[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 1535 Introduced in Senate (IS)]







106th CONGRESS
  1st Session
                                S. 1535

To amend title XVIII of the Social Security Act to provide for coverage 
of outpatient prescription drugs under part B of the Medicare Program, 
                        and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             August 5, 1999

   Mr. Grams introduced the following bill; which was read twice and 
                  referred to the Committee on Finance

_______________________________________________________________________

                                 A BILL


 
To amend title XVIII of the Social Security Act to provide for coverage 
of outpatient prescription drugs under part B of the Medicare Program, 
                        and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medicare Ensuring Prescription Drugs 
for Seniors Act of 1999''.

SEC. 2. MEDICARE COVERAGE OF OUTPATIENT PRESCRIPTION DRUGS.

    (a) Description of Covered Outpatient Drugs.--
            (1) Coverage.--Section 1861(s)(2)(J) of the Social Security 
        Act (42 U.S.C. 1395x(s)(2)(J)) is amended to read as follows:
            ``(J) covered outpatient drugs;''.
            (2) Drugs described.--Section 1861(t) of the Social 
        Security Act (42 U.S.C. 1395x(t)) is amended--
                    (A) in the heading, by adding at the end the 
                following: ``; Covered Outpatient Drugs'';
                    (B) in paragraph (1), by striking ``paragraph (2)'' 
                and inserting ``the succeeding paragraphs of this 
                subsection''; and
                    (C) by striking paragraph (2) and inserting the 
                following:
    ``(2) Subject to paragraph (3), the term `covered outpatient drug' 
means--
            ``(A) a drug which may be dispensed only upon prescription 
        and--
                    ``(i) which is approved for safety and 
                effectiveness as a prescription drug under section 505 
                of the Federal Food, Drug, and Cosmetic Act;
                    ``(ii)(I) which was commercially used or sold in 
                the United States before the date of the enactment of 
                the Drug Amendments of 1962 or which is identical, 
                similar, or related (within the meaning of section 
                310.6(b)(1) of title 21 of the Code of Federal 
                Regulations) to such a drug, and (II) which has not 
                been the subject of a final determination by the 
                Secretary that it is a `new drug' (within the meaning 
                of section 201(p) of the Federal Food, Drug, and 
                Cosmetic Act) or an action brought by the Secretary 
                under section 301, 302(a), or 304(a) of such Act to 
                enforce section 502(f) or 505(a) of such Act; or
                    ``(iii)(I) which is described in section 107(c)(3) 
                of the Drug Amendments of 1962 and for which the 
                Secretary has determined there is a compelling 
                justification for its medical need, or is identical, 
                similar, or related (within the meaning of section 
                310.6(b)(1) of title 21 of the Code of Federal 
                Regulations) to such a drug, and (II) for which the 
                Secretary has not issued a notice of an opportunity for 
                a hearing under section 505(e) of the Federal Food, 
                Drug, and Cosmetic Act on a proposed order of the 
                Secretary to withdraw approval of an application for 
                such drug 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;
            ``(B) a biological product which--
                    ``(i) may only be dispensed upon prescription;
                    ``(ii) is licensed under section 351 of the Public 
                Health Service Act; and
                    ``(iii) is produced at an establishment licensed 
                under such section to produce such product; and
            ``(C) insulin approved under appropriate Federal law.
    ``(3) The term `covered outpatient drug' does not include--
            ``(A) any drug, biological product, or insulin when 
        furnished as part of, or as incident to, a diagnostic service 
        or any other item or service for which payment may be made 
        under this title (other than physicians' services or services 
        which would be physicians' services if furnished by a 
        physician); or
            ``(B) any drug that is intravenously administered in a home 
        setting.''.
            (3) Conforming amendments repealing separate coverage of 
        certain drugs and products.--(A) Effective January 1, 2001, 
        section 1861(s)(2) of the Social Security Act (42 U.S.C. 
        1395x(s)(2)) is amended--
                    (i) in each of subparagraphs (A) and (B), by 
                striking ``(including drugs'' and all that follows 
                through ``self-administered)'';
                    (ii) by striking subparagraphs (G), (I), (O), (Q), 
                and (T);
                    (iii) in subparagraph (R), by adding ``and'' at the 
                end; and
                    (iv) in subparagraph (S), by striking ``; and'' at 
                the end.
            (B) Effective January 1, 2001, section 1861 of the Social 
        Security Act (42 U.S.C. 1395x) is amended by striking 
        subsection (kk).
            (C) Effective January 1, 2001, section 1881(b) of the 
        Social Security Act (42 U.S.C. 1395rr(b)) is amended--
                    (i) in the first sentence of paragraph (1)--
                            (I) by striking ``, (B)'' and inserting ``, 
                        and (B)''; and
                            (II) by striking ``, and (C)'' and all that 
                        follows and inserting a period; and
                    (ii) in paragraph (11)--
                            (I) by striking ``(11)(A)'' and inserting 
                        ``(11)''; and
                            (II) by striking subparagraphs (B) and (C).
    (b) Deductible and Payment Amounts.--(1) Section 1833(a)(1)(S) of 
the Social Security Act (42 U.S.C. 1395l(a)(1)(S)) is amended to read 
as follows: ``(S) with respect to expenses incurred for covered 
outpatient drugs, the amounts paid shall be the amounts determined 
under section 1834(e)(2);''.
    (2) Section 1833(a)(2) of the Social Security Act (42 U.S.C. 
1395l(a)(2)) is amended in the matter preceding subparagraph (A) by 
inserting ``(other than covered outpatient drugs)'' after ``(2) in the 
case of services''.
    (3) Section 1833(b) of the Social Security Act (42 U.S.C. 1395l(b)) 
is amended--
            (A) in paragraph (1), by inserting ``or for covered 
        outpatient drugs'' after ``1861(s)(10)(A)''; and
            (B) in paragraph (2), by striking ``osteoporosis drug (as 
        defined in section 1861(kk))'' and inserting ``covered 
        outpatient drug (as defined in section 1861(t))''.
    (4) Section 1834 of the Social Security Act (42 U.S.C. 1395m) is 
amended by inserting after subsection (d) the following:
    ``(e) Payment for Covered Outpatient Drugs.--
            ``(1) Deductible.--
                    ``(A) Application.--
                            ``(i) In general.--Except as provided in 
                        clause (ii), payment shall be made under 
                        paragraph (2) only with respect to expenses 
                        incurred by an individual for covered 
                        outpatient drugs during a month on or after 
                        such date in the month as the Secretary 
                        determines that the individual has incurred 
                        expenses in the month for covered outpatient 
                        drugs (during a period in which the individual 
                        is entitled to benefits under this part) equal 
                        to the amount of the prescription drug 
                        deductible specified in subparagraph (C) for 
                        that month.
                            ``(ii) Waiver of deductible for low-income 
                        individuals.--The prescription drug deductible 
                        established under this paragraph shall not 
                        apply to an individual whose income is not 
                        greater than 135 percent of the income official 
                        poverty line (as defined by the Office of 
                        Management and Budget, and revised annually in 
                        accordance with section 673(2) of the Omnibus 
                        Budget Reconciliation Act of 1981) applicable 
                        to a family of the size involved.
                    ``(B) Response to application.--If the system 
                described in section 1842(o)(4) has not been 
                established and an individual applies to the Secretary 
                to establish that the individual has met the 
                requirement of subparagraph (A), the Secretary shall 
                promptly notify the individual (and, if the application 
                was submitted by or through a participating pharmacy, 
                the pharmacy) as to the date (if any) as of which the 
                individual has met such requirement.
                    ``(C) Prescription drug deductible amount.--The 
                prescription drug deductible specified in this 
                subparagraph for each month--
                            ``(i) in 2001, is $150 for an individual 
                        (or $300 for a married couple, both of whom 
                        enrolled under this part); and
                            ``(ii) in any succeeding year, is the 
                        prescription drug deductible for a month in the 
                        preceding year, increased by the percentage by 
                        which the monthly premium under section 1839 
                        for months during the year exceeds the monthly 
                        premium under such section for months during 
                        the preceding year.
            ``(2) Payment amount.--Subject to the prescription drug 
        deductible established under paragraph (1)(A), the amount 
        payable under this part with respect to a covered outpatient 
        drug is equal to 75 percent of the lesser of--
                    ``(A) the actual charge for the drug; or
                    ``(B) the average wholesale price for the drug.
            ``(3) Prohibition of formulary.--Nothing in this title 
        (other than section 1862(c)) shall be construed as authorizing 
        the Secretary to exclude from coverage or to deny payment--
                    ``(A) for any specific covered outpatient drug, or 
                specific class of covered outpatient drug; or
                    ``(B) for any specific use of such a drug for a 
                specific indication unless such exclusion is pursuant 
                to section 1862(a)(1) based on a finding by the 
                Secretary that such use is not safe or is not 
                effective.
            ``(4) Reports on utilization and effects on prices.--
                    ``(A) Compilation of information.--The Secretary 
                shall compile information on--
                            ``(i) manufacturers' prices for covered 
                        outpatient drugs, and on charges of pharmacists 
                        for covered outpatient drugs; and
                            ``(ii) the use of covered outpatient drugs 
                        by individuals entitled to benefits under this 
                        part.
                    ``(B) Reports.--The Secretary shall submit to the 
                Committees on Ways and Means and Commerce of the House 
                of Representatives and the Committee on Finance of the 
                Senate a report, in May and November of 2000 and 2001 
                and in May of each succeeding year, providing the 
                information compiled under subparagraph (A). Each 
                report submitted after 2002 shall include an 
                explanation of the extent to which the increases in 
                outlays for covered outpatient drugs under this part 
                are due to the factors described in clauses (i) and 
                (ii) of subparagraph (A).''.
    (c) Participating Pharmacies; Civil Money Penalties.--
            (1) Participating pharmacies.--Section 1842 of the Social 
        Security Act (42 U.S.C. 1395t) is amended--
                    (A) in subsection (h)--
                            (i) in paragraph (1), by inserting before 
                        the period at the end of the second sentence 
                        the following: ``, except that, with respect to 
                        a supplier of covered outpatient drugs, the 
                        term `participating supplier' means a 
                        participating pharmacy (as defined in 
                        subsection (o)(1))''; and
                            (ii) in paragraph (4), by adding at the end 
                        the following: ``In publishing directories 
                        under this paragraph, the Secretary shall 
                        provide for separate directories (wherever 
                        appropriate) for participating pharmacies.''; 
                        and
                    (B) by striking subsection (o) and inserting the 
                following:
    ``(o)(1) For purposes of this section, the term `participating 
pharmacy' means, with respect to covered outpatient drugs dispensed on 
or after January 1, 2001, an entity which is authorized under State law 
to dispense covered outpatient drugs and which has entered into an 
agreement with the Secretary, providing at least the following:
            ``(A) The entity agrees to accept payment under this part 
        on an assignment-related basis for all covered outpatient drugs 
        dispensed to an individual entitled to benefits under this part 
        (in this subsection referred to as a `Medicare beneficiary') 
        during a year after--
                    ``(i) the Secretary has notified the entity, 
                through the electronic system described in paragraph 
                (4); or
                    ``(ii) in the absence of such a system, the entity 
                is otherwise notified that the Secretary has 
                determined,
        that the individual has met the prescription drug deductible 
        with respect to such drugs under section 1834(e)(1) for the 
        year.
            ``(B) The entity agrees--
                    ``(i) not to refuse to dispense covered outpatient 
                drugs stocked by the entity to any medicare 
                beneficiary; and
                    ``(ii) not to charge any Medicare beneficiary 
                (regardless of whether or not the beneficiary is 
                enrolled in a Medicare+Choice plan offered by a 
                Medicare+Choice organization under part C) more for 
                such drugs than the amount such entity charges to the 
                general public (as determined by the Secretary in 
                regulations).
            ``(C) The entity agrees to keep patient records (including 
        records on expenses) for all covered outpatient drugs dispensed 
        to all Medicare beneficiaries.
            ``(D) The entity agrees to submit information (in a manner 
        specified by the Secretary to be necessary to administer this 
        title) on all purchases of covered outpatient drugs dispensed 
        to Medicare beneficiaries.
            ``(E) The entity agrees--
                    ``(i) to offer to counsel, or to offer to provide 
                information (consistent with State law respecting the 
                provision of such information) to, each Medicare 
                beneficiary on the appropriate use of a drug to be 
                dispensed and whether there are potential interactions 
                between the drug and other drugs dispensed to the 
                beneficiary; and
                    ``(ii) to advise the beneficiary on the 
                availability (consistent with State laws respecting 
                substitution of drugs) of therapeutically equivalent 
                covered outpatient drugs.
Nothing in this paragraph shall be construed as requiring a pharmacy 
operated by a Medicare+Choice organization under part C for the 
exclusive benefit of its members to dispense covered outpatient drugs 
to individuals who are not members of the organization.
    ``(2) The Secretary shall provide to each participating pharmacy--
            ``(A) a distinctive emblem (suitable for display to the 
        public) indicating that the pharmacy is a participating 
        pharmacy; and
            ``(B) upon request, such electronic equipment and technical 
        assistance (other than the costs of obtaining, maintaining, or 
        expanding telephone service) as the Secretary determines may be 
        necessary for the pharmacy to submit claims using the 
        electronic system established under paragraph (4).
    ``(3) The Secretary shall provide for periodic audits of 
participating pharmacies to ensure--
            ``(A) compliance with the requirements for participation 
        under this title; and
            ``(B) the accuracy of information submitted by the 
        pharmacies under this title.
    ``(4) The Secretary shall establish, by not later than January 1, 
2001, a point-of-sale electronic system for use by carriers and 
participating pharmacies in the submission of information respecting 
covered outpatient drugs dispensed to Medicare beneficiaries under this 
part.
    ``(5) Notwithstanding subsection (b)(3)(B), payment for covered 
outpatient drugs may be made on the basis of an assignment described in 
clause (ii) of that subsection only to a participating pharmacy.''.
            (2) Civil money penalties for violation of participation 
        agreement, for excessive charges for nonparticipating 
        pharmacies, and for failure to provide survey information.--
        Section 1128A(a) of the Social Security Act (42 U.S.C. 1320a-
        7a(a)) is amended--
                    (A) in paragraph (2)(C), by inserting ``or to be a 
                participating pharmacy under section 1842(o)'' after 
                ``1842(h)(1)'';
                    (B) in paragraph (6), by striking ``, or'' at the 
                end;
                    (C) in paragraph (7), by adding ``or'' at the end; 
                and
                    (D) by inserting after paragraph (7) the following:
            ``(8) in the case of a participating or nonparticipating 
        pharmacy (as defined for purposes of part B of title XVIII), 
        presents or causes to be presented to any person a request for 
        payment for covered outpatient drugs dispensed to an individual 
        entitled to benefits under part B of title XVIII and for which 
        the amount charged by the pharmacy is greater than the amount 
        the pharmacy charges the general public (as determined by the 
        Secretary in regulations);''.
    (d) Limitation on Length of Prescription.--Section 1862(c) of the 
Social Security Act (42 U.S.C. 1395y(c)) is amended--
            (1) by redesignating subparagraphs (A) through (D) of 
        paragraph (1) as clauses (i) through (iv), respectively;
            (2) in paragraph (2)(A), by striking ``paragraph (1)'' and 
        inserting ``subparagraph (A)'';
            (3) by redesignating subparagraphs (A) and (B) of paragraph 
        (2) as clauses (i) and (ii), respectively;
            (4) by redesignating paragraphs (1) and (2) as 
        subparagraphs (A) and (B), respectively;
            (5) by inserting ``(1)'' after ``(c)''; and
            (6) by adding at the end the following:
    ``(2) No payment may be made under part B for any expense incurred 
for a covered outpatient drug if the drug is dispensed in a quantity 
exceeding a supply of 30 days or such longer period of time (not to 
exceed 90 days, except in exceptional circumstances) as the Secretary 
may authorize.''.
    (e) Use of Carriers, Fiscal Intermediaries, and Other Entities in 
Administration.--
            (1) Authorizing use of other entities in electronic claims 
        system.--Section 1842(f) of the Social Security Act (42 U.S.C. 
        1395u(f)) is amended--
                    (A) in paragraph (1), by striking ``and'' at the 
                end;
                    (B) in paragraph (2), by striking the period at the 
                end and inserting ``; and''; and
                    (C) by adding at the end the following:
            ``(3) with respect to implementation and operation (and 
        related functions) of the electronic system established under 
        subsection (o)(4), a voluntary association, corporation, 
        partnership, or other nongovernmental organization, which the 
        Secretary determines to be qualified to conduct such 
        activities.''.
            (2) Additional functions of carriers.--Section 1842(b)(3) 
        of the Social Security Act (42 U.S.C. 1395u(b)(3)) is amended--
                    (A) in subparagraph (I), by striking ``and'' at the 
                end;
                    (B) by redesignating subparagraph (L) as 
                subparagraph (J); and
                    (C) by inserting after subparagraph (J) (as so 
                redesignated) the following:
            ``(K) if such carrier makes determinations or payments with 
        respect to covered outpatient drugs, will--
                    ``(i) receive information transmitted under the 
                electronic system established under subsection (o)(4); 
                and
                    ``(ii) respond to requests by participating 
                pharmacies (and any individual entitled to benefits 
                under this part) as to whether or not such an 
                individual has met the prescription drug deductible 
                established under section 1834(e)(1) for the month; and
            ``(L) will enter into such contracts with organizations 
        described in subsection (f)(3) as the Secretary determines may 
        be necessary to implement and operate (and for related 
        functions with respect to) the electronic system established 
        under subsection (o)(4) for covered outpatient drugs under this 
        part.''.
            (3) Special contract provisions for electronic claims 
        system.--
                    (A) Payment on other than a cost basis.--Section 
                1842(c)(1) of the Social Security Act (42 U.S.C. 
                1395u(c)(1)) is amended--
                            (i) by inserting ``(A)'' after ``(c)(1)'';
                            (ii) in the first sentence, by inserting 
                        ``, except as provided in subparagraph (B),'' 
                        after ``under this part, and''; and
                            (iii) by adding at the end the following:
    ``(B) To the extent that a contract under this section provides for 
implementation and operation (and related functions) of the electronic 
system established under subsection (o)(4) for covered outpatient 
drugs, the Secretary may provide for payment for such activities based 
on any method of payment determined by the Secretary to be 
appropriate.''.
                    (B) Application of different performance 
                standards.--The Secretary of Health and Human Services, 
                before entering into contracts under section 1842 of 
                the Social Security Act with respect to the 
                implementation and operation (and related functions) of 
                an electronic system for covered outpatient drugs, 
                shall establish standards with respect to performance 
                with respect to activities relating to such system. The 
provisions of section 1153(e)(2) and paragraphs (1) and (2) of section 
1153(h) of such Act shall apply to such activities in the same manner 
as they apply to contracts with peer review organizations, instead of 
the requirements of the second and third sentences of section 
1842(b)(2)(A) of such Act.
                    (C) Use of regional carriers.--Section 
                1842(b)(2)(A) of the Social Security Act (42 U.S.C. 
                1395u(b)(2)(A)) is amended by adding at the end the 
                following: ``With respect to activities relating to 
                implementation and operation (and related functions) of 
                the electronic system established under subsection 
                (o)(4), the Secretary may enter into contracts with 
                carriers under this section to perform such activities 
                on a regional basis.''.
            (4) Delay in application of coordinated benefits with 
        medigap.--The provisions of subparagraph (B) of section 
        1842(h)(3) of the Social Security Act shall not apply to 
        covered outpatient drugs (other than drugs described in section 
        1861(s)(2)(J) of such Act as in effect on the day before the 
        date of the enactment of this Act) dispensed before January 1, 
        2002.
            (5) Batch prompt processing of claims.--Section 1842(c) of 
        the Social Security Act (42 U.S.C. 1395u(c)), is amended--
                    (A) by redesignating paragraph (6) as paragraph 
                (7);
                    (B) in paragraphs (2)(A) and (3)(A), by striking 
                ``Each'' and inserting ``Except as provided in 
                paragraph (6), each''; and
                    (C) by inserting after paragraph (5) the following:
    ``(6)(A) Each contract under this section which provides for the 
disbursement of funds, as described in subsection (a)(1)(B), with 
respect to claims for payment for covered outpatient drugs shall 
provide for a payment cycle under which each carrier will, on a monthly 
basis, make a payment with respect to all claims which were received 
and approved for payment in the period since the most recent date on 
which such a payment was made with respect to the participating 
pharmacy or individual submitting the claim.
    ``(B) If payment is not issued, mailed, or otherwise transmitted 
within 5 days of when such a payment is required to be made under 
subparagraph (A), interest shall be paid at the rate used for purposes 
of section 3902(a) of title 31, United States Code (relating to 
interest penalties for failure to make prompt payments) for the period 
beginning on the day after such 5-day period and ending on the date on 
which payment is made.''.
    (f) Conforming Amendments.--
            (1) The first sentence of section 1866(a)(2)(A) (42 U.S.C. 
        1395cc(a)(2)(A)) is amended by inserting ``1834(e),'' after 
        ``1833(b),''.
            (2) Section 1903(i)(5) (42 U.S.C. 1396b(i)(5)) is amended 
        by striking ``section 1862(c)'' and inserting ``section 
        1862(c)(1)''.
    (g) Prescription Drug Payment Review Commission.--Part B is amended 
by inserting after section 1844 the following:

             ``prescription drug payment review commission

    ``Sec. 1845. (a) Establishment.--
            ``(1) In general.--The Director of the Congressional Office 
        of Technology Assessment (in this section referred to as the 
        `Director' and the `Office', respectively) shall provide for 
        the appointment of a Prescription Drug Payment Review 
        Commission (in this section referred to as the `Commission'), 
        to be composed of individuals with expertise in the provision 
        and financing of covered outpatient drugs appointed by the 
        Director (without regard to the provisions of title 5, United 
        States Code, governing appointments in the competitive 
        service).
            ``(2) Membership and terms.--The Commission shall consist 
        of 11 individuals. Members of the Commission shall first be 
        appointed by not later than January 1, 2000, for a term of 3 
        years, except that the Director may provide initially for such 
        shorter terms as will ensure that (on a continuing basis) the 
        terms of not more than 4 members expire in any 1 year.
            ``(3) Qualifications.--The membership of the Commission 
        shall include--
                    ``(A) recognized experts in the fields of health 
                care economics, medicine, pharmacology, pharmacy, and 
                prescription drug reimbursement;
                    ``(B) representatives of the prescription drug 
                manufacturing industry; and
                    ``(C) at least 1 individual who is a beneficiary 
                under this title.
    ``(b) Reports.--
            ``(1) In general.--Not later than May 1 of each year 
        (beginning in 2001), the Commission shall submit an annual 
        report to Congress concerning methods of determining payment 
for covered outpatient drugs under this part.
            ``(2) Contents.--Beginning with the annual report required 
        to be submitted in 2002, such report shall include, with 
        respect to the previous year, information on--
                    ``(A) increases in manufacturers' prices for 
                covered outpatient drugs and in charges of pharmacists 
                for covered outpatient drugs;
                    ``(B) the level of utilization of covered 
                outpatient drugs by medicare beneficiaries; and
                    ``(C) administrative costs relating to covered 
                outpatient drugs.
    ``(c) Application of MedPAC Provisions.--The following provisions 
of section 1805 shall apply to the Commission in the same manner as 
they apply to the Medicare Payment Advisory Commission:
            ``(1) Subsection (c)(4) (relating to compensation of 
        members).
            ``(2) Subsection (d) (relating to staffing and 
        administration).
            ``(3) Subsection (e) (relating to powers of the Commission 
        generally).
            ``(4) Subsection (f)(1) (relating to requests for 
        appropriations).
    ``(d) Funding.--The Secretary shall provide to the Commission, from 
amounts appropriated to the Department of Health and Human Services, 
such sums as may be necessary to carry out the provisions of this 
section. Such sums shall not be payable from amounts appropriated to 
the Federal Hospital Insurance Trust Fund or the Federal Supplementary 
Medical Insurance Trust Fund.''.
    (h) Development of Standard Medicare Claims Form.--
            (1) In general.--The Secretary of Health and Human Services 
        shall develop, in consultation with representatives of 
        pharmacies and other interested individuals, a 1-page standard 
        claims form (and a standard electronic claims format) to be 
        used in requests for payment for covered outpatient drugs under 
        the medicare program and other third-party payors.
            (2) Distribution.--Not later than October 1, 2000, the 
        Secretary of Health and Human Services shall distribute 
        official sample copies of the form and format developed under 
        paragraph (1) to pharmacies and other interested parties.
    (i) Effective Dates.--
            (1) In general.--Except as otherwise provided, the 
        amendments made by this section shall apply to items dispensed 
        on or after January 1, 2001.
            (2) Carriers.--The amendments made by subsection (e) shall 
        take effect on the date of enactment of this Act, except that 
        the amendments made by subsection (e)(5) shall take effect on 
        January 1, 2002, but shall not be construed as requiring 
        payment before February 1, 2002.
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