U.S Code last checked for updates: May 26, 2024
§ 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)), in receiving an immunization with a qualified pediatric vaccine (as defined in subsection (h)(8)) from a program-registered provider (as defined in subsection (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 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
(B)
Special rules where vaccine is unavailable
(C)
Special rules where State is a manufacturer
(i)
Payments in lieu of vaccines
(ii)
Determination of value
(b)
Vaccine-eligible children
For purposes of this section:
(1)
In general
(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)).
(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
1
 So in original. Probably should be capitalized.
plan approved under this subchapter.
(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
(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), 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
(d)
Negotiation of contracts with manufacturers
(1)
In general
(2)
Authority to decline contracts
(3)
Contract price
(A)
In general
(B)
Negotiation of discounted price for current vaccines
(C)
Negotiation of discounted price for new vaccines
(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
(6)
Assuring adequate supply of vaccines
(7)
Multiple suppliers
(e)
Use of pediatric vaccines list
(f)
Requirement of State maintenance of immunization laws
(g)
Termination
(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).
(7)
The term “program-registered provider” has the meaning given such term in subsection (c).
(8)
The term “qualified pediatric vaccine” means a pediatric vaccine with respect to which a contract is in effect under subsection (d).
(9)
The terms “vaccine-eligible child”, “federally vaccine-eligible child”, and “State vaccine-eligible child” have the meaning given such terms in subsection (b).
(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.)
cite as: 42 USC 1396s