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Saying that important clinical trials do not include enough seniors, President Clinton on June 7, 2000, announced that Medicare will revise its payment policy to reimburse the routine patient care costs of clinical trials. The change means that 40 million seniors will have access to cancer clinical trials, a move that could speed new treatments into regular use.
Current policy discourages Medicare from paying for what are called routine care costs - items like office visits and tests - for patients enrolled in clinical trials. Uncertain about who will pay, seniors shy away from the trials, which are research studies that move new treatments from the lab to the clinic.
In an Executive Memorandum, Clinton directed the Department of Health and Human Services, the cabinet-level agency in charge of Medicare, to immediately begin reimbursing claims for routine patient care costs of clinical trials. In addition, the order initiates an education campaign aimed at Medicare beneficiaries and providers, and directs DHHS to track Medicare clinical trials spending.
"We must help more seniors participate in clinical trials that test new therapies for illnesses, from cancer to heart disease to Alzheimer's," Clinton said at a press conference on the White House lawn. "A major factor keeping seniors out of clinical trials is lack of certainty that their expenses will be covered by insurance." He added that Medicare's current policies on clinical trials payment are unclear.
The issue of clinical trials coverage has been on the political table for several years, but bills introduced in Congress seeking Medicare and insurance coverage for cancer clinical trials have repeatedly stalled. The proponents of these measures received a boost in late 1999 when a report from the Institute of Medicine recommended that Medicare cover the costs of all clinical trials, not just those for cancer.
Clinton took his lead from this report, citing it as a primary factor in his decision. He also quoted statistics from a recent study that showed severe under-representation of seniors in cancer clinical trials. Sixty-three percent of all cancer patients are older than 65, yet this group comprises just 33 percent of enrollees in cancer clinical trials.
Several members of Congress who pushed for the change praised the president's announcement. Among them was Connecticut Rep. Nancy Johnson, who pointed to pediatric clinical trials as a model. The long-term survival rate for children with cancer jumped from 50 percent in the 1970s to 75 percent as of June 2000. Over half of all pediatric cancer patients participate in clinical trials.
"We hope to see the same kind of expansion in treatment and cure rates and life expectancy in seniors that we've seen in children," Johnson said at a press conference at the Capitol.
But for that to happen, seniors will have to actually enroll in clinical trials, something not guaranteed by the announcement. Florida Sen. Connie Mack said getting large numbers of the elderly into the studies will require extra effort from the medical community. "This is a two-way street. We've removed some of the barriers to participation. But there is also a responsibility on the side of the medical community to get the message out to patients that clinical trials are available."
Ellen Stovall, executive director of the National Coalition for Cancer Survivorship and a former clinical trial patient, said, "This is a glorious day for seniors in this country. Because as those of us in the cancer community know, care in a clinical trial may very well represent the best treatment option for someone with a serious illness."
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