The initial reaction to President Clintons June directive on Medicare payment for patient care costs in clinical trials was extremely positive. Senators Jay Rockefeller (D-WV) and Connie Mack (R-FL), who have long and unsuccessfully pushed a Medicare clinical trials bill exclusively focused on cancer trials, issued glowing press releases. But that was then. After knowing details of how Medicare planned to implement the Presidents directive, some senators, some patient advocacy groups, and the American Society of Clinical Oncology (ASCO) were greatly disappointed. Deborah Kamin, the director of public policy at ASCO, says she is hopeful the administration will get it right. The major problem was that the executive memorandum drafted by the Health Care Financing Administration (HCFA) would have excluded all services related to delivery of chemotherapy drugs that are not FDA approved. Essentially none of the routine patient care costs for participating in clinical trials would have been paid.
There is no question that cancer clinical trials need better enrollment. National Cancer Institute (NCI) Director Richard Klausner says the S9623 trial run by the Southwest Oncology Group, which is looking at high-dose chemotherapy and bone marrow transplant, has only attracted 500 of the 1,000 patients it needs. Part of that studys enrollment problem is the somewhat bad press on results of bone marrow studies. Clintons June announcement could give S9623 and other trials a boost by making it clear that Medicare will pay for all patient care costs in clinical trials. In the past, Medicare has sometimes paid for those costs, sometimes not. That helps explain this eye-catching statistic: elderly women make up 44% of breast cancer patients but only 1.6% of women over age 65 are in clinical trials for the disease. Clinton said that Medicare would not only pay routine patient care costs, but costs arising from medical complications as well. But the exective memorandum issued by HCFA fell far short of Clintons promise.