The Association of American Cancer Institutes
(AACI), representing 86 of the nation’s premier
academic and freestanding cancer centers,
appreciates this opportunity to comment on
Medicare’s reconsideration of the clinical
trials national coverage decision. AACI cancer
centers play a central role in designing and
executing the great majority of cancer clinical
trials conducted in the United States, and many
present day curative therapies were developed in
the context of clinical trials at our centers.

The AACI joined with many of our colleagues in
the cancer community in applauding the June 7,
2000 directive that required Medicare to cover
routine costs for patients participating in
qualified clinical trials. Most cancer clinical
trials carried out at AACI cancer centers are
considered “qualifying” for this purpose. AACI
is pleased that CMS is reconsidering the
clinical trials coverage decision if it will
result in an improved policy, particularly if it
will increase access to clinical trials and
address current barriers to participation still
affecting some seniors.

Specifically, we are concerned that participants
who are enrolled in Medicare managed care plans
are subject to certain financial penalties if
they choose to enroll in a clinical trial. The
current policy stipulates that Medicare managed
care patients enrolled in clinical trials are
responsible for 20% of medical expenses, which
many patients find to be prohibitive, and a
major disincentive to trial participation. AACI
urges a careful review of this policy and
strongly encourages a change that would ensure
that patients enrolled in Medicare managed care
plans are able to participate in clinical trials
without incurring a financial penalty.

We appreciate your consideration of our views
and look forward to an additional opportunity to
provide input once the proposed clinical trials
coverage decision memorandum is issued early
next year.