MEDICARE TO COVER PATIENTS INVOLVED IN CLINICAL TRIALS

In a fact sheet dated September 19, 2000, the federal Health Care Financing Administration (HCFA-administers both Medicare and Medi-caid) Press Office issued a final national coverage decision to implement President Clinton's order for Medicare to cover the routine health costs of beneficiaries in clinical trials. It not only implements the President's order to cover the "routine costs" of this group, but also expands the definition of such costs to include payment of most other beneficiary costs that were previously non-covered.

ELIGIBLE TRIALS:
Any trials funded through the NIH, the CDC, HCFA, the Agency for Healthcare Research and Quality, the Dept. of Defense, the Dept. of Veterans Affairs, conducted under an Investigational New Drug application approved by the FDA or those drug trials exempt from having an Investigational New Drug application under FDA regulations.

WHAT'S COVERED:

• Costs associated with providing items and services that would otherwise be covered by Medicare if they were not provided in the context of a clinical trial.
• Items and services required "solely for the provision of the investigational item or service". For example, for the administration of a chemotherapy drug that is being tested in a trial, including the provision of anti-nausea drugs to prevent complications from the chemo drug.
• Monitoring and evaluation, device implantation, and room and board for hospital stay required as part of the clinical trial.

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