
From the U.S. Code Online via GPO Access
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[Laws in effect as of January 23, 2000]
[Document affected by Public Law 106-554 Section 1(a)(6)]
[Document affected by Public Law 106-554 Section 1(a)(6)[102(c)]]
[Document affected by Public Law 106-554 Section 1(a)(6)[313(a)]]
[Document affected by Public Law 106-554 Section 1(a)(6)[522(b)]]
[Document affected by Public Law 107-105 Section 3(a)]
[Document affected by Public Law 107-105 Section 3(b)]
[CITE: 42USC1395y]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                       CHAPTER 7--SOCIAL SECURITY
 
        SUBCHAPTER XVIII--HEALTH INSURANCE FOR AGED AND DISABLED
 
                    Part D--Miscellaneous Provisions
 
Sec. 1395y. Exclusions from coverage and medicare as secondary 
        payer
        

(a) Items or services specifically excluded

    Notwithstanding any other provision of this subchapter, no payment 
may be made under part A or part B of this subchapter for any expenses 
incurred for items or services--
        (1)(A) which, except for items and services described in a 
    succeeding subparagraph, are not reasonable and necessary for the 
    diagnosis or treatment of illness or injury or to improve the 
    functioning of a malformed body member,
        (B) in the case of items and services described in section 
    1395x(s)(10) of this title, which are not reasonable and necessary 
    for the prevention of illness,
        (C) in the case of hospice care, which are not reasonable and 
    necessary for the palliation or management of terminal illness,
        (D) in the case of clinical care items and services provided 
    with the concurrence of the Secretary and with respect to research 
    and experimentation conducted by, or under contract with, the 
    Medicare Payment Advisory Commission or the Secretary, which are not 
    reasonable and necessary to carry out the purposes of section 
    1395ww(e)(6) of this title,\1\
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        (E) in the case of research conducted pursuant to section 1320b-
    12 of this title, which is not reasonable and necessary to carry out 
    the purposes of that section,
        (F) in the case of screening mammography, which is performed 
    more frequently than is covered under section 1395m(c)(2) of this 
    title or which is not conducted by a facility described in section 
    1395m(c)(1)(B) of this title, and, in the case of screening pap 
    smear and screening pelvic exam, which is performed more frequently 
    than is provided under section 1395x(nn) of this title,
        (G) in the case of prostate cancer screening tests (as defined 
    in section 1395x(oo) of this title), which are performed more 
    frequently than is covered under such section,
        (H) in the case of colorectal cancer screening tests, which are 
    performed more frequently than is covered under section 1395m(d) of 
    this title, and
        (I) the frequency and duration of home health services which are 
    in excess of normative guidelines that the Secretary shall establish 
    by regulation;
        (2) for which the individual furnished such items or services 
    has no legal obligation to pay, and which no other person (by reason 
    of such individual's membership in a prepayment plan or otherwise) 
    has a legal obligation to provide or pay for, except in the case of 
    Federally qualified health center services;
        (3) which are paid for directly or indirectly by a governmental 
    entity (other than under this chapter and other than under a health 
    benefits or insurance plan established for employees of such an 
    entity), except in the case of rural health clinic services, as 
    defined in section 1395x(aa)(1) of this title,,\2\ in the case of 
    Federally qualified health center services, as defined in section 
    1395x(aa)(3) of this title, and in such other cases as the Secretary 
    may specify;
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        (4) which are not provided within the United States (except for 
    inpatient hospital services furnished outside the United States 
    under the conditions described in section 1395f(f) of this title 
    and, subject to such conditions, limitations, and requirements as 
    are provided under or pursuant to this subchapter, physicians' 
    services and ambulance services furnished an individual in 
    conjunction with such inpatient hospital services but only for the 
    period during which such inpatient hospital services were 
    furnished);
        (5) which are required as a result of war, or of an act of war, 
    occurring after the effective date of such individual's current 
    coverage under such part;
        (6) which constitute personal comfort items (except, in the case 
    of hospice care, as is otherwise permitted under paragraph (1)(C));
        (7) where such expenses are for routine physical checkups, 
    eyeglasses (other than eyewear described in section 1395x(s)(8) of 
    this title) or eye examinations for the purpose of prescribing, 
    fitting, or changing eyeglasses, procedures performed (during the 
    course of any eye examination) to determine the refractive state of 
    the eyes, hearing aids or examinations therefor, or immunizations 
    (except as otherwise allowed under section 1395x(s)(10) of this 
    title and subparagraph (B), (F), (G), or (H) of paragraph (1));
        (8) where such expenses are for orthopedic shoes or other 
    supportive devices for the feet, other than shoes furnished pursuant 
    to section 1395x(s)(12) of this title;
        (9) where such expenses are for custodial care (except, in the 
    case of hospice care, as is otherwise permitted under paragraph 
    (1)(C));
        (10) where such expenses are for cosmetic surgery or are 
    incurred in connection therewith, except as required for the prompt 
    repair of accidental injury or for improvement of the functioning of 
    a malformed body member;
        (11) where such expenses constitute charges imposed by immediate 
    relatives of such individual or members of his household;
        (12) where such expenses are for services in connection with the 
    care, treatment, filling, removal, or replacement of teeth or 
    structures directly supporting teeth, except that payment may be 
    made under part A of this subchapter in the case of inpatient 
    hospital services in connection with the provision of such dental 
    services if 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;
        (13) where such expenses are for--
            (A) the treatment of flat foot conditions and the 
        prescription of supportive devices therefor,
            (B) the treatment of subluxations of the foot, or
            (C) routine foot care (including the cutting or removal of 
        corns or calluses, the trimming of nails, and other routine 
        hygienic care);

        (14) which are other than physicians' services (as defined in 
    regulations promulgated specifically for purposes of this 
    paragraph), services described by section 1395x(s)(2)(K) of this 
    title, certified nurse-midwife services, qualified psychologist 
    services, and services of a certified registered nurse anesthetist, 
    and which are furnished to an individual who is a patient of a 
    hospital or critical access hospital by an entity other than the 
    hospital or critical access hospital, unless the services are 
    furnished under arrangements (as defined in section 1395x(w)(1) of 
    this title) with the entity made by the hospital or critical access 
    hospital;
        (15)(A) which are for services of an assistant at surgery in a 
    cataract operation (including subsequent insertion of an intraocular 
    lens) unless, before the surgery is performed, the appropriate 
    utilization and quality control peer review organization (under part 
    B of subchapter XI of this chapter) or a carrier under section 1395u 
    of this title has approved of the use of such an assistant in the 
    surgical procedure based on the existence of a complicating medical 
    condition, or
        (B) which are for services of an assistant at surgery to which 
    section 1395w-4(i)(2)(B) of this title applies;
        (16) in the case in which funds may not be used for such items 
    and services under the Assisted Suicide Funding Restriction Act of 
    1997 [42 U.S.C. 14401 et seq.];
        (17) where the expenses are for an item or service furnished in 
    a competitive acquisition area (as established by the Secretary 
    under section 1395w-3(a) of this title) by an entity other than an 
    entity with which the Secretary has entered into a contract under 
    section 1395w-3(b) of this title for the furnishing of such an item 
    or service in that area, unless the Secretary finds that the 
    expenses were incurred in a case of urgent need, or in other 
    circumstances specified by the Secretary;
        (18) which are covered skilled nursing facility services 
    described in section 1395yy(e)(2)(A)(i) of this title and which are 
    furnished to an individual who is a resident of a skilled nursing 
    facility or of a part of a facility that includes a skilled nursing 
    facility (as determined under regulations), by an entity other than 
    the skilled nursing facility, unless the services are furnished 
    under arrangements (as defined in section 1395x(w)(1) of this title) 
    with the entity made by the skilled nursing facility;
        (19) which are for items or services which are furnished 
    pursuant to a private contract described in section 1395a(b) of this 
    title;
        (20) in the case of outpatient occupational therapy services or 
    outpatient physical therapy services furnished as an incident to a 
    physician's professional services (as described in section 
    1395x(s)(2)(A) of this title), that do not meet the standards and 
    conditions (other than any licensing requirement specified by the 
    Secretary) under the second sentence of section 1395x(p) of this 
    title (or under such sentence through the operation of section 
    1395x(g) of this title) as such standards and conditions would apply 
    to such therapy services if furnished by a therapist; or
        (21) where such expenses are for home health services (including 
    medical supplies described in section 1395x(m)(5) of this title, but 
    excluding durable medical equipment to the extent provided for in 
    such section) furnished to an individual who is under a plan of care 
    of the home health agency if the claim for payment for such services 
    is not submitted by the agency.

Paragraph (7) shall not apply to Federally qualified health center 
services described in section 1395x(aa)(3)(B) of this title.

(b) Medicare as secondary payer

               (1) Requirements of group health plans

        (A) Working aged under group health plans

            (i) In general

                A group health plan--
                    (I) may not take into account that an individual (or 
                the individual's spouse) who is covered under the plan 
                by virtue of the individual's current employment status 
                with an employer is entitled to benefits under this 
                subchapter under section 426(a) of this title, and
                    (II) shall provide that any individual age 65 or 
                older (and the spouse age 65 or older of any individual) 
                who has current employment status with an employer shall 
                be entitled to the same benefits under the plan under 
                the same conditions as any such individual (or spouse) 
                under age 65.
            (ii) Exclusion of group health plan of a small 
                    employer

                Clause (i) shall not apply to a group health plan unless 
            the plan is a plan of, or contributed to by, an employer 
            that has 20 or more employees for each working day in each 
            of 20 or more calendar weeks in the current calendar year or 
            the preceding calendar year.
            (iii) Exception for small employers in multiemployer 
                    or multiple employer group health plans

                Clause (i) also shall not apply with respect to 
            individuals enrolled in a multiemployer or multiple employer 
            group health plan if the coverage of the individuals under 
            the plan is by virtue of current employment status with an 
            employer that does not have 20 or more individuals in 
            current employment status for each working day in each of 20 
            or more calendar weeks in the current calendar year and the 
            preceding calendar year; except that the exception provided 
            in this clause shall only apply if the plan elects treatment 
            under this clause.
            (iv) Exception for individuals with end stage renal 
                    disease

                Subparagraph (C) shall apply instead of clause (i) to an 
            item or service furnished in a month to an individual if for 
            the month the individual is, or (without regard to 
            entitlement under section 426 of this title) would upon 
            application be, entitled to benefits under section 426-1 of 
            this title.
            (v) ``Group health plan'' defined

                In this subparagraph, and subparagraph (C), the term 
            ``group health plan'' has the meaning given such term in 
            section 5000(b)(1) of the Internal Revenue Code of 1986, 
            without regard to section 5000(d) of such Code.

        (B) Disabled individuals in large group health plans

            (i) In general

                A large group health plan (as defined in clause (iii)) 
            may not take into account that an individual (or a member of 
            the individual's family) who is covered under the plan by 
            virtue of the individual's current employment status with an 
            employer is entitled to benefits under this subchapter under 
            section 426(b) of this title.
            (ii) Exception for individuals with end stage renal 
                    disease

                Subparagraph (C) shall apply instead of clause (i) to an 
            item or service furnished in a month to an individual if for 
            the month the individual is, or (without regard to 
            entitlement under section 426 of this title) would upon 
            application be, entitled to benefits under section 426-1 of 
            this title.
            (iii) ``Large group health plan'' defined

                In this subparagraph, the term ``large group health 
            plan'' has the meaning given such term in section 5000(b)(2) 
            of the Internal Revenue Code of 1986, without regard to 
            section 5000(d) of such Code.

        (C) Individuals with end stage renal disease

            A group health plan (as defined in subparagraph (A)(v))--
                (i) may not take into account that an individual is 
            entitled to or eligible for benefits under this subchapter 
            under section 426-1 of this title during the 12-month period 
            which begins with the first month in which the individual 
            becomes entitled to benefits under part A of this subchapter 
            under the provisions of section 426-1 of this title, or, if 
            earlier, the first month in which the individual would have 
            been entitled to benefits under such part under the 
            provisions of section 426-1 of this title if the individual 
            had filed an application for such benefits; and
                (ii) may not differentiate in the benefits it provides 
            between individuals having end stage renal disease and other 
            individuals covered by such plan on the basis of the 
            existence of end stage renal disease, the need for renal 
            dialysis, or in any other manner;

        except that clause (ii) shall not prohibit a plan from paying 
        benefits secondary to this subchapter when an individual is 
        entitled to or eligible for benefits under this subchapter under 
        section 426-1 of this title after the end of the 12-month period 
        described in clause (i). Effective for items and services 
        furnished on or after February 1, 1991, and before August 5, 
        1997,\3\ (with respect to periods beginning on or after February 
        1, 1990), this subparagraph shall be applied by substituting 
        ``18-month'' for ``12-month'' each place it appears. Effective 
        for items and services furnished on or after August 5, 1997,\3\ 
        (with respect to periods beginning on or after the date that is 
        18 months prior to August 5, 1997), clauses (i) and (ii) shall 
        be applied by substituting ``30-month'' for ``12-month'' each 
        place it appears.
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        (D) Treatment of certain members of religious orders

            In this subsection, an individual shall not be considered to 
        be employed, or an employee, with respect to the performance of 
        services as a member of a religious order which are considered 
        employment only by virtue of an election made by the religious 
        order under section 3121(r) of the Internal Revenue Code of 
        1986.

        (E) General provisions

            For purposes of this subsection:
            (i) Aggregation rules

                    (I) All employers treated as a single employer under 
                subsection (a) or (b) of section 52 of the Internal 
                Revenue Code of 1986 shall be treated as a single 
                employer.
                    (II) All employees of the members of an affiliated 
                service group (as defined in section 414(m) of such 
                Code) shall be treated as employed by a single employer.
                    (III) Leased employees (as defined in section 
                414(n)(2) of such Code) shall be treated as employees of 
                the person for whom they perform services to the extent 
                they are so treated under section 414(n) of such Code.

          In applying sections of the Internal Revenue Code of 1986 
            under this clause, the Secretary shall rely upon regulations 
            and decisions of the Secretary of the Treasury respecting 
            such sections.
            (ii) ``Current employment status'' defined

                An individual has ``current employment status'' with an 
            employer if the individual is an employee, is the employer, 
            or is associated with the employer in a business 
            relationship.
            (iii) Treatment of self-employed persons as 
                    employers

                The term ``employer'' includes a self-employed person.

        (F) Limitation on beneficiary liability

            An individual who is entitled to benefits under this 
        subchapter and is furnished an item or service for which such 
        benefits are incorrectly paid is not liable for repayment of 
        such benefits under this paragraph unless payment of such 
        benefits was made to the individual.

                    (2) Medicare secondary payer

        (A) In general

            Payment under this subchapter may not be made, except as 
        provided in subparagraph (B), with respect to any item or 
        service to the extent that--
                (i) payment has been made, or can reasonably be expected 
            to be made, with respect to the item or service as required 
            under paragraph (1), or
                (ii) payment has been made, or can reasonably be 
            expected to be made promptly (as determined in accordance 
            with regulations) under a workmen's compensation law or plan 
            of the United States or a State or under an automobile or 
            liability insurance policy or plan (including a self-insured 
            plan) or under no fault insurance.

        In this subsection, the term ``primary plan'' means a group 
        health plan or large group health plan, to the extent that 
        clause (i) applies, and a workmen's compensation law or plan, an 
        automobile or liability insurance policy or plan (including a 
        self-insured plan) or no fault insurance, to the extent that 
        clause (ii) applies.

        (B) Conditional payment

            (i) Repayment required

                Any payment under this subchapter with respect to any 
            item or service to which subparagraph (A) applies shall be 
            conditioned on reimbursement to the appropriate Trust Fund 
            established by this subchapter when notice or other 
            information is received that payment for such item or 
            service has been or could be made under such subparagraph. 
            If reimbursement is not made to the appropriate Trust Fund 
            before the expiration of the 60-day period that begins on 
            the date such notice or other information is received, the 
            Secretary may charge interest (beginning with the date on 
            which the notice or other information is received) on the 
            amount of the reimbursement until reimbursement is made (at 
            a rate determined by the Secretary in accordance with 
            regulations of the Secretary of the Treasury applicable to 
            charges for late payments).
            (ii) Action by United States

                In order to recover payment under this subchapter for 
            such an item or service, the United States may bring an 
            action against any entity which is required or responsible 
            (directly, as a third-party administrator, or otherwise) to 
            make payment with respect to such item or service (or any 
            portion thereof) under a primary plan (and may, in 
            accordance with paragraph (3)(A) collect double damages 
            against that entity), or against any other entity (including 
            any physician or provider) that has received payment from 
            that entity with respect to the item or service, and may 
            join or intervene in any action related to the events that 
            gave rise to the need for the item or service. The United 
            States may not recover from a third-party administrator 
            under this clause in cases where the third-party 
            administrator would not be able to recover the amount at 
            issue from the employer or group health plan and is not 
            employed by or under contract with the employer or group 
            health plan at the time the action for recovery is initiated 
            by the United States or for whom it provides administrative 
            services due to the insolvency or bankruptcy of the employer 
            or plan.
            (iii) Subrogation rights

                The United States shall be subrogated (to the extent of 
            payment made under this subchapter for such an item or 
            service) to any right under this subsection of an individual 
            or any other entity to payment with respect to such item or 
            service under a primary plan.
            (iv) Waiver of rights

                The Secretary may waive (in whole or in part) the 
            provisions of this subparagraph in the case of an individual 
            claim if the Secretary determines that the waiver is in the 
            best interests of the program established under this 
            subchapter.
            (v) Claims-filing period

                Notwithstanding any other time limits that may exist for 
            filing a claim under an employer group health plan, the 
            United States may seek to recover conditional payments in 
            accordance with this subparagraph where the request for 
            payment is submitted to the entity required or responsible 
            under this subsection to pay with respect to the item or 
            service (or any portion thereof) under a primary plan within 
            the 3-year period beginning on the date on which the item or 
            service was furnished.

        (C) Treatment of questionnaires

            The Secretary may not fail to make payment under 
        subparagraph (A) solely on the ground that an individual failed 
        to complete a questionnaire concerning the existence of a 
        primary plan.

                           (3) Enforcement

        (A) Private cause of action

            There is established a private cause of action for damages 
        (which shall be in an amount double the amount otherwise 
        provided) in the case of a primary plan which fails to provide 
        for primary payment (or appropriate reimbursement) in accordance 
        with such paragraphs (1) and (2)(A).

        (B) Reference to excise tax with respect to nonconforming group 
                health plans

            For provision imposing an excise tax with respect to 
        nonconforming group health plans, see section 5000 of the 
        Internal Revenue Code of 1986.

        (C) Prohibition of financial incentives not to enroll in a group 
                health plan or a large group health plan

            It is unlawful for an employer or other entity to offer any 
        financial or other incentive for an individual entitled to 
        benefits under this subchapter not to enroll (or to terminate 
        enrollment) under a group health plan or a large group health 
        plan which would (in the case of such enrollment) be a primary 
        plan (as defined in paragraph (2)(A)). Any entity that violates 
        the previous sentence is subject to a civil money penalty of not 
        to exceed $5,000 for each such violation. The provisions of 
        section 1320a-7a of this title (other than subsections (a) and 
        (b)) shall apply to a civil money penalty under the previous 
        sentence in the same manner as such provisions apply to a 
        penalty or proceeding under section 1320a-7a(a) of this title.

                    (4) Coordination of benefits

        Where payment for an item or service by a primary plan is less 
    than the amount of the charge for such item or service and is not 
    payment in full, payment may be made under this subchapter (without 
    regard to deductibles and coinsurance under this subchapter) for the 
    remainder of such charge, but--
            (A) payment under this subchapter may not exceed an amount 
        which would be payable under this subchapter for such item or 
        service if paragraph (2)(A) did not apply; and
            (B) payment under this subchapter, when combined with the 
        amount payable under the primary plan, may not exceed--
                (i) in the case of an item or service payment for which 
            is determined under this subchapter on the basis of 
            reasonable cost (or other cost-related basis) or under 
            section 1395ww of this title, the amount which would be 
            payable under this subchapter on such basis, and
                (ii) in the case of an item or service for which payment 
            is authorized under this subchapter on another basis--
                    (I) the amount which would be payable under the 
                primary plan (without regard to deductibles and 
                coinsurance under such plan), or
                    (II) the reasonable charge or other amount which 
                would be payable under this subchapter (without regard 
                to deductibles and coinsurance under this subchapter),

          whichever is greater.

          (5) Identification of secondary payer situations

        (A) Requesting matching information

            (i) Commissioner of Social Security

                The Commissioner of Social Security shall, not less 
            often than annually, transmit to the Secretary of the 
            Treasury a list of the names and TINs of medicare 
            beneficiaries (as defined in section 6103(l)(12) of the 
            Internal Revenue Code of 1986) and request that the 
            Secretary disclose to the Commissioner the information 
            described in subparagraph (A) of such section.
            (ii) Administrator

                The Administrator of the Health Care Financing 
            Administration shall request, not less often than annually, 
            the Commissioner of the Social Security Administration to 
            disclose to the Administrator the information described in 
            subparagraph (B) of section 6103(l)(12) of the Internal 
            Revenue Code of 1986.

        (B) Disclosure to fiscal intermediaries and carriers

            In addition to any other information provided under this 
        subchapter to fiscal intermediaries and carriers, the 
        Administrator shall disclose to such intermediaries and carriers 
        (or to such a single intermediary or carrier as the Secretary 
        may designate) the information received under subparagraph (A) 
        for purposes of carrying out this subsection.

        (C) Contacting employers

            (i) In general

                With respect to each individual (in this subparagraph 
            referred to as an ``employee'') who was furnished a written 
            statement under section 6051 of the Internal Revenue Code of 
            1986 by a qualified employer (as defined in section 
            6103(l)(12)(E)(iii) of such Code), as disclosed under 
            subparagraph (B), the appropriate fiscal intermediary or 
            carrier shall contact the employer in order to determine 
            during what period the employee or employee's spouse may be 
            (or have been) covered under a group health plan of the 
            employer and the nature of the coverage that is or was 
            provided under the plan (including the name, address, and 
            identifying number of the plan).
            (ii) Employer response

                Within 30 days of the date of receipt of the inquiry, 
            the employer shall notify the intermediary or carrier making 
            the inquiry as to the determinations described in clause 
            (i). An employer (other than a Federal or other governmental 
            entity) who willfully or repeatedly fails to provide timely 
            and accurate notice in accordance with the previous sentence 
            shall be subject to a civil money penalty of not to exceed 
            $1,000 for each individual with respect to which such an 
            inquiry is made. The provisions of section 1320a-7a of this 
            title (other than subsections (a) and (b)) shall apply to a 
            civil money penalty under the previous sentence in the same 
            manner as such provisions apply to a penalty or proceeding 
            under section 1320a-7a(a) of this title.

        (D) Obtaining information from beneficiaries

            Before an individual applies for benefits under part A of 
        this subchapter or enrolls under part B of this subchapter, the 
        Administrator shall mail the individual a questionnaire to 
        obtain information on whether the individual is covered under a 
        primary plan and the nature of the coverage provided under the 
        plan, including the name, address, and identifying number of the 
        plan.

       (6) Screening requirements for providers and suppliers

        (A) In general

            Notwithstanding any other provision of this subchapter, no 
        payment may be made for any item or service furnished under part 
        B of this subchapter unless the entity furnishing such item or 
        service completes (to the best of its knowledge and on the basis 
        of information obtained from the individual to whom the item or 
        service is furnished) the portion of the claim form relating to 
        the availability of other health benefit plans.

        (B) Penalties

            An entity that knowingly, willfully, and repeatedly fails to 
        complete a claim form in accordance with subparagraph (A) or 
        provides inaccurate information relating to the availability of 
        other health benefit plans on a claim form under such 
        subparagraph shall be subject to a civil money penalty of not to 
        exceed $2,000 for each such incident. The provisions of section 
        1320a-7a of this title (other than subsections (a) and (b)) 
        shall apply to a civil money penalty under the previous sentence 
        in the same manner as such provisions apply to a penalty or 
        proceeding under section 1320a-7a(a) of this title.

(c) Drug products

    No payment may be made under part B of this subchapter for any 
expenses incurred for--
        (1) a drug product--
            (A) which is described in section 107(c)(3) of the Drug 
        Amendments of 1962,
            (B) which may be dispensed only upon prescription,
            (C) for which the Secretary has issued a notice of an 
        opportunity for a hearing under subsection (e) of section 355 of 
        title 21 on a proposed order of the Secretary to withdraw 
        approval of an application for such drug product under such 
        section because the Secretary has determined that the drug is 
        less than effective for all conditions of use prescribed, 
        recommended, or suggested in its labeling, and
            (D) for which the Secretary has not determined there is a 
        compelling justification for its medical need; and

        (2) any other drug product--
            (A) which is identical, related, or similar (as determined 
        in accordance with section 310.6 of title 21 of the Code of 
        Federal Regulations) to a drug product described in paragraph 
        (1), and
            (B) for which the Secretary has not determined there is a 
        compelling justification for its medical need,

until such time as the Secretary withdraws such proposed order.

(d) Repealed. Pub. L. 100-93, Sec. 8(c)(1)(A), Aug. 18, 1987, 101 Stat. 
        692

(e) Item or service by excluded individual or entity or at direction of 
        excluded physician; limitation of liability of beneficiaries 
        with respect to services furnished by excluded individuals and 
        entities

    (1) No payment may be made under this subchapter with respect to any 
item or service (other than an emergency item or service, not including 
items or services furnished in an emergency room of a hospital) 
furnished--
        (A) by an individual or entity during the period when such 
    individual or entity is excluded pursuant to section 1320a-7, 1320a-
    7a, 1320c-5 or 1395u(j)(2) of this title from participation in the 
    program under this subchapter; or
        (B) at the medical direction or on the prescription of a 
    physician during the period when he is excluded pursuant to section 
    1320a-7, 1320a-7a, 1320c-5 or 1395u(j)(2) of this title from 
    participation in the program under this subchapter and when the 
    person furnishing such item or service knew or had reason to know of 
    the exclusion (after a reasonable time period after reasonable 
    notice has been furnished to the person).

    (2) Where an individual eligible for benefits under this subchapter 
submits a claim for payment for items or services furnished by an 
individual or entity excluded from participation in the programs under 
this subchapter, pursuant to section 1320a-7, 1320a-7a, 1320c-5, 1320c-9 
(as in effect on September 2, 1982), 1395u(j)(2), 1395y(d) (as in effect 
on August 18, 1987), or 1395cc of this title, and such beneficiary did 
not know or have reason to know that such individual or entity was so 
excluded, then, to the extent permitted by this subchapter, and 
notwithstanding such exclusion, payment shall be made for such items or 
services. In each such case the Secretary shall notify the beneficiary 
of the exclusion of the individual or entity furnishing the items or 
services. Payment shall not be made for items or services furnished by 
an excluded individual or entity to a beneficiary after a reasonable 
time (as determined by the Secretary in regulations) after the Secretary 
has notified the beneficiary of the exclusion of that individual or 
entity.

(f) Utilization guidelines for provision of home health services

    The Secretary shall establish utilization guidelines for the 
determination of whether or not payment may be made, consistent with 
paragraph (1)(A) of subsection (a) of this section, under part A or part 
B of this subchapter for expenses incurred with respect to the provision 
of home health services, and shall provide for the implementation of 
such guidelines through a process of selective postpayment coverage 
review by intermediaries or otherwise.

(g) Contracts with utilization and quality control peer review 
        organizations

    The Secretary shall, in making the determinations under paragraphs 
(1) and (9) of subsection (a) of this section, and for the purposes of 
promoting the effective, efficient, and economical delivery of health 
care services, and of promoting the quality of services of the type for 
which payment may be made under this subchapter, enter into contracts 
with utilization and quality control peer review organizations pursuant 
to part B of subchapter XI of this chapter.

(h) Repealed. Pub. L. 104-224, Sec. 1, Oct. 2, 1996, 110 Stat. 3031

(i) Awards and contracts for original research and experimentation of 
        new and existing medical procedures; conditions

    In order to supplement the activities of the Medicare Payment 
Advisory Commission under section 1395ww(e) of this title in assessing 
the safety, efficacy, and cost-effectiveness of new and existing medical 
procedures, the Secretary may carry out, or award grants or contracts 
for, original research and experimentation of the type described in 
clause (ii) of section 1395ww(e)(6)(E) of this title with respect to 
such a procedure if the Secretary finds that--
        (1) such procedure is not of sufficient commercial value to 
    justify research and experimentation by a commercial organization;
        (2) research and experimentation with respect to such procedure 
    is not of a type that may appropriately be carried out by an 
    institute, division, or bureau of the National Institutes of Health; 
    and
        (3) such procedure has the potential to be more cost-effective 
    in the treatment of a condition than procedures currently in use 
    with respect to such condition.

(Aug. 14, 1935, ch. 531, title XVIII, Sec. 1862, as added Pub. L. 89-97, 
title I, Sec. 102(a), July 30, 1965, 79 Stat. 325; amended Pub. L. 90-
248, title I, Secs. 127(b), 128, Jan. 2, 1968, 81 Stat. 846, 847; Pub. 
L. 92-603, title II, Secs. 210, 211(c)(1), 229(a), 256(c), Oct. 30, 
1972, 86 Stat. 1382, 1384, 1408, 1447; Pub. L. 93-233, Sec. 18(k)(3), 
Dec. 31, 1973, 87 Stat. 970; Pub. L. 93-480, Sec. 4(a), Oct. 26, 1974, 
88 Stat. 1454; Pub. L. 94-182, title I, Sec. 103, Dec. 31, 1975, 89 
Stat. 1051; Pub. L. 95-142, Secs. 7(a), 13(a), (b)(1), (2), Oct. 25, 
1977, 91 Stat. 1192, 1197, 1198; Pub. L. 95-210, Sec. 1(f), Dec. 13, 
1977, 91 Stat. 1487; Pub. L. 96-272, title III, Sec. 308(a), June 17, 
1980, 94 Stat. 531; Pub. L. 96-499, title IX, Secs. 913(b), 936(c), 
939(a), 953, Dec. 5, 1980, 94 Stat. 2620, 2640, 2647; Pub. L. 96-611, 
Sec. 1(a)(3), Dec. 28, 1980, 94 Stat. 3566; Pub. L. 97-35, title XXI, 
Secs. 2103(a)(1), 2146(a), 2152(a), Aug. 13, 1981, 95 Stat. 787, 800, 
802; Pub. L. 97-248, title I, Secs. 116(b), 122(f), (g)(1), 128(a)(2)-
(4), 142, 148(a), Sept. 3, 1982, 96 Stat. 353, 362, 366, 381, 394; Pub. 
L. 97-448, title III, Sec. 309(b)(10), Jan. 12, 1983, 96 Stat. 2409; 
Pub. L. 98-21, title VI, Secs. 601(f), 602(e), Apr. 20, 1983, 97 Stat. 
162, 163; Pub. L. 98-369, div. B, title III, Secs. 2301(a), 2304(c), 
2313(c), 2344(a)-(c), 2354(b)(30), (31), July 18, 1984, 98 Stat. 1063, 
1068, 1078, 1095, 1101, 1102; Pub. L. 99-272, title IX, Secs. 9201(a), 
9307(a), 9401(c)(1), Apr. 7, 1986, 100 Stat. 170, 193, 199; Pub. L. 99-
509, title IX, Secs. 9316(b), 9319(a), (b), 9320(h)(1), 9343(c)(1), Oct. 
21, 1986, 100 Stat. 2007, 2010, 2011, 2016, 2040; Pub. L. 99-514, 
Sec. 2, Oct. 22, 1986, 100 Stat. 2095; Pub. L. 100-93, Secs. 8(c)(1), 
(3), 10, Aug. 18, 1987, 101 Stat. 692, 693, 696; Pub. L. 100-203, title 
IV, Secs. 4009(j)(6)(C), 4034(a), 4036(a)(1), 4039(c)(1), 4072(c), 
4085(i)(15), (16), Dec. 22, 1987, 101 Stat. 1330-59, 1330-77, 1330-79, 
1330-82, 1330-117, 1330-133; Pub. L. 100-360, title II, Secs. 202(d), 
204(d)(2), 205(e)(1), title IV, Sec. 411(f)(4)(D)(i), (i)(4)(D), July 1, 
1988, 102 Stat. 715, 729, 731, 778, 790; Pub. L. 100-485, title VI, 
Sec. 608(d)(7), (24)(C), Oct. 13, 1988, 102 Stat. 2415, 2421; Pub. L. 
101-234, title II, Sec. 201(a), Dec. 13, 1989, 103 Stat. 1981; Pub. L. 
101-239, title VI, Secs. 6003(g)(3)(D)(xi), 6103(b)(3)(B), 6115(b), 
6202(a)(2)(A), (b)(1), (e)(1), 6411(d)(2), Dec. 19, 1989, 103 Stat. 
2154, 2199, 2219, 2228, 2229, 2234, 2271; Pub. L. 101-508, title IV, 
Secs. 4107(b), 4153(b)(2)(B), 4157(c)(1), 4161(a)(3)(C), 4163(d)(2), 
4203(a)(1), (b), (c)(1), 4204(g)(1), Nov. 5, 1990, 104 Stat. 1388-62, 
1388-84, 1388-89, 1388-94, 1388-100, 1388-107, 1388-112; Pub. L. 103-66, 
title XIII, Secs. 13561(a)(1), (b)-(d)(1), (e)(1), 13581(b)(1), Aug. 10, 
1993, 107 Stat. 593, 594, 611; Pub. L. 103-432, title I, 
Secs. 145(c)(1), 147(e)(6), 151(a)(1)(A), (C), (2)(A), (b)(3)(A), (B), 
(c)(1), (4)-(6), (9)(B), 156(a)(2)(D), 157(b)(7), Oct. 31, 1994, 108 
Stat. 4427, 4430, 4432-4436, 4441, 4442; Pub. L. 104-224, Sec. 1, Oct. 
2, 1996, 110 Stat. 3031; Pub. L. 104-226, Sec. 1(b)(1), Oct. 2, 1996, 
110 Stat. 3033; Pub. L. 105-12, Sec. 9(a)(1), Apr. 30, 1997, 111 Stat. 
26; Pub. L. 105-33, title IV, Secs. 4022(b)(1)(B), 4102(c), 4103(c), 
4104(c)(3), 4201(c)(1), 4319(b), 4432(b)(1), 4507(a)(2)(B), 
4511(a)(2)(C), 4541(b), 4603(c)(2)(C), 4614(a), 4631(a)(1), (b), (c)(1), 
4632(a), 4633(a), (b), Aug. 5, 1997, 111 Stat. 354, 361, 362, 365, 373, 
394, 420, 441, 442, 456, 471, 474, 486, 487; Pub. L. 106-113, div. B, 
Sec. 1000(a)(6) [title III, Secs. 305(b), 321(k)(10)], Nov. 29, 1999, 
113 Stat. 1536, 1501A-362, 1501A-367.)

                       References in Text

    Parts A and B of this subchapter, referred to in text, are 
classified to sections 1395c et seq. and 1395j et seq., respectively, of 
this title.
    Section 1395ww(e)(6) of this title, referred to in subsec. 
(a)(1)(D), was repealed by Pub. L. 105-33, title IV, 
Sec. 4022(b)(1)(A)(i), Aug. 5, 1997, 111 Stat. 354.
    Part B of subchapter XI of this chapter, referred to in subsecs. 
(a)(15) and (g), is classified to section 1320c et seq. of this title.
    The Assisted Suicide Funding Restriction Act of 1997, referred to in 
subsec. (a)(16), is Pub. L. 105-12, Apr. 30, 1997, 111 Stat. 23, which 
is classified principally to chapter 138 (Sec. 14401 et seq.) of this 
title. For complete classification of this Act to the Code, see Short 
Title note set out under section 14401 of this title and Tables.
    The Internal Revenue Code of 1986, referred to in subsec. (b), is 
classified generally to Title 26, Internal Revenue Code.
    Section 107(c)(3) of the Drug Amendments of 1962, referred to in 
subsec. (c)(1)(A), is section 107(c)(3) of Pub. L. 87-781, title I, Oct. 
10, 1962, 76 Stat. 788, which is set out as an Effective Date of 1962 
Amendment note under section 321 of Title 21, Food and Drugs.


                               Amendments

    1999--Subsec. (a)(7). Pub. L. 106-113, Sec. 1000(a)(6) [title III, 
Sec. 321(k)(10)], substituted ``subparagraph'' for ``subparagraphs''.
    Subsec. (a)(21). Pub. L. 106-113, Sec. 1000(a)(6) [title III, 
Sec. 305(b)], inserted ``(including medical supplies described in 
section 1395x(m)(5) of this title, but excluding durable medical 
equipment to the extent provided for in such section)'' after ``home 
health services''.
    1997--Subsec. (a)(1)(D). Pub. L. 105-33, Sec. 4022(b)(1)(B), 
substituted ``Medicare Payment Advisory Commission'' for ``Prospective 
Payment Assessment Commission''.
    Subsec. (a)(1)(F). Pub. L. 105-33, Sec. 4102(c), inserted ``and 
screening pelvic exam'' after ``screening pap smear''.
    Subsec. (a)(1)(G). Pub. L. 105-33, Sec. 4103(c)(1), added subpar. 
(G).
    Subsec. (a)(1)(H). Pub. L. 105-33, Sec. 4104(c)(3)(A), added subpar. 
(H).
    Subsec. (a)(1)(I). Pub. L. 105-33, Sec. 4614(a), added subpar. (I).
    Subsec. (a)(7). Pub. L. 105-33, Sec. 4104(c)(3)(B), substituted 
``(G), or (H)'' for ``or (G)''.
    Pub. L. 105-33, Sec. 4103(c)(2), substituted ``subparagraphs (B), 
(F), or (G) of paragraph (1)'' for ``paragraph (1)(B) or under paragraph 
(1)(F)''.
    Subsec. (a)(14). Pub. L. 105-33, Sec. 4511(a)(2)(C), substituted 
``section 1395x(s)(2)(K) of this title'' for ``section 1395x(s)(2)(K)(i) 
or 1395x(s)(2)(K)(iii) of this title''.
    Pub. L. 105-33, Sec. 4201(c)(1), substituted ``critical access'' for 
``rural primary care'' wherever appearing.
    Subsec. (a)(16). Pub. L. 105-12 added par. (16).
    Subsec. (a)(17). Pub. L. 105-33, Sec. 4319(b), added par. (17).
    Subsec. (a)(18). Pub. L. 105-33, Sec. 4432(b)(1), added par. (18).
    Subsec. (a)(19). Pub. L. 105-33, Sec. 4507(a)(2)(B), added par. 
(19).
    Subsec. (a)(20). Pub. L. 105-33, Sec. 4541(b), added par. (20).
    Subsec. (a)(21). Pub. L. 105-33, Sec. 4603(c)(2)(C), added par. 
(21).
    Subsec. (b)(1)(B)(i). Pub. L. 105-33, Sec. 4631(a)(1)(A), 
substituted ``in clause (iii))'' for ``in clause (iv))''.
    Subsec. (b)(1)(B)(iii), (iv). Pub. L. 105-33, Sec. 4631(a)(1)(B), 
(C), redesignated cl. (iv) as (iii) and struck out heading and text of 
former cl. (iii). Text read as follows: ``Clause (i) shall only apply to 
items and services furnished on or after January 1, 1987, and before 
October 1, 1998.''
    Subsec. (b)(1)(C). Pub. L. 105-33, Sec. 4631(b), in concluding 
provisions, substituted ``August 5, 1997'' for ``October 1, 1998'' and 
inserted at end ``Effective for items and services furnished on or after 
August 5, 1997, (with respect to periods beginning on or after the date 
that is 18 months prior to August 5, 1997), clauses (i) and (ii) shall 
be applied by substituting `30-month' for `12-month' each place it 
appears.''
    Subsec. (b)(1)(F). Pub. L. 105-33, Sec. 4633(b), added subpar. (F).
    Subsec. (b)(2)(B)(ii). Pub. L. 105-33, Sec. 4633(a), substituted 
``(directly, as a third-party administrator, or otherwise) to make 
payment'' for ``under this subsection to pay'' and inserted at end ``The 
United States may not recover from a third-party administrator under 
this clause in cases where the third-party administrator would not be 
able to recover the amount at issue from the employer or group health 
plan and is not employed by or under contract with the employer or group 
health plan at the time the action for recovery is initiated by the 
United States or for whom it provides administrative services due to the 
insolvency or bankruptcy of the employer or plan.''
    Subsec. (b)(2)(B)(v). Pub. L. 105-33, Sec. 4632(a), added cl. (v).
    Subsec. (b)(5)(C)(iii). Pub. L. 105-33, Sec. 4631(c)(1), struck out 
heading and text of cl. (iii). Text read as follows: ``Clause (ii) shall 
not apply to inquiries made after September 30, 1998.''
    Subsec. (i). Pub. L. 105-33, Sec. 4022(b)(1)(B), substituted 
``Medicare Payment Advisory Commission'' for ``Prospective Payment 
Assessment Commission'' in introductory provisions.
    1996--Subsec. (b)(5)(B). Pub. L. 104-226, Sec. 1(b)(1)(A), 
substituted ``under subparagraph (A) for purposes of carrying out this 
subsection'' for ``under--
        ``(i) subparagraph (A), and
        ``(ii) section 1320b-14 of this title,
for purposes of carrying out this subsection''.
    Subsec. (b)(5)(C)(i). Pub. L. 104-226, Sec. 1(b)(1)(B), substituted 
``disclosed under subparagraph (B)'' for ``disclosed under subparagraph 
(B)(i)''.
    Subsec. (h). Pub. L. 104-224 struck out subsec. (h) which required 
Secretary to provide registry of all cardiac pacemaker devices and 
pacemaker leads for which payment was made under this chapter.
    1994--Subsec. (a)(1)(F). Pub. L. 103-432, Sec. 145(c)(1), 
substituted ``is not conducted by a facility described in section 
1395m(c)(1)(B) of this title'' for ``or which does not meet the 
standards established under section 1395m(c)(3) of this title''.
    Subsec. (a)(14). Pub. L. 103-432, Sec. 156(a)(2)(D)(i), inserted 
``or'' at end.
    Pub. L. 103-432, Sec. 147(e)(6), substituted ``section 
1395x(s)(2)(K)(i) or 1395x(s)(2)(K)(iii) of this title'' for ``section 
1395x(s)(2)(K)(i) of this title''.
    Subsec. (a)(15). Pub. L. 103-432, Sec. 156(a)(2)(D)(ii), substituted 
period for ``; or'' at end.
    Subsec. (a)(16). Pub. L. 103-432, Sec. 156(a)(2)(D)(iii), struck out 
par. (16) which read as follows: ``furnished in connection with a 
surgical procedure for which a second opinion is required under section 
1320c-13(c)(2) of this title and has not been obtained.''
    Subsec. (b)(1)(A)(i)(II). Pub. L. 103-432, Sec. 151(c)(1)(A), 
substituted ``older (and the spouse age 65 or older of any individual) 
who has current employment status with an employer'' for ``over (and the 
individual's spouse age 65 or older) who is covered under the plan by 
virtue of the individual's current employment status with an employer''.
    Subsec. (b)(1)(A)(ii). Pub. L. 103-432, Sec. 151(c)(1)(B), 
substituted ``employer that has 20 or more employees'' for ``employer or 
employee organization that has 20 or more individuals in current 
employment status''.
    Subsec. (b)(1)(A)(v). Pub. L. 103-432, Sec. 151(c)(9)(B), made 
technical amendment to directory language of Pub. L. 103-66, 
Sec. 13561(e)(1)(D). See 1993 Amendment note below.
    Subsec. (b)(1)(C). Pub. L. 103-432, Sec. 151(c)(5), substituted 
``paying benefits secondary to this subchapter when'' for ``taking into 
account that'' in closing provisions.
    Pub. L. 103-432, Sec. 151(c)(4), substituted ``this subparagraph'' 
for ``clauses (i) and (ii)'' after ``February 1, 1990),'' in last 
sentence.
    Subsec. (b)(2)(B)(i). Pub. L. 103-432, Sec. 151(b)(3)(A), (B), 
substituted ``Repayment required'' for ``Primary plans'' in heading and 
inserted at end ``If reimbursement is not made to the appropriate Trust 
Fund before the expiration of the 60-day period that begins on the date 
such notice or other information is received, the Secretary may charge 
interest (beginning with the date on which the notice or other 
information is received) on the amount of the reimbursement until 
reimbursement is made (at a rate determined by the Secretary in 
accordance with regulations of the Secretary of the Treasury applicable 
to charges for late payments).''
    Subsec. (b)(2)(C). Pub. L. 103-432, Sec. 151(a)(1)(C), added subpar. 
(C).
    Subsec. (b)(3)(C). Pub. L. 103-432, Sec. 157(b)(7), substituted 
``group health plan or a large group health plan'' for ``group health 
plan'' in heading and text, struck out ``, unless such incentive is also 
offered to all individuals who are eligible for coverage under the 
plan'' after ``(as defined in paragraph (2)(A))'', and substituted 
``(other than subsections (a) and (b))'' for ``(other than the first 
sentence of subsection (a) and other than subsection (b))''.
    Subsec. (b)(5)(C)(i). Pub. L. 103-432, Sec. 151(c)(6), substituted 
``section 6103(l)(12)(E)(iii) of such Code'' for ``section 
6103(l)(12)(D)(iii) of such Code''.
    Subsec. (b)(5)(D). Pub. L. 103-432, Sec. 151(a)(1)(A), added subpar. 
(D).
    Subsec. (b)(6). Pub. L. 103-432, Sec. 151(a)(2)(A), added par. (6).
    1993--Subsec. (b)(1)(A)(i). Pub. L. 103-66, Sec. 13561(e)(1)(A), 
amended subcls. (I) and (II) generally. Prior to amendment, subcls. (I) 
and (II) read as follows:
    ``(I) may not take into account, for any item or service furnished 
to an individual 65 years of age or older at the time the individual is 
covered under the plan by reason of the current employment of the 
individual (or the individual's spouse), that the individual is entitled 
to benefits under this subchapter under section 426(a) of this title, 
and
    ``(II) shall provide that any employee age 65 or older, and any 
employee's spouse age 65 or older, shall be entitled to the same 
benefits under the plan under the same conditions as any employee, and 
the spouse of such employee, under age 65.''
    Subsec. (b)(1)(A)(ii). Pub. L. 103-66, Sec. 13561(e)(1)(B), 
substituted ``unless the plan is a plan of, or contributed to by, an 
employer or employee organization that has 20 or more individuals in 
current employment status'' for ``unless the plan is sponsored by or 
contributed to by an employer that has 20 or more employees''.
    Subsec. (b)(1)(A)(iii). Pub. L. 103-66, Sec. 13561(e)(1)(C), 
substituted ``by virtue of current employment status with an employer 
that does not have 20 or more individuals in current employment status 
for each working day in each of 20 or more calendar weeks in the current 
calendar year and'' for ``by virtue of employment with an employer that 
does not have 20 or more employees for each working day in each of 20 or 
more calendar weeks in the current calendar year or''.
    Subsec. (b)(1)(A)(iv). Pub. L. 103-66, Sec. 13561(c)(2), substituted 
``Subparagraph (C) shall apply instead of clause (i)'' for ``Clause (i) 
shall not apply'' and inserted ``(without regard to entitlement under 
section 426 of this title)'' after ``individual is, or''.
    Subsec. (b)(1)(A)(v). Pub. L. 103-66, Sec. 13561(e)(1)(D), as 
amended by Pub. L. 103-432, Sec. 151(c)(9)(B), inserted before period at 
end ``, without regard to section 5000(d) of such Code''.
    Subsec. (b)(1)(B). Pub. L. 103-66, Sec. 13561(e)(1)(E), substituted 
``individuals'' for ``active individuals'' in heading.
    Subsec. (b)(1)(B)(i). Pub. L. 103-66, Sec. 13561(e)(1)(F), 
substituted ``clause (iv)) may not take into account that an individual 
(or a member of the individual's family) who is covered under the plan 
by virtue of the individual's current employment status with an 
employer'' for ``clause (iv)(II)) may not take into account that an 
active individual (as defined in clause (iv)(I))''.
    Subsec. (b)(1)(B)(ii). Pub. L. 103-66, Sec. 13561(c)(2), substituted 
``Subparagraph (C) shall apply instead of clause (i)'' for ``Clause (i) 
shall not apply'' and inserted ``(without regard to entitlement under 
section 426 of this title)'' after ``individual is, or''.
    Subsec. (b)(1)(B)(iii). Pub. L. 103-66, Sec. 13561(b), substituted 
``1998'' for ``1995''.
    Subsec. (b)(1)(B)(iv). Pub. L. 103-66, Sec. 13561(e)(1)(G), amended 
heading and text generally. Prior to amendment, text defined ``active 
individual'' and ``large group health plan''.
    Subsec. (b)(1)(C). Pub. L. 103-66, Sec. 13561(c)(1), (3), 
substituted ``or eligible for benefits under this subchapter under'' for 
``benefits under this subchapter solely by reason of'' in cl. (i) and 
concluding provisions and substituted ``before October 1, 1998'' for 
``on or before January 1, 1996'' in concluding provisions.
    Subsec. (b)(1)(E). Pub. L. 103-66, Sec. 13561(e)(1)(H), added cls. 
(ii) and (iii).
    Pub. L. 103-66, Sec. 13561(d)(1), added subpar. (E).
    Subsec. (b)(5)(B). Pub. L. 103-66, Sec. 13581(b)(1)(A), substituted 
``under--'' for ``under subparagraph (A) for the purposes of carrying 
out this subsection.'' and added cls. (i) and (ii) and concluding 
provisions.
    Subsec. (b)(5)(C)(i). Pub. L. 103-66, Sec. 13581(b)(1)(B), 
substituted ``subparagraph (B)(i)'' for ``subparagraph (B)''.
    Subsec. (b)(5)(C)(iii). Pub. L. 103-66, Sec. 13561(a)(1), 
substituted ``1998'' for ``1995''.
    1990--Subsec. (a). Pub. L. 101-508, Sec. 4161(a)(3)(C)(iii), 
inserted at end ``Paragraph (7) shall not apply to Federally qualified 
health center services described in section 1395x(aa)(3)(B) of this 
title.''
    Subsec. (a)(1)(A). Pub. L. 101-508, Sec. 4163(d)(2)(A)(i), 
substituted ``a succeeding subparagraph'' for ``subparagraph (B), (C), 
(D), or (E)''.
    Subsec. (a)(1)(F). Pub. L. 101-508, Sec. 4163(d)(2)(A)(ii)-(iv), 
added subpar. (F).
    Subsec. (a)(2). Pub. L. 101-508, Sec. 4161(a)(3)(C)(i), inserted 
before semicolon at end ``, except in the case of Federally qualified 
health center services''.
    Subsec. (a)(3). Pub. L. 101-508, Sec. 4161(a)(3)(C)(ii), inserted 
``, in the case of Federally qualified health center services, as 
defined in section 1395x(aa)(3) of this title,'' after ``section 
1395x(aa)(1) of this title,''.
    Subsec. (a)(7). Pub. L. 101-508, Sec. 4163(d)(2)(B), inserted ``or 
under paragraph (1)(F)'' after ``paragraph (1)(B)''.
    Pub. L. 101-508, Sec. 4153(b)(2)(B), inserted ``(other than eyewear 
described in section 1395x(s)(8) of this title)'' after first reference 
to ``eyeglasses''.
    Subsec. (a)(14). Pub. L. 101-508, Sec. 4157(c)(1), inserted ``, 
services described by section 1395x(s)(2)(K)(i) of this title, certified 
nurse-midwife services, qualified psychologist services, and services of 
a certified registered nurse anesthetist,'' after ``this paragraph)'' 
and struck out before semicolon at end ``or are services of a certified 
registered nurse anesthetist''.
    Subsec. (a)(15). Pub. L. 101-508, Sec. 4107(b), designated existing 
provisions as par. (A), substituted ``, or'' for ``; or'' at end, and 
added par. (B).
    Subsec. (b)(1)(B)(iii). Pub. L. 101-508, Sec. 4203(b), substituted 
``October 1, 1995'' for ``January 1, 1992''.
    Subsec. (b)(1)(C). Pub. L. 101-508, Sec. 4203(c)(1)(B), inserted at 
end ``Effective for items and services furnished on or after February 1, 
1991, and on or before January 1, 1996, (with respect to periods 
beginning on or after February 1, 1990), clauses (i) and (ii) shall be 
applied by substituting `18-month' for `12-month' each place it 
appears.''
    Subsec. (b)(1)(C)(i). Pub. L. 101-508, Sec. 4203(c)(1)(A), 
substituted ``during the 12-month period which begins with the first 
month in which the individual becomes entitled to benefits under part A 
of this subchapter under the provisions of section 426-1 of this title, 
or, if earlier, the first month in which the individual would have been 
entitled to benefits under such part under the provisions of section 
426-1 of this title if the individual had filed an application for such 
benefits; and'' for ``during the 12-month period which begins with the 
earlier of--
        ``(I) the month in which a regular course of renal dialysis is 
    initiated, or
        ``(II) in the case of an individual who receives a kidney 
    transplant, the first month in which he would be eligible for 
    benefits under part A of this subchapter (if he had filed an 
    application for such benefits) under the provisions of section 426-
    1(b)(1)(B) of this title; and''.
    Subsec. (b)(3)(C). Pub. L. 101-508, Sec. 4204(g)(1), added subpar. 
(C).
    Subsec. (b)(5)(C)(iii). Pub. L. 101-508, Sec. 4203(a)(1), 
substituted ``September 30, 1995'' for ``September 30, 1991''.
    1989--Pub. L. 101-239, Sec. 6202(b)(1)(A), inserted ``and medicare 
as secondary payer'' in section catchline.
    Subsec. (a)(1)(A). Pub. L. 101-234 repealed Pub. L. 100-360, 
Sec. 204(d)(2)(A)(i), and provided that the provisions of law amended or 
repealed by such section are restored or revived as if such section had 
not been enacted, see 1988 Amendment note below.
    Subsec. (a)(1)(E). Pub. L. 101-239, Sec. 6103(b)(3)(B), substituted 
``section 1320b-12'' for ``section 1395ll(c)''.
    Subsec. (a)(1)(F). Pub. L. 101-239, Sec. 6115(b), inserted before 
semicolon at end ``, and, in the case of screening pap smear, which is 
performed more frequently than is provided under 1395x(nn) of this 
title''.
    Pub. L. 101-234 repealed Pub. L. 100-360, Sec. 204(d)(2)(A)(ii)-
(iv), and provided that the provisions of law amended or repealed by 
such section are restored or revived as if such section had not been 
enacted, see 1988 Amendment note below.
    Subsec. (a)(1)(G), (6), (7). Pub. L. 101-234 repealed Pub. L. 100-
360, Secs. 204(d)(2)(B), 205(e)(1), and provided that the provisions of 
law amended or repealed by such sections are restored or revived as if 
such sections had not been enacted, see 1988 Amendment notes below.
    Subsec. (a)(14). Pub. L. 101-239, Sec. 6003(g)(3)(D)(xi), 
substituted ``hospital or rural primary care hospital'' for ``hospital'' 
in three places.
    Subsec. (b). Pub. L. 101-239, Sec. 6202(b)(1)(B), amended heading 
and text generally, substituting pars. (1) to (4) relating to medicare 
as secondary payer for former pars. (1) to (5) relating to items or 
services paid under workmen's compensation laws and end stage renal 
disease program.
    Subsec. (b)(1)(D). Pub. L. 101-239, Sec. 6202(e)(1), added subpar. 
(D).
    Subsec. (b)(5). Pub. L. 101-239, Sec. 6202(a)(2)(A), added par. (5).
    Subsec. (c). Pub. L. 101-234 repealed Pub. L. 100-360, Sec. 202(d), 
and provided that the provisions of law amended or repealed by such 
section are restored or revived as if such section had not been enacted, 
see 1988 Amendment note below.
    Subsec. (e)(1). Pub. L. 101-239, Sec. 6411(d)(2), inserted ``, not 
including items or services furnished in an emergency room of a 
hospital'' after ``(other than an emergency item or service''.
    1988--Subsec. (a)(1)(A). Pub. L. 100-360, Sec. 204(d)(2)(A)(i), 
substituted ``a succeeding subparagraph'' for ``subparagraph (B), (C), 
(D), or (E)''.
    Subsec. (a)(1)(F). Pub. L. 100-360, Sec. 204(d)(2)(A)(ii)-(iv), 
added subpar. (F) relating to screening mammography.
    Subsec. (a)(1)(G). Pub. L. 100-360, Sec. 205(e)(1)(A), as amended by 
Pub. L. 100-485, Sec. 608(d)(7), added subpar. (G) relating to in-home 
care for chronically dependent individuals.
    Subsec. (a)(6). Pub. L. 100-360, Sec. 205(e)(1)(B), inserted ``and 
except, in the case of in-home care, as is otherwise permitted under 
paragraph (1)(G)'' after ``paragraph (1)(C)''.
    Subsec. (a)(7). Pub. L. 100-360, Sec. 204(d)(2)(B), inserted ``or 
under paragraph (1)(F)'' after ``(1)(B)''.
    Subsec. (a)(15). Pub. L. 100-360, Sec. 411(f)(4)(D)(i), inserted 
``(including subsequent insertion of an intraocular lens)'' after 
``operation''.
    Subsec. (c). Pub. L. 100-360, Sec. 202(d), designated existing 
provisions as par. (1), redesignated former par. (1) as subpar. (A), 
redesignated former subpars. (A) to (D) as cls. (i) to (iv), 
redesignated former par. (2) as subpar. (B), redesignated former subpar. 
(A) as cl. (i) and substituted ``subparagraph (A)'' for ``paragraph 
(1)'', redesignated former subpar. (B) as cl. (ii), and added par. (2) 
prohibiting payment for expenses incurred for a covered outpatient drug 
if the drug is dispensed in a quantity exceeding a supply of 30 days 
with an exception.
    Subsec. (e)(1). Pub. L. 100-360, Sec. 411(i)(4)(D)(i), as amended by 
Pub. L. 100-485, Sec. 608(d)(24)(C)(i), designated existing provisions 
of subsec. (e) as par. (1), redesignated former par. (1) as subpar. (A), 
substituted ``, 1320a-7a, 1320c-5 or 1395u(j)(2)'' for ``or section 
1320a-7a'', redesignated former par. (2) as subpar. (B), and substituted 
``, 1320a-7a, 1320c-5 or 1395u(j)(2)'' for ``or section 1320a-7a''.
    Subsec. (e)(2). Pub. L. 100-360, Sec. 411(i)(4)(D)(ii), as amended 
by Pub. L. 100-485, Sec. 608(d)(24)(C)(ii), amended former section 
1395aaa of this title by striking out the catchline ``Limitation of 
liability of beneficiaries with respect to services furnished by 
excluded individuals and entities'', substituting ``(2)'' for the 
section designation, inserting ``1395u(j)(2),'' in text, and 
transferring the text to par. (2) of subsec. (e) of this section.
    1987--Subsec. (a)(1)(A). Pub. L. 100-203, Sec. 4085(i)(15), 
substituted ``(D), or (E)'' for ``or (D)''.
    Subsec. (a)(8). Pub. L. 100-203, Sec. 4072(c), inserted ``, other 
than shoes furnished pursuant to section 1395x(s)(12) of this title'' 
before semicolon.
    Subsec. (a)(14). Pub. L. 100-203, Sec. 4085(i)(16), substituted ``a 
patient'' for ``an patient''.
    Pub. L. 100-203, Sec. 4009(j)(6)(C), made technical amendment to 
Pub. L. 99-509, Sec. 9320(h)(1). See 1986 Amendment note below.
    Subsec. (b)(2)(A)(ii). Pub. L. 100-203, Sec. 4036(a)(1), substituted 
``can reasonably be expected to be made under such a plan'' for ``the 
Secretary determines will be made under such a plan as promptly as would 
otherwise be the case if payment were made by the Secretary under this 
subchapter''.
    Subsec. (b)(4)(B)(i). Pub. L. 100-203, Sec. 4034(a), substituted 
``subsection (b) of section 5000 of the Internal Revenue Code of 1986 
without regard to subsection (d) of such section'' for ``section 5000(b) 
of the Internal Revenue Code of 1986''.
    Subsec. (d). Pub. L. 100-93, Sec. 8(c)(1)(A), struck out subsec. 
(d), which provided that no payment be made under this subchapter for 
any item or services to an individual by a person where Secretary 
determines such person knowingly and willfully made any false statement 
or representation of a material fact, submitted excessive bills or 
requests, or furnished excessive services or supplies, and provided a 
dissatisfied person with a hearing on determination of the Secretary.
    Subsec. (e) [formerly Sec. 1395aaa]. Pub. L. 100-93, Sec. 10, added 
par. (2). See 1988 Amendment note above.
    Pub. L. 100-93, Sec. 8(c)(1)(B), amended subsec. (e) generally. 
Prior to amendment, subsec. (e) read as follows: ``No payment may be 
made under this subchapter with respect to any item or service furnished 
by a physician or other individual during the period when he is barred 
pursuant to section 1320a-7 of this title from participation in the 
program under this subchapter.''
    Subsec. (h)(1)(B). Pub. L. 100-203, Sec. 4039(c)(1)(A), substituted 
``law (and any amount paid to a provider under any such warranty),'' for 
``law,''.
    Subsec. (h)(1)(D). Pub. L. 100-203, Sec. 4039(c)(1)(B), inserted 
``in determining the amount subject to repayment under paragraph 
(2)(C),'' after ``(3),''.
    Subsec. (h)(2)(C). Pub. L. 100-203, Sec. 4039(c)(1)(C), added 
subpar. (C).
    Subsec. (h)(4). Pub. L. 100-93, Sec. 8(c)(3), substituted 
``subsections (c), (f), and (g) of section 1320a-7 of this title'' for 
``paragraphs (2) and (3) of subsection (d) of this section''.
    Subsec. (h)(4)(B). Pub. L. 100-203, Sec. 4039(c)(1)(D), substituted 
``, has improperly'' for ``or has improperly'' and inserted ``or has 
failed to make repayment to the Secretary as required under paragraph 
(2)(C),'' after ``(2)(B),''.
    1986--Subsec. (a)(1)(E). Pub. L. 99-509, Sec. 9316(b), added subpar. 
(E).
    Subsec. (a)(14). Pub. L. 99-509, Sec. 9343(c)(1), substituted 
``patient'' for ``inpatient''.
    Pub. L. 99-509, Sec. 9320(h)(1), as amended by Pub. L. 100-203, 
Sec. 4009(j)(6)(C), inserted ``or are services of a certified registered 
nurse anesthetist'' after ``hospital'' at end.
    Subsec. (a)(15). Pub. L. 99-272, Sec. 9307(a), added par. (15).
    Subsec. (a)(16). Pub. L. 99-272, Sec. 9401(c)(1), added par. (16).
    Subsec. (b)(2)(A). Pub. L. 99-514 substituted ``Internal Revenue 
Code of 1986'' for ``Internal Revenue Code of 1954''.
    Subsec. (b)(3)(A)(i). Pub. L. 99-272, Sec. 9201(a)(1), substituted 
``(or to the spouse of such individual)'' for ``who is under 70 years of 
age during any part of such month (or to the spouse of such individual, 
if the spouse is under 70 years of age during any part of such month)''.
    Subsec. (b)(3)(A)(iii). Pub. L. 99-272, Sec. 9201(a)(2), struck out 
``and ending with the month before the month in which such individual 
attains the age of 70'' after ``section 426(a) of this title''.
    Subsec. (b)(3)(A)(iv). Pub. L. 99-514 substituted ``Internal Revenue 
Code of 1986'' for ``Internal Revenue Code of 1954''.
    Subsec. (b)(4). Pub. L. 99-509, Sec. 9319(a), added par. (4).
    Subsec. (b)(5). Pub. L. 99-509, Sec. 9319(b), added par. (5).
    1984--Subsec. (a)(12). Pub. L. 98-369, Sec. 2354(b)(30), struck out 
second comma after ``dental procedure''.
    Subsec. (b)(1). Pub. L. 98-369, Sec. 2344(a), substituted ``to be 
made promptly'' for ``to be made'' and ``has been or could be made under 
such a law'' for ``has been made under such a law'', and inserted ``In 
order to recover payment made under this subchapter for an item or 
service, the United States may bring an action against any entity which 
would be responsible for payment with respect to such item or service 
(or any portion thereof) under such a law, policy, plan, or insurance, 
or against any entity (including any physician or provider) which has 
been paid with respect to such item or service under such law, policy, 
plan, or insurance, and may join or intervene in any action related to 
the events that gave rise to the need for such item or service. The 
United States shall be subrogated (to the extent of payment made under 
this subchapter for an item or service) to any right of an individual or 
any other entity to payment with respect to such item or service under 
such a law, policy, plan, or insurance.''
    Subsec. (b)(2)(B). Pub. L. 98-369, Sec. 2344(b), substituted ``has 
been or could be made under a plan'' for ``has been made under a plan'', 
and inserted ``In order to recover payment made under this subchapter 
for an item or service, the United States may bring an action against 
any entity which would be responsible for payment with respect to such 
item or service (or any portion thereof) under such a plan, or against 
any entity (including any physician or provider) which has been paid 
with respect to such item or service under such plan, and may join or 
intervene in any action related to the events that gave rise to the need 
for such item or service. The United States shall be subrogated (to the 
extent of payment made under this subchapter for an item or service) to 
any right of an individual or any other entity to payment with respect 
to such item or service under such a plan.''
    Subsec. (b)(3)(A)(i). Pub. L. 98-369, Sec. 2301(a), struck out 
``over 64 but'' before ``under 70 years'' in two places.
    Subsec. (b)(3)(A)(ii). Pub. L. 98-369, Sec. 2344(c), substituted 
``has been or could be made under a group health plan'' for ``has been 
made under a group health plan'', and inserted ``In order to recover 
payment made under this title for an item or service, the United States 
may bring an action against any entity which would be responsible for 
payment with respect to such item or service (or any portion thereof) 
under such a plan, or against any entity (including any physician or 
provider) which has been paid with respect to such item or service under 
such plan, and may join or intervene in any action related to the events 
that gave rise to the need for such item or service. The United States 
shall be subrogated (to the extent of payment made under this title for 
an item or service) to any right of an individual or any other entity to 
payment with respect to such item or service under such a plan.''
    Subsec. (b)(3)(A)(iii). Pub. L. 98-369, Sec. 2354(b)(31), inserted 
``before the month'' after ``ending with the month''.
    Subsec. (h). Pub. L. 98-369, Sec. 2304(c), added subsec. (h).
    Subsec. (i). Pub. L. 98-369, Sec. 2313(c), added subsec. (i).
    1983--Subsec. (a)(1)(A). Pub. L. 98-21, Sec. 601(f)(1), inserted 
reference to subpar. (D).
    Subsec. (a)(1)(D). Pub. L. 98-21, Sec. 601(f)(2)-(4), added subpar. 
(D).
    Subsec. (a)(14). Pub. L. 98-21, Sec. 602(e), added par. (14).
    Subsec. (b)(3)(A)(i). Pub. L. 97-448 inserted ``in any month'' after 
``service furnished'', and ``during any part of such month'' after ``70 
years of age'' wherever appearing.
    1982--Subsec. (a)(1). Pub. L. 97-248, Sec. 122(f)(1), designated 
existing provisions as subpars. (A) and (B), in subpar. (A) as so 
designated inserted exception to provisions for items and services 
described in subpar. (B) or (C), substituted ``and'' for ``or'' as the 
connector between provisions, and added subpar. (C).
    Subsec. (a)(6). Pub. L. 97-248, Sec. 122(f)(2), inserted ``(except, 
in the case of hospice care, as is otherwise permitted under paragraph 
(1)(C))''.
    Subsec. (a)(7). Pub. L. 97-248, Sec. 122(f)(3), substituted 
``paragraph (1)(B)'' for ``paragraph (1)''.
    Subsec. (a)(9). Pub. L. 97-248, Sec. 122(f)(4), inserted ``(except, 
in the case of hospice care, as is otherwise permitted under paragraph 
(1)(C))''.
    Subsec. (b)(1). Pub. L. 97-248, Sec. 128(a)(2), struck out ``or 
plan'' after ``service has been made under such a law''.
    Subsec. (b)(2)(A). Pub. L. 97-248, Sec. 128(a)(3), substituted 
``section 162(i)(2)'' for ``section 162(h)(2)''.
    Subsec. (b)(2)(B). Pub. L. 97-248, Sec. 128(a)(4), inserted 
``furnished'' before ``to an individual''.
    Subsec. (b)(3). Pub. L. 97-248, Sec. 116(b), added par. (3).
    Subsec. (d)(1)(C). Pub. L. 97-248, Sec. 148(a), substituted ``on the 
basis of information acquired by the Secretary in the administration of 
this subchapter'' for ``, on the basis of reports transmitted to him in 
accordance with section 1320c-6 of this title (or, in the absence of any 
such report, on the basis of such data as he acquires in the 
administration of the program under this subchapter),''.
    Subsec. (f). Pub. L. 97-248, Sec. 122(g)(1), substituted ``paragraph 
(1)(A)'' for ``paragraph (1)''.
    Subsec. (g). Pub. L. 97-248, Sec. 142, added subsec. (g).
    1981--Subsec. (b). Pub. L. 97-35, Sec. 2146(a), designated existing 
provisions as par. (1) and added par. (2).
    Subsec. (c). Pub. L. 97-35, Sec. 2103(a)(1), added subsec. (c).
    Subsec. (f). Pub. L. 97-35, Sec. 2152(a), added subsec. (f).
    1980--Subsec. (a)(1). Pub. L. 96-611, Sec. 1(a)(3)(A), inserted ``, 
or, in the case of items and services described in section 1395x(s)(10) 
of this title, which are not reasonable and necessary for the prevention 
of illness'' after ``of a malformed body member''.
    Subsec. (a)(7). Pub. L. 96-611, Sec. 1(a)(3)(B), inserted ``(except 
as otherwise allowed under section 1395x(s)(10) of this title and 
paragraph (1))'' after ``immunizations''.
    Subsec. (a)(12). Pub. L. 96-499, Sec. 936(c), inserted ``or because 
of the severity of the dental procedure,'' after ``and clinical 
status''.
    Subsec. (a)(13)(C). Pub. L. 96-499, Sec. 939(a), struck out ``, 
warts,'' after ``corns''.
    Subsec. (b). Pub. L. 96-499, Sec. 953, inserted ``or under an 
automobile or liability insurance policy or plan (including a self-
insured plan) or under no fault insurance'' and ``, policy, plan, or 
insurance'' after ``or a State'' and ``, policy, plan, or insurance'' 
after ``law or plan'' and inserted provision authorizing the Secretary 
to waive the provisions of this subsection in the case of an individual 
claim if he determined that the probability of recovery or amount 
involved did not warrant the pursuit of the claim.
    Subsec. (d)(4). Pub. L. 96-272 added par. (4).
    Subsec. (e). Pub. L. 96-499, Sec. 913(b), substituted provisions 
barring payment under this subchapter with respect to items or services 
furnished by a physician or other individual during a period when such 
physician or other individual was barred pursuant to section 1320a-7 of 
this title from participation under this subchapter for provisions 
authorizing the Secretary to suspend a physician or individual 
practitioner from participation under this subchapter upon determining 
that such physician or practitioner had been convicted of a criminal 
offense related to such physician's or practitioner's involvement in the 
programs under this subchapter or the program under subchapter XIX of 
this chapter.
    1977--Subsec. (a)(3). Pub. L. 95-210 substituted ``except in the 
case of rural health clinic services, as defined in section 1395x(aa)(1) 
of this title, and in such other cases as the Secretary may specify'' 
for ``except in such cases as the Secretary may specify''.
    Subsec. (d)(1)(B). Pub. L. 95-142, Sec. 13(b)(1), struck out 
requirement for concurrence of appropriate program review team for 
finding of Secretary under this paragraph.
    Subsec. (d)(1)(C). Pub. L. 95-142, Sec. 13(b)(2), substituted 
provisions relating to determinations by the Secretary on the basis of 
reports transmitted to him in accordance with section 1320c-6 of this 
title or other data acquired in the administration of this subchapter, 
for provisions relating to determinations by the Secretary with the 
concurrence of appropriate review team members.
    Subsec. (d)(4). Pub. L. 95-142, Sec. 13(a), struck out par. (4) 
which set forth provisions relating to appointment and functions of 
program review teams.
    Subsec. (e). Pub. L. 95-142, Sec. 7(a), added subsec. (e).
    1975--Subsec. (c). Pub. L. 94-182 struck out subsec. (c) prohibiting 
payments to Federal employees under this subchapter unless a 
determination and certification by the Secretary of a modification of 
any health benefits plan under chapter 89 of Title 5 was made which 
would allow a Federal employee benefits under part A or B of this 
subchapter.
    1974--Subsec. (c). Pub. L. 93-480 substituted ``January 1, 1976'' 
for ``January 1, 1975''.
    1973--Subsec. (a)(12). Pub. L. 93-233 substituted ``the provision of 
such dental services if the individual, because of his underlying 
medical condition and clinical status, requires hospitalization in 
connection with the provision of such services'' for ``a dental 
procedure where the individual suffers from impairments of such severity 
as to require hospitalization''.
    1972--Subsec. (a)(4). Pub. L. 92-603, Sec. 211(c)(1), inserted 
reference to physicians' services and ambulance services furnished an 
individual in conjunction with emergency inpatient hospital services.
    Subsec. (a)(12). Pub. L. 92-603, Sec. 256(c), authorized payment 
under part A in the case of inpatient hospital services in connection 
with a dental procedure where the individual suffers from impairments of 
such severity as to require hospitalization.
    Subsec. (c). Pub. L. 92-603, Sec. 210, added subsec. (c).
    Subsec. (d). Pub. L. 92-603, Sec. 229(a), added subsec. (d).
    1968--Subsec. (a)(7). Pub. L. 90-248, Sec. 128, prohibited payment 
for procedures performed (during the course of any eye examination) to 
determine the refractive state of the eyes.
    Subsec. (a)(13). Pub. L. 90-248, Sec. 127(b), added par. (13).


                    Effective Date of 1999 Amendment

    Amendment by section 1000(a)(6) [title III, Sec. 305(b)] of Pub. L. 
106-113 applicable to payments for services provided on or after Nov. 
29, 1999, see Sec. 1000(a)(6) [title III, Sec. 305(c)] of Pub. L. 106-
113, set out as a note under section 1395u of this title.
    Amendment by section 1000(a)(6) [title III, Sec. 321(k)(10)] of Pub. 
L. 106-113 effective as if included in the enactment of the Balanced 
Budget Act of 1997, Pub. L. 105-33, except as otherwise provided, see 
section 1000(a)(6) [title III, Sec. 321(m)] of Pub. L. 106-113, set out 
as a note under section 1395d of this title.


                    Effective Date of 1997 Amendments

    Amendment by Pub. L. 105-12 effective Apr. 30, 1997, and applicable 
to Federal payments made pursuant to obligations incurred after Apr. 30, 
1997, for items and services provided on or after such date, subject to 
also being applicable with respect to contracts entered into, renewed, 
or extended after Apr. 30, 1997, as well as contracts entered into 
before Apr. 30, 1997, to the extent permitted under such contracts, see 
section 11 of Pub. L. 105-12, set out as an Effective Date note under 
section 14401 of this title.
    Amendment by section 4022(b)(1)(B) of Pub. L. 105-33 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 Pub. L. 105-33, set out as an Effective Date; Transition; 
Transfer of Functions note under section 1395b-6 of this title.
    Amendment by section 4102(c) of Pub. L. 105-33 applicable to items 
and services furnished on or after Jan. 1, 1998, see section 4102(e) of 
Pub. L. 105-33, set out as a note under section 1395l of this title.
    Amendment by section 4103(c) of Pub. L. 105-33 applicable to items 
and services furnished on or after Jan. 1, 2000, see section 4103(e) of 
Pub. L. 105-33, set out as a note under section 1395l of this title.
    Amendment by section 4104(c)(3) of Pub. L. 105-33 applicable to 
items and services furnished on or after Jan. 1, 1998, see section 
4104(e) of Pub. L. 105-33, set out as a note under section 1395l of this 
title.
    Amendment by section 4201(c)(1) of Pub. L. 105-33 applicable to 
services furnished on or after Oct. 1, 1997, see section 4201(d) of Pub. 
L. 105-33, set out as a note under section 1395f of this title.
    Amendment by section 4432(b)(1) of Pub. L. 105-33 applicable to 
items and services furnished on or after July 1, 1998, see section 
4432(d) of Pub. L. 105-33, set out as a note under section 1395i-3 of 
this title.
    Amendment by section 4507(a)(2)(B) of Pub. L. 105-33 applicable with 
respect to contracts entered into on and after Jan. 1, 1998, see section 
4507(c) of Pub. L. 105-33, set out as a note under section 1395a of this 
title.
    Amendment by section 4511(a)(2)(C) of Pub. L. 105-33 applicable with 
respect to services furnished and supplies provided on and after Jan. 1, 
1998, see section 4511(e) of Pub. L. 105-33, set out as a note under 
section 1395k of this title.
    Amendment by section 4541(b) of Pub. L. 105-33 applicable to 
services furnished on or after Jan. 1, 1998, including portions of cost 
reporting periods occurring on or after such date, see section 4541(e) 
of Pub. L. 105-33, set out as a note under section 1395l of this title.
    Amendment by section 4603(c)(2)(C) of Pub. L. 105-33 applicable to 
cost reporting periods beginning on or after Oct. 1, 1999, except as 
otherwise provided, see section 4603(d) of Pub. L. 105-33, set out as an 
Effective Date note under section 1395fff of this title.
    Section 4614(c) of Pub. L. 105-33 provided that: ``The amendments 
made by this section [amending this section] apply to services furnished 
on or after October 1, 1997.''
    Section 4632(b) of Pub. L. 105-33 provided that: ``The amendments 
made by this section [amending this section] apply to items and services 
furnished on or after the date of the enactment of this Act [Aug. 5, 
1997].''
    Section 4633(c) of Pub. L. 105-33 provided that: ``The amendments 
made by this section [amending this section] apply to items and services 
furnished on or after the date of the enactment of this Act [Aug. 5, 
1997].''


                    Effective Date of 1994 Amendment

    Amendment by section 145(c)(1) of Pub. L. 103-432 applicable to 
mammography furnished by a facility on and after the first date that the 
certificate requirements of section 263b(b) of this title apply to such 
mammography conducted by such facility, see section 145(d) of Pub. L. 
103-432, set out as a note under section 1395m of this title.
    Amendment by section 147(e)(6) of Pub. L. 103-432 effective as if 
included in the enactment of Pub. L. 101-508, see section 147(g) of Pub. 
L. 103-432, set out as a note under section 1320a-3a of this title.
    Section 151(a)(2)(B) of Pub. L. 103-432 provided that: ``The 
amendment made by subparagraph (A) [amending this section] shall apply 
with respect to items and services furnished on or after the expiration 
of the 120-day period beginning on the date of the enactment of this Act 
[Oct. 31, 1994].''
    Section 151(b)(3)(C) of Pub. L. 103-432 provided that: ``The 
amendments made by this paragraph [amending this section] shall apply to 
payments for items and services furnished on or after the date of the 
enactment of this Act [Oct. 31, 1994].''
    Section 151(c)(1), (9) of Pub. L. 103-432 provided that the 
amendment made by that section is effective as if included in the 
enactment of Pub. L. 103-66.
    Section 151(c)(4) of Pub. L. 103-432 provided that the amendment 
made by that section is effective as if included in the enactment of 
Pub. L. 101-508.
    Section 151(c)(5), (6) of Pub. L. 103-432 provided that the 
amendment made by that section is effective as if included in the 
enactment of Pub. L. 101-239.
    Amendment by section 156(a)(2)(D) of Pub. L. 103-432 applicable to 
services provided on or after Oct. 31, 1994, see section 156(a)(3) of 
Pub. L. 103-432, set out as a note under section 1320c-3 of this title.
    Section 157(b)(8) of Pub. L. 103-432 provided that: ``The amendments 
made by this subsection [amending this section, section 1395mm of this 
title, and provisions set out as notes under section 1395mm of this 
title] shall take effect as if included in the enactment of OBRA-1990 
[Pub. L. 101-508].''


                    Effective Date of 1993 Amendment

    Section 151(c)(10) of Pub. L. 103-432 provided that: ``The amendment 
made by section 13561(e)(1)(G) of OBRA-1993 [Pub. L. 103-66, amending 
this section], to the extent it relates to the definition of large group 
health plan, shall be effective as if included in the enactment of OBRA-
1989 [Pub. L. 101-239].''
    Amendment by section 13561(d)(1) of Pub. L. 103-66 effective 90 days 
after Aug. 10, 1993, see section 13561(d)(3) of Pub. L. 103-66, set out 
as a note under section 5000 of Title 26, Internal Revenue Code.
    Section 13561(e)(1)(D) of Pub. L. 103-66, as amended by Pub. L. 103-
432, title I, Sec. 151(c)(9)(A), Oct. 31, 1994, 108 Stat. 4436, provided 
that the amendment made by that section is effective as if included in 
the enactment of Pub. L. 101-239.
    Section 13581(d) of Pub. L. 103-66 provided that: ``The amendments 
made by this section [enacting section 1320b-14 of this title and 
amending this section, section 1396a of this title, and section 552a of 
Title 5, Government Organization and Employees] shall take effect on 
January 1, 1994.''


                    Effective Date of 1990 Amendment

    Amendment by section 4153(b)(2)(B) of Pub. L. 101-508 applicable to 
items furnished on or after Jan. 1, 1991, see section 4153(b)(2)(C) of 
Pub. L. 101-508, set out as a note under section 1395x of this title.
    Amendment by section 4157(c)(1) of Pub. L. 101-508 applicable to 
services furnished on or after Jan. 1, 1991, see section 4157(d) of Pub. 
L. 101-508, set out as a note under section 1395k of this title.
    Amendment by section 4161(a)(3)(C) of Pub. L. 101-508 applicable to 
services furnished on or after Oct. 1, 1991, see section 4161(a)(8) of 
Pub. L. 101-508, set out as a note under section 1395k of this title.
    Amendment by section 4163(d)(2)(A)(i)-(iii), (B) of Pub. L. 101-508 
applicable to screening mammography performed on or after Jan. 1, 1991, 
see section 4163(e) of Pub. L. 101-508, as amended, set out as a note 
under section 1395l of this title.
    Section 4163(d)(3) of Pub. L. 101-508, as added by Pub. L. 103-432, 
title I, Sec. 147(f)(5)(A), Oct. 31, 1994, 108 Stat. 4431, provided 
that: ``The amendment made by paragraph (2)(A)(iv) [amending this 
section] shall apply to screening pap smears performed on or after July 
1, 1990.''
    Section 4204(g)(2) of Pub. L. 101-508 provided that: ``The amendment 
made by paragraph (1) [amending this section] shall apply to incentives 
offered on or after the date of the enactment of this Act [Nov. 5, 
1990].''


                    Effective Date of 1989 Amendments

    Amendment by section 6115(b) of Pub. L. 101-239 applicable to 
screening pap smears performed on or after July 1, 1990, see section 
6115(d) of Pub. L. 101-239, set out as a note under section 1395x of 
this title.
    Amendment by section 6202(b)(1) of Pub. L. 101-239 applicable to 
items and services furnished after Dec. 19, 1989, see section 6202(b)(5) 
of Pub. L. 101-239, set out as a note under section 162 of Title 26, 
Internal Revenue Code.
    Section 6202(e)(2) of Pub. L. 101-239 provided that: ``The amendment 
made by paragraph (1) [amending this section] shall apply to items and 
services furnished on or after October 1, 1989.''
    Amendment by Pub. L. 101-234 effective Jan. 1, 1990, see section 
201(c) of Pub. L. 101-234, set out as a note under section 1320a-7a of 
this title.


                    Effective Date of 1988 Amendments

    Amendment by Pub. L. 100-485 effective as if included in the 
enactment of the Medicare Catastrophic Coverage Act of 1988, Pub. L. 
100-360, see section 608(g)(1) of Pub. L. 100-485, set out as a note 
under section 704 of this title.
    Amendment by section 202(d) of Pub. L. 100-360 applicable to items 
dispensed on or after Jan. 1, 1990, see section 202(m)(1) of Pub. L. 
100-360, set out as a note under section 1395u of this title.
    Amendment by section 204(d)(2) of Pub. L. 100-360 applicable to 
screening mammography performed on or after Jan. 1, 1990, see section 
204(e) of Pub. L. 100-360, set out as a note under section 1395m of this 
title.
    Amendment by section 205(e)(1) of Pub. L. 100-360 applicable to 
items and services furnished on or after Jan. 1, 1990, see section 
205(f) of Pub. L. 100-360, set out as a note under section 1395k of this 
title.
    Except as specifically provided in section 411 of Pub. L. 100-360, 
amendment by section 411(i)(4)(D) of Pub. L. 100-360, as it relates to a 
provision in the Omnibus Budget Reconciliation Act of 1987, Pub. L. 100-
203, effective as if included in the enactment of that provision in Pub. 
L. 100-203, see section 411(a) of Pub. L. 100-360, set out as a 
Reference to OBRA; Effective Date note under section 106 of Title 1, 
General Provisions.
    Section 411(f)(4)(D)(ii) of Pub. L. 100-360 provided that: ``The 
amendment made by clause (i) [amending this section] shall apply to 
operations performed on or after 60 days after the date of the enactment 
of this Act [July 1, 1988].''


                    Effective Date of 1987 Amendments

    Section 4009(j)(6) of Pub. L. 100-203, provided that the amendment 
made by that section is effective as if included in the enactment of 
Pub. L. 99-509.
    Section 4034(b) of Pub. L. 100-203 provided that: ``The amendment 
made by subsection (a) [amending this section] shall be effective as if 
included in the enactment of section 9319(a) of the Omnibus Budget 
Reconciliation Act of 1986 [Pub. L. 99-509].''
    Section 4036(a)(2) of Pub. L. 100-203 provided that: ``The amendment 
made by paragraph (1) [amending this section] shall apply with respect 
to items and services furnished on or after 30 days after the date of 
the enactment of this Act [Dec. 22, 1987].''
    Section 4039(c)(2) of Pub. L. 100-203 provided that: ``The 
amendments made by paragraph (1) [amending this section] shall become 
effective on January 1, 1988.''
    For effective date of amendment by section 4072(c) of Pub. L. 100-
203, see section 4072(e) of Pub. L. 100-203, set out as a note under 
section 1395x of this title.
    Amendment by Pub. L. 100-93 effective at end of fourteen-day period 
beginning Aug. 18, 1987, and inapplicable to administrative proceedings 
commenced before end of such period, see section 15(a) of Pub. L. 100-
93, set out as a note under section 1320a-7 of this title.


                    Effective Date of 1986 Amendments

    Section 9319(f) of Pub. L. 99-509 provided that:
    ``(1) Except as provided in paragraph (2), the amendments made by 
this section [enacting section 5000 of Title 26, Internal Revenue Code, 
and amending this section and sections 1395p and 1395r of this title] 
shall apply to items and services furnished on or after January 1, 1987.
    ``(2) The amendments made by subsection (c) [amending sections 1395p 
and 1395r of this title] shall apply to enrollments occurring on or 
after January 1, 1987.''
    Amendment by section 9320(h)(1) of Pub. L. 99-509 applicable to 
services furnished on or after Jan. 1, 1989, with exceptions for 
hospitals located in rural areas which meet certain requirements related 
to certified registered nurse anesthetists, see section 9320(i), (k) of 
Pub. L. 99-509, as amended, set out as notes under section 1395k of this 
title.
    Amendment by section 9343(c)(1) of Pub. L. 99-509 applicable to 
services furnished after June 30, 1987, see section 9343(h)(2) of Pub. 
L. 99-509, as amended, set out as a note under section 1395l of this 
title.
    Section 9201(d)(1) of Pub. L. 99-272 provided that: ``The amendments 
made by subsection (a) [amending this section] shall apply with respect 
to items and services furnished on or after May 1, 1986.''
    Amendment by section 9307(a) of Pub. L. 99-272 applicable to 
services performed on or after Apr. 1, 1986, see section 9307(e) of Pub. 
L. 99-272, set out as a note under section 1320c-3 of this title.


                    Effective Date of 1984 Amendment

    Section 2301(c)(1) of Pub. L. 98-369 provided that: ``The amendment 
made by subsection (a) [amending this section] shall be effective with 
respect to items and services furnished on or after January 1, 1985.''
    Amendment by section 2304(c) of Pub. L. 98-369 applicable to 
pacemaker devices and leads implanted or removed on or after the 
effective date of final regulations promulgated to carry out such 
amendment, see section 2304(d) of Pub. L. 98-369, set out as a note 
below.
    Section 2313(e) of Pub. L. 98-369 provided that: ``The amendments 
made by this section [amending this section and section 1395ww of this 
title] shall become effective on the date of the enactment of this Act 
[July 18, 1984].''
    Section 2344(d) of Pub. L. 98-369 provided that: ``The amendments 
made by this section [amending this section] shall apply to items and 
services furnished on or after the date of the enactment of this Act 
[July 18, 1984].''
    Amendment by section 2354(b)(30), (31) of Pub. L. 98-369 effective 
July 18, 1984, but not to be construed as changing or affecting any 
right, liability, status, or interpretation which existed (under the 
provisions of law involved) before that date, see section 2354(e)(1) of 
Pub. L. 98-369, set out as a note under section 1320a-1 of this title.


                    Effective Date of 1983 Amendments

    Amendment by section 601(f) of Pub. L. 98-21 applicable to items and 
services furnished by or under arrangement with a hospital beginning 
with its first cost reporting period that begins on or after Oct. 1, 
1983, any change in a hospital's cost reporting period made after 
November 1982 to be recognized for such purposes only if the Secretary 
finds good cause therefor, and amendment by section 602(e)(3) of Pub. L. 
98-21 effective Oct. 1, 1983, see section 604(a)(1), (2) of Pub. L. 98-
21, set out as a note under section 1395ww of this title.
    Amendment by Pub. L. 97-448 effective as if originally included as a 
part of this section as this section was amended by the Tax Equity and 
Fiscal Responsibility Act of 1982, Pub. L. 97-248, see section 309(c)(2) 
of Pub. L. 97-448, set out as a note under section 426-1 of this title.


                    Effective Date of 1982 Amendment

    Amendment by section 116(b) of Pub. L. 97-248 applicable with 
respect to items and services furnished on or after Jan. 1, 1983, see 
section 116(c) of Pub. L. 97-248, set out as a note under section 623 of 
Title 29, Labor.
    Amendment by section 122(f), (g)(1) of Pub. L. 97-248 applicable to 
hospice care provided on or after Nov. 1, 1983, see section 122(h)(1) of 
Pub. L. 97-248, as amended, set out as a note under section 1395c of 
this title.
    Amendment by section 128(a)(2)-(4) of Pub. L. 97-248 effective as if 
originally included as part of this section as this section was amended 
by the Omnibus Budget Reconciliation Act of 1981, Pub. L. 97-35, see 
section 128(e)(2) of Pub. L. 97-248, set out as a note under section 
1395x of this title.
    Amendment by sections 142 and 148(a) of Pub. L. 97-248 effective 
with respect to contracts entered into or renewed on or after Sept. 3, 
1982, see section 149 of Pub. L. 97-248, set out as an Effective Date 
note under section 1320c of this title.


                    Effective Date of 1981 Amendment

    Section 2103(a)(2) of Pub. L. 97-35 provided that: ``The amendment 
made by paragraph (1) [amending this section] shall apply with respect 
to expenses incurred on or after October 1, 1981.''
    Section 2146(c)(1) of Pub. L. 97-35 provided that: ``The amendments 
made by subsection (a) [amending this section] shall become effective on 
October 1, 1981.''


                    Effective Date of 1980 Amendments

    Amendment by Pub. L. 96-611 effective July 1, 1981, and applicable 
to services furnished on or after that date, see section 2 of Pub. L. 
96-611, set out as a note under section 1395l of this title.
    Amendment by section 936(c) of Pub. L. 96-499 applicable with 
respect to services provided on or after July 1, 1981, see section 
936(d) of Pub. L. 96-499, set out as a note under section 1395f of this 
title.
    Section 939(b) of Pub. L. 96-499 provided that: ``The amendment made 
by subsection (a) [amending this section] shall apply with respect to 
services furnished on or after July 1, 1981.''


                    Effective Date of 1977 Amendments

    Amendment by Pub. L. 95-210 applicable to services rendered on or 
after first day of third calendar month which begins after Dec. 31, 
1977, see section 1(j) of Pub. L. 95-210, set out as a note under 
section 1395k of this title.
    Section 13(c) of Pub. L. 95-142 provided that: ``The amendments made 
by this section [amending this section and sections 1320c-6 and 1395cc 
of this title] shall take effect on the date of the enactment of this 
Act [Oct. 25, 1977].''


                    Effective Date of 1973 Amendment

    Amendment by Pub. L. 93-233 effective with respect to admissions 
subject to the provisions of section 1395(a)(2) of this title which 
occur after Dec. 31, 1973, see section 18(z-3)(2) of Pub. L. 93-233, set 
out as a note under section 1395f of this title.


                    Effective Date of 1972 Amendment

    Amendment by section 211(c)(1) of Pub. L. 92-603 applicable to 
services furnished with respect to admissions occurring after Dec. 31, 
1972, see section 211(d) of Pub. L. 92-603, set out as a note under 
section 1395f of this title.
    Amendment by section 256(c) of Pub. L. 92-603 applicable with 
respect to admissions occurring after the second month following the 
month of enactment of Pub. L. 92-603 which was approved on Oct. 30, 
1972, see section 256(d) of Pub. L. 92-603, set out as a note under 
section 1395f of this title.


                    Effective Date of 1968 Amendment

    Amendment by section 127(b) of Pub. L. 90-248 applicable with 
respect to services furnished after Dec. 31, 1967, see section 127(c) of 
Pub. L. 90-248, set out as a note under section 1395x of this title.


       Notification to Physicians of Excessive Home Health Visits

    Section 4614(b) of Pub. L. 105-33 provided that: ``The Secretary of 
Health and Human Services may establish a process for notifying a 
physician in cases in which the number of home health visits, furnished 
under title XVIII of the Social Security Act [this subchapter] pursuant 
to a prescription or certification of the physician, significantly 
exceeds such threshold (or thresholds) as the Secretary specifies. The 
Secretary may adjust such threshold to reflect demonstrated differences 
in the need for home health services among different beneficiaries.''


               Distribution of Questionnaire by Contractor

    Section 151(a)(1)(B) of Pub. L. 103-432 provided that: ``The 
Secretary of Health and Human Services shall enter into an agreement 
with an entity not later than 60 days after the date of the enactment of 
the Social Security Act Amendments of 1994 [Oct. 31, 1994], to 
distribute the questionnaire described in section 1862(b)(5)(D) of the 
Social Security Act [subsec. (b)(5)(D) of this section] (as added by 
subparagraph (A)).''


 Retroactive Exemption for Certain Situations Involving Religious Orders

    Section 13561(f) of Pub. L. 103-66 provided that: ``Section 
1862(b)(1)(D) of the Social Security Act [subsec. (b)(1)(D) of this 
section] applies, with respect to items and services furnished before 
October 1, 1989, to any claims that the Secretary of Health and Human 
Services had not identified as of that date as subject to the provisions 
of section 1862(b) of such Act.''


            GAO Study of Extension of Secondary Payer Period

    Section 4203(c)(2) of Pub. L. 101-508, as amended by Pub. L. 103-
432, title I, Sec. 151(c)(7), Oct. 31, 1994, 108 Stat. 4436, provided 
that:
    ``(A) The Comptroller General shall conduct a study of the impact of 
the second sentence of section 1862(b)(1)(C) of the Social Security Act 
[subsec. (b)(1)(C) of this section], and shall include in such report 
information relating to--
        ``(i) the number (and geographic distribution) of such 
    individuals for whom medicare is secondary;
        ``(ii) the amount of savings to the medicare program achieved 
    annually by reason of the application of such sentence;
        ``(iii) the effect on access to employment, and employment-based 
    health insurance, for such individuals and their family members 
    (including coverage by employment-based health insurance of cost-
    sharing requirements under medicare after such employment-based 
    insurance becomes secondary);
        ``(iv) the effect on the amount paid for each dialysis treatment 
    under employment-based health insurance;
        ``(v) the effect on cost-sharing requirements under employment-
    based health insurance (and on out-of-pocket expenses of such 
    individuals) during the period for which medicare is secondary; and
        ``(vi) the appropriateness of applying the provisions of section 
    1862(b)(1)(C) of such Act [subsec. (b)(1)(C) of this section] to all 
    group health plans, without regard to the number of employees 
    covered by such plans.
    ``(B) The Comptroller General shall submit a preliminary report on 
the study conducted under subparagraph (A) to the Committees on Ways and 
Means and Energy and Commerce [Committee on Energy and Commerce now 
Committee on Commerce] of the House of Representatives and the Committee 
on Finance of the Senate not later than January 1, 1993, and a final 
report on such study not later than January 1, 1995.''
    [Section 151(c)(7) of Pub. L. 103-432 provided that the amendment 
made by that section to section 4203(c)(2) of Pub. L. 101-508, set out 
above, is effective as if included in the enactment of Pub. L. 101-508.]


   Deadline for First Transmittal and Request of Matching Information

    Section 6202(a)(2)(B) of Pub. L. 101-239 provided that: ``The 
Commissioner of Social Security shall first--
        ``(i) transmit to the Secretary of the Treasury information 
    under paragraph (5)(A)(i) of section 1862(b) of the Social Security 
    Act [subsec. (b)(5)(A)(i) of this section] (as inserted by 
    subparagraph (A)), and
        ``(ii) request from the Secretary disclosure of information 
    described in section 6013(l)(12)(A) of the Internal Revenue Code of 
    1986 [26 U.S.C. 6013(l)(12)(A)],
by not later than 14 days after the date of the enactment of this Act 
[Dec. 19, 1989].''


  Designation of Pediatric Hospitals as Meeting Certification as Heart 
                           Transplant Facility

    Section 4009(b) of Pub. L. 100-203 provided that: ``For purposes of 
determining whether a pediatric hospital that performs pediatric heart 
transplants meets the criteria established by the Secretary of Health 
and Human Services for facilities in which the heart transplants 
performed will be considered to meet the requirement of section 
1862(a)(1)(A) of the Social Security Act [subsec. (a)(1)(A) of this 
section], the Secretary shall treat such a hospital as meeting such 
criteria if--
        ``(1) the hospital's pediatric heart transplant program is 
    operated jointly by the hospital and another facility that meets 
    such criteria,
        ``(2) the unified program shares the same transplant surgeons 
    and quality assurance program (including oversight committee, 
    patient protocol, and patient selection criteria), and
        ``(3) the hospital demonstrates to the satisfaction of the 
    Secretary that it is able to provide the specialized facilities, 
    services, and personnel that are required by pediatric heart 
    transplant patients.''


Approval of Surgical Assistants for Procedures Performed April 1, 1986, 
                          to December 15, 1986

    Section 1895(b)(16)(C) of Pub. L. 99-514 provided that: ``For 
purposes of section 1862(a)(15) of the Social Security Act (42 U.S.C. 
1395y(a)(15)), added by section 9307(a)(3) of COBRA, and for surgical 
procedures performed during the period beginning on April 1, 1986, and 
ending on December 15, 1986, a carrier is deemed to have approved the 
use of an assistant in a surgical procedure, before the surgery is 
performed, based on the existence of a complicating medical condition if 
the carrier determines after the surgery is performed that the use of 
the assistant in the procedure was appropriate based on the existence of 
a complicating medical condition before or during the surgery.''


      Extending Waiver of Liability Provisions to Hospice Programs

    Section 9305(f) of Pub. L. 99-509, as amended by Pub. L. 100-360, 
title IV, Sec. 426(a), July 1, 1988, 102 Stat. 814; Pub. L. 101-508, 
title IV, Sec. 4008(a)(2), Nov. 5, 1990, 104 Stat. 1388-44, provided 
that:
    ``(1) In general.--The Secretary of Health and Human Services shall, 
for purposes of determining whether payments to a hospice program should 
be denied pursuant to section 1862(a)(1)(C) of the Social Security Act 
[subsec. (a)(1)(C) of this section], apply (under section 1879(a) of 
such Act [section 1395pp(a) of this title]) a presumption of compliance 
of 2.5 percent (based on the number of days of hospice care billed) in a 
manner substantially similar to that provided to home health agencies 
under policies in effect as of July 1, 1985.
    ``(2) Effective date.--Paragraph (1) shall apply to hospice care 
furnished on or after the first day of the first month that begins at 
least 6 months after the date of the enactment of this Act [Oct. 21, 
1986] and before December 31, 1995.''
    [Section 4008(a)(3) of Pub. L. 101-508 provided that: ``The 
amendments made by paragraphs (1) and (2) [amending section 9305(f) of 
Pub. L. 99-509, set out above, and section 9126(c) of Pub. L. 99-272, 
set out below] shall take effect on the date of the enactment of this 
Act [Nov. 5, 1990].'']


   Study of Impact on Disabled Beneficiaries and Family of Amendments 
  Relating to Large Group Health Plans and Medicare as Secondary Payer

    Section 9319(e) of Pub. L. 99-509 directed Comptroller General to 
study and report to Congress, not later than Mar. 1, 1990, the impact of 
the amendments made by this section (enacting section 5000 of Title 26, 
Internal Revenue Code, and amending this section and sections 1395p and 
1395r of this title) on access of disabled individuals and members of 
their family to employment and health insurance, such report to include 
information relating to number of disabled medicare beneficiaries for 
whom medicare has become secondary, either through their employment or 
the employment of a family member, amount of savings to the medicare 
program achieved annually through this provision, and effect on 
employment, and employment-based health coverage, of disabled 
individuals and family members.


            Reinstatement of Waiver of Liability Presumption

    Section 9126(c) of Pub. L. 99-272, as amended by Pub. L. 100-360, 
title IV, Sec. 426(b), July 1, 1988, 102 Stat. 814; Pub. L. 101-508, 
title IV, Sec. 4008(a)(1), Nov. 5, 1990, 104 Stat. 1388-44, provided 
that: ``The Secretary of Health and Human Services shall, for purposes 
of determining whether payments to a skilled nursing facility should be 
denied pursuant to section 1862(a)(1)(A) of the Social Security Act 
[subsec. (a)(1)(A) of this section], apply the same presumption of 
compliance (5 percent) as in effect under regulations as of July 1, 
1985. Such presumption shall apply for the period beginning with the 
first month beginning after the date of the enactment of this Act [Apr. 
7, 1986] and ending on December 31, 1995.''


                     Home Health Waiver of Liability

    Section 9205 of Pub. L. 99-272, as amended by Pub. L. 100-360, title 
IV, Sec. 426(d), July 1, 1988, 102 Stat. 814; Pub. L. 103-432, title I, 
Sec. 158(b)(1), Oct. 31, 1994, 108 Stat. 4442, provided that: ``The 
Secretary of Health and Human Services shall, for purposes of 
determining whether payments to a home health agency should be denied 
pursuant to section 1862(a)(1)(A) of the Social Security Act [subsec. 
(a)(1)(A) of this section], apply a presumption of compliance (2.5 
percent) in the same manner as under the regulations in effect as of 
July 1, 1985. Such presumption shall apply until December 31, 1995.''
    [Section 158(b)(2) of Pub. L. 103-432 provided that: ``The amendment 
made by paragraph (1) [amending section 9205 of Pub. L. 99-272, set out 
above] shall take effect as if included in the enactment of OBRA-1990 
[Pub. L. 101-508].'']


Recommendations and Guidelines for Elimination of Assistants at Surgery; 
                           Report to Congress

    Section 9307(d) of Pub. L. 99-272 provided that the Secretary of 
Health and Human Services, after consultation with the Physician Payment 
Review Commission, develop recommendations and guidelines respecting 
other surgical procedures for which an assistant at surgery was 
generally not medically necessary and circumstances under which use of 
an assistant at surgery was generally appropriate but should be subject 
to prior approval of an appropriate entity and that the Secretary report 
to Congress, not later than January 1, 1987, on these recommendations 
and guidelines.


Pacemaker Reimbursement Review and Reform; Promulgation of Regulations; 
                Effective Date of Pacemaker Registration

    Section 2304(d) of Pub. L. 98-369 provided that: ``The Secretary of 
Health and Human Services shall promulgate final regulations to carry 
out this section and the amendment made by this section [amending this 
section and enacting provisions set out as a note under section 1395l of 
this title] prior to January 1, 1985, and the amendment made by 
subsection (c) [amending this section] shall apply to pacemaker devices 
and leads implanted or removed on or after the effective date of such 
regulations.''


               Payment for Debridement of Mycotic Toenails

    Section 2325 of Pub. L. 98-369 provided that: ``The Secretary shall 
provide, pursuant to section 1862(a) of the Social Security Act [subsec. 
(a) of this section], that payment will not be made under part B of 
title XVIII of such Act [part B of this subchapter] for a physician's 
debridement of mycotic toenails to the extent such debridement is 
performed for a patient more frequently than once every 60 days, unless 
the medical necessity for more frequent treatment is documented by the 
billing physician.''


 Interim Waiver in Certain Cases of Billing Rule for Items and Services 
                     Other Than Physicians' Services

    Section 602(k) of Pub. L. 98-21, as amended by Pub. L. 99-272, title 
IX, Sec. 9112(a), Apr. 7, 1986, 100 Stat. 163, provided that:
    ``(1) The Secretary of Health and Human Services may, for any cost 
reporting period beginning prior to October 1, 1986, waive the 
requirements of sections 1862(a)(14) and 1866(a)(1)(H) of the Social 
Security Act [subsec. (a)(14) of this section and section 
1395cc(a)(1)(H) of this title] in the case of a hospital which has 
followed a practice, since prior to October 1, 1982, of allowing direct 
billing under part B of title XVIII of such Act [part B of this 
subchapter] for services (other than physicians' services) so 
extensively, that immediate compliance with those requirements would 
threaten the stability of patient care. Any such waiver shall provide 
that such billing may continue to be made under part B of such title but 
that the payments to such hospital under part A of such title [part A of 
this subchapter] shall be reduced by the amount of the billings for such 
services under part B of such title. If such a waiver is granted, at the 
end of the waiver period the Secretary may provide for such methods of 
payments under part A as is appropriate, given the organizational 
structure of the institution.
    ``(2) In the case of a hospital which is receiving payments pursuant 
to a waiver under paragraph (1), payment of the adjustment for indirect 
costs of approved educational activities shall be made as if the 
hospital were receiving under part A of title XVIII of the Social 
Security Act all the payments which are made under part B of such title 
solely by reason of such waiver.
    ``(3) Any waiver granted under paragraph (1) shall provide that, 
with respect to those items and services billed under part B of title 
XVIII of the Social Security Act solely by reason of such waiver--
        ``(A) payment under such part shall be equal to 100 percent of 
    the reasonable charge or other applicable payment base for the items 
    and services; and
        ``(B) the entity furnishing the items and services must agree to 
    accept the amount paid pursuant to subparagraph (A) as the full 
    charge for the items and services.''
    [Section 9112(b) of Pub. L. 99-272 provided that:
    [``(1) Section 602(k)(2) of the Social Security Amendments of 1983 
(as added by subsection (a)) [set out above] shall apply to cost 
reporting periods beginning on or after January 1, 1986.
    [``(2) Section 602(k)(3) of the Social Security Amendments of 1983 
(as added by subsection (a)) [set out above] shall apply to items and 
services furnished after the end of the 10-day period beginning on the 
date of the enactment of this Act [Apr. 7, 1986].'']


              Prohibition of Payment for Ineffective Drugs

    Section 115(b) of Pub. L. 97-248 provided that: ``No provision of 
law limiting the use of funds for purposes of enforcing or implementing 
section 1862(c) [subsec. (c) of this section] or section 1903(i)(5) 
[section 1396b(i)(5) of this title] of the Social Security Act, section 
2103 of the Omnibus Budget Reconciliation Act of 1981 [section 2103 of 
Pub. L. 97-35, amending sections 1395y and 1396b of this title and 
enacting provisions set out as notes under sections 1395y and 1396b of 
this title], or any rule or regulation issued pursuant to any such 
section (including any provision contained in, or incorporated by 
reference into, any appropriation Act or resolution making continuing 
appropriations) shall apply to any period after September 30, 1982, 
unless such provision of law is enacted after the date of the enactment 
of this Act [Sept. 3, 1982] and specifically states that such provision 
is to supersede this section.''


             Establishment and Implementation of Guidelines

    Section 2152(b) of Pub. L. 97-35 directed the Secretary of Health 
and Human Services to establish, and provide for the implementation of, 
the guidelines described in subsec. (f) of this section not later than 
Oct. 1, 1981.


 Report to Congressional Committees on Implementation of Certification 
    Requirements Relating to Modification of Health Benefits Plan or 
                    Program; Failure To Submit Report

    Section 4(b) of Pub. L. 93-480 provided that the Civil Service 
Commission and the Secretary of Health, Education, and Welfare submit a 
report on or before Mar. 1, 1975, on the steps which have been taken, 
and the steps which are planned, to enable the Secretary to make the 
determination and certification referred to in former subsec. (c) of 
this section and that if such report is not submitted by Mar. 1, 1975, 
the date specified in former subsec. (c) shall be deemed to be July 1, 
1975, rather than Jan. 1, 1976.

                  Section Referred to in Other Sections

    This section is referred to in sections 1320a-7a, 1320c, 1320c-3, 
1320c-7, 1320c-8, 1395h, 1395l, 1395m, 1395p, 1395r, 1395u, 1395w-22, 
1395x, 1395cc, 1395ff, 1395gg, 1395oo, 1395pp, 1395ss, 1395ww, 1395ddd, 
1395eee, 1395ggg, 1396b of this title; title 10 section 1095; title 26 
sections 5000, 6103; title 45 section 231f.
