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Union Calendar No. 570

106TH CONGRESS

2D SESSION H. R. 762

[Report No. 106–950]

To amend the Public Health Service Act to provide for research and services

with respect to lupus.

IN THE HOUSE OF REPRESENTATIVES

FEBRUARY 12, 1999

Mrs. MEEK of Florida (for herself, Ms. ROS-LEHTINEN, Ms. PELOSI, Mr.

COOK, Mr. CLAY, Mrs. THURMAN, Ms. JACKSON-LEE of Texas, Mr.

BONIOR, Mr. MEEKS of New York, Mr. GOODE, Mr. PASTOR, Mr.

DEFAZIO, Mrs. MINK of Hawaii, Mr. HOLDEN, Mr. QUINN, Mr. SHOWS,

Ms. KILPATRICK, Mr. GREEN of Texas, Mr. FILNER, Mr. BLAGOJEVICH,

Mr. SERRANO, Mr. MORAN of Kansas, and Mr. BALDACCI) introduced the

following bill; which was referred to the Committee on Commerce

OCTOBER 10, 2000

Additional sponsors: Mrs. MALONEY of New York, Mr. GEJDENSON, Mr.

FROST, Mr. ROMERO-BARCELO ́

, Mrs. CLAYTON, Mr. HALL of Ohio, Mr.

MCGOVERN, Mr. ACKERMAN, Mr. UPTON, Mr. STARK, Mr. GUTIERREZ,

Mrs. MORELLA, Mr. MORAN of Virginia, Mr. DELAHUNT, Mr. SANDLIN,

Mr. DIXON, Mr. FORD, Ms. MILLENDER-MCDONALD, Mr. WAXMAN, Mr.

TOWNS, Ms. SLAUGHTER, Mr. FRANK of Massachusetts, Mr. DAVIS of Illinois, Mr. WEXLER, Mr. RANGEL, Mr. FOLEY, Mr. WYNN, Mr. WALSH,

Mr. PAYNE, Ms. LOFGREN, Mr. LEWIS of Georgia, Mr. LATOURETTE,

Mr. MCHUGH, Mr. BENTSEN, Mr. HAYWORTH, Ms. KAPTUR, Mr.

BISHOP, Mrs. LOWEY, Mr. NADLER, Mr. COYNE, Mrs. JONES of Ohio,

Mr. RAHALL, Ms. WATERS, Mr. DIAZ-BALART, Mrs. CHRISTENSEN, Ms.

RIVERS, Ms. BROWN of Florida, Ms. ROYBAL-ALARD, Mr. LIPINSKI, Mr.

MENENDEZ, Mr. HASTINGS of Florida, Mr. NEAL of Massachusetts, Mr.

FALEOMAVAEGA, Mr. HILLIARD, Mr. RUSH, Mr. BOEHLERT, Mr. WATT

of North Carolina, Mrs. KELLY, Mr. PRICE of North Carolina, Mr.

DEUTSCH, Mr. ETHERIDGE, Mr. HINCHEY, Mr. JEFFERSON, Mr.

GRAHAM, Mr. MOLLOHAN, Mr. MATSUI, Mr. THOMPSON of Mississippi,

Mr. BRADY of Pennsylvania, Mr. WEINER, Ms. MCKINNEY, Mr.

CUMINGS, Mr. BORSKI, Mr. ENGLISH, Mr. VENTO, Mr. ANDREWS, Mr.
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LANTOS, Mr. OBERSTAR, Ms. WOOLSEY, Mr. JACKSON of Illinois, Mr.

ROTHMAN, Mrs. CAPPS, Mr. CONYERS, Mr. MARTINEZ, Mr. MOORE, Mr.

KUCINICH, Mr. HOUGHTON, Mr. COSTELLO, Mr. LUCAS of Oklahoma,

Mr. GOODLING, Mr. DAVIS of Virginia, Mr. CAPUANO, Mr. OLVER, Mr.

STUPAK, Ms. EDDIE BERNICE JOHNSON of Texas, Mr. KING, Mr. INSLEE, Mr. KILDEE, Mr. CLEMENT, Mr. LARSON, Mr. BOUCHER, Mr.

HOEFFEL, Mr. MASCARA, Mr. PALLONE, Mr. WOLF, Ms. PRYCE of Ohio,

Ms. VELA ́

ZQUEZ, Mr. GONZALEZ, Mr. LAMPSON, Ms. NORTON, Mr.

BERRY, Mrs. JOHNSON of Connecticut, Mr. WU, Mr. SCOTT, Mr. ENGEL,

Mr. KENNEDY of Rhode Island, Ms. CARSON, Mr. MCNULTY, Mr.

LAHOOD, Mrs. MCCARTHY of New York, Mr. CLYBURN, Mr. SHAW, Ms.

LEE, Mr. LEWIS of California, Mr. OWENS, Ms. SCHAKOWSKY, Mr.

FATTAH, Mr. FARR of California, Mr. SMITH of New Jersey, Mr.

SAXTON, Mr. REYES, Mr. HOLT, Mr. PASCRELL, Mr. WISE, Mr. ALLEN,

Mr. BARRETT of Wisconsin, Mr. GILCHREST, Mr. OSE, Ms. STABENOW,

Mr. MCDERMOTT, Mr. SHERWOOD, Mr. MCCARTHY of Missouri, Mr. LAFALCE, Mr. MALONEY of Connecticut, Mr. SPRATT, Mr. GILMAN, Mr.

NEY, Mr. DOYLE, Mr. SKELTON, Mr. MURTHA, Mr. BILBRAY, Ms. DANNER, Mr. BROWN of Ohio, Mr. EVANS, Mr. SANDERS, Mr. BERMAN, Mr.

BOSWELL, Mr. ROEMER, Mr. ISAKSON, Mr. RODRIGUEZ, Mr. GARY MILLER of California, Mr. KLINK, Mrs. TAUSCHER, Mrs. EMERSON, Mr.

MOAKLEY, Mr. CROWLEY, Mrs. NAPOLITANO, Mr. BARTLETT of Maryland, Mr. DREIER, Mr. DICKS, Mr. PHELPS, Ms. SANCHEZ, Mr. MCINTYRE, Mr. SHERMAN, Mr. ORTIZ, Mr. YOUNG of Alaska, Mr.

ABERCROBMIE, Mr. SWEENEY, Mrs. CHENOWETH-HAGE, Mr. BARCIA,

Ms. BERKLEY, Mr. BURTON of Indiana, Mr. GEPHARDT, Mr. MEEHAN,

Ms. BALDWIN, Mr. SCHAFFER, Mr. FORBES, Mr. BLUNT, Mr.

MCINTOSH, Mr. PETERSON of Minnesota, Mr. SPENCE, Mr. KLECZKA,

Ms. ESHOO, Mr. HINOJOSA, Mrs. ROUKEMA, Mr. JOHN, Mr. THOMPSON

of California, Mr. DICKEY, Mr. GEORGE MILLER of California, Mr. KANJORSKI, Mr. BAIRD, Mr. EWING, Mr. HALL of Texas, Mr. YOUNG of

Florida, Mr. DEAL of Georgia, Mr. CALVERT, Mr. HORN, Mr. TURNER,

Mr. CRAMER, Mr. SISISKY, Mr. JENKINS, Mr. DUNCAN, Mr. COOKSEY,

Mr. SMITH of Washington, Mr. VISCLOSKY, Mrs. FOWLER, Mr. STRICKLAND, Mr. GORDON, Mr. REYNOLDS, Mr. FRANKS of New Jersey, Ms.

HOOLEY of Oregon, Mr. GALLEGLY, Mr. TOOMEY, and Mr. LOBIONDO

OCTOBER 10, 2000

Reported with an amendment, committed to the Committee of the Whole

House on the State of the Union, and ordered to be printed
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[Strike out all after the enacting clause and insert the part printed in italic]

[For text of introduced bill, see copy of bill as introduced on February 12, 1999]

A BILL

To amend the Public Health Service Act to provide for

research and services with respect to lupus.

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 ‘‘Lupus Research and

5 Care Amendments of 2000’’.

6 SEC. 2. FINDINGS.

7 The Congress finds that—

8 (1) lupus is a serious, complex, inflammatory,

9 autoimmune disease of particular concern to women;

10 (2) lupus affects women 9 times more often than

11 men;

12 (3) there are 3 main types of lupus: systemic

13 lupus, a serious form of the disease that affects many

14 parts of the body; discoid lupus, a form of the disease

15 that affects mainly the skin; and drug-induced lupus

16 caused by certain medications;

17 (4) lupus can be fatal if not detected and treated

18 early;
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1 (5) the disease can simultaneously affect various

2 areas of the body, such as the skin, joints, kidneys,

3 and brain, and can be difficult to diagnose because

4 the symptoms of lupus are similar to those of many

5 other diseases;

6 (6) lupus disproportionately affects African7 American women, as the prevalence of the disease

8 among such women is 3 times the prevalence among

9 white women, and an estimated 1 in 250 African10 American women between the ages of 15 and 65 devel11 ops the disease;

12 (7) it has been estimated that between 1,400,000

13 and 2,000,000 Americans have been diagnosed with

14 the disease, and that many more have undiagnosed

15 cases;

16 (8) current treatments for the disease can be ef17 fective, but may lead to damaging side effects;

18 (9) many victims of the disease suffer debili19 tating pain and fatigue, making it difficult to main20 tain employment and lead normal lives; and

21 (10) in fiscal year 1996, the amount allocated by

22 the National Institutes of Health for research on

lupus was $33,000,000, which is less than 1 23 ⁄2 of 1 per24 cent of the budget for such Institutes.
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1 TITLE I—RESEARCH ON LUPUS

2 SEC. 101. EXPANSION AND INTENSIFICATION OF ACTIVI3 TIES.

4 Subpart 4 of part C of title IV of the Public Health

5 Service Act (42 U.S.C. 285d et seq.) is amended by insert6 ing after section 441 the following section:

7 ‘‘LUPUS

8 ‘‘SEC. 441A. (a) IN GENERAL.—The Director of the In9 stitute shall expand and intensify research and related ac10 tivities of the Institute with respect to lupus.

11 ‘‘(b) COORDINATION WITH OTHER INSTITUTES.—The

12 Director of the Institute shall coordinate the activities of

13 the Director under subsection (a) with similar activities

14 conducted by the other national research institutes and

15 agencies of the National Institutes of Health to the extent

16 that such Institutes and agencies have responsibilities that

17 are related to lupus.

18 ‘‘(c) PROGRAMS FOR LUPUS.—In carrying out sub19 section (a), the Director of the Institute shall conduct or

20 support research to expand the understanding of the causes

21 of, and to find a cure for, lupus. Activities under such sub22 section shall include conducting and supporting the fol23 lowing:
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1 ‘‘(1) Research to determine the reasons under2 lying the elevated prevalence of lupus in women, in3 cluding African-American women.

4 ‘‘(2) Basic research concerning the etiology and

5 causes of the disease.

6 ‘‘(3) Epidemiological studies to address the fre7 quency and natural history of the disease and the dif8 ferences among the sexes and among racial and ethnic

9 groups with respect to the disease.

10 ‘‘(4) The development of improved diagnostic

11 techniques.

12 ‘‘(5) Clinical research for the development and

13 evaluation of new treatments, including new biologi14 cal agents.

15 ‘‘(6) Information and education programs for

16 health care professionals and the public.

17 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—For the

18 purpose of carrying out this section, there are authorized

19 to be appropriated such sums as may be necessary for each

20 of the fiscal years 2001 through 2003.’’.

21 TITLE II—DELIVERY OF

22 SERVICES REGARDING LUPUS

23 SEC. 201. ESTABLISHMENT OF PROGRAM OF GRANTS.

24 (a) IN GENERAL.—The Secretary of Health and

25 Human Services shall in accordance with this title make
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1 grants to provide for projects for the establishment, oper2 ation, and coordination of effective and cost-efficient sys3 tems for the delivery of essential services to individuals with

4 lupus and their families.

5 (b) RECIPIENTS OF GRANTS.—A grant under sub6 section (a) may be made to an entity only if the entity

7 is a public or nonprofit private entity, which may include

8 a State or local government; a public or nonprofit private

9 hospital, community-based organization, hospice, ambula10 tory care facility, community health center, migrant health

11 center, or homeless health center; or other appropriate pub12 lic or nonprofit private entity.

13 (c) CERTAIN ACTIVITIES.—To the extent practicable

14 and appropriate, the Secretary shall ensure that projects

15 under subsection (a) provide services for the diagnosis and

16 disease management of lupus. Activities that the Secretary

17 may authorize for such projects may also include the fol18 lowing:

19 (1) Delivering or enhancing outpatient, ambula20 tory, and home-based health and support services, in21 cluding case management and comprehensive treat22 ment services, for individuals with lupus; and deliv23 ering or enhancing support services for their families.

24 (2) Delivering or enhancing inpatient care man25 agement services that prevent unnecessary hos-
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1 pitalization or that expedite discharge, as medically

2 appropriate, from inpatient facilities of individuals

3 with lupus.

4 (3) Improving the quality, availability, and or5 ganization of health care and support services (in6 cluding transportation services, attendant care, home7 maker services, day or respite care, and providing

8 counseling on financial assistance and insurance) for

9 individuals with lupus and support services for their

10 families.

11 (d) INTEGRATION WITH OTHER PROGRAMS.—To the

12 extent practicable and appropriate, the Secretary shall inte13 grate the program under this title with other grant pro14 grams carried out by the Secretary, including the program

15 under section 330 of the Public Health Service Act.

16 SEC. 202. CERTAIN REQUIREMENTS.

17 A grant may be made under section 201 only if the

18 applicant involved makes the following agreements:

19 (1) Not more than 5 percent of the grant will be

20 used for administration, accounting, reporting, and

21 program oversight functions.

22 (2) The grant will be used to supplement and not

23 supplant funds from other sources related to the treat24 ment of lupus.
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1 (3) The applicant will abide by any limitations

2 deemed appropriate by the Secretary on any charges

3 to individuals receiving services pursuant to the

4 grant. As deemed appropriate by the Secretary, such

5 limitations on charges may vary based on the finan6 cial circumstances of the individual receiving services.

7 (4) The grant will not be expended to make pay8 ment for services authorized under section 201(a) to

9 the extent that payment has been made, or can rea10 sonably be expected to be made, with respect to such

11 services—

12 (A) under any State compensation pro13 gram, under an insurance policy, or under any

14 Federal or State health benefits program; or

15 (B) by an entity that provides health serv16 ices on a prepaid basis.

17 (5) The applicant will, at each site at which the

18 applicant provides services under section 201(a), post

19 a conspicuous notice informing individuals who re20 ceive the services of any Federal policies that apply

21 to the applicant with respect to the imposition of

22 charges on such individuals.

23 SEC. 203. TECHNICAL ASSISTANCE.

24 The Secretary may provide technical assistance to as25 sist entities in complying with the requirements of this title
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1 in order to make such entities eligible to receive grants

2 under section 201.

3 SEC. 204. DEFINITIONS.

4 For purposes of this title:

5 (1) The term ‘‘official poverty line’’ means the

6 poverty line established by the Director of the Office

7 of Management and Budget and revised by the Sec8 retary in accordance with section 673(2) of the Omni9 bus Budget Reconciliation Act of 1981.

10 (2) The term ‘‘Secretary’’ means the Secretary of

11 Health and Human Services.

12 SEC. 205. AUTHORIZATION OF APPROPRIATIONS.

13 For the purpose of carrying out this title, there are

14 authorized to be appropriated such sums as may be nec15 essary for each of the fiscal years 2001 through 2003.

Union Calendar No. 570

106TH CONGRESS

2D SESSION H. R. 762

[Report No. 106–950]

A BILL

To amend the Public Health Service Act to provide

for research and services with respect to lupus.

OCTOBER 10, 2000

Reported with an amendment, committed to the Committee of the Whole House on the State of the Union,

and ordered to be printed