The American Society of ClinicalOncology
recently urged Congress to pass the Medicare Cancer Clinical Trials
Coverage Act without delay.
The bipartisan bill, reintroduced in the Senate by Senators Connie
Mack (R-FL) and Jay Rockefeller (D-WV), would establish a
demonstration project to guarantee Medicare beneficiaries coverage of
routine patient care costs in cancer clinical trials. Similar
legislation has been introduced in the House by Representatives
Johnson and Cardin.
Clinical trials advance both patient care and cancer
research, said John R. Durant, MD, executive vice president of
ASCO. Without them, we would not have new drugs to treat
cancer, nor would we be able to provide state-of-the-art care to
Currently, the Medicare programs policy regarding clinical
trials coverage is confusing and inconsistent, leaving patients in a
state of uncertainty and fear about whether necessary care offered in
a trial will be reimbursed. Even though federal regulations state
that Medicare will cover usual patient care costs provided in
research settings, some Medicare carriers deem such care
experimental and therefore deny coverage. Any denials are
disastrous to patients whose best available treatment option is in a
Only through clinical trials can advances in basic research be
translated into improved therapies for individuals with cancer,
said Dr. Durant. Barriers to participation in peer-reviewed
trials, including insurance denials as well as the perceived threat
of such denials, must be eliminated.
Because over one half of all cancers are diagnosed in persons age 65
or older, it is critical that this population be well-represented in
cancer research. Unless senior citizens are included in clinical
trials, research results cannot take into account the potentially
different effects cancer and cancer treatments have on their bodies.
Denying Medicare beneficiaries access to clinical trials is
discriminatory and may call into question the validity of clinical
trial results as applied to this age group, said Dr. Durant.