I 
110TH CONGRESS 
1ST SESSION H. R. 4705 
To amend the Public Health Service Act to increase the availability of 
vaccines, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
DECEMBER 13, 2007 
Mr. WAXMAN introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce, and in addition to the Committees on 
Education and Labor, Ways and Means, and Oversight and Government 
Reform, for a period to be subsequently determined by the Speaker, in 
each case for consideration of such provisions as fall within the jurisdic-
tion of the committee concerned 
A BILL 
To amend the Public Health Service Act to increase the 
availability of vaccines, 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 ‘‘Vaccines for the Unin-
sured Adult Act of 2008’’. 
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SEC. 2. CERTAIN AUTHORITIES REGARDING ADULT IMMU-
NIZATIONS. 
(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 ADULT IM-
MUNIZATIONS. 
‘‘(a) 
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) and the 
payment of a fee for the administration of such vac-
cines, 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, 2009, 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-
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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 is entitled to receive payment 
for the administration of such vaccine; and 
‘‘(ii) no vaccine is distributed under the 
program to a provider, and no payment is made 
for the administration of the vaccine by such a 
provider, unless the provider is a program-reg-
istered 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, other 
than subsection (f) of such section 1928) 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-eli-
gible children under the program under such section 
1928, except to the extent that such a provision con-
flicts with this subsection. The preceding sentence 
may not be construed as having any effect on the 
program under title XIX of the Social Security Act, 
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or as having the effect that, in the program 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 any 
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— 
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‘‘(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-
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tion of such vaccines to all vaccine-eligible 
adults in the State on or after October 1, 2009. 
‘‘(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) and the requirement of subpara-
graph (D). 
‘‘(D) REQUIREMENT
OF
STATE
MAINTE-
NANCE OF IMMUNIZATION LAWS.—In the case 
of a State that had in effect as of July 1, 2008, 
a law that requires some or all health insurance 
policies or plans to provide some coverage with 
respect to an adult vaccine, the Secretary may 
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not approve the State’s application under sub-
paragraph (C) unless the State certifies to the 
Secretary that the State has not modified or re-
pealed such law in a manner that reduces the 
amount of coverage so required. 
‘‘(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. 
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‘‘(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) PAYMENT
FOR
VACCINE
ADMINISTRA-
TION.— 
‘‘(A) IN GENERAL.—The amount of pay-
ment for vaccine administration under the pro-
gram under this section shall be the same as 
the amount established under the physician fee 
schedule under section 1848 of the Social Secu-
rity Act for payment for administration of a 
vaccine under part B of title XVIII of such Act. 
‘‘(B) ADMINISTRATIVE
CONTRACTS.—The 
Secretary shall enter into such contracts or 
agreements with qualified carriers or inter-
mediaries as may be necessary for the proc-
essing of claims for payment for vaccine admin-
istration under this section. 
‘‘(7) 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-
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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 and with respect to the payment 
for vaccine administration. 
‘‘(b) EMERGENCY
RESPONSE
PLAN
REGARDING 
SHORTAGES.— 
‘‘(1) DEVELOPMENT OF PLAN.—The Secretary 
shall develop and maintain a plan for the response 
of the Secretary to potential shortages in supplies of 
vaccines that would constitute public health emer-
gencies. The plan shall include provisions with re-
spect to— 
‘‘(A) communication among the relevant 
entities; 
‘‘(B) distribution of available supplies of 
the vaccine involved; 
‘‘(C) the designation of populations to be 
given priority for immunizations; 
‘‘(D) interactions with State and local gov-
ernments; 
‘‘(E) the use of the vaccine stockpile; and 
‘‘(F) special considerations for specific vac-
cines. 
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‘‘(2) COMPLETION OF PLAN.—The initial plan 
under paragraph (1) shall be completed not later 
than 12 months after the date of the enactment of 
the Vaccines for the Uninsured Act of 2008. 
‘‘(3) STUDY ON REALLOCATION OF VACCINE.— 
Not later than 1 year after the date of the enact-
ment of the Vaccines for the Uninsured Act of 2008, 
the Secretary shall complete a study and submit a 
report to the Congress on successful models and al-
ternatives for tracking and facilitating, in consulta-
tion with State and local health officials, reallocation 
of vaccine at the local level in times of shortage or 
emergency. 
‘‘(c) 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 
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as may be necessary for each of the fiscal years 
2009 through 2013. 
‘‘(d) 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) The term ‘federally recommended vaccine’, 
with respect to an adult, means an approved vaccine 
that— 
‘‘(A) is recommended by the Advisory 
Committee on Immunization Practices (an advi-
sory committee established by the Secretary, 
acting through the Director of the Centers for 
Disease Control and Prevention) with respect to 
adults generally; or 
‘‘(B) is recommended by such Advisory 
Committee with respect to any group of adults 
because of their health condition, their employ-
ment status, or any other factor.’’. 
(b) APPLICATION OF PEDIATRIC VACCINE MAINTE-
NANCE OF EFFORT PROVISIONS TO ADULT VACCINES.— 
(1) UNDER ERISA.— 
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(A) IN GENERAL.—Section 609(d) of Em-
ployee Retirement Income Security Act of 1974 
(29 U.S.C. 1169(d)) is amended— 
(i) in the heading, by inserting ‘‘OR 
ADULT’’ after ‘‘PEDIATRIC’’; and 
(ii) by adding at the end the fol-
lowing: ‘‘A group health plan may not re-
duce its coverage of the costs of adult vac-
cines 
(as 
defined 
under 
section 
317A(a)(5)(B) of the Public Health Serv-
ice Act) below the coverage provided by the 
plan as of July 1, 2008.’’. 
(B) MONITORING
BY
IG.—The Inspector 
General of the Department of Labor shall sub-
mit an annual report to the Congress on imple-
mentation and enforcement of the requirement 
of section 609(d) of the Employee Retirement 
Income Security Act of 1974 (29 U.S.C. 
1169(d)), as amended by subparagraph (A), 
that a group health plan not reduce its coverage 
of the costs of adult vaccines below the coverage 
provided by the plan as of July 1, 2008. 
(2) UNDER IRC.— 
(A) IN GENERAL.—Section 4980B(f)(1) of 
the Internal Revenue Code of 1986 is amended 
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by inserting after ‘‘1993,’’ the following: ‘‘the 
coverage of the costs of adult vaccines (as de-
fined in section 317A(a)(5)(B) of the Public 
Health Service Act) is not reduced below the 
coverage provided by the plan as of July 1, 
2008,’’. 
(B) MONITORING
BY
IG.—The Inspector 
General of the Department of the Treasury 
shall submit an annual report to the Congress 
on implementation and enforcement of the re-
quirement of section 4980B(f)(1) of the Inter-
nal Revenue Code of 1986, as amended by sub-
paragraph (A), that a group health plan not re-
duce its coverage of the costs of adult vaccines 
below the coverage provided by the plan as of 
July 1, 2008. 
(3) UNDER PHSA.— 
(A) IN
GENERAL.—Section 13631(d) of 
the Omnibus Budget Reconciliation Act of 1993 
(Public Law 103–66; relating to title XXII of 
the Public Health Service Act) is amended— 
(i) in the heading, by inserting ‘‘OR 
ADULT’’ after ‘‘PEDIATRIC’’; and 
(ii) in paragraph (1), by adding at the 
end the following: ‘‘Such requirement also 
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includes, with respect to a group health 
plan for plan years beginning after the 
date of the enactment of this sentence, the 
requirement that the group health plan not 
reduce its coverage of the costs of adult 
vaccines 
(as 
defined 
in 
section 
317A(a)(5)(B) of the Public Health Serv-
ice Act) below the coverage provided by the 
plan as of July 1, 2008.’’. 
(B) MONITORING
BY
IG.—The Inspector 
General of the Department of Health and 
Human Services shall submit an annual report 
to the Congress on implementation and enforce-
ment of the requirement of section 13631(d) of 
the Omnibus Budget Reconciliation Act of 1993 
(Public Law 103–66), as amended by subpara-
graph (A), that a group health plan not reduce 
its coverage of the costs of adult vaccines below 
the coverage provided by the plan as of July 1, 
2008. 
(4) EFFECTIVE DATE.—The amendments made 
by paragraphs (1)(A), (2)(A), and (3)(A) shall apply 
to group health plans for plan years beginning after 
the date of the enactment of this Act. 
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SEC. 3. AMENDMENTS TO PROGRAM OF VACCINE-RELATED 
GRANTS TO STATES. 
Section 317 of the Public Health Service Act (42 
U.S.C. 247b) is amended— 
(1) in subsection (j), by adding at the end the 
following: 
‘‘(3)(A) For grants described in subsection (l) 
(relating to immunizing individuals without charge), 
there 
are 
authorized 
to 
be 
appropriated 
$500,000,000 for fiscal year 2009 and such sums as 
may be necessary for each subsequent fiscal year. 
‘‘(B) Of the amount appropriated pursuant to 
this paragraph for each of fiscal years 2009 and 
2010, the Secretary shall reserve not less than 
$80,000,000 for the purpose of providing immuniza-
tions for adults who have not, prior to fiscal year 
2009, been served by immunization programs car-
ried out with grants made pursuant to this section’’; 
and 
(2) by adding at the end the following: 
‘‘(l)(1) In making grants under subsection (a), the 
Secretary may make grants for preventive health service 
programs to provide immunizations without charge. 
‘‘(2) Subject to paragraphs (3) through (5), grants 
made pursuant to this subsection shall be made in accord-
ance with criteria of the Secretary issued under para-
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graphs (1) and (2) of subsection (j) for immunization pro-
grams. The preceding sentence may not be construed as 
terminating the authority of the Secretary to modify such 
criteria. 
‘‘(3) Grants made pursuant to this subsection may 
be expended to improve the ability of a State health au-
thority, a political subdivision of a State, or another public 
entity to improve an immunization program, including 
through the following: 
‘‘(A) 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. 
‘‘(B) 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(d)) 
for the populations. 
‘‘(C) Educating care givers, health care profes-
sionals, and the public about the need to be immu-
nized. 
‘‘(D) Consulting with health care providers with 
respect to ensuring proper and timely immunizations 
for their patients. 
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‘‘(E) Investigating and responding to outbreaks 
of vaccine-preventable diseases. 
‘‘(F) Developing and modifying plans to re-
spond to potential shortages in supplies of vaccines. 
‘‘(G) Preparing reports under paragraph (5) 
and any additional reports that are submitted to the 
Secretary pursuant to this paragraph. 
‘‘(4) A condition for the receipt of a grant by a State, 
a political subdivision of a State, or another public entity 
made pursuant to this paragraph for a fiscal year is that 
the State, political subdivision, or public entity have (or 
agree to develop, in the case of a grant for fiscal year 
2008) a State plan that— 
‘‘(A) ensures the distribution and administra-
tion of vaccines in the event that the Secretary de-
clares a shortage of approved vaccines as a public 
health emergency; and 
‘‘(B) 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 
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‘‘(v) to the extent practicable, vaccine man-
ufacturers and suppliers. 
‘‘(5) 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’’. 
SEC. 4. 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— 
(1) in subsection (a), by striking ‘‘and (i)’’ and 
inserting ‘‘, (i), and (j)’’; and 
(2) by adding at the end the following new sub-
section: 
‘‘(j) 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 federally recommended vac-
cine (as defined in section 317A(d) of the Public Health 
Service Act).’’. 
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(b) 
CONFORMING
AMENDMENT.—Section 
1916A(a)(1) of such Act (42 U.S.C. 1396o–1(a)(1)) is 
amended by inserting ‘‘(other than subsection (j))’’ after 
‘‘Notwithstanding sections 1916’’. 
(c) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall take effect on the date of the enact-
ment of this Act. 
SEC. 5. MEDICARE AND MEDICAID PROGRAMS; STANDARDS 
TO MEASURE USAGE AND COVERAGE OF 
ADULT IMMUNIZATIONS. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services, acting through the Administrator of the 
Centers for Medicare & Medicaid Services, shall establish 
standards for the measurement of use by beneficiaries 
under the Medicare and Medicaid programs of routinely 
recommended adult immunizations. 
(b) STUDY FOR USE OF STANDARDS AS A QUALITY 
MEASURE.—The Secretary of Health and Human Serv-
ices, acting through the Administrator of the Centers for 
Medicare & Medicaid Services, shall conduct a study to 
determine the feasibility and advisability of including adult 
immunization by Medicare and Medicaid beneficiaries, as 
a performance measure under quality initiatives conducted 
by the Secretary under the Medicare and Medicaid pro-
grams. 
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(c) MEASUREMENT OF USAGE BY HEALTH CARE 
WORKERS.—The Secretary of Health and Human Serv-
ices, acting through the Administrator of the Centers for 
Medicare & Medicaid Services, shall establish standards 
for the measurement of use by health care workers, as 
defined by the Secretary for purposes of this section, 
working in a provider of services (as defined in section 
1861(u) of the Social Security Act (42 U.S.C. 1395x(u)) 
of adult immunizations for influenza. 
(d) ASSESSMENT OF BEST PRACTICES TO IMPROVE 
COVERAGE OF ADULT IMMUNIZATIONS.—The Secretary 
of Health and Human Services, acting through the Agency 
for Healthcare Research and Quality, shall conduct a 
study of the best practices of health insurers and managed 
care organizations to encourage the use of adult immuni-
zations by enrollees of such insurers and organizations. 
SEC. 6. STUDY ON ADULT IMMUNIZATION FOR INFLUENZA 
FOR HEALTH CARE WORKERS AS A QUALITY 
INDICATOR FOR PURPOSES OF ACCREDITA-
TION. 
(a) STUDY.—The Secretary of Health and Human 
Services shall conduct a study to determine the feasibility 
and advisability of including as a requirement of accredita-
tion of a provider of services (as defined in section 1861(u) 
of the Social Security Act (42 U.S.C. 1395x(u)) compli-
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ance with recommended adult immunizations, including 
influenza, for all health care workers employed by the pro-
vider of services. Any such requirement should include a 
provision for informed refusal by the health care worker 
of the immunization and appropriate documentation of 
usage and refusal of such immunizations. 
(b) REPORT.—Not later than one year after the date 
of the enactment of this Act, the Secretary shall submit 
to Congress a report on the study conducted under sub-
section (a), and shall include in that report a description 
of the difficulties of implementing such a requirement as 
well as recommendations for the resolution of those dif-
ficulties. 
SEC. 7. FEHBP COVERAGE OF QUALIFIED IMMUNIZATION 
SERVICES. 
(a) IN GENERAL.—Section 8902 of title 5, United 
States Code, is amended by adding at the end the fol-
lowing: 
‘‘(p)(1) A contract may not be made or a plan ap-
proved which does not (A) offer qualified immunization 
services to eligible enrollees, and (B) provide for the waiv-
er of any deductible that might otherwise apply with re-
spect to any such services provided to any such enrollee. 
‘‘(2) For purposes of this subsection— 
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‘‘(A) the term ‘qualified immunization services’ 
means the provision and administration of all feder-
ally recommended vaccines (as defined in section 
317A(d) of the Public Health Service Act); and 
‘‘(B) the term ‘eligible enrollee’, as used with 
respect to a health benefits plan, means an indi-
vidual enrolled in such plan under this chapter who 
is 18 years of age or older.’’. 
(b) EFFECTIVE DATE.—The amendment made by 
this section shall apply to services provided under any con-
tract entered into or renewed for any contract year begin-
ning later than 9 months after the date of the enactment 
of this Act. 
Æ 
VerDate Aug 31 2005 
04:37 Dec 15, 2007
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bajohnson on PROD1PC71 with BILLS