[Congressional Record Volume 150, Number 125 (Wednesday, October 6, 2004)]
[House]
[Pages H8255-H8257]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
RESEARCH REVIEW ACT OF 2004
Mr. BILIRAKIS. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 5213) to expand research information regarding
multidisciplinary research projects and epidemiological studies, as
amended.
The Clerk read as follows:
H.R. 5213
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 ``Research Review Act of
2004''.
SEC. 2. MULTI-DISCIPLINARY RESEARCH TEAM AND CONSORTIA
REPORT.
(a) In General.--The Secretary of Health and Human Services
(referred to in this Act as the ``Secretary''), in
coordination with the Director of the National Institutes of
Health, shall prepare a report outlining the methods by which
the Roadmap for Medical Research, an initiative of such
Institutes, has advanced the use of multidisciplinary
research teams and consortia of research institutions to
advance treatments, develop new therapies, and collaborate on
clinical trials, including with respect to spinal cord injury
and paralysis research.
(b) Report.--Not later than February 1, 2005, the Secretary
shall submit the report under subsection (a) to the Committee
on Energy and Commerce of the House of Representatives and to
the Committe on Health, Education, Labor, and Pensions of the
Senate.
SEC. 3. EPIDEMIOLOGICAL STUDY REPORT.
(a) In General.--The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, shall
prepare a report outlining the epidemiological studies
currently under way at such Centers, future planned studies,
the criteria involved in determining what epidemiological
studies to conduct, defer, or suspend, and the scope of those
studies, including with respect to the inflammatory bowel
disease epidemiological study. The report shall include a
description of the activities the Centers for Disease Control
and Prevention undertakes to establish partnerships with
research and patient advocacy communities to expand
epidemiological studies.
(b) Report.--Not later than May 1, 2005, the Secretary
shall submit the report under subsection (a) to the Committee
on Energy and Commerce of the House of Representatives and to
the Committee on Health, Education, Labor, and Pensions of
the Senate.
SEC. 4. STUDY BY GOVERNMENT ACCOUNTABILITY OFFICE ON MEDICARE
AND MEDICAID COVERAGE STANDARDS.
(a) In General.--The Comptroller General of the United
States shall conduct a study on the coverage standards that,
under the programs under titles XVIII and XIX of the Social
Security Act (commonly known as Medicare and Medicaid,
respectively), apply to patients with inflammatory bowel
disease for the following therapies:
(1) Parenteral nutrition.
(2) Enteral nutrition formula.
(3) Medically necessary food products.
(4) Ostomy supplies.
(5) Therapies approved by the Food and Drug Administration
for Crohn's disease and ulcerative colitis.
(b) Content.--The study under subsection (a) shall take
into account the appropriate outpatient or home health care
delivery settings.
(c) Report.--Not later than six months after the date of
the enactment of this Act, the Comptroller General shall
submit to the Congress a report describing the findings of
the study under subsection (a).
SEC. 5. STUDY BY GOVERNMENT ACCOUNTABILITY OFFICE INVOLVING
DISABILITY INSURANCE.
(a) In General.--The Comptroller General of the United
States shall conduct a study of the problems patients
encounter when applying for disability insurance benefits
under title II of the Social Security Act. The study shall
include recommendations for improving the application process
for patients with inflammatory bowel disease.
(b) Report.--Not later than six months after the date of
the enactment of this Act, the Comptroller General shall
submit to the Congress a report describing the findings of
the study under subsection (a).
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Florida (Mr. Bilirakis) and the gentleman from Ohio (Mr. Brown) each
will control 20 minutes.
The Chair recognizes the gentleman from Florida (Mr. Bilirakis).
General Leave
Mr. BILIRAKIS. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days within which to revise and extend their
remarks and include extraneous material on H.R. 5213, as amended.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Florida?
There was no objection.
Mr. BILIRAKIS. Mr. Speaker, I yield myself such time as I may
consume.
Mr. Speaker, I rise today in support of H.R. 5213, the Research
Review Act. I introduced this legislation only with the fantastic
cooperation of my colleagues and friends, the gentlewoman from New York
(Mrs. Kelly) and the gentleman from Ohio (Mr. Brown) from Ohio, the
ranking member on my subcommittee. It was with their cooperation and
with the hard work of members of the staff, Mr. Speaker, we were able
to get this thing done at really almost the 11th hour.
As chairman of the Committee on Energy and Commerce, Subcommittee on
Health, I am extremely concerned, as I think all of us are, about how
Federal agencies that fall under our committee's jurisdiction set their
priorities for disease research. Every day I have patients, along with
their families and friends, looking to me to increase research funding
for diseases and conditions that afflict them or their loved ones.
While I know that it is not in anyone's best interests to mandate
agencies to conduct research into specific diseases, I do believe it is
my job, I believe it is our job, to ensure that the Federal initiatives
are sufficient.
Next year, I look forward to working with the gentleman from Texas
(Chairman Barton), the gentleman from Ohio (Mr. Brown) and the
gentleman from Michigan (Mr. Dingell) and all the members of the
Committee on Energy and Commerce to reauthorize the National Institutes
of Health. My subcommittee has held five hearings during this Congress,
the 108th, to highlight research activities at the NIH and to educate
members and others about the work that the NIH is doing so we can
assess how to help NIH better meet its stated mission.
One thing that has become clear is that while NIH is an exemplary
agency, its transparency and accountability in letting Members of
Congress and the public know what research is being funded and why
could be improved. Providing the public with information is not a
problem that is unique to the NIH, however; many of our agencies have
similar problems translating their efforts to the public.
I introduced H.R. 5213 to take an additional step in assisting
Congress to understand the process of Federal agencies. I believe that
this legislation will assist Members of Congress as we work with
Federal agencies in the future. It will allow two agencies, the NIH and
the CDC, to highlight their involvement using the examples of two
debilitating conditions that afflict many individuals, paralysis and
inflammatory bowel disease, which we refer to as IBD.
[[Page H8256]]
H.R. 5213 directs the Secretary of Health and Human Services, in
coordination with the Director of the National Institutes of Health, to
prepare a report outlining the methods by which the roadmap for medical
research created by Director Dr. Elias Zerhouni has advanced the use of
multidisciplinary research teams and institutions to advance
treatments, develop new therapies and collaborate in clinical trials,
and to also include in this report how this relates to the Federal
research initiatives into spinal cord and paralysis research.
The bill also requires the Director of the Centers for Disease
Control and Prevention, CDC, to prepare a report outlining
epidemiological studies conducted at the CDC, including the irritated
bowel disease study currently under way at CDC. The study would include
a description of the activity CDC is undertaking to establish
partnerships with research and patient advocacy groups to expand these
studies, such as the partnership between the CDC and the Chron's and
Colitis Foundation.
Additionally, H.R. 5213 directs the General Accounting Office to
conduct studies on the Medicare and Medicaid coverage standards that
apply to patients with inflammatory bowel disease for therapy, such as
medically necessary food products and nutrition services, and the
problems that IBD patients encounter when applying for Social Security
disability benefits.
Both paralysis and inflammatory bowel disease are crippling diseases,
Mr. Speaker, though in very different ways, and both can be extremely
debilitating.
I would like to thank the Christopher Reeve Foundation and, in
particular, Mr. Christopher Reeve and the Chron's and Colitis
Foundation for all of their help. I have worked closely with both of
these groups, as well, as I indicated, with the gentlewoman from New
York (Mrs. Kelly) and the gentleman from Ohio (Mr. Brown) to develop
this legislation.
I do want to thank the staff, Mr. Ford from the other side, Cheryl
Jaeger and Jeanne Haggerty of our staff on this side, for their hard
work in getting this piece of legislation ready to come to the floor
today; and also I would like to thank the gentleman from Texas
(Chairman Barton) for his leadership in working to provide oversight
and reauthorize these Federal agencies; and obviously the cooperation I
have always had with the gentleman from Ohio (Mr. Brown).
I urge my colleagues to approve this important bipartisan bill.
Mr. Speaker, I reserve the balance of my time.
Mr. BROWN of Ohio. Mr. Speaker, I yield myself 3 minutes.
Mr. Speaker, over the past 20 or so years, overall inpatient, that is
hospital and rehabilitation, overall inpatient days for those living
with paralysis have been cut in half. However, those individuals living
with paralysis still face astronomical medical costs, and only one-
third remain employed after becoming paralyzed.
Fortunately, we stand on the brink of amazing breakthroughs in
science for those living with paralysis, with spinal cord injury and
other physical disabilities. Through the Christopher Reeve Paralysis
Foundation, Christopher Reeve and his wife, Dana, have courageously
pushed forward by helping thousands of patients and their families
adjust to the dramatic changes engendered by paralysis and by investing
in the awareness and advancement of medical research.
I have been honored to cosponsor the Christopher Reeve Paralysis Act
in the past two Congresses, alongside my friend, the chairman of the
Subcommittee on Health, the gentleman from Florida (Mr. Bilirakis).
This legislation is an important step toward understanding the
developments and advancements in paralysis and spinal cord injury
research and will help our Nation's leaders in medical research set
their priorities for the future.
I am also pleased that this legislation includes several provisions
relating to the inflammatory bowel disease known as IBD. I have heard
from many Ohioans who suffer through this disease, including a
remarkable young woman named Sarah Levin.
Sarah Levin takes 11 medications a day. She has endured major surgery
and taken steroids that have compromised her physical health. She has
been forced to miss work again and again, because Chron's disease can
flare up at any time.
Despite the difficult conditions, Sarah has joined her father and
thousands of advocates across this country working on legislation
focusing on IBD.
{time} 1630
Like so many others, she has been tireless. She has been positive.
And her efforts have made a real difference for many of those who are
suffering.
This legislation will examine the epidemiology of IBD and therapies
currently approved by FDA for the treatment of this debilitating
condition.
These studies will also examine appropriate settings for the
treatment of IBD and barriers that currently exist for those IBD
patients applying for Social Security disability benefits.
This bill contains important measures that promote the public health,
and I urge my colleagues to support it.
Mr. Speaker, I reserve the balance of my time.
Mr. BILIRAKIS. Mr. Speaker, I yield such time as she may consume to
the gentlewoman from New York (Mrs. Kelly), who probably knows more
about IBD, with the exception of the medical doctors in the Congress,
and she shares that information with us, and we are just very indebted
to her for making us aware of the horrors of this disease.
Mrs. KELLY. Mr. Speaker, I rise today in support of this measure,
H.R. 5213, the Research Review Act of 2004.
This bill represents an important step forward in a long struggle by
so many important people in the Crohn's and colitis advocacy
communities, patients and their families who have worked so hard to
support and advance this legislation. My legislation was H.R. 290, the
Inflammatory Bowel Disease Act. We have rolled that bill into this act,
and I am very grateful to my colleague, the gentleman from Florida (Mr.
Bilirakis), for his interest in this issue and for his leadership in
getting this bill to the Floor.
Crohn's Disease and ulcerative colitis, collectively known as
inflammatory bowel disease, are chronic disorders of the
gastrointestinal tract that cause severe pain and suffering in the more
than 1 million Americans who are afflicted. We are at an exciting time
with respect to the prospect for research and advances on these
challenging diseases.
A few years ago, the scientific community discovered the first gene
associated with Crohn's disease. This landmark discovery and other
advancements in the field have opened up exciting new research pathways
which have the potential to lead to better treatments and, hopefully,
soon, one day, a cure. However, more needs to be done. This legislation
seeks to further this momentum by capitalizing on these promising
opportunities.
The IBD epidemiologic study at the Centers for Disease Control is
critical to our understanding of the scope of this group of diseases.
The CDC, together with the Crohn's and Colitis Foundation of America,
have made significant strides toward uncovering vital information about
the people who are afflicted with digestive disorders and how many
there are out there. This will provide the foundation to move forward
with research and disease management and then a cure. We should
encourage this type of public-private partnership, and I hope that the
CDC will support this worthy project on a long-term basis.
Again, I really want to thank my colleague, the gentleman from
Florida (Mr. Bilirakis), and my colleague, the gentleman from Texas
(Mr. Barton), and my colleague, the gentleman from Ohio (Mr. Brown),
for their work on this. I encourage all Members to support this
measure.
Mr. Speaker, I hope that all Members will vote for this bill.
Mr. BROWN of Ohio. Mr. Speaker, I have no further speakers, and I
yield back the balance of my time.
Mr. BILIRAKIS. Mr. Speaker, I have no further speakers, and I yield
back the balance of my time.
The SPEAKER pro tempore (Mr. Culberson). The question is on the
motion offered by the gentleman from Florida (Mr. Bilirakis) that the
House suspend the rules and pass the bill, H.R. 5213, as amended.
[[Page H8257]]
The question was taken.
The SPEAKER pro tempore. In the opinion of the Chair, two-thirds of
those present have voted in the affirmative.
Mr. BILIRAKIS. Mr. Speaker, on that I demand the yeas and nays.
The yeas and nays were ordered.
The SPEAKER pro tempore. Pursuant to clause 8 of rule XX and the
Chair's prior announcement, further proceedings on this motion will be
postponed.
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