---
kind: "section"
citation: "42 U.S.C. § 1396s"
title: "42"
title_heading: "The Public Health and Welfare"
number: "1396s"
heading: "Program for distribution of pediatric vaccines"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/1396s"
units:
  - "Chapter 7 — Social Security"
  - "Subchapter XIX — Grants to States for Medical Assistance Programs"
---

# §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](/usc/42/1396a.md?p=a-62), each [State](/usc/42/619.md?p=5) 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](/usc/42/1382c.md?p=c) (as defined in [subsection (b)](#b)), in receiving an immunization with a qualified pediatric vaccine (as defined in [subsection (h)(8)](#h-8)) from a program-registered provider (as defined in [subsection (c)](#c)) 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](/usc/42/1382c.md?p=c) 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](/usc/42/1301.md?p=a-6) shall provide under [subsection (d)](#d) for the purchase and delivery on behalf of each [State](/usc/42/619.md?p=5) meeting the requirement of [section 1396a(a)(62) of this title](/usc/42/1396a.md?p=a-62) (or, with respect to vaccines administered by an [Indian tribe](/usc/42/619.md?p=4-A) or [tribal organization](/usc/42/619.md?p=4-A) to [Indian](/usc/42/619.md?p=4-A) children, directly to the tribe or organization), without charge to the [State](/usc/42/619.md?p=5), of such quantities of qualified pediatric vaccines as may be necessary for the [administration](/usc/42/1301.md?p=a-10) of such vaccines to all federally vaccine-eligible children in the [State](/usc/42/619.md?p=5) 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](/usc/42/619.md?p=5) of the vaccines (or payment under [subparagraph (C)](#a-2-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)](#d), the [Secretary](/usc/42/1301.md?p=a-6) shall provide for the purchase and delivery of the available vaccine in accordance with priorities established by the [Secretary](/usc/42/1301.md?p=a-6), with priority given to federally vaccine-eligible children unless the [Secretary](/usc/42/1301.md?p=a-6) 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](/usc/42/619.md?p=5) that manufactures a pediatric vaccine the [Secretary](/usc/42/1301.md?p=a-6), instead of providing the vaccine on behalf of a [State](/usc/42/619.md?p=5) under [subparagraph (A)](#a-2-A), shall provide to the [State](/usc/42/619.md?p=5) an amount equal to the value of the quantity of such vaccine that otherwise would have been delivered on behalf of the [State](/usc/42/619.md?p=5) under such subparagraph, but only if the [State](/usc/42/619.md?p=5) 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](/usc/42/619.md?p=5) under [clause (i)](#a-2-C-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)](#d). If more than 1 such contract is in effect, the [Secretary](/usc/42/1301.md?p=a-6) 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](/usc/42/1382c.md?p=c)” means a [child](/usc/42/1382c.md?p=c) who is a federally vaccine-eligible [child](/usc/42/1382c.md?p=c) (as defined in [paragraph (2)](#b-2)) or a [State](/usc/42/619.md?p=5) vaccine-eligible [child](/usc/42/1382c.md?p=c) (as defined in [paragraph (3)](#b-3)).
  - (2) **Federally vaccine-eligible child—**
    - (A) **In general—** The term “federally vaccine-eligible [child](/usc/42/1382c.md?p=c)” means any of the following children:
      - (i) A medicaid-eligible [child](/usc/42/1382c.md?p=c).
      - (ii) A [child](/usc/42/1382c.md?p=c) who is not insured.
      - (iii) A [child](/usc/42/1382c.md?p=c) who (I) is administered a qualified pediatric vaccine by a [federally-qualified health center](/usc/42/1396d.md?p=l-2-B) (as defined in [section 1396d(l)(2)(B)](/usc/42/1396d.md?p=l-2-B) of this title) or a [rural health clinic](/usc/42/1396d.md?p=l-1) (as defined in [section 1396d(l)(1)](/usc/42/1396d.md?p=l-1) of this title), and (II) is not insured with respect to the vaccine.
      - (iv) A [child](/usc/42/1382c.md?p=c) who is an [Indian](/usc/42/619.md?p=4-A) (as defined in [subsection (h)(3)](#h-3)).
    - (B) **Definitions—** In [subparagraph (A)](#b-2-A):
      - (i) The term “medicaid-eligible” means, with respect to a [child](/usc/42/1382c.md?p=c), a [child](/usc/42/1382c.md?p=c) who is entitled to [medical assistance](/usc/42/1396d.md?p=a) under a [state](/usc/42/619.md?p=5)[^1] plan approved under this subchapter.
      - (ii) The term “insured” means, with respect to a [child](/usc/42/1382c.md?p=c)—
        - (I) for purposes of [subparagraph (A)(ii)](#b-2-A-ii), that the [child](/usc/42/1382c.md?p=c) is enrolled under, and entitled to benefits under, a health insurance policy or plan, [including](/usc/42/1301.md?p=b) a [group health plan](/usc/42/1397jj.md?p=c-3), a prepaid [health plan](/usc/42/1320d.md?p=5), or an employee welfare benefit plan under the Employee Retirement Income Security Act of 1974 [[29 U.S.C. 1001](/usc/29/1001.md) et seq.]; and
        - (II) for purposes of subparagraph (A)(iii)(II) with respect to a pediatric vaccine, that the [child](/usc/42/1382c.md?p=c) 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](/usc/42/619.md?p=5) vaccine-eligible [child](/usc/42/1382c.md?p=c)” means, with respect to a [State](/usc/42/619.md?p=5) and a qualified pediatric vaccine, a [child](/usc/42/1382c.md?p=c) who is within a class of children for which the [State](/usc/42/619.md?p=5) is purchasing the vaccine pursuant to [subsection (d)(4)(B)](#d-4-B).
- (c) **Program-registered providers—**
  - (1) **Defined—** In this section, except as otherwise provided, the term “program-registered provider” means, with respect to a [State](/usc/42/619.md?p=5), any [health care provider](/usc/42/1320d.md?p=3) that—
    - (A) is licensed or otherwise authorized for [administration](/usc/42/1301.md?p=a-10) of pediatric vaccines under the law of the [State](/usc/42/619.md?p=5) in which the [administration](/usc/42/1301.md?p=a-10) occurs (subject to [section 254f(e) of this title](/usc/42/254f.md?p=e)), without regard to whether or not the provider participates in the plan under this subchapter;
    - (B) submits to the [State](/usc/42/619.md?p=5) an executed provider agreement described in [paragraph (2)](#c-2); and
    - (C) has not been found, by the [Secretary](/usc/42/1301.md?p=a-6) or the [State](/usc/42/619.md?p=5), to have violated such agreement or other applicable requirements established by the [Secretary](/usc/42/1301.md?p=a-6) or the [State](/usc/42/619.md?p=5) 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](/usc/42/1301.md?p=a-6) may require) that the provider agrees as follows:
    - (A)
      - (i) Before administering a qualified pediatric vaccine to a [child](/usc/42/1382c.md?p=c), the provider will ask a parent of the [child](/usc/42/1382c.md?p=c) such questions as are necessary to determine whether the [child](/usc/42/1382c.md?p=c) is a vaccine-eligible [child](/usc/42/1382c.md?p=c), 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](/usc/42/1301.md?p=a-6), maintain records of responses made to the questions.
      - (iii) The provider will, upon request, make such records available to the [State](/usc/42/619.md?p=5) and to the [Secretary](/usc/42/1301.md?p=a-6), subject to [section 1396a(a)(7) of this title](/usc/42/1396a.md?p=a-7).
    - (B)
      - (i) Subject to [clause (ii)](#c-2-B-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](/usc/42/17061.md?p=2) referred to in [subsection (e)](#e), 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](/usc/42/619.md?p=5) law, [including](/usc/42/1301.md?p=b) any such law relating to any religious or other exemption.
    - (C)
      - (i) In administering a qualified pediatric vaccine to a vaccine-eligible [child](/usc/42/1382c.md?p=c), 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](/usc/42/1382c.md?p=c) for whom an immunization with the vaccine is sought from the provider.
      - (ii) The provider may impose a fee for the [administration](/usc/42/1301.md?p=a-10) of a qualified pediatric vaccine so long as the fee in the case of a federally vaccine-eligible [child](/usc/42/1382c.md?p=c) does not exceed the costs of such [administration](/usc/42/1301.md?p=a-10) (as determined by the [Secretary](/usc/42/1301.md?p=a-6) based on actual regional costs for such [administration](/usc/42/1301.md?p=a-10)).
      - (iii) The provider will not deny [administration](/usc/42/1301.md?p=a-10) of a qualified pediatric vaccine to a vaccine-eligible [child](/usc/42/1382c.md?p=c) due to the inability of the [child](/usc/42/1382c.md?p=c)’s parent to pay an [administration](/usc/42/1301.md?p=a-10) fee.
  - (3) **Encouraging involvement of providers—** Each program under this section shall provide, in accordance with criteria established by the [Secretary](/usc/42/1301.md?p=a-6)—
    - (A) for encouraging the following to become program-registered providers: private [health care providers](/usc/42/1320d.md?p=3), the [Indian](/usc/42/619.md?p=4-A) Health Service, [health care providers](/usc/42/1320d.md?p=3) that receive funds under title V of the [Indian](/usc/42/619.md?p=4-A) Health Care Improvement Act [[25 U.S.C. 1651](/usc/25/1651.md) et seq.], and health programs or [facilities](/usc/42/1320a–3.md?p=c-5-B) operated by [Indian tribes](/usc/42/619.md?p=4-A) or [tribal organizations](/usc/42/619.md?p=4-A); 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](/usc/42/1301.md?p=a-6) may permit in order to prevent fraud and [abuse](/usc/42/1397j.md?p=1) and for related purposes, a [State](/usc/42/619.md?p=5) may not impose additional qualifications or conditions, in addition to the requirements of [paragraph (1)](#c-1), in order that a provider qualify as a program-registered provider under this section. This subsection does not limit the exercise of [State](/usc/42/619.md?p=5) authority under [section 1396n(b) of this title](/usc/42/1396n.md?p=b).
- (d) **Negotiation of contracts with manufacturers—**
  - (1) **In general—** For the purpose of meeting obligations under this section, the [Secretary](/usc/42/1301.md?p=a-6) 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](/usc/42/1301.md?p=a-6) to purchase vaccines. The [Secretary](/usc/42/1301.md?p=a-6) 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)](#a-2-A).
  - (2) **Authority to decline contracts—** The [Secretary](/usc/42/1301.md?p=a-6) may decline to enter into such contracts and may modify or extend such contracts.
  - (3) **Contract price—**
    - (A) **In general—** The [Secretary](/usc/42/1301.md?p=a-6), 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](/usc/42/619.md?p=5) under the option under [paragraph (4)(B)](#d-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](/usc/42/247b.md?p=j-1) as of May 1, 1993, no price for the purchase of such vaccine for vaccine-eligible children shall be agreed to by the [Secretary](/usc/42/1301.md?p=a-6) under this subsection if the price per dose of such vaccine ([including](/usc/42/1301.md?p=b) 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](/usc/42/1301.md?p=a-2) 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)](#d-3-B), the price for the purchase of such vaccine shall be a discounted price negotiated by the [Secretary](/usc/42/1301.md?p=a-6) that may be established without regard to such subparagraph.
  - (4) **Quantities and terms of delivery—** Under such contracts—
    - (A) the [Secretary](/usc/42/1301.md?p=a-6) shall provide, consistent with [paragraph (6)](#d-6), for the purchase and delivery on behalf of [States](/usc/42/619.md?p=5) (and tribes and [tribal organizations](/usc/42/619.md?p=4-A)) of quantities of pediatric vaccines for federally vaccine-eligible children; and
    - (B) each [State](/usc/42/619.md?p=5), at the option of the [State](/usc/42/619.md?p=5), shall be permitted to obtain additional quantities of pediatric vaccines (subject to amounts specified to the [Secretary](/usc/42/1301.md?p=a-6) by the [State](/usc/42/619.md?p=5) in advance of negotiations) through purchasing the vaccines from the manufacturers at the applicable price negotiated by the [Secretary](/usc/42/1301.md?p=a-6) consistent with [paragraph (3)](#d-3), if (i) the [State](/usc/42/619.md?p=5) agrees that the vaccines will be used to provide immunizations only for children who are not federally vaccine-eligible children and (ii) the [State](/usc/42/619.md?p=5) provides to the [Secretary](/usc/42/1301.md?p=a-6) such information (at a time and manner specified by the [Secretary](/usc/42/1301.md?p=a-6), [including](/usc/42/1301.md?p=b) in advance of negotiations under [paragraph (1)](#d-1)) as the [Secretary](/usc/42/1301.md?p=a-6) determines to be necessary, to provide for quantities of pediatric vaccines for the [State](/usc/42/619.md?p=5) 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](/usc/42/1301.md?p=a-6) 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](/usc/42/1301.md?p=a-6) may enter into a contract referred to in [paragraph (1)](#d-1) only if the manufacturer involved agrees to submit to the [Secretary](/usc/42/1301.md?p=a-6) such reports as the [Secretary](/usc/42/1301.md?p=a-6) determines to be appropriate to assure compliance with the contract and if, with respect to a [State](/usc/42/619.md?p=5) 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](/usc/42/619.md?p=5) 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)](#d-3)).
  - (6) **Assuring adequate supply of vaccines—** The [Secretary](/usc/42/1301.md?p=a-6), in negotiations under [paragraph (1)](#d-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](/usc/42/1301.md?p=a-6) shall negotiate for a 6-month supply of vaccines in addition to the quantity that the [Secretary](/usc/42/1301.md?p=a-6) otherwise would provide for in such negotiations. In carrying out this paragraph, the [Secretary](/usc/42/1301.md?p=a-6) 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](/usc/42/1301.md?p=a-6) shall, as appropriate, enter into a contract referred to in [paragraph (1)](#d-1) with each manufacturer of the vaccine that meets the terms and conditions of the [Secretary](/usc/42/1301.md?p=a-6) for an award of such a contract ([including](/usc/42/1301.md?p=b) terms and conditions regarding safety and quality). With respect to multiple contracts entered into pursuant to this paragraph, the [Secretary](/usc/42/1301.md?p=a-6) may have in effect different prices under each of such contracts and, with respect to a purchase by [States](/usc/42/619.md?p=5) pursuant to [paragraph (4)(B)](#d-4-B), the [Secretary](/usc/42/1301.md?p=a-6) shall determine which of such contracts will be applicable to the purchase.
- (e) **Use of pediatric vaccines list—** The [Secretary](/usc/42/1301.md?p=a-6) shall use, for the purpose of the purchase, delivery, and [administration](/usc/42/1301.md?p=a-10) of pediatric vaccines under this section, the list established (and periodically reviewed and as appropriate revised) by the [Advisory Committee](/usc/42/17061.md?p=2) on Immunization [Practices](/usc/42/17061.md?p=19) (an [advisory committee](/usc/42/17061.md?p=2) established by the [Secretary](/usc/42/1301.md?p=a-6), acting through the [Director](/usc/42/11851.md?p=5) of the Centers for Disease Control and Prevention).
- (f) **Requirement of State maintenance of immunization laws—** In the case of a [State](/usc/42/619.md?p=5) 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](/usc/42/619.md?p=5) program under this section does not comply with the requirements of this section unless the [State](/usc/42/619.md?p=5) certifies to the [Secretary](/usc/42/1301.md?p=a-6) that the [State](/usc/42/619.md?p=5) 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](/usc/42/1396a.md?p=a-62), 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](/usc/42/1382c.md?p=c)” 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](/usc/42/619.md?p=4-A)”, “[Indian tribe](/usc/42/619.md?p=4-A)” and “[tribal organization](/usc/42/619.md?p=4-A)” have the meanings given such terms in section 4 of the [Indian](/usc/42/619.md?p=4-A) Health Care Improvement Act [[25 U.S.C. 1603](/usc/25/1603.md)].
  - (4) The term “manufacturer” means any [corporation](/usc/42/1301.md?p=a-4), organization, or institution, whether public or private ([including](/usc/42/1301.md?p=b) Federal, [State](/usc/42/619.md?p=5), and local departments, [agencies](/usc/42/1397n–12.md?p=1), 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](/usc/42/1301.md?p=b), with respect to a [child](/usc/42/1382c.md?p=c), an individual who qualifies as a legal guardian under [State](/usc/42/619.md?p=5) law.
  - (6) The term “pediatric vaccine” means a vaccine included on the list under [subsection (e)](#e).
  - (7) The term “program-registered provider” has the meaning given such term in [subsection (c)](#c).
  - (8) The term “qualified pediatric vaccine” means a pediatric vaccine with respect to which a contract is in effect under [subsection (d)](#d).
  - (9) The terms “vaccine-eligible [child](/usc/42/1382c.md?p=c)”, “federally vaccine-eligible [child](/usc/42/1382c.md?p=c)”, and “[State](/usc/42/619.md?p=5) vaccine-eligible [child](/usc/42/1382c.md?p=c)” have the meaning given such terms in [subsection (b)](#b).

## Footnotes

[^1]: So in original. Probably should be capitalized.

## Source credit

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

## Notes

### Editorial Notes

### 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, which is classified principally to chapter 18 (§ 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. Title V of the Act is classified generally to subchapter IV (§ 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, § 1928, formerly § 1920, as added Apr. 7, 1986, Pub. L. 99–272, title IX, § 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, § 13631(b)(1), Aug. 10, 1993, 107 Stat. 637, and transferred to section 1396v of this title.

### Statutory Notes and Related Subsidiaries

### 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.