(Circulation. 2000;102:e9016.)
© 2000 American Heart Association, Inc.
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Cardiovascular News
Paying for Clinical Trials
On June 7, 2000, when President Clinton directed the federal Health Care Financing Administration (HCFA) to pay for the costs associated with clinical trials, he opened the door to such therapies for many older Americans. He did not, however, define what costs and which trials would be covered. In a "national coverage decision" issued in mid-August, HCFA defined the kinds of trials that would be covered and what "routine patient care costs" are.
As expected, routine costs mean all items and services usually available to Medicare beneficiaries, such as hospital and physician services and diagnostic tests. Excluded from coverage are the investigational item or service itself, items and services needed exclusively for data collection, or those that are provided by the trial’s sponsor without charge.
More difficult is how to define the kinds of trials that will be covered. For example, HCFA wants to cover only those trials set to answer questions about an item or service that would normally fall within the benefit category of Medicare, such as physician services, durable medical equipment, and diagnostic testing. Trials involving cosmetic surgery and hearing aids, which are excluded by law from coverage, would not be part of the covered clinical trials. Studies that test toxicity levels or the basic biology of a disease would not be covered, nor would those that enroll healthy volunteers rather than people with a diagnosed disease.
The agency would also deem some trials as automatically covered, such
as those funded by the National Institutes of Health,