Saying that important clinical trials do not include enough seniors, President
Clinton announced on 08 June 2000 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
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 late last year 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 today. 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."