I 
109TH CONGRESS 
1ST SESSION H. R. 3502
To amend the Public Health Service Act with respect to immunizations 
against vaccine-preventable diseases, including influenza, and for other 
purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 28, 2005
Mr. WAXMAN (for himself, Mr. BROWN of Ohio, and Ms. ROYBAL-ALLARD) 
introduced the following bill; which was referred to the Committee on En-
ergy and Commerce, and in addition to the Committees on Ways and 
Means and Education and the Workforce, for a period to be subsequently 
determined by the Speaker, in each case for consideration of such provi-
sions as fall within the jurisdiction of the committee concerned 
A BILL 
To amend the Public Health Service Act with respect to 
immunizations against vaccine-preventable diseases, in-
cluding influenza, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Vaccine Access and 
Supply Act’’.
SEC. 2. CERTAIN AUTHORITIES REGARDING INFLUENZA 
AND OTHER VACCINES. 
(a) IN GENERAL.—Part B of title III of the Public 
Health Service Act (42 U.S.C. 243 et seq.) is amended—
(1) by redesignating section 317A as section 
317A–1; and 
(2) by inserting after section 317 the following 
section: 
‘‘SEC. 317A. CERTAIN AUTHORITIES REGARDING INFLU-
ENZA AND OTHER VACCINES. 
‘‘(a) PURCHASE OF UNSOLD DOSES OF PERIODIC-
CHANGE VACCINES.—
‘‘(1) PRODUCER-SPECIFIC
NEGOTIATION
ON 
SUPPLY FOR SEASON.—In the case of influenza vac-
cine and each other periodic-change vaccine, the Sec-
retary shall, for each applicable vaccine season, ne-
gotiate with each producer of the vaccine to reach an 
agreement on the number of doses of the vaccine 
that the producer will manufacture for such season. 
The Secretary is not required under the preceding 
sentence to enter into such an agreement with any 
producer. 
‘‘(2) PURCHASE OF PERCENTAGE OF UNSOLD 
DOSES.—With respect to the number of doses of a 
periodic-change vaccine manufactured for an appli-
cable vaccine season by a producer in accordance
with an agreement under paragraph (1), the Sec-
retary shall purchase from the producer 50 percent 
of such doses that are unsold for the season. 
‘‘(3) PRICE PER DOSE.—
‘‘(A) AVERAGE SALES PRICE.—Subject to 
subparagraph (B), the price per dose paid by 
the Secretary in a purchase of periodic-change 
vaccine under paragraph (2) shall be the aver-
age sales price for the vaccine for the applicable 
vaccine season, as determined by the Secretary. 
‘‘(B) AUDITS; ADJUSTMENTS.—The Sec-
retary may enter into an agreement under para-
graph (1) with a producer regarding a periodic-
change vaccine only if the agreement includes a 
provision that permits the Secretary to conduct 
audits of sales of such vaccine at wholesale by 
the producer. The average sales price deter-
mined under subparagraph (A) for a dose of 
the vaccine for an applicable vaccine season 
shall be adjusted by the Secretary as deter-
mined necessary by the Secretary on the basis 
of such audits and on the basis of any other in-
formation available to the Secretary on sales of 
the vaccine at wholesale.
‘‘(4) DEFINITIONS.—For purposes of this sec-
tion: 
‘‘(A) The term ‘periodic-change vaccine’ 
means a federally recommended vaccine (as de-
fined in subsection (g)) that is designed only for 
a single applicable vaccine season due to char-
acteristics of the etiologic agent or agents for 
the disease involved, or due to characteristics of 
the vaccine, that adversely affect the extent to 
which the vaccine is safe and effective after 
such season. Such term includes influenza vac-
cine. 
‘‘(B) The term ‘producer’ means a person 
who—
‘‘(i) manufactures an approved vac-
cine (as defined in subsection (g)); or 
‘‘(ii) who intends to manufacture such 
a vaccine and is determined by the Sec-
retary to have the capacity to meet legal 
requirements applicable to such manufac-
turing. 
‘‘(C)(i) The term ‘vaccine season’, with re-
spect to a periodic-change vaccine, means a 
consecutive number of months, not exceeding 
24 months, during which the Secretary rec-
ommends that the public in general, or par-
ticular populations, as the case may be, receive 
immunizations against the disease involved. 
‘‘(ii) The term ‘applicable vaccine season’, 
with respect to a periodic-change vaccine, 
means the vaccine season that is applicable to 
such vaccine. 
‘‘(5) DIRECT
SPENDING.—The requirement 
under paragraph (2) that the Secretary make pur-
chases of doses of periodic-change vaccine con-
stitutes budget authority in advance of appropria-
tions Acts, and represents the obligation of the 
United States to make outlays for such purchases in 
accordance with this subsection. 
‘‘(b) 
IMMUNIZATION
PROGRAM
FOR
ELIGIBLE 
ADULTS.—
‘‘(1) IN GENERAL.—The Secretary shall by reg-
ulation establish a program for the distribution of 
qualified adult vaccines through States with ap-
proved applications under paragraph (4)(C), under 
which program—
‘‘(A) each vaccine-eligible adult, in receiv-
ing an immunization with a qualified adult vac-
cine from a program-registered provider on or 
after October 1, 2006, 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 vaccine to a vaccine-eli-
gible adult 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) RELATIONSHIP
TO
PROGRAM
FOR
DIS-
TRIBUTION
OF
PEDIATRIC
VACCINES.—The provi-
sions of the program under section 1928 of the So-
cial Security Act (including provisions taking effect 
on or after the effective date of this section) apply 
with respect to immunizations for vaccine-eligible 
adults under the program under paragraph (1) to 
the same extent and in the same manner as such 
provisions apply with respect to immunizations for 
vaccine-eligible children under the program under 
such section 1928, except to the extent that such a 
provision conflicts with this subsection. The pre-
ceding section may not be construed as having any 
effect on the program under title XIX of the Social
Security Act, or as having the effect that, in the pro-
gram under paragraph (1), State plans comparable 
to State plans under section 1902 of such Act are 
required. 
‘‘(3) VACCINE-ELIGIBLE ADULT.—
‘‘(A) IN GENERAL.—For purposes of this 
subsection, the term ‘vaccine-eligible adult’ 
means a federally vaccine-eligible adult or a 
State vaccine-eligible adult. 
‘‘(B) 
FEDERALLY
VACCINE-ELIGIBLE 
ADULT.—For purposes of this subsection, the 
term ‘federally vaccine-eligible adult’ means 
each of the following: 
‘‘(i) An adult who is not insured. 
‘‘(ii) An adult who—
‘‘(I) is administered a qualified 
adult vaccine by a Federally-qualified 
health center (as defined in section 
1905(l)(2)(B)) of the Social Security 
Act), by any other entity that is a cov-
ered entity under section 340B(a)(4), 
or by any public clinic; and 
‘‘(II) is not insured with respect 
to the vaccine. 
‘‘(iii) An adult who—
‘‘(I) is administered a qualified 
adult vaccine while incarcerated in a 
Federal, State, or local penal or cor-
rectional 
institution, 
including 
an 
adult who is held pending judicial or 
administrative proceedings; and 
‘‘(II) is not insured with respect 
to the vaccine. 
‘‘(C) STATE VACCINE-ELIGIBLE ADULT.—
For purposes of this subsection, the term ‘State 
vaccine-eligible adult’ means, with respect to a 
State and a qualified adult vaccine, an adult 
who is within a class of adults for which the 
State is purchasing the vaccine pursuant to 
provisions that apply pursuant to paragraph 
(2). 
‘‘(4) PARTICIPATION OF STATES.—
‘‘(A) IN GENERAL.—In the case or each 
State with an approved application under sub-
paragraph (C), the Secretary shall provide, in 
accordance with provisions that apply pursuant 
to paragraph (2), for the purchase and delivery 
on behalf of the State, without charge to the 
State, of such quantities of qualified adult vac-
cines as may be necessary for the administra-
tion of such vaccines to all vaccine-eligible 
adults in the State on or after October 1, 2006. 
‘‘(B) PROGRAM CRITERIA.—The Secretary, 
in accordance with provisions that apply pursu-
ant to paragraph (2), shall establish criteria for 
State programs under paragraph (1). 
‘‘(C) STATE APPLICATION.—A State may 
participate in the program under paragraph (1) 
only if the State submits to the Secretary an 
application for such participation. The Sec-
retary shall approve any such application 
that—
‘‘(i) is submitted in such form and 
such manner as the Secretary may require; 
and 
‘‘(ii) demonstrates that the State is in 
compliance with criteria under subpara-
graph (B). 
‘‘(5) ADDITIONAL DEFINITIONS.—For purposes 
of this subsection: 
‘‘(A) The term ‘adult’ means an individual 
who is not a child as defined in section 1928 of 
the Social Security Act. 
‘‘(B) The term ‘adult vaccine’ means a fed-
erally recommended vaccine for adults.
‘‘(C)(i) The term ‘insured’, with respect to 
an adult, means that the adult 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 em-
ployee welfare benefit plan under the Employee 
Retirement Income Security Act of 1974. 
‘‘(ii) An adult is not insured with respect 
to a qualified adult vaccine if the adult is enti-
tled to benefits under such a health insurance 
policy or plan, but such benefits are not avail-
able with respect to the cost of such vaccine. 
‘‘(D) The term ‘qualified adult vaccine’ 
means an adult vaccine with respect to which a 
contract is in effect pursuant to provisions that 
apply pursuant to paragraph (2). 
‘‘(6) DIRECT
SPENDING.—The requirement 
under paragraph (1) that the Secretary carry out a 
program constitutes budget authority in advance of 
appropriations Acts, and represents the obligation of 
the Federal Government to make outlays to provide 
for immunizations of vaccine-eligible adults in ac-
cordance with this subsection, including with respect 
to program-registered providers and with respect to
the purchase and delivery of qualified adult vaccines 
on behalf of States. 
‘‘(c) INFORMATION ON LOCATION OF SUPPLIES OF 
VACCINES; EMERGENCY AUTHORITY OF SECRETARY.—
‘‘(1) IN GENERAL.—If the Secretary publishes 
in the Federal Register a declaration that there is 
a shortage of an approved vaccine that constitutes a 
public health emergency, each person who is a man-
ufacturer or distributor of the vaccine shall provide 
to the Secretary such information as the Secretary 
may require with respect to the location of supplies 
of the vaccine, including supplies in the possession 
of the person, supplies scheduled to be received by 
the person, and supplies sold by the person. Any 
such person who fails to comply with an order of the 
Secretary under the preceding sentence is liable to 
the United States for a civil penalty not exceeding 
$1,000 for each day for which the person is in viola-
tion of the order. 
‘‘(2) AVAILABILITY TO STATES.—Upon the re-
quest of a State, the Secretary shall provide to the 
State the information collected by the Secretary 
under paragraph (1) that relates to the State. 
‘‘(d) EMERGENCY
RESPONSE
PLAN
REGARDING 
SHORTAGES.—The Secretary shall develop and maintain
a plan for the response of the Secretary to potential short-
ages in supplies of vaccines that would constitute public 
health emergencies. The plan shall include provisions with 
respect to communication among the relevant entities; dis-
tribution of available supplies of the vaccine involved; the 
designation of populations to be given priority for immuni-
zations; interactions with State and local governments; use 
of the vaccine stockpile; and special considerations for spe-
cific vaccines. The initial plan shall be completed not later 
than 12 months after the date of the enactment of the 
Vaccine Access and Supply Act. 
‘‘(e) RESEARCH.—For the purpose of carrying out re-
search toward the development of new vaccines for human 
use, including vaccines to prevent or control pandemic in-
fections, there are authorized to be appropriated 
$250,000,000 for fiscal year 2006, and such sums as may 
be necessary for each of the fiscal years 2007 through 
2010. Such authorization is in addition to any other au-
thorizations of appropriations for such purpose. 
‘‘(f) EDUCATION PROGRAM REGARDING ADULT IM-
MUNIZATIONS.—
‘‘(1) IN GENERAL.—The Secretary shall develop 
and implement a program to promote, among the 
adult population, immunizations with federally rec-
ommended vaccines.
‘‘(2) CONTENT
OF
PROGRAM.—The program 
developed under paragraph (1) shall include the use 
of a mass media campaign. 
‘‘(3) AUTHORIZATION
OF
APPROPRIATIONS.—
For the purpose of carrying out this subsection, 
there are authorized to be appropriated such sums 
as may be necessary for each of the fiscal years 
2006 through 2010. 
‘‘(g) GENERAL DEFINITIONS.—For purposes of this 
section: 
‘‘(1) The term ‘approved vaccine’ means a vac-
cine for which a biologics license under section 351 
is in effect. 
‘‘(2)(A) The term ‘federally recommended vac-
cine’, with respect to an adult, means an approved 
vaccine recommended by the Advisory Committee on 
Immunization Practices (an advisory committee es-
tablished by the Secretary, acting through the Direc-
tor of the Centers for Disease Control and Preven-
tion). 
‘‘(B) The term ‘federally recommended vaccine’, 
with respect to a child, means a vaccine on the list 
referred to in section 1928(e) of the Social Security 
Act.’’.
(b) IMMUNIZATIONS FOR ELIGIBLE ADULTS; CON-
TINUED COVERAGE UNDER GROUP HEALTH PLANS.—
With respect to the program under section 317A(b) of the 
Public Health Service Act (as added by subsection (a) of 
this section) (referred to in this subsection as the ‘‘adult 
program’’): 
(1) Pursuant to paragraph (2) of such section, 
the provisions of section 1928 of the Social Security 
Act (referred to in this section as the ‘‘pediatric pro-
gram’’) that apply with respect to the adult program 
include subsection (f) of the pediatric program (re-
lating to State maintenance of immunization laws). 
(2) Section 609(d) of the Employee Retirement 
Income Security Act, and the effective date for such 
section (under section 4301(d) of Public Law 103–
66), apply with respect to the adult program to the 
same extent and in the same manner as such section 
and effective date apply with respect to the pediatric 
program. For purposes of such section 609(d) as ap-
plied pursuant to the preceding sentence, the ref-
erence in such section to May 1, 1993, shall be con-
sidered a reference to July 1, 2005. 
(3) Section 4980B(f)(1) of the Internal Rev-
enue Code of 1986 (as added by section 13422(a) of 
Public Law 103–66) applies with respect to adult
vaccines (as defined in the adult program) to the 
same extent and in the same manner as such section 
applies with respect to pediatric vaccines. For pur-
poses of such section 4980B(f)(1) as applied pursu-
ant to the preceding sentence, the reference in such 
section to May 1, 1993, shall be considered a ref-
erence to July 1, 2005. This paragraph applies with 
respect to plan years beginning after the date of the 
enactment of this Act. 
(4) Section 13631(d) of Public Law 103–66 
(relating to title XXII of the Public Health Service 
Act) applies with respect to the adult program to the 
same extent and in the same manner as such section 
applies with respect to the pediatric program. For 
purposes of such section 13631(d) as applied pursu-
ant to the preceding sentence, the reference in such 
section to May 1, 1993, shall be considered a ref-
erence to July 1, 2005. 
SEC. 3. PROGRAM FOR DISTRIBUTION OF PEDIATRIC VAC-
CINES. 
(a) INCLUSION OF ALL PUBLIC CLINICS.—Section 
1928(b)(2)(A)(iii)(I) of the Social Security Act (42 U.S.C. 
1396s(b)(2)(A)(iii)(I)) is amended—
(1) by striking ‘‘or a rural health clinic’’ and in-
serting ‘‘, a rural health clinic’’; and
(2) by inserting ‘‘or a public clinic,’’ after 
‘‘1905(l)(1)),’’. 
(b) AUTHORITY TO REMOVE CERTAIN LIMITATIONS 
ON
PAYMENTS
TO
MANUFACTURERS.—Section 
1928(d)(3)(B) of the Social Security Act (42 U.S.C. 
1396s(d)(3)(B)) is amended by adding at the end the fol-
lowing: ‘‘In the case of a contract entered into on or after 
the date of the enactment of the Vaccine Access and Sup-
ply Act, the limitation established in the preceding sen-
tence with respect to the price per dose of a pediatric vac-
cine does not apply if the Secretary determines that the 
limitation is having a significant adverse effect on the 
availability of sufficient supplies of the vaccine.’’. 
(c) 
SALES
FROM
6-MONTH
SUPPLY.—Section 
1928(d)(6) of the Social Security Act (42 U.S.C. 
1396s(d)(6)) is amended by inserting before the last sen-
tence the following: ‘‘The Secretary may sell such quan-
tities of vaccines from such supply as the Secretary deter-
mines appropriate. Proceeds received from such sales shall 
be available to the Secretary only for the purposes of pro-
curing pediatric vaccine stockpiles under this section and 
shall remain available until expended.’’.
SEC. 4. AMENDMENTS TO PROGRAM OF VACCINE-RELATED 
GRANTS TO STATES. 
Section 317(j) of the Public Health Service Act (42 
U.S.C. 247b(j)) is amended by adding at the end the fol-
lowing paragraph: 
‘‘(3)(A)(i) For fiscal year 2006, the Secretary shall 
make grants described in paragraphs (1) and (2) (relating 
to immunizing individuals without charge) in an aggregate 
amount not exceeding $515,536,000. 
‘‘(ii) Of the amount available under subparagraph 
(A) for fiscal year 2006, the Secretary shall reserve not 
less than $80,000,000 for the purpose of providing immu-
nizations for adults who have not, prior to fiscal year 
2006, been served by immunization programs carried out 
with grants made pursuant to paragraph (1) or (2). 
‘‘(B)(i) For fiscal year 2007 and each subsequent fis-
cal year, the Secretary shall make grants described in 
paragraphs (1) and (2) in an aggregate amount equal to 
the sum of the amounts determined under subclauses (I) 
and (II), as follows: 
‘‘(I) Of the aggregate amount provided in such 
grants for fiscal year 2006, the Secretary shall de-
termine the portion that was obligated to purchase 
vaccines. The amount determined under this sub-
clause is such portion as increased to offset the per-
centage increase in the average sales price for such
vaccines for the most recent five-year period for 
which data are available, taking into account reports 
under subparagraph (F) (in the case of fiscal year 
2007 and subsequent fiscal years). 
‘‘(II) Of the aggregate amount provided in such 
grants for fiscal year 2006, the Secretary shall de-
termine the portion that was obligated for purposes 
other than the purchase of vaccines. The amount de-
termined under this subclause is such portion as in-
creased to offset the percentage increase in the Con-
sumer Price Index for all urban consumers (all 
items; United States city average) for the most re-
cent five-year period for which data are available. 
‘‘(ii) Of the amount available under clause (i) for a 
fiscal year, the Secretary shall, for the purpose described 
in subparagraph (A)(ii), reserve not less than the amount 
specified in such subparagraph as increased in accordance 
with the same methodology as applies under clause (i). 
‘‘(C) Subject to subparagraphs (D) through (F)), 
grants made pursuant to this paragraph shall be made in 
accordance with criteria of the Secretary issued under 
paragraphs (1) and (2) for immunization programs. The 
preceding sentence may not be construed as terminating 
the authority of the Secretary to modify such criteria.
‘‘(D) The purposes for which grants made pursuant 
to this paragraph may be expended by a State or political 
subdivision include the following: 
‘‘(i) Conducting assessments to determine the 
number of adults in the area involved who need im-
munizations and the barriers to providing immuniza-
tions to such adults. 
‘‘(ii) Developing and implementing strategies to 
increase the rate of immunizations in populations in 
which a significant number of individuals have not 
received immunizations with the federally rec-
ommended vaccines (as defined in section 317A(g)) 
for the populations. 
‘‘(iii) Educating care givers, health care profes-
sionals, and the public about the need to be immu-
nized. 
‘‘(iv) Consulting with health care providers with 
respect to ensuring proper and timely immunizations 
for their patients. 
‘‘(v) Investigating and responding to outbreaks 
of vaccine-preventable diseases. 
‘‘(vi) Developing and modifying plans to re-
spond to potential shortages in supplies of vaccines.
‘‘(vii) Preparing reports under subparagraph 
(F) and any additional reports that are submitted to 
the Secretary pursuant to this paragraph. 
‘‘(E) A condition for the receipt by a State of a grant 
made pursuant to this paragraph for a fiscal year is that 
the State have (or agree to develop, in the case of a grant 
for fiscal year 2006) a State plan that—
‘‘(i) ensures the distribution and administration 
of vaccines in the event that the Secretary declares 
a shortage of approved vaccines as a public health 
emergency; and 
‘‘(ii) includes plans for communication and co-
ordination between—
‘‘(I) State and local public health depart-
ments; 
‘‘(II) community health centers; 
‘‘(III) hospitals; 
‘‘(IV) private physicians licensed within the 
State; and 
‘‘(V) to the extent practicable, vaccine 
manufacturers and suppliers. 
‘‘(F) A condition for the receipt of a grant made pur-
suant to this paragraph for a fiscal year is that the appli-
cant involved agree to submit to the Secretary a report 
that specifies for such year the quantity of each type of
vaccine purchased with the grant and the per-dose cost 
of the vaccine. 
‘‘(G) The requirements under subparagraphs (A) and 
(B) that the Secretary make grants constitutes budget au-
thority in advance of appropriations Acts, and represents 
the obligation of the Federal Government to make outlays 
to provide for immunizations without charge pursuant to 
the grants in accordance with this paragraph.’’. 
SEC. 5. ONE-YEAR NOTICE ON DISCONTINUING MANUFAC-
TURE OF VACCINE. 
Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by inserting after section 506C the following section: 
‘‘SEC. 506D. DISCONTINUANCE OF VACCINE. 
‘‘(a) IN GENERAL.—
‘‘(1) NOTICE TO SECRETARY.—A manufacturer 
of a vaccine approved by the Secretary shall notify 
the Secretary of a discontinuance of the manufac-
ture of the vaccine at least 12 months prior to the 
date of the discontinuance. 
‘‘(2) DIRECTOR
OF
CENTERS
FOR
DISEASE 
CONTROL AND PREVENTION.—Promptly after receiv-
ing a notice under paragraph (1), the Secretary shall 
inform the Director of the Centers for Disease Con-
trol and Prevention of the notice. Promptly after de-
termining that a reduction under subsection (b) ap-
plies with respect to such a notice, the Secretary 
shall inform such Director of the reduction. 
‘‘(3) RELATIONSHIP TO SEPARATE NOTICE PRO-
GRAM.—In the case of a vaccine that is approved by 
the Secretary and is a drug described in section 
506C(a), this section applies to the vaccine in lieu 
of section 506C. 
‘‘(b) REDUCTION IN NOTIFICATION PERIOD.—The 
notification period required under subsection (a) for a 
manufacturer may be reduced if the manufacturer certifies 
to the Secretary that good cause exists for the reduction, 
such as a situation in which—
‘‘(1) a public health problem may result from 
continuation of the manufacturing for the 12-month 
period; 
‘‘(2) a biomaterials shortage prevents the con-
tinuation of the manufacturing for the 12-month pe-
riod; 
‘‘(3) a liability problem may exist for the manu-
facturer if the manufacturing is continued for the 
12-month period; 
‘‘(4) continuation of the manufacturing for the 
12-month period may cause substantial economic 
hardship for the manufacturer;
‘‘(5) the manufacturer has filed for bankruptcy 
under chapter 7 or 11 of title 11, United States 
Code; or 
‘‘(6) the manufacturer can continue the dis-
tribution of the vaccine involved for 12 months. 
‘‘(c) DISTRIBUTION.—To the maximum extent prac-
ticable, the Secretary shall distribute information on the 
discontinuation of the manufacture of vaccines to appro-
priate physician and patient organizations.’’. 
SEC. 6. PROGRAM FOR PEDIATRIC VACCINE STOCKPILE; 
PARTICIPATION 
OF 
MANUFACTURERS 
OF 
VACCINES. 
(a) IN GENERAL.—Not later than 30 days after the 
date of the enactment of this Act, the Secretary of Health 
and Human Services, in consultation with the Chairman 
of the Securities and Exchange Commission, shall submit 
to the Congress a plan to facilitate the participation of 
manufacturers of pediatric vaccines in the program oper-
ated by the Secretary to maintain a six-month supply of 
such vaccines (commonly referred to as the pediatric vac-
cine stockpile). With respect to the purchase of pediatric 
vaccines for such program, the plan shall include, as nec-
essary, provisions for the accounting-rules treatment of 
amounts paid by the Secretary to such manufacturers that
will permit the manufacturers to treat the amounts as rev-
enue upon receipt of the amounts. 
(b) DEFINITION.—For purposes of subsection (a), 
the term ‘‘pediatric vaccine’’ means a vaccine on the list 
referred to in section 1928(e) of the Social Security Act. 
SEC. 7. PROHIBITION ON MEDICAID COST-SHARING FOR 
VACCINES 
RECOMMENDED 
BY 
ADVISORY 
COMMITTEE ON IMMUNIZATION PRACTICES. 
(a) IN GENERAL.—Section 1916 of the Social Secu-
rity Act (42 U.S.C. 1396o) is amended by adding at the 
end the following: 
‘‘(h) The State plan shall require that no provider 
participating under the State plan may impose a copay-
ment, cost sharing charge, or similar charge for admin-
istering to an adult individual who is eligible for medical 
assistance under such plan a vaccine that is included on 
the recommended vaccine schedule for adults that is estab-
lished (and periodically reviewed and appropriately re-
vised) by the Advisory Committee on Immunization Prac-
tices of the Centers for Disease Control and Prevention 
and that is otherwise covered under the State plan.’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall take effect on October 1, 2005. 
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