WASHINGTONCall it Fear of Filing. A survey by the
American Society of Clinical Oncology (ASCO) indicates that
third-party payers, including Medicare, are more willing to cover
patient-care costs in cancer clinical trials than is commonly
assumed. Yet often physicians wont discuss enrollment in such
trials with patients out of fear that insurers will deny payment.
An important point is that even if most claims are eventually
paid, the threat of denial does inhibit and does prevent physicians,
nurses, and other members of the health care team from enrolling
[cancer patients] and, in fact, even talking to individuals about
clinical trials, said ASCO president Joseph S. Bailes, MD.
The problem with the Medicare program is the feeling that these
costs will not be reimbursed.
He discussed the soon-to-be-published survey at a Capitol Hill
briefing sponsored by the National Coalition for Cancer Research. The
meeting was the second in recent months aimed at countering
perceptions in Congress that it would be too costly for Medicare to
pay patient-care costs if beneficiaries were enrolled in cancer
clinical trials. These concerns are based largely on two points
raised by the Congressional Budget Office: That treating patients in
clinical trials costs far more than providing standard care, and that
patient-care costs are not now covered by third-party payers.
Two identical bills pending in the House and Senate, both titled
The Medicare Cancer Clinical Trials Coverage Act , would
establish a 5-year demonstration project that would cover routine
care costs for patients enrolled in cancer clinical trials approved
by the National Institutes of Health, National Cancer Institute
cooperative groups, FDA, and Departments of Veterans Affairs and Defense.
Up to 90% of children and teens and 3% of adults between age 20
and 65 with cancer participate in clinical trials, noted Harmon
J. Eyre, MD, American Cancer Society vice president for research and
cancer control. Over age 65, where cancer rates are the
highest, only 1.5% of individuals actually go on clinical trials.
The aging of the US population will dramatically increase the number
of Americans who develop the disease, Dr. Eyre said. Many
people have projected that over the next 10 to 20 years, cancer could
become the leading cause of death in America, unless we make a major
effort to move forward on it, and participation in clinical trials is
one area where we need to move, he said.
ASCO sent questionnaires last year to its roughly 9,000 members
working in the United States and received 3,550 responses. The data
analysis was completed earlier this year. It is the most
comprehensive look at the clinical trials situation in cancer in the
United States, Dr. Bailes said. We looked at three areas:
oncologists experiences and perceptions associated with
clinical trial participation; pharmaceutical industry involvement in
clinical trials; and non-patient-care costs associated with
conducting clinical trials, ie, the research costs.
The survey clearly demonstrated how important oncologists consider
clinical trials. Oncology is a scientifically driven
specialty, Dr. Bailes said. Eighty percent of clinical
oncologists have participated in clinical trials in the last 3 years.
ASCO members described several problems they faced in enrolling
patients in cancer clinical trials. These include excessive
paperwork, inadequate research funding, and strict eligibility
requirements for entrance. The lack of assured third-party
payments was clearly a barrier to participation, Dr. Bailes added.
Nonetheless, oncologists who do enroll patients in clinical trials
submit reimbursement claims for routine patient-care costs to
Medicare and other insurers in about 95% of their cases, according to
the surveyand less than 10% of these claims are denied, except
for bone marrow transplants.
Dr. Bailes also cited a General Accounting Office survey of NCI
cancer cooperative groups, which found only one instance in a sample
of 39 studies in which Medicare had denied reimbursement for
patient-care costs. So the assumption that this is really not
being paid for in the Medicare program is not borne out by the
data, Dr. Bailes said. The conclusion that can be drawn
from this is that the cost of coverage for clinical trials
patient-care costs is already in the system and would probably have
very little overall impact on Medicare, he added.
Dr. Bailes emphasized the importance of knowing how various cancer
drugs affect older patients. The only way to make certain that
these drugs dont have differential effects is to increase the
number of elderly in clinical trials, he said.
The first of the two NCCR briefings on the Medicare coverage bills,
which was held in May, focused on whether the patient-care costs of
cancer clinical trials were higher than the costs of providing
It included presentations by researchers from Memorial
Sloan-Kettering Cancer Center, the University of Texas M.D. Anderson
Cancer Center, and the Barbara Ann Karmanos Cancer Center in Detroit.
Studies at these institutions showed that the cost differences were
essentially negligible, and, in some instances, clinical trials cost
significantly less (see Oncology News International, June 1999,
A study presented at the second briefing buttressed this conclusion.
Researchers at the Mayo Clinic examined the overall 5-year medical
costs in 61 matched pairs of patients treated in NCI-sponsored phase
II/III clinical chemotherapy trials. At 6 months, the clinical trial
costs were $18,492 vs $17,427 for routine therapy; at 1 year, the
difference was $24,660 vs $23,763; and at 5 years, the costs were
$43,495 vs $41,375. None of the differences was statistically significant.
$38 a Month
The difference at 5 years was approximately 5%. This translates
to $38 a month, said Michael J. OConnell, MD, professor
of oncology, Mayo Clinic. NCI-supported clinical trials added
little, if any, to the cost of medical care in this population of
Some critics oppose Medicare coverage for patient costs in
FDA-sanctioned trials funded by for-profit pharmaceutical companies.
But Dr. OConnell argued the importance of paying the costs of
older patients in such studies. Historically, the most
promising drugs have emerged from the NCI drug screening
program, he said Now, the most promising new
drugsangiogenesis inhibitors, vaccines, monoclonal
antibodiesare coming from private industry. It is very
important for pharmaceutical-supported studies to also be