procedures for appealing determinations relating to the imposition of such sanctions.
(2)(A) The intermediate sanctions developed under paragraph (1) shall include—
(i) directed plans of correction,
(ii) civil money penalties in an amount not to exceed $10,000 for each day of substantial noncompliance,
(iii) payment for the costs of onsite monitoring by an agency responsible for conducting surveys, and
(iv) suspension of all or part of the payments to which a provider or clinical laboratory would otherwise be entitled under this subchapter with respect to clinical diagnostic laboratory tests furnished on or after the date on which the Secretary determines that intermediate sanctions should be imposed pursuant to subsection (a).
The provisions of
(B) The sanctions specified in subparagraph (A) are in addition to sanctions otherwise available under State or Federal law.
(3) The Secretary shall develop and implement specific procedures with respect to when and how each of the intermediate sanctions developed under paragraph (1) is to be applied, the amounts of any penalties, and the severity of each of these penalties. Such procedures shall be designed so as to minimize the time between identification of violations and imposition of these sanctions and shall provide for the imposition of incrementally more severe penalties for repeated or uncorrected deficiencies.
(Aug. 14, 1935, ch. 531, title XVIII, §1846, as added
Editorial Notes
Amendments
1990—
1989—
1988—
Subsec. (a).
Subsec. (b)(1)(A).
Subsec. (b)(2)(A).
Subsec. (b)(2)(A)(ii).
Subsec. (b)(2)(A)(iii).
Subsec. (b)(2)(A)(iv).
Subsec. (b)(3).
Statutory Notes and Related Subsidiaries
Effective Date of 1990 Amendment
Amendment by
Effective Date of 1989 Amendment
Amendment by
Effective Date of 1988 Amendments
Amendment by
Amendment by section 203(e)(4) of
Except as specifically provided in section 411 of
Effective Date
§1395w–3. Competitive acquisition of certain items and services
(a) Establishment of competitive acquisition programs
(1) Implementation of programs
(A) In general
The Secretary shall establish and implement programs under which competitive acquisition areas are established throughout the United States for contract award purposes for the furnishing under this part of competitively priced items and services (described in paragraph (2)) for which payment is made under this part. Such areas may differ for different items and services.
(B) Phased-in implementation
The programs—
(i) shall be phased in among competitive acquisition areas in a manner consistent with subparagraph (D) so that the competition under the programs occurs in—
(I) 10 of the largest metropolitan statistical areas in 2007;
(II) an additional 91 of the largest metropolitan statistical areas in 2011; and
(III) additional areas after 2011 (or, in the case of national mail order for items and services, after 2010); and
(ii) may be phased in first among the highest cost and highest volume items and services or those items and services that the Secretary determines have the largest savings potential.
(C) Waiver of certain provisions
In carrying out the programs, the Secretary may waive such provisions of the Federal Acquisition Regulation as are necessary for the efficient implementation of this section, other than provisions relating to confidentiality of information and such other provisions as the Secretary determines appropriate.
(D) Changes in competitive acquisition programs
(i) Round 1 of competitive acquisition program
Notwithstanding subparagraph (B)(i)(I) and in implementing the first round of the competitive acquisition programs under this section—
(I) the contracts awarded under this section before July 15, 2008, are terminated, no payment shall be made under this subchapter on or after July 15, 2008, based on such a contract, and, to the extent that any damages may be applicable as a result of the termination of such contracts, such damages shall be payable from the Federal Supplementary Medical Insurance Trust Fund under
(II) the Secretary shall conduct the competition for such round in a manner so that it occurs in 2009 with respect to the same items and services and the same areas, except as provided in subclauses (III) and (IV);
(III) the Secretary shall exclude Puerto Rico so that such round of competition covers 9, instead of 10, of the largest metropolitan statistical areas; and
(IV) there shall be excluded negative pressure wound therapy items and services.
Nothing in subclause (I) shall be construed to provide an independent cause of action or right to administrative or judicial review with regard to the termination provided under such subclause.
(ii) Round 2 of competitive acquisition program
In implementing the second round of the competitive acquisition programs under this section described in subparagraph (B)(i)(II)—
(I) the metropolitan statistical areas to be included shall be those metropolitan statistical areas selected by the Secretary for such round as of June 1, 2008;
(II) the Secretary shall include the next 21 largest metropolitan statistical areas by total population (after those selected under subclause (I)) for such round; and
(III) the Secretary may subdivide metropolitan statistical areas with populations (based upon the most recent data from the Census Bureau) of at least 8,000,000 into separate areas for competitive acquisition purposes.
(iii) Exclusion of certain areas in subsequent rounds of competitive acquisition programs
In implementing subsequent rounds of the competitive acquisition programs under this section, including under subparagraph (B)(i)(III), for competitions occurring before 2015, the Secretary shall exempt from the competitive acquisition program (other than national mail order) the following:
(I) Rural areas.
(II) Metropolitan statistical areas not selected under round 1 or round 2 with a population of less than 250,000.
(III) Areas with a low population density within a metropolitan statistical area that is otherwise selected, as determined for purposes of paragraph (3)(A).
(E) Verification by OIG
The Inspector General of the Department of Health and Human Services shall, through post-award audit, survey, or otherwise, assess the process used by the Centers for Medicare & Medicaid Services to conduct competitive bidding and subsequent pricing determinations under this section that are the basis for pivotal bid amounts and single payment amounts for items and services in competitive bidding areas under rounds 1 and 2 of the competitive acquisition programs under this section and may continue to verify such calculations for subsequent rounds of such programs.
(F) Supplier feedback on missing financial documentation
(i) In general
In the case of a bid where one or more covered documents in connection with such bid have been submitted not later than the covered document review date specified in clause (ii), the Secretary—
(I) shall provide, by not later than 45 days (in the case of the first round of the competitive acquisition programs as described in subparagraph (B)(i)(I)) or 90 days (in the case of a subsequent round of such programs) after the covered document review date, for notice to the bidder of all such documents that are missing as of the covered document review date; and
(II) may not reject the bid on the basis that any covered document is missing or has not been submitted on a timely basis, if all such missing documents identified in the notice provided to the bidder under subclause (I) are submitted to the Secretary not later than 10 business days after the date of such notice.
(ii) Covered document review date
The covered document review date specified in this clause with respect to a competitive acquisition program is the later of—
(I) the date that is 30 days before the final date specified by the Secretary for submission of bids under such program; or
(II) the date that is 30 days after the first date specified by the Secretary for submission of bids under such program.
(iii) Limitations of process
The process provided under this subparagraph—
(I) applies only to the timely submission of covered documents;
(II) does not apply to any determination as to the accuracy or completeness of covered documents submitted or whether such documents meet applicable requirements;
(III) shall not prevent the Secretary from rejecting a bid based on any basis not described in clause (i)(II); and
(IV) shall not be construed as permitting a bidder to change bidding amounts or to make other changes in a bid submission.
(iv) Covered document defined
In this subparagraph, the term "covered document" means a financial, tax, or other document required to be submitted by a bidder as part of an original bid submission under a competitive acquisition program in order to meet required financial standards. Such term does not include other documents, such as the bid itself or accreditation documentation.
(G) Requiring bid bonds for bidding entities
With respect to rounds of competitions beginning under this subsection for contracts beginning not earlier than January 1, 2017, and not later than January 1, 2019, an entity may not submit a bid for a competitive acquisition area unless, as of the deadline for bid submission, the entity has obtained (and provided the Secretary with proof of having obtained) a bid surety bond (in this paragraph referred to as a "bid bond") in a form specified by the Secretary consistent with subparagraph (H) and in an amount that is not less than $50,000 and not more than $100,000 for each competitive acquisition area in which the entity submits the bid.
(H) Treatment of bid bonds submitted
(i) For bidders that submit bids at or below the median and are offered but do not accept the contract
In the case of a bidding entity that is offered a contract for any product category for a competitive acquisition area, if—
(I) the entity's composite bid for such product category and area was at or below the median composite bid rate for all bidding entities included in the calculation of the single payment amounts for such product category and area; and
(II) the entity does not accept the contract offered for such product category and area,
the bid bond submitted by such entity for such area shall be forfeited by the entity and the Secretary shall collect on it.
(ii) Treatment of other bidders
In the case of a bidding entity for any product category for a competitive acquisition area, if the entity does not meet the bid forfeiture conditions in subclauses (I) and (II) of clause (i) for any product category for such area, the bid bond submitted by such entity for such area shall be returned within 90 days of the public announcement of the contract suppliers for such area.
(2) Items and services described
The items and services referred to in paragraph (1) are the following:
(A) Durable medical equipment and medical supplies
Covered items (as defined in
(B) Other equipment and supplies
Items and services described in
(C) Off-the-shelf orthotics
Orthotics described in
(D) Lymphedema compression treatment items
Lymphedema compression treatment items (as defined in
(3) Exception authority
In carrying out the programs under this section, the Secretary may exempt—
(A) rural areas and areas with low population density within urban areas that are not competitive, unless there is a significant national market through mail order for a particular item or service; and
(B) items and services for which the application of competitive acquisition is not likely to result in significant savings.
(4) Special rule for certain rented items of durable medical equipment and oxygen
In the case of a covered item for which payment is made on a rental basis under
(5) Physician authorization
(A) In general
With respect to items or services included within a particular HCPCS code, the Secretary may establish a process for certain items and services under which a physician may prescribe a particular brand or mode of delivery of an item or service within such code if the physician determines that use of the particular item or service would avoid an adverse medical outcome on the individual, as determined by the Secretary.
(B) No effect on payment amount
A prescription under subparagraph (A) shall not affect the amount of payment otherwise applicable for the item or service under the code involved.
(6) Application
For each competitive acquisition area in which the program is implemented under this subsection with respect to items and services, the payment basis determined under the competition conducted under subsection (b) shall be substituted for the payment basis otherwise applied under
(7) Exemption from competitive acquisition
The programs under this section shall not apply to the following:
(A) Certain off-the-shelf orthotics
Items and services described in paragraph (2)(C) if furnished—
(i) by a physician or other practitioner (as defined by the Secretary) to the physician's or practitioner's own patients as part of the physician's or practitioner's professional service; or
(ii) by a hospital to the hospital's own patients during an admission or on the date of discharge.
(B) Certain durable medical equipment
Those items and services described in paragraph (2)(A)—
(i) that are furnished by a hospital to the hospital's own patients during an admission or on the date of discharge; and
(ii) to which such programs would not apply, as specified by the Secretary, if furnished by a physician to the physician's own patients as part of the physician's professional service.
(b) Program requirements
(1) In general
The Secretary shall conduct a competition among entities supplying items and services described in subsection (a)(2) for each competitive acquisition area in which the program is implemented under subsection (a) with respect to such items and services.
(2) Conditions for awarding contract
(A) In general
The Secretary may not award a contract to any entity under the competition conducted in an 1 competitive acquisition area pursuant to paragraph (1) to furnish such items or services unless the Secretary finds all of the following:
(i) The entity meets applicable quality standards specified by the Secretary under
(ii) The entity meets applicable financial standards specified by the Secretary, taking into account the needs of small providers.
(iii) The total amounts to be paid to contractors in a competitive acquisition area are expected to be less than the total amounts that would otherwise be paid.
(iv) Access of individuals to a choice of multiple suppliers in the area is maintained.
(v) The entity meets applicable State licensure requirements.
(B) Timely implementation of program
Any delay in the implementation of quality standards under
(3) Contents of contract
(A) In general
A contract entered into with an entity under the competition conducted pursuant to paragraph (1) is subject to terms and conditions that the Secretary may specify.
(B) Term of contracts
The Secretary shall recompete contracts under this section not less often than once every 3 years.
(C) Disclosure of subcontractors
(i) Initial disclosure
Not later than 10 days after the date a supplier enters into a contract with the Secretary under this section, such supplier shall disclose to the Secretary, in a form and manner specified by the Secretary, the information on—
(I) each subcontracting relationship that such supplier has in furnishing items and services under the contract; and
(II) whether each such subcontractor meets the requirement of
(ii) Subsequent disclosure
Not later than 10 days after such a supplier subsequently enters into a subcontracting relationship described in clause (i)(II), such supplier shall disclose to the Secretary, in such form and manner, the information described in subclauses (I) and (II) of clause (i).
(4) Limit on number of contractors
(A) In general
The Secretary may limit the number of contractors in a competitive acquisition area to the number needed to meet projected demand for items and services covered under the contracts. In awarding contracts, the Secretary shall take into account the ability of bidding entities to furnish items or services in sufficient quantities to meet the anticipated needs of individuals for such items or services in the geographic area covered under the contract on a timely basis.
(B) Multiple winners
The Secretary shall award contracts to multiple entities submitting bids in each area for an item or service.
(5) Payment
(A) In general
Payment under this part for competitively priced items and services described in subsection (a)(2) shall be based on bids submitted and accepted under this section for such items and services. Based on such bids the Secretary shall determine a single payment amount for each item or service in each competitive acquisition area.
(B) Reduced beneficiary cost-sharing
(i) Application of coinsurance
Payment under this section for items and services shall be in an amount equal to 80 percent of the payment basis described in subparagraph (A).
(ii) Application of deductible
Before applying clause (i), the individual shall be required to meet the deductible described in
(C) Payment on assignment-related basis
Payment for any item or service furnished by the entity may only be made under this section on an assignment-related basis.
(D) Construction
Nothing in this section shall be construed as precluding the use of an advanced beneficiary notice with respect to a competitively priced item and service.
(6) Participating contractors
(A) In general
Except as provided in subsection (a)(4), payment shall not be made for items and services described in subsection (a)(2) furnished by a contractor and for which competition is conducted under this section unless—
(i) the contractor has submitted a bid for such items and services under this section; and
(ii) the Secretary has awarded a contract to the contractor for such items and services under this section.
(B) Bid defined
In this section, the term "bid" means an offer to furnish an item or service for a particular price and time period that includes, where appropriate, any services that are attendant to the furnishing of the item or service.
(C) Rules for mergers and acquisitions
In applying subparagraph (A) to a contractor, the contractor shall include a successor entity in the case of a merger or acquisition, if the successor entity assumes such contract along with any liabilities that may have occurred thereunder.
(D) Protection of small suppliers
In developing procedures relating to bids and the awarding of contracts under this section, the Secretary shall take appropriate steps to ensure that small suppliers of items and services have an opportunity to be considered for participation in the program under this section.
(7) Consideration in determining categories for bids
The Secretary may consider the clinical efficiency and value of specific items within codes, including whether some items have a greater therapeutic advantage to individuals.
(8) Authority to contract for education, monitoring, outreach, and complaint services
The Secretary may enter into contracts with appropriate entities to address complaints from individuals who receive items and services from an entity with a contract under this section and to conduct appropriate education of and outreach to such individuals and monitoring quality of services with respect to the program.
(9) Authority to contract for implementation
The Secretary may contract with appropriate entities to implement the competitive bidding program under this section.
(10) Special rule in case of competition for diabetic testing strips
(A) In general
With respect to the competitive acquisition program for diabetic testing strips conducted after the first round of the competitive acquisition programs, if an entity does not demonstrate to the Secretary that its bid covers types of diabetic testing strip products that, in the aggregate and taking into account volume for the different products, cover 50 percent (or such higher percentage as the Secretary may specify) of all such types of products, the Secretary shall reject such bid. With respect to bids to furnish such types of products on or after January 1, 2019, the volume for such types of products shall be determined by the Secretary through the use of multiple sources of data (from mail order and non-mail order Medicare markets), including market-based data measuring sales of diabetic testing strip products that are not exclusively sold by a single retailer from such markets.
(B) Study of types of testing strip products
Before 2011, the Inspector General of the Department of Health and Human Services shall conduct a study to determine the types of diabetic testing strip products by volume that could be used to make determinations pursuant to subparagraph (A) for the first competition under the competitive acquisition program described in such subparagraph and submit to the Secretary a report on the results of the study. The Inspector General shall also conduct such a study and submit such a report before the Secretary conducts a subsequent competitive acquistion 2 program described in subparagraph (A).
(C) Demonstration of ability to furnish types of diabetic testing strip products
With respect to bids to furnish diabetic testing strip products on or after January 1, 2019, an entity shall attest to the Secretary that the entity has the ability to obtain an inventory of the types and quantities of diabetic testing strip products that will allow the entity to furnish such products in a manner consistent with its bid and—
(i) demonstrate to the Secretary, through letters of intent with manufacturers, wholesalers, or other suppliers, or other evidence as the Secretary may specify, such ability; or
(ii) demonstrate to the Secretary that it made a good faith attempt to obtain such a letter of intent or such other evidence.
(D) Use of unlisted types in calculation of percentage
With respect to bids to furnish diabetic testing strip products on or after January 1, 2019, in determining under subparagraph (A) whether a bid submitted by an entity under such subparagraph covers 50 percent (or such higher percentage as the Secretary may specify) of all types of diabetic testing strip products, the Secretary may not attribute a percentage to types of diabetic testing strip products that the Secretary does not identify by brand, model, and market share volume.
(E) Adherence to demonstration
(i) In general
In the case of an entity that is furnishing diabetic testing strip products on or after January 1, 2019, under a contract entered into under the competition conducted pursuant to paragraph (1), the Secretary shall establish a process to monitor, on an ongoing basis, the extent to which such entity continues to cover the product types included in the entity's bid.
(ii) Termination
If the Secretary determines that an entity described in clause (i) fails to maintain in inventory, or otherwise maintain ready access to (through requirements, contracts, or otherwise) a type of product included in the entity's bid, the Secretary may terminate such contract unless the Secretary finds that the failure of the entity to maintain inventory of, or ready access to, the product is the result of the discontinuation of the product by the product manufacturer, a market-wide shortage of the product, or the introduction of a newer model or version of the product in the market involved.
(11) Additional special rules in case of competition for diabetic testing strips
(A) In general
With respect to an entity that is furnishing diabetic testing strip products to individuals under a contract entered into under the competitive acquisition program established under this section, the entity shall furnish to each individual a brand of such products that is compatible with the home blood glucose monitor selected by the individual.
(B) Prohibition on influencing and incentivizing
An entity described in subparagraph (A) may not attempt to influence or incentivize an individual to switch the brand of glucose monitor or diabetic testing strip product selected by the individual, including by—
(i) persuading, pressuring, or advising the individual to switch; or
(ii) furnishing information about alternative brands to the individual where the individual has not requested such information.
(C) Provision of information
(i) Standardized information
Not later than January 1, 2019, the Secretary shall develop and make available to entities described in subparagraph (A) standardized information that describes the rights of an individual with respect to such an entity. The information described in the preceding sentence shall include information regarding—
(I) the requirements established under subparagraphs (A) and (B);
(II) the right of the individual to purchase diabetic testing strip products from another mail order supplier of such products or a retail pharmacy if the entity is not able to furnish the brand of such product that is compatible with the home blood glucose monitor selected by the individual; and
(III) the right of the individual to return diabetic testing strip products furnished to the individual by the entity.
(ii) Requirement
With respect to diabetic testing strip products furnished on or after the date on which the Secretary develops the standardized information under clause (i), an entity described in subparagraph (A) may not communicate directly to an individual until the entity has verbally provided the individual with such standardized information.
(D) Order refills
With respect to diabetic testing strip products furnished on or after January 1, 2019, the Secretary shall require an entity furnishing diabetic testing strip products to an individual to contact and receive a request from the individual for such products not more than 14 days prior to dispensing a refill of such products to the individual.
(12) No administrative or judicial review
There shall be no administrative or judicial review under
(A) the establishment of payment amounts under paragraph (5);
(B) the awarding of contracts under this section;
(C) the designation of competitive acquisition areas under subsection (a)(1)(A) and the identification of areas under subsection (a)(1)(D)(iii);
(D) the phased-in implementation under subsection (a)(1)(B) and implementation of subsection (a)(1)(D);
(E) the selection of items and services for competitive acquisition under subsection (a)(2);
(F) the bidding structure and number of contractors selected under this section; or
(G) the implementation of the special rule described in paragraph (10).
(c) Program Advisory and Oversight Committee
(1) Establishment
The Secretary shall establish a Program Advisory and Oversight Committee (hereinafter in this section referred to as the "Committee").
(2) Membership; terms
The Committee shall consist of such members as the Secretary may appoint who shall serve for such term as the Secretary may specify.
(3) Duties
(A) Advice
The Committee shall provide advice to the Secretary with respect to the following functions:
(i) The implementation of the program under this section.
(ii) The establishment of financial standards for purposes of subsection (b)(2)(A)(ii).
(iii) The establishment of requirements for collection of data for the efficient management of the program.
(iv) The development of proposals for efficient interaction among manufacturers, providers of services, suppliers (as defined in
(v) The establishment of quality standards under
(B) Additional duties
The Committee shall perform such additional functions to assist the Secretary in carrying out this section as the Secretary may specify.
(4) Inapplicability of chapter 10 of title 5
The provisions of
(5) Termination
The Committee shall terminate on December 31, 2011.
(d) Report
Not later than July 1, 2011, the Secretary shall submit to Congress a report on the programs under this section. The report shall include information on savings, reductions in cost-sharing, access to and quality of items and services, and satisfaction of individuals.
(e) Repealed. Pub. L. 110–275, title I, §145(a)(1), July 15, 2008, 122 Stat. 2547
(f) Competitive acquisition ombudsman
The Secretary shall provide for a competitive acquisition ombudsman within the Centers for Medicare & Medicaid Services in order to respond to complaints and inquiries made by suppliers and individuals relating to the application of the competitive acquisition program under this section. The ombudsman may be within the office of the Medicare Beneficiary Ombudsman appointed under
(Aug. 14, 1935, ch. 531, title XVIII, §1847, as added
Editorial Notes
References in Text
The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (a)(2)(A), is act June 25, 1938, ch. 675,
Prior Provisions
A prior section 1395w–3, act Aug. 14, 1935, ch. 531, title XVIII, §1847, as added July 1, 1988,
Amendments
2022—Subsec. (a)(2)(D).
Subsec. (c)(4).
2019—Subsec. (a)(2)(A).
2018—Subsec. (b)(10)(A).
Subsec. (b)(10)(C) to (E).
Subsec. (b)(11), (12).
2016—Subsec. (a)(2)(A).
2015—Subsec. (a)(1)(G), (H).
Subsec. (b)(2)(A)(v).
2010—Subsec. (a)(1)(B)(i)(II).
Subsec. (a)(1)(D)(ii)(II), (III).
2008—Subsec. (a)(1)(B)(i).
Subsec. (a)(1)(B)(i)(II).
Subsec. (a)(1)(B)(i)(III).
Subsec. (a)(1)(D) to (F).
Subsec. (a)(2)(A).
Subsec. (a)(7).
Subsec. (b)(3)(C).
Subsec. (b)(10).
Subsec. (b)(11).
Subsec. (b)(11)(C).
Subsec. (b)(11)(D).
Subsec. (b)(11)(G).
Subsec. (c)(5).
Subsec. (d).
Subsec. (e).
Subsec. (f).
2003—
1999—Subsec. (b)(2).
Statutory Notes and Related Subsidiaries
Effective Date of 2008 Amendment
Amendment by section 154 of
Effective Date of 1999 Amendment
Amendment by
Construction of 2015 Amendment
Non-Application of Medicare Fee Schedule Adjustments for Wheelchair Accessories and Seat and Back Cushions When Furnished in Connection With Complex Rehabilitative Manual Wheelchairs
"(1)
"(2)
Implementation of 2018 Amendment
"(1)
"(2)
GAO Report on Impact of Competitive Acquisition on Suppliers
"(A)
"(B)
"(C)
"(i) Beneficiary access to items and services under the program, including the impact on such access of awarding contracts to bidders that—
"(I) did not have a physical presence in an area where they received a contract; or
"(II) had no previous experience providing the product category they were contracted to provide.
"(ii) Beneficiary satisfaction with the program and cost savings to beneficiaries under the program.
"(iii) Costs to suppliers of participating in the program and recommendations about ways to reduce those costs without compromising quality standards or savings to the Medicare program.
"(iv) Impact of the program on small business suppliers.
"(v) Analysis of the impact on utilization of different items and services paid within the same Healthcare Common Procedure Coding System (HCPCS) code.
"(vi) Costs to the Centers for Medicare & Medicaid Services, including payments made to contractors, for administering the program compared with administration of a fee schedule, in comparison with the relative savings of the program.
"(vii) Impact on access, Medicare spending, and beneficiary spending of any difference in treatment for diabetic testing supplies depending on how such supplies are furnished.
"(viii) Such other topics as the Comptroller General determines to be appropriate."
Report on Activities of Suppliers
Study by GAO
1 So in original. Probably should be "a".
2 So in original. Probably should be "acquisition".
§1395w–3a. Use of average sales price payment methodology
(a) Application
(1) In general
Except as provided in paragraph (2), this section shall apply to payment for drugs and biologicals that are described in
(2) Election
This section shall not apply in the case of a physician who elects under subsection (a)(1)(A)(ii) of
(b) Payment amount
(1) In general
Subject to paragraph (7) and subsections (d)(3)(C) and (e), the amount of payment determined under this section for the billing and payment code for a drug or biological (based on a minimum dosage unit) is, subject to applicable deductible and coinsurance—
(A) in the case of a multiple source drug (as defined in subsection (c)(6)(C)), 106 percent of the amount determined under paragraph (3) for a multiple source drug furnished before April 1, 2008, or 106 percent of the amount determined under paragraph (6) for a multiple source drug furnished on or after April 1, 2008;
(B) in the case of a single source drug or biological (as defined in subsection (c)(6)(D)), 106 percent of the amount determined under paragraph (4) or in the case of such a drug or biological product that is a selected drug (as referred to in
(C) in the case of a biosimilar biological product (as defined in subsection (c)(6)(H)), the amount determined under paragraph (8).
(2) Specification of unit
(A) Specification by manufacturer
The manufacturer of a drug or biological shall specify the unit associated with each National Drug Code (including package size) as part of the submission of data under
(B) Unit defined
In this section, the term "unit" means, with respect to each National Drug Code (including package size) associated with a drug or biological, the lowest identifiable quantity (such as a capsule or tablet, milligram of molecules, or grams) of the drug or biological that is dispensed, exclusive of any diluent without reference to volume measures pertaining to liquids. For years after 2004, the Secretary may establish the unit for a manufacturer to report and methods for counting units as the Secretary determines appropriate to implement this section.
(3) Multiple source drug
For all drug products included within the same multiple source drug billing and payment code, the amount specified in this paragraph is the volume-weighted average of the average sales prices reported under
(A) computing the sum of the products (for each National Drug Code assigned to such drug products) of—
(i) the manufacturer's average sales price (as defined in subsection (c)); and
(ii) the total number of units specified under paragraph (2) sold; and
(B) dividing the sum determined under subparagraph (A) by the sum of the total number of units under subparagraph (A)(ii) for all National Drug Codes assigned to such drug products.
(4) Single source drug or biological
The amount specified in this paragraph for a single source drug or biological is the lesser of the following:
(A) Average sales price
The average sales price as determined using the methodology applied under paragraph (3) for single source drugs and biologicals furnished before April 1, 2008, and using the methodology applied under paragraph (6) for single source drugs and biologicals furnished on or after April 1, 2008, for all National Drug Codes assigned to such drug or biological product.
(B) Wholesale acquisition cost (WAC)
The wholesale acquisition cost (as defined in subsection (c)(6)(B)) using the methodology applied under paragraph (3) for single source drugs and biologicals furnished before April 1, 2008, and using the methodology applied under paragraph (6) for single source drugs and biologicals furnished on or after April 1, 2008, for all National Drug Codes assigned to such drug or biological product.
(5) Basis for payment amount
The payment amount shall be determined under this subsection based on information reported under subsection (f) and without regard to any special packaging, labeling, or identifiers on the dosage form or product or package.
(6) Use of volume-weighted average sales prices in calculation of average sales price
(A) In general
For all drug products included within the same multiple source drug billing and payment code, the amount specified in this paragraph is the volume-weighted average of the average sales prices reported under
(i) computing the sum of the products (for each National Drug Code assigned to such drug products) of—
(I) the manufacturer's average sales price (as defined in subsection (c)), determined by the Secretary without dividing such price by the total number of billing units for the National Drug Code for the billing and payment code; and
(II) the total number of units specified under paragraph (2) sold; and
(ii) dividing the sum determined under clause (i) by the sum of the products (for each National Drug Code assigned to such drug products) of—
(I) the total number of units specified under paragraph (2) sold; and
(II) the total number of billing units for the National Drug Code for the billing and payment code.
(B) Billing unit defined
For purposes of this subsection, the term "billing unit" means the identifiable quantity associated with a billing and payment code, as established by the Secretary.
(7) Special rule
Beginning with April 1, 2008, the payment amount for—
(A) each single source drug or biological described in
(i) the payment amount that would be determined for such drug or biological applying such subsection; or
(ii) the payment amount that would have been determined for such drug or biological if such subsection were not applied; and
(B) a multiple source drug described in
(i) the payment amount that would be determined for such drug or biological taking into account the application of such subsection; or
(ii) the payment amount that would have been determined for such drug or biological if such subsection were not applied.
(8) Biosimilar biological product
(A) In general
Subject to subparagraph (B), the amount specified in this paragraph for a biosimilar biological product described in paragraph (1)(C) is the sum of—
(i) the average sales price as determined using the methodology described under paragraph (6) applied to a biosimilar biological product for all National Drug Codes assigned to such product in the same manner as such paragraph is applied to drugs described in such paragraph; and
(ii) 6 percent of the amount determined under paragraph (4) for the reference biological product (as defined in subsection (c)(6)(I)).
(B) Temporary payment increase
(i) In general
In the case of a qualifying biosimilar biological product that is furnished during the applicable 5-year period for such product, the amount specified in this paragraph for such product with respect to such period is the sum determined under subparagraph (A), except that clause (ii) of such subparagraph shall be applied by substituting "8 percent" for "6 percent".
(ii) Applicable 5-year period
For purposes of clause (i), the applicable 5-year period for a qualifying biosimilar biological product is—
(I) in the case of such a product for which payment was made under this paragraph as of September 30, 2022, the 5-year period beginning on October 1, 2022; and
(II) in the case of such a product for which payment is first made under this paragraph during a calendar quarter during the period beginning October 1, 2022, and ending December 31, 2027, the 5-year period beginning on the first day of such calendar quarter during which such payment is first made.
(iii) Qualifying biosimilar biological product defined
For purposes of this subparagraph, the term "qualifying biosimilar biological product" means a biosimilar biological product described in paragraph (1)(C) with respect to which—
(I) in the case of a product described in clause (ii)(I), the average sales price under paragraph (8)(A)(i) for a calendar quarter during the 5-year period described in such clause is not more than the average sales price under paragraph (4)(A) for such quarter for the reference biological product; and
(II) in the case of a product described in clause (ii)(II), the average sales price under paragraph (8)(A)(i) for a calendar quarter during the 5-year period described in such clause is not more than the average sales price under paragraph (4)(A) for such quarter for the reference biological product.
(c) Manufacturer's average sales price
(1) In general
For purposes of this section, subject to paragraphs (2) and (3), the manufacturer's "average sales price" means, of a drug or biological for a National Drug Code for a calendar quarter for a manufacturer for a unit—
(A) the manufacturer's sales to all purchasers (excluding sales exempted in paragraph (2)) in the United States for such drug or biological in the calendar quarter; divided by
(B) the total number of such units of such drug or biological sold by the manufacturer in such quarter.
(2) Certain sales exempted from computation
In calculating the manufacturer's average sales price under this subsection, the following sales shall be excluded:
(A) Sales exempt from best price
Sales exempt from the inclusion in the determination of "best price" under
(B) Sales at nominal charge
Such other sales as the Secretary identifies as sales to an entity that are merely nominal in amount (as applied for purposes of
(3) Sale price net of discounts
In calculating the manufacturer's average sales price under this subsection, such price shall include volume discounts, prompt pay discounts, cash discounts, free goods that are contingent on any purchase requirement, chargebacks, and rebates (other than rebates under subsection (i),
(4) Payment methodology in cases where average sales price during first quarter of sales is unavailable
(A) In general
Subject to subparagraph (B), in the case of a drug or biological during an initial period (not to exceed a full calendar quarter) in which data on the prices for sales for the drug or biological is not sufficiently available from the manufacturer to compute an average sales price for the drug or biological, the Secretary may determine the amount payable under this section—
(i) in the case of a drug or biological furnished prior to January 1, 2019, based on—
(I) the wholesale acquisition cost; or
(II) the methodologies in effect under this part on November 1, 2003, to determine payment amounts for drugs or biologicals; and
(ii) in the case of a drug or biological furnished on or after January 1, 2019—
(I) at an amount not to exceed 103 percent of the wholesale acquisition cost; or
(II) based on the methodologies in effect under this part on November 1, 2003, to determine payment amounts for drugs or biologicals.
(B) Limitation on payment amount for biosimilar biological products during initial period
In the case of a biosimilar biological product furnished on or after July 1, 2024, during the initial period described in subparagraph (A) with respect to the biosimilar biological product, the amount payable under this section for the biosimilar biological product is the lesser of the following:
(i) The amount determined under clause (ii) of such subparagraph for the biosimilar biological product.
(ii) The amount determined under subsection (b)(1)(B) for the reference biological product.
(5) Frequency of determinations
(A) In general on a quarterly basis
The manufacturer's average sales price, for a drug or biological of a manufacturer, shall be calculated by such manufacturer under this subsection on a quarterly basis. In making such calculation insofar as there is a lag in the reporting of the information on rebates and chargebacks under paragraph (3) so that adequate data are not available on a timely basis, the manufacturer shall apply a methodology based on a 12-month rolling average for the manufacturer to estimate costs attributable to rebates and chargebacks. For years after 2004, the Secretary may establish a uniform methodology under this subparagraph to estimate and apply such costs.
(B) Updates in payment amounts
The payment amounts under subsection (b) shall be updated by the Secretary on a quarterly basis and shall be applied based upon the manufacturer's average sales price calculated for the most recent calendar quarter for which data is available.
(C) Use of contractors; implementation
The Secretary may contract with appropriate entities to calculate the payment amount under subsection (b). Notwithstanding any other provision of law, the Secretary may implement, by program instruction or otherwise, any of the provisions of this section.
(6) Definitions and other rules
In this section:
(A) Manufacturer
The term "manufacturer" means, with respect to a drug or biological, the manufacturer (as defined in
(B) Wholesale acquisition cost
The term "wholesale acquisition cost" means, with respect to a drug or biological, the manufacturer's list price for the drug or biological to wholesalers or direct purchasers in the United States, not including prompt pay or other discounts, rebates or reductions in price, for the most recent month for which the information is available, as reported in wholesale price guides or other publications of drug or biological pricing data.
(C) Multiple source drug
(i) In general
The term "multiple source drug" means, for a calendar quarter, a drug for which there are 2 or more drug products which—
(I) are rated as therapeutically equivalent (under the Food and Drug Administration's most recent publication of "Approved Drug Products with Therapeutic Equivalence Evaluations"),
(II) except as provided in subparagraph (E), are pharmaceutically equivalent and bioequivalent, as determined under subparagraph (F) and as determined by the Food and Drug Administration, and
(III) are sold or marketed in the United States during the quarter.
(ii) Exception
With respect to single source drugs or biologicals that are within the same billing and payment code as of October 1, 2003, the Secretary shall treat such single source drugs or biologicals as if the single source drugs or biologicals were multiple source drugs.
(D) Single source drug or biological
The term "single source drug or biological" means—
(i) a biological; or
(ii) a drug which is not a multiple source drug and which is produced or distributed under a new drug application approved by the Food and Drug Administration, including a drug product marketed by any cross-licensed producers or distributors operating under the new drug application.
(E) Exception from pharmaceutical equivalence and bioequivalence requirement
Subparagraph (C)(ii) shall not apply if the Food and Drug Administration changes by regulation the requirement that, for purposes of the publication described in subparagraph (C)(i), in order for drug products to be rated as therapeutically equivalent, they must be pharmaceutically equivalent and bioequivalent, as defined in subparagraph (F).
(F) Determination of pharmaceutical equivalence and bioequivalence
For purposes of this paragraph—
(i) drug products are pharmaceutically equivalent if the products contain identical amounts of the same active drug ingredient in the same dosage form and meet compendial or other applicable standards of strength, quality, purity, and identity; and
(ii) drugs are bioequivalent if they do not present a known or potential bioequivalence problem, or, if they do present such a problem, they are shown to meet an appropriate standard of bioequivalence.
(G) Inclusion of vaccines
In applying provisions of
(H) Biosimilar biological product
The term "biosimilar biological product" means a biological product approved under an abbreviated application for a license of a biological product that relies in part on data or information in an application for another biological product licensed under
(I) Reference biological product
The term "reference biological product" means the biological product licensed under such
(d) Monitoring of market prices
(1) In general
The Inspector General of the Department of Health and Human Services shall conduct studies, which may include surveys, to determine the widely available market prices of drugs and biologicals to which this section applies, as the Inspector General, in consultation with the Secretary, determines to be appropriate.
(2) Comparison of prices
Based upon such studies and other data for drugs and biologicals, the Inspector General shall compare the average sales price under this section for drugs and biologicals with—
(A) the widely available market price for such drugs and biologicals (if any); and
(B) the average manufacturer price (as determined under
(3) Limitation on average sales price
(A) In general
The Secretary may disregard the average sales price for a drug or biological that exceeds the widely available market price or the average manufacturer price for such drug or biological by the applicable threshold percentage (as defined in subparagraph (B)).
(B) Applicable threshold percentage defined
In this paragraph, the term "applicable threshold percentage" means—
(i) in 2005, in the case of an average sales price for a drug or biological that exceeds widely available market price or the average manufacturer price, 5 percent; and
(ii) in 2006 and subsequent years, the percentage applied under this subparagraph subject to such adjustment as the Secretary may specify for the widely available market price or the average manufacturer price, or both.
(C) Authority to adjust average sales price
If the Inspector General finds that the average sales price for a drug or biological exceeds such widely available market price or average manufacturer price for such drug or biological by the applicable threshold percentage, the Inspector General shall inform the Secretary (at such times as the Secretary may specify to carry out this subparagraph) and the Secretary shall, effective as of the next quarter, substitute for the amount of payment otherwise determined under this section for such drug or biological the lesser of—
(i) the widely available market price for the drug or biological (if any); or
(ii) 103 percent of the average manufacturer price (as determined under
(4) Civil money penalty
(A) Misrepresentation
If the Secretary determines that a manufacturer has made a misrepresentation in the reporting of the manufacturer's average sales price for a drug or biological, the Secretary may apply a civil money penalty in an amount of up to $10,000 for each such price misrepresentation and for each day in which such price misrepresentation was applied.
(B) Failure to provide timely information
If the Secretary determines that a manufacturer described in subsection (f)(2) has failed to report on information described in
(C) False information
Any manufacturer required to submit information under subsection (f)(2) that knowingly provides false information is subject to a civil money penalty in an amount not to exceed $100,000 for each item of false information. Such civil money penalties are in addition to other penalties as may be prescribed by law.
(D) Increasing oversight and enforcement
For calendar quarters beginning on or after January 1, 2022,
(i) each reference to "under this subparagraph and subsection (c)(4)(B)(ii)(III)" were a reference to "under this subparagraph, subsection (c)(4)(B)(ii)(III), and subparagraphs (A), (B), and (C) of
(ii) the reference to "activities related to the oversight and enforcement of this section and agreements under this section" were a reference to "activities related to the oversight and enforcement of this section and under subsection (f)(2) of
(E) Procedures
The provisions of
(5) Widely available market price
(A) In general
In this subsection, the term "widely available market price" means the price that a prudent physician or supplier would pay for the drug or biological. In determining such price, the Inspector General shall take into account the discounts, rebates, and other price concessions routinely made available to such prudent physicians or suppliers for such drugs or biologicals.
(B) Considerations
In determining the price under subparagraph (A), the Inspector General shall consider information from one or more of the following sources:
(i) Manufacturers.
(ii) Wholesalers.
(iii) Distributors.
(iv) Physician supply houses.
(v) Specialty pharmacies.
(vi) Group purchasing arrangements.
(vii) Surveys of physicians.
(viii) Surveys of suppliers.
(ix) Information on such market prices from insurers.
(x) Information on such market prices from private health plans.
(e) Authority to use alternative payment in response to public health emergency
In the case of a public health emergency under
(f) Quarterly report on average sales price
(1) In general
For requirements for reporting the manufacturer's average sales price (and, if required to make payment, the manufacturer's wholesale acquisition cost) for the drug or biological under this section, see
(2) Manufacturers without a rebate agreement under subchapter xix
(A) In general
If the manufacturer of a drug or biological described in subparagraph (C), (E), or (G) of
(B) Audit
Information reported under subparagraph (A) is subject to audit by the Inspector General of the Department of Health and Human Services.
(C) Verification
The Secretary may survey wholesalers and manufacturers that directly distribute drugs or biologicals described in subparagraph (A), when necessary, to verify manufacturer prices and manufacturer's average sales prices (including wholesale acquisition cost) if required to make payment reported under subparagraph (A). The Secretary may impose a civil monetary penalty in an amount not to exceed $100,000 on a wholesaler, manufacturer, or direct seller, if the wholesaler, manufacturer, or direct seller of such a drug or biological refuses a request for information about charges or prices by the Secretary in connection with a survey under this subparagraph or knowingly provides false information. The provisions of
(D) Confidentiality
Notwithstanding any other provision of law, information disclosed by manufacturers or wholesalers under this paragraph (other than the wholesale acquisition cost for purposes of carrying out this section) is confidential and shall not be disclosed by the Secretary in a form which discloses the identity of a specific manufacturer or wholesaler or prices charged for drugs or biologicals by such manufacturer or wholesaler, except—
(i) as the Secretary determines to be necessary to carry out this section (including the determination and implementation of the payment amount), or to carry out
(ii) to permit the Comptroller General of the United States to review the information provided;
(iii) to permit the Director of the Congressional Budget Office to review the information provided;
(iv) to permit the Medicare Payment Advisory Commission to review the information provided; and
(v) to permit the Medicaid and CHIP Payment and Access Commission to review the information provided.
(g) Payment adjustment for certain drugs for which there is a self-administered NDC
(1) OIG studies
The Inspector General of the Department of Health and Human Services shall conduct periodic studies to identify National Drug Codes for drug or biological products that are self-administered for which payment may not be made under this part because such products are not covered pursuant to
(2) Payment adjustment
If the Inspector General identifies a National Drug Code for a drug or biological product under paragraph (1), the Inspector General shall inform the Secretary (at such times as the Secretary may specify to carry out this paragraph) and the Secretary shall, to the extent the Secretary deems appropriate, apply as the amount of payment under this section for the applicable billing and payment code the lesser of—
(A) the amount of payment that would be determined under this section for such billing and payment code if such National Drug Code for such product so identified under paragraph (1) were excluded from such determination; or
(B) the amount of payment otherwise determined under this section for such billing and payment code without application of this subsection.
(3) Application to certain identified products
In the case of a National Drug Code for a drug or biological product that is self-administered for which payment is not made under this part because such product is not covered pursuant to
(A) the amount of payment that would be determined under this section for such billing and payment code if such National Drug Code for such drug or biological products so identified were excluded from such determination; or
(B) the amount of payment otherwise determined under this section for such billing and payment code without application of this subsection.
(h) Refund for certain discarded single-dose container or single-use package drugs
(1) Secretarial provision of information
(A) In general
For each calendar quarter beginning on or after January 1, 2023, the Secretary shall, with respect to a refundable single-dose container or single-use package drug (as defined in paragraph (8)), report to each manufacturer (as defined in subsection (c)(6)(A)) of such refundable single-dose container or single-use package drug the following for the calendar quarter:
(i) Subject to subparagraph (C), information on the total number of units of the billing and payment code of such drug, if any, that were discarded during such quarter, as determined using a mechanism such as the JW modifier used as of November 15, 2021 (or any such successor modifier that includes such data as determined appropriate by the Secretary).
(ii) The refund amount that the manufacturer is liable for pursuant to paragraph (3).
(B) Determination of discarded amounts
For purposes of subparagraph (A)(i), with respect to a refundable single-dose container or single-use package drug furnished during a quarter, the amount of such drug that was discarded shall be determined based on the amount of such drug that was unused and discarded for each drug on the date of service.
(C) Exclusion of units of packaged drugs
The total number of units of the billing and payment code of a refundable single-dose container or single-use package drug of a manufacturer furnished during a calendar quarter for purposes of subparagraph (A)(i), and the determination of the estimated total allowed charges for the drug in the quarter for purposes of paragraph (3)(A)(ii), shall not include such units that are packaged into the payment amount for an item or service and are not separately payable.
(2) Manufacturer requirement
For each calendar quarter beginning on or after January 1, 2023, the manufacturer of a refundable single-dose container or single-use package drug shall, for such drug, provide to the Secretary a refund that is equal to the amount specified in paragraph (3) for such drug for such quarter.
(3) Refund amount
(A) In general
The amount of the refund specified in this paragraph is, with respect to a refundable single-dose container or single-use package drug of a manufacturer assigned to a billing and payment code for a calendar quarter beginning on or after January 1, 2023, an amount equal to the estimated amount (if any) by which—
(i) the product of—
(I) the total number of units of the billing and payment code for such drug that were discarded during such quarter (as determined under paragraph (1)); and
(II)(aa) in the case of a refundable single-dose container or single-use package drug that is a single source drug or biological, the amount of payment determined for such drug or biological under subsection (b)(1)(B) for such quarter; or
(bb) in the case of a refundable single-dose container or single-use package drug that is a biosimilar biological product, the amount of payment determined for such product under subsection (b)(1)(C) for such quarter; exceeds
(ii) an amount equal to the applicable percentage (as defined in subparagraph (B)) of the estimated total allowed charges for such drug under this part during the quarter.
(B) Applicable percentage defined
(i) In general
For purposes of subparagraph (A)(ii), the term "applicable percentage" means—
(I) subject to subclause (II), 10 percent; and
(II) if applicable, in the case of a refundable single-dose container or single-use package drug described in clause (ii), a percentage specified by the Secretary pursuant to such clause.
(ii) Treatment of drugs that have unique circumstances
In the case of a refundable single-dose container or single-use package drug that has unique circumstances involving similar loss of product as that described in paragraph (8)(B)(ii), the Secretary, through notice and comment rulemaking, may increase the applicable percentage otherwise applicable under clause (i)(I) as determined appropriate by the Secretary.
(4) Frequency
Amounts required to be refunded pursuant to paragraph (2) shall be paid in regular intervals (as determined appropriate by the Secretary).
(5) Refund deposits
Amounts paid as refunds pursuant to paragraph (2) shall be deposited into the Federal Supplementary Medical Insurance Trust Fund established under
(6) Enforcement
(A) Audits
(i) Manufacturer audits
Each manufacturer of a refundable single-dose container or single-use package drug that is required to provide a refund under this subsection shall be subject to periodic audit with respect to such drug and such refunds by the Secretary.
(ii) Provider audits
The Secretary shall conduct periodic audits of claims submitted under this part with respect to refundable single-dose container or single-use package drugs in accordance with the authority under
(B) Civil money penalty
(i) In general
The Secretary shall impose a civil money penalty on a manufacturer of a refundable single-dose container or single-use package drug who has failed to comply with the requirement under paragraph (2) for such drug for a calendar quarter in an amount equal to the sum of—
(I) the amount that the manufacturer would have paid under such paragraph with respect to such drug for such quarter; and
(II) 25 percent of such amount.
(ii) Application
The provisions of
(7) Implementation
The Secretary shall implement this subsection through notice and comment rulemaking.
(8) Definition of refundable single-dose container or single-use package drug
(A) In general
Except as provided in subparagraph (B), in this subsection, the term "refundable single-dose container or single-use package drug" means a single source drug or biological (as defined in subsection (c)(6)(D)) or a biosimilar biological product (as defined in subsection (c)(6)(H)) for which payment is made under this part and that is furnished from a single-dose container or single-use package.
(B) Exclusions
The term "refundable single-dose container or single-use package drug" does not include—
(i) a drug or biological that is either a radiopharmaceutical or an imaging agent;
(ii) a drug or biological approved by the Food and Drug Administration for which dosage and administration instructions included in the labeling require filtration during the drug preparation process, prior to dilution and administration, and require that any unused portion of such drug after the filtration process be discarded after the completion of such filtration process; or
(iii) a drug or biological approved by the Food and Drug Administration on or after November 15, 2021, and with respect to which payment has been made under this part for fewer than 18 months.
(9) Report to Congress
Not later than 3 years after November 15, 2021, the Office of the Inspector General, after consultation with the Centers for Medicare & Medicaid Services and the Food and Drug Administration, shall submit to the Committee on Finance of the Senate and the Committee on Energy and Commerce and the Committee on Ways and Means of the House of Representatives, a report on any impact this section is reported to have on the licensure, market entry, market retention, or marketing of biosimilar biological products. Such report shall be updated periodically at the direction of the Committee on Finance of the Senate and the Committee on Energy and Commerce and the Committee on Ways and Means of the House of Representatives.
(i) Rebate by manufacturers for single source drugs and biologicals with prices increasing faster than inflation
(1) Requirements
(A) Secretarial provision of information
Not later than 6 months after the end of each calendar quarter beginning on or after January 1, 2023, the Secretary shall, for each part B rebatable drug, report to each manufacturer of such part B rebatable drug the following for such calendar quarter:
(i) Information on the total number of units of the billing and payment code described in subparagraph (A)(i) of paragraph (3) with respect to such drug and calendar quarter.
(ii) Information on the amount (if any) of the excess average sales price increase described in subparagraph (A)(ii) of such paragraph for such drug and calendar quarter.
(iii) The rebate amount specified under such paragraph for such part B rebatable drug and calendar quarter.
(B) Manufacturer requirement
For each calendar quarter beginning on or after January 1, 2023, the manufacturer of a part B rebatable drug shall, for such drug, not later than 30 days after the date of receipt from the Secretary of the information described in subparagraph (A) for such calendar quarter, provide to the Secretary a rebate that is equal to the amount specified in paragraph (3) for such drug for such calendar quarter.
(C) Transition rule for reporting
The Secretary may, for each part B rebatable drug, delay the timeframe for reporting the information described in subparagraph (A) for calendar quarters beginning in 2023 and 2024 until not later than September 30, 2025.
(2) Part B rebatable drug defined
(A) In general
In this subsection, the term "part B rebatable drug" means a single source drug or biological (as defined in subparagraph (D) of subsection (c)(6)), including a biosimilar biological product (as defined in subparagraph (H) of such subsection) but excluding a qualifying biosimilar biological product (as defined in subsection (b)(8)(B)(iii)), for which payment is made under this part, except such term shall not include such a drug or biological—
(i) if, as determined by the Secretary, the average total allowed charges for such drug or biological under this part for a year per individual that uses such a drug or biological are less than, subject to subparagraph (B), $100; or
(ii) that is a vaccine described in subparagraph (A) or (B) of
(B) Increase
The dollar amount applied under subparagraph (A)(i)—
(i) for 2024, shall be the dollar amount specified under such subparagraph for 2023, increased by the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12-month period ending with June of the previous year; and
(ii) for a subsequent year, shall be the dollar amount specified in this clause (or clause (i)) for the previous year (without application of subparagraph (C)), increased by the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12-month period ending with June of the previous year.
(C) Rounding
Any dollar amount determined under subparagraph (B) that is not a multiple of $10 shall be rounded to the nearest multiple of $10.
(3) Rebate amount
(A) In general
For purposes of paragraph (1), the amount specified in this paragraph for a part B rebatable drug assigned to a billing and payment code for a calendar quarter is, subject to subparagraphs (B) and (G) and paragraph (4), the estimated amount equal to the product of—
(i) the total number of units determined under subparagraph (B) for the billing and payment code of such drug; and
(ii) the amount (if any) by which—
(I) the amount equal to—
(aa) in the case of a part B rebatable drug described in paragraph (1)(B) of subsection (b), 106 percent of the amount determined under paragraph (4) of such section 2 for such drug during the calendar quarter; or
(bb) in the case of a part B rebatable drug described in paragraph (1)(C) of such subsection, the payment amount under such paragraph for such drug during the calendar quarter; exceeds
(II) the inflation-adjusted payment amount determined under subparagraph (C) for such part B rebatable drug during the calendar quarter.
(B) Total number of units
For purposes of subparagraph (A)(i), the total number of units for the billing and payment code with respect to a part B rebatable drug furnished during a calendar quarter described in subparagraph (A) is equal to—
(i) the number of units for the billing and payment code of such drug furnished during such calendar quarter, minus
(ii) the number of units for such billing and payment code of such drug furnished during such calendar quarter—
(I) with respect to which the manufacturer provides a discount under the program under
(II) that are packaged into the payment amount for an item or service and are not separately payable.
(C) Determination of inflation-adjusted payment amount
The inflation-adjusted payment amount determined under this subparagraph for a part B rebatable drug for a calendar quarter is—
(i) the payment amount for the billing and payment code for such drug in the payment amount benchmark quarter (as defined in subparagraph (D)); increased by
(ii) the percentage by which the rebate period CPI–U (as defined in subparagraph (F)) for the calendar quarter exceeds the benchmark period CPI–U (as defined in subparagraph (E)).
(D) Payment amount benchmark quarter
The term "payment amount benchmark quarter" means the calendar quarter beginning July 1, 2021.
(E) Benchmark period CPI–U
The term "benchmark period CPI–U" means the consumer price index for all urban consumers (United States city average) for January 2021.
(F) Rebate period CPI–U
The term "rebate period CPI–U" means, with respect to a calendar quarter described in subparagraph (C), the greater of the benchmark period CPI–U and the consumer price index for all urban consumers (United States city average) for the first month of the calendar quarter that is two calendar quarters prior to such described calendar quarter.
(G) Reduction or waiver for shortages and severe supply chain disruptions
The Secretary shall reduce or waive the amount under subparagraph (A) with respect to a part B rebatable drug and a calendar quarter—
(i) in the case of a part B rebatable drug that is described as currently in shortage on the shortage list in effect under
(ii) in the case of a biosimilar biological product, when the Secretary determines there is a severe supply chain disruption during the calendar quarter, such as that caused by a natural disaster or other unique or unexpected event.
(4) Special treatment of certain drugs and exemption
(A) Subsequently approved drugs
In the case of a part B rebatable drug first approved or licensed by the Food and Drug Administration after December 1, 2020, clause (i) of paragraph (3)(C) shall be applied as if the term "payment amount benchmark quarter" were defined under paragraph (3)(D) as the third full calendar quarter after the day on which the drug was first marketed and clause (ii) of paragraph (3)(C) shall be applied as if the term "benchmark period CPI–U" were defined under paragraph (3)(E) as if the reference to "January 2021" under such paragraph were a reference to "the first month of the first full calendar quarter after the day on which the drug was first marketed".
(B) Timeline for provision of rebates for subsequently approved drugs
In the case of a part B rebatable drug first approved or licensed by the Food and Drug Administration after December 1, 2020, paragraph (1)(B) shall be applied as if the reference to "January 1, 2023" under such paragraph were a reference to "the later of the 6th full calendar quarter after the day on which the drug was first marketed or January 1, 2023".
(C) Selected drugs
In the case of a part B rebatable drug that is a selected drug (as defined in
(5) Application to beneficiary coinsurance
In the case of a part B rebatable drug furnished on or after April 1, 2023, if the payment amount described in paragraph (3)(A)(ii)(I) (or, in the case of a part B rebatable drug that is a selected drug (as defined in
(A) in computing the amount of any coinsurance applicable under this part to an individual to whom such drug is furnished, the computation of such coinsurance shall be equal to 20 percent of the inflation-adjusted payment amount determined under paragraph (3)(C) for such part B rebatable drug; and
(B) the amount of such coinsurance for such calendar quarter, as computed under subparagraph (A), shall be applied as a percent, as determined by the Secretary, to the payment amount that would otherwise apply under subparagraphs (B) or (C) of subsection (b)(1).
(6) Rebate deposits
Amounts paid as rebates under paragraph (1)(B) shall be deposited into the Federal Supplementary Medical Insurance Trust Fund established under
(7) Civil money penalty
If a manufacturer of a part B rebatable drug has failed to comply with the requirements under paragraph (1)(B) for such drug for a calendar quarter, the manufacturer shall be subject to, in accordance with a process established by the Secretary pursuant to regulations, a civil money penalty in an amount equal to at least 125 percent of the amount specified in paragraph (3) for such drug for such calendar quarter. The provisions of
(8) Limitation on administrative or judicial review
There shall be no administrative or judicial review of any of the following:
(A) The determination of units under this subsection.
(B) The determination of whether a drug is a part B rebatable drug under this subsection.
(C) The calculation of the rebate amount under this subsection.
(D) The computation of coinsurance under paragraph (5) of this subsection.
(E) The computation of amounts paid under
(j) Judicial review
There shall be no administrative or judicial review under
(1) determinations of payment amounts under this section, including the assignment of National Drug Codes to billing and payment codes;
(2) the identification of units (and package size) under subsection (b)(2);
(3) the method to allocate rebates, chargebacks, and other price concessions to a quarter if specified by the Secretary;
(4) the manufacturer's average sales price when it is used for the determination of a payment amount under this section; and
(5) the disclosure of the average manufacturer price by reason of an adjustment under subsection (d)(3)(C) or (e).
(Aug. 14, 1935, ch. 531, title XVIII, §1847A, as added
Editorial Notes
References in Text
Subsection (g)(7), referred to in subsec. (i)(4)(C), does not define "applicable period" because subsec. (g) of this section does not have a par. (7). However, such term is defined in
Amendments
2022—Subsec. (b)(1)(B).
Subsec. (b)(8).
Subsec. (c)(3).
Subsec. (c)(4).
Subsecs. (i), (j).
2021—Subsecs. (h), (i).
2020—Subsec. (b)(2)(A).
Subsec. (b)(3).
Subsec. (b)(6)(A).
Subsec. (c)(6)(A).
Subsec. (d)(4)(A).
Subsec. (d)(4)(B).
Subsec. (d)(4)(C), (D).
Subsec. (d)(4)(E).
Subsec. (f).
Subsecs. (g), (h).
2019—Subsec. (c)(4).
"(A) the wholesale acquisition cost; or
"(B) the methodologies in effect under this part on November 1, 2003, to determine payment amounts for drugs or biologicals."
2010—Subsec. (b)(1)(C).
Subsec. (b)(8).
Subsec. (c)(6)(H), (I).
2007—Subsec. (b)(1).
Subsec. (b)(1)(A).
Subsec. (b)(4)(A), (B).
Subsec. (b)(6).
Subsec. (b)(7).
Statutory Notes and Related Subsidiaries
Effective Date of 2010 Amendment
Report on Sales to Pharmacy Benefit Managers
"(A)
"(B)
Inspector General Report on Adequacy of Reimbursement Rate Under Average Sales Price Methodology
"(A)
"(B)
Application of 2003 Amendment to Physician Specialties
Amendment by section 303 of
Notwithstanding section 303(j) of
1 So in original. The comma probably should not appear.
2 So in original. Probably should be "subsection".
3 See References in Text note below.
§1395w–3b. Competitive acquisition of outpatient drugs and biologicals
(a) Implementation of competitive acquisition
(1) Implementation of program
(A) In general
The Secretary shall establish and implement a competitive acquisition program under which—
(i) competitive acquisition areas are established for contract award purposes for acquisition of and payment for categories of competitively biddable drugs and biologicals (as defined in paragraph (2)) under this part;
(ii) each physician is given the opportunity annually to elect to obtain drugs and biologicals under the program, rather than under
(iii) each physician who elects to obtain drugs and biologicals under the program makes an annual selection under paragraph (5) of the contractor through which drugs and biologicals within a category of drugs and biologicals will be acquired and delivered to the physician under this part.
This section shall not apply in the case of a physician who elects
(B) Implementation
For purposes of implementing the program, the Secretary shall establish categories of competitively biddable drugs and biologicals. The Secretary shall phase in the program with respect to those categories beginning in 2006 in such manner as the Secretary determines to be appropriate.
(C) Waiver of certain provisions
In order to promote competition, in carrying out the program the Secretary may waive such provisions of the Federal Acquisition Regulation as are necessary for the efficient implementation of this section, other than provisions relating to confidentiality of information and such other provisions as the Secretary determines appropriate.
(D) Exclusion authority
The Secretary may exclude competitively biddable drugs and biologicals (including a class of such drugs and biologicals) from the competitive bidding system under this section if the application of competitive bidding to such drugs or biologicals—
(i) is not likely to result in significant savings; or
(ii) is likely to have an adverse impact on access to such drugs or biologicals.
(2) Competitively biddable drugs and biologicals and program defined
For purposes of this section—
(A) Competitively biddable drugs and biologicals defined
The term "competitively biddable drugs and biologicals" means a drug or biological described in
(B) Program
The term "program" means the competitive acquisition program under this section.
(C) Competitive acquisition area; area
The terms "competitive acquisition area" and "area" mean an appropriate geographic region established by the Secretary under the program.
(D) Contractor
The term "contractor" means an entity that has entered into a contract with the Secretary under this section.
(3) Application of program payment methodology
(A) In general
With respect to competitively biddable drugs and biologicals which are supplied under the program in an area and which are prescribed by a physician who has elected this section to apply—
(i) the claim for such drugs and biologicals shall be submitted by the contractor that supplied the drugs and biologicals;
(ii) collection of amounts of any deductible and coinsurance applicable with respect to such drugs and biologicals shall be the responsibility of such contractor and shall not be collected unless the drug or biological is administered to the individual involved; and
(iii) the payment under this section (and related amounts of any applicable deductible and coinsurance) for such drugs and biologicals shall be made only to such contractor upon receipt of a claim for a drug or biological supplied by the contractor for administration to a beneficiary.
(B) Process for adjustments
The Secretary shall provide a process for adjustments to payments in the case in which payment is made for drugs and biologicals which were billed at the time of dispensing but which were not actually administered.
(C) Information for purposes of cost-sharing
The Secretary shall provide a process by which physicians submit information to contractors for purposes of the collection of any applicable deductible or coinsurance amounts under subparagraph (A)(ii).
(D) Post-payment review process
The Secretary shall establish (by program instruction or otherwise) a post-payment review process (which may include the use of statistical sampling) to assure that payment is made for a drug or biological under this section only if the drug or biological has been administered to a beneficiary. The Secretary shall recoup, offset, or collect any overpayments determined by the Secretary under such process.
(4) Contract required
Payment may not be made under this part for competitively biddable drugs and biologicals prescribed by a physician who has elected this section to apply within a category and a competitive acquisition area with respect to which the program applies unless—
(A) the drugs or biologicals are supplied by a contractor with a contract under this section for such category of drugs and biologicals and area; and
(B) the physician has elected such contractor under paragraph (5) for such category and area.
(5) Contractor selection process
(A) Annual selection
(i) In general
The Secretary shall provide a process for the selection of a contractor, on an annual basis and in such exigent circumstances as the Secretary may provide and with respect to each category of competitively biddable drugs and biologicals for an area by selecting physicians.
(ii) Timing of selection
The selection of a contractor under clause (i) shall be made at the time of the election described in
(B) Information on contractors
The Secretary shall make available to physicians on an ongoing basis, through a directory posted on the Internet website of the Centers for Medicare & Medicaid Services or otherwise and upon request, a list of the contractors under this section in the different competitive acquisition areas.
(C) Selecting physician defined
For purposes of this section, the term "selecting physician" means, with respect to a contractor and category and competitive acquisition area, a physician who has elected this section to apply and has selected to apply under this section such contractor for such category and area.
(b) Program requirements
(1) Contract for competitively biddable drugs and biologicals
The Secretary shall conduct a competition among entities for the acquisition of competitively biddable drugs and biologicals. Notwithstanding any other provision of this subchapter, in the case of a multiple source drug, the Secretary shall conduct such competition among entities for the acquisition of at least one competitively biddable drug and biological within each billing and payment code within each category for each competitive acquisition area.
(2) Conditions for awarding contract
(A) In general
The Secretary may not award a contract to any entity under the competition conducted in a competitive acquisition area pursuant to paragraph (1) with respect to the acquisition of competitively biddable drugs and biologicals within a category unless the Secretary finds that the entity meets all of the following with respect to the contract period involved:
(i) Capacity to supply competitively biddable drug or biological within category
(I) In general
The entity has sufficient arrangements to acquire and to deliver competitively biddable drugs and biologicals within such category in the area specified in the contract.
(II) Shipment methodology
The entity has arrangements in effect for the shipment at least 5 days each week of competitively biddable drugs and biologicals under the contract and for the timely delivery (including for emergency situations) of such drugs and biologicals in the area under the contract.
(ii) Quality, service, financial performance and solvency standards
The entity meets quality, service, financial performance, and solvency standards specified by the Secretary, including—
(I) the establishment of procedures for the prompt response and resolution of complaints of physicians and individuals and of inquiries regarding the shipment of competitively biddable drugs and biologicals; and
(II) a grievance and appeals process for the resolution of disputes.
(B) Additional considerations
The Secretary may refuse to award a contract under this section, and may terminate such a contract, with an entity based upon—
(i) the suspension or revocation, by the Federal Government or a State government, of the entity's license for the distribution of drugs or biologicals (including controlled substances); or
(ii) the exclusion of the entity under
(C) Application of Medicare Provider Ombudsman
For provision providing for a program-wide Medicare Provider Ombudsman to review complaints, see
(3) Awarding multiple contracts for a category and area
The Secretary may limit (but not below 2) the number of qualified entities that are awarded such contracts for any category and area. The Secretary shall select among qualified entities based on the following:
(A) The bid prices for competitively biddable drugs and biologicals within the category and area.
(B) Bid price for distribution of such drugs and biologicals.
(C) Ability to ensure product integrity.
(D) Customer service.
(E) Past experience in the distribution of drugs and biologicals, including controlled substances.
(F) Such other factors as the Secretary may specify.
(4) Terms of contracts
(A) In general
A contract entered into with an entity under the competition conducted pursuant to paragraph (1) is subject to terms and conditions that the Secretary may specify consistent with this section.
(B) Period of contracts
A contract under this section shall be for a term of 3 years, but may be terminated by the Secretary or the entity with appropriate, advance notice.
(C) Integrity of drug and biological distribution system
A contractor (as defined in subsection (a)(2)(D)) shall—
(i) acquire all drug and biological products it distributes directly from the manufacturer or from a distributor that has acquired the products directly from the manufacturer; and
(ii) comply with any product integrity safeguards as may be determined to be appropriate by the Secretary.
Nothing in this subparagraph shall be construed to relieve or exempt any contractor from the provisions of the Federal Food, Drug, and Cosmetic Act [
(D) Compliance with code of conduct and fraud and abuse rules
Under the contract—
(i) the contractor shall comply with a code of conduct, specified or recognized by the Secretary, that includes standards relating to conflicts of interest; and
(ii) the contractor shall comply with all applicable provisions relating to prevention of fraud and abuse, including compliance with applicable guidelines of the Department of Justice and the Inspector General of the Department of Health and Human Services.
(E) Direct delivery of drugs and biologicals to physicians
Under the contract the contractor shall only supply competitively biddable drugs and biologicals directly to the selecting physicians and not directly to individuals, except under circumstances and settings where an individual currently receives a drug or biological in the individual's home or other non-physician office setting as the Secretary may provide. The contractor shall not deliver drugs and biologicals to a selecting physician except upon receipt of a prescription for such drugs and biologicals, and such necessary data as may be required by the Secretary to carry out this section. This section does not—
(i) require a physician to submit a prescription for each individual treatment; or
(ii) change a physician's flexibility in terms of writing a prescription for drugs or biologicals for a single treatment or a course of treatment.
(5) Permitting access to drugs and biologicals
The Secretary shall establish rules under this section under which drugs and biologicals which are acquired through a contractor under this section may be used to resupply inventories of such drugs and biologicals which are administered consistent with safe drug practices and with adequate safeguards against fraud and abuse. The previous sentence shall apply if the physicians can demonstrate to the Secretary all of the following:
(A) The drugs or biologicals are required immediately.
(B) The physician could not have reasonably anticipated the immediate requirement for the drugs or biologicals.
(C) The contractor could not deliver to the physician the drugs or biologicals in a timely manner.
(D) The drugs or biologicals were administered in an emergency situation.
(6) Construction
Nothing in this section shall be construed as waiving applicable State requirements relating to licensing of pharmacies.
(c) Bidding process
(1) In general
In awarding a contract for a category of drugs and biologicals in an area under the program, the Secretary shall consider with respect to each entity seeking to be awarded a contract the bid price and the other factors referred to in subsection (b)(3).
(2) Bid defined
In this section, the term "bid" means an offer to furnish a competitively biddable drug or biological for a particular price and time period.
(3) Bidding on a national or regional basis
Nothing in this section shall be construed as precluding a bidder from bidding for contracts in all areas of the United States or as requiring a bidder to submit a bid for all areas of the United States.
(4) Uniformity of bids within area
The amount of the bid submitted under a contract offer for any competitively biddable drug or biological for an area shall be the same for that drug or biological for all portions of that area.
(5) Confidentiality of bids
The provisions of subparagraph (D) of
(A) in that subparagraph to a "manufacturer or wholesaler" is deemed a reference to a "bidder" under this section;
(B) in that section to "prices charged for drugs" is deemed a reference to a "bid" submitted under this section; and
(C) in clause (i) of that section to "this section", is deemed a reference to "part B of subchapter XVIII".
(6) Inclusion of costs
The bid price submitted in a contract offer for a competitively biddable drug or biological shall—
(A) include all costs related to the delivery of the drug or biological to the selecting physician (or other point of delivery); and
(B) include the costs of dispensing (including shipping) of such drug or biological and management fees, but shall not include any costs related to the administration of the drug or biological, or wastage, spillage, or spoilage.
(7) Price adjustments during contract period; disclosure of costs
Each contract awarded shall provide for—
(A) disclosure to the Secretary the contractor's reasonable, net acquisition costs for periods specified by the Secretary, not more often than quarterly, of the contract; and
(B) appropriate price adjustments over the period of the contract to reflect significant increases or decreases in a contractor's reasonable, net acquisition costs, as so disclosed.
(d) Computation of payment amounts
(1) In general
Payment under this section for competitively biddable drugs or biologicals shall be based on bids submitted and accepted under this section for such drugs or biologicals in an area. Based on such bids the Secretary shall determine a single payment amount for each competitively biddable drug or biological in the area.
(2) Special rules
The Secretary shall establish rules regarding the use under this section of the alternative payment amount provided under
(A) New drugs and biologicals
A competitively biddable drug or biological for which a payment and billing code has not been established.
(B) Other cases
Such other exceptional cases as the Secretary may specify in regulations.
(e) Cost-sharing
(1) Application of coinsurance
Payment under this section for competitively biddable drugs and biologicals shall be in an amount equal to 80 percent of the payment basis described in subsection (d)(1).
(2) Deductible
Before applying paragraph (1), the individual shall be required to meet the deductible described in
(3) Collection
Such coinsurance and deductible shall be collected by the contractor that supplies the drug or biological involved. Subject to subsection (a)(3)(B), such coinsurance and deductible may be collected in a manner similar to the manner in which the coinsurance and deductible are collected for durable medical equipment under this part.
(f) Special payment rules
(1) Use in exclusion cases
If the Secretary excludes a drug or biological (or class of drugs or biologicals) under subsection (a)(1)(D), the Secretary may provide for payment to be made under this part for such drugs and biologicals (or class) using the payment methodology under
(2) Application of requirement for assignment
For provision requiring assignment of claims for competitively biddable drugs and biologicals, see
(3) Protection for beneficiary in case of medical necessity denial
For protection of individuals against liability in the case of medical necessity determinations, see
(g) Judicial review
There shall be no administrative or judicial review under
(1) the establishment of payment amounts under subsection (d)(1);
(2) the awarding of contracts under this section;
(3) the establishment of competitive acquisition areas under subsection (a)(2)(C);
(4) the phased-in implementation under subsection (a)(1)(B);
(5) the selection of categories of competitively biddable drugs and biologicals for competitive acquisition under such subsection or the selection of a drug in the case of multiple source drugs; or
(6) the bidding structure and number of contractors selected under this section.
(Aug. 14, 1935, ch. 531, title XVIII, §1847B, as added
Editorial Notes
References in Text
The Federal Food, Drug, and Cosmetic Act, referred to in subsec. subsec. (b)(4)(C), is act June 25, 1938, ch. 675,
Amendments
2006—Subsec. (a)(3)(A)(iii).
"(I) shall be made only to such contractor; and
"(II) shall be conditioned upon the administration of such drugs and biologicals."
Subsec. (a)(3)(D).
Statutory Notes and Related Subsidiaries
Effective Date of 2006 Amendment
"(1) on or after April 1, 2007; and
"(2) on or after July 1, 2006, and before April 1, 2007, for claims that are unpaid as of April 1, 2007."
Construction of 2006 Amendment
"(1) requiring the conduct of any additional competition under subsection (b)(1) of section 1847B of the Social Security Act (
"(2) requiring any additional process for elections by physicians under subsection (a)(1)(A)(ii) of such section or additional selection by a selecting physician of a contractor under subsection (a)(5) of such section."
Report
Application of 2003 Amendment to Physician Specialties
Amendment by section 303 of
Notwithstanding section 303(j) of
1 See References in Text note below.
§1395w–4. Payment for physicians' services
(a) Payment based on fee schedule
(1) In general
Effective for all physicians' services (as defined in subsection (j)(3)) furnished under this part during a year (beginning with 1992) for which payment is otherwise made on the basis of a reasonable charge or on the basis of a fee schedule under
(A) the actual charge for the service, or
(B) subject to the succeeding provisions of this subsection, the amount determined under the fee schedule established under subsection (b) for services furnished during that year (in this subsection referred to as the "fee schedule amount").
(2) Transition to full fee schedule
(A) Limiting reductions and increases to 15 percent in 1992
(i) Limit on increase
In the case of a service in a fee schedule area (as defined in subsection (j)(2)) for which the adjusted historical payment basis (as defined in subparagraph (D)) is less than 85 percent of the fee schedule amount for services furnished in 1992, there shall be substituted for the fee schedule amount an amount equal to the adjusted historical payment basis plus 15 percent of the fee schedule amount otherwise established (without regard to this paragraph).
(ii) Limit in reduction
In the case of a service in a fee schedule area for which the adjusted historical payment basis exceeds 115 percent of the fee schedule amount for services furnished in 1992, there shall be substituted for the fee schedule amount an amount equal to the adjusted historical payment basis minus 15 percent of the fee schedule amount otherwise established (without regard to this paragraph).
(B) Special rule for 1993, 1994, and 1995
If a physicians' service in a fee schedule area is subject to the provisions of subparagraph (A) in 1992, for physicians' services furnished in the area—
(i) during 1993, there shall be substituted for the fee schedule amount an amount equal to the sum of—
(I) 75 percent of the fee schedule amount determined under subparagraph (A), adjusted by the update established under subsection (d)(3) for 1993, and
(II) 25 percent of the fee schedule amount determined under paragraph (1) for 1993 without regard to this paragraph;
(ii) during 1994, there shall be substituted for the fee schedule amount an amount equal to the sum of—
(I) 67 percent of the fee schedule amount determined under clause (i), adjusted by the update established under subsection (d)(3) for 1994 and as adjusted under subsection (c)(2)(F)(ii) and under section 13515(b) of the Omnibus Budget Reconciliation Act of 1993, and
(II) 33 percent of the fee schedule amount determined under paragraph (1) for 1994 without regard to this paragraph; and
(iii) during 1995, there shall be substituted for the fee schedule amount an amount equal to the sum of—
(I) 50 percent of the fee schedule amount determined under clause (ii) adjusted by the update established under subsection (d)(3) for 1995, and
(II) 50 percent of the fee schedule amount determined under paragraph (1) for 1995 without regard to this paragraph.
(C) Special rule for anesthesia and radiology services
With respect to physicians' services which are anesthesia services, the Secretary shall provide for a transition in the same manner as a transition is provided for other services under subparagraph (B). With respect to radiology services, "109 percent" and "9 percent" shall be substituted for "115 percent" and "15 percent", respectively, in subparagraph (A)(ii).
(D) "Adjusted historical payment basis" defined
(i) In general
In this paragraph, the term "adjusted historical payment basis" means, with respect to a physicians' service furnished in a fee schedule area, the weighted average prevailing charge applied in the area for the service in 1991 (as determined by the Secretary without regard to physician specialty and as adjusted to reflect payments for services with customary charges below the prevailing charge or other payment limitations imposed by law or regulation) adjusted by the update established under subsection (d)(3) for 1992.
(ii) Application to radiology services
In applying clause (i) in the case of physicians' services which are radiology services (including radiologist services, as defined in
(iii) Nuclear medicine services
In applying clause (i) in the case of physicians' services which are nuclear medicine services, there shall be substituted for the weighted average prevailing charge the amount provided under section 6105(b) of the Omnibus Budget Reconciliation Act of 1989.
(3) Incentives for participating physicians and suppliers
In applying paragraph (1)(B) in the case of a nonparticipating physician or a nonparticipating supplier or other person, the fee schedule amount shall be 95 percent of such amount otherwise applied under this subsection (without regard to this paragraph). In the case of physicians' services (including services which the Secretary excludes pursuant to subsection (j)(3)) of a nonparticipating physician, supplier, or other person for which payment is made under this part on a basis other than the fee schedule amount, the payment shall be based on 95 percent of the payment basis for such services furnished by a participating physician, supplier, or other person.
(4) Special rule for medical direction
(A) In general
With respect to physicians' services furnished on or after January 1, 1994, and consisting of medical direction of two, three, or four concurrent anesthesia cases, except as provided in paragraph (5), the fee schedule amount to be applied shall be equal to one-half of the amount described in subparagraph (B).
(B) Amount
The amount described in this subparagraph, for a physician's medical direction of the performance of anesthesia services, is the following percentage of the fee schedule amount otherwise applicable under this section if the anesthesia services were personally performed by the physician alone:
(i) For services furnished during 1994, 120 percent.
(ii) For services furnished during 1995, 115 percent.
(iii) For services furnished during 1996, 110 percent.
(iv) For services furnished during 1997, 105 percent.
(v) For services furnished after 1997, 100 percent.
(5) Incentives for electronic prescribing
(A) Adjustment
(i) In general
Subject to subparagraph (B) and subsection (m)(2)(B), with respect to covered professional services furnished by an eligible professional during 2012, 2013 or 2014, if the eligible professional is not a successful electronic prescriber for the reporting period for the year (as determined under subsection (m)(3)(B)), the fee schedule amount for such services furnished by such professional during the year (including the fee schedule amount for purposes of determining a payment based on such amount) shall be equal to the applicable percent of the fee schedule amount that would otherwise apply to such services under this subsection (determined after application of paragraph (3) but without regard to this paragraph).
(ii) Applicable percent
For purposes of clause (i), the term "applicable percent" means—
(I) for 2012, 99 percent;
(II) for 2013, 98.5 percent; and
(III) for 2014, 98 percent.
(B) Significant hardship exception
The Secretary may, on a case-by-case basis, exempt an eligible professional from the application of the payment adjustment under subparagraph (A) if the Secretary determines, subject to annual renewal, that compliance with the requirement for being a successful electronic prescriber would result in a significant hardship, such as in the case of an eligible professional who practices in a rural area without sufficient Internet access.
(C) Application
(i) Physician reporting system rules
Paragraphs (5), (6), and (8) of subsection (k) shall apply for purposes of this paragraph in the same manner as they apply for purposes of such subsection.
(ii) Incentive payment validation rules
Clauses (ii) and (iii) of subsection (m)(5)(D) shall apply for purposes of this paragraph in a similar manner as they apply for purposes of such subsection.
(D) Definitions
For purposes of this paragraph:
(i) Eligible professional; covered professional services
The terms "eligible professional" and "covered professional services" have the meanings given such terms in subsection (k)(3).
(ii) Physician reporting system
The term "physician reporting system" means the system established under subsection (k).
(iii) Reporting period
The term "reporting period" means, with respect to a year, a period specified by the Secretary.
(6) Special rule for teaching anesthesiologists
With respect to physicians' services furnished on or after January 1, 2010, in the case of teaching anesthesiologists involved in the training of physician residents in a single anesthesia case or two concurrent anesthesia cases, the fee schedule amount to be applied shall be 100 percent of the fee schedule amount otherwise applicable under this section if the anesthesia services were personally performed by the teaching anesthesiologist alone and paragraph (4) shall not apply if—
(A) the teaching anesthesiologist is present during all critical or key portions of the anesthesia service or procedure involved; and
(B) the teaching anesthesiologist (or another anesthesiologist with whom the teaching anesthesiologist has entered into an arrangement) is immediately available to furnish anesthesia services during the entire procedure.
(7) Incentives for meaningful use of certified EHR technology
(A) Adjustment
(i) In general
Subject to subparagraphs (B) and (D), with respect to covered professional services furnished by an eligible professional during each of 2015 through 2018, if the eligible professional is not a meaningful EHR user (as determined under subsection (o)(2)) for an EHR reporting period for the year, the fee schedule amount for such services furnished by such professional during the year (including the fee schedule amount for purposes of determining a payment based on such amount) shall be equal to the applicable percent of the fee schedule amount that would otherwise apply to such services under this subsection (determined after application of paragraph (3) but without regard to this paragraph).
(ii) Applicable percent
Subject to clause (iii), for purposes of clause (i), the term "applicable percent" means—
(I) for 2015, 99 percent (or, in the case of an eligible professional who was subject to the application of the payment adjustment under subsection (a)(5) for 2014, 98 percent);
(II) for 2016, 98 percent; and
(III) for 2017 and 2018, 97 percent.
(iii) Authority to decrease applicable percentage for 2018
For 2018, if the Secretary finds that the proportion of eligible professionals who are meaningful EHR users (as determined under subsection (o)(2)) is less than 75 percent, the applicable percent shall be decreased by 1 percentage point from the applicable percent in the preceding year.
(B) Significant hardship exception
The Secretary may, on a case-by-case basis (and, with respect to the payment adjustment under subparagraph (A) for 2017, for categories of eligible professionals, as established by the Secretary and posted on the Internet website of the Centers for Medicare & Medicaid Services prior to December 15, 2015, an application for which must be submitted to the Secretary by not later than March 15, 2016), exempt an eligible professional from the application of the payment adjustment under subparagraph (A) if the Secretary determines, subject to annual renewal, that compliance with the requirement for being a meaningful EHR user would result in a significant hardship, such as in the case of an eligible professional who practices in a rural area without sufficient Internet access. The Secretary shall exempt an eligible professional from the application of the payment adjustment under subparagraph (A) with respect to a year, subject to annual renewal, if the Secretary determines that compliance with the requirement for being a meaningful EHR user is not possible because the certified EHR technology used by such professional has been decertified under a program kept or recognized pursuant to
(C) Application of physician reporting system rules
Paragraphs (5), (6), and (8) of subsection (k) shall apply for purposes of this paragraph in the same manner as they apply for purposes of such subsection.
(D) Non-application to hospital-based and ambulatory surgical center-based eligible professionals
(i) Hospital-based
No payment adjustment may be made under subparagraph (A) in the case of hospital-based eligible professionals (as defined in subsection (o)(1)(C)(ii)).
(ii) Ambulatory surgical center-based
Subject to clause (iv), no payment adjustment may be made under subparagraph (A) for 2017 and 2018 in the case of an eligible professional with respect to whom substantially all of the covered professional services furnished by such professional are furnished in an ambulatory surgical center.
(iii) Determination
The determination of whether an eligible professional is an eligible professional described in clause (ii) may be made on the basis of—
(I) the site of service (as defined by the Secretary); or
(II) an attestation submitted by the eligible professional.
Determinations made under subclauses (I) and (II) shall be made without regard to any employment or billing arrangement between the eligible professional and any other supplier or provider of services.
(iv) Sunset
Clause (ii) shall no longer apply as of the first year that begins more than 3 years after the date on which the Secretary determines, through notice and comment rulemaking, that certified EHR technology applicable to the ambulatory surgical center setting is available.
(E) Definitions
For purposes of this paragraph:
(i) Covered professional services
The term "covered professional services" has the meaning given such term in subsection (k)(3).
(ii) EHR reporting period
The term "EHR reporting period" means, with respect to a year, a period (or periods) specified by the Secretary.
(iii) Eligible professional
The term "eligible professional" means a physician, as defined in
(8) Incentives for quality reporting
(A) Adjustment
(i) In general
With respect to covered professional services furnished by an eligible professional during each of 2015 through 2018, if the eligible professional does not satisfactorily submit data on quality measures for covered professional services for the quality reporting period for the year (as determined under subsection (m)(3)(A)), the fee schedule amount for such services furnished by such professional during the year (including the fee schedule amount for purposes of determining a payment based on such amount) shall be equal to the applicable percent of the fee schedule amount that would otherwise apply to such services under this subsection (determined after application of paragraphs (3), (5), and (7), but without regard to this paragraph).
(ii) Applicable percent
For purposes of clause (i), the term "applicable percent" means—
(I) for 2015, 98.5 percent; and
(II) for 2016, 2017, and 2018, 98 percent.
(B) Application
(i) Physician reporting system rules
Paragraphs (5), (6), and (8) of subsection (k) shall apply for purposes of this paragraph in the same manner as they apply for purposes of such subsection.
(ii) Incentive payment validation rules
Clauses (ii) and (iii) of subsection (m)(5)(D) shall apply for purposes of this paragraph in a similar manner as they apply for purposes of such subsection.
(C) Definitions
For purposes of this paragraph:
(i) Eligible professional; covered professional services
The terms "eligible professional" and "covered professional services" have the meanings given such terms in subsection (k)(3).
(ii) Physician reporting system
The term "physician reporting system" means the system established under subsection (k).
(iii) Quality reporting period
The term "quality reporting period" means, with respect to a year, a period specified by the Secretary.
(9) Information reporting on services included in global surgical packages
With respect to services for which a physician is required to report information in accordance with subsection (c)(8)(B)(i), the Secretary may through rulemaking delay payment of 5 percent of the amount that would otherwise be payable under the physician fee schedule under this section for such services until the information so required is reported.
(b) Establishment of fee schedules
(1) In general
Before November 1 of the preceding year, for each year beginning with 1998, subject to subsection (p), the Secretary shall establish, by regulation, fee schedules that establish payment amounts for all physicians' services furnished in all fee schedule areas (as defined in subsection (j)(2)) for the year. Except as provided in paragraph (2), each such payment amount for a service shall be equal to the product of—
(A) the relative value for the service (as determined in subsection (c)(2)),
(B) the conversion factor (established under subsection (d)) for the year, and
(C) the geographic adjustment factor (established under subsection (e)(2)) for the service for the fee schedule area.
(2) Treatment of radiology services and anesthesia services
(A) Radiology services
With respect to radiology services (including radiologist services, as defined in
(B) Anesthesia services
In establishing the fee schedule for anesthesia services for which a relative value guide has been established under section 4048(b) of the Omnibus Budget Reconciliation Act of 1987, the Secretary shall use, to the extent practicable, such relative value guide, with appropriate adjustment of the conversion factor, in a manner to assure that the fee schedule amounts for anesthesia services are consistent with the fee schedule amounts for other services determined by the Secretary to be of comparable value. In applying the previous sentence, the Secretary shall adjust the conversion factor by geographic adjustment factors in the same manner as such adjustment is made under paragraph (1)(C).
(C) Consultation
The Secretary shall consult with the Physician Payment Review Commission and organizations representing physicians or suppliers who furnish radiology services and anesthesia services in applying subparagraphs (A) and (B).
(3) Treatment of interpretation of electrocardiograms
The Secretary—
(A) shall make separate payment under this section for the interpretation of electrocardiograms performed or ordered to be performed as part of or in conjunction with a visit to or a consultation with a physician, and
(B) shall adjust the relative values established for visits and consultations under subsection (c) so as not to include relative value units for interpretations of electrocardiograms in the relative value for visits and consultations.
(4) Special rule for imaging services
(A) In general
In the case of imaging services described in subparagraph (B) furnished on or after January 1, 2007, if—
(i) the technical component (including the technical component portion of a global fee) of the service established for a year under the fee schedule described in paragraph (1) without application of the geographic adjustment factor described in paragraph (1)(C), exceeds
(ii) the Medicare OPD fee schedule amount established under the prospective payment system for hospital outpatient department services under paragraph (3)(D) of
the Secretary shall substitute the amount described in clause (ii), adjusted by the geographic adjustment factor described in paragraph (1)(C), for the fee schedule amount for such technical component for such year.
(B) Imaging services described
For purposes of subparagraph (A), imaging services described in this subparagraph are imaging and computer-assisted imaging services, including X-ray, ultrasound (including echocardiography), nuclear medicine (including positron emission tomography), magnetic resonance imaging, computed tomography, and fluoroscopy, but excluding diagnostic and screening mammography, and for 2010, 2011, and the first 2 months of 2012, dual-energy x-ray absorptiometry services (as described in paragraph (6)).
(C) Adjustment in imaging utilization rate
With respect to fee schedules established for 2011, 2012, and 2013, in the methodology for determining practice expense relative value units for expensive diagnostic imaging equipment under the final rule published by the Secretary in the Federal Register on November 25, 2009 (42 CFR 410 et al.), the Secretary shall use a 75 percent assumption instead of the utilization rates otherwise established in such final rule. With respect to fee schedules established for 2014 and subsequent years, in such methodology, the Secretary shall use a 90 percent utilization rate.
(D) Adjustment in technical component discount on single-session imaging involving consecutive body parts
For services furnished on or after July 1, 2010, the Secretary shall increase the reduction in payments attributable to the multiple procedure payment reduction applicable to the technical component for imaging under the final rule published by the Secretary in the Federal Register on November 21, 2005 (part 405 of title 42, Code of Federal Regulations) from 25 percent to 50 percent.
(5) Treatment of intensive cardiac rehabilitation program
(A) In general
In the case of an intensive cardiac rehabilitation program described in
(B) Definition of session
Each of the services described in subparagraphs (A) through (E) of
(C) Multiple sessions per day
Payment may be made for up to 6 sessions per day of the series of 72 one-hour sessions of intensive cardiac rehabilitation services described in
(6) Treatment of bone mass scans
For dual-energy x-ray absorptiometry services (identified in 2006 by HCPCS codes 76075 and 76077 (and any succeeding codes)) furnished during 2010, 2011, and the first 2 months of 2012, instead of the payment amount that would otherwise be determined under this section for such years, the payment amount shall be equal to 70 percent of the product of—
(A) the relative value for the service (as determined in subsection (c)(2)) for 2006;
(B) the conversion factor (established under subsection (d)) for 2006; and
(C) the geographic adjustment factor (established under subsection (e)(2)) for the service for the fee schedule area for 2010, 2011, and the first 2 months of 2012, respectively.
(7) Adjustment in discount for certain multiple therapy services
In the case of therapy services furnished on or after January 1, 2011, and before April 1, 2013, and for which payment is made under fee schedules established under this section, instead of the 25 percent multiple procedure payment reduction specified in the final rule published by the Secretary in the Federal Register on November 29, 2010, the reduction percentage shall be 20 percent. In the case of such services furnished on or after April 1, 2013, and for which payment is made under such fee schedules, instead of the 25 percent multiple procedure payment reduction specified in such final rule, the reduction percentage shall be 50 percent.
(8) Encouraging care management for individuals with chronic care needs
(A) In general
In order to encourage the management of care for individuals with chronic care needs the Secretary shall, subject to subparagraph (B), make payment (as the Secretary determines to be appropriate) under this section for chronic care management services furnished on or after January 1, 2015, by a physician (as defined in
(B) Policies relating to payment
In carrying out this paragraph, with respect to chronic care management services, the Secretary shall—
(i) make payment to only one applicable provider for such services furnished to an individual during a period;
(ii) not make payment under subparagraph (A) if such payment would be duplicative of payment that is otherwise made under this subchapter for such services; and
(iii) not require that an annual wellness visit (as defined in
(9) Special rule to incentivize transition from traditional X-ray imaging to digital radiography
(A) Limitation on payment for film X-ray imaging services
In the case of an imaging service (including the imaging portion of a service) that is an X-ray taken using film and that is furnished during 2017 or a subsequent year, the payment amount for the technical component (including the technical component portion of a global service) of such service that would otherwise be determined under this section (without application of this paragraph and before application of any other adjustment under this section) for such year shall be reduced by 20 percent.
(B) Phased-in limitation on payment for computed radiography imaging services
In the case of an imaging service (including the imaging portion of a service) that is an X-ray taken using computed radiography technology—
(i) in the case of such a service furnished during 2018, 2019, 2020, 2021, or 2022, the payment amount for the technical component (including the technical component portion of a global service) of such service that would otherwise be determined under this section (without application of this paragraph and before application of any other adjustment under this section) for such year shall be reduced by 7 percent; and
(ii) in the case of such a service furnished during 2023 or a subsequent year, the payment amount for the technical component (including the technical component portion of a global service) of such service that would otherwise be determined under this section (without application of this paragraph and before application of any other adjustment under this section) for such year shall be reduced by 10 percent.
(C) Computed radiography technology defined
For purposes of this paragraph, the term "computed radiography technology" means cassette-based imaging which utilizes an imaging plate to create the image involved.
(D) Implementation
In order to implement this paragraph, the Secretary shall adopt appropriate mechanisms which may include use of modifiers.
(10) Reduction of discount in payment for professional component of multiple imaging services
In the case of the professional component of imaging services furnished on or after January 1, 2017, instead of the 25 percent reduction for multiple procedures specified in the final rule published by the Secretary in the Federal Register on November 28, 2011, as amended in the final rule published by the Secretary in the Federal Register on November 16, 2012, the reduction percentage shall be 5 percent.
(11) Special rule for certain radiation therapy services
The code definitions, the work relative value units under subsection (c)(2)(C)(i), and the direct inputs for the practice expense relative value units under subsection (c)(2)(C)(ii) for radiation treatment delivery and related imaging services (identified in 2016 by HCPCS G-codes G6001 through G6015) for the fee schedule established under this subsection for services furnished in 2017, 2018, and 2019 shall be the same as such definitions, units, and inputs for such services for the fee schedule established for services furnished in 2016.
(12) Payment for psychotherapy for crisis services furnished in an applicable site of service
(A) In general
The Secretary shall establish new HCPCS codes under the fee schedule established under this subsection for services described in subparagraph (B) that are furnished on or after January 1, 2024.
(B) Services described
The services described in this subparagraph are psychotherapy for crisis services that are a furnished in an applicable site of service.
(C) Amount of payment
For services described in subparagraph (B) that are furnished to an individual in a year (beginning with 2024), in lieu of the fee schedule amount that would otherwise be determined under this subsection for such year, the fee schedule amount for such services for such year shall be equal to 150 percent of the fee schedule amount for non-facility sites of service for such year determined for services identified, as of January 1, 2022, by HCPCS codes 90839 and 90840 (and any succeeding codes).
(D) Definitions
In this paragraph:
(i) Applicable site of service
The term "applicable site of service" means a site of service other than a site where the facility rate under the fee schedule under this subsection applies and other than an office setting.
(ii) Psychotherapy for crisis services
The code descriptions for services described in subparagraph (B) shall be the same as the code descriptions for services identified, as of January 1, 2022, by HCPCS codes 90839 and 90840 (and any succeeding codes), except that such new codes shall be limited to services furnished in an applicable site of service.
(c) Determination of relative values for physicians' services
(1) Division of physicians' services into components
In this section, with respect to a physicians' service:
(A) "Work component" defined
The term "work component" means the portion of the resources used in furnishing the service that reflects physician time and intensity in furnishing the service. Such portion shall—
(i) include activities before and after direct patient contact, and
(ii) be defined, with respect to surgical procedures, to reflect a global definition including pre-operative and post-operative physicians' services.
(B) "Practice expense component" defined
The term "practice expense component" means the portion of the resources used in furnishing the service that reflects the general categories of expenses (such as office rent and wages of personnel, but excluding malpractice expenses) comprising practice expenses.
(C) "Malpractice component" defined
The term "malpractice component" means the portion of the resources used in furnishing the service that reflects malpractice expenses in furnishing the service.
(2) Determination of relative values
(A) In general
(i) Combination of units for components
The Secretary shall develop a methodology for combining the work, practice expense, and malpractice relative value units, determined under subparagraph (C), for each service in a manner to produce a single relative value for that service. Such relative values are subject to adjustment under subparagraph (F)(i) and section 13515(b) of the Omnibus Budget Reconciliation Act of 1993.
(ii) Extrapolation
The Secretary may use extrapolation and other techniques to determine the number of relative value units for physicians' services for which specific data are not available and shall take into account recommendations of the Physician Payment Review Commission and the results of consultations with organizations representing physicians who provide such services.
(B) Periodic review and adjustments in relative values
(i) Periodic review
The Secretary, not less often than every 5 years, shall review the relative values established under this paragraph for all physicians' services.
(ii) Adjustments
(I) In general
The Secretary shall, to the extent the Secretary determines to be necessary and subject to subclause (II) and paragraph (7), adjust the number of such units to take into account changes in medical practice, coding changes, new data on relative value components, or the addition of new procedures. The Secretary shall publish an explanation of the basis for such adjustments.
(II) Limitation on annual adjustments
Subject to clauses (iv) and (v), the adjustments under subclause (I) for a year may not cause the amount of expenditures under this part for the year to differ by more than $20,000,000 from the amount of expenditures under this part that would have been made if such adjustments had not been made.
(iii) Consultation
The Secretary, in making adjustments under clause (ii), shall consult with the Medicare Payment Advisory Commission and organizations representing physicians.
(iv) Exemption of certain additional expenditures from budget neutrality
The additional expenditures attributable to—
(I) subparagraph (H) shall not be taken into account in applying clause (ii)(II) for 2004;
(II) subparagraph (I) insofar as it relates to a physician fee schedule for 2005 or 2006 shall not be taken into account in applying clause (ii)(II) for drug administration services under the fee schedule for such year for a specialty described in subparagraph (I)(ii)(II);
(III) subparagraph (J) insofar as it relates to a physician fee schedule for 2005 or 2006 shall not be taken into account in applying clause (ii)(II) for drug administration services under the fee schedule for such year;
(IV) subsection (b)(6) shall not be taken into account in applying clause (ii)(II) for 2010, 2011, or the first 2 months of 2012;
(V) subsection (t) shall not be taken into account in applying clause (ii)(II) for 2021, 2022, 2023, or 2024; and
(VI) subsection (b)(12) shall not be taken into account in applying clause (ii)(II) for 2024.
(v) Exemption of certain reduced expenditures from budget-neutrality calculation
The following reduced expenditures, as estimated by the Secretary, shall not be taken into account in applying clause (ii)(II):
(I) Reduced payment for multiple imaging procedures
Effective for fee schedules established beginning with 2007, reduced expenditures attributable to the multiple procedure payment reduction for imaging under the final rule published by the Secretary in the Federal Register on November 21, 2005 (42 CFR 405, et al.) insofar as it relates to the physician fee schedules for 2006 and 2007.
(II) OPD payment cap for imaging services
Effective for fee schedules established beginning with 2007, reduced expenditures attributable to subsection (b)(4).
(III) Change in utilization rate for certain imaging services
Effective for fee schedules established beginning with 2011, reduced expenditures attributable to the changes in the utilization rate applicable to 2011 and 2014, as described in the first and second sentence, respectively, of subsection (b)(4)(C).
(IV), (V) Repealed. Pub. L. 111–152, title I, §1107(2), Mar. 30, 2010, 124 Stat. 1050
(VI) Additional reduced payment for multiple imaging procedures
Effective for fee schedules established beginning with 2010 (but not applied for services furnished prior to July 1, 2010), reduced expenditures attributable to the increase in the multiple procedure payment reduction from 25 to 50 percent (as described in subsection (b)(4)(D)).
(VII) Reduced expenditures for multiple therapy services
Effective for fee schedules established beginning with 2011, reduced expenditures attributable to the multiple procedure payment reduction for therapy services (as described in subsection (b)(7)).
(VIII) Reduced expenditures attributable to application of quality incentives for computed tomography
Effective for fee schedules established beginning with 2016, reduced expenditures attributable to the application of the quality incentives for computed tomography under
(IX) Reductions for misvalued services if target not met
Effective for fee schedules beginning with 2016, reduced expenditures attributable to the application of the target recapture amount described in subparagraph (O)(iii).
(X) Reduced expenditures attributable to incentives to transition to digital radiography
Effective for fee schedules established beginning with 2017, reduced expenditures attributable to subparagraph (A) of subsection (b)(9) and effective for fee schedules established beginning with 2018, reduced expenditures attributable to subparagraph (B) of such subsection.
(XI) Discount in payment for professional component of imaging services
Effective for fee schedules established beginning with 2017, reduced expenditures attributable to subsection (b)(10).
(vi) Alternative application of budget-neutrality adjustment
Notwithstanding subsection (d)(9)(A), effective for fee schedules established beginning with 2009, with respect to the 5-year review of work relative value units used in fee schedules for 2007 and 2008, in lieu of continuing to apply budget-neutrality adjustments required under clause (ii) for 2007 and 2008 to work relative value units, the Secretary shall apply such budget-neutrality adjustments to the conversion factor otherwise determined for years beginning with 2009.
(C) Computation of relative value units for components
For purposes of this section for each physicians' service—
(i) Work relative value units
The Secretary shall determine a number of work relative value units for the service or group of services based on the relative resources incorporating physician time and intensity required in furnishing the service or group of services.
(ii) Practice expense relative value units
The Secretary shall determine a number of practice expense relative value units for the service for years before 1999 equal to the product of—
(I) the base allowed charges (as defined in subparagraph (D)) for the service, and
(II) the practice expense percentage for the service (as determined under paragraph (3)(C)(ii)),
and for years beginning with 1999 based on the relative practice expense resources involved in furnishing the service or group of services. For 1999, such number of units shall be determined based 75 percent on such product and based 25 percent on the relative practice expense resources involved in furnishing the service. For 2000, such number of units shall be determined based 50 percent on such product and based 50 percent on such relative practice expense resources. For 2001, such number of units shall be determined based 25 percent on such product and based 75 percent on such relative practice expense resources. For a subsequent year, such number of units shall be determined based entirely on such relative practice expense resources.
(iii) Malpractice relative value units
The Secretary shall determine a number of malpractice relative value units for the service or group of services for years before 2000 equal to the product of—
(I) the base allowed charges (as defined in subparagraph (D)) for the service or group of services, and
(II) the malpractice percentage for the service or group of services (as determined under paragraph (3)(C)(iii)),
and for years beginning with 2000 based on the malpractice expense resources involved in furnishing the service or group of services.
(D) "Base allowed charges" defined
In this paragraph, the term "base allowed charges" means, with respect to a physician's service, the national average allowed charges for the service under this part for services furnished during 1991, as estimated by the Secretary using the most recent data available.
(E) Reduction in practice expense relative value units for certain services
(i) In general
Subject to clause (ii), the Secretary shall reduce the practice expense relative value units applied to services described in clause (iii) furnished in—
(I) 1994, by 25 percent of the number by which the number of practice expense relative value units (determined for 1994 without regard to this subparagraph) exceeds the number of work relative value units determined for 1994,
(II) 1995, by an additional 25 percent of such excess, and
(III) 1996, by an additional 25 percent of such excess.
(ii) Floor on reductions
The practice expense relative value units for a physician's service shall not be reduced under this subparagraph to a number less than 128 percent of the number of work relative value units.
(iii) Services covered
For purposes of clause (i), the services described in this clause are physicians' services that are not described in clause (iv) and for which—
(I) there are work relative value units, and
(II) the number of practice expense relative value units (determined for 1994) exceeds 128 percent of the number of work relative value units (determined for such year).
(iv) Excluded services
For purposes of clause (iii), the services described in this clause are services which the Secretary determines at least 75 percent of which are provided under this subchapter in an office setting.
(F) Budget neutrality adjustments
The Secretary—
(i) shall reduce the relative values for all services (other than anesthesia services) established under this paragraph (and, in the case of anesthesia services, the conversion factor established by the Secretary for such services) by such percentage as the Secretary determines to be necessary so that, beginning in 1996, the amendment made by section 13514(a) of the Omnibus Budget Reconciliation Act of 1993 would not result in expenditures under this section that exceed the amount of such expenditures that would have been made if such amendment had not been made, and
(ii) shall reduce the amounts determined under subsection (a)(2)(B)(ii)(I) by such percentage as the Secretary determines to be required to assure that, taking into account the reductions made under clause (i), the amendment made by section 13514(a) of the Omnibus Budget Reconciliation Act of 1993 would not result in expenditures under this section in 1994 that exceed the amount of such expenditures that would have been made if such amendment had not been made.
(G) Adjustments in relative value units for 1998
(i) In general
The Secretary shall—
(I) subject to clauses (iv) and (v), reduce the practice expense relative value units applied to any services described in clause (ii) furnished in 1998 to a number equal to 110 percent of the number of work relative value units, and
(II) increase the practice expense relative value units for office visit procedure codes during 1998 by a uniform percentage which the Secretary estimates will result in an aggregate increase in payments for such services equal to the aggregate decrease in payments by reason of subclause (I).
(ii) Services covered
For purposes of clause (i), the services described in this clause are physicians' services that are not described in clause (iii) and for which—
(I) there are work relative value units, and
(II) the number of practice expense relative value units (determined for 1998) exceeds 110 percent of the number of work relative value units (determined for such year).
(iii) Excluded services
For purposes of clause (ii), the services described in this clause are services which the Secretary determines at least 75 percent of which are provided under this subchapter in an office setting.
(iv) Limitation on aggregate reallocation
If the application of clause (i)(I) would result in an aggregate amount of reductions under such clause in excess of $390,000,000, such clause shall be applied by substituting for 110 percent such greater percentage as the Secretary estimates will result in the aggregate amount of such reductions equaling $390,000,000.
(v) No reduction for certain services
Practice expense relative value units for a procedure performed in an office or in a setting out of an office shall not be reduced under clause (i) if the in-office or out-of-office practice expense relative value, respectively, for the procedure would increase under the proposed rule on resource-based practice expenses issued by the Secretary on June 18, 1997 (62 Federal Register 33158 et seq.).
(H) Adjustments in practice expense relative value units for certain drug administration services beginning in 2004
(i) Use of survey data
In establishing the physician fee schedule under subsection (b) with respect to payments for services furnished on or after January 1, 2004, the Secretary shall, in determining practice expense relative value units under this subsection, utilize a survey submitted to the Secretary as of January 1, 2003, by a physician specialty organization pursuant to section 212 of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999 if the survey—
(I) covers practice expenses for oncology drug administration services; and
(II) meets criteria established by the Secretary for acceptance of such surveys.
(ii) Pricing of clinical oncology nurses in practice expense methodology
If the survey described in clause (i) includes data on wages, salaries, and compensation of clinical oncology nurses, the Secretary shall utilize such data in the methodology for determining practice expense relative value units under subsection (c).
(iii) Work relative value units for certain drug administration services
In establishing the relative value units under this paragraph for drug administration services described in clause (iv) furnished on or after January 1, 2004, the Secretary shall establish work relative value units equal to the work relative value units for a level 1 office medical visit for an established patient.
(iv) Drug administration services described
The drug administration services described in this clause are physicians' services—
(I) which are classified as of October 1, 2003, within any of the following groups of procedures: therapeutic or diagnostic infusions (excluding chemotherapy); chemotherapy administration services; and therapeutic, prophylactic, or diagnostic injections;
(II) for which there are no work relative value units assigned under this subsection as of such date; and
(III) for which national relative value units have been assigned under this subsection as of such date.
(I) Adjustments in practice expense relative value units for certain drug administration services beginning with 2005
(i) In general
In establishing the physician fee schedule under subsection (b) with respect to payments for services furnished on or after January 1, 2005 or 2006, the Secretary shall adjust the practice expense relative value units for such year consistent with clause (ii).
(ii) Use of supplemental survey data
(I) In general
Subject to subclause (II), if a specialty submits to the Secretary by not later than March 1, 2004, for 2005, or March 1, 2005, for 2006, data that includes expenses for the administration of drugs and biologicals for which the payment amount is determined pursuant to
(II) Limitation on specialty
Subclause (I) shall apply to a specialty only insofar as not less than 40 percent of payments for the specialty under this subchapter in 2002 are attributable to the administration of drugs and biologicals, as determined by the Secretary.
(III) Application
This clause shall not apply with respect to a survey to which subparagraph (H)(i) applies.
(J) Provisions for appropriate reporting and billing for physicians' services associated with the administration of covered outpatient drugs and biologicals
(i) Evaluation of codes
The Secretary shall promptly evaluate existing drug administration codes for physicians' services to ensure accurate reporting and billing for such services, taking into account levels of complexity of the administration and resource consumption.
(ii) Use of existing processes
In carrying out clause (i), the Secretary shall use existing processes for the consideration of coding changes and, to the extent coding changes are made, shall use such processes in establishing relative values for such services.
(iii) Implementation
In carrying out clause (i), the Secretary shall consult with representatives of physician specialties affected by the implementation of
(iv) Subsequent, budget neutral adjustments permitted
Nothing in subparagraph (H) or (I) or this subparagraph shall be construed as preventing the Secretary from providing for adjustments in practice expense relative value units under (and consistent with) subparagraph (B) for years after 2004, 2005, or 2006, respectively.
(K) Potentially misvalued codes
(i) In general
The Secretary shall—
(I) periodically identify services as being potentially misvalued using criteria specified in clause (ii); and
(II) review and make appropriate adjustments to the relative values established under this paragraph for services identified as being potentially misvalued under subclause (I).
(ii) Identification of potentially misvalued codes
For purposes of identifying potentially misvalued codes pursuant to clause (i)(I), the Secretary shall examine codes (and families of codes as appropriate) based on any or all of the following criteria:
(I) Codes that have experienced the fastest growth.
(II) Codes that have experienced substantial changes in practice expenses.
(III) Codes that describe new technologies or services within an appropriate time period (such as 3 years) after the relative values are initially established for such codes.
(IV) Codes which are multiple codes that are frequently billed in conjunction with furnishing a single service.
(V) Codes with low relative values, particularly those that are often billed multiple times for a single treatment.
(VI) Codes that have not been subject to review since implementation of the fee schedule.
(VII) Codes that account for the majority of spending under the physician fee schedule.
(VIII) Codes for services that have experienced a substantial change in the hospital length of stay or procedure time.
(IX) Codes for which there may be a change in the typical site of service since the code was last valued.
(X) Codes for which there is a significant difference in payment for the same service between different sites of service.
(XI) Codes for which there may be anomalies in relative values within a family of codes.
(XII) Codes for services where there may be efficiencies when a service is furnished at the same time as other services.
(XIII) Codes with high intra-service work per unit of time.
(XIV) Codes with high practice expense relative value units.
(XV) Codes with high cost supplies.
(XVI) Codes as determined appropriate by the Secretary.
(iii) Review and adjustments
(I) The Secretary may use existing processes to receive recommendations on the review and appropriate adjustment of potentially misvalued services described in clause (i)(II).
(II) The Secretary may conduct surveys, other data collection activities, studies, or other analyses as the Secretary determines to be appropriate to facilitate the review and appropriate adjustment described in clause (i)(II).
(III) The Secretary may use analytic contractors to identify and analyze services identified under clause (i)(I), conduct surveys or collect data, and make recommendations on the review and appropriate adjustment of services described in clause (i)(II).
(IV) The Secretary may coordinate the review and appropriate adjustment described in clause (i)(II) with the periodic review described in subparagraph (B).
(V) As part of the review and adjustment described in clause (i)(II), including with respect to codes with low relative values described in clause (ii), the Secretary may make appropriate coding revisions (including using existing processes for consideration of coding changes) which may include consolidation of individual services into bundled codes for payment under the fee schedule under subsection (b).
(VI) The provisions of subparagraph (B)(ii)(II) and paragraph (7) shall apply to adjustments to relative value units made pursuant to this subparagraph in the same manner as such provisions apply to adjustments under subparagraph (B)(ii)(I).
(iv) Treatment of certain radiation therapy services
Radiation treatment delivery and related imaging services identified under subsection (b)(11) shall not be considered as potentially misvalued services for purposes of this subparagraph and subparagraph (O) for 2017, 2018, and 2019.
(L) Validating relative value units
(i) In general
The Secretary shall establish a process to validate relative value units under the fee schedule under subsection (b).
(ii) Components and elements of work
The process described in clause (i) may include validation of work elements (such as time, mental effort and professional judgment, technical skill and physical effort, and stress due to risk) involved with furnishing a service and may include validation of the pre-, post-, and intra-service components of work.
(iii) Scope of codes
The validation of work relative value units shall include a sampling of codes for services that is the same as the codes listed under subparagraph (K)(ii).
(iv) Methods
The Secretary may conduct the validation under this subparagraph using methods described in subclauses (I) through (V) of subparagraph (K)(iii) as the Secretary determines to be appropriate.
(v) Adjustments
The Secretary shall make appropriate adjustments to the work relative value units under the fee schedule under subsection (b). The provisions of subparagraph (B)(ii)(II) shall apply to adjustments to relative value units made pursuant to this subparagraph in the same manner as such provisions apply to adjustments under subparagraph (B)(ii)(II).
(M) Authority to collect and use information on physicians' services in the determination of relative values
(i) Collection of information
Notwithstanding any other provision of law, the Secretary may collect or obtain information on the resources directly or indirectly related to furnishing services for which payment is made under the fee schedule established under subsection (b). Such information may be collected or obtained from any eligible professional or any other source.
(ii) Use of information
Notwithstanding any other provision of law, subject to clause (v), the Secretary may (as the Secretary determines appropriate) use information collected or obtained pursuant to clause (i) in the determination of relative values for services under this section.
(iii) Types of information
The types of information described in clauses (i) and (ii) may, at the Secretary's discretion, include any or all of the following:
(I) Time involved in furnishing services.
(II) Amounts and types of practice expense inputs involved with furnishing services.
(III) Prices (net of any discounts) for practice expense inputs, which may include paid invoice prices or other documentation or records.
(IV) Overhead and accounting information for practices of physicians and other suppliers.
(V) Any other element that would improve the valuation of services under this section.
(iv) Information collection mechanisms
Information may be collected or obtained pursuant to this subparagraph from any or all of the following:
(I) Surveys of physicians, other suppliers, providers of services, manufacturers, and vendors.
(II) Surgical logs, billing systems, or other practice or facility records.
(III) Electronic health records.
(IV) Any other mechanism determined appropriate by the Secretary.
(v) Transparency of use of information
(I) In general
Subject to subclauses (II) and (III), if the Secretary uses information collected or obtained under this subparagraph in the determination of relative values under this subsection, the Secretary shall disclose the information source and discuss the use of such information in such determination of relative values through notice and comment rulemaking.
(II) Thresholds for use
The Secretary may establish thresholds in order to use such information, including the exclusion of information collected or obtained from eligible professionals who use very high resources (as determined by the Secretary) in furnishing a service.
(III) Disclosure of information
The Secretary shall make aggregate information available under this subparagraph but shall not disclose information in a form or manner that identifies an eligible professional or a group practice, or information collected or obtained pursuant to a nondisclosure agreement.
(vi) Incentive to participate
The Secretary may provide for such payments under this part to an eligible professional that submits such solicited information under this subparagraph as the Secretary determines appropriate in order to compensate such eligible professional for such submission. Such payments shall be provided in a form and manner specified by the Secretary.
(vii) Administration
(viii) Definition of eligible professional
In this subparagraph, the term "eligible professional" has the meaning given such term in subsection (k)(3)(B).
(ix) Funding
For purposes of carrying out this subparagraph, in addition to funds otherwise appropriated, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under
(N) Authority for alternative approaches to establishing practice expense relative values
The Secretary may establish or adjust practice expense relative values under this subsection using cost, charge, or other data from suppliers or providers of services, including information collected or obtained under subparagraph (M).
(O) Target for relative value adjustments for misvalued services
With respect to fee schedules established for each of 2016 through 2018, the following shall apply:
(i) Determination of net reduction in expenditures
For each year, the Secretary shall determine the estimated net reduction in expenditures under the fee schedule under this section with respect to the year as a result of adjustments to the relative values established under this paragraph for misvalued codes.
(ii) Budget neutral redistribution of funds if target met and counting overages towards the target for the succeeding year
If the estimated net reduction in expenditures determined under clause (i) for the year is equal to or greater than the target for the year—
(I) reduced expenditures attributable to such adjustments shall be redistributed for the year in a budget neutral manner in accordance with subparagraph (B)(ii)(II); and
(II) the amount by which such reduced expenditures exceeds the target for the year shall be treated as a reduction in expenditures described in clause (i) for the succeeding year, for purposes of determining whether the target has or has not been met under this subparagraph with respect to that year.
(iii) Exemption from budget neutrality if target not met
If the estimated net reduction in expenditures determined under clause (i) for the year is less than the target for the year, reduced expenditures in an amount equal to the target recapture amount shall not be taken into account in applying subparagraph (B)(ii)(II) with respect to fee schedules beginning with 2016.
(iv) Target recapture amount
For purposes of clause (iii), the target recapture amount is, with respect to a year, an amount equal to the difference between—
(I) the target for the year; and
(II) the estimated net reduction in expenditures determined under clause (i) for the year.
(v) Target
For purposes of this subparagraph, with respect to a year, the target is calculated as 0.5 percent (or, for 2016, 1.0 percent) of the estimated amount of expenditures under the fee schedule under this section for the year.
(3) Component percentages
For purposes of paragraph (2), the Secretary shall determine a work percentage, a practice expense percentage, and a malpractice percentage for each physician's service as follows:
(A) Division of services by specialty
For each physician's service or class of physicians' services, the Secretary shall determine the average percentage of each such service or class of services that is performed, nationwide, under this part by physicians in each of the different physician specialties (as identified by the Secretary).
(B) Division of specialty by component
The Secretary shall determine the average percentage division of resources, among the work component, the practice expense component, and the malpractice component, used by physicians in each of such specialties in furnishing physicians' services. Such percentages shall be based on national data that describe the elements of physician practice costs and revenues, by physician specialty. The Secretary may use extrapolation and other techniques to determine practice costs and revenues for specialties for which adequate data are not available.
(C) Determination of component percentages
(i) Work percentage
The work percentage for a service (or class of services) is equal to the sum (for all physician specialties) of—
(I) the average percentage division for the work component for each physician specialty (determined under subparagraph (B)), multiplied by
(II) the proportion (determined under subparagraph (A)) of such service (or services) performed by physicians in that specialty.
(ii) Practice expense percentage
For years before 2002, the practice expense percentage for a service (or class of services) is equal to the sum (for all physician specialties) of—
(I) the average percentage division for the practice expense component for each physician specialty (determined under subparagraph (B)), multiplied by
(II) the proportion (determined under subparagraph (A)) of such service (or services) performed by physicians in that specialty.
(iii) Malpractice percentage
For years before 1999, the malpractice percentage for a service (or class of services) is equal to the sum (for all physician specialties) of—
(I) the average percentage division for the malpractice component for each physician specialty (determined under subparagraph (B)), multiplied by
(II) the proportion (determined under subparagraph (A)) of such service (or services) performed by physicians in that specialty.
(D) Periodic recomputation
The Secretary may, from time to time, provide for the recomputation of work percentages, practice expense percentages, and malpractice percentages determined under this paragraph.
(4) Ancillary policies
The Secretary may establish ancillary policies (with respect to the use of modifiers, local codes, and other matters) as may be necessary to implement this section.
(5) Coding
The Secretary shall establish a uniform procedure coding system for the coding of all physicians' services. The Secretary shall provide for an appropriate coding structure for visits and consultations. The Secretary may incorporate the use of time in the coding for visits and consultations. The Secretary, in establishing such coding system, shall consult with the Physician Payment Review Commission and other organizations representing physicians.
(6) No variation for specialists
The Secretary may not vary the conversion factor or the number of relative value units for a physicians' service based on whether the physician furnishing the service is a specialist or based on the type of specialty of the physician.
(7) Phase-in of significant relative value unit (RVU) reductions
Effective for fee schedules established beginning with 2016, for services that are not new or revised codes, if the total relative value units for a service for a year would otherwise be decreased by an estimated amount equal to or greater than 20 percent as compared to the total relative value units for the previous year, the applicable adjustments in work, practice expense, and malpractice relative value units shall be phased-in over a 2-year period.
(8) Global surgical packages
(A) Prohibition of implementation of rule regarding global surgical packages
(i) In general
The Secretary shall not implement the policy established in the final rule published on November 13, 2014 (79 Fed. Reg. 67548 et seq.), that requires the transition of all 10-day and 90-day global surgery packages to 0-day global periods.
(ii) Construction
Nothing in clause (i) shall be construed to prevent the Secretary from revaluing misvalued codes for specific surgical services or assigning values to new or revised codes for surgical services.
(B) Collection of data on services included in global surgical packages
(i) In general
Subject to clause (ii), the Secretary shall through rulemaking develop and implement a process to gather, from a representative sample of physicians, beginning not later than January 1, 2017, information needed to value surgical services. Such information shall include the number and level of medical visits furnished during the global period and other items and services related to the surgery and furnished during the global period, as appropriate. Such information shall be reported on claims at the end of the global period or in another manner specified by the Secretary. For purposes of carrying out this paragraph (other than clause (iii)), the Secretary shall transfer from the Federal Supplemental Medical Insurance Trust Fund under
(ii) Reassessment and potential sunset
Every 4 years, the Secretary shall reassess the value of the information collected pursuant to clause (i). Based on such a reassessment and by regulation, the Secretary may discontinue the requirement for collection of information under such clause if the Secretary determines that the Secretary has adequate information from other sources, such as qualified clinical data registries, surgical logs, billing systems or other practice or facility records, and electronic health records, in order to accurately value global surgical services under this section.
(iii) Inspector general audit
The Inspector General of the Department of Health and Human Services shall audit a sample of the information reported under clause (i) to verify the accuracy of the information so reported.
(C) Improving accuracy of pricing for surgical services
For years beginning with 2019, the Secretary shall use the information reported under subparagraph (B)(i) as appropriate and other available data for the purpose of improving the accuracy of valuation of surgical services under the physician fee schedule under this section.
(d) Conversion factors
(1) Establishment
(A) In general
The conversion factor for each year shall be the conversion factor established under this subsection for the previous year (or, in the case of 1992, specified in subparagraph (B)) adjusted by the update (established under paragraph (3)) for the year involved (for years before 2001) and, for years beginning with 2001 and ending with 2025, multiplied by the update (established under paragraph (4) or a subsequent paragraph) for the year involved. There shall be two separate conversion factors for each year beginning with 2026, one for items and services furnished by a qualifying APM participant (as defined in
(B) Special provision for 1992
For purposes of subparagraph (A), the conversion factor specified in this subparagraph is a conversion factor (determined by the Secretary) which, if this section were to apply during 1991 using such conversion factor, would result in the same aggregate amount of payments under this part for physicians' services as the estimated aggregate amount of the payments under this part for such services in 1991.
(C) Special rules for 1998
Except as provided in subparagraph (D), the single conversion factor for 1998 under this subsection shall be the conversion factor for primary care services for 1997, increased by the Secretary's estimate of the weighted average of the three separate updates that would otherwise occur were it not for the enactment of
(D) Special rules for anesthesia services
The separate conversion factor for anesthesia services for a year shall be equal to 46 percent of the single conversion factor (or, beginning with 2026, applicable conversion factor) established for other physicians' services, except as adjusted for changes in work, practice expense, or malpractice relative value units.
(E) Publication and dissemination of information
The Secretary shall—
(i) cause to have published in the Federal Register not later than November 1 of each year (beginning with 2000) the conversion factor which will apply to physicians' services for the succeeding year, the update determined under paragraph (4) for such succeeding year, and the allowed expenditures under such paragraph for such succeeding year; and
(ii) make available to the Medicare Payment Advisory Commission and the public by March 1 of each year (beginning with 2000) an estimate of the sustainable growth rate and of the conversion factor which will apply to physicians' services for the succeeding year and data used in making such estimate.
(2) Repealed. Pub. L. 105–33, title IV, §4502(b), Aug. 5, 1997, 111 Stat. 433
(3) Update for 1999 and 2000
(A) In general
Unless otherwise provided by law, subject to subparagraph (D) and the budget-neutrality factor determined by the Secretary under subsection (c)(2)(B)(ii), the update to the single conversion factor established in paragraph (1)(C) for 1999 and 2000 is equal to the product of—
(i) 1 plus the Secretary's estimate of the percentage increase in the MEI (as defined in
(ii) 1 plus the Secretary's estimate of the update adjustment factor for the year (divided by 100),
minus 1 and multiplied by 100.
(B) Update adjustment factor
For purposes of subparagraph (A)(ii), the "update adjustment factor" for a year is equal (as estimated by the Secretary) to—
(i) the difference between (I) the sum of the allowed expenditures for physicians' services (as determined under subparagraph (C)) for the period beginning April 1, 1997, and ending on March 31 of the year involved, and (II) the amount of actual expenditures for physicians' services furnished during the period beginning April 1, 1997, and ending on March 31 of the preceding year; divided by
(ii) the actual expenditures for physicians' services for the 12-month period ending on March 31 of the preceding year, increased by the sustainable growth rate under subsection (f) for the fiscal year which begins during such 12-month period.
(C) Determination of allowed expenditures
For purposes of this paragraph and paragraph (4), the allowed expenditures for physicians' services for the 12-month period ending with March 31 of—
(i) 1997 is equal to the actual expenditures for physicians' services furnished during such 12-month period, as estimated by the Secretary; or
(ii) a subsequent year is equal to the allowed expenditures for physicians' services for the previous year, increased by the sustainable growth rate under subsection (f) for the fiscal year which begins during such 12-month period.
(D) Restriction on variation from medicare economic index
Notwithstanding the amount of the update adjustment factor determined under subparagraph (B) for a year, the update in the conversion factor under this paragraph for the year may not be—
(i) greater than 100 times the following amount: (1.03 + (MEI percentage/100)) −1; or
(ii) less than 100 times the following amount: (0.93 + (MEI percentage/100)) −1,
where "MEI percentage" means the Secretary's estimate of the percentage increase in the MEI (as defined in
(4) Update for years beginning with 2001 and ending with 2014
(A) In general
Unless otherwise provided by law, subject to the budget-neutrality factor determined by the Secretary under subsection (c)(2)(B)(ii) and subject to adjustment under subparagraph (F), the update to the single conversion factor established in paragraph (1)(C) for a year beginning with 2001 and ending with 2014 is equal to the product of—
(i) 1 plus the Secretary's estimate of the percentage increase in the MEI (as defined in
(ii) 1 plus the Secretary's estimate of the update adjustment factor under subparagraph (B) for the year.
(B) Update adjustment factor
For purposes of subparagraph (A)(ii), subject to subparagraph (D) and the succeeding paragraphs of this subsection, the "update adjustment factor" for a year is equal (as estimated by the Secretary) to the sum of the following:
(i) Prior year adjustment component
An amount determined by—
(I) computing the difference (which may be positive or negative) between the amount of the allowed expenditures for physicians' services for the prior year (as determined under subparagraph (C)) and the amount of the actual expenditures for such services for that year;
(II) dividing that difference by the amount of the actual expenditures for such services for that year; and
(III) multiplying that quotient by 0.75.
(ii) Cumulative adjustment component
An amount determined by—
(I) computing the difference (which may be positive or negative) between the amount of the allowed expenditures for physicians' services (as determined under subparagraph (C)) from April 1, 1996, through the end of the prior year and the amount of the actual expenditures for such services during that period;
(II) dividing that difference by actual expenditures for such services for the prior year as increased by the sustainable growth rate under subsection (f) for the year for which the update adjustment factor is to be determined; and
(III) multiplying that quotient by 0.33.
(C) Determination of allowed expenditures
For purposes of this paragraph:
(i) Period up to April 1, 1999
The allowed expenditures for physicians' services for a period before April 1, 1999, shall be the amount of the allowed expenditures for such period as determined under paragraph (3)(C).
(ii) Transition to calendar year allowed expenditures
Subject to subparagraph (E), the allowed expenditures for—
(I) the 9-month period beginning April 1, 1999, shall be the Secretary's estimate of the amount of the allowed expenditures that would be permitted under paragraph (3)(C) for such period; and
(II) the year of 1999, shall be the Secretary's estimate of the amount of the allowed expenditures that would be permitted under paragraph (3)(C) for such year.
(iii) Years beginning with 2000
The allowed expenditures for a year (beginning with 2000) is equal to the allowed expenditures for physicians' services for the previous year, increased by the sustainable growth rate under subsection (f) for the year involved.
(D) Restriction on update adjustment factor
The update adjustment factor determined under subparagraph (B) for a year may not be less than −0.07 or greater than 0.03.
(E) Recalculation of allowed expenditures for updates beginning with 2001
For purposes of determining the update adjustment factor for a year beginning with 2001, the Secretary shall recompute the allowed expenditures for previous periods beginning on or after April 1, 1999, consistent with subsection (f)(3).
(F) Transitional adjustment designed to provide for budget neutrality
Under this subparagraph the Secretary shall provide for an adjustment to the update under subparagraph (A)—
(i) for each of 2001, 2002, 2003, and 2004, of −0.2 percent; and
(ii) for 2005 of +0.8 percent.
(5) Update for 2004 and 2005
The update to the single conversion factor established in paragraph (1)(C) for each of 2004 and 2005 shall be not less than 1.5 percent.
(6) Update for 2006
The update to the single conversion factor established in paragraph (1)(C) for 2006 shall be 0 percent.
(7) Conversion factor for 2007
(A) In general
The conversion factor that would otherwise be applicable under this subsection for 2007 shall be the amount of such conversion factor divided by the product of—
(i) 1 plus the Secretary's estimate of the percentage increase in the MEI (as defined in
(ii) 1 plus the Secretary's estimate of the update adjustment factor under paragraph (4)(B) for 2007.
(B) No effect on computation of conversion factor for 2008
The conversion factor under this subsection shall be computed under paragraph (1)(A) for 2008 as if subparagraph (A) had never applied.
(8) Update for 2008
(A) In general
Subject to paragraph (7)(B), in lieu of the update to the single conversion factor established in paragraph (1)(C) that would otherwise apply for 2008, the update to the single conversion factor shall be 0.5 percent.
(B) No effect on computation of conversion factor for 2009
The conversion factor under this subsection shall be computed under paragraph (1)(A) for 2009 and subsequent years as if subparagraph (A) had never applied.
(9) Update for 2009
(A) In general
Subject to paragraphs (7)(B) and (8)(B), in lieu of the update to the single conversion factor established in paragraph (1)(C) that would otherwise apply for 2009, the update to the single conversion factor shall be 1.1 percent.
(B) No effect on computation of conversion factor for 2010 and subsequent years
The conversion factor under this subsection shall be computed under paragraph (1)(A) for 2010 and subsequent years as if subparagraph (A) had never applied.
(10) Update for January through May of 2010
(A) In general
Subject to paragraphs (7)(B), (8)(B), and (9)(B), in lieu of the update to the single conversion factor established in paragraph (1)(C) that would otherwise apply for 2010 for the period beginning on January 1, 2010, and ending on May 31, 2010, the update to the single conversion factor shall be 0 percent for 2010.
(B) No effect on computation of conversion factor for remaining portion of 2010 and subsequent years
The conversion factor under this subsection shall be computed under paragraph (1)(A) for the period beginning on June 1, 2010, and ending on December 31, 2010, and for 2011 and subsequent years as if subparagraph (A) had never applied.
(11) Update for June through December of 2010
(A) In general
Subject to paragraphs (7)(B), (8)(B), (9)(B), and (10)(B), in lieu of the update to the single conversion factor established in paragraph (1)(C) that would otherwise apply for 2010 for the period beginning on June 1, 2010, and ending on December 31, 2010, the update to the single conversion factor shall be 2.2 percent.
(B) No effect on computation of conversion factor for 2011 and subsequent years
The conversion factor under this subsection shall be computed under paragraph (1)(A) for 2011 and subsequent years as if subparagraph (A) had never applied.
(12) Update for 2011
(A) In general
Subject to paragraphs (7)(B), (8)(B), (9)(B), (10)(B), and (11)(B), in lieu of the update to the single conversion factor established in paragraph (1)(C) that would otherwise apply for 2011, the update to the single conversion factor shall be 0 percent.
(B) No effect on computation of conversion factor for 2012 and subsequent years
The conversion factor under this subsection shall be computed under paragraph (1)(A) for 2012 and subsequent years as if subparagraph (A) had never applied.
(13) Update for 2012
(A) In general
Subject to paragraphs (7)(B), (8)(B), (9)(B), (10)(B), (11)(B), and (12)(B), in lieu of the update to the single conversion factor established in paragraph (1)(C) that would otherwise apply for 2012, the update to the single conversion factor shall be zero percent.
(B) No effect on computation of conversion factor for 2013 and subsequent years
The conversion factor under this subsection shall be computed under paragraph (1)(A) for 2013 and subsequent years as if subparagraph (A) had never applied.
(14) Update for 2013
(A) In general
Subject to paragraphs (7)(B), (8)(B), (9)(B), (10)(B), (11)(B), (12)(B), and (13)(B), in lieu of the update to the single conversion factor established in paragraph (1)(C) that would otherwise apply for 2013, the update to the single conversion factor for such year shall be zero percent.
(B) No effect on computation of conversion factor for 2014 and subsequent years
The conversion factor under this subsection shall be computed under paragraph (1)(A) for 2014 and subsequent years as if subparagraph (A) had never applied.
(15) Update for 2014
(A) In general
Subject to paragraphs (7)(B), (8)(B), (9)(B), (10)(B), (11)(B), (12)(B), (13)(B), and (14)(B), in lieu of the update to the single conversion factor established in paragraph (1)(C) that would otherwise apply for 2014, the update to the single conversion factor shall be 0.5 percent.
(B) No effect on computation of conversion factor for subsequent years
The conversion factor under this subsection shall be computed under paragraph (1)(A) for 2015 and subsequent years as if subparagraph (A) had never applied.
(16) Update for January through June of 2015
Subject to paragraphs (7)(B), (8)(B), (9)(B), (10)(B), (11)(B), (12)(B), (13)(B), (14)(B), and (15)(B), in lieu of the update to the single conversion factor established in paragraph (1)(C) that would otherwise apply for 2015 for the period beginning on January 1, 2015, and ending on June 30, 2015, the update to the single conversion factor shall be 0.0 percent.
(17) Update for July through December of 2015
The update to the single conversion factor established in paragraph (1)(C) for the period beginning on July 1, 2015, and ending on December 31, 2015, shall be 0.5 percent.
(18) Update for 2016 through 2019
The update to the single conversion factor established in paragraph (1)(C)—
(A) for 2016 and each subsequent year through 2018 shall be 0.5 percent; and
(B) for 2019 shall be 0.25 percent.
(19) Update for 2020 through 2025
The update to the single conversion factor established in paragraph (1)(C) for 2020 and each subsequent year through 2025 shall be 0.0 percent.
(20) Update for 2026 and subsequent years
For 2026 and each subsequent year, the update to the qualifying APM conversion factor established under paragraph (1)(A) is 0.75 percent, and the update to the nonqualifying APM conversion factor established under such paragraph is 0.25 percent.
(e) Geographic adjustment factors
(1) Establishment of geographic indices
(A) In general
Subject to subparagraphs (B), (C), (E), (G), (H), and (I), the Secretary shall establish—
(i) an index which reflects the relative costs of the mix of goods and services comprising practice expenses (other than malpractice expenses) in the different fee schedule areas compared to the national average of such costs,
(ii) an index which reflects the relative costs of malpractice expenses in the different fee schedule areas compared to the national average of such costs, and
(iii) an index which reflects ¼ of the difference between the relative value of physicians' work effort in each of the different fee schedule areas and the national average of such work effort.
(B) Class-specific geographic cost-of-practice indices
The Secretary may establish more than one index under subparagraph (A)(i) in the case of classes of physicians' services, if, because of differences in the mix of goods and services comprising practice expenses for the different classes of services, the application of a single index under such clause to different classes of such services would be substantially inequitable.
(C) Periodic review and adjustments in geographic adjustment factors
The Secretary, not less often than every 3 years, shall, in consultation with appropriate representatives of physicians, review the indices established under subparagraph (A) and the geographic index values applied under this subsection for all fee schedule areas. Based on such review, the Secretary may revise such index and adjust such index values, except that, if more than 1 year has elasped 2 since the date of the last previous adjustment, the adjustment to be applied in the first year of the next adjustment shall be ½ of the adjustment that otherwise would be made.
(D) Use of recent data
In establishing indices and index values under this paragraph, the Secretary shall use the most recent data available relating to practice expenses, malpractice expenses, and physician work effort in different fee schedule areas.
(E) Floor at 1.0 on work geographic index
After calculating the work geographic index in subparagraph (A)(iii), for purposes of payment for services furnished on or after January 1, 2004, and before October 1, 2025, the Secretary shall increase the work geographic index to 1.00 for any locality for which such work geographic index is less than 1.00.
(G) 3 Floor for practice expense, malpractice, and work geographic indices for services furnished in Alaska
For purposes of payment for services furnished in Alaska on or after January 1, 2004, and before January 1, 2006, after calculating the practice expense, malpractice, and work geographic indices in clauses (i), (ii), and (iii) of subparagraph (A) and in subparagraph (B), the Secretary shall increase any such index to 1.67 if such index would otherwise be less than 1.67. For purposes of payment for services furnished in the State described in the preceding sentence on or after January 1, 2009, after calculating the work geographic index in subparagraph (A)(iii), the Secretary shall increase the work geographic index to 1.5 if such index would otherwise be less than 1.5 1
(H) Practice expense geographic adjustment for 2010 and subsequent years
(i) For 2010
Subject to clause (iii), for services furnished during 2010, the employee wage and rent portions of the practice expense geographic index described in subparagraph (A)(i) shall reflect ½ of the difference between the relative costs of employee wages and rents in each of the different fee schedule areas and the national average of such employee wages and rents.
(ii) For 2011
Subject to clause (iii), for services furnished during 2011, the employee wage and rent portions of the practice expense geographic index described in subparagraph (A)(i) shall reflect ½ of the difference between the relative costs of employee wages and rents in each of the different fee schedule areas and the national average of such employee wages and rents.
(iii) Hold harmless
The practice expense portion of the geographic adjustment factor applied in a fee schedule area for services furnished in 2010 or 2011 shall not, as a result of the application of clause (i) or (ii), be reduced below the practice expense portion of the geographic adjustment factor under subparagraph (A)(i) (as calculated prior to the application of such clause (i) or (ii), respectively) for such area for such year.
(iv) Analysis
The Secretary shall analyze current methods of establishing practice expense geographic adjustments under subparagraph (A)(i) and evaluate data that fairly and reliably establishes distinctions in the costs of operating a medical practice in the different fee schedule areas. Such analysis shall include an evaluation of the following:
(I) The feasibility of using actual data or reliable survey data developed by medical organizations on the costs of operating a medical practice, including office rents and non-physician staff wages, in different fee schedule areas.
(II) The office expense portion of the practice expense geographic adjustment described in subparagraph (A)(i), including the extent to which types of office expenses are determined in local markets instead of national markets.
(III) The weights assigned to each of the categories within the practice expense geographic adjustment described in subparagraph (A)(i).
(v) Revision for 2012 and subsequent years
As a result of the analysis described in clause (iv), the Secretary shall, not later than January 1, 2012, make appropriate adjustments to the practice expense geographic adjustment described in subparagraph (A)(i) to ensure accurate geographic adjustments across fee schedule areas, including—
(I) basing the office rents component and its weight on office expenses that vary among fee schedule areas; and
(II) considering a representative range of professional and non-professional personnel employed in a medical office based on the use of the American Community Survey data or other reliable data for wage adjustments.
Such adjustments shall be made without regard to adjustments made pursuant to clauses (i) and (ii) and shall be made in a budget neutral manner.
(I) Floor for practice expense index for services furnished in frontier States
(i) In general
Subject to clause (ii), for purposes of payment for services furnished in a frontier State (as defined in
(ii) Limitation
This subparagraph shall not apply to services furnished in a State that receives a non-labor related share adjustment under
(2) Computation of geographic adjustment factor
For purposes of subsection (b)(1)(C), for all physicians' services for each fee schedule area the Secretary shall establish a geographic adjustment factor equal to the sum of the geographic cost-of-practice adjustment factor (specified in paragraph (3)), the geographic malpractice adjustment factor (specified in paragraph (4)), and the geographic physician work adjustment factor (specified in paragraph (5)) for the service and the area.
(3) Geographic cost-of-practice adjustment factor
For purposes of paragraph (2), the "geographic cost-of-practice adjustment factor", for a service for a fee schedule area, is the product of—
(A) the proportion of the total relative value for the service that reflects the relative value units for the practice expense component, and
(B) the geographic cost-of-practice index value for the area for the service, based on the index established under paragraph (1)(A)(i) or (1)(B) (as the case may be).
(4) Geographic malpractice adjustment factor
For purposes of paragraph (2), the "geographic malpractice adjustment factor", for a service for a fee schedule area, is the product of—
(A) the proportion of the total relative value for the service that reflects the relative value units for the malpractice component, and
(B) the geographic malpractice index value for the area, based on the index established under paragraph (1)(A)(ii).
(5) Geographic physician work adjustment factor
For purposes of paragraph (2), the "geographic physician work adjustment factor", for a service for a fee schedule area, is the product of—
(A) the proportion of the total relative value for the service that reflects the relative value units for the work component, and
(B) the geographic physician work index value for the area, based on the index established under paragraph (1)(A)(iii).
(6) Use of MSAs as fee schedule areas in California
(A) In general
Subject to the succeeding provisions of this paragraph and notwithstanding the previous provisions of this subsection, for services furnished on or after January 1, 2017, the fee schedule areas used for payment under this section applicable to California shall be the following:
(i) Each Metropolitan Statistical Area (each in this paragraph referred to as an "MSA"), as defined by the Director of the Office of Management and Budget as of December 31 of the previous year, shall be a fee schedule area.
(ii) All areas not included in an MSA shall be treated as a single rest-of-State fee schedule area.
(B) Transition for MSAs previously in rest-of-state payment locality or in locality 3
(i) In general
For services furnished in California during a year beginning with 2017 and ending with 2021 in an MSA in a transition area (as defined in subparagraph (D)), subject to subparagraph (C), the geographic index values to be applied under this subsection for such year shall be equal to the sum of the following:
(I) Current law component
The old weighting factor (described in clause (ii)) for such year multiplied by the geographic index values under this subsection for the fee schedule area that included such MSA that would have applied in such area (as estimated by the Secretary) if this paragraph did not apply.
(II) MSA-based component
The MSA-based weighting factor (described in clause (iii)) for such year multiplied by the geographic index values computed for the fee schedule area under subparagraph (A) for the year (determined without regard to this subparagraph).
(ii) Old weighting factor
The old weighting factor described in this clause—
(I) for 2017, is 5/6; and
(II) for each succeeding year, is the old weighting factor described in this clause for the previous year minus 1/6.
(iii) MSA-based weighting factor
The MSA-based weighting factor described in this clause for a year is 1 minus the old weighting factor under clause (ii) for that year.
(C) Hold harmless
For services furnished in a transition area in California during a year beginning with 2017, the geographic index values to be applied under this subsection for such year shall not be less than the corresponding geographic index values that would have applied in such transition area (as estimated by the Secretary) if this paragraph did not apply.
(D) Transition area defined
In this paragraph, the term "transition area" means each of the following fee schedule areas for 2013:
(i) The rest-of-State payment locality.
(ii) Payment locality 3.
(E) References to fee schedule areas
Effective for services furnished on or after January 1, 2017, for California, any reference in this section to a fee schedule area shall be deemed a reference to a fee schedule area established in accordance with this paragraph.
(f) Sustainable growth rate
(1) Publication
The Secretary shall cause to have published in the Federal Register not later than—
(A) November 1, 2000, the sustainable growth rate for 2000 and 2001; and
(B) November 1 of each succeeding year through 2014 the sustainable growth rate for such succeeding year and each of the preceding 2 years.
(2) Specification of growth rate
The sustainable growth rate for all physicians' services for a fiscal year (beginning with fiscal year 1998 and ending with fiscal year 2000) and a year beginning with 2000 and ending with 2014 shall be equal to the product of—
(A) 1 plus the Secretary's estimate of the weighted average percentage increase (divided by 100) in the fees for all physicians' services in the applicable period involved,
(B) 1 plus the Secretary's estimate of the percentage change (divided by 100) in the average number of individuals enrolled under this part (other than Medicare+Choice plan enrollees) from the previous applicable period to the applicable period involved,
(C) 1 plus the Secretary's estimate of the annual average percentage growth in real gross domestic product per capita (divided by 100) during the 10-year period ending with the applicable period involved, and
(D) 1 plus the Secretary's estimate of the percentage change (divided by 100) in expenditures for all physicians' services in the applicable period (compared with the previous applicable period) which will result from changes in law and regulations, determined without taking into account estimated changes in expenditures resulting from the update adjustment factor determined under subsection (d)(3)(B) or (d)(4)(B), as the case may be,
minus 1 and multiplied by 100.
(3) Data to be used
For purposes of determining the update adjustment factor under subsection (d)(4)(B) for a year beginning with 2001, the sustainable growth rates taken into consideration in the determination under paragraph (2) shall be determined as follows:
(A) For 2001
For purposes of such calculations for 2001, the sustainable growth rates for fiscal year 2000 and the years 2000 and 2001 shall be determined on the basis of the best data available to the Secretary as of September 1, 2000.
(B) For 2002
For purposes of such calculations for 2002, the sustainable growth rates for fiscal year 2000 and for years 2000, 2001, and 2002 shall be determined on the basis of the best data available to the Secretary as of September 1, 2001.
(C) For 2003 and succeeding years
For purposes of such calculations for a year after 2002—
(i) the sustainable growth rates for that year and the preceding 2 years shall be determined on the basis of the best data available to the Secretary as of September 1 of the year preceding the year for which the calculation is made; and
(ii) the sustainable growth rate for any year before a year described in clause (i) shall be the rate as most recently determined for that year under this subsection.
Nothing in this paragraph shall be construed as affecting the sustainable growth rates established for fiscal year 1998 or fiscal year 1999.
(4) Definitions
In this subsection:
(A) Services included in physicians' services
The term "physicians' services" includes other items and services (such as clinical diagnostic laboratory tests and radiology services), specified by the Secretary, that are commonly performed or furnished by a physician or in a physician's office, but does not include services furnished to a Medicare+Choice plan enrollee.
(B) Medicare+Choice plan enrollee
The term "Medicare+Choice plan enrollee" means, with respect to a fiscal year, an individual enrolled under this part who has elected to receive benefits under this subchapter for the fiscal year through a Medicare+Choice plan offered under part C, and also includes an individual who is receiving benefits under this part through enrollment with an eligible organization with a risk-sharing contract under
(C) Applicable period
The term "applicable period" means—
(i) a fiscal year, in the case of fiscal year 1998, fiscal year 1999, and fiscal year 2000; or
(ii) a calendar year with respect to a year beginning with 2000;
as the case may be.
(g) Limitation on beneficiary liability
(1) Limitation on actual charges
(A) In general
In the case of a nonparticipating physician or nonparticipating supplier or other person (as defined in
(i) Application of limiting charge
No person may bill or collect an actual charge for the service in excess of the limiting charge described in paragraph (2) for such service.
(ii) No liability for excess charges
No person is liable for payment of any amounts billed for the service in excess of such limiting charge.
(iii) Correction of excess charges
If such a physician, supplier, or other person bills, but does not collect, an actual charge for a service in violation of clause (i), the physician, supplier, or other person shall reduce on a timely basis the actual charge billed for the service to an amount not to exceed the limiting charge for the service.
(iv) Refund of excess collections
If such a physician, supplier, or other person collects an actual charge for a service in violation of clause (i), the physician, supplier, or other person shall provide on a timely basis a refund to the individual charged in the amount by which the amount collected exceeded the limiting charge for the service. The amount of such a refund shall be reduced to the extent the individual has an outstanding balance owed by the individual to the physician.
(B) Sanctions
If a physician, supplier, or other person—
(i) knowingly and willfully bills or collects for services in violation of subparagraph (A)(i) on a repeated basis, or
(ii) fails to comply with clause (iii) or (iv) of subparagraph (A) on a timely basis,
the Secretary may apply sanctions against the physician, supplier, or other person in accordance with paragraph (2) of
(C) Timely basis
For purposes of this paragraph, a correction of a bill for an excess charge or refund of an amount with respect to a violation of subparagraph (A)(i) in the case of a service is considered to be provided "on a timely basis", if the reduction or refund is made not later than 30 days after the date the physician, supplier, or other person is notified by the carrier under this part of such violation and of the requirements of subparagraph (A).
(2) "Limiting charge" defined
(A) For 1991
For physicians' services of a physician furnished during 1991, other than radiologist services subject to
(i) the maximum allowable actual charge (as determined under
(ii) the recognized payment amount for the service of the physician (as a nonparticipating physician) as of such date.
In the case of evaluation and management services (as specified in
(B) For 1992
For physicians' services furnished during 1992, other than radiologist services subject to
(i) the limiting charge (as determined under subparagraph (A) as of December 31, 1991) for the service, exceeds
(ii) the recognized payment amount for the service for nonparticipating physicians as of such date.
(C) After 1992
For physicians' services furnished in a year after 1992, the "limiting charge" shall be 115 percent of the recognized payment amount under this part for nonparticipating physicians or for nonparticipating suppliers or other persons.
(D) Recognized payment amount
In this section, the term "recognized payment amount" means, for services furnished on or after January 1, 1992, the fee schedule amount determined under subsection (a) (or, if payment under this part is made on a basis other than the fee schedule under this section, 95 percent of the other payment basis), and, for services furnished during 1991, the applicable percentage (as defined in
(3) Limitation on charges for medicare beneficiaries eligible for medicaid benefits
(A) In general
Payment for physicians' services furnished on or after April 1, 1990, to an individual who is enrolled under this part and eligible for any medical assistance (including as a qualified medicare beneficiary, as defined in
(B) Penalty
A person may not bill for physicians' services subject to subparagraph (A) other than on an assignment-related basis. No person is liable for payment of any amounts billed for such a service in violation of the previous sentence. If a person knowingly and willfully bills for physicians' services in violation of the first sentence, the Secretary may apply sanctions against the person in accordance with
(4) Physician submission of claims
(A) In general
For services furnished on or after September 1, 1990, within 1 year after the date of providing a service for which payment is made under this part on a reasonable charge or fee schedule basis, a physician, supplier, or other person (or an employer or facility in the cases described in
(i) shall complete and submit a claim for such service on a standard claim form specified by the Secretary to the carrier on behalf of a beneficiary, and
(ii) may not impose any charge relating to completing and submitting such a form.
(B) Penalty
(i) With respect to an assigned claim wherever a physician, provider, supplier or other person (or an employer or facility in the cases described in
(ii) If a physician, supplier, or other person (or an employer or facility in the cases described in
(5) Electronic billing; direct deposit
The Secretary shall encourage and develop a system providing for expedited payment for claims submitted electronically. The Secretary shall also encourage and provide incentives allowing for direct deposit as payments for services furnished by participating physicians. The Secretary shall provide physicians with such technical information as necessary to enable such physicians to submit claims electronically. The Secretary shall submit a plan to Congress on this paragraph by May 1, 1990.
(6) Monitoring of charges
(A) In general
The Secretary shall monitor—
(i) the actual charges of nonparticipating physicians for physicians' services furnished on or after January 1, 1991, to individuals enrolled under this part, and
(ii) changes (by specialty, type of service, and geographic area) in (I) the proportion of expenditures for physicians' services provided under this part by participating physicians, (II) the proportion of expenditures for such services for which payment is made under this part on an assignment-related basis, and (III) the amounts charged above the recognized payment amounts under this part.
(B) Report
The Secretary shall, by not later than April 15 of each year (beginning in 1992), report to the Congress information on the extent to which actual charges exceed limiting charges, the number and types of services involved, and the average amount of excess charges and information regarding the changes described in subparagraph (A)(ii).
(C) Plan
If the Secretary finds that there has been a significant decrease in the proportions described in subclauses (I) and (II) of subparagraph (A)(ii) or an increase in the amounts described in subclause (III) of that subparagraph, the Secretary shall develop a plan to address such a problem and transmit to Congress recommendations regarding the plan. The Medicare Payment Advisory Commission shall review the Secretary's plan and recommendations and transmit to Congress its comments regarding such plan and recommendations.
(7) Monitoring of utilization and access
(A) In general
The Secretary shall monitor—
(i) changes in the utilization of and access to services furnished under this part within geographic, population, and service related categories,
(ii) possible sources of inappropriate utilization of services furnished under this part which contribute to the overall level of expenditures under this part, and
(iii) factors underlying these changes and their interrelationships.
(B) Report
The Secretary shall by not later than April 15,5 of each year (beginning with 1991) report to the Congress on the changes described in subparagraph (A)(i) and shall include in the report an examination of the factors (including factors relating to different services and specific categories and groups of services and geographic and demographic variations in utilization) which may contribute to such changes.
(C) Recommendations
The Secretary shall include in each annual report under subparagraph (B) recommendations—
(i) addressing any identified patterns of inappropriate utilization,
(ii) on utilization review,
(iii) on physician education or patient education,
(iv) addressing any problems of beneficiary access to care made evident by the monitoring process, and
(v) on such other matters as the Secretary deems appropriate.
The Medicare Payment Advisory Commission shall comment on the Secretary's recommendations and in developing its comments, the Commission shall convene and consult a panel of physician experts to evaluate the implications of medical utilization patterns for the quality of and access to patient care.
(h) Sending information to physicians
Before the beginning of each year (beginning with 1992), the Secretary shall send to each physician or nonparticipating supplier or other person furnishing physicians' services (as defined in subsection (j)(3)) furnishing physicians' services under this part, for services commonly performed by the physician, supplier, or other person, information on fee schedule amounts that apply for the year in the fee schedule area for participating and non-participating physicians, and the maximum amount that may be charged consistent with subsection (g)(2). Such information shall be transmitted in conjunction with notices to physicians, suppliers, and other persons under
(i) Miscellaneous provisions
(1) Restriction on administrative and judicial review
There shall be no administrative or judicial review under
(A) the determination of the adjusted historical payment basis (as defined in subsection (a)(2)(D)(i)),
(B) the determination of relative values and relative value units under subsection (c), including adjustments under subsections (c)(2)(F), (c)(2)(H), and (c)(2)(I) and section 13515(b) of the Omnibus Budget Reconciliation Act of 1993,
(C) the determination of conversion factors under subsection (d), including without limitation a prospective redetermination of the sustainable growth rates for any or all previous fiscal years,
(D) the establishment of geographic adjustment factors under subsection (e),
(E) the establishment of the system for the coding of physicians' services under this section, and
(F) the collection and use of information in the determination of relative values under subsection (c)(2)(M).
(2) Assistants-at-surgery
(A) In general
Subject to subparagraph (B), in the case of a surgical service furnished by a physician, if payment is made separately under this part for the services of a physician serving as an assistant-at-surgery, the fee schedule amount shall not exceed 16 percent of the fee schedule amount otherwise determined under this section for the global surgical service involved.
(B) Denial of payment in certain cases
If the Secretary determines, based on the most recent data available, that for a surgical procedure (or class of surgical procedures) the national average percentage of such procedure performed under this part which involve the use of a physician as an assistant at surgery is less than 5 percent, no payment may be made under this part for services of an assistant at surgery involved in the procedure.
(3) No comparability adjustment
For physicians' services for which payment under this part is determined under this section—
(A) a carrier may not make any adjustment in the payment amount under
(B) no payment adjustment may be made under
(C)
(j) Definitions
In this section:
(1) Category
For services furnished before January 1, 1998, the term "category" means, with respect to physicians' services, surgical services, and all physicians' services other than surgical services (as defined by the Secretary and including anesthesia services), primary care services (as defined in
(2) Fee schedule area
Except as provided in subsection (e)(6)(D), the term "fee schedule area" means a locality used under
(3) Physicians' services
The term "physicians' services" includes items and services described in paragraphs (1), (2)(A), (2)(D), (2)(G), (2)(P) (with respect to services described in subparagraphs (A) and (C) of
(4) Practice expenses
The term "practice expenses" includes all expenses for furnishing physicians' services, excluding malpractice expenses, physician compensation, and other physician fringe benefits.
(k) Quality reporting system
(1) In general
The Secretary shall implement a system for the reporting by eligible professionals of data on quality measures specified under paragraph (2). Such data shall be submitted in a form and manner specified by the Secretary (by program instruction or otherwise), which may include submission of such data on claims under this part.
(2) Use of consensus-based quality measures
(A) For 2007
(i) In general
For purposes of applying this subsection for the reporting of data on quality measures for covered professional services furnished during the period beginning July 1, 2007, and ending December 31, 2007, the quality measures specified under this paragraph are the measures identified as 2007 physician quality measures under the Physician Voluntary Reporting Program as published on the public website of the Centers for Medicare & Medicaid Services as of December 20, 2006, except as may be changed by the Secretary based on the results of a consensus-based process in January of 2007, if such change is published on such website by not later than April 1, 2007.
(ii) Subsequent refinements in application permitted
The Secretary may, from time to time (but not later than July 1, 2007), publish on such website (without notice or opportunity for public comment) modifications or refinements (such as code additions, corrections, or revisions) for the application of quality measures previously published under clause (i), but may not, under this clause, change the quality measures under the reporting system.
(iii) Implementation
Notwithstanding any other provision of law, the Secretary may implement by program instruction or otherwise this subsection for 2007.
(B) For 2008 and 2009
(i) In general
For purposes of reporting data on quality measures for covered professional services furnished during 2008 and 2009, the quality measures specified under this paragraph for covered professional services shall be measures that have been adopted or endorsed by a consensus organization (such as the National Quality Forum or AQA), that include measures that have been submitted by a physician specialty, and that the Secretary identifies as having used a consensus-based process for developing such measures. Such measures shall include structural measures, such as the use of electronic health records and electronic prescribing technology.
(ii) Proposed set of measures
Not later than August 15 of each of 2007 and 2008, the Secretary shall publish in the Federal Register a proposed set of quality measures that the Secretary determines are described in clause (i) and would be appropriate for eligible professionals to use to submit data to the Secretary in 2008 or 2009, as applicable. The Secretary shall provide for a period of public comment on such set of measures.
(iii) Final set of measures
Not later than November 15 of each of 2007 and 2008, the Secretary shall publish in the Federal Register a final set of quality measures that the Secretary determines are described in clause (i) and would be appropriate for eligible professionals to use to submit data to the Secretary in 2008 or 2009, as applicable.
(C) For 2010 and subsequent years
(i) In general
Subject to clause (ii), for purposes of reporting data on quality measures for covered professional services furnished during 2010 and each subsequent year, subject to subsection (m)(3)(C), the quality measures (including electronic prescribing quality measures) specified under this paragraph shall be such measures selected by the Secretary from measures that have been endorsed by the entity with a contract with the Secretary under
(ii) Exception
In the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the entity with a contract under
(D) Opportunity to provide input on measures for 2009 and subsequent years
For each quality measure (including an electronic prescribing quality measure) adopted by the Secretary under subparagraph (B) (with respect to 2009) or subparagraph (C), the Secretary shall ensure that eligible professionals have the opportunity to provide input during the development, endorsement, or selection of measures applicable to services they furnish.
(3) Covered professional services and eligible professionals defined
For purposes of this subsection:
(A) Covered professional services
The term "covered professional services" means services for which payment is made under, or is based on, the fee schedule established under this section and which are furnished by an eligible professional.
(B) Eligible professional
The term "eligible professional" means any of the following:
(i) A physician.
(ii) A practitioner described in
(iii) A physical or occupational therapist or a qualified speech-language pathologist.
(iv) Beginning with 2009, a qualified audiologist (as defined in
(4) Use of registry-based reporting
As part of the publication of proposed and final quality measures for 2008 under clauses (ii) and (iii) of paragraph (2)(B), the Secretary shall address a mechanism whereby an eligible professional may provide data on quality measures through an appropriate medical registry (such as the Society of Thoracic Surgeons National Database) or through a Maintenance of Certification program operated by a specialty body of the American Board of Medical Specialties that meets the criteria for such a registry, as identified by the Secretary.
(5) Identification units
For purposes of applying this subsection, the Secretary may identify eligible professionals through billing units, which may include the use of the Provider Identification Number, the unique physician identification number (described in
(6) Education and outreach
The Secretary shall provide for education and outreach to eligible professionals on the operation of this subsection.
(7) Limitations on review
There shall be no administrative or judicial review under
(8) Implementation
The Secretary shall carry out this subsection acting through the Administrator of the Centers for Medicare & Medicaid Services.
(9) Continued application for purposes of MIPS and for certain professionals volunteering to report
The Secretary shall, in accordance with subsection (q)(1)(F), carry out the provisions of this subsection—
(A) for purposes of subsection (q); and
(B) for eligible professionals who are not MIPS eligible professionals (as defined in subsection (q)(1)(C)) for the year involved.
(l) Physician Assistance and Quality Initiative Fund
(1) Establishment
The Secretary shall establish under this subsection a Physician Assistance and Quality Initiative Fund (in this subsection referred to as the "Fund") which shall be available to the Secretary for physician payment and quality improvement initiatives, which may include application of an adjustment to the update of the conversion factor under subsection (d).
(2) Funding
(A) Amount available
(i) In general
Subject to clause (ii), there shall be available to the Fund the following amounts:
(I) For expenditures during 2008, an amount equal to $150,500,000.
(II) For expenditures during 2009, an amount equal to $24,500,000.
(ii) Limitations on expenditures
(I) 2008
The amount available for expenditures during 2008 shall be reduced as provided by subparagraph (A) of section 225(c)(1) and section 524 of the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2008 (division G of the Consolidated Appropriations Act, 2008).
(II) 2009
The amount available for expenditures during 2009 shall be reduced as provided by subparagraph (B) of such section 225(c)(1).
(B) Timely obligation of all available funds for services
The Secretary shall provide for expenditures from the Fund in a manner designed to provide (to the maximum extent feasible) for the obligation of the entire amount available for expenditures, after application of subparagraph (A)(ii), during—
(i) 2008 for payment with respect to physicians' services furnished during 2008; and
(ii) 2009 for payment with respect to physicians' services furnished during 2009.
(C) Payment from Trust Fund
The amount specified in subparagraph (A) shall be available to the Fund, as expenditures are made from the Fund, from the Federal Supplementary Medical Insurance Trust Fund under
(D) Funding limitation
Amounts in the Fund shall be available in advance of appropriations in accordance with subparagraph (B) but only if the total amount obligated from the Fund does not exceed the amount available to the Fund under subparagraph (A). The Secretary may obligate funds from the Fund only if the Secretary determines (and the Chief Actuary of the Centers for Medicare & Medicaid Services and the appropriate budget officer certify) that there are available in the Fund sufficient amounts to cover all such obligations incurred consistent with the previous sentence.
(E) Construction
In the case that expenditures from the Fund are applied to, or otherwise affect, a conversion factor under subsection (d) for a year, the conversion factor under such subsection shall be computed for a subsequent year as if such application or effect had never occurred.
(m) Incentive payments for quality reporting
(1) Incentive payments
(A) In general
For 2007 through 2014, with respect to covered professional services furnished during a reporting period by an eligible professional, if—
(i) there are any quality measures that have been established under the physician reporting system that are applicable to any such services furnished by such professional for such reporting period; and
(ii) the eligible professional satisfactorily submits (as determined under this subsection) to the Secretary data on such quality measures in accordance with such reporting system for such reporting period,
in addition to the amount otherwise paid under this part, there also shall be paid to the eligible professional (or to an employer or facility in the cases described in clause (A) of
(B) Applicable quality percent
For purposes of subparagraph (A), the term "applicable quality percent" means—
(i) for 2007 and 2008, 1.5 percent;
(ii) for 2009 and 2010, 2.0 percent;
(iii) for 2011, 1.0 percent; and
(iv) for 2012, 2013, and 2014, 0.5 percent.
(2) Incentive payments for electronic prescribing
(A) In general
Subject to subparagraph (D), for 2009 through 2013, with respect to covered professional services furnished during a reporting period by an eligible professional, if the eligible professional is a successful electronic prescriber for such reporting period, in addition to the amount otherwise paid under this part, there also shall be paid to the eligible professional (or to an employer or facility in the cases described in clause (A) of
(B) Limitation with respect to electronic prescribing quality measures
The provisions of this paragraph and subsection (a)(5) shall not apply to an eligible professional (or, in the case of a group practice under paragraph (3)(C), to the group practice) if, for the reporting period (or, for purposes of subsection (a)(5), for the reporting period for a year)—
(i) the allowed charges under this part for all covered professional services furnished by the eligible professional (or group, as applicable) for the codes to which the electronic prescribing quality measure applies (as identified by the Secretary and published on the Internet website of the Centers for Medicare & Medicaid Services as of January 1, 2008, and as subsequently modified by the Secretary) are less than 10 percent of the total of the allowed charges under this part for all such covered professional services furnished by the eligible professional (or the group, as applicable); or
(ii) if determined appropriate by the Secretary, the eligible professional does not submit (including both electronically and nonelectronically) a sufficient number (as determined by the Secretary) of prescriptions under part D.
If the Secretary makes the determination to apply clause (ii) for a period, then clause (i) shall not apply for such period.
(C) Applicable electronic prescribing percent
For purposes of subparagraph (A), the term "applicable electronic prescribing percent" means—
(i) for 2009 and 2010, 2.0 percent;
(ii) for 2011 and 2012, 1.0 percent; and
(iii) for 2013, 0.5 percent.
(D) Limitation with respect to EHR incentive payments
The provisions of this paragraph shall not apply to an eligible professional (or, in the case of a group practice under paragraph (3)(C), to the group practice) if, for the EHR reporting period the eligible professional (or group practice) receives an incentive payment under subsection (o)(1)(A) with respect to a certified EHR technology (as defined in subsection (o)(4)) that has the capability of electronic prescribing.
(3) Satisfactory reporting and successful electronic prescriber described
(A) In general
For purposes of paragraph (1), an eligible professional shall be treated as satisfactorily submitting data on quality measures for covered professional services for a reporting period (or, for purposes of subsection (a)(8), for the quality reporting period for the year) if quality measures have been reported as follows:
(i) Three or fewer quality measures applicable
If there are no more than 3 quality measures that are provided under the physician reporting system and that are applicable to such services of such professional furnished during the period, each such quality measure has been reported under such system in at least 80 percent of the cases in which such measure is reportable under the system.
(ii) Four or more quality measures applicable
If there are 4 or more quality measures that are provided under the physician reporting system and that are applicable to such services of such professional furnished during the period, at least 3 such quality measures have been reported under such system in at least 80 percent of the cases in which the respective measure is reportable under the system.
For years after 2008, quality measures for purposes of this subparagraph shall not include electronic prescribing quality measures.
(B) Successful electronic prescriber
(i) In general
For purposes of paragraph (2) and subsection (a)(5), an eligible professional shall be treated as a successful electronic prescriber for a reporting period (or, for purposes of subsection (a)(5), for the reporting period for a year) if the eligible professional meets the requirement described in clause (ii), or, if the Secretary determines appropriate, the requirement described in clause (iii). If the Secretary makes the determination under the preceding sentence to apply the requirement described in clause (iii) for a period, then the requirement described in clause (ii) shall not apply for such period.
(ii) Requirement for submitting data on electronic prescribing quality measures
The requirement described in this clause is that, with respect to covered professional services furnished by an eligible professional during a reporting period (or, for purposes of subsection (a)(5), for the reporting period for a year), if there are any electronic prescribing quality measures that have been established under the physician reporting system and are applicable to any such services furnished by such professional for the period, such professional reported each such measure under such system in at least 50 percent of the cases in which such measure is reportable by such professional under such system.
(iii) Requirement for electronically prescribing under part D
The requirement described in this clause is that the eligible professional electronically submitted a sufficient number (as determined by the Secretary) of prescriptions under part D during the reporting period (or, for purposes of subsection (a)(5), for the reporting period for a year).
(iv) Use of part D data
Notwithstanding
(v) Standards for electronic prescribing
To the extent practicable, in determining whether eligible professionals meet the requirements under clauses (ii) and (iii) for purposes of clause (i), the Secretary shall ensure that eligible professionals utilize electronic prescribing systems in compliance with standards established for such systems pursuant to the Part D Electronic Prescribing Program under
(C) Satisfactory reporting measures for group practices
(i) In general
By January 1, 2010, the Secretary shall establish and have in place a process under which eligible professionals in a group practice (as defined by the Secretary) shall be treated as satisfactorily submitting data on quality measures under subparagraph (A) and as meeting the requirement described in subparagraph (B)(ii) for covered professional services for a reporting period (or, for purposes of subsection (a)(5), for a reporting period for a year), or, for purposes of subsection (a)(8), for a quality reporting period for the year if, in lieu of reporting measures under subsection (k)(2)(C), the group practice reports measures determined appropriate by the Secretary, such as measures that target high-cost chronic conditions and preventive care, in a form and manner, and at a time, specified by the Secretary.
(ii) Statistical sampling model
The process under clause (i) shall provide and, for 2016 and subsequent years, may provide for the use of a statistical sampling model to submit data on measures, such as the model used under the Physician Group Practice demonstration project under
(iii) No double payments
Payments to a group practice under this subsection by reason of the process under clause (i) shall be in lieu of the payments that would otherwise be made under this subsection to eligible professionals in the group practice for satisfactorily submitting data on quality measures.
(D) Satisfactory reporting measures through participation in a qualified clinical data registry
For 2014 and subsequent years, the Secretary shall treat an eligible professional as satisfactorily submitting data on quality measures under subparagraph (A) and, for 2016 and subsequent years, subparagraph (A) or (C) if, in lieu of reporting measures under subsection (k)(2)(C), the eligible professional is satisfactorily participating, as determined by the Secretary, in a qualified clinical data registry (as described in subparagraph (E)) for the year.
(E) Qualified clinical data registry
(i) In general
The Secretary shall establish requirements for an entity to be considered a qualified clinical data registry. Such requirements shall include a requirement that the entity provide the Secretary with such information, at such times, and in such manner, as the Secretary determines necessary to carry out this subsection.
(ii) Considerations
In establishing the requirements under clause (i), the Secretary shall consider whether an entity—
(I) has in place mechanisms for the transparency of data elements and specifications, risk models, and measures;
(II) requires the submission of data from participants with respect to multiple payers;
(III) provides timely performance reports to participants at the individual participant level; and
(IV) supports quality improvement initiatives for participants.
(iii) Measures
With respect to measures used by a qualified clinical data registry—
(I)
(II) measures endorsed by the entity with a contract with the Secretary under
(iv) Consultation
In carrying out this subparagraph, the Secretary shall consult with interested parties.
(v) Determination
The Secretary shall establish a process to determine whether or not an entity meets the requirements established under clause (i). Such process may involve one or both of the following:
(I) A determination by the Secretary.
(II) A designation by the Secretary of one or more independent organizations to make such determination.
(F) Authority to revise satisfactorily reporting data
For years after 2009, the Secretary, in consultation with stakeholders and experts, may revise the criteria under this subsection for satisfactorily submitting data on quality measures under subparagraph (A) and the criteria for submitting data on electronic prescribing quality measures under subparagraph (B)(ii).
(4) Form of payment
The payment under this subsection shall be in the form of a single consolidated payment.
(5) Application
(A) Physician reporting system rules
Paragraphs (5), (6), and (8) of subsection (k) shall apply for purposes of this subsection in the same manner as they apply for purposes of such subsection.
(B) Coordination with other bonus payments
The provisions of this subsection shall not be taken into account in applying subsections (m) and (u) of
(C) Implementation
Notwithstanding any other provision of law, for 2007, 2008, and 2009, the Secretary may implement by program instruction or otherwise this subsection.
(D) Validation
(i) In general
Subject to the succeeding provisions of this subparagraph, for purposes of determining whether a measure is applicable to the covered professional services of an eligible professional under this subsection for 2007 and 2008, the Secretary shall presume that if an eligible professional submits data for a measure, such measure is applicable to such professional.
(ii) Method
The Secretary may establish procedures to validate (by sampling or other means as the Secretary determines to be appropriate) whether measures applicable to covered professional services of an eligible professional have been reported.
(iii) Denial of payment authority
If the Secretary determines that an eligible professional (or, in the case of a group practice under paragraph (3)(C), the group practice) has not reported measures applicable to covered professional services of such professional, the Secretary shall not pay the incentive payment under this subsection. If such payments for such period have already been made, the Secretary shall recoup such payments from the eligible professional (or the group practice).
(E) Limitations on review
Except as provided in subparagraph (I), there shall be no administrative or judicial review under
(i) the determination of measures applicable to services furnished by eligible professionals under this subsection;
(ii) the determination of satisfactory reporting under this subsection;
(iii) the determination of a successful electronic prescriber under paragraph (3), the limitation under paragraph (2)(B), and the exception under subsection (a)(5)(B); and
(iv) the determination of any incentive payment under this subsection and the payment adjustment under paragraphs (5)(A) and (8)(A) of subsection (a).
(F) Extension
For 2008 through reporting periods occurring in 2015, the Secretary shall establish and, for reporting periods occurring in 2016 and subsequent years, the Secretary may establish alternative criteria for satisfactorily reporting under this subsection and alternative reporting periods under paragraph (6)(C) for reporting groups of measures under subsection (k)(2)(B) and for reporting using the method specified in subsection (k)(4).
(G) Posting on website
The Secretary shall post on the Internet website of the Centers for Medicare & Medicaid Services, in an easily understandable format, a list of the names of the following:
(i) The eligible professionals (or, in the case of reporting under paragraph (3)(C), the group practices) who satisfactorily submitted data on quality measures under this subsection.
(ii) The eligible professionals (or, in the case of reporting under paragraph (3)(C), the group practices) who are successful electronic prescribers.
(H) Feedback
The Secretary shall provide timely feedback to eligible professionals on the performance of the eligible professional with respect to satisfactorily submitting data on quality measures under this subsection.
(I) Informal appeals process
The Secretary shall, by not later than January 1, 2011, establish and have in place an informal process for eligible professionals to seek a review of the determination that an eligible professional did not satisfactorily submit data on quality measures under this subsection.
(6) Definitions
For purposes of this subsection:
(A) Eligible professional; covered professional services
The terms "eligible professional" and "covered professional services" have the meanings given such terms in subsection (k)(3).
(B) Physician reporting system
The term "physician reporting system" means the system established under subsection (k).
(C) Reporting period
(i) In general
Subject to clauses (ii) and (iii), the term "reporting period" means—
(I) for 2007, the period beginning on July 1, 2007, and ending on December 31, 2007; and
(II) for 2008 and subsequent years, the entire year.
(ii) Authority to revise reporting period
For years after 2009, the Secretary may revise the reporting period under clause (i) if the Secretary determines such revision is appropriate, produces valid results on measures reported, and is consistent with the goals of maximizing scientific validity and reducing administrative burden. If the Secretary revises such period pursuant to the preceding sentence, the term "reporting period" shall mean such revised period.
(iii) Reference
Any reference in this subsection to a reporting period with respect to the application of subsection (a)(5) (a)(8) 7 shall be deemed a reference to the reporting period under subsection (a)(5)(D)(iii) or the quality reporting period under subsection (a)(8)(D)(iii),8 respectively.
(7) Integration of physician quality reporting and EHR reporting
Not later than January 1, 2012, the Secretary shall develop a plan to integrate reporting on quality measures under this subsection with reporting requirements under subsection (o) relating to the meaningful use of electronic health records. Such integration shall consist of the following:
(A) The selection of measures, the reporting of which would both demonstrate—
(i) meaningful use of an electronic health record for purposes of subsection (o); and
(ii) quality of care furnished to an individual.
(B) Such other activities as specified by the Secretary.
(8) Additional incentive payment
(A) In general
For 2011 through 2014, if an eligible professional meets the requirements described in subparagraph (B), the applicable quality percent for such year, as described in clauses (iii) and (iv) of paragraph (1)(B), shall be increased by 0.5 percentage points.
(B) Requirements described
In order to qualify for the additional incentive payment described in subparagraph (A), an eligible professional shall meet the following requirements:
(i) The eligible professional shall—
(I) satisfactorily submit data on quality measures for purposes of paragraph (1) for a year; and
(II) have such data submitted on their behalf through a Maintenance of Certification Program (as defined in subparagraph (C)(i)) that meets—
(aa) the criteria for a registry (as described in subsection (k)(4)); or
(bb) an alternative form and manner determined appropriate by the Secretary.
(ii) The eligible professional, more frequently than is required to qualify for or maintain board certification status—
(I) participates in such a Maintenance of Certification program for a year; and
(II) successfully completes a qualified Maintenance of Certification Program practice assessment (as defined in subparagraph (C)(ii)) for such year.
(iii) A Maintenance of Certification program submits to the Secretary, on behalf of the eligible professional, information—
(I) in a form and manner specified by the Secretary, that the eligible professional has successfully met the requirements of clause (ii) (which may be in the form of a structural measure);
(II) if requested by the Secretary, on the survey of patient experience with care (as described in subparagraph (C)(ii)(II)); and
(III) as the Secretary may require, on the methods, measures, and data used under the Maintenance of Certification Program and the qualified Maintenance of Certification Program practice assessment.
(C) Definitions
For purposes of this paragraph:
(i) The term "Maintenance of Certification Program" means a continuous assessment program, such as qualified American Board of Medical Specialties Maintenance of Certification program or an equivalent program (as determined by the Secretary), that advances quality and the lifelong learning and self-assessment of board certified specialty physicians by focusing on the competencies of patient care, medical knowledge, practice-based learning, interpersonal and communication skills and professionalism. Such a program shall include the following:
(I) The program requires the physician to maintain a valid, unrestricted medical license in the United States.
(II) The program requires a physician to participate in educational and self-assessment programs that require an assessment of what was learned.
(III) The program requires a physician to demonstrate, through a formalized, secure examination, that the physician has the fundamental diagnostic skills, medical knowledge, and clinical judgment to provide quality care in their respective specialty.
(IV) The program requires successful completion of a qualified Maintenance of Certification Program practice assessment as described in clause (ii).
(ii) The term "qualified Maintenance of Certification Program practice assessment" means an assessment of a physician's practice that—
(I) includes an initial assessment of an eligible professional's practice that is designed to demonstrate the physician's use of evidence-based medicine;
(II) includes a survey of patient experience with care; and
(III) requires a physician to implement a quality improvement intervention to address a practice weakness identified in the initial assessment under subclause (I) and then to remeasure to assess performance improvement after such intervention.
(9) Continued application for purposes of MIPS and for certain professionals volunteering to report
The Secretary shall, in accordance with subsection (q)(1)(F), carry out the processes under this subsection—
(A) for purposes of subsection (q); and
(B) for eligible professionals who are not MIPS eligible professionals (as defined in subsection (q)(1)(C)) for the year involved.
(n) Physician Feedback Program
(1) Establishment
(A) In general
(i) Establishment
The Secretary shall establish a Physician Feedback Program (in this subsection referred to as the "Program").
(ii) Reports on resources
The Secretary shall use claims data under this subchapter (and may use other data) to provide confidential reports to physicians (and, as determined appropriate by the Secretary, to groups of physicians) that measure the resources involved in furnishing care to individuals under this subchapter.
(iii) Inclusion of certain information
If determined appropriate by the Secretary, the Secretary may include information on the quality of care furnished to individuals under this subchapter by the physician (or group of physicians) in such reports.
(B) Resource use
The resources described in subparagraph (A)(ii) may be measured—
(i) on an episode basis;
(ii) on a per capita basis; or
(iii) on both an episode and a per capita basis.
(2) Implementation
The Secretary shall implement the Program by not later than January 1, 2009.
(3) Data for reports
To the extent practicable, reports under the Program shall be based on the most recent data available.
(4) Authority to focus initial application
The Secretary may focus the initial application of the Program as appropriate, such as focusing the Program on—
(A) physician specialties that account for a certain percentage of all spending for physicians' services under this subchapter;
(B) physicians who treat conditions that have a high cost or a high volume, or both, under this subchapter;
(C) physicians who use a high amount of resources compared to other physicians;
(D) physicians practicing in certain geographic areas; or
(E) physicians who treat a minimum number of individuals under this subchapter.
(5) Authority to exclude certain information if insufficient information
The Secretary may exclude certain information regarding a service from a report under the Program with respect to a physician (or group of physicians) if the Secretary determines that there is insufficient information relating to that service to provide a valid report on that service.
(6) Adjustment of data
To the extent practicable, the Secretary shall make appropriate adjustments to the data used in preparing reports under the Program, such as adjustments to take into account variations in health status and other patient characteristics. For adjustments for reports on utilization under paragraph (9), see subparagraph (D) of such paragraph.
(7) Education and outreach
The Secretary shall provide for education and outreach activities to physicians on the operation of, and methodologies employed under, the Program.
(8) Disclosure exemption
Reports under the Program shall be exempt from disclosure under
(9) Reports on utilization
(A) Development of episode grouper
(i) In general
The Secretary shall develop an episode grouper that combines separate but clinically related items and services into an episode of care for an individual, as appropriate.
(ii) Timeline for development
The episode grouper described in subparagraph (A) 9 shall be developed by not later than January 1, 2012.
(iii) Public availability
The Secretary shall make the details of the episode grouper described in subparagraph (A) 9 available to the public.
(iv) Endorsement
The Secretary shall seek endorsement of the episode grouper described in subparagraph (A) 9 by the entity with a contract under
(B) Reports on utilization
Effective beginning with 2012, the Secretary shall provide reports to physicians that compare, as determined appropriate by the Secretary, patterns of resource use of the individual physician to such patterns of other physicians.
(C) Analysis of data
The Secretary shall, for purposes of preparing reports under this paragraph, establish methodologies as appropriate, such as to—
(i) attribute episodes of care, in whole or in part, to physicians;
(ii) identify appropriate physicians for purposes of comparison under subparagraph (B); and
(iii) aggregate episodes of care attributed to a physician under clause (i) into a composite measure per individual.
(D) Data adjustment
In preparing reports under this paragraph, the Secretary shall make appropriate adjustments, including adjustments—
(i) to account for differences in socioeconomic and demographic characteristics, ethnicity, and health status of individuals (such as to recognize that less healthy individuals may require more intensive interventions); and
(ii) to eliminate the effect of geographic adjustments in payment rates (as described in subsection (e)).
(E) Public availability of methodology
The Secretary shall make available to the public—
(i) the methodologies established under subparagraph (C);
(ii) information regarding any adjustments made to data under subparagraph (D); and
(iii) aggregate reports with respect to physicians.
(F) Definition of physician
In this paragraph:
(i) In general
The term "physician" has the meaning given that term in
(ii) Treatment of groups
Such term includes, as the Secretary determines appropriate, a group of physicians.
(G) Limitations on review
There shall be no administrative or judicial review under
(10) Coordination with other value-based purchasing reforms
The Secretary shall coordinate the Program with the value-based payment modifier established under subsection (p) and, as the Secretary determines appropriate, other similar provisions of this subchapter.
(11) Reports ending with 2017
Reports under the Program shall not be provided after December 31, 2017. See subsection (q)(12) for reports under the eligible professionals Merit-based Incentive Payment System.
(o) Incentives for adoption and meaningful use of certified EHR technology
(1) Incentive payments
(A) In general
(i) In general
Subject to the succeeding subparagraphs of this paragraph, with respect to covered professional services furnished by an eligible professional during a payment year (as defined in subparagraph (E)), if the eligible professional is a meaningful EHR user (as determined under paragraph (2)) for the EHR reporting period with respect to such year, in addition to the amount otherwise paid under this part, there also shall be paid to the eligible professional (or to an employer or facility in the cases described in clause (A) of
(ii) No incentive payments with respect to years after 2016
No incentive payments may be made under this subsection with respect to a year after 2016.
(B) Limitations on amounts of incentive payments
(i) In general
In no case shall the amount of the incentive payment provided under this paragraph for an eligible professional for a payment year exceed the applicable amount specified under this subparagraph with respect to such eligible professional and such year.
(ii) Amount
Subject to clauses (iii) through (v), the applicable amount specified in this subparagraph for an eligible professional is as follows:
(I) For the first payment year for such professional, $15,000 (or, if the first payment year for such eligible professional is 2011 or 2012, $18,000).
(II) For the second payment year for such professional, $12,000.
(III) For the third payment year for such professional, $8,000.
(IV) For the fourth payment year for such professional, $4,000.
(V) For the fifth payment year for such professional, $2,000.
(VI) For any succeeding payment year for such professional, $0.
(iii) Phase down for eligible professionals first adopting EHR after 2013
If the first payment year for an eligible professional is after 2013, then the amount specified in this subparagraph for a payment year for such professional is the same as the amount specified in clause (ii) for such payment year for an eligible professional whose first payment year is 2013.
(iv) Increase for certain eligible professionals
In the case of an eligible professional who predominantly furnishes services under this part in an area that is designated by the Secretary (under
(v) No incentive payment if first adopting after 2014
If the first payment year for an eligible professional is after 2014 then the applicable amount specified in this subparagraph for such professional for such year and any subsequent year shall be $0.
(C) Non-application to hospital-based eligible professionals
(i) In general
No incentive payment may be made under this paragraph in the case of a hospital-based eligible professional.
(ii) Hospital-based eligible professional
For purposes of clause (i), the term "hospital-based eligible professional" means, with respect to covered professional services furnished by an eligible professional during the EHR reporting period for a payment year, an eligible professional, such as a pathologist, anesthesiologist, or emergency physician, who furnishes substantially all of such services in a hospital inpatient or emergency room setting and through the use of the facilities and equipment, including qualified electronic health records, of the hospital. The determination of whether an eligible professional is a hospital-based eligible professional shall be made on the basis of the site of service (as defined by the Secretary) and without regard to any employment or billing arrangement between the eligible professional and any other provider.
(D) Payment
(i) Form of payment
The payment under this paragraph may be in the form of a single consolidated payment or in the form of such periodic installments as the Secretary may specify.
(ii) Coordination of application of limitation for professionals in different practices
In the case of an eligible professional furnishing covered professional services in more than one practice (as specified by the Secretary), the Secretary shall establish rules to coordinate the incentive payments, including the application of the limitation on amounts of such incentive payments under this paragraph, among such practices.
(iii) Coordination with Medicaid
The Secretary shall seek, to the maximum extent practicable, to avoid duplicative requirements from Federal and State governments to demonstrate meaningful use of certified EHR technology under this subchapter and subchapter XIX. The Secretary may also adjust the reporting periods under such subchapter and such subsections in order to carry out this clause.
(E) Payment year defined
(i) In general
For purposes of this subsection, the term "payment year" means a year beginning with 2011.
(ii) First, second, etc. payment year
The term "first payment year" means, with respect to covered professional services furnished by an eligible professional, the first year for which an incentive payment is made for such services under this subsection. The terms "second payment year", "third payment year", "fourth payment year", and "fifth payment year" mean, with respect to covered professional services furnished by such eligible professional, each successive year immediately following the first payment year for such professional.
(2) Meaningful EHR user
(A) In general
An eligible professional shall be treated as a meaningful EHR user for an EHR reporting period for a payment year (or, for purposes of subsection (a)(7), for an EHR reporting period under such subsection for a year, or pursuant to subparagraph (D) for purposes of subsection (q), for a performance period under such subsection for a year) if each of the following requirements is met:
(i) Meaningful use of certified EHR technology
The eligible professional demonstrates to the satisfaction of the Secretary, in accordance with subparagraph (C)(i), that during such period the professional is using certified EHR technology in a meaningful manner, which shall include the use of electronic prescribing as determined to be appropriate by the Secretary.
(ii) Information exchange
The eligible professional demonstrates to the satisfaction of the Secretary, in accordance with subparagraph (C)(i), that during such period such certified EHR technology is connected in a manner that provides, in accordance with law and standards applicable to the exchange of information, for the electronic exchange of health information to improve the quality of health care, such as promoting care coordination, and the professional demonstrates (through a process specified by the Secretary, such as the use of an attestation) that the professional has not knowingly and willfully taken action (such as to disable functionality) to limit or restrict the compatibility or interoperability of the certified EHR technology.
(iii) Reporting on measures using EHR
Subject to subparagraph (B)(ii) and subsection (q)(5)(B)(ii)(II) and using such certified EHR technology, the eligible professional submits information for such period, in a form and manner specified by the Secretary, on such clinical quality measures and such other measures as selected by the Secretary under subparagraph (B)(i).
The Secretary may provide for the use of alternative means for meeting the requirements of clauses (i), (ii), and (iii) in the case of an eligible professional furnishing covered professional services in a group practice (as defined by the Secretary). The Secretary shall seek to improve the use of electronic health records and health care quality over time.
(B) Reporting on measures
(i) Selection
The Secretary shall select measures for purposes of subparagraph (A)(iii) but only consistent with the following:
(I) The Secretary shall provide preference to clinical quality measures that have been endorsed by the entity with a contract with the Secretary under
(II) Prior to any measure being selected under this subparagraph, the Secretary shall publish in the Federal Register such measure and provide for a period of public comment on such measure.
(ii) Limitation
The Secretary may not require the electronic reporting of information on clinical quality measures under subparagraph (A)(iii) unless the Secretary has the capacity to accept the information electronically, which may be on a pilot basis.
(iii) Coordination of reporting of information
In selecting such measures, and in establishing the form and manner for reporting measures under subparagraph (A)(iii), the Secretary shall seek to avoid redundant or duplicative reporting otherwise required, including reporting under subsection (k)(2)(C).
(C) Demonstration of meaningful use of certified EHR technology and information exchange
(i) In general
A professional may satisfy the demonstration requirement of clauses (i) and (ii) of subparagraph (A) through means specified by the Secretary, which may include—
(I) an attestation;
(II) the submission of claims with appropriate coding (such as a code indicating that a patient encounter was documented using certified EHR technology);
(III) a survey response;
(IV) reporting under subparagraph (A)(iii); and
(V) other means specified by the Secretary.
(ii) Use of part D data
Notwithstanding
(D) Continued application for purposes of MIPS
With respect to 2019 and each subsequent payment year, the Secretary shall, for purposes of subsection (q) and in accordance with paragraph (1)(F) of such subsection, determine whether an eligible professional who is a MIPS eligible professional (as defined in subsection (q)(1)(C)) for such year is a meaningful EHR user under this paragraph for the performance period under subsection (q) for such year. The provisions of subparagraphs (B) and (D) of subsection (a)(7),5 shall apply to assessments of MIPS eligible professionals under subsection (q) with respect to the performance category described in subsection (q)(2)(A)(iv) in an appropriate manner which may be similar to the manner in which such provisions apply with respect to payment adjustments made under subsection (a)(7)(A).
(3) Application
(A) Physician reporting system rules
Paragraphs (5), (6), and (8) of subsection (k) shall apply for purposes of this subsection in the same manner as they apply for purposes of such subsection.
(B) Coordination with other payments
The provisions of this subsection shall not be taken into account in applying the provisions of subsection (m) of this section and of
(C) Limitations on review
There shall be no administrative or judicial review under
(i) the methodology and standards for determining payment amounts under this subsection and payment adjustments under subsection (a)(7)(A), including the limitation under paragraph (1)(B) and coordination under clauses (ii) and (iii) of paragraph (1)(D);
(ii) the methodology and standards for determining a meaningful EHR user under paragraph (2), including selection of measures under paragraph (2)(B), specification of the means of demonstrating meaningful EHR use under paragraph (2)(C), and the hardship exception under subsection (a)(7)(B);
(iii) the methodology and standards for determining a hospital-based eligible professional under paragraph (1)(C); and
(iv) the specification of reporting periods under paragraph (5) and the selection of the form of payment under paragraph (1)(D)(i).
(D) Posting on website
The Secretary shall post on the Internet website of the Centers for Medicare & Medicaid Services, in an easily understandable format, a list of the names, business addresses, and business phone numbers of the eligible professionals who are meaningful EHR users and, as determined appropriate by the Secretary, of group practices receiving incentive payments under paragraph (1).
(4) Certified EHR technology defined
For purposes of this section, the term "certified EHR technology" means a qualified electronic health record (as defined in
(5) Definitions
For purposes of this subsection:
(A) Covered professional services
The term "covered professional services" has the meaning given such term in subsection (k)(3).
(B) EHR reporting period
The term "EHR reporting period" means, with respect to a payment year, any period (or periods) as specified by the Secretary.
(C) Eligible professional
The term "eligible professional" means a physician, as defined in
(p) Establishment of value-based payment modifier
(1) In general
The Secretary shall establish a payment modifier that provides for differential payment to a physician or a group of physicians under the fee schedule established under subsection (b) based upon the quality of care furnished compared to cost (as determined under paragraphs (2) and (3), respectively) during a performance period. Such payment modifier shall be separate from the geographic adjustment factors established under subsection (e).
(2) Quality
(A) In general
For purposes of paragraph (1), quality of care shall be evaluated, to the extent practicable, based on a composite of measures of the quality of care furnished (as established by the Secretary under subparagraph (B)).
(B) Measures
(i) The Secretary shall establish appropriate measures of the quality of care furnished by a physician or group of physicians to individuals enrolled under this part, such as measures that reflect health outcomes. Such measures shall be risk adjusted as determined appropriate by the Secretary.
(ii) The Secretary shall seek endorsement of the measures established under this subparagraph by the entity with a contract under
(C) Continued application for purposes of MIPS
The Secretary shall, in accordance with subsection (q)(1)(F), carry out subparagraph (B) for purposes of subsection (q).
(3) Costs
For purposes of paragraph (1), costs shall be evaluated, to the extent practicable, based on a composite of appropriate measures of costs established by the Secretary (such as the composite measure under the methodology established under subsection (n)(9)(C)(iii)) that eliminate the effect of geographic adjustments in payment rates (as described in subsection (e)), and take into account risk factors (such as socioeconomic and demographic characteristics, ethnicity, and health status of individuals (such as to recognize that less healthy individuals may require more intensive interventions) 10 and other factors determined appropriate by the Secretary. With respect to 2019 and each subsequent year, the Secretary shall, in accordance with subsection (q)(1)(F), carry out this paragraph for purposes of subsection (q).
(4) Implementation
(A) Publication of measures, dates of implementation, performance period
Not later than January 1, 2012, the Secretary shall publish the following:
(i) The measures of quality of care and costs established under paragraphs (2) and (3), respectively.
(ii) The dates for implementation of the payment modifier (as determined under subparagraph (B)).
(iii) The initial performance period (as specified under subparagraph (B)(ii)).
(B) Deadlines for implementation
(i) Initial implementation
Subject to the preceding provisions of this subparagraph, the Secretary shall begin implementing the payment modifier established under this subsection through the rulemaking process during 2013 for the physician fee schedule established under subsection (b).
(ii) Initial performance period
(I) In general
The Secretary shall specify an initial performance period for application of the payment modifier established under this subsection with respect to 2015.
(II) Provision of information during initial performance period
During the initial performance period, the Secretary shall, to the extent practicable, provide information to physicians and groups of physicians about the quality of care furnished by the physician or group of physicians to individuals enrolled under this part compared to cost (as determined under paragraphs (2) and (3), respectively) with respect to the performance period.
(iii) Application
The Secretary shall apply the payment modifier established under this subsection for items and services furnished on or after January 1, 2015, with respect to specific physicians and groups of physicians the Secretary determines appropriate, and for services furnished on or after January 1, 2017, with respect to all physicians and groups of physicians. Such payment modifier shall not be applied for items and services furnished on or after January 1, 2019.
(C) Budget neutrality
The payment modifier established under this subsection shall be implemented in a budget neutral manner.
(5) Systems-based care
The Secretary shall, as appropriate, apply the payment modifier established under this subsection in a manner that promotes systems-based care.
(6) Consideration of special circumstances of certain providers
In applying the payment modifier under this subsection, the Secretary shall, as appropriate, take into account the special circumstances of physicians or groups of physicians in rural areas and other underserved communities.
(7) Application
For purposes of the initial application of the payment modifier established under this subsection during the period beginning on January 1, 2015, and ending on December 31, 2016, the term "physician" has the meaning given such term in
(8) Definitions
For purposes of this subsection:
(A) Costs
The term "costs" means expenditures per individual as determined appropriate by the Secretary. In making the determination under the preceding sentence, the Secretary may take into account the amount of growth in expenditures per individual for a physician compared to the amount of such growth for other physicians.
(B) Performance period
The term "performance period" means a period specified by the Secretary.
(9) Coordination with other value-based purchasing reforms
The Secretary shall coordinate the value-based payment modifier established under this subsection with the Physician Feedback Program under subsection (n) and, as the Secretary determines appropriate, other similar provisions of this subchapter.
(10) Limitations on review
There shall be no administrative or judicial review under
(A) the establishment of the value-based payment modifier under this subsection;
(B) the evaluation of quality of care under paragraph (2), including the establishment of appropriate measures of the quality of care under paragraph (2)(B);
(C) the evaluation of costs under paragraph (3), including the establishment of appropriate measures of costs under such paragraph;
(D) the dates for implementation of the value-based payment modifier;
(E) the specification of the initial performance period and any other performance period under paragraphs (4)(B)(ii) and (8)(B), respectively;
(F) the application of the value-based payment modifier under paragraph (7); and
(G) the determination of costs under paragraph (8)(A).
(q) Merit-based Incentive Payment System
(1) Establishment
(A) In general
Subject to the succeeding provisions of this subsection, the Secretary shall establish an eligible professional Merit-based Incentive Payment System (in this subsection referred to as the "MIPS") under which the Secretary shall—
(i) develop a methodology for assessing the total performance of each MIPS eligible professional according to performance standards under paragraph (3) for a performance period (as established under paragraph (4)) for a year;
(ii) using such methodology, provide for a composite performance score in accordance with paragraph (5) for each such professional for each performance period; and
(iii) use such composite performance score of the MIPS eligible professional for a performance period for a year to determine and apply a MIPS adjustment factor (and, as applicable, an additional MIPS adjustment factor) under paragraph (6) to the professional for the year.
Notwithstanding subparagraph (C)(ii), under the MIPS, the Secretary shall permit any eligible professional (as defined in subsection (k)(3)(B)) to report on applicable measures and activities described in paragraph (2)(B).
(B) Program implementation
The MIPS shall apply to payments for covered professional services (as defined in subsection (k)(3)(A)) furnished on or after January 1, 2019.
(C) MIPS eligible professional defined
(i) In general
For purposes of this subsection, subject to clauses (ii) and (iv), the term "MIPS eligible professional" means—
(I) for the first and second years for which the MIPS applies to payments (and for the performance period for such first and second year), a physician (as defined in
(II) for the third year for which the MIPS applies to payments (and for the performance period for such third year) and for each succeeding year (and for the performance period for each such year), the professionals described in subclause (I), such other eligible professionals (as defined in subsection (k)(3)(B)) as specified by the Secretary, and a group that includes such professionals.
(ii) Exclusions
For purposes of clause (i), the term "MIPS eligible professional" does not include, with respect to a year, an eligible professional (as defined in subsection (k)(3)(B)) who—
(I) is a qualifying APM participant (as defined in
(II) subject to clause (vii), is a partial qualifying APM participant (as defined in clause (iii)) for the most recent period for which data are available and who, for the performance period with respect to such year, does not report on applicable measures and activities described in paragraph (2)(B) that are required to be reported by such a professional under the MIPS; or
(III) for the performance period with respect to such year, does not exceed the low-volume threshold measurement selected under clause (iv).
(iii) Partial qualifying APM participant
For purposes of this subparagraph, the term "partial qualifying APM participant" means, with respect to a year, an eligible professional for whom the Secretary determines the minimum payment percentage (or percentages), as applicable, described in paragraph (2) of
(I) with respect to 2019 and 2020, the reference in subparagraph (A) of such paragraph to 25 percent was instead a reference to 20 percent;
(II) with respect to each of 2021 through 2026—
(aa) the reference in subparagraph (B)(i) of such paragraph to 50 percent was instead a reference to 40 percent; and
(bb) the references in subparagraph (B)(ii) of such paragraph to 50 percent and 25 percent of such paragraph 7 were instead references to 40 percent and 20 percent, respectively; and
(III) with respect to 2027 and subsequent years—
(aa) the reference in subparagraph (C)(i) of such paragraph to 75 percent was instead a reference to 50 percent; and
(bb) the references in subparagraph (C)(ii) of such paragraph to 75 percent and 25 percent of such paragraph 7 were instead references to 50 percent and 20 percent, respectively.
(iv) Selection of low-volume threshold measurement
The Secretary shall select a low-volume threshold to apply for purposes of clause (ii)(III), which may include one or more or a combination of the following:
(I) The minimum number (as determined by the Secretary) of—
(aa) for performance periods beginning before January 1, 2018, individuals enrolled under this part who are treated by the eligible professional for the performance period involved; and
(bb) for performance periods beginning on or after January 1, 2018, individuals enrolled under this part who are furnished covered professional services (as defined in subsection (k)(3)(A)) by the eligible professional for the performance period involved.
(II) The minimum number (as determined by the Secretary) of covered professional services (as defined in subsection (k)(3)(A)) furnished to individuals enrolled under this part by such professional for such performance period.
(III) The minimum amount (as determined by the Secretary) of—
(aa) for performance periods beginning before January 1, 2018, allowed charges billed by such professional under this part for such performance period; and
(bb) for performance periods beginning on or after January 1, 2018, allowed charges for covered professional services (as defined in subsection (k)(3)(A)) billed by such professional for such performance period.
(v) Treatment of new Medicare enrolled eligible professionals
In the case of a professional who first becomes a Medicare enrolled eligible professional during the performance period for a year (and had not previously submitted claims under this subchapter such as a person, an entity, or a part of a physician group or under a different billing number or tax identifier), such professional shall not be treated under this subsection as a MIPS eligible professional until the subsequent year and performance period for such subsequent year.
(vi) Clarification
In the case of items and services furnished during a year by an individual who is not a MIPS eligible professional (including pursuant to clauses (ii) and (v)) with respect to a year, in no case shall a MIPS adjustment factor (or additional MIPS adjustment factor) under paragraph (6) apply to such individual for such year.
(vii) Partial qualifying APM participant clarifications
(I) Treatment as MIPS eligible professional
In the case of an eligible professional who is a partial qualifying APM participant, with respect to a year, and who, for the performance period for such year, reports on applicable measures and activities described in paragraph (2)(B) that are required to be reported by such a professional under the MIPS, such eligible professional is considered to be a MIPS eligible professional with respect to such year.
(II) Not eligible for qualifying APM participant payments
In no case shall an eligible professional who is a partial qualifying APM participant, with respect to a year, be considered a qualifying APM participant (as defined in paragraph (2) of
(D) Application to group practices
(i) In general
Under the MIPS:
(I) Quality performance category
The Secretary shall establish and apply a process that includes features of the provisions of subsection (m)(3)(C) for MIPS eligible professionals in a group practice with respect to assessing performance of such group with respect to the performance category described in clause (i) of paragraph (2)(A).
(II) Other performance categories
The Secretary may establish and apply a process that includes features of the provisions of subsection (m)(3)(C) for MIPS eligible professionals in a group practice with respect to assessing the performance of such group with respect to the performance categories described in clauses (ii) through (iv) of such paragraph.
(ii) Ensuring comprehensiveness of group practice assessment
The process established under clause (i) shall to the extent practicable reflect the range of items and services furnished by the MIPS eligible professionals in the group practice involved.
(E) Use of registries
Under the MIPS, the Secretary shall encourage the use of qualified clinical data registries pursuant to subsection (m)(3)(E) in carrying out this subsection.
(F) Application of certain provisions
In applying a provision of subsection (k), (m), (o), or (p) for purposes of this subsection, the Secretary shall—
(i) adjust the application of such provision to ensure the provision is consistent with the provisions of this subsection; and
(ii) not apply such provision to the extent that the provision is duplicative with a provision of this subsection.
(G) Accounting for risk factors
(i) Risk factors
Taking into account the relevant studies conducted and recommendations made in reports under section 2(d) of the Improving Medicare Post-Acute Care Transformation Act of 2014, and, as appropriate, other information, including information collected before completion of such studies and recommendations, the Secretary, on an ongoing basis, shall, as the Secretary determines appropriate and based on an individual's health status and other risk factors—
(I) assess appropriate adjustments to quality measures, resource use measures, and other measures used under the MIPS; and
(II) assess and implement appropriate adjustments to payment adjustments, composite performance scores, scores for performance categories, or scores for measures or activities under the MIPS.
(2) Measures and activities under performance categories
(A) Performance categories
Under the MIPS, the Secretary shall use the following performance categories (each of which is referred to in this subsection as a performance category) in determining the composite performance score under paragraph (5):
(i) Quality.
(ii) Resource use.
(iii) Clinical practice improvement activities.
(iv) Meaningful use of certified EHR technology.
(B) Measures and activities specified for each category
For purposes of paragraph (3)(A) and subject to subparagraph (C), measures and activities specified for a performance period (as established under paragraph (4)) for a year are as follows:
(i) Quality
For the performance category described in subparagraph (A)(i), the quality measures included in the final measures list published under subparagraph (D)(i) for such year and the list of quality measures described in subparagraph (D)(vi) used by qualified clinical data registries under subsection (m)(3)(E).
(ii) Resource use
For the performance category described in subparagraph (A)(ii), the measurement of resource use for such period under subsection (p)(3), using the methodology under subsection (r) as appropriate, and, as feasible and applicable, accounting for the cost of drugs under part D.
(iii) Clinical practice improvement activities
For the performance category described in subparagraph (A)(iii), clinical practice improvement activities (as defined in subparagraph (C)(v)(III)) under subcategories specified by the Secretary for such period, which shall include at least the following:
(I) The subcategory of expanded practice access, such as same day appointments for urgent needs and after hours access to clinician advice.
(II) The subcategory of population management, such as monitoring health conditions of individuals to provide timely health care interventions or participation in a qualified clinical data registry.
(III) The subcategory of care coordination, such as timely communication of test results, timely exchange of clinical information to patients and other providers, and use of remote monitoring or telehealth.
(IV) The subcategory of beneficiary engagement, such as the establishment of care plans for individuals with complex care needs, beneficiary self-management assessment and training, and using shared decision-making mechanisms. This subcategory shall include as an activity, for performance periods beginning on or after January 1, 2022, use of a real-time benefit tool as described in
(V) The subcategory of patient safety and practice assessment, such as through use of clinical or surgical checklists and practice assessments related to maintaining certification.
(VI) The subcategory of participation in an alternative payment model (as defined in
In establishing activities under this clause, the Secretary shall give consideration to the circumstances of small practices (consisting of 15 or fewer professionals) and practices located in rural areas and in health professional shortage areas (as designated under
(iv) Meaningful EHR use
For the performance category described in subparagraph (A)(iv), the requirements established for such period under subsection (o)(2) for determining whether an eligible professional is a meaningful EHR user.
(C) Additional provisions
(i) Emphasizing outcome measures under the quality performance category
In applying subparagraph (B)(i), the Secretary shall, as feasible, emphasize the application of outcome measures.
(ii) Application of additional system measures
The Secretary may use measures used for a payment system other than for physicians, such as measures for inpatient hospitals, for purposes of the performance categories described in clauses (i) and (ii) of subparagraph (A). For purposes of the previous sentence, the Secretary may not use measures for hospital outpatient departments, except in the case of items and services furnished by emergency physicians, radiologists, and anesthesiologists.
(iii) Global and population-based measures
The Secretary may use global measures, such as global outcome measures, and population-based measures for purposes of the performance category described in subparagraph (A)(i).
(iv) Application of measures and activities to non-patient-facing professionals
In carrying out this paragraph, with respect to measures and activities specified in subparagraph (B) for performance categories described in subparagraph (A), the Secretary—
(I) shall give consideration to the circumstances of professional types (or subcategories of those types determined by practice characteristics) who typically furnish services that do not involve face-to-face interaction with a patient; and
(II) may, to the extent feasible and appropriate, take into account such circumstances and apply under this subsection with respect to MIPS eligible professionals of such professional types or subcategories, alternative measures or activities that fulfill the goals of the applicable performance category.
In carrying out the previous sentence, the Secretary shall consult with professionals of such professional types or subcategories.
(v) Clinical practice improvement activities
(I) Request for information
In initially applying subparagraph (B)(iii), the Secretary shall use a request for information to solicit recommendations from stakeholders to identify activities described in such subparagraph and specifying criteria for such activities.
(II) Contract authority for clinical practice improvement activities performance category
In applying subparagraph (B)(iii), the Secretary may contract with entities to assist the Secretary in—
(aa) identifying activities described in subparagraph (B)(iii);
(bb) specifying criteria for such activities; and
(cc) determining whether a MIPS eligible professional meets such criteria.
(III) Clinical practice improvement activities defined
For purposes of this subsection, the term "clinical practice improvement activity" means an activity that relevant eligible professional organizations and other relevant stakeholders identify as improving clinical practice or care delivery and that the Secretary determines, when effectively executed, is likely to result in improved outcomes.
(D) Annual list of quality measures available for MIPS assessment
(i) In general
Under the MIPS, the Secretary, through notice and comment rulemaking and subject to the succeeding clauses of this subparagraph, shall, with respect to the performance period for a year, establish an annual final list of quality measures from which MIPS eligible professionals may choose for purposes of assessment under this subsection for such performance period. Pursuant to the previous sentence, the Secretary shall—
(I) not later than November 1 of the year prior to the first day of the first performance period under the MIPS, establish and publish in the Federal Register a final list of quality measures; and
(II) not later than November 1 of the year prior to the first day of each subsequent performance period, update the final list of quality measures from the previous year (and publish such updated final list in the Federal Register), by—
(aa) removing from such list, as appropriate, quality measures, which may include the removal of measures that are no longer meaningful (such as measures that are topped out);
(bb) adding to such list, as appropriate, new quality measures; and
(cc) determining whether or not quality measures on such list that have undergone substantive changes should be included in the updated list.
(ii) Call for quality measures
(I) In general
Eligible professional organizations and other relevant stakeholders shall be requested to identify and submit quality measures to be considered for selection under this subparagraph in the annual list of quality measures published under clause (i) and to identify and submit updates to the measures on such list. For purposes of the previous sentence, measures may be submitted regardless of whether such measures were previously published in a proposed rule or endorsed by an entity with a contract under
(II) Eligible professional organization defined
In this subparagraph, the term "eligible professional organization" means a professional organization as defined by nationally recognized specialty boards of certification or equivalent certification boards.
(iii) Requirements
In selecting quality measures for inclusion in the annual final list under clause (i), the Secretary shall—
(I) provide that, to the extent practicable, all quality domains (as defined in subsection (s)(1)(B)) are addressed by such measures; and
(II) ensure that such selection is consistent with the process for selection of measures under subsections (k), (m), and (p)(2).
(iv) Peer review
Before including a new measure in the final list of measures published under clause (i) for a year, the Secretary shall submit for publication in applicable specialty-appropriate, peer-reviewed journals such measure and the method for developing and selecting such measure, including clinical and other data supporting such measure.
(v) Measures for inclusion
The final list of quality measures published under clause (i) shall include, as applicable, measures under subsections (k), (m), and (p)(2), including quality measures from among—
(I) measures endorsed by a consensus-based entity;
(II) measures developed under subsection (s); and
(III) measures submitted under clause (ii)(I).
Any measure selected for inclusion in such list that is not endorsed by a consensus-based entity shall have a focus that is evidence-based.
(vi) Exception for qualified clinical data registry measures
Measures used by a qualified clinical data registry under subsection (m)(3)(E) shall not be subject to the requirements under clauses (i), (iv), and (v). The Secretary shall publish the list of measures used by such qualified clinical data registries on the Internet website of the Centers for Medicare & Medicaid Services.
(vii) Exception for existing quality measures
Any quality measure specified by the Secretary under subsection (k) or (m), including under subsection (m)(3)(E), and any measure of quality of care established under subsection (p)(2) for the reporting period or performance period under the respective subsection beginning before the first performance period under the MIPS—
(I) shall not be subject to the requirements under clause (i) (except under items (aa) and (cc) of subclause (II) of such clause) or to the requirement under clause (iv); and
(II) shall be included in the final list of quality measures published under clause (i) unless removed under clause (i)(II)(aa).
(viii) Consultation with relevant eligible professional organizations and other relevant stakeholders
Relevant eligible professional organizations and other relevant stakeholders, including State and national medical societies, shall be consulted in carrying out this subparagraph.
(ix) Optional application
The process under
(3) Performance standards
(A) Establishment
Under the MIPS, the Secretary shall establish performance standards with respect to measures and activities specified under paragraph (2)(B) for a performance period (as established under paragraph (4)) for a year.
(B) Considerations in establishing standards
In establishing such performance standards with respect to measures and activities specified under paragraph (2)(B), the Secretary shall consider the following:
(i) Historical performance standards.
(ii) Improvement.
(iii) The opportunity for continued improvement.
(4) Performance period
The Secretary shall establish a performance period (or periods) for a year (beginning with 2019). Such performance period (or periods) shall begin and end prior to the beginning of such year and be as close as possible to such year. In this subsection, such performance period (or periods) for a year shall be referred to as the performance period for the year.
(5) Composite performance score
(A) In general
Subject to the succeeding provisions of this paragraph and taking into account, as available and applicable, paragraph (1)(G), the Secretary shall develop a methodology for assessing the total performance of each MIPS eligible professional according to performance standards under paragraph (3) with respect to applicable measures and activities specified in paragraph (2)(B) with respect to each performance category applicable to such professional for a performance period (as established under paragraph (4)) for a year. Using such methodology, the Secretary shall provide for a composite assessment (using a scoring scale of 0 to 100) for each such professional for the performance period for such year. In this subsection such a composite assessment for such a professional with respect to a performance period shall be referred to as the "composite performance score" for such professional for such performance period.
(B) Incentive to report; encouraging use of certified EHR technology for reporting quality measures
(i) Incentive to report
Under the methodology established under subparagraph (A), the Secretary shall provide that in the case of a MIPS eligible professional who fails to report on an applicable measure or activity that is required to be reported by the professional, the professional shall be treated as achieving the lowest potential score applicable to such measure or activity.
(ii) Encouraging use of certified EHR technology and qualified clinical data registries for reporting quality measures
Under the methodology established under subparagraph (A), the Secretary shall—
(I) encourage MIPS eligible professionals to report on applicable measures with respect to the performance category described in paragraph (2)(A)(i) through the use of certified EHR technology and qualified clinical data registries; and
(II) with respect to a performance period, with respect to a year, for which a MIPS eligible professional reports such measures through the use of such EHR technology, treat such professional as satisfying the clinical quality measures reporting requirement described in subsection (o)(2)(A)(iii) for such year.
(C) Clinical practice improvement activities performance score
(i) Rule for certification
A MIPS eligible professional who is in a practice that is certified as a patient-centered medical home or comparable specialty practice, as determined by the Secretary, with respect to a performance period shall be given the highest potential score for the performance category described in paragraph (2)(A)(iii) for such period.
(ii) APM participation
Participation by a MIPS eligible professional in an alternative payment model (as defined in
(iii) Subcategories
A MIPS eligible professional shall not be required to perform activities in each subcategory under paragraph (2)(B)(iii) or participate in an alternative payment model in order to achieve the highest potential score for the performance category described in paragraph (2)(A)(iii).
(D) Achievement and improvement
(i) Taking into account improvement
Beginning with the second year to which the MIPS applies, in addition to the achievement of a MIPS eligible professional, if data sufficient to measure improvement is available, the methodology developed under subparagraph (A)—
(I) in the case of the performance score for the performance category described in clauses (i) and (ii) of paragraph (2)(A), subject to clause (iii), shall take into account the improvement of the professional; and
(II) in the case of performance scores for other performance categories, may take into account the improvement of the professional.
(ii) Assigning higher weight for achievement
Subject to clause (i), under the methodology developed under subparagraph (A), the Secretary may assign a higher scoring weight under subparagraph (F) with respect to the achievement of a MIPS eligible professional than with respect to any improvement of such professional applied under clause (i) with respect to a measure, activity, or category described in paragraph (2).
(iii) Transition years
For each of the second, third, fourth, and fifth years for which the MIPS applies to payments, the performance score for the performance category described in paragraph (2)(A)(ii) shall not take into account the improvement of the professional involved.
(E) Weights for the performance categories
(i) In general
Under the methodology developed under subparagraph (A), subject to subparagraph (F)(i) and clause (ii), the composite performance score shall be determined as follows:
(I) Quality
(aa) In general
Subject to item (bb), thirty percent of such score shall be based on performance with respect to the category described in clause (i) of paragraph (2)(A). In applying the previous sentence, the Secretary shall, as feasible, encourage the application of outcome measures within such category.
(bb) First 5 years
For each of the first through fifth years for which the MIPS applies to payments, the percentage applicable under item (aa) shall be increased in a manner such that the total percentage points of the increase under this item for the respective year equals the total number of percentage points by which the percentage applied under subclause (II)(bb) for the respective year is less than 30 percent.
(II) Resource use
(aa) In general
Subject to item (bb), thirty percent of such score shall be based on performance with respect to the category described in clause (ii) of paragraph (2)(A).
(bb) First 5 years
For the first year for which the MIPS applies to payments, not more than 10 percent of such score shall be based on performance with respect to the category described in clause (ii) of paragraph (2)(A). For each of the second, third, fourth, and fifth years for which the MIPS applies to payments, not less than 10 percent and not more than 30 percent of such score shall be based on performance with respect to the category described in clause (ii) of paragraph (2)(A). Nothing in the previous sentence shall be construed, with respect to a performance period for a year described in the previous sentence, as preventing the Secretary from basing 30 percent of such score for such year with respect to the category described in such clause (ii), if the Secretary determines, based on information posted under subsection (r)(2)(I) that sufficient resource use measures are ready for adoption for use under the performance category under paragraph (2)(A)(ii) for such performance period.
(III) Clinical practice improvement activities
Fifteen percent of such score shall be based on performance with respect to the category described in clause (iii) of paragraph (2)(A).
(IV) Meaningful use of certified EHR technology
Twenty-five percent of such score shall be based on performance with respect to the category described in clause (iv) of paragraph (2)(A).
(ii) Authority to adjust percentages in case of high EHR meaningful use adoption
In any year in which the Secretary estimates that the proportion of eligible professionals (as defined in subsection (o)(5)) who are meaningful EHR users (as determined under subsection (o)(2)) is 75 percent or greater, the Secretary may reduce the percent applicable under clause (i)(IV), but not below 15 percent. If the Secretary makes such reduction for a year, subject to subclauses (I)(bb) and (II)(bb) of clause (i), the percentages applicable under one or more of subclauses (I), (II), and (III) of clause (i) for such year shall be increased in a manner such that the total percentage points of the increase under this clause for such year equals the total number of percentage points reduced under the preceding sentence for such year.
(F) Certain flexibility for weighting performance categories, measures, and activities
Under the methodology under subparagraph (A), if there are not sufficient measures and activities (described in paragraph (2)(B)) applicable and available to each type of eligible professional involved, the Secretary shall assign different scoring weights (including a weight of 0)—
(i) which may vary from the scoring weights specified in subparagraph (E), for each performance category based on the extent to which the category is applicable to the type of eligible professional involved; and
(ii) for each measure and activity specified under paragraph (2)(B) with respect to each such category based on the extent to which the measure or activity is applicable and available to the type of eligible professional involved.
(G) Resource use
Analysis of the performance category described in paragraph (2)(A)(ii) shall include results from the methodology described in subsection (r)(5), as appropriate.
(H) Inclusion of quality measure data from other payers
In applying subsections (k), (m), and (p) with respect to measures described in paragraph (2)(B)(i), analysis of the performance category described in paragraph (2)(A)(i) may include data submitted by MIPS eligible professionals with respect to items and services furnished to individuals who are not individuals entitled to benefits under part A or enrolled under part B.
(I) Use of voluntary virtual groups for certain assessment purposes
(i) In general
In the case of MIPS eligible professionals electing to be a virtual group under clause (ii) with respect to a performance period for a year, for purposes of applying the methodology under subparagraph (A) with respect to the performance categories described in clauses (i) and (ii) of paragraph (2)(A)—
(I) the assessment of performance provided under such methodology with respect to such performance categories that is to be applied to each such professional in such group for such performance period shall be with respect to the combined performance of all such professionals in such group for such period; and
(II) with respect to the composite performance score provided under this paragraph for such performance period for each such MIPS eligible professional in such virtual group, the components of the composite performance score that assess performance with respect to such performance categories shall be based on the assessment of the combined performance under subclause (I) for such performance categories and performance period.
(ii) Election of practices to be a virtual group
The Secretary shall, in accordance with the requirements under clause (iii), establish and have in place a process to allow an individual MIPS eligible professional or a group practice consisting of not more than 10 MIPS eligible professionals to elect, with respect to a performance period for a year to be a virtual group under this subparagraph with at least one other such individual MIPS eligible professional or group practice. Such a virtual group may be based on appropriate classifications of providers, such as by geographic areas or by provider specialties defined by nationally recognized specialty boards of certification or equivalent certification boards.
(iii) Requirements
The requirements for the process under clause (ii) shall—
(I) provide that an election under such clause, with respect to a performance period, shall be made before the beginning of such performance period and may not be changed during such performance period;
(II) provide that an individual MIPS eligible professional and a group practice described in clause (ii) may elect to be in no more than one virtual group for a performance period and that, in the case of such a group practice that elects to be in such virtual group for such performance period, such election applies to all MIPS eligible professionals in such group practice;
(III) provide that a virtual group be a combination of tax identification numbers;
(IV) provide for formal written agreements among MIPS eligible professionals electing to be a virtual group under this subparagraph; and
(V) include such other requirements as the Secretary determines appropriate.
(6) MIPS payments
(A) MIPS adjustment factor
Taking into account paragraph (1)(G), the Secretary shall specify a MIPS adjustment factor for each MIPS eligible professional for a year. Such MIPS adjustment factor for a MIPS eligible professional for a year shall be in the form of a percent and shall be determined—
(i) by comparing the composite performance score of the eligible professional for such year to the performance threshold established under subparagraph (D)(i) for such year;
(ii) in a manner such that the adjustment factors specified under this subparagraph for a year result in differential payments under this paragraph reflecting that—
(I) MIPS eligible professionals with composite performance scores for such year at or above such performance threshold for such year receive zero or positive payment adjustment factors for such year in accordance with clause (iii), with such professionals having higher composite performance scores receiving higher adjustment factors; and
(II) MIPS eligible professionals with composite performance scores for such year below such performance threshold for such year receive negative payment adjustment factors for such year in accordance with clause (iv), with such professionals having lower composite performance scores receiving lower adjustment factors;
(iii) in a manner such that MIPS eligible professionals with composite scores described in clause (ii)(I) for such year, subject to clauses (i) and (ii) of subparagraph (F), receive a zero or positive adjustment factor on a linear sliding scale such that an adjustment factor of 0 percent is assigned for a score at the performance threshold and an adjustment factor of the applicable percent specified in subparagraph (B) is assigned for a score of 100; and
(iv) in a manner such that—
(I) subject to subclause (II), MIPS eligible professionals with composite performance scores described in clause (ii)(II) for such year receive a negative payment adjustment factor on a linear sliding scale such that an adjustment factor of 0 percent is assigned for a score at the performance threshold and an adjustment factor of the negative of the applicable percent specified in subparagraph (B) is assigned for a score of 0; and
(II) MIPS eligible professionals with composite performance scores that are equal to or greater than 0, but not greater than ¼ of the performance threshold specified under subparagraph (D)(i) for such year, receive a negative payment adjustment factor that is equal to the negative of the applicable percent specified in subparagraph (B) for such year.
(B) Applicable percent defined
For purposes of this paragraph, the term "applicable percent" means—
(i) for 2019, 4 percent;
(ii) for 2020, 5 percent;
(iii) for 2021, 7 percent; and
(iv) for 2022 and subsequent years, 9 percent.
(C) Additional MIPS adjustment factors for exceptional performance
For 2019 and each subsequent year through 2024, in the case of a MIPS eligible professional with a composite performance score for a year at or above the additional performance threshold under subparagraph (D)(ii) for such year, in addition to the MIPS adjustment factor under subparagraph (A) for the eligible professional for such year, subject to subparagraph (F)(iv), the Secretary shall specify an additional positive MIPS adjustment factor for such professional and year. Such additional MIPS adjustment factors shall be in the form of a percent and determined by the Secretary in a manner such that professionals having higher composite performance scores above the additional performance threshold receive higher additional MIPS adjustment factors.
(D) Establishment of performance thresholds
(i) Performance threshold
For each year of the MIPS, the Secretary shall compute a performance threshold with respect to which the composite performance score of MIPS eligible professionals shall be compared for purposes of determining adjustment factors under subparagraph (A) that are positive, negative, and zero. Subject to clauses (iii) and (iv), such performance threshold for a year shall be the mean or median (as selected by the Secretary) of the composite performance scores for all MIPS eligible professionals with respect to a prior period specified by the Secretary. The Secretary may reassess the selection of the mean or median under the previous sentence every 3 years.
(ii) Additional performance threshold for exceptional performance
In addition to the performance threshold under clause (i), for each year of the MIPS (beginning with 2019 and ending with 2024), the Secretary shall compute an additional performance threshold for purposes of determining the additional MIPS adjustment factors under subparagraph (C). For each such year, subject to clause (iii), the Secretary shall apply either of the following methods for computing such additional performance threshold for such a year:
(I) The threshold shall be the score that is equal to the 25th percentile of the range of possible composite performance scores above the performance threshold determined under clause (i).
(II) The threshold shall be the score that is equal to the 25th percentile of the actual composite performance scores for MIPS eligible professionals with composite performance scores at or above the performance threshold with respect to the prior period described in clause (i).
(iii) Special rule for initial 5 years
With respect to each of the first five years to which the MIPS applies, the Secretary shall, prior to the performance period for such years, establish a performance threshold for purposes of determining MIPS adjustment factors under subparagraph (A) and a threshold for purposes of determining additional MIPS adjustment factors under subparagraph (C). Each such performance threshold shall—
(I) be based on a period prior to such performance periods; and
(II) take into account—
(aa) data available with respect to performance on measures and activities that may be used under the performance categories under subparagraph (2)(B); and
(bb) other factors determined appropriate by the Secretary.
(iv) Additional special rule for third, fourth and fifth years of MIPS
For purposes of determining MIPS adjustment factors under subparagraph (A), in addition to the requirements specified in clause (iii), the Secretary shall increase the performance threshold with respect to each of the third, fourth, and fifth years to which the MIPS applies to ensure a gradual and incremental transition to the performance threshold described in clause (i) (as estimated by the Secretary) with respect to the sixth year to which the MIPS applies.
(E) Application of MIPS adjustment factors
In the case of covered professional services (as defined in subsection (k)(3)(A)) furnished by a MIPS eligible professional during a year (beginning with 2019), the amount otherwise paid under this part with respect to such covered professional services and MIPS eligible professional for such year, shall be multiplied by—
(i) 1, plus
(ii) the sum of—
(I) the MIPS adjustment factor determined under subparagraph (A) divided by 100, and
(II) as applicable, the additional MIPS adjustment factor determined under subparagraph (C) divided by 100.
(F) Aggregate application of MIPS adjustment factors
(i) Application of scaling factor
(I) In general
With respect to positive MIPS adjustment factors under subparagraph (A)(ii)(I) for eligible professionals whose composite performance score is above the performance threshold under subparagraph (D)(i) for such year, subject to subclause (II), the Secretary shall increase or decrease such adjustment factors by a scaling factor in order to ensure that the budget neutrality requirement of clause (ii) is met.
(II) Scaling factor limit
In no case may the scaling factor applied under this clause exceed 3.0.
(ii) Budget neutrality requirement
(I) In general
Subject to clause (iii), the Secretary shall ensure that the estimated amount described in subclause (II) for a year is equal to the estimated amount described in subclause (III) for such year.
(II) Aggregate increases
The amount described in this subclause is the estimated increase in the aggregate allowed charges resulting from the application of positive MIPS adjustment factors under subparagraph (A) (after application of the scaling factor described in clause (i)) to MIPS eligible professionals whose composite performance score for a year is above the performance threshold under subparagraph (D)(i) for such year.
(III) Aggregate decreases
The amount described in this subclause is the estimated decrease in the aggregate allowed charges resulting from the application of negative MIPS adjustment factors under subparagraph (A) to MIPS eligible professionals whose composite performance score for a year is below the performance threshold under subparagraph (D)(i) for such year.
(iii) Exceptions
(I) In the case that all MIPS eligible professionals receive composite performance scores for a year that are below the performance threshold under subparagraph (D)(i) for such year, the negative MIPS adjustment factors under subparagraph (A) shall apply with respect to such MIPS eligible professionals and the budget neutrality requirement of clause (ii) and the additional adjustment factors under clause (iv) shall not apply for such year.
(II) In the case that, with respect to a year, the application of clause (i) results in a scaling factor equal to the maximum scaling factor specified in clause (i)(II), such scaling factor shall apply and the budget neutrality requirement of clause (ii) shall not apply for such year.
(iv) Additional incentive payment adjustments
(I) In general
Subject to subclause (II), in specifying the MIPS additional adjustment factors under subparagraph (C) for each applicable MIPS eligible professional for a year, the Secretary shall ensure that the estimated aggregate increase in payments under this part resulting from the application of such additional adjustment factors for MIPS eligible professionals in a year shall be equal (as estimated by the Secretary) to $500,000,000 for each year beginning with 2019 and ending with 2024.
(II) Limitation on additional incentive payment adjustments
The MIPS additional adjustment factor under subparagraph (C) for a year for an applicable MIPS eligible professional whose composite performance score is above the additional performance threshold under subparagraph (D)(ii) for such year shall not exceed 10 percent. The application of the previous sentence may result in an aggregate amount of additional incentive payments that are less than the amount specified in subclause (I).
(7) Announcement of result of adjustments
Under the MIPS, the Secretary shall, not later than 30 days prior to January 1 of the year involved, make available to MIPS eligible professionals the MIPS adjustment factor (and, as applicable, the additional MIPS adjustment factor) under paragraph (6) applicable to the eligible professional for covered professional services (as defined in subsection (k)(3)(A)) furnished by the professional for such year. The Secretary may include such information in the confidential feedback under paragraph (12).
(8) No effect in subsequent years
The MIPS adjustment factors and additional MIPS adjustment factors under paragraph (6) shall apply only with respect to the year involved, and the Secretary shall not take into account such adjustment factors in making payments to a MIPS eligible professional under this part in a subsequent year.
(9) Public reporting
(A) In general
The Secretary shall, in an easily understandable format, make available on the Physician Compare Internet website of the Centers for Medicare & Medicaid Services the following:
(i) Information regarding the performance of MIPS eligible professionals under the MIPS, which—
(I) shall include the composite score for each such MIPS eligible professional and the performance of each such MIPS eligible professional with respect to each performance category; and
(II) may include the performance of each such MIPS eligible professional with respect to each measure or activity specified in paragraph (2)(B).
(ii) The names of eligible professionals in eligible alternative payment models 11 (as defined in
(B) Disclosure
The information made available under this paragraph shall indicate, where appropriate, that publicized information may not be representative of the eligible professional's entire patient population, the variety of services furnished by the eligible professional, or the health conditions of individuals treated.
(C) Opportunity to review and submit corrections
The Secretary shall provide for an opportunity for a professional described in subparagraph (A) to review, and submit corrections for, the information to be made public with respect to the professional under such subparagraph prior to such information being made public.
(D) Aggregate information
The Secretary shall periodically post on the Physician Compare Internet website aggregate information on the MIPS, including the range of composite scores for all MIPS eligible professionals and the range of the performance of all MIPS eligible professionals with respect to each performance category.
(10) Consultation
The Secretary shall consult with stakeholders in carrying out the MIPS, including for the identification of measures and activities under paragraph (2)(B) and the methodologies developed under paragraphs (5)(A) and (6) and regarding the use of qualified clinical data registries. Such consultation shall include the use of a request for information or other mechanisms determined appropriate.
(11) Technical assistance to small practices and practices in health professional shortage areas
(A) In general
The Secretary shall enter into contracts or agreements with appropriate entities (such as quality improvement organizations, regional extension centers (as described in
(i) the performance categories described in clauses (i) through (iv) of paragraph (2)(A); or
(ii) how to transition to the implementation of and participation in an alternative payment model as described in
(B) Funding for technical assistance
For purposes of implementing subparagraph (A), the Secretary shall provide for the transfer from the Federal Supplementary Medical Insurance Trust Fund established under
(12) Feedback and information to improve performance
(A) Performance feedback
(i) In general
Beginning July 1, 2017, the Secretary—
(I) shall make available timely (such as quarterly) confidential feedback to MIPS eligible professionals on the performance of such professionals with respect to the performance categories under clauses (i) and (ii) of paragraph (2)(A); and
(II) may make available confidential feedback to such professionals on the performance of such professionals with respect to the performance categories under clauses (iii) and (iv) of such paragraph.
(ii) Mechanisms
The Secretary may use one or more mechanisms to make feedback available under clause (i), which may include use of a web-based portal or other mechanisms determined appropriate by the Secretary. With respect to the performance category described in paragraph (2)(A)(i), feedback under this subparagraph shall, to the extent an eligible professional chooses to participate in a data registry for purposes of this subsection (including registries under subsections (k) and (m)), be provided based on performance on quality measures reported through the use of such registries. With respect to any other performance category described in paragraph (2)(A), the Secretary shall encourage provision of feedback through qualified clinical data registries as 12 described in subsection (m)(3)(E)).
(iii) Use of data
For purposes of clause (i), the Secretary may use data, with respect to a MIPS eligible professional, from periods prior to the current performance period and may use rolling periods in order to make illustrative calculations about the performance of such professional.
(iv) Disclosure exemption
Feedback made available under this subparagraph shall be exempt from disclosure under
(v) Receipt of information
The Secretary may use the mechanisms established under clause (ii) to receive information from professionals, such as information with respect to this subsection.
(B) Additional information
(i) In general
Beginning July 1, 2018, the Secretary shall make available to MIPS eligible professionals information, with respect to individuals who are patients of such MIPS eligible professionals, about items and services for which payment is made under this subchapter that are furnished to such individuals by other suppliers and providers of services, which may include information described in clause (ii). Such information may be made available under the previous sentence to such MIPS eligible professionals by mechanisms determined appropriate by the Secretary, which may include use of a web-based portal. Such information may be made available in accordance with the same or similar terms as data are made available to accountable care organizations participating in the shared savings program under
(ii) Type of information
For purposes of clause (i), the information described in this clause,5 is the following:
(I) With respect to selected items and services (as determined appropriate by the Secretary) for which payment is made under this subchapter and that are furnished to individuals, who are patients of a MIPS eligible professional, by another supplier or provider of services during the most recent period for which data are available (such as the most recent three-month period), such as the name of such providers furnishing such items and services to such patients during such period, the types of such items and services so furnished, and the dates such items and services were so furnished.
(II) Historical data, such as averages and other measures of the distribution if appropriate, of the total, and components of, allowed charges (and other figures as determined appropriate by the Secretary).
(13) Review
(A) Targeted review
The Secretary shall establish a process under which a MIPS eligible professional may seek an informal review of the calculation of the MIPS adjustment factor (or factors) applicable to such eligible professional under this subsection for a year. The results of a review conducted pursuant to the previous sentence shall not be taken into account for purposes of paragraph (6) with respect to a year (other than with respect to the calculation of such eligible professional's MIPS adjustment factor for such year or additional MIPS adjustment factor for such year) after the factors determined in subparagraph (A) and subparagraph (C) of such paragraph have been determined for such year.
(B) Limitation
Except as provided for in subparagraph (A), there shall be no administrative or judicial review under
(i) The methodology used to determine the amount of the MIPS adjustment factor under paragraph (6)(A) and the amount of the additional MIPS adjustment factor under paragraph (6)(C) and the determination of such amounts.
(ii) The establishment of the performance standards under paragraph (3) and the performance period under paragraph (4).
(iii) The identification of measures and activities specified under paragraph (2)(B) and information made public or posted on the Physician Compare Internet website of the Centers for Medicare & Medicaid Services under paragraph (9).
(iv) The methodology developed under paragraph (5) that is used to calculate performance scores and the calculation of such scores, including the weighting of measures and activities under such methodology.
(r) Collaborating with the physician, practitioner, and other stakeholder communities to improve resource use measurement
(1) In general
In order to involve the physician, practitioner, and other stakeholder communities in enhancing the infrastructure for resource use measurement, including for purposes of the Merit-based Incentive Payment System under subsection (q) and alternative payment models under
(2) Development of care episode and patient condition groups and classification codes
(A) In general
In order to classify similar patients into care episode groups and patient condition groups, the Secretary shall undertake the steps described in the succeeding provisions of this paragraph.
(B) Public availability of existing efforts to design an episode grouper
Not later than 180 days after April 16, 2015, the Secretary shall post on the Internet website of the Centers for Medicare & Medicaid Services a list of the episode groups developed pursuant to subsection (n)(9)(A) and related descriptive information.
(C) Stakeholder input
The Secretary shall accept, through the date that is 120 days after the day the Secretary posts the list pursuant to subparagraph (B), suggestions from physician specialty societies, applicable practitioner organizations, and other stakeholders for episode groups in addition to those posted pursuant to such subparagraph, and specific clinical criteria and patient characteristics to classify patients into—
(i) care episode groups; and
(ii) patient condition groups.
(D) Development of proposed classification codes
(i) In general
Taking into account the information described in subparagraph (B) and the information received under subparagraph (C), the Secretary shall—
(I) establish care episode groups and patient condition groups, which account for a target of an estimated ½ of expenditures under parts A and B (with such target increasing over time as appropriate); and
(II) assign codes to such groups.
(ii) Care episode groups
In establishing the care episode groups under clause (i), the Secretary shall take into account—
(I) the patient's clinical problems at the time items and services are furnished during an episode of care, such as the clinical conditions or diagnoses, whether or not inpatient hospitalization occurs, and the principal procedures or services furnished; and
(II) other factors determined appropriate by the Secretary.
(iii) Patient condition groups
In establishing the patient condition groups under clause (i), the Secretary shall take into account—
(I) the patient's clinical history at the time of a medical visit, such as the patient's combination of chronic conditions, current health status, and recent significant history (such as hospitalization and major surgery during a previous period, such as 3 months); and
(II) other factors determined appropriate by the Secretary, such as eligibility status under this subchapter (including eligibility under
(E) Draft care episode and patient condition groups and classification codes
Not later than 270 days after the end of the comment period described in subparagraph (C), the Secretary shall post on the Internet website of the Centers for Medicare & Medicaid Services a draft list of the care episode and patient condition codes established under subparagraph (D) (and the criteria and characteristics assigned to such code).
(F) Solicitation of input
The Secretary shall seek, through the date that is 120 days after the Secretary posts the list pursuant to subparagraph (E), comments from physician specialty societies, applicable practitioner organizations, and other stakeholders, including representatives of individuals entitled to benefits under part A or enrolled under this part, regarding the care episode and patient condition groups (and codes) posted under subparagraph (E). In seeking such comments, the Secretary shall use one or more mechanisms (other than notice and comment rulemaking) that may include use of open door forums, town hall meetings, or other appropriate mechanisms.
(G) Operational list of care episode and patient condition groups and codes
Not later than 270 days after the end of the comment period described in subparagraph (F), taking into account the comments received under such subparagraph, the Secretary shall post on the Internet website of the Centers for Medicare & Medicaid Services an operational list of care episode and patient condition codes (and the criteria and characteristics assigned to such code).
(H) Subsequent revisions
Not later than November 1 of each year (beginning with 2018), the Secretary shall, through rulemaking, make revisions to the operational lists of care episode and patient condition codes as the Secretary determines may be appropriate. Such revisions may be based on experience, new information developed pursuant to subsection (n)(9)(A), and input from the physician specialty societies, applicable practitioner organizations, and other stakeholders, including representatives of individuals entitled to benefits under part A or enrolled under this part.
(I) Information
The Secretary shall, not later than December 31st of each year (beginning with 2018), post on the Internet website of the Centers for Medicare & Medicaid Services information on resource use measures in use under subsection (q), resource use measures under development and the time-frame for such development, potential future resource use measure topics, a description of stakeholder engagement, and the percent of expenditures under part A and this part that are covered by resource use measures.
(3) Attribution of patients to physicians or practitioners
(A) In general
In order to facilitate the attribution of patients and episodes (in whole or in part) to one or more physicians or applicable practitioners furnishing items and services, the Secretary shall undertake the steps described in the succeeding provisions of this paragraph.
(B) Development of patient relationship categories and codes
The Secretary shall develop patient relationship categories and codes that define and distinguish the relationship and responsibility of a physician or applicable practitioner with a patient at the time of furnishing an item or service. Such patient relationship categories shall include different relationships of the physician or applicable practitioner to the patient (and the codes may reflect combinations of such categories), such as a physician or applicable practitioner who—
(i) considers themself to have the primary responsibility for the general and ongoing care for the patient over extended periods of time;
(ii) considers themself to be the lead physician or practitioner and who furnishes items and services and coordinates care furnished by other physicians or practitioners for the patient during an acute episode;
(iii) furnishes items and services to the patient on a continuing basis during an acute episode of care, but in a supportive rather than a lead role;
(iv) furnishes items and services to the patient on an occasional basis, usually at the request of another physician or practitioner; or
(v) furnishes items and services only as ordered by another physician or practitioner.
(C) Draft list of patient relationship categories and codes
Not later than one year after April 16, 2015, the Secretary shall post on the Internet website of the Centers for Medicare & Medicaid Services a draft list of the patient relationship categories and codes developed under subparagraph (B).
(D) Stakeholder input
The Secretary shall seek, through the date that is 120 days after the Secretary posts the list pursuant to subparagraph (C), comments from physician specialty societies, applicable practitioner organizations, and other stakeholders, including representatives of individuals entitled to benefits under part A or enrolled under this part, regarding the patient relationship categories and codes posted under subparagraph (C). In seeking such comments, the Secretary shall use one or more mechanisms (other than notice and comment rulemaking) that may include open door forums, town hall meetings, web-based forums, or other appropriate mechanisms.
(E) Operational list of patient relationship categories and codes
Not later than 240 days after the end of the comment period described in subparagraph (D), taking into account the comments received under such subparagraph, the Secretary shall post on the Internet website of the Centers for Medicare & Medicaid Services an operational list of patient relationship categories and codes.
(F) Subsequent revisions
Not later than November 1 of each year (beginning with 2018), the Secretary shall, through rulemaking, make revisions to the operational list of patient relationship categories and codes as the Secretary determines appropriate. Such revisions may be based on experience, new information developed pursuant to subsection (n)(9)(A), and input from the physician specialty societies, applicable practitioner organizations, and other stakeholders, including representatives of individuals entitled to benefits under part A or enrolled under this part.
(4) Reporting of information for resource use measurement
Claims submitted for items and services furnished by a physician or applicable practitioner on or after January 1, 2018, shall, as determined appropriate by the Secretary, include—
(A) applicable codes established under paragraphs (2) and (3); and
(B) the national provider identifier of the ordering physician or applicable practitioner (if different from the billing physician or applicable practitioner).
(5) Methodology for resource use analysis
(A) In general
In order to evaluate the resources used to treat patients (with respect to care episode and patient condition groups), the Secretary shall, as the Secretary determines appropriate—
(i) use the patient relationship codes reported on claims pursuant to paragraph (4) to attribute patients (in whole or in part) to one or more physicians and applicable practitioners;
(ii) use the care episode and patient condition codes reported on claims pursuant to paragraph (4) as a basis to compare similar patients and care episodes and patient condition groups; and
(iii) conduct an analysis of resource use (with respect to care episodes and patient condition groups of such patients).
(B) Analysis of patients of physicians and practitioners
In conducting the analysis described in subparagraph (A)(iii) with respect to patients attributed to physicians and applicable practitioners, the Secretary shall, as feasible—
(i) use the claims data experience of such patients by patient condition codes during a common period, such as 12 months; and
(ii) use the claims data experience of such patients by care episode codes—
(I) in the case of episodes without a hospitalization, during periods of time (such as the number of days) determined appropriate by the Secretary; and
(II) in the case of episodes with a hospitalization, during periods of time (such as the number of days) before, during, and after the hospitalization.
(C) Measurement of resource use
In measuring such resource use, the Secretary—
(i) shall use per patient total allowed charges for all services under part A and this part (and, if the Secretary determines appropriate, part D) for the analysis of patient resource use, by care episode codes and by patient condition codes; and
(ii) may, as determined appropriate, use other measures of allowed charges (such as subtotals for categories of items and services) and measures of utilization of items and services (such as frequency of specific items and services and the ratio of specific items and services among attributed patients or episodes).
(D) Stakeholder input
The Secretary shall seek comments from the physician specialty societies, applicable practitioner organizations, and other stakeholders, including representatives of individuals entitled to benefits under part A or enrolled under this part, regarding the resource use methodology established pursuant to this paragraph. In seeking comments the Secretary shall use one or more mechanisms (other than notice and comment rulemaking) that may include open door forums, town hall meetings, web-based forums, or other appropriate mechanisms.
(6) Implementation
To the extent that the Secretary contracts with an entity to carry out any part of the provisions of this subsection, the Secretary may not contract with an entity or an entity with a subcontract if the entity or subcontracting entity currently makes recommendations to the Secretary on relative values for services under the fee schedule for physicians' services under this section.
(7) Limitation
There shall be no administrative or judicial review under
(A) care episode and patient condition groups and codes established under paragraph (2);
(B) patient relationship categories and codes established under paragraph (3); and
(C) measurement of, and analyses of resource use with respect to, care episode and patient condition codes and patient relationship codes pursuant to paragraph (5).
(8) Administration
(9) Definitions
In this subsection:
(A) Physician
The term "physician" has the meaning given such term in
(B) Applicable practitioner
The term "applicable practitioner" means—
(i) a physician assistant, nurse practitioner, and clinical nurse specialist (as such terms are defined in
(ii) beginning January 1, 2019, such other eligible professionals (as defined in subsection (k)(3)(B)) as specified by the Secretary.
(10) Clarification
The provisions of
(s) Priorities and funding for measure development
(1) Plan identifying measure development priorities and timelines
(A) Draft measure development plan
Not later than January 1, 2016, the Secretary shall develop, and post on the Internet website of the Centers for Medicare & Medicaid Services, a draft plan for the development of quality measures for application under the applicable provisions (as defined in paragraph (5)). Under such plan the Secretary shall—
(i) address how measures used by private payers and integrated delivery systems could be incorporated under subchapter XVIII;
(ii) describe how coordination, to the extent possible, will occur across organizations developing such measures; and
(iii) take into account how clinical best practices and clinical practice guidelines should be used in the development of quality measures.
(B) Quality domains
For purposes of this subsection, the term "quality domains" means at least the following domains:
(i) Clinical care.
(ii) Safety.
(iii) Care coordination.
(iv) Patient and caregiver experience.
(v) Population health and prevention.
(C) Consideration
In developing the draft plan under this paragraph, the Secretary shall consider—
(i) gap analyses conducted by the entity with a contract under
(ii) whether measures are applicable across health care settings;
(iii) clinical practice improvement activities submitted under subsection (q)(2)(C)(iv) for identifying possible areas for future measure development and identifying existing gaps with respect to such measures; and
(iv) the quality domains applied under this subsection.
(D) Priorities
In developing the draft plan under this paragraph, the Secretary shall give priority to the following types of measures:
(i) Outcome measures, including patient reported outcome and functional status measures.
(ii) Patient experience measures.
(iii) Care coordination measures.
(iv) Measures of appropriate use of services, including measures of over use.
(E) Stakeholder input
The Secretary shall accept through March 1, 2016, comments on the draft plan posted under paragraph (1)(A) from the public, including health care providers, payers, consumers, and other stakeholders.
(F) Final measure development plan
Not later than May 1, 2016, taking into account the comments received under this subparagraph, the Secretary shall finalize the plan and post on the Internet website of the Centers for Medicare & Medicaid Services an operational plan for the development of quality measures for use under the applicable provisions. Such plan shall be updated as appropriate.
(2) Contracts and other arrangements for quality measure development
(A) In general
The Secretary shall enter into contracts or other arrangements with entities for the purpose of developing, improving, updating, or expanding in accordance with the plan under paragraph (1) quality measures for application under the applicable provisions. Such entities shall include organizations with quality measure development expertise.
(B) Prioritization
(i) In general
In entering into contracts or other arrangements under subparagraph (A), the Secretary shall give priority to the development of the types of measures described in paragraph (1)(D).
(ii) Consideration
In selecting measures for development under this subsection, the Secretary shall consider—
(I) whether such measures would be electronically specified; and
(II) clinical practice guidelines to the extent that such guidelines exist.
(3) Annual report by the Secretary
(A) In general
Not later than May 1, 2017, and annually thereafter, the Secretary shall post on the Internet website of the Centers for Medicare & Medicaid Services a report on the progress made in developing quality measures for application under the applicable provisions.
(B) Requirements
Each report submitted pursuant to subparagraph (A) shall include the following:
(i) A description of the Secretary's efforts to implement this paragraph.
(ii) With respect to the measures developed during the previous year—
(I) a description of the total number of quality measures developed and the types of such measures, such as an outcome or patient experience measure;
(II) the name of each measure developed;
(III) the name of the developer and steward of each measure;
(IV) with respect to each type of measure, an estimate of the total amount expended under this subchapter to develop all measures of such type; and
(V) whether the measure would be electronically specified.
(iii) With respect to measures in development at the time of the report—
(I) the information described in clause (ii), if available; and
(II) a timeline for completion of the development of such measures.
(iv) A description of any updates to the plan under paragraph (1) (including newly identified gaps and the status of previously identified gaps) and the inventory of measures applicable under the applicable provisions.
(v) Other information the Secretary determines to be appropriate.
(4) Stakeholder input
With respect to paragraph (1), the Secretary shall seek stakeholder input with respect to—
(A) the identification of gaps where no quality measures exist, particularly with respect to the types of measures described in paragraph (1)(D);
(B) prioritizing quality measure development to address such gaps; and
(C) other areas related to quality measure development determined appropriate by the Secretary.
(5) Definition of applicable provisions
In this subsection, the term "applicable provisions" means the following provisions:
(A) Subsection (q)(2)(B)(i).
(B) section 13 1395l(z)(3)(D) of this title.
(6) Funding
For purposes of carrying out this subsection, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under
(7) Administration
(t) Supporting physicians and other professionals in adjusting to Medicare payment changes during 2021 through 2024
(1) In general
In order to support physicians and other professionals in adjusting to changes in payment for physicians' services during 2021, 2022, 2023, and 2024, the Secretary shall increase fee schedules under subsection (b) that establish payment amounts for—
(A) such services furnished on or after January 1, 2021, and before January 1, 2022, by 3.75 percent;
(B) such services furnished on or after January 1, 2022, and before January 1, 2023, by 3.0 percent;
(C) such services furnished on or after January 1, 2023, and before January 1, 2024, by 2.5 percent;
(D) such services furnished on or after January, 1, 2024, and before March 9, 2024, by 1.25 percent; and
(E) such services furnished on or after March 9, 2024, and before January 1, 2025, by 2.93 percent.
(2) Implementation
(A) Administration
Notwithstanding any other provision of law, the Secretary may implement this subsection by program instruction or otherwise.
(B) Limitation
There shall be no administrative or judicial review under
(C) Application only for 2021 through 2024
The increase in fee schedules that establish payment amounts under this subsection for services furnished in 2021, 2022, 2023, or 2024 shall not be taken into account in determining such fee schedules that establish payment amounts for services furnished in years after 2021, 2022, 2023, or 2024, respectively.
(3) Funding
For purposes of increasing the fee schedules that establish payment amounts pursuant to this subsection—
(A) there shall be transferred from the General Fund of the Treasury to the Federal Supplementary Medical Insurance Trust Fund under
(B) in the event the Secretary determines additional amounts are necessary, such amounts shall be available from the Federal Supplementary Medical Insurance Trust Fund.
(Aug. 14, 1935, ch. 531, title XVIII, §1848, as added
Editorial Notes
References in Text
Section 13515(b) of the Omnibus Budget Reconciliation Act of 1993, referred to in subsecs. (a)(2)(B)(ii)(I), (c)(2)(A)(i), and (i)(1)(B), is section 13515(b) of
Section 6105(b) of the Omnibus Budget Reconciliation Act of 1989, referred to in subsec. (a)(2)(D)(ii), (iii), is section 6105(b) of
Section 4048(b) of the Omnibus Budget Reconciliation Act of 1987, referred to in subsec. (b)(2)(B), is section 4048(b) of
Section 13514(a) of the Omnibus Budget Reconciliation Act of 1993, referred to in subsec. (c)(2)(F), is section 13514(a) of
Section 212 of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999, referred to in subsec. (c)(2)(H)(i), (I)(ii)(I), is section 1000(a)(6) [title II, §212] of
The Balanced Budget Act of 1997, referred to in subsec. (d)(1)(C), is
Section 225(c)(1) and section 524 of the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2008, referred to in subsec. (l)(2)(A)(ii)(I), (II), are sections 225(c)(1) of title II and 524 of title V of div. G of
Section 2(d) of the Improving Medicare Post-Acute Care Transformation Act of 2014, referred to in subsec. (q)(1)(G)(i), is section 2(d) of
Codification
The text of section 101(c) of
Amendments
2025—Subsec. (e)(1)(E).
2024—Subsec. (e)(1)(E).
Subsec. (q)(1)(C)(iii)(II).
Subsec. (q)(1)(C)(iii)(III).
Subsec. (t)(1)(D).
Subsec. (t)(1)(E).
2023—Subsec. (e)(1)(E).
2022—Subsec. (b)(12).
Subsec. (c)(2)(B)(iv)(V).
Subsec. (c)(2)(B)(iv)(VI).
Subsec. (q)(1)(C)(iii)(II).
Subsec. (q)(1)(C)(iii)(III).
Subsec. (t).
Subsec. (t)(1).
Subsec. (t)(1)(C), (D).
Subsec. (t)(2)(C).
2021—Subsec. (c)(2)(B)(iv)(V).
Subsec. (t).
Subsec. (t)(1).
Subsec. (t)(2)(C).
2020—Subsec. (c)(2)(B)(iv)(V).
Subsec. (e)(1)(E).
Subsec. (q)(1)(C)(iii)(II).
Subsec. (q)(1)(C)(iii)(III).
Subsec. (q)(2)(B)(iii)(IV).
Subsec. (t).
2019—Subsec. (e)(1)(E).
2018—Subsec. (b)(11).
Subsec. (c)(2)(K)(iv).
Subsec. (d)(18).
Subsec. (e)(1)(E).
Subsec. (o)(2)(A).
Subsec. (q)(1)(B).
Subsec. (q)(1)(C)(iv)(I).
Subsec. (q)(1)(C)(iv)(II).
Subsec. (q)(1)(C)(iv)(III).
Subsec. (q)(5)(D)(i)(I).
Subsec. (q)(5)(D)(iii).
Subsec. (q)(5)(E)(i)(I)(bb).
Subsec. (q)(5)(E)(i)(II)(bb).
Subsec. (q)(6)(D)(i).
Subsec. (q)(6)(D)(ii).
Subsec. (q)(6)(D)(iii).
Subsec. (q)(6)(D)(iv).
Subsec. (q)(6)(E).
Subsec. (q)(7).
Subsec. (r)(2)(I).
Subsec. (s)(5)(B).
2016—Subsec. (a)(7)(B).
Subsec. (a)(7)(D).
Subsec. (o)(2)(D).
2015—Subsec. (a)(7)(A)(i).
Subsec. (a)(7)(A)(ii)(III).
Subsec. (a)(7)(A)(iii).
Subsec. (a)(7)(B).
Subsec. (a)(8)(A)(i).
Subsec. (a)(8)(A)(ii)(II).
Subsec. (a)(9).
Subsec. (b)(8).
Subsec. (b)(9).
Subsec. (b)(10).
Subsec. (b)(11).
Subsec. (c)(2)(B)(v)(X).
Subsec. (c)(2)(B)(v)(XI).
Subsec. (c)(2)(K)(iv).
Subsec. (c)(8).
Subsec. (d)(1)(A).
Subsec. (d)(1)(D).
Subsec. (d)(4).
Subsec. (d)(4)(A).
Subsec. (d)(16) to (20).
Subsec. (e)(1)(E).
Subsec. (f)(1)(B).
Subsec. (f)(2).
Subsec. (k)(9).
Subsec. (m)(3)(C)(ii).
Subsec. (m)(3)(D).
Subsec. (m)(5)(F).
Subsec. (m)(7) to (9).
Subsec. (n)(11).
Subsec. (o)(2)(A).
Subsec. (o)(2)(A)(ii).
Subsec. (o)(2)(A)(iii).
Subsec. (o)(2)(D).
Subsec. (p)(2)(C).
Subsec. (p)(3).
Subsec. (p)(4)(B)(iii).
"(I) beginning on January 1, 2015, with respect to specific physicians and groups of physicians the Secretary determines appropriate; and
"(II) beginning not later than January 1, 2017, with respect to all physicians and groups of physicians."
Subsec. (q).
Subsec. (r).
Subsec. (s).
2014—Subsec. (c)(2)(B)(ii)(I).
Subsec. (c)(2)(B)(v)(VIII).
Subsec. (c)(2)(B)(v)(IX).
Subsec. (c)(2)(C)(i).
Subsec. (c)(2)(C)(ii).
Subsec. (c)(2)(C)(iii).
Subsec. (c)(2)(K)(ii).
Subsec. (c)(2)(K)(iii)(VI).
Subsec. (c)(2)(M).
Subsec. (c)(2)(N).
Subsec. (c)(2)(O).
Subsec. (c)(2)(O)(iii).
Subsec. (c)(2)(O)(v).
Subsec. (c)(7).
Subsec. (d)(15).
Subsec. (d)(15)(A).
Subsec. (d)(15)(B).
Subsec. (d)(16).
Subsec. (e)(1)(E).
Subsec. (e)(6).
Subsec. (i)(1)(F).
Subsec. (j)(2).
2013—Subsec. (b)(4)(C).
Subsec. (b)(7).
Subsec. (c)(2)(B)(v)(III).
Subsec. (d)(14).
Subsec. (d)(15).
Subsec. (e)(1)(E).
Subsec. (m)(3)(D) to (F).
2012—Subsec. (d)(13).
Subsec. (d)(13)(A).
Subsec. (d)(13)(B).
Subsec. (e)(1)(E).
2011—Subsec. (b)(4)(B), (6).
Subsec. (c)(2)(B)(iv)(IV).
Subsec. (d)(13).
Subsec. (e)(1)(E).
2010—Subsec. (a)(8).
Subsec. (b)(1).
Subsec. (b)(4)(B).
Subsec. (b)(4)(C).
"(i) in the case of services furnished on or after January 1, 2010, and before January 1, 2013, a 65 percent (rather than 50 percent) presumed rate of utilization of imaging equipment;
"(ii) in the case of services furnished on or after January 1, 2013, and before January 1, 2014, a 70 percent (rather than 50 percent) presumed rate of utilization of imaging equipment; and
"(iii) in the case of services furnished on or after January 1, 2014, a 75 percent (rather than 50 percent) presumed rate of utilization of imaging equipment."
Subsec. (b)(4)(D).
Subsec. (b)(6).
Subsec. (b)(7).
Subsec. (c)(2)(B)(iv)(IV).
Subsec. (c)(2)(B)(v)(III) to (V).
"(III)
"(IV)
"(V)
Subsec. (c)(2)(B)(v)(VI).
Subsec. (c)(2)(B)(v)(VII).
Subsec. (c)(2)(B)(vii).
Subsec. (c)(2)(K), (L).
Subsec. (d)(10).
"(A)
"(B)
Subsec. (d)(10)(A).
Subsec. (d)(10)(B).
Subsec. (d)(11).
Subsec. (d)(11)(A).
Subsec. (d)(11)(B).
Subsec. (d)(12).
Subsec. (e)(1)(A).
Subsec. (e)(1)(E).
Subsec. (e)(1)(H).
Subsec. (e)(1)(H)(i).
Subsec. (e)(1)(I).
Subsec. (j)(3).
Subsec. (k)(4).
Subsec. (m)(1)(A).
Subsec. (m)(1)(B)(iii), (iv).
Subsec. (m)(3)(A).
Subsec. (m)(3)(C)(i).
Subsec. (m)(5)(E).
Subsec. (m)(5)(E)(iv).
Subsec. (m)(5)(H), (I).
Subsec. (m)(6)(C)(i)(II).
Subsec. (m)(6)(C)(iii).
Subsec. (m)(7).
Subsec. (n)(1)(A).
Subsec. (n)(1)(B).
Subsec. (n)(4).
Subsec. (n)(6).
Subsec. (n)(9), (10).
Subsec. (o)(1)(C)(ii).
Subsec. (p).
2009—Subsec. (a)(5)(A)(i).
Subsec. (a)(5)(A)(ii)(III).
Subsec. (a)(7).
Subsec. (d)(10).
Subsec. (m)(2)(A).
Subsec. (m)(2)(D).
Subsec. (o).
2008—Subsec. (a)(4)(A).
Subsec. (a)(5).
Subsec. (a)(6).
Subsec. (b)(5).
Subsec. (c)(2)(B)(vi).
Subsec. (d)(8).
Subsec. (d)(8)(A).
Subsec. (d)(8)(B).
Subsec. (d)(9).
Subsec. (e)(1)(A).
Subsec. (e)(1)(E).
Subsec. (e)(1)(G).
Subsec. (j)(3).
Subsec. (k)(2)(C), (D).
Subsec. (k)(3)(B)(iv).
Subsec. (l)(2)(A)(i)(III).
Subsec. (l)(2)(A)(i)(IV).
Subsec. (l)(2)(A)(ii)(III).
Subsec. (l)(2)(A)(ii)(IV).
Subsec. (l)(2)(B).
"(iii) 2013 for payment with respect to physicians' services furnished during 2013; and
"(iv) 2014 for payment with respect to physicians' services furnished during 2014."
Subsec. (l)(2)(B)(iv).
Subsec. (m).
Subsec. (m)(1).
Subsec. (m)(2).
Subsec. (m)(3).
Subsec. (m)(3)(A).
Subsec. (m)(3)(B).
Subsec. (m)(3)(C), (D).
Subsec. (m)(5)(A).
Subsec. (m)(5)(B).
Subsec. (m)(5)(C).
Subsec. (m)(5)(D)(i).
Subsec. (m)(5)(D)(ii).
Subsec. (m)(5)(D)(iii).
Subsec. (m)(5)(E).
Subsec. (m)(5)(E)(ii).
Subsec. (m)(5)(E)(iii).
Subsec. (m)(5)(E)(iv).
Subsec. (m)(5)(F).
Subsec. (m)(5)(G).
Subsec. (m)(6)(A).
Subsec. (m)(6)(B).
Subsec. (m)(6)(C).
"(i) for 2007, the period beginning on July 1, 2007, and ending on December 31, 2007; and
"(ii) for 2008, all of 2008."
Subsec. (m)(6)(D).
Subsec. (n).
2007—Subsec. (d)(4)(B).
Subsec. (d)(8).
Subsec. (e)(1)(E).
Subsec. (k)(2)(B).
Subsec. (l)(2)(A).
Subsec. (l)(2)(B).
2006—Subsec. (b)(4).
Subsec. (c)(2)(B)(ii)(II).
Subsec. (c)(2)(B)(iv).
Subsec. (c)(2)(B)(v).
Subsec. (c)(2)(B)(v)(II).
Subsec. (d)(4)(B).
Subsec. (d)(6).
Subsec. (d)(7).
Subsec. (e)(1)(E).
Subsec. (j)(3).
Subsec. (k).
Subsec. (l).
2003—Subsec. (c)(2)(B)(ii)(II).
Subsec. (c)(2)(B)(iv).
Subsec. (c)(2)(H) to (J).
Subsec. (d)(4)(B).
Subsec. (d)(5).
Subsec. (e)(1)(A).
Subsec. (e)(1)(E).
Subsec. (e)(1)(G).
Subsec. (f)(2)(C).
Subsec. (i)(1)(B).
Subsec. (i)(1)(C).
Subsec. (i)(3)(A).
Subsec. (j)(3).
2000—Subsec. (j)(3).
1999—Subsec. (d)(1)(A).
Subsec. (d)(1)(E).
"(i) 1991, the conversion factor which will apply to physicians' services for 1992, and the update determined under paragraph (3) for 1992; and
"(ii) each succeeding year, the conversion factor which will apply to physicians' services for the following year and the update determined under paragraph (3) for such year."
Subsec. (d)(3).
Subsec. (d)(3)(A).
Subsec. (d)(3)(C).
Subsec. (d)(4).
Subsec. (f)(1).
Subsec. (f)(2).
Subsec. (f)(2)(A).
Subsec. (f)(2)(B), (C).
Subsec. (f)(2)(D).
Subsec. (f)(3).
Subsec. (f)(3)(C).
Subsec. (f)(4).
Subsec. (j)(3).
1997—Subsec. (b)(1).
Subsec. (c)(2)(B)(iii).
Subsec. (c)(2)(C)(ii).
Subsec. (c)(2)(C)(iii).
Subsec. (c)(2)(G).
Subsec. (c)(3)(C)(ii).
Subsec. (c)(3)(C)(iii).
Subsec. (d)(1)(A).
Subsec. (d)(1)(C).
Subsec. (d)(1)(D).
Subsec. (d)(1)(E).
Subsec. (d)(2).
Subsec. (d)(2)(F).
Subsec. (d)(3).
Subsec. (f).
Subsec. (f)(1)(B).
Subsec. (f)(2).
Subsec. (f)(3).
Subsec. (f)(4), (5).
Subsec. (g)(3)(A).
Subsec. (g)(6)(C), (7)(C).
Subsec. (j)(1).
Subsec. (j)(3).
1994—Subsec. (a)(2)(D)(iii).
Subsec. (c)(2)(C)(ii).
Subsec. (c)(3)(C)(ii).
Subsec. (c)(4).
Subsec. (e)(1)(C).
Subsec. (e)(1)(D).
Subsec. (f)(2)(A)(i).
Subsec. (f)(2)(C).
Subsec. (g)(1).
Subsec. (g)(3)(B).
Subsec. (g)(6)(B).
Subsec. (i)(3).
1993—Subsec. (a)(2)(B)(ii)(I).
Subsec. (a)(3).
Subsec. (a)(4).
Subsec. (b)(3).
Subsec. (c)(2)(A)(i).
Subsec. (c)(2)(E).
Subsec. (c)(2)(F).
Subsec. (d)(3)(A)(i).
Subsec. (d)(3)(A)(iv) to (vi).
Subsec. (d)(3)(B)(ii).
Subsec. (f)(2)(B).
Subsec. (g)(1).
Subsec. (g)(2)(C).
Subsec. (g)(2)(D).
Subsec. (h).
Subsec. (i)(1)(B).
Subsec. (j)(1).
Subsec. (j)(3).
1990—Subsec. (a)(1).
Subsec. (a)(2)(C).
Subsec. (a)(2)(D)(ii).
Subsec. (a)(2)(D)(iii).
Subsec. (a)(4).
Subsec. (b)(3).
Subsec. (c)(1)(B).
Subsec. (c)(3).
Subsec. (c)(3)(C)(ii)(II), (iii)(II).
Subsec. (c)(4).
Subsec. (c)(5), (6).
Subsec. (d)(1)(A).
Subsec. (d)(1)(C)(i).
Subsec. (d)(1)(C)(ii).
Subsec. (d)(2)(A).
Subsec. (d)(2)(A)(ii).
Subsec. (d)(2)(E)(i).
Subsec. (d)(2)(E)(ii)(I).
Subsec. (d)(3)(A)(i).
Subsec. (d)(3)(A)(iii).
Subsec. (d)(3)(B)(i).
Subsec. (d)(3)(B)(ii).
Subsec. (e)(1)(A).
Subsec. (e)(1)(C).
Subsec. (f)(1)(C).
Subsec. (f)(1)(D)(i).
Subsec. (f)(2)(A).
Subsec. (f)(2)(A)(i).
Subsec. (f)(2)(A)(ii).
Subsec. (f)(2)(A)(iii).
Subsec. (f)(2)(A)(iv).
Subsec. (f)(2)(C).
Subsec. (f)(4)(A).
Subsec. (f)(4)(B).
Subsec. (g)(2)(A).
Subsec. (g)(2)(B).
Subsec. (i)(1)(A).
Subsec. (i)(2).
Subsec. (i)(3).
Subsec. (j)(1).
Statutory Notes and Related Subsidiaries
Change of Name
References to Medicare+Choice deemed to refer to Medicare Advantage or MA, subject to an appropriate transition provided by the Secretary of Health and Human Services in the use of those terms, see section 201 of
Effective Date of 2015 Amendment
Effective Date of 2010 Amendment
Amendment by section 4103(c)(2) of
Effective Date of 2008 Amendment
Effective Date of 2007 Amendment
"(i)
"(ii)
Effective Date of 2006 Amendment
Amendment by section 5112(c) of
Effective Date of 2003 Amendment
Effective Date of 2000 Amendment
Amendment by
Effective Date of 1999 Amendment
Amendment by section 1000(a)(6) [title III, §321(k)(5)] of
Effective Date of 1997 Amendment
Amendment by section 4022(b)(2)(B), (C) of
Amendment by section 4102(d) of
Amendment by section 4103(d) of
Amendment by section 4104(d) of
Amendment by section 4105(a)(2) of
Amendment by section 4106(b) of
Amendment by section 4714(b)(2) of
Effective Date of 1994 Amendment
Amendment by section 123(a) of
Amendment by section 126(b)(6), (g)(2)(B), (5)–(7), (10)(A) of
Effective Date of 1993 Amendment
"(1) to volume performance standard rates of increase established under section 1848(f) of the Social Security Act [
"(2) to adjustment in updates in the conversion factors for physicians' services under section 1848(d)(3)(B) of such Act for physicians' services to be furnished in calendar years before 1996."
Amendment by section 13515(a)(1) of
Effective Date of 1990 Amendment
Amendment by section 4102(b), (g)(2) of
Amendment by section 4104(b)(2) of
Amendment by section 4106(b)(1) of
Transfer of Functions
Physician Payment Review Commission (PPRC) was terminated and its assets and staff transferred to the Medicare Payment Advisory Commission (MedPAC) by section 4022(c)(2), (3) of
Termination of Reporting Requirements
For termination, effective May 15, 2000, of provisions of law requiring submittal to Congress of any annual, semiannual, or other regular periodic report listed in House Document No. 103–7 (in which item 8 on page 94 identifies a reporting provision which, as subsequently amended, is contained in subsec. (g)(6)(B) of this section and in which item 9 on page 94 identifies a reporting provision which is contained in subsec. (g)(7)(B) of this section), see section 3003 of
Improving Mobile Crisis Care in Medicare
"(b)
"(c)
"(d)
"(1) psychotherapy for crisis services billed under the Medicare physician fee schedule under section 1848 of the Social Security Act (
"(2) behavioral health integration services.
"(e)
"(1)
"(2)
"(3)
"(4)
Moratorium on Payment Under the Medicare Physician Fee Schedule of the Add On Code for Inherently Complex Evaluation and Management Visits
"(a)
"(b)
Implementation
Education and Outreach Campaign
"(A)
"(B)
"(i) be directed by the Office of Rural Health Policy of the Department of Health and Human Services and the Office of Minority Health of the Centers for Medicare & Medicaid Services; and
"(ii) focus on encouraging participation by underserved rural populations and racial and ethnic minority populations."
Recommendations for Achieving Widespread Electronic Health Record (EHR) Interoperability
"(A)
"(B)
"(i)
"(ii)
"(C)
"(D)
"(i) to adjust payments for not being meaningful EHR users under the Medicare EHR incentive programs; and
"(ii) for criteria for decertifying certified EHR technology products."
[As used in section 106(b)(1) of
Disclosure of Data Used To Establish Multiple Procedure Payment Reduction Policy
Centers for Medicare & Medicaid Services To Study Reform of Physician Reimbursements
"(1)
"(2)
"(3)
Implementation of 2010 Amendment
"(A)
"(B) Notwithstanding any other provision of law, the Secretary may implement subparagraphs (K) and (L) of [section] 1848(c)(2) of the Social Security Act [
"(C) [Repealed section 4505(d) of
"(D) Except for provisions related to confidentiality of information, the provisions of the Federal Acquisition Regulation shall not apply to this section or the amendment made by this section."
Authority To Incorporate Maintenance of Certification Programs Into Measures of Quality of Care
No Change in Billing
No Effect on Incentive Payments for 2007 or 2008
Adjustment for Medicare Mental Health Services
"(a)
"(1)
"(2)
"(b)
"(1) insight oriented, behavior modifying, or supportive psychotherapy; or
"(2) interactive psychotherapy.
"(c)
Transfer of Funds to Part B Trust Fund
Transitional Bonus Incentive Payments for Quality Reporting in 2007 and 2008
Treatment of Other Services Currently in the Nonphysician Work Pool
Payment for Multiple Chemotherapy Agents Furnished on a Single Day Through the Push Technique
"(A)
"(B)
"(C)
Transitional Adjustment
"(A)
"(B)
"(i) during 2004, is 32 percent; and
"(ii) during 2005, is 3 percent."
MedPAC Review and Reports; Secretarial Response
"(A)
"(i) for items and services furnished by oncologists; and
"(ii) for drug administration services furnished by other specialists.
"(B)
"(i) the quality of care furnished to individuals enrolled under part B and the satisfaction of such individuals with that care;
"(ii) the adequacy of reimbursement as applied in, and the availability in, different geographic areas and to different physician practice sizes; and
"(iii) the impact on physician practices.
"(C)
"(i) not later than January 1, 2006, a report on the review conducted under subparagraph (A)(i); and
"(ii) not later than January 1, 2007, a report on the review conducted under subparagraph (A)(ii).
Each such report may include such recommendations regarding further adjustments in such payments as the Commission deems appropriate.
"(D)
Multiple Chemotherapy Agents, Other Services Currently on the Non-Physician Work Pool, and Transitional Adjustment
Application of 2003 Amendment to Physician Specialties
Amendment by section 303 of
Notwithstanding section 303(j) of
GAO Study of Geographic Differences in Payments for Physicians' Services
"(1)
"(A) an assessment of the validity of the geographic adjustment factors used for each component of the fee schedule;
"(B) an evaluation of the measures used for such adjustment, including the frequency of revisions;
"(C) an evaluation of the methods used to determine professional liability insurance costs used in computing the malpractice component, including a review of increases in professional liability insurance premiums and variation in such increases by State and physician specialty and methods used to update the geographic cost of practice index and relative weights for the malpractice component; and
"(D) an evaluation of the effect of the adjustment to the physician work geographic index under section 1848(e)(1)(E) of the Social Security Act [
"(i) differences in recruitment costs and retention rates for physicians, including specialists, between large urban areas and other areas; and
"(ii) the mobility of physicians, including specialists, over the last decade.
"(2)
Amendments Not Treated as Change in Law and Regulation in Sustainable Growth Rate Determination
Collaborative Demonstration-Based Review of Physician Practice Expense Geographic Adjustment Data
"(a)
"(b)
"(c)
"(1)
"(2)
MedPAC Report on Payment for Physicians' Services
"(a)
"(1) The effect of such refinements on payment for physicians' services.
"(2) The interaction of the practice expense component with other components of and adjustments to payment for physicians' services under such section.
"(3) The appropriateness of the amount of compensation by reason of such refinements.
"(4) The effect of such refinements on access to care by medicare beneficiaries to physicians' services.
"(5) The effect of such refinements on physician participation under the medicare program.
"(b)
"(1) An analysis of recent and historic growth in the components that the Secretary [of Health and Human Services] includes under the sustainable growth rate (under section 1848(f) of the Social Security Act (
"(2) An examination of the relative growth of volume in physicians' services between medicare beneficiaries and other populations.
"(3) An analysis of the degree to which new technology, including coverage determinations of the Centers for Medicare & Medicaid Services, has affected the volume of physicians' services.
"(4) An examination of the impact on volume of demographic changes.
"(5) An examination of shifts in the site of service or services that influence the number and intensity of services furnished in physicians' offices and the extent to which changes in reimbursement rates to other providers have effected these changes.
"(6) An evaluation of the extent to which the Centers for Medicare & Medicaid Services takes into account the impact of law and regulations on the sustainable growth rate."
MedPAC Study of Payment for Cardio-Thoracic Surgeons
"(a)
"(b)
Report on Physician Compensation
Treatment of Certain Physician Pathology Services Under Medicare
"(a)
"(b)
"(1)
"(2)
"(A) is entitled to benefits under part A, or enrolled under part B, or both, of such title [
"(B) is not enrolled in any of the following:
"(i) A Medicare+Choice plan under part C of such title [
"(ii) A plan offered by an eligible organization under section 1876 of such Act (
"(iii) A program of all-inclusive care for the elderly (PACE) under section 1894 of such Act (
"(iv) A social health maintenance organization (SHMO) demonstration project established under section 4018(b) of the Omnibus Budget Reconciliation Act of 1987 (
"(c)
"(d)
"(1)
"(2)
One-Time Publication of Information on Transition
"(i) the allowed expenditures under subclauses (I) and (II) of subsection (d)(4)(C)(ii) of section 1848 of the Social Security Act (
"(ii) the estimated actual expenditures described in subsection (d) of such section for 1999; and
"(iii) the sustainable growth rate under subsection (f) of such section for 2000."
Use of Data Collected by Organizations and Entities in Determining Practice Expense Relative Values
"(a)
"(b)
Consultation With Organizations in Establishing Payment Amounts for Services Provided by Physicians
Development of Resource-Based Practice Expense Relative Value Units
Application of Certain Budget Neutrality Provisions
Development of Resource-Based Methodology for Practice Expenses
"(1)
"(2)
Application of Subsection (c)(2)(B)(ii)(II), (iii)
Report on Review Process
Relative Value for Pediatric Services
Budget Neutrality Adjustment
For provisions requiring reduction of relative values established under subsec. (c) of this section and amounts determined under subsec. (a)(2)(B)(ii)(I) of this section for 1994 (to be applied for that year and subsequent years) in order to assure that the amendments to this section and
Ancillary Policies; Adjustment for Independent Laboratories Furnishing Physician Pathology Services
Computation of Conversion Factor for 1992
Publication of Performance Standard Rates
Study of Regional Variations in Impact of Medicare Physician Payment Reform
"(a)
"(1) factors that may explain geographic variations in Medicare reasonable charges for physicians' services that are not attributable to variations in physician practice costs (including the supply of physicians in an area and area variations in the mix of services furnished);
"(2) the extent to which the geographic practice cost indices applied under the fee schedule established under section 1848 of the Social Security Act [
"(3) the impact of the transition to a national, resource-based fee schedule for physicians' services under Medicare on access to physicians' services in areas that experience a disproportionately large reduction in payments for physicians' services under the fee schedule by reason of such variations; and
"(4) appropriate adjustments or modifications in the transition to, or manner of determining payments under, the fee schedule established under section 1848 of the Social Security Act, to compensate for such variations and ensure continued access to physicians' services for Medicare beneficiaries in such areas.
"(b)
Statewide Fee Schedule Areas for Physicians' Services
"(1) the adjusted historical payment basis (as defined in section 1848(a)(2)(D) of such Act (
"(2) the fee schedule amount (as referred to in section 1848(a) (
for physicians' services (as defined in section 1848(j)(3) of such Act (
Studies
Distribution of Model Fee Schedule
1 So in original. Probably should be followed by a period.
2 So in original. Probably should be "elapsed".
3 So in original. No subpar. (F) has been enacted.
4 So in original. Probably should be "than".
5 So in original. The comma probably should not appear.
6 So in original. Probably should be followed by a comma.
8 So in original. Probably should be "(a)(8)(C)(iii),".
9 So in original. Probably means cl. (i) of this subpar.
10 So in original. Probably should be followed by a second closing parenthesis.
12 So in original. Probably should be preceded by an opening parenthesis.
13 So in original. Probably should be "Section".
§1395w–5. Public reporting of performance information
(a) In general
(1) Development
Not later than January 1, 2011, the Secretary shall develop a Physician Compare Internet website with information on physicians enrolled in the Medicare program under section 1866(j) of the Social Security Act (
(2) Plan
Not later than January 1, 2013, and with respect to reporting periods that begin no earlier than January 1, 2012, the Secretary shall also implement a plan for making publicly available through Physician Compare, consistent with subsection (c), information on physician performance that provides comparable information for the public on quality and patient experience measures with respect to physicians enrolled in the Medicare program under such section 1866(j). To the extent scientifically sound measures that are developed consistent with the requirements of this section are available, such information, to the extent practicable, shall include—
(A) measures collected under the Physician Quality Reporting Initiative;
(B) an assessment of patient health outcomes and the functional status of patients;
(C) an assessment of the continuity and coordination of care and care transitions, including episodes of care and risk-adjusted resource use;
(D) an assessment of efficiency;
(E) an assessment of patient experience and patient, caregiver, and family engagement;
(F) an assessment of the safety, effectiveness, and timeliness of care; and
(G) other information as determined appropriate by the Secretary.
(b) Other required considerations
In developing and implementing the plan described in subsection (a)(2), the Secretary shall, to the extent practicable, include—
(1) processes to assure that data made public, either by the Centers for Medicare & Medicaid Services or by other entities, is statistically valid and reliable, including risk adjustment mechanisms used by the Secretary;
(2) processes by which a physician or other eligible professional whose performance on measures is being publicly reported has a reasonable opportunity, as determined by the Secretary, to review his or her individual results before they are made public;
(3) processes by the Secretary to assure that the implementation of the plan and the data made available on Physician Compare provide a robust and accurate portrayal of a physician's performance;
(4) data that reflects the care provided to all patients seen by physicians, under both the Medicare program and, to the extent practicable, other payers, to the extent such information would provide a more accurate portrayal of physician performance;
(5) processes to ensure appropriate attribution of care when multiple physicians and other providers are involved in the care of a patient;
(6) processes to ensure timely statistical performance feedback is provided to physicians concerning the data reported under any program subject to public reporting under this section; and
(7) implementation of computer and data systems of the Centers for Medicare & Medicaid Services that support valid, reliable, and accurate public reporting activities authorized under this section.
(c) Ensuring patient privacy
The Secretary shall ensure that information on physician performance and patient experience is not disclosed under this section in a manner that violates sections 1 552 or 552a of title 5 with regard to the privacy of individually identifiable health information.
(d) Feedback from multi-stakeholder groups
The Secretary shall take into consideration input provided by multi-stakeholder groups, consistent with sections 1890(b)(7) and 1890A of the Social Security Act [
(e) Consideration of transition to value-based purchasing
In developing the plan under this 2 subsection (a)(2), the Secretary shall, as the Secretary determines appropriate, consider the plan to transition to a value-based purchasing program for physicians and other practitioners developed under section 131 of the Medicare Improvements for Patients and Providers Act of 2008 (
(f) Report to Congress
Not later than January 1, 2015, the Secretary shall submit to Congress a report on the Physician Compare Internet website developed under subsection (a)(1). Such report shall include information on the efforts of and plans made by the Secretary to collect and publish data on physician quality and efficiency and on patient experience of care in support of value-based purchasing and consumer choice, together with recommendations for such legislation and administrative action as the Secretary determines appropriate.
(g) Expansion
At any time before the date on which the report is submitted under subsection (f), the Secretary may expand (including expansion to other providers of services and suppliers under title XVIII of the Social Security Act [
(h) Financial incentives to encourage consumers to choose high quality providers
The Secretary may establish a demonstration program, not later than January 1, 2019, to provide financial incentives to Medicare beneficiaries who are furnished services by high quality physicians, as determined by the Secretary based on factors in subparagraphs (A) through (G) of subsection (a)(2). In no case may Medicare beneficiaries be required to pay increased premiums or cost sharing or be subject to a reduction in benefits under title XVIII of the Social Security Act as a result of such demonstration program. The Secretary shall ensure that any such demonstration program does not disadvantage those beneficiaries without reasonable access to high performing physicians or create financial inequities under such title.
(i) Definitions
In this section:
(1) Eligible professional
The term "eligible professional" has the meaning given that term for purposes of the Physician Quality Reporting Initiative under section 1848 of the Social Security Act (
(2) Physician
The term "physician" has the meaning given that term in section 1861(r) of such Act (
(3) Physician Compare
The term "Physician Compare" means the Internet website developed under subsection (a)(1).
(4) Secretary
The term "Secretary" means the Secretary of Health and Human Services.
(
Editorial Notes
References in Text
Section 3014 of this Act, referred to in subsec. (d), is section 3014 of
Section 131 of the Medicare Improvements for Patients and Providers Act of 2008, referred to in subsec. (e), is section 131 of
The Social Security Act, referred to in subsecs. (g) and (h), is act Aug. 14, 1935, ch. 531,
Codification
Section was enacted as part of the Patient Protection and Affordable Care Act, and not as part of the Social Security Act which comprises this chapter.
1 So in original. Probably should be "section".
2 So in original. The word "this" probably should not appear.
§1395w–6. Empowering beneficiary choices through continued access to information on physicians' services
(a) In general
On an annual basis (beginning with 2015), the Secretary shall make publicly available, in an easily understandable format, information with respect to physicians and, as appropriate, other eligible professionals on items and services furnished to Medicare beneficiaries under title XVIII of the Social Security Act (
(b) Type and manner of information
The information made available under this section shall be similar to the type of information in the Medicare Provider Utilization and Payment Data: Physician and Other Supplier Public Use File released by the Secretary with respect to 2012 and shall be made available in a manner similar to the manner in which the information in such file is made available.
(c) Requirements
The information made available under this section shall include, at a minimum, the following:
(1) Information on the number of services furnished by the physician or other eligible professional under part B of title XVIII of the Social Security Act (
(2) Information on submitted charges and payments for services under such part.
(3) A unique identifier for the physician or other eligible professional that is available to the public, such as a national provider identifier.
(d) Searchability
The information made available under this section shall be searchable by at least the following:
(1) The specialty or type of the physician or other eligible professional.
(2) Characteristics of the services furnished, such as volume or groupings of services.
(3) The location of the physician or other eligible professional.
(e) Integration on physician compare
Beginning with 2016, the Secretary shall integrate the information made available under this section on Physician Compare.
(f) Definitions
In this section:
(1) Eligible professional; physician; Secretary
The terms "eligible professional", "physician", and "Secretary" have the meaning given such terms in
(2) Physician compare
The term "Physician Compare" means the Physician Compare Internet website of the Centers for Medicare & Medicaid Services (or a successor website).
(
Editorial Notes
References in Text
The Social Security Act, referred to in subsecs. (a) and (c)(1), is act Aug. 14, 1935, ch. 531,
Codification
Section was enacted as part of the Medicare Access and CHIP Reauthorization Act of 2015, and not as part of the Social Security Act which comprises this chapter.
Part C—Medicare+Choice Program
Editorial Notes
Prior Provisions
A prior part C of this subchapter, consisting of section 1395x et seq., was redesignated part E of this subchapter.
Statutory Notes and Related Subsidiaries
Change of Name
References to Medicare+Choice deemed to refer to Medicare Advantage or MA, subject to an appropriate transition provided by the Secretary of Health and Human Services in the use of those terms, see section 201 of
§1395w–21. Eligibility, election, and enrollment
(a) Choice of medicare benefits through Medicare+Choice plans
(1) In general
Subject to the provisions of this section, each Medicare+Choice eligible individual (as defined in paragraph (3)) is entitled to elect to receive benefits (other than qualified prescription drug benefits) under this subchapter—
(A) through the original medicare fee-for-service program under parts A and B, or
(B) through enrollment in a Medicare+Choice plan under this part,
and may elect qualified prescription drug coverage in accordance with
(2) Types of Medicare+Choice plans that may be available
A Medicare+Choice plan may be any of the following types of plans of health insurance:
(A) Coordinated care plans (including regional plans)
(i) In general
Coordinated care plans which provide health care services, including but not limited to health maintenance organization plans (with or without point of service options), plans offered by provider-sponsored organizations (as defined in
(ii) Specialized MA plans for special needs individuals
Specialized MA plans for special needs individuals (as defined in
(B) Combination of MSA plan and contributions to Medicare+Choice MSA
An MSA plan, as defined in
(C) Private fee-for-service plans
A Medicare+Choice private fee-for-service plan, as defined in
(3) Medicare+Choice eligible individual
In this subchapter, the term "Medicare+Choice eligible individual" means an individual who is entitled to benefits under part A and enrolled under part B.
(b) Special rules
(1) Residence requirement
(A) In general
Except as the Secretary may otherwise provide and except as provided in subparagraph (C), an individual is eligible to elect a Medicare+Choice plan offered by a Medicare+Choice organization only if the plan serves the geographic area in which the individual resides.
(B) Continuation of enrollment permitted
Pursuant to rules specified by the Secretary, the Secretary shall provide that an MA local plan may offer to all individuals residing in a geographic area the option to continue enrollment in the plan, notwithstanding that the individual no longer resides in the service area of the plan, so long as the plan provides that individuals exercising this option have, as part of the benefits under the original medicare fee-for-service program option, reasonable access within that geographic area to the full range of basic benefits, subject to reasonable cost sharing liability in obtaining such benefits.
(C) Continuation of enrollment permitted where service changed
Notwithstanding subparagraph (A) and in addition to subparagraph (B), if a Medicare+Choice organization eliminates from its service area a Medicare+Choice payment area that was previously within its service area, the organization may elect to offer individuals residing in all or portions of the affected area who would otherwise be ineligible to continue enrollment the option to continue enrollment in an MA local plan it offers so long as—
(i) the enrollee agrees to receive the full range of basic benefits (excluding emergency and urgently needed care) exclusively at facilities designated by the organization within the plan service area; and
(ii) there is no other Medicare+Choice plan offered in the area in which the enrollee resides at the time of the organization's election.
(2) Special rule for certain individuals covered under FEHBP or eligible for veterans or military health benefits
(A) FEHBP
An individual who is enrolled in a health benefit plan under
(B) VA and DOD
The Secretary may apply rules similar to the rules described in subparagraph (A) in the case of individuals who are eligible for health care benefits under
(3) Limitation on eligibility of qualified medicare beneficiaries and other medicaid beneficiaries to enroll in an MSA plan
An individual who is a qualified medicare beneficiary (as defined in
(4) Coverage under MSA plans
(A) In general
Under rules established by the Secretary, an individual is not eligible to enroll (or continue enrollment) in an MSA plan for a year unless the individual provides assurances satisfactory to the Secretary that the individual will reside in the United States for at least 183 days during the year.
(B) Evaluation
The Secretary shall regularly evaluate the impact of permitting enrollment in MSA plans under this part on selection (including adverse selection), use of preventive care, access to care, and the financial status of the Trust Funds under this subchapter.
(C) Reports
The Secretary shall submit to Congress periodic reports on the numbers of individuals enrolled in such plans and on the evaluation being conducted under subparagraph (B).
(c) Process for exercising choice
(1) In general
The Secretary shall establish a process through which elections described in subsection (a) are made and changed, including the form and manner in which such elections are made and changed. Subject to paragraph (4), such elections shall be made or changed only during coverage election periods specified under subsection (e) and shall become effective as provided in subsection (f).
(2) Coordination through Medicare+Choice organizations
(A) Enrollment
Such process shall permit an individual who wishes to elect a Medicare+Choice plan offered by a Medicare+Choice organization to make such election through the filing of an appropriate election form with the organization.
(B) Disenrollment
Such process shall permit an individual, who has elected a Medicare+Choice plan offered by a Medicare+Choice organization and who wishes to terminate such election, to terminate such election through the filing of an appropriate election form with the organization.
(3) Default
(A) Initial election
(i) In general
Subject to clause (ii), an individual who fails to make an election during an initial election period under subsection (e)(1) is deemed to have chosen the original medicare fee-for-service program option.
(ii) Seamless continuation of coverage
The Secretary may establish procedures under which an individual who is enrolled in a health plan (other than Medicare+Choice plan) offered by a Medicare+Choice organization at the time of the initial election period and who fails to elect to receive coverage other than through the organization is deemed to have elected the Medicare+Choice plan offered by the organization (or, if the organization offers more than one such plan, such plan or plans as the Secretary identifies under such procedures).
(B) Continuing periods
An individual who has made (or is deemed to have made) an election under this section is considered to have continued to make such election until such time as—
(i) the individual changes the election under this section, or
(ii) the Medicare+Choice plan with respect to which such election is in effect is discontinued or, subject to subsection (b)(1)(B), no longer serves the area in which the individual resides.
(4) Deemed enrollment relating to converted reasonable cost reimbursement contracts
(A) In general
On the first day of the annual, coordinated election period under subsection (e)(3) for plan years beginning on or after January 1, 2017, an MA eligible individual described in clause (i) or (ii) of subparagraph (B) is deemed, unless the individual elects otherwise, to have elected to receive benefits under this subchapter through an applicable MA plan (and shall be enrolled in such plan) beginning with such plan year, if—
(i) the individual is enrolled in a reasonable cost reimbursement contract under
(ii) such reasonable cost reimbursement contract was extended or renewed for the last reasonable cost reimbursement contract year of the contract (as described in subclause (I) of
(iii) the eligible organization that is offering such reasonable cost reimbursement contract provided the notice described in subclause (III) of such section that the contract was to be converted;
(iv) the applicable MA plan—
(I) is the plan that was converted from the reasonable cost reimbursement contract described in clause (iii);
(II) is offered by the same entity (or an organization affiliated with such entity that has a common ownership interest of control) that entered into such contract; and
(III) is offered in the service area where the individual resides;
(v) in the case of reasonable cost reimbursement contracts that provide coverage under parts A and B (and, to the extent the Secretary determines it to be feasible, contracts that provide only part B coverage), the difference between the estimated individual costs (as determined applicable by the Secretary) for the applicable MA plan and such costs for the predecessor cost plan does not exceed a threshold established by the Secretary; and
(vi) the applicable MA plan—
(I) provides coverage for enrollees transitioning from the converted reasonable cost reimbursement contract to such plan to maintain current providers of services and suppliers and course of treatment at the time of enrollment for a period of at least 90 days after enrollment; and
(II) during such period, pays such providers of services and suppliers for items and services furnished to the enrollee an amount that is not less than the amount of payment applicable for such items and services under the original Medicare fee-for-service program under parts A and B.
(B) MA eligible individuals described
(i) Without prescription drug coverage
An MA eligible individual described in this clause, with respect to a plan year, is an MA eligible individual who is enrolled in a reasonable cost reimbursement contract under
(ii) With prescription drug coverage
An MA eligible individual described in this clause, with respect to a plan year, is an MA eligible individual who is enrolled in a reasonable cost reimbursement contract under
(I) through such contract; or
(II) through a prescription drug plan, if the sponsor of such plan is the same entity (or an organization affiliated with such entity) that entered into such contract.
(C) Applicable MA plan defined
In this paragraph, the term "applicable MA plan" means, in the case of an individual described in—
(i) subparagraph (B)(i), an MA plan that is not an MA–PD plan; and
(ii) subparagraph (B)(ii), an MA–PD plan.
(D) Identification and notification of deemed individuals
Not later than 45 days before the first day of the annual, coordinated election period under subsection (e)(3) for plan years beginning on or after January 1, 2017, the Secretary shall identify and notify the individuals who will be subject to deemed elections under subparagraph (A) on the first day of such period.
(d) Providing information to promote informed choice
(1) In general
The Secretary shall provide for activities under this subsection to broadly disseminate information to medicare beneficiaries (and prospective medicare beneficiaries) on the coverage options provided under this section in order to promote an active, informed selection among such options.
(2) Provision of notice
(A) Open season notification
At least 15 days before the beginning of each annual, coordinated election period (as defined in subsection (e)(3)(B)), the Secretary shall mail to each Medicare+Choice eligible individual residing in an area the following:
(i) General information
The general information described in paragraph (3).
(ii) List of plans and comparison of plan options
A list identifying the Medicare+Choice plans that are (or will be) available to residents of the area and information described in paragraph (4) concerning such plans. Such information shall be presented in a comparative form.
(iii) Additional information
Any other information that the Secretary determines will assist the individual in making the election under this section.
The mailing of such information shall be coordinated, to the extent practicable, with the mailing of any annual notice under
(B) Notifications required
(i) Notification to newly eligible Medicare Advantage eligible individuals
To the extent practicable, the Secretary shall, not later than 30 days before the beginning of the initial Medicare+Choice enrollment period for an individual described in subsection (e)(1), mail to the individual the information described in subparagraph (A).
(ii) Notification related to certain deemed elections
The Secretary shall require a Medicare Advantage organization that is offering a Medicare Advantage plan that has been converted from a reasonable cost reimbursement contract pursuant to
(I) a notification that such individual will, on such day, be deemed to have made an election with respect to such plan to receive benefits under this subchapter through an MA plan or MA–PD plan (and shall be enrolled in such plan) for the next plan year under subsection (c)(4)(A), but that the individual may make a different election during the annual, coordinated election period for such year;
(II) the information described in subparagraph (A);
(III) a description of the differences between such MA plan or MA–PD plan and the reasonable cost reimbursement contract in which the individual was most recently enrolled with respect to benefits covered under such plans, including cost-sharing, premiums, drug coverage, and provider networks;
(IV) information about the special period for elections under subsection (e)(2)(F); and
(V) other information the Secretary may specify.
(C) Form
The information disseminated under this paragraph shall be written and formatted using language that is easily understandable by medicare beneficiaries.
(D) Periodic updating
The information described in subparagraph (A) shall be updated on at least an annual basis to reflect changes in the availability of Medicare+Choice plans and the benefits and Medicare+Choice monthly basic and supplemental beneficiary premiums for such plans.
(3) General information
General information under this paragraph, with respect to coverage under this part during a year, shall include the following:
(A) Benefits under original medicare fee-for-service program option
A general description of the benefits covered under the original medicare fee-for-service program under parts A and B, including—
(i) covered items and services,
(ii) beneficiary cost sharing, such as deductibles, coinsurance, and copayment amounts, and
(iii) any beneficiary liability for balance billing.
(B) Election procedures
Information and instructions on how to exercise election options under this section.
(C) Rights
A general description of procedural rights (including grievance and appeals procedures) of beneficiaries under the original medicare fee-for-service program and the Medicare+Choice program and the right to be protected against discrimination based on health status-related factors under
(D) Information on medigap and medicare select
A general description of the benefits, enrollment rights, and other requirements applicable to medicare supplemental policies under
(E) Potential for contract termination
The fact that a Medicare+Choice organization may terminate its contract, refuse to renew its contract, or reduce the service area included in its contract, under this part, and the effect of such a termination, nonrenewal, or service area reduction may have on individuals enrolled with the Medicare+Choice plan under this part.
(F) Catastrophic coverage and single deductible
In the case of an MA regional plan, a description of the catastrophic coverage and single deductible applicable under the plan.
(4) Information comparing plan options
Information under this paragraph, with respect to a Medicare+Choice plan for a year, shall include the following:
(A) Benefits
The benefits covered under the plan, including the following:
(i) Covered items and services beyond those provided under the original medicare fee-for-service program.
(ii) Any beneficiary cost sharing, including information on the single deductible (if applicable) under
(iii) Any maximum limitations on out-of-pocket expenses.
(iv) In the case of an MSA plan, differences in cost sharing, premiums, and balance billing under such a plan compared to under other Medicare+Choice plans.
(v) In the case of a Medicare+Choice private fee-for-service plan, differences in cost sharing, premiums, and balance billing under such a plan compared to under other Medicare+Choice plans.
(vi) The extent to which an enrollee may obtain benefits through out-of-network health care providers.
(vii) The extent to which an enrollee may select among in-network providers and the types of providers participating in the plan's network.
(viii) The organization's coverage of emergency and urgently needed care.
(B) Premiums
(i) In general
The monthly amount of the premium charged to an individual.
(ii) Reductions
The reduction in part B premiums, if any.
(C) Service area
The service area of the plan.
(D) Quality and performance
To the extent available, plan quality and performance indicators for the benefits under the plan (and how they compare to such indicators under the original medicare fee-for-service program under parts A and B in the area involved), including—
(i) disenrollment rates for medicare enrollees electing to receive benefits through the plan for the previous 2 years (excluding disenrollment due to death or moving outside the plan's service area),
(ii) information on medicare enrollee satisfaction,
(iii) information on health outcomes, and
(iv) the recent record regarding compliance of the plan with requirements of this part (as determined by the Secretary).
(E) Supplemental benefits
Supplemental health care benefits, including any reductions in cost-sharing under
(5) Maintaining a toll-free number and Internet site
The Secretary shall maintain a toll-free number for inquiries regarding Medicare+Choice options and the operation of this part in all areas in which Medicare+Choice plans are offered and an Internet site through which individuals may electronically obtain information on such options and Medicare+Choice plans.
(6) Use of non-Federal entities
The Secretary may enter into contracts with non-Federal entities to carry out activities under this subsection.
(7) Provision of information
A Medicare+Choice organization shall provide the Secretary with such information on the organization and each Medicare+Choice plan it offers as may be required for the preparation of the information referred to in paragraph (2)(A).
(e) Coverage election periods
(1) Initial choice upon eligibility to make election if Medicare+Choice plans available to individual
If, at the time an individual first becomes entitled to benefits under part A and enrolled under part B, there is one or more Medicare+Choice plans offered in the area in which the individual resides, the individual shall make the election under this section during a period specified by the Secretary such that if the individual elects a Medicare+Choice plan during the period, coverage under the plan becomes effective as of the first date on which the individual may receive such coverage. If any portion of an individual's initial enrollment period under part B occurs after the end of the annual, coordinated election period described in paragraph (3)(B)(iii), the initial enrollment period under this part shall further extend through the end of the individual's initial enrollment period under part B.
(2) Open enrollment and disenrollment opportunities
Subject to paragraph (5)—
(A) Continuous open enrollment and disenrollment through 2005
At any time during the period beginning January 1, 1998, and ending on December 31, 2005, a Medicare+Choice eligible individual may change the election under subsection (a)(1).
(B) Continuous open enrollment and disenrollment for first 6 months during 2006
(i) In general
Subject to clause (ii), subparagraph (C)(iii),1 and subparagraph (D), at any time during the first 6 months of 2006, or, if the individual first becomes a Medicare+Choice eligible individual during 2006, during the first 6 months during 2006 in which the individual is a Medicare+Choice eligible individual, a Medicare+Choice eligible individual may change the election under subsection (a)(1).
(ii) Limitation of one change
An individual may exercise the right under clause (i) only once. The limitation under this clause shall not apply to changes in elections effected during an annual, coordinated election period under paragraph (3) or during a special enrollment period under the first sentence of paragraph (4).
(C) Annual 45-day period from 2011 through 2018 for disenrollment from MA plans to elect to receive benefits under the original Medicare fee-for-service program
Subject to subparagraph (D), at any time during the first 45 days of a year (beginning with 2011 and ending with 2018), an individual who is enrolled in a Medicare Advantage plan may change the election under subsection (a)(1), but only with respect to coverage under the original medicare fee-for-service program under parts A and B, and may elect qualified prescription drug coverage in accordance with
(D) Continuous open enrollment for institutionalized individuals
At any time after 2005 in the case of a Medicare+Choice eligible individual who is institutionalized (as defined by the Secretary), the individual may elect under subsection (a)(1)—
(i) to enroll in a Medicare+Choice plan; or
(ii) to change the Medicare+Choice plan in which the individual is enrolled.
(E) Limited continuous open enrollment of original fee-for-service enrollees in medicare advantage non-prescription drug plans
(i) In general
On any date during the period beginning on January 1, 2007, and ending on July 31, 2007, on which a Medicare Advantage eligible individual is an unenrolled fee-for-service individual (as defined in clause (ii)), the individual may elect under subsection (a)(1) to enroll in a Medicare Advantage plan that is not an MA–PD plan.
(ii) Unenrolled fee-for-service individual defined
In this subparagraph, the term "unenrolled fee-for-service individual" means, with respect to a date, a Medicare Advantage eligible individual who—
(I) is receiving benefits under this subchapter through enrollment in the original medicare fee-for-service program under parts A and B;
(II) is not enrolled in an MA plan on such date; and
(III) as of such date is not otherwise eligible to elect to enroll in an MA plan.
(iii) Limitation of one change during the applicable period
An individual may exercise the right under clause (i) only once during the period described in such clause.
(iv) No effect on coverage under a prescription drug plan
Nothing in this subparagraph shall be construed as permitting an individual exercising the right under clause (i)—
(I) who is enrolled in a prescription drug plan under part D, to disenroll from such plan or to enroll in a different prescription drug plan; or
(II) who is not enrolled in a prescription drug plan, to enroll in such a plan.
(F) Special period for certain deemed elections
(i) In general
At any time during the period beginning after the last day of the annual, coordinated election period under paragraph (3) in which an individual is deemed to have elected to enroll in an MA plan or MA–PD plan under subsection (c)(4) and ending on the last day of February of the first plan year for which the individual is enrolled in such plan, such individual may change the election under subsection (a)(1) (including changing the MA plan or MA–PD plan in which the individual is enrolled).
(ii) Limitation of one change
An individual may exercise the right under clause (i) only once during the applicable period described in such clause. The limitation under this clause shall not apply to changes in elections effected during an annual, coordinated election period under paragraph (3) or during a special enrollment period under paragraph (4).
(G) Continuous open enrollment and disenrollment for first 3 months in 2016 and subsequent years
(i) In general
Subject to clause (ii) and subparagraph (D)—
(I) in the case of an MA eligible individual who is enrolled in an MA plan, at any time during the first 3 months of a year (beginning with 2019); or
(II) in the case of an individual who first becomes an MA eligible individual during a year (beginning with 2019) and enrolls in an MA plan, during the first 3 months during such year in which the individual is an MA eligible individual;
such MA eligible individual may change the election under subsection (a)(1).
(ii) Limitation of one change during open enrollment period each year
An individual may change the election pursuant to clause (i) only once during the applicable 3-month period described in such clause in each year. The limitation under this clause shall not apply to changes in elections effected during an annual, coordinated election period under paragraph (3) or during a special enrollment period under paragraph (4).
(iii) Limited application to part D
Clauses (i) and (ii) of this subparagraph shall only apply with respect to changes in enrollment in a prescription drug plan under part D in the case of an individual who, previous to such change in enrollment, is enrolled in a Medicare Advantage plan.
(iv) Limitations on marketing
Pursuant to subsection (j), no unsolicited marketing or marketing materials may be sent to an individual described in clause (i) during the continuous open enrollment and disenrollment period established for the individual under such clause, notwithstanding marketing guidelines established by the Centers for Medicare & Medicaid Services.
(3) Annual, coordinated election period
(A) In general
Subject to paragraph (5), each individual who is eligible to make an election under this section may change such election during an annual, coordinated election period.
(B) Annual, coordinated election period
For purposes of this section, the term "annual, coordinated election period" means—
(i) with respect to a year before 2002, the month of November before such year;
(ii) with respect to 2002, 2003, 2004, and 2005, the period beginning on November 15 and ending on December 31 of the year before such year;
(iii) with respect to 2006, the period beginning on November 15, 2005, and ending on May 15, 2006;
(iv) with respect to 2007, 2008, 2009, and 2010, the period beginning on November 15 and ending on December 31 of the year before such year; and
(v) with respect to 2012 and succeeding years, the period beginning on October 15 and ending on December 7 of the year before such year.
(C) Medicare+Choice health information fairs
During the fall season of each year (beginning with 1999) and during the period described in subparagraph (B)(iii), in conjunction with the annual coordinated election period defined in subparagraph (B), the Secretary shall provide for a nationally coordinated educational and publicity campaign to inform Medicare+Choice eligible individuals about Medicare+Choice plans and the election process provided under this section.
(D) Special information campaigns
During November 1998 the Secretary shall provide for an educational and publicity campaign to inform Medicare+Choice eligible individuals about the availability of Medicare+Choice plans, and eligible organizations with risk-sharing contracts under
(4) Special election periods
Effective as of January 1, 2006, an individual may discontinue an election of a Medicare+Choice plan offered by a Medicare+Choice organization other than during an annual, coordinated election period and make a new election under this section if—
(A)(i) the certification of the organization or plan under this part has been terminated, or the organization or plan has notified the individual of an impending termination of such certification; or
(ii) the organization has terminated or otherwise discontinued providing the plan in the area in which the individual resides, or has notified the individual of an impending termination or discontinuation of such plan;
(B) the individual is no longer eligible to elect the plan because of a change in the individual's place of residence or other change in circumstances (specified by the Secretary, but not including termination of the individual's enrollment on the basis described in clause (i) or (ii) of subsection (g)(3)(B));
(C) the individual demonstrates (in accordance with guidelines established by the Secretary) that—
(i) the organization offering the plan substantially violated a material provision of the organization's contract under this part in relation to the individual (including the failure to provide an enrollee on a timely basis medically necessary care for which benefits are available under the plan or the failure to provide such covered care in accordance with applicable quality standards); or
(ii) the organization (or an agent or other entity acting on the organization's behalf) materially misrepresented the plan's provisions in marketing the plan to the individual; or
(D) the individual meets such other exceptional conditions as the Secretary may provide.
Effective as of January 1, 2006, an individual who, upon first becoming eligible for benefits under part A at age 65, enrolls in a Medicare+Choice plan under this part, the individual may discontinue the election of such plan, and elect coverage under the original fee-for-service plan, at any time during the 12-month period beginning on the effective date of such enrollment.
(5) Special rules for MSA plans
Notwithstanding the preceding provisions of this subsection, an individual—
(A) may elect an MSA plan only during—
(i) an initial open enrollment period described in paragraph (1), or
(ii) an annual, coordinated election period described in paragraph (3)(B);
(B) subject to subparagraph (C), may not discontinue an election of an MSA plan except during the periods described in clause (ii) or (iii) of subparagraph (A) and under the first sentence of paragraph (4); and
(C) who elects an MSA plan during an annual, coordinated election period, and who never previously had elected such a plan, may revoke such election, in a manner determined by the Secretary, by not later than December 15 following the date of the election.
(6) Open enrollment periods
Subject to paragraph (5), a Medicare+Choice organization—
(A) shall accept elections or changes to elections during the initial enrollment periods described in paragraph (1), during the period described in paragraph (2)(F), during the month of November 1998 and during the annual, coordinated election period under paragraph (3) for each subsequent year, and during special election periods described in the first sentence of paragraph (4); and
(B) may accept other changes to elections at such other times as the organization provides.
(f) Effectiveness of elections and changes of elections
(1) During initial coverage election period
An election of coverage made during the initial coverage election period under subsection (e)(1) shall take effect upon the date the individual becomes entitled to benefits under part A and enrolled under part B, except as the Secretary may provide (consistent with
(2) During continuous open enrollment periods
An election or change of coverage made under subsection (e)(2) shall take effect with the first day of the first calendar month following the date on which the election or change is made.
(3) Annual, coordinated election period
An election or change of coverage made during an annual, coordinated election period (as defined in subsection (e)(3)(B), other than the period described in clause (iii) of such subsection) in a year shall take effect as of the first day of the following year.
(4) Other periods
An election or change of coverage made during any other period under subsection (e)(4) shall take effect in such manner as the Secretary provides in a manner consistent (to the extent practicable) with protecting continuity of health benefit coverage.
(g) Guaranteed issue and renewal
(1) In general
Except as provided in this subsection, a Medicare+Choice organization shall provide that at any time during which elections are accepted under this section with respect to a Medicare+Choice plan offered by the organization, the organization will accept without restrictions individuals who are eligible to make such election.
(2) Priority
If the Secretary determines that a Medicare+Choice organization, in relation to a Medicare+Choice plan it offers, has a capacity limit and the number of Medicare+Choice eligible individuals who elect the plan under this section exceeds the capacity limit, the organization may limit the election of individuals of the plan under this section but only if priority in election is provided—
(A) first to such individuals as have elected the plan at the