[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 733 Introduced in Senate (IS)]

103d CONGRESS
  1st Session
                                 S. 733

 To provide for the immunization of all children in the United States 
     against vaccine-preventable diseases, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                April 1 (legislative day, March 3), 1993

 Mr. Riegle (for himself, Mr. Kennedy, Mr. Metzenbaum, Mr. Wellstone, 
 and Ms. Mikulski) introduced the following bill; which was read twice 
                and referred to the Committee on Finance

_______________________________________________________________________

                                 A BILL


 
 To provide for the immunization of all children in the United States 
     against vaccine-preventable diseases, 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 ``Comprehensive Child Health 
Immunization Act of 1993''.

SEC. 2. FINDINGS AND PURPOSE.

    (a) Findings.--
            (1) Current circumstances.--Congress finds the following:
                    (A) Immunizations are among the most cost-effective 
                means of preventing disease.
                    (B) Although Federal support for childhood 
                immunizations has been in existence since 1962, the 
                full potential of immunizations remains to be achieved. 
                Enactment and enforcement of school immunization 
                requirements have resulted in excellent immunization 
                levels (96 percent or greater) in school children. 
                However, approximately 80 percent of vaccine doses 
                should be received before the second birthday in order 
                to protect children during their most vulnerable 
                periods. Many children do not receive their basic 
                immunizations by that time, and in some inner cities as 
                few as 10 percent of 2-year-olds have received a 
                complete series. This low level of immunizations has 
                been reflected in recent years by outbreaks of measles 
                among inadequately immunized preschool children.
                    (C) The childhood immunization services delivery 
                infrastructure is both public and private. There is 
                considerable evidence to suggest that the private 
                infrastructure has been eroded over the past decade as 
                a result of the significantly increased cost of 
                privately purchased vaccines.
                    (D) Prices for privately purchased vaccines exceed 
                the prices paid for like vaccines in some other 
                industrialized nations by over 2500 percent.
                    (E) High vaccine costs, coupled with the growing 
                number of uninsured and underinsured families, has 
                resulted in private physicians increasingly referring 
                their private-pay patients to overburdened public 
                clinics for vaccinations.
                    (F) Eleven States now have programs that provide 
                vaccines without charge to both public and private 
                health care providers. Other States that have sought to 
                establish such programs have been denied additional 
                discounted vaccines by manufacturers.
                    (G) There is no evidence to suggest that a 
                negotiated price that takes into account the reasonable 
                cost of production, marketing, research and 
                development, and distribution will not fairly 
                compensate vaccine manufacturers. Indeed, a recent 
                report by the Congressional Office of Technology 
                Assessment supports the proposition that negotiated 
                rates can assure fair compensation while holding down 
                costs.
                    (H) The Secretary of Health and Human Services has 
                experience negotiating vaccine purchase through the 
                Federal contract system.
                    (I) The National Vaccine Injury Compensation 
                Program is an essential element in a comprehensive 
                immunization program and should be applied to 
                additional vaccines recommended for universal use in 
                children.
            (2) Needed actions.--With respect to actions necessary to 
        ensure the full immunization of children at the earliest 
        possible age, Congress finds the following:
                    (A) The Federal Government should purchase and 
                provide free of charge to health care providers 
                vaccines recommended for universal use in children. 
                This action will not only remove financial barriers to 
                immunization that impede children from being vaccinated 
                at the appropriate time, but will also facilitate the 
                development of an immunization tracking system.
                    (B) The Federal Government and the States should 
                develop linked registries to track the immunization 
                status of the Nation's children. The registry system 
                should have the capability to notify parents of 
                inadequately immunized children of the need to protect 
                their children with specific vaccines.
                    (C) The coordinated national information and 
                education outreach initiative operated through the 
                Department of Health and Human Services should be 
                sustained to bring needed information to parents and 
                health care providers and focus their attention on the 
                importance of achieving the full and timely 
                immunization of children at the earliest appropriate 
                age.
                    (D) Private and public health insurers should be 
                encouraged to provide adequate reimbursement for the 
                administration of childhood vaccines.
                    (E) Volunteer community activities to promote the 
                full immunization of children at the earliest 
                appropriate age should be encouraged.
                    (F) The National Vaccine Injury Compensation 
                Program should be extended and improved. Vaccine 
                information materials should be simplified to ensure 
                that parents can understand the benefits and risks of 
                vaccines.
    (b) Purpose.--It is the purpose of this Act to ensure that all 
children in the United States are fully immunized against vaccine 
preventable infectious diseases at the earliest appropriate age.

SEC. 3. FEDERAL PURCHASE OF CHILDHOOD VACCINES.

    (a) Establishment of Program.--The Social Security Act (42 U.S.C. 
301 et seq.) is amended by adding at the end thereof the following new 
title:

          ``TITLE XXI--FEDERAL PURCHASE OF CHILDHOOD VACCINES

                      ``purchase by the secretary

    ``Sec. 2101. (a) Purchase of Vaccines.--
            ``(1) In general.--The Secretary shall regularly contract 
        for the purchase of vaccines included on the list promulgated 
        by the Secretary pursuant to section 1931 (referred to in this 
        section as `recommended childhood vaccines') in amounts--
                    ``(A) necessary for distribution under the Public 
                Health Service Act to meet anticipated needs for the 
                routine and catch-up immunization of children in the 
                United States in accordance with the recommendations 
                promulgated under section 1931 and for foreseeable 
                outbreak control activities;
                    ``(B) necessary for the maintenance of a reserve 
                vaccine supply sufficient for a 6-month period; and
                    ``(C) which take into account minimum waste due to 
                breakage or other unavoidable losses.
            ``(2) Consultations.--
                    ``(A) Preprocurement consultations.--The Secretary 
                may consult with representatives of State governments, 
                experts in vaccine delivery, health care providers, and 
                others with expertise in purchasing and pricing 
                pharmaceutical products prior to soliciting bids or 
                offers for recommended childhood vaccines under this 
                section. Health care providers shall also furnish 
                periodic estimates to the States of the providers' 
                future dosage needs for recommended childhood vaccines 
                distributed under the Public Health Service Act. States 
                receiving Federal grants for immunization registries 
                shall report such data to the Secretary. All reports 
                shall be made with such frequency and in such detail as 
                the Secretary may prescribe.
                    ``(B) Consultations with federal agencies.--The 
                Secretary shall, in order to determine the appropriate 
                vaccines and amounts of vaccines to be purchased under 
                paragraph (1), consult with Federal agencies involved 
                in research regarding, or the regulation, procurement, 
                or distribution of, recommended childhood vaccines. 
                Such consultation may be effected through the 
                establishment of a Vaccine Requirements Panel to be 
                composed entirely of representatives of the relevant 
                Federal agencies, or through such other means as the 
                Secretary determines appropriate.
            ``(3) Cost or pricing data.--
                    ``(A) In general.--The Secretary shall negotiate a 
                reasonable price for vaccines to be purchased under 
                this section that fairly takes into account the excise 
                tax under section 4131 of the Internal Revenue Code of 
                1986 and the various costs described in subparagraph 
                (C).
                    ``(B) Manufacturers.--A manufacturer of recommended 
                childhood vaccines shall provide cost or pricing data 
                in support of the manufacturer's proposed price at the 
                time the manufacturer responds to a procurement 
                instituted by the Secretary under this section. A 
                manufacturer shall also provide such data upon the 
                request of the Secretary whenever the Secretary 
                determines that contract modifications are necessary.
                    ``(C) Type of information.--The information 
                required under subparagraph (B) shall include data 
                related to the research and development costs of the 
                vaccine, production costs, handling, shipping, and 
                other costs associated with delivering the vaccine to 
                health care providers and States in accordance with the 
                distribution plan of the Secretary (through the 
                manufacturers or a State, as the case may be) under the 
                Public Health Service Act, marketing costs, profit 
                levels sufficient to encourage future investments in 
                research and development of new or improved vaccines, 
                the cost of maintaining adequate capacity for outbreak 
                control, and any other data the Secretary determines 
                appropriate.
            ``(4) Confidentiality of data.--
                    ``(A) In general.--Information provided to the 
                Secretary under paragraph (3) shall be treated as trade 
                secret or confidential information subject to section 
                552(b)(4) of title 5, United States Code, and section 
                1905 of title 18, United States Code, and shall not be 
                revealed to any person other than those authorized by 
                the Secretary in connection with carrying out official 
                duties under this section.
                    ``(B) Prohibition on withholding.--Subparagraph (A) 
                shall not be construed as authorizing the withholding 
                of information provided under paragraph (3) from any 
                duly authorized subcommittee or committee of the 
                Congress. If the Secretary provides such information to 
                any subcommittee or committee, the Secretary shall give 
                written notice to the manufacturer that provided the 
                information.
                    ``(C) Written procedures.--The Secretary shall 
                establish written procedures to ensure the 
                confidentiality of information provided under paragraph 
                (3).
            ``(5) Prohibition on additional shipping or handling 
        charges.--Each contract for the purchase of recommended 
        childhood vaccines under this section shall contain a provision 
        by which the manufacturer agrees to ship or otherwise arrange 
        for the delivery of such vaccines in accordance with the 
        distribution plan of the Secretary (through the manufacturers 
        or a State, as the case may be) without imposing any additional 
        charge for shipping, handling, or any other cost on the health 
        care provider or State to which the vaccine is shipped or 
        delivered.
            ``(6) Multiple suppliers.--To ensure a reliable and 
        adequate supply of vaccine and to stimulate competition, the 
        Secretary shall enter into contracts when feasible with 
        multiple manufacturers of the same recommended childhood 
        vaccine, under such terms and conditions and utilizing such 
        procurement processes as the Secretary determines appropriate.
            ``(7) Reporting requirements.--Each contract for the 
        purchase of recommended childhood vaccines under this section 
        shall require the manufacturer to report in a standardized form 
        to the Secretary, or the Secretary's designee, and appropriate 
        States, at intervals determined by the Secretary, data 
        regarding the destination of the vaccines by lot number, and 
        any other information related to the vaccines purchased that 
        the Secretary may require.
    ``(b) Funding.--There shall be made available for expenditure by 
the Secretary, out of the Comprehensive Child Immunization Account in 
the Treasury of the United States established pursuant to section 3(b) 
of the Comprehensive Child Health Immunization Act of 1993, such 
amounts as are required to carry out this section for fiscal year 1995 
and for each fiscal year thereafter during which this section remains 
in effect.''.
    (b) Funding for Program.--
            (1) Maintenance of separately identifiable account.--There 
        shall be established in the Treasury of the United States a 
        Comprehensive Child Immunization Account for the purpose of 
        funding the activities under section 2101 of the Social 
        Security Act (as added by subsection (a) of this section).
            (2) Source of receipts.--Receipts shall be credited to the 
        account established under paragraph (1) as may be provided in 
        Federal law.
    (c) Termination of Program.--Such 2101 of the Social Security Act 
(as added by subsection (a) of this section) shall cease to be in 
effect beginning on such date as may be prescribed by a Federal law 
providing for immunization services for all children as part of a 
broad-based reform of the national health care system.

SEC. 4. REQUIREMENTS CONCERNING IMMUNIZATIONS OF CHILDREN UNDER STATE 
              MEDICAID PROGRAMS.

    (a) Coverage of Immunizations under Early and Periodic Screening, 
Diagnosis, and Testing (EPSDT).--Section 1905(r)(1)(B)(iii) of the 
Social Security Act (42 U.S.C. 1396d(r)(1)(B)(iii)) is amended to read 
as follows:
                    ``(iii) administration of appropriate recommended 
                childhood vaccines included on the list promulgated by 
                the Secretary under section 1931, taking into account 
                the health history of the individual,''.
    (b) Reimbursement Rates for Recommended Childhood Vaccines.--
Section 1902(a)(13) of the Social Security Act (42 U.S.C. 1396a(a)(13)) 
is amended--
            (1) by striking ``and'' at the end of subparagraph (E);
            (2) by inserting ``and'' at the end of subparagraph (F); 
        and
            (3) by adding at the end the following new subparagraph:
                    ``(G) that payments to providers shall include 
                amounts, as appropriate, as reimbursement for the 
                administration of recommended childhood vaccines in 
                accordance with section 1905(r)(1)(B)(iii);''.
    (c) Recommended Childhood Vaccines.--Title XIX of the Social 
Security Act (42 U.S.C. 1396 et seq.) is amended by adding at the end 
the following new section:

                    ``recommended childhood vaccines

    ``Sec. 1931. Not later than October 1, 1994, (and periodically 
thereafter as the Secretary determines appropriate in view of advances 
in scientific understanding in the areas of immunization and disease 
control) the Secretary shall promulgate a list of vaccines that provide 
immunization against naturally occurring infectious diseases and are 
recommended for universal use in children. The Secretary shall 
concurrently promulgate recommendations regarding the appropriate 
dosage for each such vaccine, and the age or ages of children at which 
each vaccine should be administered.''.
    (d) Effective Dates.--
            (1) In general.--Except as provided in paragraph (2), the 
        amendments made by subsections (a) and (b) shall be effective 
        with respect to calendar quarters beginning on and after 
        October 1, 1994.
            (2) Extension for state law amendment.--In the case of a 
        State plan under title XIX of the Social Security Act which the 
        Secretary of Health and Human Services determines requires 
        State legislation in order for the plan to meet the additional 
        requirements imposed by the amendments made by subsection (b), 
        the State plan shall not be regarded as failing to comply with 
        the requirements of such title solely on the basis of its 
        failure to meet these additional requirements before the first 
        day of the first calendar quarter beginning after the close of 
        the first regular session of the State legislature that begins 
        after the date of enactment of this Act. For purposes of the 
        previous sentence, in the case of a State that has a 2-year 
        legislative session, each year of such session shall be deemed 
        to be a separate regular session of the State legislature.

SEC. 5. NATIONAL VACCINE INJURY COMPENSATION PROGRAM AMENDMENTS.

    (a) Use of Vaccine Injury Compensation Trust Fund.--
            (1) Section 9510(c)(1) of the Internal Revenue Code of 1986 
        is amended by striking out ``, and before October 1, 1992,''.
            (2) Section 6601(r) of the Omnibus Budget Reconciliation 
        Act of 1989 is amended by striking out ``$2,500,000 for each of 
        fiscal years 1991 and 1992'' each place it appears and 
        inserting in lieu thereof `` $3,000,000 for fiscal year 1994 
        and each fiscal year thereafter''.
    (b) Permanent Extension of Authority to Impose Taxes for the 
Vaccine Injury Compensation Trust Fund.--
            (1) Permanent extension of tax.--Section 4131(c) of the 
        Internal Revenue Code of 1986 is repealed.
            (2) Reinstatement of tax.--The tax imposed by section 4131 
        of the Internal Revenue Code of 1986 is hereby reinstated 
        effective April 1, 1993.

SEC. 6. NATIONAL IMMUNIZATION TRACKING SYSTEM.

    On such date as section 2101 of the Social Security Act (as added 
by section 3(a) of this Act) shall cease to be in effect as provided in 
section 3(c) of this Act, the Secretary of Health and Human Services 
shall implement a program to ensure participation of all health care 
providers in a national immunization tracking system.

                                 <all>

S 733 IS----2