The American Society of Clinical Oncology (ASCO),
the leading medical professional society for
physicians involved in cancer treatment and
research, is pleased to submit comments on
Medicare’s NCA Tracking Sheet for Clinical Trial
Policy (CAG-00071R), posted July 10, 2006. ASCO
was intimately involved in the development of the
Clinical Trial Policy, has an intense interest in
its continued success, and offers the following
comments in response to the internally generated
coverage inquiry.

Background

In the early 1990’s ASCO developed a policy
position in support of insurance coverage of
routine patient care costs incurred in clinical
trials. The policy was prompted by numerous
insurance denials, from both Medicare and private
payers, based on the theory that routine patient
care was “experimental” or “investigational” if
provided in the context of a clinical trial. ASCO
worked with Members of Congress to develop a
legislative proposal to require Medicare coverage
of these patient care costs.

Advocates for the legislation also initiated
discussion with Executive Branch officials to urge
that coverage be accomplished through an
administrative interpretation of the sort that was
eventually issued by President Clinton in his
Executive Memorandum of June 7, 2000. The
resulting Clinical Trial Policy was implemented
through a National Coverage Decision (NCD),
effective September 19, 2000.

Impact of the Policy

There has been no systematic or comprehensive
study of the policy’s impact since its inception,
but anecdotal information indicates that it has
had a beneficial impact on participation of
Medicare beneficiaries in clinical trials. In
addition, because of the influence of Medicare
policy on private payers, there appears to be much
more willingness to provide corresponding coverage
to non-Medicare patients in the private sector. In
both Medicare and private payment situations, a
significant impediment to participation in
clinical trials has been removed by the increased
coverage of routine patient care costs. More
generally, the policy has reinforced the position
long advocated by the cancer community that access
to clinical trials is an important component of
quality cancer care, and we very much appreciate
the role of Medicare in supporting that message.

While ASCO has been very pleased with the
operation of the policy, there have been several
concerns repeatedly raised by ASCO members, and we
welcome the opportunity to convey those concerns,
together with an attempt to address the issues
raised by Medicare officials themselves.

Issues Raised by Medicare

ASCO has views on a number of the issues
identified in the Tracking Sheet:

• Issue #1 – Clinical Costs in Research Studies—We
would welcome additional clarification of this
issue by CMS. It is not clear what types of
studies CMS has in mind.

• Issue #2 – Clinical Trial Registration—The
environment for clinical trial registration is
rapidly evolving with an increasing number of
trials being registered, often with
www.clinicaltrials.gov, the registration site of
the National Institutes of Health (NIH). Many
pharmaceutical companies adhere to the policy
articulated by their trade association, PhRMA,
which supports trial registration. The situation
is complicated by the fact that legislation is
under consideration that might require
registration of trials, but not necessarily with
the NIH site. ASCO supports trial registration to
make information about available trials accessible
to both patients and physicians and would endorse
a decision by Medicare to make clinical trials
coverage contingent upon registration in an
appropriate data base, but only for phase II and
III and later trials. Some phase I trials (those
undertaken with therapeutic intent) are included
in the current Medicare coverage policy, but the
current consensus among both industry and
interested legislators seems to be that
registration of phase I trials should remain
voluntary. Therefore, if Medicare makes coverage
contingent on registration, this requirement
should apply only to phase II and III trials and
beyond—i.e. phase IV post-marketing trials.

• Issue #3 – Inclusion of Medicare
Beneficiaries—The underlying rationale for the
Clinical Trial Policy was to enable and encourage
Medicare beneficiaries to participate in clinical
trials; if additional strategies to accomplish
this result are required, ASCO would be among the
first to support them. Our information, however,
indicates that there are already ample assurances
for participation by the elderly in many clinical
trials. National Cancer Institute (NCI)
cooperative group trials, for example, have no
upper age limit on enrollment of subjects, and, in
fact, many include special provisions to encourage
and facilitate enrollment of the Medicare
beneficiary population. There will inevitably be
some trials in which safety considerations may
limit participation, but those would seem to be
the exception rather than the rule. Given the
current situation, we would question the utility
of any restrictive criteria, as they would seem
counterproductive to participation by Medicare
beneficiaries. If the goal is to increase Medicare
beneficiary enrollment in clinical trials, then
coverage should include all otherwise approved
trials that do not specifically exclude enrollment
of older individuals to maximize beneficiaries’
opportunities to participate.

• Issue #4 – Routine Patient Care Costs —There is
a need for further clarification of what
constitutes routine patient care costs, as opposed
to costs occasioned by the research. But such
clarification should be accomplished in a manner
that does not burden research institutions and
that takes into account differing circumstances in
different types of trials. In industry-sponsored
trials, the industry sponsor and the investigators
should be able to identify, through a process of
collaborative communication, those costs that are
required solely for the trial, are thus
non-routine, and are not covered by Medicare under
the policy. Industry sponsors should provide
reimbursement for these additional diagnostic
tests and services that are required for research
purposes. In NCI-sponsored clinical trials without
industry funding, though, there may be no
additional funding for non-routine diagnostic
tests, many of which are included to ensure
patient safety, and we would encourage flexibility
on the part of Medicare officials in that setting.
More specificity in delineating routine vs.
research tests would be very helpful across the
board, as the current lack of clarity causes
unnecessary administrative burdens to document
compliance with the policy. ASCO would be pleased
to work with Medicare officials to address
uncertainties concerning routine patient care
costs in both industry-sponsored and NCI-sponsored
clinical trials.

One specific issue that has arisen with some
Medicare contractors is the assumption that the
sponsor’s payment of some tests for privately
insured patients automatically renders those tests
“non-routine” for Medicare purposes. Frequently
the sponsor’s payment is an exception to its usual
payment practices, prompted by the fact that the
private insurer refused to cover the costs because
it lacks a policy like Medicare’s. That should not
be the basis for Medicare’s retreat from coverage
if the patient care costs are otherwise considered
routine, as those costs are being covered by the
sponsor only on an individualized humanitarian or
charitable basis, not “customarily” as stated in
the Medicare policy.

• Issue #5 – Self-certification—We agree that the
self-certification provisions should be removed.

• Issue #6 – Oversight of IND-Exempt Trials—At the
time the current Clinical Trial Policy was
negotiated and implemented in September 2000, the
cancer community strongly supported inclusion of
so-called IND-exempt trials within the scope of
coverage under the policy. This advocacy was based
on recognition of the important role of these
trials in the process of determining optimal usage
of cancer drugs. Some of these trials are
investigator-initiated at cancer centers or other
academic institutions, and others originate
through collaboration between industry and
investigators. In every instance, the Food and
Drug Administration (FDA) has determined that the
regulatory burden involved in submission of an IND
is unnecessary. Also, FDA requires that sponsors
and investigators conduct these trials in
compliance with FDA regulations regarding
institutional review, informed consent, and
promotion and charging for investigational drugs.
ASCO believes it is important to maintain
incentives for participation in these IND-exempt
trials, including coverage of routine patient care
costs, and we would oppose additional burdens or
curtailment of current coverage.

• Issues #7-9 – Additional Items & Services—Issues
7 through 9 all relate to potential expansion of
coverage to currently non-covered items or
services. The primary area in which ASCO has
observed that the current Clinical Trial Policy is
too restrictive is in its application to bone
marrow transplantation (BMT) in certain cancers.
BMT for certain conditions has been the subject of
Medicare non-coverage decisions. In some other
conditions, the available data in the 65 and over
population are considered inadequate, making the
BMT an investigational procedure, and thus not a
covered Medicare benefit. Consequently, BMTs are
often rejected for coverage under the Clinical
Trial Policy.

We believe there may be several ways in which BMT
coverage could be made less restrictive. First,
Medicare could recognize that, although BMT taken
in total is considered an investigational
procedure for certain cancers, it is comprised of
covered component elements like hospital stays,
approved chemotherapy and the like, albeit
sometimes with greater intensity than usual.
Second, since many experts believe Medicare
beneficiaries could take advantage of BMT for a
number of cancers not currently covered, Medicare
might consider it in the category of “coverage
with evidence development,” where coverage would
be extended in exchange for the collection of
data. Third, Medicare should allow coverage for
under-65, disabled beneficiaries, where available
data is adequate.

In a cancer like multiple myeloma, where
allogeneic BMT may be effective in treating
Medicare beneficiaries, the National Cancer
Institute has initiated high-priority clinical
trials to test that hypothesis, but Medicare's
current Clinical Trials Policy effectively bars
participation by beneficiaries by not covering
patient care costs in the trials. This is a lost
opportunity that could be corrected through
revisions to the policy.

We believe coverage of these BMT procedures meets
all three of the "overarching goals" of the
Clinical Trial Policy:

"1) to allow Medicare beneficiaries to participate
in research studies;

2) to encourage the conduct of research studies
that add to the knowledge base about the
efficient, appropriate, effective, and
cost-effective use of products and technologies in
the Medicare population, thus improving the
quality of care that Medicare beneficiaries
receive; and

3) to allow Medicare beneficiaries to receive care
that may have a health benefit, but for which
evidence for the effectiveness of the treatment or
service is insufficient to allow for full,
unrestricted coverage."

ASCO accordingly urges revisions to enhance access
of beneficiaries undergoing BMT to the coverage of
patient care costs in the context of clinical trials.

Additional Concern re: Medicare Managed Care

Many Medicare beneficiaries, especially those with
limited resources, turn to managed care
alternatives. The coverage of routine patient care
costs is currently available to these
beneficiaries because Medicare covers those costs
on a fee-for-service basis, but they are compelled
to pay the full fee-for-service copayment rather
than the reduced or nonexistent copayment exacted
by their managed care plan.

This circumstance is the result of failure by the
Centers for Medicare & Medicaid Services (CMS) to
adjust payments to Medicare managed care plans as
required by statute, §1853(c)(7) of the Social
Security Act, to reflect additional costs
occasioned by the September 2000 Clinical Trial
Policy. ASCO has urged CMS to act to make the
required adjustment so that managed care plans
will begin to apply their usual copayments to the
costs of routine patient care costs, but to date
there has been no satisfactory response from CMS
(see attached correspondence). As Medicare
undertakes a reconsideration of the Clinical Trial
Policy, ASCO urges CMS to make the statutorily
mandated adjustments that will facilitate the
participation of managed care enrollees in cancer
clinical trials.

* * *

Thank you for the opportunity to provide these
comments. We look forward to working with you to
make the Clinical Trial Policy even better for the
benefit of Medicare cancer patients.

Sincerely,

Joseph S. Bailes, MD
Interim Executive Vice President