[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.

                                
