[Congressional Record Volume 141, Number 167 (Thursday, October 26, 1995)]
[Extensions of Remarks]
[Page E2042]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




      CANCER-RELATED INSURANCE REFORM--COVERAGE OF CLINICAL TRIALS

                                 ______


                         HON. RONALD D. COLEMAN

                                of texas

                    in the house of representatives

                       Wednesday, October 25, 1995

  Mr. COLEMAN. Mr. Speaker, clinical trials provide the best available 
treatment for many patients with cancer, AIDS, and other life-
threatening diseases, for whom standard therapies offer a limited 
chance for survival or enhanced quality of life. This is particularly 
true for children with cancer, over 60 to 70 percent are treated in 
clinical trials.
  However, many health care insurers refuse to reimburse patient care 
costs which result from participating in clinical trials by claiming 
such therapy is ``investigational'' or ``experimental.'' When this 
happens, individuals cannot receive what potentially may be the best 
treatment for their condition unless they can afford to pay significant 
out-of-pocket expenses often running into thousands of dollars. Unless 
these patient care costs are included in a standard benefits package, 
it is likely that the reformed system will evolve into one of two tiers 
of care--potentially one in which only the wealthy have access to the 
best anticancer treatments.
  Reimbursement denials impede the ability to conduct effective and 
timely clinical research by increasing administrative burdens on 
medical institutions and reducing the number of patients eligible to 
participate in trials. If reimbursement is not available, fewer 
hospitals will be willing to participate in clinical research and the 
opportunity to test new and effective treatments will be lost. The data 
collected while providing state-of-the-art care to patients in clinical 
trial advance medical science and improve our ability to provide cost-
effective therapies.


                    coverage of unlabeled drug uses

  Between one-half and three-fourths of all anticancer therapy involves 
uses of drugs for purposes other than those described in FDA-approved 
labeling. Frequently insurers will refuse to reimburse so-called 
``unlabeled'' uses of approved anticancer drugs referring to the 
treatment as ``experimental'' or ``investigational''.
  This trend has been criticized by the FDA as depriving the patients 
of the most effective therapy as well as discouraging drug development. 
The FDA has made it clear that the drug's label is in no way intended 
to regulate or restrict the ability of practicing doctors to use the 
drug for other purposes consistent with their professional judgment. 
Additionally, many of the unlabeled uses are for a combination of 
drugs. The FDA does not routinely approve combinations of drugs.
  Any health care reform measure should include coverage of unlabeled 
drug uses in the treatment of cancer and other life-threatening 
diseases which has been referenced in the medical compendia or other 
peer-reviewed literature.


                       access to specialized care

  The rapid increase in the number of managed care systems across the 
country has led to growing concerns regarding the ability to access 
specialized cancer care. For example, often managed care plans do not 
include any pediatric oncologist in their networks. If no specialized 
care is available, the individual is often penalized for going outside 
of the network to find the proper care.
  Managed care plans should contract with a sufficient number of 
oncologists and specialized cancer centers or allow the members to go 
outside of the network without penalization.
  Managed care enrollees should have appropriate access to specialists 
providing cancer screening and diagnosis, as well as treatment. Timely 
screening and referral to specialized care not only saves lives, but 
also contributes to a more cost-effective and efficient health care 
system.

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