|
U.S. Code as of:
01/19/04
Section 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.
(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.
|
|