HR 4705 IHCommentsClose CommentsPermalink

To amend the Public Health Service Act to increase the availability of vaccines, and for other purposes.CommentsClose CommentsPermalink

December 13, 2007

Mr. WAXMAN 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 concernedCommentsClose CommentsPermalink

To amend the Public Health Service Act to increase the availability of vaccines, and for other purposes.CommentsClose CommentsPermalink

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,CommentsClose CommentsPermalink

SECTION 1. SHORT TITLE.

This Act may be cited as the `Vaccines for the Uninsured Adult Act of 2008'.CommentsClose CommentsPermalink

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--CommentsClose CommentsPermalink





(1) by redesignating section 317A as section 317A-1; andCommentsClose CommentsPermalink





(2) by inserting after section 317 the following section:CommentsClose CommentsPermalink

`SEC. 317A. CERTAIN AUTHORITIES REGARDING ADULT IMMUNIZATIONS.

`(a) Immunization Program for Eligible Adults-CommentsClose CommentsPermalink





`(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--CommentsClose CommentsPermalink





`(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; andCommentsClose CommentsPermalink





`(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; andCommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(3) VACCINE-ELIGIBLE ADULT-CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(B) FEDERALLY VACCINE-ELIGIBLE ADULT- For purposes of this subsection, the term `federally vaccine-eligible adult' means any of the following:CommentsClose CommentsPermalink





`(i) An adult who is not insured.CommentsClose CommentsPermalink





`(ii) An adult who--CommentsClose CommentsPermalink





`(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; andCommentsClose CommentsPermalink





`(II) is not insured with respect to the vaccine.CommentsClose CommentsPermalink





`(iii) An adult who--CommentsClose CommentsPermalink





`(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; andCommentsClose CommentsPermalink





`(II) is not insured with respect to the vaccine.CommentsClose CommentsPermalink





`(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).CommentsClose CommentsPermalink





`(4) PARTICIPATION OF STATES-CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(B) PROGRAM CRITERIA- The Secretary, in accordance with provisions that apply pursuant to paragraph (2), shall establish criteria for State programs under paragraph (1).CommentsClose CommentsPermalink





`(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--CommentsClose CommentsPermalink





`(i) is submitted in such form and such manner as the Secretary may require; andCommentsClose CommentsPermalink





`(ii) demonstrates that the State is in compliance with criteria under subparagraph (B) and the requirement of subparagraph (D).CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(5) ADDITIONAL DEFINITIONS- For purposes of this subsection:CommentsClose CommentsPermalink





`(A) The term `adult' means an individual who is not a child as defined in section 1928 of the Social Security Act.CommentsClose CommentsPermalink





`(B) The term `adult vaccine' means a federally recommended vaccine for adults.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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).CommentsClose CommentsPermalink





`(6) PAYMENT FOR VACCINE ADMINISTRATION-CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(b) Emergency Response Plan Regarding Shortages-CommentsClose CommentsPermalink





`(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--CommentsClose CommentsPermalink





`(A) communication among the relevant entities;CommentsClose CommentsPermalink





`(B) distribution of available supplies of the vaccine involved;CommentsClose CommentsPermalink





`(C) the designation of populations to be given priority for immunizations;CommentsClose CommentsPermalink





`(D) interactions with State and local governments;CommentsClose CommentsPermalink





`(E) the use of the vaccine stockpile; andCommentsClose CommentsPermalink





`(F) special considerations for specific vaccines.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(c) Education Program Regarding Adult Immunizations-CommentsClose CommentsPermalink





`(1) IN GENERAL- The Secretary shall develop and implement a program to promote, among the adult population, immunizations with federally recommended vaccines.CommentsClose CommentsPermalink





`(2) CONTENT OF PROGRAM- The program developed under paragraph (1) shall include the use of a mass media campaign.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(d) General Definitions- For purposes of this section:CommentsClose CommentsPermalink





`(1) The term `approved vaccine' means a vaccine for which a biologics license under section 351 is in effect.CommentsClose CommentsPermalink





`(2) The term `federally recommended vaccine', with respect to an adult, means an approved vaccine that--CommentsClose CommentsPermalink





`(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; orCommentsClose CommentsPermalink





`(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.'.CommentsClose CommentsPermalink





(b) Application of Pediatric Vaccine Maintenance of Effort Provisions to Adult Vaccines-CommentsClose CommentsPermalink





(1) UNDER ERISA-CommentsClose CommentsPermalink





(A) IN GENERAL- Section 609(d) of Employee Retirement Income Security Act of 1974 (29 U.S.C. 1169(d)) is amended--CommentsClose CommentsPermalink





(i) in the heading, by inserting `or Adult' after `Pediatric'; andCommentsClose CommentsPermalink





(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.'.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(2) UNDER IRC-CommentsClose CommentsPermalink





(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,'.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(3) UNDER PHSA-CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(i) in the heading, by inserting `or Adult' after `Pediatric'; andCommentsClose CommentsPermalink





(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.'.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink

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--CommentsClose CommentsPermalink





(1) in subsection (j), by adding at the end the following:CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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'; andCommentsClose CommentsPermalink





(2) by adding at the end the following:CommentsClose CommentsPermalink





`(l)(1) In making grants under subsection (a), the Secretary may make grants for preventive health service programs to provide immunizations without charge.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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:CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(C) Educating care givers, health care professionals, and the public about the need to be immunized.CommentsClose CommentsPermalink





`(D) Consulting with health care providers with respect to ensuring proper and timely immunizations for their patients.CommentsClose CommentsPermalink





`(E) Investigating and responding to outbreaks of vaccine-preventable diseases.CommentsClose CommentsPermalink





`(F) Developing and modifying plans to respond to potential shortages in supplies of vaccines.CommentsClose CommentsPermalink





`(G) Preparing reports under paragraph (5) and any additional reports that are submitted to the Secretary pursuant to this paragraph.CommentsClose CommentsPermalink





`(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--CommentsClose CommentsPermalink





`(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; andCommentsClose CommentsPermalink





`(B) includes plans for communication and coordination between--CommentsClose CommentsPermalink





`(i) State and local public health departments;CommentsClose CommentsPermalink





`(ii) community health centers;CommentsClose CommentsPermalink





`(iii) hospitals;CommentsClose CommentsPermalink





`(iv) private physicians licensed within the State; andCommentsClose CommentsPermalink





`(v) to the extent practicable, vaccine manufacturers and suppliers.CommentsClose CommentsPermalink





`(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'.CommentsClose CommentsPermalink

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--CommentsClose CommentsPermalink





(1) in subsection (a), by striking `and (i)' and inserting `, (i), and (j)'; andCommentsClose CommentsPermalink





(2) by adding at the end the following new subsection:CommentsClose CommentsPermalink





`(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).'.CommentsClose CommentsPermalink





(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'.CommentsClose CommentsPermalink





(c) Effective Date- The amendment made by subsection (a) shall take effect on the date of the enactment of this Act.CommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink

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:CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(2) For purposes of this subsection--CommentsClose CommentsPermalink





`(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); andCommentsClose CommentsPermalink





`(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.'.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink