Medicare to Cover Clinical Trial Costs
June 7, 2000 (Washington) -- Medicare will immediately begin covering the
routine care costs for seniors and the disabled in clinical trials, President
Clinton announced Wednesday in a special executive memorandum. Clinton's move
is intended to encourage senior enrollment in clinical trials, which may speed
progress toward disease treatments and cures.
Only about 1% of the nation's seniors participates in clinical trials, even
though they suffer the brunt of the nation's diseases, according to
This week, the Health Care Financing Administration (HCFA) will inform
physicians, hospitals, and other providers that it will reimburse standard
costs, including hospital and physician visits and routine lab tests, as well
as those costs that are due to medical complications associated with
participation in trials.
Although the sponsors of clinical studies usually pick up the costs of
experimental agents and therapies, Medicare policies on the coverage of
standard care delivered to patients while in trials have been unclear. That has
presented potential trial enrollees with the unattractive option of paying
out-of-pocket for expenses that would otherwise be covered.
The cost question is a barrier to enrollment in clinical trials, according
to a survey discussed at the annual meeting of the American Society of Clinical
Oncology held in May.
Some 63% of cancer patients are older than 65, but they constitute only 33%
of those enrolled in clinical trials. For breast cancer patients, the
statistics are even worse. Women over 65 make up 44% of breast cancer patients,
but less than 2% of elderly women are in clinical trials for the condition.
According to the White House, the low participation in clinical trials means
"scientists often need between three and five years to enroll enough
participants in a clinical trial to generate ? meaningful results" that
could lead to improvements in diagnosing and treating diseases.
Robert Comis, MD, president of the Coalition of National Cancer Cooperative
Groups, calls Clinton's announcement "tremendous news." He tells WebMD,
"We've been making a lot of progress on the private side, but HCFA has been
the last frontier -- probably the greatest threat to the clinical trials
Alzheimer's Association official Stephen McConnell says, "Large-scale
clinical trials are the only way we are going to discover effective means to
delay, prevent, and treat Alzheimer's disease. It is essential that we remove
any ... barriers to participation." And cost can be a huge barrier.
The Medicare clinical trials issue has drawn intense interest for years. A
bipartisan group of House and Senate lawmakers had been pressing for
legislation requiring coverage of costs for those in cancer studies, with the
Institute of Medicine in December backing coverage for patients in all manner
of clinical trials.
There are still other hurdles to getting seniors more involved in research,
though. Comis tells WebMD that researchers and disease advocates need to assure
older people that their age will not work against them in a trial. "When
we've looked at the impact of age on response in clinical trials, the elderly
patients do just as well," he says. "We have to get that word out and
assure people that age ... is not a negative factor in response to