[Congressional Record (Bound Edition), Volume 150 (2004), Part 15]
[House]
[Pages 21136-21137]
[From the U.S. 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.
  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

[[Page 21137]]

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.
  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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