MEDICAL DEVICE MANUFACTURERS ASSOCIATION
Innovation Today For Better Health Care
TomorrowTM

On behalf of the Medical Device Manufacturers
Association (MDMA), a national trade association
representing the innovative sector of the
medical device market, I am filing the following
comments to the Centers for Medicare and
Medicaid Services’ (CMS) Tracking Sheet
regarding the reconsideration of its national
coverage decision (NCD) on Medicare coverage of
clinical trials. MDMA represents hundreds of
medical device companies, and our mission is to
ensure that patients have access to the latest
advancements in medical technology, most of
which are developed by small, research-driven
medical device companies.

Introduction and Summary of Issues and
Recommendations

MDMA appreciates the opportunity to comment on
the Tracking Sheet to redefine Medicare coverage
of clinical trials. MDMA and its members
supported CMS’ 2000 NCD to cover routine patient
care costs for Medicare beneficiaries enrolled
in clinical trials. We are pleased that CMS has
recognized the importance of enabling Medicare
beneficiaries to participate in clinical trials,
as the elderly bear a disproportionate burden of
disease and other adverse medical conditions in
the United States. MDMA supports the efforts of
CMS to refine criteria for the coverage of
routine patient care costs of Medicare patients
enrolled in clinical trials. Medicare patients
deserve early access to innovations in medical
technology that could contribute greatly to
their quality of life.


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MDMA recommends that CMS make the following
improvements in drafting the proposed Clinical
Research Policy (CRP):

• Retain the current coverage for IDE
trials in addition to the CRP;
• Make a process available for a wide
range of trials and research studies to qualify
for Medicare coverage;
• Encourage beneficiary participation in
trials without imposing minimum enrollment
thresholds;
• Provide coverage of humanitarian use
devices and their clinical trials;
• Limit additional data requirements; and
• Clarify that a clinical trial sponsor is
not a primary payer simply because the sponsor
agrees to pay for certain uncovered costs.

These recommendations are detailed below.

RETAIN THE CURRENT COVERAGE FOR IDE TRIALS
SEPARATE FROM THE CRP

In updating its policy on Medicare coverage of
clinical trials, MDMA requests that CMS
expressly state that its current policy
regarding coverage of IDE trials for Category A
and B devices is separate from the NCD and
remains unchanged. CMS regulations long have
provided for coverage of costs in clinical
trials for IDE trials involving a Category B
device. These regulations were amended in 2004
to add coverage for routine care services
related to IDE trials using certain Category A
devices. The existing regulations
appropriately permit patient access to important
medical technologies available in a clinical
trial, while the trials provide important
information about the outcomes of such
interventions. CMS should acknowledge the
success of the regulations permitting coverage
for IDE trials of Category A and B devices in
the CRP and expressly encourage device
manufacturers, study sites, and Medicare
contractors to continue to work together to use
this mechanism to obtain coverage for Medicare
beneficiaries enrolled in these clinical trials.

PROVIDE A PROCESS FOR RESEARCH STUDIES OTHER
THAN THOSE DEEMED IN THE NCD TO QUALIFY FOR
MEDICARE COVERAGE

MDMA also requests that CMS provide an
alternative to the self-certification process to
make Medicare coverage of routine clinical costs
available for research studies not deemed
automatically qualified. Although this self-
certification process was not implemented
subsequent to the issuance of the 2000 NCD, we
understand that draft criteria were developed
for determining the trials that should be
covered through this process. If CMS removes
the self-certification option as suggested in
the Tracking Sheet, we encourage CMS to offer an


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alternative process for research studies that do
not meet the qualifying criteria for automatic
coverage. MDMA is greatly concerned that the
failure to include these types of clinical
trials in the CRP will continue to harm
beneficiary access to advanced medical devices.

Under the Medicare statute, Medicare pays for
reasonable and necessary items and services.
This rule holds true even where a beneficiary is
receiving care through a clinical trial or other
research study. Allowing research studies not
currently listed in the 2000 NCD to qualify for
coverage of routine costs is consistent with the
basic coverage rules set forth in the Medicare
statute and providing such a process will help
to ensure that Medicare beneficiaries have
access to research studies appropriate for their
medical needs. For example, in addition to the
Category A and B IDE trials already covered
under the Medicare statute and regulations as
discussed above, Medicare should cover routine
care provided in the context of other device
trials performed to obtain FDA approval or
clearance.

CMS SHOULD PROVIDE COVERAGE OF HUMANITARIAN USE
DEVICES AND THEIR CLINICAL TRIALS

MDMA also recommends that CMS clarify that
coverage of clinical trials involving
humanitarian use devices (HUDs) are included in
the list of qualifying trials for which Medicare
coverage of routine costs is deemed. We also
urge CMS simply to cover the device as well,
although we realize that determination may be
separate from the development of the CRP. A HUD
is a “medical device intended to benefit
patients in the treatment or diagnosis of a
disease or condition that affects or is
manifested in fewer than 4,000 individuals in
the United States per year.” The Food and
Drug Administration (FDA) considers a
Humanitarian Device Exemption (HDE) when no
comparable device is available to treat or
diagnose the condition or if a comparable device
is available under an approved HDE application
or being studied under an approved IDE. HUDs
are used by a very small number of patients,
even though they often are essential to
preserving and enhancing the health and well-
being of the patients for whom they are
designed.

In order to encourage the development of
innovative technologies for those vulnerable
patients with rare diseases and conditions,
adequate payment is essential. This is
particularly crucial for the smaller device
companies that drive medical device innovation.
FDA regulations expressly limit the amount that
a manufacturer may charge for a HUD, and device
manufacturers are prohibited from making a
profit on HUDs. Innovation in HUDs is
negatively affected by the fact that many
smaller companies do not have the financial
resources to support the nationwide marketing,
distribution, and status of larger, more well-
recognized companies in the medical industry.
Many companies, especially small companies,
simply cannot afford to undertake the research
that leads to life-saving technologies for rare
diseases and conditions because payment for
these devices frequently does not cover the
costs of bringing such technologies to market.


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Coverage of routine costs in clinical trials for
HUDs, as well as coverage of the device itself,
would help assure that small device companies
are able to continue to bring these new and
innovative medical technologies to market and
avoids creating unnecessary barriers for
Medicare beneficiaries who need these therapies.

ENCOURAGE BENEFICIARY ENROLLMENT IN CLINICAL
TRIALS WITHOUT MANDATING PARTICIPATION THRESHOLDS

MDMA strongly supports efforts to increase
enrollment of Medicare beneficiaries in clinical
trials. We hope that the CRP will foster such
increased enrollment and that CMS will take
steps to educate Medicare beneficiaries about
the availability of such trials. MDMA is
concerned, however, about CMS’ suggestion in the
Tracking Sheet that the agency may consider
standards to assure that a clinical research
study includes a representative sample of
Medicare beneficiaries by demographic and
clinical characteristics in order to receive
Medicare coverage. Medicare beneficiaries often
are not considered eligible for clinical trials
due to comorbidities and other reasons. As a
result, it often is difficult to enroll
sufficient numbers of Medicare beneficiaries in
a clinical trial for the trial population to be
representative of the general population on a
percentage basis. This is particularly true for
device trials that often include a limited
number of participants and for which FDA may
impose eligibility standards that render many
Medicare patients ineligible for participation.

MDMA requests that any policy designed to
increase Medicare beneficiary participation in
clinical trials recognizes the challenges of
enrolling Medicare beneficiaries. We believe
that any effort to restrict Medicare coverage to
trials enrolling certain numbers of
beneficiaries will not only limit the
availability of clinical trials to those
Medicare beneficiaries that are eligible for and
choose to enroll in a trial, but also would be
inconsistent with Medicare’s coverage of
reasonable and necessary items and services. In
order to ensure that Medicare coverage is
available to those beneficiaries who do qualify
for and choose to enroll in clinical trials, it
is critical that CMS not impose stringent
criteria that in fact hinder beneficiary
participation in them.

CMS SHOULD LIMIT THE IMPOSITION OF ADDITIONAL
DATA COLLECTION AND OTHER REQUIREMENTS

MDMA urges CMS to work carefully with
stakeholders in determining any additional data
activities or other requirements imposed on
clinical trials beyond those required by FDA.
It is critical to the survival of the medical
device industry that additional requirements, if
any, are minimal. In order to minimize the
financial impact of any such requirements,
clinical trial sponsors must have certainty
about the duration and scope of such
requirements. Such standards should be
predictable and should be established prior to
the onset of a trial. The possibility of
additional costs imposed by CMS requirements is
a particular concern for small companies who
must invest a significant percentage of their
resources to get a new technology through the
FDA approval process and typically have few
available resources left to collect data beyond
that


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required by FDA. Unlike large manufacturers who
can spread the cost of additional enrollees
across many products, small manufacturers may
have only one or two products on the market and
are not able to absorb such costs.

Data collection or methodology requirements
would be particularly burdensome for HUD
trials. As discussed above, these devices are
not permitted to be profitable, and the addition
of burdensome requirements would further hinder
the development of innovative technologies for
rare diseases or conditions.

The medical device industry only has existed as
a regulated industry since 1976, yet it is one
of the major contributors to advances in health
care. Our industry is characterized by small
innovators who are struggling to finance the
rising costs of higher and higher standards of
evidence that can lead to longer times to
market. Although MDMA supports the development
of rigorous evidence on the value of
innovations, we ask that CMS be cognizant of the
burdens on small device manufacturers in
considering the range of data collection
activities, methodology requirements, or other
requirements it imposes on clinical trials
eligible for Medicare coverage.

CLARIFY MEDICARE’S ROLE IN PAYING FOR ROUTINE
COSTS

CMS sometimes has taken the position that if a
clinical trial sponsor agrees to cover adverse
events not covered by another payer, then that
sponsor becomes the primary payer for medical
costs arising out of the clinical trial.
Because of this uncertainty, trial sites are
reluctant to include Medicare participants
because Medicare payment is uncertain and
unpredictable. The result is that Medicare
beneficiaries frequently are under-enrolled in
clinical trials, denying beneficiaries the
opportunity to receive the most appropriate care
and discouraging future innovation that benefits
Medicare patients. We strongly urge CMS to
clarify that the clinical trial sponsor is not
deemed a health care insurer who may be treated
as a primary payer under the Medicare Secondary
Payer rules where the sponsor has offered in an
informed consent document and related clinical
trial agreement to make payment for uncovered
expenses relating to illness or injury resulting
from the trial.

It is essential to the success of innovative and
potentially lifesaving medical technologies that
clinical trials involving devices qualify for
payment of routine costs. Innovative products
offer technological advantages that allow more
patients to receive care safely, avoiding
complications and lowering the ultimate costs to
Medicare. Without certainty of Medicare
payments, Medicare beneficiaries often are
denied access to trials that could provide
potentially lifesaving technologies to them as
well as provide Medicare with more robust
evidence regarding the use of these therapies in
the Medicare population.

CONCLUSION

MDMA has long supported expanded beneficiary
access to important new medical technologies and
procedures. MDMA urges CMS to implement
policies that make it possible to increase


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participation of Medicare beneficiaries in
clinical trials by expanding the range of trials
for which coverage is deemed available as well
as increasing efforts to educate beneficiaries
about the availability and importance of trial
participation. We also believe that it is
essential that Medicare take steps to clarify
for Medicare beneficiaries and health care
providers that Medicare reimbursement will be
provided for clinical trials and other studies.

MDMA thanks CMS for the opportunity to comment
on this Tracking Sheet. As always, MDMA looks
forward to working with the agency in the future
to improve access to the best and innovative
technologies that our industry has to offer, and
we look forward to commenting on the proposed
CRP.

Sincerely,
Mark B. Leahey
Executive Director
Medical Device Manufacturers Association