
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 23, 2000]
[Document not affected by Public Laws enacted between
  January 23, 2000 and December 4, 2001]
[CITE: 42USC1396s]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                       CHAPTER 7--SOCIAL SECURITY
 
    SUBCHAPTER XIX--GRANTS TO STATES FOR MEDICAL ASSISTANCE PROGRAMS
 
Sec. 1396s. Program for distribution of pediatric vaccines


(a) Establishment of program

                           (1) In general

        In order to meet the requirement of section 1396a(a)(62) of this 
    title, each State shall establish a pediatric vaccine distribution 
    program (which may be administered by the State department of 
    health), consistent with the requirements of this section, under 
    which--
            (A) each vaccine-eligible child (as defined in subsection 
        (b) of this section), in receiving an immunization with a 
        qualified pediatric vaccine (as defined in subsection (h)(8) of 
        this section) from a program-registered provider (as defined in 
        subsection (c) of this section) on or after October 1, 1994, is 
        entitled to receive the immunization without charge for the cost 
        of such vaccine; and
            (B)(i) each program-registered provider who administers such 
        a pediatric vaccine to a vaccine-eligible child on or after such 
        date is entitled to receive such vaccine under the program 
        without charge either for the vaccine or its delivery to the 
        provider, and (ii) no vaccine is distributed under the program 
        to a provider unless the provider is a program-registered 
        provider.

    (2) Delivery of sufficient quantities of pediatric vaccines 
               to immunize federally vaccine-eligible children

        (A) In general

            The Secretary shall provide under subsection (d) of this 
        section for the purchase and delivery on behalf of each State 
        meeting the requirement of section 1396a(a)(62) of this title 
        (or, with respect to vaccines administered by an Indian tribe or 
        tribal organization to Indian children, directly to the tribe or 
        organization), without charge to the State, of such quantities 
        of qualified pediatric vaccines as may be necessary for the 
        administration of such vaccines to all federally vaccine-
        eligible children in the State on or after October 1, 1994. This 
        paragraph constitutes budget authority in advance of 
        appropriations Acts, and represents the obligation of the 
        Federal Government to provide for the purchase and delivery to 
        States of the vaccines (or payment under subparagraph (C)) in 
        accordance with this paragraph.

        (B) Special rules where vaccine is unavailable

            To the extent that a sufficient quantity of a vaccine is not 
        available for purchase or delivery under subsection (d) of this 
        section, the Secretary shall provide for the purchase and 
        delivery of the available vaccine in accordance with priorities 
        established by the Secretary, with priority given to federally 
        vaccine-eligible children unless the Secretary finds there are 
        other public health considerations.

        (C) Special rules where State is a manufacturer

            (i) Payments in lieu of vaccines

                In the case of a State that manufactures a pediatric 
            vaccine the Secretary, instead of providing the vaccine on 
            behalf of a State under subparagraph (A), shall provide to 
            the State an amount equal to the value of the quantity of 
            such vaccine that otherwise would have been delivered on 
            behalf of the State under such subparagraph, but only if the 
            State agrees that such payments will only be used for 
            purposes relating to pediatric immunizations.
            (ii) Determination of value

                In determining the amount to pay a State under clause 
            (i) with respect to a pediatric vaccine, the value of the 
            quantity of vaccine shall be determined on the basis of the 
            price in effect for the qualified pediatric vaccine under 
            contracts under subsection (d) of this section. If more than 
            1 such contract is in effect, the Secretary shall determine 
            such value on the basis of the average of the prices under 
            the contracts, after weighting each such price in relation 
            to the quantity of vaccine under the contract involved.

(b) Vaccine-eligible children

    For purposes of this section:

                           (1) In general

        The term ``vaccine-eligible child'' means a child who is a 
    federally vaccine-eligible child (as defined in paragraph (2)) or a 
    State vaccine-eligible child (as defined in paragraph (3)).

                (2) Federally vaccine-eligible child

        (A) In general

            The term ``federally vaccine-eligible child'' means any of 
        the following children:
                (i) A medicaid-eligible child.
                (ii) A child who is not insured.
                (iii) A child who (I) is administered a qualified 
            pediatric vaccine by a federally-qualified health center (as 
            defined in section 1396d(l)(2)(B) of this title) or a rural 
            health clinic (as defined in section 1396d(l)(1) of this 
            title), and (II) is not insured with respect to the vaccine.
                (iv) A child who is an Indian (as defined in subsection 
            (h)(3) of this section).

        (B) Definitions

            In subparagraph (A):
                (i) The term ``medicaid-eligible'' means, with respect 
            to a child, a child who is entitled to medical assistance 
            under a state \1\ plan approved under this subchapter.
---------------------------------------------------------------------------
    \1\ So in original. Probably should be capitalized.
---------------------------------------------------------------------------
                (ii) The term ``insured'' means, with respect to a 
            child--
                    (I) for purposes of subparagraph (A)(ii), that the 
                child is enrolled under, and entitled to benefits under, 
                a health insurance policy or plan, including a group 
                health plan, a prepaid health plan, or an employee 
                welfare benefit plan under the Employee Retirement 
                Income Security Act of 1974 [29 U.S.C. 1001 et seq.]; 
                and
                    (II) for purposes of subparagraph (A)(iii)(II) with 
                respect to a pediatric vaccine, that the child is 
                entitled to benefits under such a health insurance 
                policy or plan, but such benefits are not available with 
                respect to the cost of the pediatric vaccine.

                  (3) State vaccine-eligible child

        The term ``State vaccine-eligible child'' means, with respect to 
    a State and a qualified pediatric vaccine, a child who is within a 
    class of children for which the State is purchasing the vaccine 
    pursuant to subsection (d)(4)(B) of this section.

(c) Program-registered providers

                             (1) Defined

        In this section, except as otherwise provided, the term 
    ``program-registered provider'' means, with respect to a State, any 
    health care provider that--
            (A) is licensed or otherwise authorized for administration 
        of pediatric vaccines under the law of the State in which the 
        administration occurs (subject to section 254f(e) of this 
        title), without regard to whether or not the provider 
        participates in the plan under this subchapter;
            (B) submits to the State an executed provider agreement 
        described in paragraph (2); and
            (C) has not been found, by the Secretary or the State, to 
        have violated such agreement or other applicable requirements 
        established by the Secretary or the State consistent with this 
        section.

                       (2) Provider agreement

        A provider agreement for a provider under this paragraph is an 
    agreement (in such form and manner as the Secretary may require) 
    that the provider agrees as follows:
            (A)(i) Before administering a qualified pediatric vaccine to 
        a child, the provider will ask a parent of the child such 
        questions as are necessary to determine whether the child is a 
        vaccine-eligible child, but the provider need not independently 
        verify the answers to such questions.
            (ii) The provider will, for a period of time specified by 
        the Secretary, maintain records of responses made to the 
        questions.
            (iii) The provider will, upon request, make such records 
        available to the State and to the Secretary, subject to section 
        1396a(a)(7) of this title.
            (B)(i) Subject to clause (ii), the provider will comply with 
        the schedule, regarding the appropriate periodicity, dosage, and 
        contraindications applicable to pediatric vaccines, that is 
        established and periodically reviewed and, as appropriate, 
        revised by the advisory committee referred to in subsection (e) 
        of this section, except in such cases as, in the provider's 
        medical judgment subject to accepted medical practice, such 
        compliance is medically inappropriate.
            (ii) The provider will provide pediatric vaccines in 
        compliance with applicable State law, including any such law 
        relating to any religious or other exemption.
            (C)(i) In administering a qualified pediatric vaccine to a 
        vaccine-eligible child, the provider will not impose a charge 
        for the cost of the vaccine. A program-registered provider is 
        not required under this section to administer such a vaccine to 
        each child for whom an immunization with the vaccine is sought 
        from the provider.
            (ii) The provider may impose a fee for the administration of 
        a qualified pediatric vaccine so long as the fee in the case of 
        a federally vaccine-eligible child does not exceed the costs of 
        such administration (as determined by the Secretary based on 
        actual regional costs for such administration).
            (iii) The provider will not deny administration of a 
        qualified pediatric vaccine to a vaccine-eligible child due to 
        the inability of the child's parent to pay an administration 
        fee.

              (3) Encouraging involvement of providers

        Each program under this section shall provide, in accordance 
    with criteria established by the Secretary--
            (A) for encouraging the following to become program-
        registered providers: private health care providers, the Indian 
        Health Service, health care providers that receive funds under 
        title V of the Indian Health Care Improvement Act [25 U.S.C. 
        1651 et seq.], and health programs or facilities operated by 
        Indian tribes or tribal organizations; and
            (B) for identifying, with respect to any population of 
        vaccine-eligible children a substantial portion of whose parents 
        have a limited ability to speak the English language, those 
        program-registered providers who are able to communicate with 
        the population involved in the language and cultural context 
        that is most appropriate.

                       (4) State requirements

        Except as the Secretary may permit in order to prevent fraud and 
    abuse and for related purposes, a State may not impose additional 
    qualifications or conditions, in addition to the requirements of 
    paragraph (1), in order that a provider qualify as a program-
    registered provider under this section. This subsection does not 
    limit the exercise of State authority under section 1396n(b) of this 
    title.

(d) Negotiation of contracts with manufacturers

                           (1) In general

        For the purpose of meeting obligations under this section, the 
    Secretary shall negotiate and enter into contracts with 
    manufacturers of pediatric vaccines consistent with the requirements 
    of this subsection and, to the maximum extent practicable, 
    consolidate such contracting with any other contracting activities 
    conducted by the Secretary to purchase vaccines. The Secretary may 
    enter into such contracts under which the Federal Government is 
    obligated to make outlays, the budget authority for which is not 
    provided for in advance in appropriations Acts, for the purchase and 
    delivery of pediatric vaccines under subsection (a)(2)(A) of this 
    section.

                 (2) Authority to decline contracts

        The Secretary may decline to enter into such contracts and may 
    modify or extend such contracts.

                         (3) Contract price

        (A) In general

            The Secretary, in negotiating the prices at which pediatric 
        vaccines will be purchased and delivered from a manufacturer 
        under this subsection, shall take into account quantities of 
        vaccines to be purchased by States under the option under 
        paragraph (4)(B).

        (B) Negotiation of discounted price for current vaccines

            With respect to contracts entered into under this subsection 
        for a pediatric vaccine for which the Centers for Disease 
        Control and Prevention has a contract in effect under section 
        247b(j)(1) of this title as of May 1, 1993, no price for the 
        purchase of such vaccine for vaccine-eligible children shall be 
        agreed to by the Secretary under this subsection if the price 
        per dose of such vaccine (including delivery costs and any 
        applicable excise tax established under section 4131 of the 
        Internal Revenue Code of 1986) exceeds the price per dose for 
        the vaccine in effect under such a contract as of such date 
        increased by the percentage increase in the consumer price index 
        for all urban consumers (all items; United States city average) 
        from May 1993 to the month before the month in which such 
        contract is entered into.

        (C) Negotiation of discounted price for new vaccines

            With respect to contracts entered into for a pediatric 
        vaccine not described in subparagraph (B), the price for the 
        purchase of such vaccine shall be a discounted price negotiated 
        by the Secretary that may be established without regard to such 
        subparagraph.

                (4) Quantities and terms of delivery

        Under such contracts--
            (A) the Secretary shall provide, consistent with paragraph 
        (6), for the purchase and delivery on behalf of States (and 
        tribes and tribal organizations) of quantities of pediatric 
        vaccines for federally vaccine-eligible children; and
            (B) each State, at the option of the State, shall be 
        permitted to obtain additional quantities of pediatric vaccines 
        (subject to amounts specified to the Secretary by the State in 
        advance of negotiations) through purchasing the vaccines from 
        the manufacturers at the applicable price negotiated by the 
        Secretary consistent with paragraph (3), if (i) the State agrees 
        that the vaccines will be used to provide immunizations only for 
        children who are not federally vaccine-eligible children and 
        (ii) the State provides to the Secretary such information (at a 
        time and manner specified by the Secretary, including in advance 
        of negotiations under paragraph (1)) as the Secretary determines 
        to be necessary, to provide for quantities of pediatric vaccines 
        for the State to purchase pursuant to this subsection and to 
        determine annually the percentage of the vaccine market that is 
        purchased pursuant to this section and this subparagraph.

    The Secretary shall enter into the initial negotiations under the 
    preceding sentence not later than 180 days after August 10, 1993.

                (5) Charges for shipping and handling

        The Secretary may enter into a contract referred to in paragraph 
    (1) only if the manufacturer involved agrees to submit to the 
    Secretary such reports as the Secretary determines to be appropriate 
    to assure compliance with the contract and if, with respect to a 
    State program under this section that does not provide for the 
    direct delivery of qualified pediatric vaccines, the manufacturer 
    involved agrees that the manufacturer will provide for the delivery 
    of the vaccines on behalf of the State in accordance with such 
    program and will not impose any charges for the costs of such 
    delivery (except to the extent such costs are provided for in the 
    price established under paragraph (3)).

              (6) Assuring adequate supply of vaccines

        The Secretary, in negotiations under paragraph (1), shall 
    negotiate for quantities of pediatric vaccines such that an adequate 
    supply of such vaccines will be maintained to meet unanticipated 
    needs for the vaccines. For purposes of the preceding sentence, the 
    Secretary shall negotiate for a 6-month supply of vaccines in 
    addition to the quantity that the Secretary otherwise would provide 
    for in such negotiations. In carrying out this paragraph, the 
    Secretary shall consider the potential for outbreaks of the diseases 
    with respect to which the vaccines have been developed.

                       (7) Multiple suppliers

        In the case of the pediatric vaccine involved, the Secretary 
    shall, as appropriate, enter into a contract referred to in 
    paragraph (1) with each manufacturer of the vaccine that meets the 
    terms and conditions of the Secretary for an award of such a 
    contract (including terms and conditions regarding safety and 
    quality). With respect to multiple contracts entered into pursuant 
    to this paragraph, the Secretary may have in effect different prices 
    under each of such contracts and, with respect to a purchase by 
    States pursuant to paragraph (4)(B), the Secretary shall determine 
    which of such contracts will be applicable to the purchase.

(e) Use of pediatric vaccines list

    The Secretary shall use, for the purpose of the purchase, delivery, 
and administration of pediatric vaccines under this section, the list 
established (and periodically reviewed and as appropriate revised) by 
the Advisory Committee on Immunization Practices (an advisory committee 
established by the Secretary, acting through the Director of the Centers 
for Disease Control and Prevention).

(f) Requirement of State maintenance of immunization laws

    In the case of a State that had in effect as of May 1, 1993, a law 
that requires some or all health insurance policies or plans to provide 
some coverage with respect to a pediatric vaccine, a State program under 
this section does not comply with the requirements of this section 
unless the State certifies to the Secretary that the State has not 
modified or repealed such law in a manner that reduces the amount of 
coverage so required.

(g) Termination

    This section, and the requirement of section 1396a(a)(62) of this 
title, shall cease to be in effect beginning on such date as may be 
prescribed in Federal law providing for immunization services for all 
children as part of a broad-based reform of the national health care 
system.

(h) Definitions

    For purposes of this section:
        (1) The term ``child'' means an individual 18 years of age or 
    younger.
        (2) The term ``immunization'' means an immunization against a 
    vaccine-preventable disease.
        (3) The terms ``Indian'', ``Indian tribe'' and ``tribal 
    organization'' have the meanings given such terms in section 4 of 
    the Indian Health Care Improvement Act [25 U.S.C. 1603].
        (4) The term ``manufacturer'' means any corporation, 
    organization, or institution, whether public or private (including 
    Federal, State, and local departments, agencies, and 
    instrumentalities), which manufactures, imports, processes, or 
    distributes under its label any pediatric vaccine. The term 
    ``manufacture'' means to manufacture, import, process, or distribute 
    a vaccine.
        (5) The term ``parent'' includes, with respect to a child, an 
    individual who qualifies as a legal guardian under State law.
        (6) The term ``pediatric vaccine'' means a vaccine included on 
    the list under subsection (e) of this section.
        (7) The term ``program-registered provider'' has the meaning 
    given such term in subsection (c) of this section.
        (8) The term ``qualified pediatric vaccine'' means a pediatric 
    vaccine with respect to which a contract is in effect under 
    subsection (d) of this section.
        (9) The terms ``vaccine-eligible child'', ``federally vaccine-
    eligible child'', and ``State vaccine-eligible child'' have the 
    meaning given such terms in subsection (b) of this section.

(Aug. 14, 1935, ch. 531, title XIX, Sec. 1928, as added Pub. L. 103-66, 
title XIII, Sec. 13631(b)(2), Aug. 10, 1993, 107 Stat. 637.)

                       References in Text

    The Employee Retirement Income Security Act of 1974, referred to in 
subsec. (b)(2)(B)(ii)(I), is Pub. L. 93-406, Sept. 2, 1974, 88 Stat. 
829, as amended, which is classified principally to chapter 18 
(Sec. 1001 et seq.) of Title 29, Labor. For complete classification of 
this Act to the Code, see Short Title note set out under section 1001 of 
Title 29 and Tables.
    The Indian Health Care Improvement Act, referred to in subsec. 
(c)(3)(A), is Pub. L. 94-437, Sept. 30, 1976, 90 Stat. 1400, as amended. 
Title V of the Act is classified generally to subchapter IV (Sec. 1651 
et seq.) of chapter 18 of Title 25, Indians. For complete classification 
of this Act to the Code, see Short Title note set out under section 1601 
of Title 25 and Tables.
    The Internal Revenue Code of 1986, referred to in subsec. (d)(3)(B), 
is classified generally to Title 26, Internal Revenue Code.


                            Prior Provisions

    A prior section 1396s, act Aug. 14, 1935, ch. 531, title XIX, 
Sec. 1928, formerly Sec. 1920, as added Apr. 7, 1986, Pub. L. 99-272, 
title IX, Sec. 9526, 100 Stat. 218, and renumbered and amended, which 
related to references to laws directly affecting medicaid program, was 
renumbered section 1931 of act Aug. 14, 1935, by Pub. L. 103-66, title 
XIII, Sec. 13631(b)(1), Aug. 10, 1993, 107 Stat. 637, and transferred to 
section 1396v of this title.


                             Effective Date

    Section applicable to payments under State plans approved under this 
subchapter for calendar quarters beginning on or after Oct. 1, 1994, see 
section 13631(i) of Pub. L. 103-66, set out as an Effective Date of 1993 
Amendment note under section 1396a of this title.

                  Section Referred to in Other Sections

    This section is referred to in sections 300gg, 1396a, 1396b, 1396d 
of this title; title 26 section 9801; title 29 sections 1169, 1181.
