[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.
                                 <all>