We appreciate the opportunity to comment on the
National Coverage Analysis for Clinical Trial
Policy (CAG-00071R) issued July 10, 2006
regarding changes to the National Coverage
Decision (NCD) for Clinical Trial Policy
established by a June 7, 2000 executive
memorandum.

Mayo Clinic has reviewed the National Coverage
Analysis (NCA) and the guidance document titled,
National Coverage Determinations with Data
Collection as a Condition of Coverage: Coverage
with Evidence Development and respectfully
submits the following comments.

1) Strategy to ensure Medicare covered
clinical studies are enrolled in the NIH clinical
trials registry website.
Currently, this process is a voluntary reporting
effort. We request the process continue to be
voluntary until CMS has implemented a new process
identifying all clinical trials, regardless of
funding sources, to be recorded in a registry.
In addition, we agree to eliminate the self-
certification process that was not implemented in
the original NCD, as it would provide no useful
information for CMS and would be an
administrative burden for providers. We feel it
would be appropriate to identify Phase II and III
trials in the registry and would consider
registering Phase I trials with therapeutic
intent, as they should have Medicare coverage as
well.

2) Whether coverage of routine clinical care
costs is warranted for studies beyond those
covered by the current policy.
The current coverage policy is only applicable to
studies that receive funding from the federal
government as deemed trials. We encourage
Medicare to continue to cover medically necessary
and reasonable routine care provided to Medicare
beneficiaries regardless of the funding source of
the research study. If the routine care is not
paid for by the research sponsor, Medicare should
provide coverage for the service. Current
definitions and guidelines for deemed studies
could be extended to all research studies
regardless of the funding source. This would
allow CMS to expand its awareness of current
research in the community and provide Medicare
payment for routine care not funded by a research
study regardless of the source of funding.

3) How a registry of all research studies
would be maintained and the potential increased
level of reporting burden on the provider
community to support the registry.
The benefit of research studies awareness to
assist with the Coverage with Evidence
Development (CED) process must be commensurable
with the reporting burden on providers and with
providing Medicare coverage for services as soon
as possible. Provider reporting should be a
simple standardized description of the research
study and the benefit category it relates to. A
streamlined process for provider reporting would
assure that efforts are commensurable with
providing CMS the information necessary to give
beneficiaries access to the latest in health
benefits.
4) Whether to allow coverage for services
that may have a health benefit, but for which
evidence of service effectiveness is insufficient
to allow for full unrestricted coverage.
By utilizing the Coverage with Study
Participation (CSP) and the Coverage with
Appropriateness Determination (CAD) process, CMS
would be able to provide coverage for services
that ordinarily would not meet existing coverage
policy. By assuring the efficacy of patient care
through the IRB jurisdiction and reporting of
trials in a registry, we agree that the elements
required by the Social Security Act section 1142
would be met. We reiterate that implementing a
streamlined process for provider reporting would
assure that efforts made are commensurable with
providing the information CMS is seeking.
5) Representative Medicare participation in
studies and patient safety.
We recommend that reliance on the IRB will be
sufficient to meet patient safety and to monitor
studies for inclusion of appropriate Medicare
beneficiary representation. Ensuring
a “representative sample” of Medicare
beneficiaries should not be a “requirement” under
this NCA. Utilizing the IRB and the Office for
Diversity in Clinical Research to monitor
Medicare beneficiary participation is required by
the Age Discrimination Act of 1975 which
prohibits discrimination on the basis of age in
any program or activity receiving Federal
financial assistance. The HHS implementing
regulations are codified at 45 CFR Part 91. No
additional criteria should be necessary, as
current regulations should meet any concerns
regarding disproportionate representation of
Medicare beneficiaries in research studies.
6) CAD process may become problematic when a
post-approval study process related to a clinical
trial begins.
Currently, the CMS NCA for carotid stenting in
post approval studies (CAG-0259N) requires
providers in a post market approval extension
study to seek FDA approval of the study to extend
Medicare coverage beyond Category B IDE clinical
trials. This creates an additional burden on
providers, as they need to seek an approval from
the FDA, which is not a current requirement. In
addition, the FDA must contact CMS in writing
indicating the efficacy of the trial. CMS must
then notify the provider of the post approval
study before coverage of routine care may begin.
We feel this is not a necessary process, as the
IRB has already approved the study for its
clinical intent and safety. It is also probable
that beneficiaries in one provider’s study may
receive more timely Medicare coverage than those
participating in the study of a provider that has
not yet gone through all of the additional
requirements. We recommend a Medicare coverage
process be implemented for post approval studies
that place the responsibility for patient safety
and clinical intent on the IRB and any current
FDA process, rather than creating a new process
relying on communications between the FDA, CMS
and the provider on a study by study basis.
Identifying the studies that meet the CAD process
in a registry would allow CMS to monitor the
process without placing additional administrative
burden on provider and federal resources for
coverage purposes.

7) Coverage for beneficiaries enrolled in
research studies when a physician has determined
that there is no alternative treatment available
and the patient is likely to die without
treatment (“compassionate use”).
We agree with the comment the Association of
American Medical Colleges submitted on August 4,
2006. It seems unreasonable to deny Medicare
payment for these treatments when no other
options exist and when the provision of treatment
may give researchers valuable information for
treating future patients with the same disease or
condition.

Thank you for the opportunity to comment. We
sincerely appreciate your consideration of these
comments. Please contact me at (507) 284-8605 if
you have any questions.

Very truly yours,
Donald Hertel
Medicare Strategy Unit
Mayo Clinic