[House Report 106-950]
[From the U.S. Government Publishing Office]
106th Congress Report
HOUSE OF REPRESENTATIVES
2d Session 106-950
======================================================================
LUPUS RESEARCH AND CARE AMENDMENTS OF 2000
_______
October 10, 2000.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Bliley, from the Committee on Commerce, submitted the following
R E P O R T
[To accompany H.R. 762]
The Committee on Commerce, to whom was referred the bill
(H.R. 762) to amend the Public Health Service Act to provide
for research and services with respect to lupus, having
considered the same, report favorably thereon with an amendment
and recommend that the bill as amended do pass.
CONTENTS
Page
Amendment........................................................ 1
Purpose and Summary.............................................. 2
Background and Need for Legislation.............................. 2
Hearings......................................................... 3
Committee Consideration.......................................... 3
Committee Votes.................................................. 3
Committee Oversight Findings..................................... 3
Committee on Government Reform Oversight Findings................ 3
New Budget Authority, Entitlement Authority, and Tax Expenditures 3
Committee Cost Estimate.......................................... 3
Congressional Budget Office Estimate............................. 6
Federal Mandates Statement....................................... 6
Advisory Committee Statement..................................... 6
Constitutional Authority Statement............................... 6
Applicability to Legislative Branch.............................. 6
Section-by-Section Analysis of the Legislation................... 6
Changes in Existing Law Made by the Bill, as Reported............ 7
Amendment
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Lupus Research and Care Amendments of
2000''.
SEC. 2. FINDINGS.
The Congress finds that--
(1) lupus is a serious, complex, inflammatory, autoimmune
disease of particular concern to women;
(2) lupus affects women 9 times more often than men;
(3) there are 3 main types of lupus: systemic lupus, a
serious form of the disease that affects many parts of the
body; discoid lupus, a form of the disease that affects mainly
the skin; and drug-induced lupus caused by certain medications;
(4) lupus can be fatal if not detected and treated early;
(5) the disease can simultaneously affect various areas of
the body, such as the skin, joints, kidneys, and brain, and can
be difficult to diagnose because the symptoms of lupus are
similar to those of many other diseases;
(6) lupus disproportionately affects African-American women,
as the prevalence of the disease among such women is 3 times
the prevalence among white women, and an estimated 1 in 250
African-American women between the ages of 15 and 65 develops
the disease;
(7) it has been estimated that between 1,400,000 and
2,000,000 Americans have been diagnosed with the disease, and
that many more have undiagnosed cases;
(8) current treatments for the disease can be effective, but
may lead to damaging side effects;
(9) many victims of the disease suffer debilitating pain and
fatigue, making it difficult to maintain employment and lead
normal lives; and
(10) in fiscal year 1996, the amount allocated by the
National Institutes of Health for research on lupus was
$33,000,000, which is less than \1/2\ of 1 percent of the
budget for such Institutes.
TITLE I--RESEARCH ON LUPUS
SEC. 101. EXPANSION AND INTENSIFICATION OF ACTIVITIES.
Subpart 4 of part C of title IV of the Public Health Service Act (42
U.S.C. 285d et seq.) is amended by inserting after section 441 the
following section:
``lupus
``Sec. 441A. (a) In General.--The Director of the Institute shall
expand and intensify research and related activities of the Institute
with respect to lupus.
``(b) Coordination With Other Institutes.--The Director of the
Institute shall coordinate the activities of the Director under
subsection (a) with similar activities conducted by the other national
research institutes and agencies of the National Institutes of Health
to the extent that such Institutes and agencies have responsibilities
that are related to lupus.
``(c) Programs for Lupus.--In carrying out subsection (a), the
Director of the Institute shall conduct or support research to expand
the understanding of the causes of, and to find a cure for, lupus.
Activities under such subsection shall include conducting and
supporting the following:
``(1) Research to determine the reasons underlying the
elevated prevalence of lupus in women, including African-
American women.
``(2) Basic research concerning the etiology and causes of
the disease.
``(3) Epidemiological studies to address the frequency and
natural history of the disease and the differences among the
sexes and among racial and ethnic groups with respect to the
disease.
``(4) The development of improved diagnostic techniques.
``(5) Clinical research for the development and evaluation of
new treatments, including new biological agents.
``(6) Information and education programs for health care
professionals and the public.
``(d) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated such sums as
may be necessary for each of the fiscal years 2001 through 2003.''.
TITLE II--DELIVERY OF SERVICES REGARDING LUPUS
SEC. 201. ESTABLISHMENT OF PROGRAM OF GRANTS.
(a) In General.--The Secretary of Health and Human Services shall in
accordance with this title make grants to provide for projects for the
establishment, operation, and coordination of effective and cost-
efficient systems for the delivery of essential services to individuals
with lupus and their families.
(b) Recipients of Grants.--A grant under subsection (a) may be made
to an entity only if the entity is a public or nonprofit private
entity, which may include a State or local government; a public or
nonprofit private hospital, community-based organization, hospice,
ambulatory care facility, community health center, migrant health
center, or homeless health center; or other appropriate public or
nonprofit private entity.
(c) Certain Activities.--To the extent practicable and appropriate,
the Secretary shall ensure that projects under subsection (a) provide
services for the diagnosis and disease management of lupus. Activities
that the Secretary may authorize for such projects may also include the
following:
(1) Delivering or enhancing outpatient, ambulatory, and home-
based health and support services, including case management
and comprehensive treatment services, for individuals with
lupus; and delivering or enhancing support services for their
families.
(2) Delivering or enhancing inpatient care management
services that prevent unnecessary hospitalization or that
expedite discharge, as medically appropriate, from inpatient
facilities of individuals with lupus.
(3) Improving the quality, availability, and organization of
health care and support services (including transportation
services, attendant care, homemaker services, day or respite
care, and providing counseling on financial assistance and
insurance) for individuals with lupus and support services for
their families.
(d) Integration With Other Programs.--To the extent practicable and
appropriate, the Secretary shall integrate the program under this title
with other grant programs carried out by the Secretary, including the
program under section 330 of the Public Health Service Act.
SEC. 202. CERTAIN REQUIREMENTS.
A grant may be made under section 201 only if the applicant involved
makes the following agreements:
(1) Not more than 5 percent of the grant will be used for
administration, accounting, reporting, and program oversight
functions.
(2) The grant will be used to supplement and not supplant
funds from other sources related to the treatment of lupus.
(3) The applicant will abide by any limitations deemed
appropriate by the Secretary on any charges to individuals
receiving services pursuant to the grant. As deemed appropriate
by the Secretary, such limitations on charges may vary based on
the financial circumstances of the individual receiving
services.
(4) The grant will not be expended to make payment for
services authorized under section 201(a) to the extent that
payment has been made, or can reasonably be expected to be
made, with respect to such services--
(A) under any State compensation program, under an
insurance policy, or under any Federal or State health
benefits program; or
(B) by an entity that provides health services on a
prepaid basis.
(5) The applicant will, at each site at which the applicant
provides services under section 201(a), post a conspicuous
notice informing individuals who receive the services of any
Federal policies that apply to the applicant with respect to
the imposition of charges on such individuals.
SEC. 203. TECHNICAL ASSISTANCE.
The Secretary may provide technical assistance to assist entities in
complying with the requirements of this title in order to make such
entities eligible to receive grants under section 201.
SEC. 204. DEFINITIONS.
For purposes of this title:
(1) The term ``official poverty line'' means the poverty line
established by the Director of the Office of Management and
Budget and revised by the Secretary in accordance with section
673(2) of the Omnibus Budget Reconciliation Act of 1981.
(2) The term ``Secretary'' means the Secretary of Health and
Human Services.
SEC. 205. AUTHORIZATION OF APPROPRIATIONS.
For the purpose of carrying out this title, there are authorized to
be appropriated such sums as may be necessary for each of the fiscal
years 2001 through 2003.
Purpose and Summary
H.R. 762 expands Federal lupus research activities through
the National Institutes of Health. The bill also authorizes the
Secretary of Health and Human Services to make grants to
projects for the delivery of essential services to individuals
with lupus and their families.
Background and Need for Legislation
Over 1.4 million Americans have lupus erythematosus, a
devastating disease that causes the immune system to attack the
body's own cells and organs. Lupus causes debilitating health
effects including extreme joint pain and swelling, constant
fevers, overwhelming fatigue, horrible skin rashes, organ
failure, and a host of other devastating symptoms. Lupus
destroys the quality of life for many of its victims. The
disease can severely damage the kidneys, heart, lungs, and
other vital organs. Lupus disables one in five of its victims,
often at a very young age. Tragically, every year thousands of
lupus victims die from complications of the disease.
Ninety percent of the victims of lupus are women, and it is
more common among women of color. Lupus is two to three times
more likely to affect African-Americans, Hispanics, Asians and
Native-Americans than women of European ancestry. Lupus tends
to strike women in their child-bearing years, between the ages
of 15 and 44, yet is difficult to diagnose. By the time some
lupus patients are diagnosed, especially in poor or rural
communities, irreversible damage to vital organs may already
have occurred. This increases the need for expensive
treatments, such as kidney dialysis or organ transplantation.
Lupus is a complicated and mysterious disease that needs
extensive study. Presently there is no cure for lupus, nor do
researchers fully understand what causes the disease. Medical
science has not discovered why lupus alternates between periods
of remission and periods of disease activity, called flares,
nor why the disease can remain mild in some individuals and
become life-threatening in others.
Lupus is an expensive disease to treat. The cost to provide
medical care for a person with lupus averages between six and
ten thousand dollars annually. The Lupus Foundation of America
estimates the economic impact of lupus on the Federal treasury
to be several billion dollars every year. These costs include
disability income payments to the tens of thousands of lupus
victims disabled every year by the disease. They also include
the cost of government-sponsored medical care provided through
the Medicare and Medicaid programs, and uncollected tax revenue
due to lost wages when individuals with lupus are unable to
work.
Current research on lupus must be enhanced in hopes of
addressing the disease. Moreover, it is important to try new
ways of providing for care to get to patients for early
diagnosis and disease management. H.R. 762 will provide for
enhanced research and allow for projects to reach out to lupus
victims and improve patient care among low-income populations.
The Committee expects these projects to provide examples that
can be followed in other private and public programs to help
victims of lupus.
Hearings
The Subcommittee on Health and Environment held a hearing
on H.R. 762 on September 13, 2000. The Subcommittee received
testimony from Ms. Tomiko Fraser, National Spokesperson, Lupus
Foundation of America, Inc.
Committee Consideration
On September 26, 2000, the Subcommittee on Health and
Environment was discharged from the further consideration of
H.R. 762. On September 26, 2000, the Full Committee met in open
markup session and ordered H.R. 762 reported, with an
amendment, by a voice vote.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the record votes
on the motion to report legislation and amendments thereto.
There were no record votes taken in connection with ordering
H.R. 762 reported. A motion by Mr. Bliley to order H.R. 762
reported to the House, with an amendment, was agreed to by a
voice vote.
The following amendment was agreed to by a voice vote:
An amendment in the nature of a substitute by Mr.
Bilirakis, No. 1, creating flexibility for the
Secretary's authority to provide grants.
Committee Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee held a legislative
hearing and made findings that are reflected in this report.
Committee on Government Reform Oversight Findings
Pursuant to clause 3(c)(4) of rule XIII of the Rules of the
House of Representatives, no oversight findings have been
submitted to the Committee by the Committee on Government
Reform.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
762, the Lupus Research and Care Amendments of 2000, would
result in no new or increased budget authority, entitlement
authority, or tax expenditures or revenues.
Committee Cost Estimate
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974.
Congressional Budget Office Estimate
The cost estimate provided by the Congressional Budget
Office pursuant to section 402 of the Congressional Budget Act
of 1974 was not timely received by the Committee. The Committee
will submit such estimate to the House upon its receipt.
Federal Mandates Statement
The estimate of Federal mandates prepared by the Director
of the Congressional Budget Office pursuant to section 423 of
the Unfunded Mandates Reform Act was not timely received by the
Committee. The Committee will submit such statement to the
House upon its receipt.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Constitutional Authority Statement
Pursuant to clause 3(d)(1) of rule XIII of the Rules of the
House of Representatives, the Committee finds that the
Constitutional authority for this legislation is provided in
Article I, section 8, clause 3, which grants Congress the power
to regulate commerce with foreign nations, among the several
States, and with the Indian tribes.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 of H.R. 762 provides the short title of the bill,
the ``Lupus Research and Care Amendments of 2000''.
Section 2. Findings
Section 2 provides findings on the serious nature of the
lupus problem in America.
TITLE I--RESEARCH ON LUPUS
Section 101. Expansion and intensification of activities
Title I of the bill amends subpart 4 of part C of title IV
of the Public Health Services Act and expands Federal lupus
medical research activities supported through the National
Institutes of Health. The provision authorizes such sums as may
be necessary for these activities for each of the fiscal years
2001 through 2003.
TITLE II--DELIVERY OF SERVICES REGARDING LUPUS
Section 201. Establishment of program of grants
Section 201 authorizes the Secretary of Health and Human
Services to make grants to projects for the delivery of
essential services to individuals with lupus and their
families.
Section 202. Certain requirements
Section 202 provides for certain requirements on grant
recipients.
Section 203. Technical assistance
Section 203 provides for technical assistance to grant
applicants.
Section 204. Definitions
Section 204 provides certain definitions.
Section 205. Authorization of appropriations
Section 205 authorizes such sums as may be necessary for
each of the fiscal years 2001 through 2003.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (new matter is
printed in italic and existing law in which no change is
proposed is shown in roman):
SECTION 441A OF THE PUBLIC HEALTH SERVICE ACT
lupus
Sec. 441A. (a) In General.--The Director of the Institute
shall expand and intensify research and related activities of
the Institute with respect to lupus.
(b) Coordination With Other Institutes.--The Director of the
Institute shall coordinate the activities of the Director under
subsection (a) with similar activities conducted by the other
national research institutes and agencies of the National
Institutes of Health to the extent that such Institutes and
agencies have responsibilities that are related to lupus.
(c) Programs for Lupus.--In carrying out subsection (a), the
Director of the Institute shall conduct or support research to
expand the understanding of the causes of, and to find a cure
for, lupus. Activities under such subsection shall include
conducting and supporting the following:
(1) Research to determine the reasons underlying the
elevated prevalence of lupus in women, including
African-American women.
(2) Basic research concerning the etiology and causes
of the disease.
(3) Epidemiological studies to address the frequency
and natural history of the disease and the differences
among the sexes and among racial and ethnic groups with
respect to the disease.
(4) The development of improved diagnostic
techniques.
(5) Clinical research for the development and
evaluation of new treatments, including new biological
agents.
(6) Information and education programs for health
care professionals and the public.
(d) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2001 through 2003.