MEDICARE: Clinton Proposes Clinical Trial Coverage
To encourage more senior citizens to participate in clinical research, President Clinton issued an executive memorandum ordering Medicare to cover routine costs for beneficiaries enrolled in clinical trials, the Wall Street Journal reports. Because researchers could not guarantee that Medicare would cover costs involved with trials, seniors have been reluctant to participate. According to a White House fact sheet, 63% of cancer patients are 65 or older, but only 25% are enrolled in clinical trials (McGinley, 6/7). Only 1% of seniors now participate in clinical trials, with patients, insurance companies and drug companies sharing the research costs. Many officials have interpreted the Medicare statute to prohibit reimbursement for routine care involved in trials, but the Institute of Medicine recommended in December that Medicare pay for participants' routine care, adding that the government might already have the authority to order Medicare to cover such costs. In the meantime, several lawmakers introduced bills that would have forced Medicare to cover clinical trials. But White House officials concluded it possessed the necessary authority to create such a mandate and "did not need to wait for Congress." According to a White House statement, "Coverage of all clinical trials ... is critically important to ensuring new breakthroughs in diagnostics, treatments and cures for many of the most devastating diseases afflicting millions of Americans of all ages." Clinical trial sponsors will continue to fund data analysis and other expenses outside the scope of routine care. HHS Secretary Donna Shalala will begin informing Medicare patients, doctors, hospitals and other care providers of the change -- effective immediately -- while federal health officials will begin tracking Medicare spending on clinical trials (Pear, New York Times, 6/7).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.