[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 732 Introduced in Senate (IS)]

103d CONGRESS
  1st Session
                                 S. 732

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

_______________________________________________________________________

                                 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 AND REFERENCES.

    (a) Short Title.--This Act may be cited as the ``Comprehensive 
Child Immunization Act of 1993''.
    (b) References.--Except as otherwise expressly provided, whenever 
in this Act an amendment or repeal is expressed in terms of an 
amendment to, or repeal of, a section or other provision, the reference 
shall be considered to be made to a section or other provision of the 
Public Health Service Act (42 U.S.C. 201 et seq.).

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 immunization services delivery 
                infrastructure to immunize children 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 strengthened and 
                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. NATIONAL IMMUNIZATION TRACKING SYSTEM.

    (a) In General.--Title XXI of the Public Health Service Act (42 
U.S.C. 300aa-1 et seq.) is amended by adding at the end thereof the 
following new subtitle:

    ``Subtitle 3--Improved Immunization and National Tracking System

``SEC. 2141. RECOMMENDED CHILDHOOD VACCINES.

    ``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.

``SEC. 2142. TRACKING OF CHILDHOOD IMMUNIZATIONS.

    ``(a) National Tracking System.--
            ``(1) Establishment.--The Secretary shall establish a 
        national system to track the immunization status of children.
            ``(2) System design.--The system established under 
        paragraph (1) shall be designed to--
                    ``(A) provide accurate and up to date surveillance 
                data regarding immunization rates at the local and 
                State levels;
                    ``(B) assist in identifying localities with 
                inadequate immunization rates to target for necessary 
                remedial actions;
                    ``(C) be used to identify unvaccinated children and 
                trigger a notification system for the parents or legal 
                guardians and health care providers of such children;
                    ``(D) be used to assist in the effective 
                administration and management of immunization programs 
                at State and local levels by providing data to guide 
                immunization program efforts;
                    ``(E) assist States and localities in tracking the 
                immunization status of children who move across 
                geographic boundaries that are covered by different 
                State or local registries; and
                    ``(F) monitor the safety and effectiveness of 
                vaccines by linking vaccine dosage information with 
                adverse events reporting under section 2125(b) and 
                disease outbreak patterns.
            ``(3) Notification of parents.--The Secretary is 
        authorized, in the case of inadequately immunized children in 
        States not receiving grants under subsection (b), to notify the 
        parents or guardians of those children receiving services 
        through paragraphs (1), (2) or (3) of section 2143(a) of the 
        need to protect their children with specific vaccine.
    ``(b) State Registry Grants.--
            ``(1) In general.--The Secretary may award grants to States 
        to enable such States to establish and operate State 
        immunization tracking registries. A State receiving a grant 
        under this section shall maintain a registry that includes the 
        following information for each child living within the State:
                    ``(A) The type and lot number of each recommended 
                childhood vaccine administered after September 30, 
                1996.
                    ``(B) An identification of the health care provider 
                administering such vaccine.
                    ``(C) The address and other demographic data needed 
                to find the child.
                    ``(D) Notations of any adverse events associated 
                with each immunization.
                    ``(E) Special religious considerations or medical 
                conditions that are contraindications for 
                immunizations.
                    ``(F) Such other information as the Secretary may 
                prescribe.
            ``(2) Grant conditions.--A State, as a condition of 
        receiving a grant under this subsection, shall comply with the 
        following requirements:
                    ``(A) The State registry shall provide for entry of 
                the birth of each infant within the state within six 
                weeks following the birth, and for timely entry 
                thereafter of all information received from health care 
                providers pursuant to section 2143(b)(2) or section 
                2125(b).
                    ``(B) Subject to subsection (c), the State shall 
                provide for the sharing of appropriate information from 
                the State's registry, including immunization status and 
                reports of adverse reactions, with health care 
                providers who offer immunizations for the purpose of 
                achieving the full immunization of all children in 
                accordance with the recommendations of the Secretary 
                under section 2141.
                    ``(C) The State shall provide for notification to 
                the parents or guardian of an inadequately immunized 
                child of the need to protect the child with specific 
                vaccine, except as provided in paragraph (1)(E).
                    ``(D) Subject to subsection (c), the State shall 
                provide for the coordination and exchange of 
                information with other State registries to allow the 
                tracking of the immunization status of children 
                changing State of residence.
                    ``(E) The State shall periodically furnish to the 
                Secretary, at such times and in such form as the 
                Secretary may prescribe, information contained in the 
                State registry.
                    ``(F) In designing its registry, the State shall 
                adhere to tracking models and systems specifications 
                prescribed by the Secretary for the purpose of ensuring 
                the mutual compatibility of the data systems and 
                electronic information technology utilized by the 
                Secretary and the various States in carrying out 
                activities under this subtitle.
                    ``(G) The State shall monitor and enforce 
                compliance by health care providers with the 
                requirements of section 2143(b). The State shall 
                establish procedures satisfactory to the Secretary for 
                terminating from participation in the recommended 
                childhood vaccine distribution program any health care 
                provider who fails to comply with the requirements of 
                section 2143(b)(1) and for reinstating such provider to 
                program participation upon receiving from such 
                provider--
                            ``(i) the reports necessary to make current 
                        and complete the information that would have 
                        been furnished to the State registry between 
                        the dates of the provider's termination and 
                        reinstatement; and
                            ``(ii) satisfactory assurances regarding 
                        the provider's future compliance.
                    ``(H) If a State distributes recommended childhood 
                vaccines within the State on behalf of the Secretary 
                pursuant to section 2143(a), the State shall compile 
                data, including lot numbers, on the vaccines 
                distributed to each health care provider and shall 
                furnish such data to the Secretary in such form and at 
                such intervals as the Secretary may prescribe.
            ``(3) Applications.--A State shall prepare and submit to 
        the Secretary an application for a grant under subsection (b) 
        in such form and containing such information as the Secretary 
        may prescribe. The application shall include--
                    ``(A) a description of the methods by which the 
                State will comply with the requirements of paragraph 
                (2);
                    ``(B) the assurances required by paragraph (4); and
                    ``(C) a description of the expenses that the State 
                will incur in connection with its responsibilities 
                under the grant.
            ``(4) Assurances.--A State submitting an application for a 
        grant under this section shall provide assurances satisfactory 
        to the Secretary that--
                    ``(A) the State's tracking registry will be fully 
                operational not later than October 1, 1996;
                    ``(B) the State's tracking registry will adhere to 
                any tracking models and systems specifications 
                prescribed by the Secretary pursuant to paragraph 
                (2)(F); and
                    ``(C) as appropriate, the State is making 
                satisfactory and timely progress toward achieving the 
                conditions described in subparagraphs (A) and (B).
            ``(5) Allowable uses of grant funds.--A State may use 
        amounts from a grant awarded under this subsection for 
        reasonable costs associated with the development and operation 
        of its registry, including computer needs, technical assistance 
        and training, education of health care providers, personnel 
        costs, travel expenses, and other appropriate activities.
            ``(6) State reports to the Secretary.--A State shall 
        prepare and submit annual reports to the Secretary concerning 
        the operation of the State's registry and other activities 
        under this subtitle. Such reports shall be in such form, 
        contain such information, and be submitted at such intervals as 
        the Secretary may prescribe.
    ``(c) Use and Disclosure of Personal Information.--
            ``(1) General rule.--No personally-identifiable information 
        relating to a child who receives recommended childhood vaccine 
        under this subtitle or to the parent or guardian of such a 
        child that is collected or maintained by the National Tracking 
        System established under subsection (a), or a State 
        immunization tracking registry established under subsection 
        (b), may be used or disclosed by any holder of such information 
        except as permitted by this subsection.
            ``(2) General permissible uses.--Information described in 
        paragraph (1) may be used or disclosed, without the consent of 
        the individual to whom it refers, or of the parent or guardian 
        of such individual, for--
                    ``(A) the tracking of children's immunization 
                status, and other purposes directly related to the 
                health of the children being tracked and of their 
                families;
                    ``(B) oversight, audit, and evaluation of the 
                immunization delivery and tracking activities, and the 
                enforcement of the provisions of this title;
                    ``(C) activities relating to establishing and 
                maintaining a safe and effective supply of recommended 
                childhood vaccine (including activities to carry out 
                part C of subtitle 2);
                    ``(D) processing of insurance claims for payment 
                for vaccine administration (but only to the extent 
                necessary to process a claim); or
                    ``(E) administration of the National Vaccine Injury 
                Compensation Program under subtitle 2.
            ``(3) Permissible use with written authorization.--
        Information described in paragraph (1) may be used or disclosed 
        with the written authorization of the individual to whom it 
        refers, or the parent or guardian of such individual, and must, 
        upon the request of such individual, or parent or guardian, be 
        provided in writing to the individual.
            ``(4) Regulations.--The Secretary is authorized to issue 
        regulations--
                    ``(A) governing the use, maintenance, and 
                disclosure, by any holder of information described in 
                paragraph (1), including appropriate administrative, 
                technical and physical safeguards to ensure that only 
                authorized persons have access to the information; and
                    ``(B) establishing conditions for access by 
                individuals, and their parents or guardians, to such 
                information about themselves.
            ``(5) Violations.--Any person who knowingly--
                    ``(A) uses or discloses information in violation of 
                this subsection; or
                    ``(B) requests or obtains any information in 
                violation of this subsection, and offers or provides 
                anything of value in exchange for the provision of the 
                information;
        shall be fined as prescribed by title 18, United States Code, 
        or imprisoned not more than 3 years, or both.
    ``(d) Authority To Use Social Security Numbers.--
            ``(1) In general.--Notwithstanding section 205 of the 
        Social Security Act or any other provision of law, the 
        Secretary and States receiving grants under subsection (b) may 
        utilize the social security number, or other means of 
        identification, of a child or of a parent or guardian of the 
        child for purposes of identification of a child in any registry 
        established under this section, and may require a child's 
        parent or guardian to furnish such number (in any case where 
        such a number has been assigned by the Social Security 
        Administration) as a condition of the child receiving 
        recommended childhood vaccine under this subtitle.
            ``(2) Authority to redisclose.--Notwithstanding section 
        205(c)(2)(C)(vii)(I) of the Social Security Act, a social 
        security number obtained in connection with activities under 
        this subtitle may be redisclosed if such redisclosure is 
        otherwise in accordance with subsection (c) of this section.
    ``(e) Reports by Secretary to the Congress.--Not later than January 
1, 1995, and biennially thereafter, the Secretary shall prepare and 
submit to the appropriate committees of Congress a report concerning 
the planning, development and operation of the national tracking system 
and the State registries.

``SEC. 2143. DISTRIBUTION OF VACCINES.

    ``(a) In General.--The Secretary shall provide for the distribution 
without charge of recommended childhood vaccines purchased by the 
Secretary under the Social Security Act to health care providers who 
serve children and who--
            ``(1) are members of a uniformed service, or are officers 
        or employees of the United States;
            ``(2) are health centers (as defined in section 2144(2));
            ``(3) provide services under section 503 of the Indian 
        Health Care Improvement Act or pursuant to a contract under 
        section 102 of the Indian Self Determination Act; or
            ``(4) are located in a State receiving a grant under 
        section 2142(b).
The Secretary may provide for such distribution through any State that 
receives a grant under section 2142(b).
    ``(b) Duties of Health Care Providers.--
            ``(1) Free provision to children.--A health care provider 
        receiving vaccine under this section may use such vaccine only 
        for administration to children and may not impose a charge for 
        such vaccine. A provider may impose a fee for the 
        administration of such vaccine, except that a provider may not 
        deny a child a vaccination due to the inability of the child's 
        parent or guardian to pay an administration fee.
            ``(2) Reporting requirements.--A health care provider 
        receiving vaccine under this section shall report to the 
        applicable State registry operated pursuant to a grant under 
        section 2142(b) (or to the Secretary if there is no such State 
        registry) the data described in section 2142(b)(1) for each 
        dose of vaccine administered to a child. The provider shall 
        additionally report to such State registry any occurrence 
        reported to the Secretary pursuant to section 2125(b). The 
        provider shall also provide regular and periodic estimates to 
        the State of the provider's future dosage needs for recommended 
        childhood vaccine distributed under this section. All reports 
        shall be made with such frequency and in such detail as the 
        Secretary may prescribe.

``SEC. 2144. DEFINITIONS.

    ``For purposes of this subtitle--
            ``(1) Health center.--The term `health center' means--
                    ``(A) a federally-qualified health center, as 
                defined in section 1905(l)(2) of the Social Security 
                Act; or
                    ``(B) a public or nonprofit private entity 
                receiving Federal funds under--
                            ``(i) section 340A (relating to grants for 
                        health services for residents of public 
                        housing); or
                            ``(ii) section 501(a)(2) of the Social 
                        Security Act (relating to special projects of 
                        regional and national significance).
            ``(2) Recommended childhood vaccine.--The term `recommended 
        childhood vaccine' is a vaccine on the list promulgated by the 
        Secretary pursuant to section 2141.

``SEC. 2145. AUTHORIZATION OF APPROPRIATIONS.

    ``For the purpose of awarding grants under section 2142 and for the 
operation of the tracking system authorized by such section, there are 
authorized to be appropriated $152,000,000 for fiscal year 1995, 
$125,000,000 for fiscal year 1996, and $35,000,000 for each of fiscal 
years 1997 through 1999.''.

SEC. 4. GRANTS FOR IMMUNIZATION.

    Section 317(j)(1) (42 U.S.C. 247b(j)(1)) is amended by adding at 
the end thereof the following new subparagraph:
    ``(C)(i) Funds that are made available for the purpose of 
strengthening the public health infrastructure and used in the delivery 
of childhood immunization services shall be used for activities that 
are consistent with a strategic plan that meets nationally established 
immunization goals and that was developed by the State in consultation 
with representatives of health care providers, health centers (as 
defined in clause (iii)), State agencies serving young children, and 
other entities involved in the prevention and control of vaccine-
preventable illnesses.
    ``(ii) For purposes of clause (i), activities designed to 
strengthen the public health infrastructure and used in the delivery of 
childhood immunization services shall include public and provider 
education, community outreach initiatives, improvements in the capacity 
of health centers and local health departments to provide immunization 
services (including expansion of the number of hours in which such 
services are provided), and activities to facilitate the development 
and operation of State immunization tracking registries.
    ``(iii) For purposes of this paragraph, the term `health center' 
means a public or nonprofit private entity receiving Federal funds 
under--
            ``(I) section 329 (relating to grants for migrant health 
        centers);
            ``(II) section 330 (relating to grants for community health 
        centers);
            ``(III) section 340 (relating to grants for health services 
        for the homeless); or
            ``(IV) section 340A (relating to grants for health services 
        for residents of public housing).''.

SEC. 5. NATIONAL VACCINE INJURY COMPENSATION PROGRAM AMENDMENTS.

    (a) Amendment of Vaccine Injury Table.--
            (1) Addition of vaccines.--Section 2114 (42 U.S.C. 300aa-
        14) is amended by adding at the end thereof the following new 
        subsection:
    ``(f) Addition of Vaccines to Table.--The Vaccine Injury Table in 
subsection (a) shall also include any recommended childhood vaccine 
included in the list promulgated by the Secretary under section 2141. 
The Secretary may modify the Table with respect to any vaccine added by 
operation of the preceding sentence only in accordance with subsection 
(c). For purposes of section 2116(b), the addition of a vaccine to the 
Table by operation of this subsection shall constitute a revision of 
this Table.''.
    (2) Limitation of actions.--Section 2116(b) (42 U.S.C. 300aa-16(b)) 
is amended by striking ``such person may file'' and inserting ``or to 
significantly increase the likelihood of obtaining compensation, such 
person may, notwithstanding section 2111(b)(2), file''.
    (b) Extension of Time for Decision.--Section 2112(d)(3)(D) (42 
U.S.C. 300aa-12(d)(3)(D)) is amended by striking ``540 days'' and 
inserting ``30 months (but for not more than 6 months at a time)''.
    (c) Simplification of Vaccine Information Materials.--
            (1) Information.--Section 2126(b) (42 U.S.C. 300aa-26(b)) 
        is amended--
                    (A) by striking ``by rule'' in the matter preceding 
                paragraph (1);
                    (B) in paragraph (1), by striking ``, opportunity 
                for a public hearing, and 90'' and inserting ``and 
                30''; and
                    (C) in paragraph (2), by striking ``, appropriate 
                health care providers and parent organizations''.
            (2) Requirements.--Section 2126(c) (42 U.S.C. 300aa-26(c)) 
        is amended--
                    (A) in the matter preceding paragraph (1), by 
                inserting ``shall be based on available data and 
                information,'' after ``such materials''; and
                    (B) by striking out paragraphs (1) through (10) and 
                inserting in lieu thereof the following new paragraphs:
            ``(1) a concise description of the benefits of the vaccine;
            ``(2) a concise description of the risks associated with 
        the vaccine; and
            ``(3) a statement of the availability of the National 
        Vaccine Injury Compensation Program.''.
            (3) Other individuals.--Subsections (a) and (d) of section 
        2126 (42 U.S.C. 300aa-26(a) and (d)) are amended by inserting 
        ``or to any other individual'' immediately after ``to the legal 
        representative of any child'' each place that such occurs.
            (4) Provider duties.--Subsection (d) of section 2126 (42 
        U.S.C. 300aa-26(d)) is amended--
                    (A) by striking all after ``subsection (a),'' the 
                second place it appears in the first sentence and 
                inserting ``supplemented with visual presentations or 
                oral explanations, in appropriate cases.''; and
                    (B) by striking ``or other information'' in the 
                last sentence.

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