Medicare Coverage of Clinical Trials

The Clinton administration memorandum on coverage of Medicare patient costs in clinical trials, which drew concern from ASCO when the White House published its incipient statement last June, has apparently morphed into a “final national coverage decision”—announced in late September—that most groups are quite happy with. Ellen Stovall, president and CEO of the National Coalition for Cancer Survivorship, says her group is very happy with the coverage document published by HCFA. She does note, however, that there is a need to monitor the new rules HCFA will be developing for coverage of a subgroup of trials—so-called IND-exempt trials run by cancer centers and pharmaceutical companies—that are testing existing drugs for new uses. Some of these trials are extremely legitimate. Some are not. No one in the cancer community wants to see Medicare pay for clinical trials involving the use of tea leaves to cure colon cancer. However, in writing rules meant to exclude Medicare coverage of those kinds of questionable trials, Stovall indicates that it will be important to ensure that those rules, based on imprecise wording, don’t exclude Medicare coverage for legitimate trials.” We will be concerned with how the language develops,” she explained. One other area of possible concern is Medicare’s intention to pay only for trials that have a “therapeutic” objective. That would rule out some phase I trials designed to test the toxicity of a new medication.