[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 1981 Introduced in Senate (IS)]







106th CONGRESS
  1st Session
                                S. 1981

 To amend title XI of the Public Health Service Act to provide for the 
 use of new genetic technologies to meet the health care needs of the 
                                public.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           November 19, 1999

  Mr. Kennedy introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 To amend title XI of the Public Health Service Act to provide for the 
 use of new genetic technologies to meet the health care needs of the 
                                public.

    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 ``Genetics and Public Health Services 
Act''.

SEC. 2. FINDINGS AND PURPOSE.

    (a) Findings.--Congress finds:
            (1) Genetic disorders comprise a spectrum of diseases 
        caused, entirely or in part, by inherited or acquired mutations 
        in a person's genes.
            (2) Included amongst the many genetic diseases are those 
        caused by a single gene mutation, such as Sickle Cell disease, 
        Cystic Fibrosis, and PKU, as well as the more common, multi-
        factorial ``genetic'' disorders, such as diabetes, mental 
        illness, heart disease, and cancer.
            (3) Current estimates are that 1 in 20 individuals will be 
        diagnosed with a single gene disorder by the age of 25 and that 
        65 percent of the population will be diagnosed during their 
        lifetime with a single gene disorder or a disorder that has a 
        genetic component.
            (4) Significant public and private resources have been 
        dedicated to genetics research, including the Human Genome 
        Project, leading to marked improvements in our understanding of 
        and increasing ability to diagnose and treat genetic disorders. 
        From 1993 to the present, the number of diagnostic tests 
        available for genetic disorders has increased more than six-
        fold. The fraction of the population recognized as having 
        genetic disorders, including disorders with a genetic 
        component, will continue to increase dramatically as medical 
        genetics knowledge advances.
            (5) Research is also leading to an expanding array of 
        available therapies that will result in new treatments for 
        genetic disorders, and may ultimately lead to cures for genetic 
        disorders.
            (6) There has yet to be a coordinated Federal effort to 
        apply research discoveries in ways that will ensure direct 
        benefit to Americans who are at risk of or living with genetic 
        disorders.
            (7) Early diagnosis and treatment can lead to prevention of 
        unnecessary human suffering, and considerable savings in costs 
        related to treating advanced disease.
            (8) To ensure that individuals benefit from genetic 
        technology and information, it is necessary to ensure the 
        availability of comprehensive genetic services including 
        education and genetic counseling, appropriate genetic 
        evaluation that is preceded by informed consent and followed by 
        the opportunity to explore the impact of the results of such 
        evaluation or other tests, and fair access to services for 
        evaluation, followup and treatment.
            (9) The field of genetics is evolving at a great pace. 
        Genetic services will create tremendous potential to improve 
        the lives of patients, but genetic services that are 
        inappropriately administered may be unnecessary or even 
        harmful. Only a well-informed society, including the health 
        workforce, policy makers, and citizens, can apply and use new 
        discoveries in a fashion that will broadly benefit the public.
            (10) At present, most States have few available public 
        health genetic services due to limited funding.
            (11) The Federal Government has historically supported and 
        administered programs that provide nongenetic, essential health 
        services, such as access to vaccinations for children, and 
        require State collection of data on certain diseases. In 
        addition, Federal agencies, including the Centers for Disease 
        Control and Prevention, the Health Resources and Services 
        Administration, and the National Institutes of Health, are 
        working collaboratively to begin to address the need for 
        genetic services.
            (12) Without additional Federal support and agency 
        oversight, however, States lack the resources needed to deal 
        adequately with the expanding genetic technologies. A new 
        commitment to genetic services should build upon existing 
        programs and provide for the establishment and support of new 
        and innovative programs.
    (b) Purpose.--It is the purpose of this Act to provide for the 
establishment of genetic grant programs to enable each State and 
territory to--
            (1) establish, expand, and maintain systems and programs to 
        provide quality genetic information, counseling, testing and 
        specialty services necessary to preserve public and personal 
        health and welfare;
            (2) initiate and promote programs and services to reduce 
        the mortality and the morbidity for heritable disorders and to 
        reduce the adverse effects on mental and physical health of 
        heritable disorders in the population;
            (3) develop within each State health agency expertise 
        capable of determining needs and level of genetic services 
        available, and of assuring the quality, provision and promotion 
        of genetic services required by residents of the State;
            (4) promote the understanding, by the public and by health 
        care providers, of genetic disorders and their diagnosis, 
        prevention, and treatment, and to provide for a mechanism for 
        public input on State genetic policy and programs;
            (5) assure that any services provided under this Act shall 
        be available to all individuals, regardless of income, race, 
        color, religion, sex, national origin, age, or disability; and
            (6) establish the following grant programs:
                    (A) A Federal-State block grant program, with 
                matching funds, to support the establishment, expansion 
                and maintenance of State resources for public health 
                genetics activities.
                    (B) A grant program to support applied public 
                health research in genetics and projects to develop and 
                test strategies and education programs to use genetic 
                information and technology to improve public health.

SEC. 3. AMENDMENT TO PUBLIC HEALTH SERVICE ACT.

    Part A of title XI of the Public Health Service Act (42 U.S.C. 
300b-1 et seq.) is amended--
            (1) by inserting after the part designation the following:

                ``Subpart I--Grants for Research''; and

            (2) by adding at the end the following:

                      ``Subpart II--Genetic Grants

``SEC. 1110. GRANTS TO STATES.

    ``(a) Block Grants.--
            ``(1) In general.--The Secretary shall award grants to 
        States for the purpose of enabling such States to establish, 
        improve and maintain State public health infrastructure for 
        genetics.
            ``(2) Administration.--The Secretary may provide for the 
        administration of the block grant program under paragraph (1) 
        through the creation of an office for genetic services, if the 
        Secretary determines such administration to be appropriate.
    ``(b) Grants for Applied Public Health Research and Systems 
Development.--
            ``(1) In general.--The Secretary shall award grants to 
        eligible entities to carry out studies or to establish pilot 
        and demonstration public health programs for the diagnosis and 
        management of genetic diseases, including diseases with a 
        genetic component, education projects for health care providers 
        and the general public, population studies relating to 
        genetics, or for other activities of the type described in 
        subsection (c).
            ``(2) Eligible entities.--To be eligible to receive a grant 
        under paragraph (1) an entity shall--
                    ``(A) be a public or nonprofit private entity, 
                including institutions of higher education;
                    ``(B) prepare and submit to the Secretary an 
                application at such time, in such manner, and 
                containing such information as the Secretary may 
                require, including whether the activities to be carried 
                out under the grant are easily replicated and the 
                strategies for translating such activities for use in 
                both the public and private sectors; and
                    ``(C) agree to provide regular reports and conduct 
                audits in accordance with subsections (b) and (c) of 
                section 1114.
    ``(c) Use of Funds.--
            ``(1) In general.--A State shall use amounts provided under 
        a grant under subsection (a) to carry out activities to--
                    ``(A) establish, expand and maintain systems to 
                provide quality genetic information, counseling, 
                testing and specialty services necessary to preserve 
                public and personal health and welfare;
                    ``(B) initiate and promote programs and services to 
                reduce the mortality and the morbidity for heritable 
                disorders and to reduce the adverse effects on mental 
                and physical health of heritable disorders in the 
                population;
                    ``(C) develop within the State health agency 
                expertise capable of determining needs and level of 
                genetic services available, and of assuring the 
                quality, provision and promotion of genetic services 
                required by residents of the State;
                    ``(D) promote the understanding, by the public and 
                by health care providers in the State, of genetic 
                disorders and their prevention and treatment, and to 
                provide for a mechanism for public input on State 
                genetic policy and programs; and
                    ``(E) assure that any services provided under this 
                subpart shall be available to all individuals, 
                regardless of income, race, color, religion, sex, 
                national origin, age, or disability.
            ``(2) Limitation.--A State may not use funds received under 
        this section to--
                    ``(A) provide cash payments to or on behalf of 
                affected individuals;
                    ``(B) provide inpatient services;
                    ``(C) purchase land or make capital improvements to 
                property;
                    ``(D) meet the matching requirements relating to 
                the receipt of other Federal funds; and
                    ``(E) provide for proprietary research or training.
    ``(d) Voluntary Participation.--The participation by any individual 
in any program or portion thereof established or operated with funds 
received under this subpart shall be wholly voluntary and shall not be 
a prerequisite to eligibility for or receipt of any other service or 
assistance from, or to participation in, any other Federal or State 
program.

``SEC. 1111. ADVISORY COMMITTEE.

    ``(a) Establishment.--The Secretary shall establish an advisory 
committee to be known as the `Advisory Committee on Genetics and Public 
Health Services' (referred to in this subpart as the `Advisory 
Committee').
    ``(b) Members.--
            ``(1) In general.--The Advisory Committee shall be composed 
        of ex officio members in accordance with paragraph (2) and an 
        odd number of appointed members, not to exceed 15, in 
        accordance with paragraph (3).
            ``(2) Ex officio members.--The ex officio members of the 
        Advisory Committee shall include the Surgeon General, the 
        Administrator of the Health Resources and Services 
        Administration, the Director of the Centers for Disease Control 
        and Prevention, and representatives of--
                    ``(A) the National Institutes of Health;
                    ``(B) the Agency for Health Care Policy and 
                Research;
                    ``(C) the Food and Drug Administration; and
                    ``(D) such other agencies and offices within the 
                Department of Health and Human Services, or other 
                Federal agencies, that administer programs dealing with 
                genetics.
            ``(3) Appointed members.--The appointed members of the 
        Advisory Committee shall be individuals appointed by the 
        Secretary to ensure input from--
                    ``(A) the various sectors of the clinical genetics 
                community that are directly involved in providing 
                clinical services, including clinical laboratory 
                services, to the public;
                    ``(B) the public, especially regarding concerns 
                about access to health care and the risk of genetic 
                discrimination;
                    ``(C) the scientific genetic and genetic 
                epidemiology community;
                    ``(D) the private sector; and
                    ``(E) State health agencies and the public health 
                community.
    ``(c) Duties.--The Advisory Committee shall--
            ``(1) provide advice and recommendations to the Secretary 
        concerning grants and projects awarded or funded under this 
        subpart;
            ``(2) provide technical information to the Secretary for 
        the development of policies and priorities for the 
        administration of grants under this subpart;
            ``(3) carry out other activities under this subpart as 
        determined appropriate by the Secretary; and
            ``(4) submit to Congress an annual report, to be prepared 
        by the Health Resources and Services Administration together 
        with the Centers for Disease Control and Prevention, concerning 
        the activities under this subpart, including a description of 
        programs that receive funding and objective measures of the 
        effects of such programs on public health.

``SEC. 1112. APPLICATION.

    ``(a) In General.--To be eligible for a block grant under section 
1110(a), a State shall prepare and submit to the Secretary an 
application that includes--
            ``(1) a statewide needs assessment that identifies specific 
        health status goals and objectives relative to genetic 
        disorders, including attention to needs of special populations;
            ``(2) a plan for addressing the needs identified in 
        priority order, and the manner in which funds under section 
        1110(a) will be used to meet the goals and objectives of the 
        State;
            ``(3) a plan for the collection of outcome data or other 
        methods of evaluating the degree to which the funds provided 
        under the grant will be used to achieve the goals and 
        objectives of the State;
            ``(4) a plan for monitoring and ensuring the quality of 
        services provided under the grant, including attention to 
        issues of access to specialty care;
            ``(5) a plan for the education of the appropriate 
        professional staff of the public health department with respect 
        to genetics, and for increasing the knowledge of health care 
        providers and the general public concerning genetic disease;
            ``(6) an assurance that the State will use funds provided 
        under the grant to supplement and, to the extent practicable, 
        to increase the level of funding that would otherwise be made 
        available by the State for genetic programs and not to supplant 
        such non-Federal funds;
            ``(7) an assurance that the State will provide matching 
        funds in accordance with section 1113(d);
            ``(8) an assurance that funds provided under the grant will 
        only be used to implement the approved plan for the State;
            ``(9) an assurance that the provision of services under the 
        plan is coordinated with services provided under programs 
        implemented in the State under title V, XVIII, XIX, XX, or XXI 
        of the Social Security Act (subject to Federal regulations 
        applicable to such program) so that the coverage of services 
        under such titles is not diminished in any way by the 
        availability of services under a genetic program implemented 
        under a grant under section 1110(a) in the State; and
            ``(10) such other information as the Secretary considers 
        appropriate.
    ``(b) Publication.--An application submitted under this section 
shall be made public by the State in such a manner as to facilitate 
comment from any person, including through hearings and other methods 
used to facilitate comments from the public. Any such comments received 
shall be addressed in the application.
    ``(c) Multistate Applications.--Two or more States may enter into 
an agreement to submit a joint multistate application for a single 
block grant under section 1110(a) in order to maximize the use of 
scarce regional resources. Any such application shall contain 
assurances that each State that is a party to the application will--
            ``(1) be addressed with respect to the requirements of 
        paragraphs (1) through (10) of subsection (a); and
            ``(2) comply with all other provisions of this subpart.

``SEC. 1113. ALLOCATION OF FUNDS.

    ``(a) In General.--For each fiscal year, the amount of the grant 
for each State or territory under section 1110(a) for the fiscal year 
involved shall be the greater of--
            ``(1) the amount determined under subsection (b) for the 
        State or territory for the fiscal year; or
            ``(2) $400,000.
    ``(b) Formula.--With respect to a State or territory, the amount 
determined under this subsection shall be equal to the amount that 
bears the same ratio to the amount appropriated for the fiscal year 
involved under section 1115 as the population of the State or territory 
bears to the population of all States and territories.
    ``(c) Redistribution of Certain Funds.--Except as provided in 
section 1115(a)(3), any amount appropriated for a fiscal year under 
section 1115 and remaining available as a result of--
            ``(1) the failure of any State or territory to submit an 
        application under section 1112, or the failure, in the 
        determination of the Secretary, of any State or territory to 
        prepare the application in compliance with such section or to 
        submit the application within a reasonable period of time; or
            ``(2) any State or territory informing the Secretary that 
        the State or territory does not intend to expend the full 
        amount of the grant made to the State or territory, or the 
        failure of the State or territory to expend the full amount 
        allocated to the State or territory by the end of the fiscal 
        year following the fiscal year for which the allocation was 
        made;
shall be redistributed to the remaining States and territories in 
proportion to the original distribution for such fiscal year to such 
States and territories.
    ``(d) Requirement for Matching Funds.--
            ``(1) In general.--The Secretary may not make a grant to a 
        State or territory under section 1110(a) unless the State or 
        territory agrees that, with respect to the costs to be incurred 
        by the State or territory in carrying out the program for which 
        the grant was awarded, the State or territory will, subject to 
        paragraph (2), make available (directly or through donations 
        from public or private entities) non-Federal contributions in 
        an amount equal to not less than $2 for every $3 of Federal 
funds provided under the grant.
            ``(2) Determination of amount of non-federal 
        contribution.--Non-Federal contributions required in paragraph 
        (1) may be in cash or in kind, fairly evaluated, including 
        plant, equipment, or services. Amounts provided by the Federal 
        Government, and any portion of any service subsidized by the 
        Federal Government, may not be included in determining the 
        amount of such non-Federal contributions.

``SEC. 1114. REGULATIONS, REPORTS, AND AUDITS.

    ``(a) Regulations.--The Secretary shall promulgate regulations 
necessary to carry out this subpart.
    ``(b) Reports.--
            ``(1) Annual report by states.--
                    ``(A) In general.--Not later than 1 year after the 
                date of enactment of the Genetics and Public Health 
                Services Act, and annually thereafter, each State and 
                territory shall prepare and submit to the Administrator 
                of the Health Resources and Services Administration a 
                report that--
                            ``(i) describes the purposes for which the 
                        State expended payments made to the State under 
                        this subpart; and
                            ``(ii) contains such additional information 
                        regarding activities authorized in section 
                        1110, and is submitted in such form, as the 
                        Secretary may require.
                    ``(B) Criteria.--The Administrator of the Health 
                Resources and Services Administration shall develop 
                criteria for the preparation and submission of the 
                annual reports under subparagraph (A).
                    ``(C) Publication.--Each State and territory shall 
                make copies of the report submitted under this 
                paragraph for the fiscal year available for public 
                inspection, and shall upon request provide a copy of 
                the report to any individual without charge or for a 
                charge not exceeding the cost of providing the copy.
            ``(2) Annual report by hrsa.--Not later than 1 year after 
        the date of enactment of the Genetics and Public Health 
        Services Act, and annually thereafter, the Health Resources and 
        Services Administration together with the Director for the 
        Centers for Disease Control and Prevention shall prepare and 
        submit to the Secretary a report that contains a summary of the 
        data contained in the reports submitted with respect to the 
        fiscal year involved under paragraph (1).
    ``(c) Fiscal Controls and Audits.--
            ``(1) In general.--Each State and territory shall establish 
        fiscal control and fund accounting procedures as may be 
        necessary to assure the proper disbursal of and accounting for 
        Federal funds paid to the State under this subpart.
            ``(2) Biennial audit.--Each State and territory shall 
        biennially audit its expenditures from payments received under 
        this subpart. Such audits shall be conducted by an entity 
        independent of any agency administering a program funded under 
        this subpart and, in-so-far as practical, in accordance with 
        the Comptroller General's standards for auditing governmental 
        organizations, programs, activities, and functions. Within 30 
        days following the date each audit is completed, the chief 
        executive officer of the State shall transmit a copy of that 
        audit to the Secretary.
            ``(3) Repayments.--Each State and territory shall, after 
        being provided by the Secretary with adequate notice and 
        opportunity for a hearing within the State or territory, repay 
        to the United States amounts found not to have been expended in 
        accordance with the requirements of this subpart. If such 
        repayment is not made, the Secretary shall, after providing the 
        State or territory with adequate notice and opportunity for a 
        hearing within the State or territory, offset such amounts 
        against the amount of any payment to which the State or 
        territory is or may become entitled under this subpart.
            ``(4) Public inspection.--A State or territory shall make 
        copies of the audits required by this subsection available for 
        public inspection within the State or territory.

``SEC. 1115. AUTHORIZATION OF APPROPRIATIONS.

    ``(a) Grants and Advisory Committee Administration.--
            ``(1) In general.--There is authorized to be appropriated 
        for making grants under section 1110(a) and for the 
        administration of the Advisory Committee under section 1111 
        $70,000,000 for each of fiscal years 2000 through 2009, and 
        such sums as may be necessary for each succeeding fiscal year.
            ``(2) Increase in authorization.--The amount described in 
        paragraph (1) for a fiscal year shall be increased from the 
        prior fiscal year based on the increase in the consumer price 
        index for such fiscal year as determined by the Secretary of 
        Labor.
            ``(3) Availability.--Subject to section 1113(c), amounts 
        appropriated for a fiscal year under paragraph (1) and 
        unexpended at the end of such fiscal year shall remain 
        available in the succeeding fiscal year.
            ``(4) Administration.--The Secretary shall ensure that, 
        with respect to block grants under section 1110(a), not more 
        than 20 percent of the amount available for any fiscal year 
        under paragraph (1) will be used for administrative expenses 
        related to such grants.
    ``(b) Grants for Applied Public Health Research and System 
Development.--There is authorized to be appropriated for making grants 
for pilot and demonstration projects under section 1110(b) $30,000,000 
for each of fiscal years 2000 through 2009, and such sums as may be 
necessary for each succeeding fiscal year.
    ``(c) Supplementation.--The Secretary shall ensure that funds made 
available under this subpart will supplement and increase the level of 
funding that would otherwise be made available by the Federal 
Government for genetic programs and not to supplant such Federal funds.

``SEC. 1116. DEFINITIONS.

    ``In this subpart:
            ``(1) Genetic counseling.--The term `genetic counseling' 
        means a communication process, the intent of which is to 
        provide individuals and families having a genetic disease or 
        condition or at risk of such a disease or condition, with 
        information about the condition and to provide information that 
        would allow individuals at risk to make informed health care 
        decisions.
            ``(2) State.--The term `State' means each of the 50 States 
        and the District of Columbia; and
            ``(2) Territory.--The term ``territory'' means the 
        Commonwealth of Puerto Rico, the Virgin Islands, Guam, American 
        Samoa, the Commonwealth of the Northern Mariana Islands, and 
        the Republic of the Marshall Islands.''.
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