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Access to Cancer Clinical Trials Act H.R. 967
07.21.01

Importance of Clinical Trials for Cancer Patients

For many individuals with leukemia, lymphoma or myeloma, care in a clinical trial may represent the best treatment option. In addition, clinical trials are critical to answering questions about the effectiveness of cancer therapies.

Unfortunately, third party payers may classify care in a clinical trial as experimental therapy and deny coverage for the individual’s routine patient care costs. Such policies deprive patients of important treatment options and may also slow the progress of clinical research. It is estimated that as few as 2-3% of adults with cancer enroll in clinical trials.

In September 2001, the Health Care Financing Administration (HCFA) established a policy of Medicare coverage for the routine patient care costs for those enrolled in clinical trials. The Medicare policy, which provides reimbursement for government sponsored trials as well as those approved by the FDA, sets the standard for clinical trials coverage that should be followed by private insurers.

In addition, the coverage decision defines routine patient care costs in a manner that will ensure beneficiaries have appropriate coverage for routine patient care costs that would be reimbursed if they were not in a trial and that trial sponsors continue to pay the costs associated with conducting the trial, including data collection and management. The Medicate coverage decision ensures that Medicare beneficiaries will not encounter reimbursement barriers if they choose not to enroll in clinical trials.

Recommendation for Action

Leukemia, lymphoma and myeloma advocates urge Congress to enact H.R. 967, the Access to Cancer Clinical Trials Act of 2001, which will require that private third party payers provide coverage for the routine patient care costs for those enrolled in clinical trials.

A comprehensive clinical trials initiative must encompass coverage of trials funded by federal agencies as well as those provided by the FDA, which includes those trials testing new drug therapies that may hold special promise for cancer patients.


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