[Congressional Record (Bound Edition), Volume 145 (1999), Part 1]
[Extensions of Remarks]
[Pages 321-322]
[From the U.S. Government Publishing Office, www.gpo.gov]



                   MEDICAL CLINICAL TRIAL LEGISLATION

                                 ______
                                 

                            HON. KEN BENTSEN

                                of texas

                    in the house of representatives

                       Wednesday, January 6, 1999

  Mr. BENTSEN. Mr. Speaker, I rise today to introduce legislation, the 
Medicare Clinical Trial Coverage Act of 1999, 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 Alzheimers.
  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 for all 
Medicare patients.
  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 Childrens' Nutrition Research Center, about the need for this 
legislation. These researchers 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 clinical trials as a 
means to ensure quality health care services. I also believe that this 
Medicare reimbursement policy would encourage other health plans to 
cover these 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. If often takes three 
to five years to enroll enough participants in a cancer clinical trial 
to make the results legitimate and statistically meaningful. In 
addition, less than three 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 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 three types of costs associated with clinical 
trials--the cost of the 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

[[Page 322]]

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 patients' 
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 (HCFA), the federal agency responsible 
for Medicare, has stated that Medicare policy should not reimburse for 
these medical services. In fact, the GAO report estimates that HCFA 
reimburses as much as 50 percent of claims made under Part B and 15 
percent of the claims made under Part A. While some physicians and 
hospitals have been able to convince Medicare to cover some of these 
patient care costs in certain trials, such coverage has been uneven and 
there is no firm rule governing them. I believe we must end this 
inconsistency and ensure that patient costs are fully covered. My 
legislation will also require all types of Medicare plans, including 
Medicare managed care plans, to guarantee such coverage.
  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 three 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.
  Last year, I was 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 pre-
myelodysplastic (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 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 all of the cost 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. I have visited with Mrs. 
Guerra and she is currently undergoing treatment.
  My legislation also includes a requirement that the Secretary of 
Labor and Health and Human Services prepare a report to determine how 
many group health plans currently cover the patient care costs 
associated with clinical trials and how much it would cost to cover all 
federally approved clinical trials. I believe that this report to 
Congress will show how cost-effective these treatments are and ensure 
that all health care plans provide access to clinical trials.
  President Clinton has also proposed similar Medicare coverage for 
patient care costs related to clinical trials, but the Administration's 
plan is limited to cancer clinical trials and is a capped entitlement. 
My legislation would include more types of federally-approved clinical 
trials, so more patients would be able to participate in these cutting-
edge therapies.

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