[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4993 Introduced in House (IH)]
110th CONGRESS
2d Session
H. R. 4993
To amend the Public Health Service Act to increase the availability of
vaccines, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
January 16, 2008
Mr. Waxman (for himself and Ms. Roybal-Allard) introduced the following
bill; which was referred to the Committee 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 jurisdiction 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 Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Vaccines for the Uninsured Adult Act
of 2008''.
SEC. 2. CERTAIN AUTHORITIES REGARDING ADULT IMMUNIZATIONS.
(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 IMMUNIZATIONS.
``(a) Immunization Program for Eligible Adults.--
``(1) In general.--The Secretary shall by regulation
establish a program for the distribution of qualified adult
vaccines through States with approved applications under
paragraph (4)(C) and the payment of a fee for the
administration of such vaccines, under which program--
``(A) each vaccine-eligible adult, in receiving an
immunization with a qualified adult vaccine 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-eligible 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-registered provider.
``(2) Relationship to program for distribution of pediatric
vaccines.--The provisions of the program under section 1928 of
the Social 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-eligible children under the program under such section
1928, except to the extent that such a provision conflicts 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, 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
covered 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
correctional 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 subparagraph (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
vaccines as may be necessary for the administration 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 pursuant 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 Secretary 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 subparagraph (B)
and the requirement of subparagraph (D).
``(D) Requirement of state maintenance 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 not approve the State's application under
subparagraph (C) 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.
``(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 federally
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 employee 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 entitled to
benefits under such a health insurance policy or plan,
but such benefits are not available 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) Payment for vaccine administration.--
``(A) In general.--The amount of payment for
vaccine administration under the program under this
section shall be the same as the amount established
under the physician fee schedule under section 1848 of
the Social Security 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 intermediaries as may be
necessary for the processing of claims for payment for
vaccine administration 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 accordance 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 emergencies. The plan shall include provisions with
respect 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
governments;
``(E) the use of the vaccine stockpile; and
``(F) special considerations for specific vaccines.
``(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 enactment 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
alternatives for tracking and facilitating, in consultation
with State and local health officials, reallocation of vaccine
at the local level in times of shortage or emergency.
``(c) Education Program Regarding Adult Immunizations.--
``(1) In general.--The Secretary shall develop and
implement a program to promote, among the adult population,
immunizations with federally recommended 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 2009 through 2013.
``(d) General Definitions.--For purposes of this section:
``(1) The term `approved vaccine' means a vaccine 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 advisory 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 employment status, or any other
factor.''.
(b) Application of Pediatric Vaccine Maintenance of Effort
Provisions to Adult Vaccines.--
(1) Under erisa.--
(A) In general.--Section 609(d) of Employee
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 following:
``A group health plan may not reduce its
coverage of the costs of adult vaccines (as
defined under section 317A(a)(5)(B) of the
Public Health Service 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 submit an annual report to
the Congress on implementation 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 by inserting
after ``1993,'' the following: ``the coverage of the
costs of adult vaccines (as defined 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 requirement of section 4980B(f)(1)
of the Internal Revenue Code of 1986, 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.
(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
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 Service 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
enforcement of the requirement of section 13631(d) of
the Omnibus Budget Reconciliation Act of 1993 (Public
Law 103-66), 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.
(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.
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
immunizations for adults who have not, prior to fiscal year
2009, been served by immunization programs carried 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 accordance with criteria of the
Secretary issued under paragraphs (1) and (2) of subsection (j) for
immunization programs. 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 authority, 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 immunizations and the
barriers to providing immunizations 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 recommended vaccines (as defined in section 317A(d))
for the populations.
``(C) Educating care givers, health care professionals, and
the public about the need to be immunized.
``(D) Consulting with health care providers with respect to
ensuring proper and timely immunizations for their patients.
``(E) Investigating and responding to outbreaks of vaccine-
preventable diseases.
``(F) Developing and modifying plans to respond 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 administration of
vaccines in the event that the Secretary declares a shortage of
approved vaccines as a public health emergency; and
``(B) includes plans for communication and coordination
between--
``(i) State and local public health departments;
``(ii) community health centers;
``(iii) hospitals;
``(iv) private physicians licensed within the
State; and
``(v) to the extent practicable, vaccine
manufacturers and suppliers.
``(5) A condition for the receipt of a grant made pursuant to this
paragraph for a fiscal year is that the applicant 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 Security 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 subsection:
``(j) The State plan shall require that no provider participating
under the State plan may impose a copayment, cost sharing charge, or
similar charge for administering to an adult individual who is eligible
for medical assistance under such plan a federally recommended vaccine
(as defined in section 317A(d) of the Public Health Service Act).''.
(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 enactment 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 Services, 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 programs.
(c) Measurement of Usage by Health Care Workers.--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 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 immunizations 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
ACCREDITATION.
(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 accreditation of a provider of services
(as defined in section 1861(u) of the Social Security Act (42 U.S.C.
1395x(u)) compliance with recommended adult immunizations, including
influenza, for all health care workers employed by the provider 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 subsection (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
difficulties.
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 following:
``(p)(1) A contract may not be made or a plan approved which does
not (A) offer qualified immunization services to eligible enrollees,
and (B) provide for the waiver of any deductible that might otherwise
apply with respect to any such services provided to any such enrollee.
``(2) For purposes of this subsection--
``(A) the term `qualified immunization services' means the
provision and administration of all federally 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 individual 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 contract entered into or renewed for any
contract year beginning later than 9 months after the date of the
enactment of this Act.
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