[Congressional Record Volume 144, Number 16 (Thursday, February 26, 1998)]
[House]
[Pages H653-H654]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                  MEDICARE CLINICAL TRIAL LEGISLATION

  The SPEAKER pro tempore (Mr. Gibbons). Under a previous order of the 
House, the gentleman from Texas (Mr. Bentsen) is recognized for 5 
minutes.
  Mr. BENTSEN. Mr. Speaker, I rise today to introduce legislation, the 
Medicare Clinical Trial Coverage Act of 1998, that would provide 
Medicare coverage for patient costs related to participation in 
clinical trials. Clinical trials are research studies that test new 
medications and therapies in clinical settings and are often the only 
treatment available for people with life-threatening diseases such as 
cancer, AIDS, heart disease, and Alzheimer's.
  As the Representative for the Texas Medical Center, where many of 
these life-saving trials are being conducted, I believe there is a real 
need for this legislation to guarantee that patients can receive the 
cutting-edge treatment they need. I believe we must ensure that 
Medicare beneficiaries can obtain the best available treatment for 
their illnesses. Without this guarantee, patients must work 
aggressively to make sure that they receive the care they need. We must 
end this uncertainty and guarantee the best available care.
  I have been contacted by many researchers at the Texas Medical 
Center, including the University of Texas MD Anderson Cancer Center, 
University of Texas Health Science Center, Baylor College of Medicine, 
and the Children's Nutrition Research Center, about the need for this 
legislation. These research institutes are conducting clinical trials 
to test new medical therapies and devices such as gene therapy, bone 
marrow transplantations, and targeted antibody therapy that will lead 
to better medical care and save lives.
  Although there may be costs associated with more access to clinical 
trials, I believe that we should ensure access to these trials as a 
means to ensure quality health care. I also believe that this Medicare 
reimbursement policy would encourage other health care plans to cover 
these otherwise routine costs.
  It is also important to note that providing Medicare coverage for 
clinical trials will increase participation in such trials and lead to 
faster development of therapies for those in need. It

[[Page H654]]

often takes 3 to 5 years to enroll enough participants in a cancer 
clinical trial to make the results legitimate and statistically 
meaningful. In addition, less than 3 percent of cancer patients, half 
of whom are over 65, currently participate in clinical trials. This 
legislation will likely increase enrollment and help researchers obtain 
meaningful results much more quickly.
  This legislation would apply to all federally-approved clinical 
trials, including those approved by the Departments of Health and Human 
Services, Veterans Affairs, Defense, and Energy; the National 
Institutes of Health; and the Food and Drug Administration.
  There are currently 3 types of costs associated with clinical trials, 
the cost of treatment or therapy itself, the cost of monitoring such 
treatments, and the cost of health care services needed by the patient. 
Clinical trials usually cover the cost of providing and monitoring the 
therapies and medications that are being tested. However, such programs 
do not cover routine patient care costs, those medical items and 
services that patients would need even if they were not participating 
in a clinical trial. Under current law, Medicare does not provide 
coverage for these costs until these treatments are established as 
standard therapies. Medicare does not consider these patient costs to 
be reasonable and necessary to medical care. My legislation would 
explicitly guarantee Medicare coverage for patient costs associated 
with clinical trials. Such costs serve as a significant obstacle to the 
ability of older Americans to participate in clinical trials.
  As I stated earlier, Medicare claims for the health care services 
associated with clinical trials are not currently reimbursable. A 
recent GAO report concluded that Medicare is currently reimbursing for 
certain costs associated with clinical trials, even though the Health 
Care Financing Administration, the Federal agency responsible for 
Medicare, has stated that Medicare policy should not reimburse for 
these services. In fact, the GAO report estimates that HCFA reimburses 
as much as 50 percent of claims made under Part B of Medicare and 15 
percent of claims made under Part A of Medicare.
  While some physicians and hospitals have been able to convince 
Medicare to cover some of these patient care costs in certain clinical 
trials, such coverage has been uneven and there is no firm rule 
governing them. I believe we must end this inconsistency.
  My legislation would also ensure that all phases of clinical trials 
are explicitly covered under this new benefit. Under the new drug 
application process, there are 3 types of clinical trials, phase I, 
phase II, and phase III trials. Phase I trials test the safety of a 
potential treatment. Phase II and III trials examine both the efficacy 
and the safety of a treatment. Phase II trials are generally smaller 
and involve fewer patients. Phase III trials include a larger number of 
patients to ensure that the proposed treatments help patients. My 
legislation requires that Medicare pay for all types of clinical 
trials.

  Mr. Speaker, I was recently contacted by a constituent about the need 
for this legislation. Mr. Keith Gunning contacted our office regarding 
his mother-in-law, Mrs. Maria Guerra. Mrs. Guerra is suffering from 
AML, a type of leukemia that is common among senior citizens. Mrs. 
Guerra was enrolled in a Medicare HMO that would not permit her to join 
a clinical trial at the University of Texas MD Anderson Cancer Center 
for the treatment she needed. After much effort, Mrs. Guerra dropped 
her Medicare HMO coverage and returned to traditional fee-for-service 
Medicare. With her new Medicare coverage, Mrs. Guerra petitioned MD 
Anderson to join a clinical trial. After much effort on the part of her 
son-in-law, Mr. Gunning, Mrs. Guerra joined a clinical trial. It is 
still unclear whether the traditional patient costs associated with her 
clinical trials will be covered by Medicare. My legislation would 
guarantee that Mrs. Guerra would get the services she needs and would 
require all types of Medicare plans to provide coverage for clinical 
trials, including Medicare managed care plans.
  Mr. Speaker, this is necessary to ensure that American patients, 
particularly older Americans, receive the best service, the best 
cutting-edge service, the best medical treatment that is available. Mr. 
Speaker, as a result, I believe this legislation will result in better 
health care for all Americans.

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