II

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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Genetics and Public

5 Health Services Act’’.

6 SEC. 2. FINDINGS AND PURPOSE.

7 (a) FINDINGS.—Congress finds:

8 (1) Genetic disorders comprise a spectrum of

9 diseases caused, entirely or in part, by inherited or

10 acquired mutations in a person’s genes.
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1 (2) Included amongst the many genetic diseases

2 are those caused by a single gene mutation, such as

3 Sickle Cell disease, Cystic Fibrosis, and PKU, as

4 well as the more common, multi-factorial ‘‘genetic’’

5 disorders, such as diabetes, mental illness, heart dis6 ease, and cancer.

7 (3) Current estimates are that 1 in 20 individ8 uals will be diagnosed with a single gene disorder by

9 the age of 25 and that 65 percent of the population

10 will be diagnosed during their lifetime with a single

11 gene disorder or a disorder that has a genetic com12 ponent.

13 (4) Significant public and private resources

14 have been dedicated to genetics research, including

15 the Human Genome Project, leading to marked im16 provements in our understanding of and increasing

17 ability to diagnose and treat genetic disorders. From

18 1993 to the present, the number of diagnostic tests

19 available for genetic disorders has increased more

20 than six-fold. The fraction of the population recog21 nized as having genetic disorders, including dis22 orders with a genetic component, will continue to in23 crease dramatically as medical genetics knowledge

24 advances.
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1 (5) Research is also leading to an expanding

2 array of available therapies that will result in new

3 treatments for genetic disorders, and may ultimately

4 lead to cures for genetic disorders.

5 (6) There has yet to be a coordinated Federal

6 effort to apply research discoveries in ways that will

7 ensure direct benefit to Americans who are at risk

8 of or living with genetic disorders.

9 (7) Early diagnosis and treatment can lead to

10 prevention of unnecessary human suffering, and con11 siderable savings in costs related to treating ad12 vanced disease.

13 (8) To ensure that individuals benefit from ge14 netic technology and information, it is necessary to

15 ensure the availability of comprehensive genetic serv16 ices including education and genetic counseling, ap17 propriate genetic evaluation that is preceded by in18 formed consent and followed by the opportunity to

19 explore the impact of the results of such evaluation

20 or other tests, and fair access to services for evalua21 tion, followup and treatment.

22 (9) The field of genetics is evolving at a great

23 pace. Genetic services will create tremendous poten24 tial to improve the lives of patients, but genetic serv25 ices that are inappropriately administered may be
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1 unnecessary or even harmful. Only a well-informed

2 society, including the health workforce, policy mak3 ers, and citizens, can apply and use new discoveries

4 in a fashion that will broadly benefit the public.

5 (10) At present, most States have few available

6 public health genetic services due to limited funding.

7 (11) The Federal Government has historically

8 supported and administered programs that provide

9 nongenetic, essential health services, such as access

10 to vaccinations for children, and require State collec11 tion of data on certain diseases. In addition, Federal

12 agencies, including the Centers for Disease Control

13 and Prevention, the Health Resources and Services

14 Administration, and the National Institutes of

15 Health, are working collaboratively to begin to ad16 dress the need for genetic services.

17 (12) Without additional Federal support and

18 agency oversight, however, States lack the resources

19 needed to deal adequately with the expanding ge20 netic technologies. A new commitment to genetic

21 services should build upon existing programs and

22 provide for the establishment and support of new

23 and innovative programs.
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1 (b) PURPOSE.—It is the purpose of this Act to pro2 vide for the establishment of genetic grant programs to

3 enable each State and territory to—

4 (1) establish, expand, and maintain systems

5 and programs to provide quality genetic information,

6 counseling, testing and specialty services necessary

7 to preserve public and personal health and welfare;

8 (2) initiate and promote programs and services

9 to reduce the mortality and the morbidity for heri10 table disorders and to reduce the adverse effects on

11 mental and physical health of heritable disorders in

12 the population;

13 (3) develop within each State health agency ex14 pertise capable of determining needs and level of ge15 netic services available, and of assuring the quality,

16 provision and promotion of genetic services required

17 by residents of the State;

18 (4) promote the understanding, by the public

19 and by health care providers, of genetic disorders

20 and their diagnosis, prevention, and treatment, and

21 to provide for a mechanism for public input on State

22 genetic policy and programs;

23 (5) assure that any services provided under this

24 Act shall be available to all individuals, regardless of
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1 income, race, color, religion, sex, national origin,

2 age, or disability; and

3 (6) establish the following grant programs:

4 (A) A Federal-State block grant program,

5 with matching funds, to support the establish6 ment, expansion and maintenance of State re7 sources for public health genetics activities.

8 (B) A grant program to support applied

9 public health research in genetics and projects

10 to develop and test strategies and education

11 programs to use genetic information and tech12 nology to improve public health.

13 SEC. 3. AMENDMENT TO PUBLIC HEALTH SERVICE ACT.

14 Part A of title XI of the Public Health Service Act

15 (42 U.S.C. 300b–1 et seq.) is amended—

16 (1) by inserting after the part designation the

17 following:

18 ‘‘Subpart I—Grants for Research’’; and

19 (2) by adding at the end the following:

20 ‘‘Subpart II—Genetic Grants

21 ‘‘SEC. 1110. GRANTS TO STATES.

22 ‘‘(a) BLOCK GRANTS.—

23 ‘‘(1) IN GENERAL.—The Secretary shall award

24 grants to States for the purpose of enabling such
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1 States to establish, improve and maintain State pub2 lic health infrastructure for genetics.

3 ‘‘(2) ADMINISTRATION.—The Secretary may

4 provide for the administration of the block grant

5 program under paragraph (1) through the creation

6 of an office for genetic services, if the Secretary de7 termines such administration to be appropriate.

8 ‘‘(b) GRANTS FOR APPLIED PUBLIC HEALTH RE9 SEARCH AND SYSTEMS DEVELOPMENT.—

10 ‘‘(1) IN GENERAL.—The Secretary shall award

11 grants to eligible entities to carry out studies or to

12 establish pilot and demonstration public health pro13 grams for the diagnosis and management of genetic

14 diseases, including diseases with a genetic compo15 nent, education projects for health care providers

16 and the general public, population studies relating to

17 genetics, or for other activities of the type described

18 in subsection (c).

19 ‘‘(2) ELIGIBLE ENTITIES.—To be eligible to re20 ceive a grant under paragraph (1) an entity shall—

21 ‘‘(A) be a public or nonprofit private enti22 ty, including institutions of higher education;

23 ‘‘(B) prepare and submit to the Secretary

24 an application at such time, in such manner,

25 and containing such information as the Sec-
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1 retary may require, including whether the ac2 tivities to be carried out under the grant are

3 easily replicated and the strategies for trans4 lating such activities for use in both the public

5 and private sectors; and

6 ‘‘(C) agree to provide regular reports and

7 conduct audits in accordance with subsections

8 (b) and (c) of section 1114.

9 ‘‘(c) USE OF FUNDS.—

10 ‘‘(1) IN GENERAL.—A State shall use amounts

11 provided under a grant under subsection (a) to carry

12 out activities to—

13 ‘‘(A) establish, expand and maintain sys14 tems to provide quality genetic information,

15 counseling, testing and specialty services nec16 essary to preserve public and personal health

17 and welfare;

18 ‘‘(B) initiate and promote programs and

19 services to reduce the mortality and the mor20 bidity for heritable disorders and to reduce the

21 adverse effects on mental and physical health of

22 heritable disorders in the population;

23 ‘‘(C) develop within the State health agen24 cy expertise capable of determining needs and

25 level of genetic services available, and of assur-
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1 ing the quality, provision and promotion of ge2 netic services required by residents of the State;

3 ‘‘(D) promote the understanding, by the

4 public and by health care providers in the

5 State, of genetic disorders and their prevention

6 and treatment, and to provide for a mechanism

7 for public input on State genetic policy and pro8 grams; and

9 ‘‘(E) assure that any services provided

10 under this subpart shall be available to all indi11 viduals, regardless of income, race, color, reli12 gion, sex, national origin, age, or disability.

13 ‘‘(2) LIMITATION.—A State may not use funds

14 received under this section to—

15 ‘‘(A) provide cash payments to or on behalf

16 of affected individuals;

17 ‘‘(B) provide inpatient services;

18 ‘‘(C) purchase land or make capital im19 provements to property;

20 ‘‘(D) meet the matching requirements re21 lating to the receipt of other Federal funds; and

22 ‘‘(E) provide for proprietary research or

23 training.

24 ‘‘(d) VOLUNTARY PARTICIPATION.—The participa25 tion by any individual in any program or portion thereof
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1 established or operated with funds received under this sub2 part shall be wholly voluntary and shall not be a pre3 requisite to eligibility for or receipt of any other service

4 or assistance from, or to participation in, any other Fed5 eral or State program.

6 ‘‘SEC. 1111. ADVISORY COMMITTEE.

7 ‘‘(a) ESTABLISHMENT.—The Secretary shall estab8 lish an advisory committee to be known as the ‘Advisory

9 Committee on Genetics and Public Health Services’ (re10 ferred to in this subpart as the ‘Advisory Committee’).

11 ‘‘(b) MEMBERS.—

12 ‘‘(1) IN GENERAL.—The Advisory Committee

13 shall be composed of ex officio members in accord14 ance with paragraph (2) and an odd number of ap15 pointed members, not to exceed 15, in accordance

16 with paragraph (3).

17 ‘‘(2) EX OFFICIO MEMBERS.—The ex officio

18 members of the Advisory Committee shall include

19 the Surgeon General, the Administrator of the

20 Health Resources and Services Administration, the

21 Director of the Centers for Disease Control and Pre22 vention, and representatives of—

23 ‘‘(A) the National Institutes of Health;

24 ‘‘(B) the Agency for Health Care Policy

25 and Research;
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1 ‘‘(C) the Food and Drug Administration;

2 and

3 ‘‘(D) such other agencies and offices within

4 the Department of Health and Human Services,

5 or other Federal agencies, that administer pro6 grams dealing with genetics.

7 ‘‘(3) APPOINTED MEMBERS.—The appointed

8 members of the Advisory Committee shall be individ9 uals appointed by the Secretary to ensure input

10 from—

11 ‘‘(A) the various sectors of the clinical ge12 netics community that are directly involved in

13 providing clinical services, including clinical lab14 oratory services, to the public;

15 ‘‘(B) the public, especially regarding con16 cerns about access to health care and the risk

17 of genetic discrimination;

18 ‘‘(C) the scientific genetic and genetic epi19 demiology community;

20 ‘‘(D) the private sector; and

21 ‘‘(E) State health agencies and the public

22 health community.

23 ‘‘(c) DUTIES.—The Advisory Committee shall—
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1 ‘‘(1) provide advice and recommendations to the

2 Secretary concerning grants and projects awarded or

3 funded under this subpart;

4 ‘‘(2) provide technical information to the Sec5 retary for the development of policies and priorities

6 for the administration of grants under this subpart;

7 ‘‘(3) carry out other activities under this sub8 part as determined appropriate by the Secretary;

9 and

10 ‘‘(4) submit to Congress an annual report, to be

11 prepared by the Health Resources and Services Ad12 ministration together with the Centers for Disease

13 Control and Prevention, concerning the activities

14 under this subpart, including a description of pro15 grams that receive funding and objective measures

16 of the effects of such programs on public health.

17 ‘‘SEC. 1112. APPLICATION.

18 ‘‘(a) IN GENERAL.—To be eligible for a block grant

19 under section 1110(a), a State shall prepare and submit

20 to the Secretary an application that includes—

21 ‘‘(1) a statewide needs assessment that identi22 fies specific health status goals and objectives rel23 ative to genetic disorders, including attention to

24 needs of special populations;
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1 ‘‘(2) a plan for addressing the needs identified

2 in priority order, and the manner in which funds

3 under section 1110(a) will be used to meet the goals

4 and objectives of the State;

5 ‘‘(3) a plan for the collection of outcome data

6 or other methods of evaluating the degree to which

7 the funds provided under the grant will be used to

8 achieve the goals and objectives of the State;

9 ‘‘(4) a plan for monitoring and ensuring the

10 quality of services provided under the grant, includ11 ing attention to issues of access to specialty care;

12 ‘‘(5) a plan for the education of the appropriate

13 professional staff of the public health department

14 with respect to genetics, and for increasing the

15 knowledge of health care providers and the general

16 public concerning genetic disease;

17 ‘‘(6) an assurance that the State will use funds

18 provided under the grant to supplement and, to the

19 extent practicable, to increase the level of funding

20 that would otherwise be made available by the State

21 for genetic programs and not to supplant such non22 Federal funds;

23 ‘‘(7) an assurance that the State will provide

24 matching funds in accordance with section 1113(d);
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1 ‘‘(8) an assurance that funds provided under

2 the grant will only be used to implement the ap3 proved plan for the State;

4 ‘‘(9) an assurance that the provision of services

5 under the plan is coordinated with services provided

6 under programs implemented in the State under title

7 V, XVIII, XIX, XX, or XXI of the Social Security

8 Act (subject to Federal regulations applicable to

9 such program) so that the coverage of services under

10 such titles is not diminished in any way by the avail11 ability of services under a genetic program imple12 mented under a grant under section 1110(a) in the

13 State; and

14 ‘‘(10) such other information as the Secretary

15 considers appropriate.

16 ‘‘(b) PUBLICATION.—An application submitted under

17 this section shall be made public by the State in such a

18 manner as to facilitate comment from any person, includ19 ing through hearings and other methods used to facilitate

20 comments from the public. Any such comments received

21 shall be addressed in the application.

22 ‘‘(c) MULTISTATE APPLICATIONS.—Two or more

23 States may enter into an agreement to submit a joint

24 multistate application for a single block grant under sec25 tion 1110(a) in order to maximize the use of scarce re-
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1 gional resources. Any such application shall contain assur2 ances that each State that is a party to the application

3 will—

4 ‘‘(1) be addressed with respect to the require5 ments of paragraphs (1) through (10) of subsection

6 (a); and

7 ‘‘(2) comply with all other provisions of this

8 subpart.

9 ‘‘SEC. 1113. ALLOCATION OF FUNDS.

10 ‘‘(a) IN GENERAL.—For each fiscal year, the amount

11 of the grant for each State or territory under section

12 1110(a) for the fiscal year involved shall be the greater

13 of—

14 ‘‘(1) the amount determined under subsection

15 (b) for the State or territory for the fiscal year; or

16 ‘‘(2) $400,000.

17 ‘‘(b) FORMULA.—With respect to a State or territory,

18 the amount determined under this subsection shall be

19 equal to the amount that bears the same ratio to the

20 amount appropriated for the fiscal year involved under

21 section 1115 as the population of the State or territory

22 bears to the population of all States and territories.

23 ‘‘(c) REDISTRIBUTION OF CERTAIN FUNDS.—Except

24 as provided in section 1115(a)(3), any amount appro-
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1 priated for a fiscal year under section 1115 and remaining

2 available as a result of—

3 ‘‘(1) the failure of any State or territory to sub4 mit an application under section 1112, or the fail5 ure, in the determination of the Secretary, of any

6 State or territory to prepare the application in com7 pliance with such section or to submit the applica8 tion within a reasonable period of time; or

9 ‘‘(2) any State or territory informing the Sec10 retary that the State or territory does not intend to

11 expend the full amount of the grant made to the

12 State or territory, or the failure of the State or ter13 ritory to expend the full amount allocated to the

14 State or territory by the end of the fiscal year fol15 lowing the fiscal year for which the allocation was

16 made;

17 shall be redistributed to the remaining States and terri18 tories in proportion to the original distribution for such

19 fiscal year to such States and territories.

20 ‘‘(d) REQUIREMENT FOR MATCHING FUNDS.—

21 ‘‘(1) IN GENERAL.—The Secretary may not

22 make a grant to a State or territory under section

23 1110(a) unless the State or territory agrees that,

24 with respect to the costs to be incurred by the State

25 or territory in carrying out the program for which
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1 the grant was awarded, the State or territory will,

2 subject to paragraph (2), make available (directly or

3 through donations from public or private entities)

4 non-Federal contributions in an amount equal to not

5 less than $2 for every $3 of Federal funds provided

6 under the grant.

7 ‘‘(2) DETERMINATION OF AMOUNT OF NON8 FEDERAL CONTRIBUTION.—Non-Federal contribu9 tions required in paragraph (1) may be in cash or

10 in kind, fairly evaluated, including plant, equipment,

11 or services. Amounts provided by the Federal Gov12 ernment, and any portion of any service subsidized

13 by the Federal Government, may not be included in

14 determining the amount of such non-Federal con15 tributions.

16 ‘‘SEC. 1114. REGULATIONS, REPORTS, AND AUDITS.

17 ‘‘(a) REGULATIONS.—The Secretary shall promulgate

18 regulations necessary to carry out this subpart.

19 ‘‘(b) REPORTS.—

20 ‘‘(1) ANNUAL REPORT BY STATES.—

21 ‘‘(A) IN GENERAL.—Not later than 1 year

22 after the date of enactment of the Genetics and

23 Public Health Services Act, and annually there24 after, each State and territory shall prepare

25 and submit to the Administrator of the Health
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1 Resources and Services Administration a report

2 that—

3 ‘‘(i) describes the purposes for which

4 the State expended payments made to the

5 State under this subpart; and

6 ‘‘(ii) contains such additional informa7 tion regarding activities authorized in sec8 tion 1110, and is submitted in such form,

9 as the Secretary may require.

10 ‘‘(B) CRITERIA.—The Administrator of the

11 Health Resources and Services Administration

12 shall develop criteria for the preparation and

13 submission of the annual reports under sub14 paragraph (A).

15 ‘‘(C) PUBLICATION.—Each State and ter16 ritory shall make copies of the report submitted

17 under this paragraph for the fiscal year avail18 able for public inspection, and shall upon re19 quest provide a copy of the report to any indi20 vidual without charge or for a charge not ex21 ceeding the cost of providing the copy.

22 ‘‘(2) ANNUAL REPORT BY HRSA.—Not later

23 than 1 year after the date of enactment of the Ge24 netics and Public Health Services Act, and annually

25 thereafter, the Health Resources and Services Ad-
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1 ministration together with the Director for the Cen2 ters for Disease Control and Prevention shall pre3 pare and submit to the Secretary a report that con4 tains a summary of the data contained in the re5 ports submitted with respect to the fiscal year in6 volved under paragraph (1).

7 ‘‘(c) FISCAL CONTROLS AND AUDITS.—

8 ‘‘(1) IN GENERAL.—Each State and territory

9 shall establish fiscal control and fund accounting

10 procedures as may be necessary to assure the proper

11 disbursal of and accounting for Federal funds paid

12 to the State under this subpart.

13 ‘‘(2) BIENNIAL AUDIT.—Each State and terri14 tory shall biennially audit its expenditures from pay15 ments received under this subpart. Such audits shall

16 be conducted by an entity independent of any agency

17 administering a program funded under this subpart

18 and, in-so-far as practical, in accordance with the

19 Comptroller General’s standards for auditing govern20 mental organizations, programs, activities, and func21 tions. Within 30 days following the date each audit

22 is completed, the chief executive officer of the State

23 shall transmit a copy of that audit to the Secretary.

24 ‘‘(3) REPAYMENTS.—Each State and territory

25 shall, after being provided by the Secretary with
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1 adequate notice and opportunity for a hearing within

2 the State or territory, repay to the United States

3 amounts found not to have been expended in accord4 ance with the requirements of this subpart. If such

5 repayment is not made, the Secretary shall, after

6 providing the State or territory with adequate notice

7 and opportunity for a hearing within the State or

8 territory, offset such amounts against the amount of

9 any payment to which the State or territory is or

10 may become entitled under this subpart.

11 ‘‘(4) PUBLIC INSPECTION.—A State or territory

12 shall make copies of the audits required by this sub13 section available for public inspection within the

14 State or territory.

15 ‘‘SEC. 1115. AUTHORIZATION OF APPROPRIATIONS.

16 ‘‘(a) GRANTS AND ADVISORY COMMITTEE ADMINIS17 TRATION.—

18 ‘‘(1) IN GENERAL.—There is authorized to be

19 appropriated for making grants under section

20 1110(a) and for the administration of the Advisory

21 Committee under section 1111 $70,000,000 for each

22 of fiscal years 2000 through 2009, and such sums

23 as may be necessary for each succeeding fiscal year.

24 ‘‘(2) INCREASE IN AUTHORIZATION.—The

25 amount described in paragraph (1) for a fiscal year
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1 shall be increased from the prior fiscal year based on

2 the increase in the consumer price index for such fis3 cal year as determined by the Secretary of Labor.

4 ‘‘(3) AVAILABILITY.—Subject to section

5 1113(c), amounts appropriated for a fiscal year

6 under paragraph (1) and unexpended at the end of

7 such fiscal year shall remain available in the suc8 ceeding fiscal year.

9 ‘‘(4) ADMINISTRATION.—The Secretary shall

10 ensure that, with respect to block grants under sec11 tion 1110(a), not more than 20 percent of the

12 amount available for any fiscal year under para13 graph (1) will be used for administrative expenses

14 related to such grants.

15 ‘‘(b) GRANTS FOR APPLIED PUBLIC HEALTH RE16 SEARCH AND SYSTEM DEVELOPMENT.—There is author17 ized to be appropriated for making grants for pilot and

18 demonstration projects under section 1110(b)

19 $30,000,000 for each of fiscal years 2000 through 2009,

20 and such sums as may be necessary for each succeeding

21 fiscal year.

22 ‘‘(c) SUPPLEMENTATION.—The Secretary shall en23 sure that funds made available under this subpart will

24 supplement and increase the level of funding that would

25 otherwise be made available by the Federal Government
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1 for genetic programs and not to supplant such Federal

2 funds.

3 ‘‘SEC. 1116. DEFINITIONS.

4 ‘‘In this subpart:

5 ‘‘(1) GENETIC COUNSELING.—The term ‘ge6 netic counseling’ means a communication process,

7 the intent of which is to provide individuals and

8 families having a genetic disease or condition or at

9 risk of such a disease or condition, with information

10 about the condition and to provide information that

11 would allow individuals at risk to make informed

12 health care decisions.

13 ‘‘(2) STATE.—The term ‘State’ means each of

14 the 50 States and the District of Columbia; and

15 ‘‘(2) TERRITORY.—The term ‘‘territory’’ means

16 the Commonwealth of Puerto Rico, the Virgin Is17 lands, Guam, American Samoa, the Commonwealth

18 of the Northern Mariana Islands, and the Republic

19 of the Marshall Islands.’’.

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