Thank you for the opportunity to comment on the
proposed changes to the national coverage
decision (NCD) governing the Centers for
Medicare and Medicaid Services’ (CMS’) Clinical
Trial Policy (to be renamed Clinical Research
Policy). America’s Health Insurance Plans (AHIP)
is the national trade association representing
the private sector in health care. AHIP’s
member companies provide health benefits to more
than 200 million Americans. We are pleased to
submit these comments on behalf of our members.

Reconsideration of the Clinical Trial Policy

The expansion of policies that would provide
coverage for clinical research requires very
careful examination of the quality of the
proposed research. Prior experience among
private insurers has shown that coverage may be
requested for clinical research studies of poor
design that would produce weak and biased
results. Such studies may present additional
risks to patients, impair efforts to strengthen
the national clinical research enterprise, and
are also likely to result in increased health
care expenditures for both public and private
insurers and consumers.

The current clinical trial policy assures a
formal review by scientific experts within
research agencies of HHS to determine the
appropriateness and relative importance of the
proposed research as well as the rigor of the
trial design. We believe that the new Clinical
Research Policy, if it intends to broaden the
research considered for coverage, needs to
include a rigorous, explicit, and transparent
process by which the scientific validity of
studies considered under the expanded policy can
be judged. The standards for study design and
overall scientific rigor should be set high for
publicly funded or endorsed studies.

We also suggest that criteria should be
developed to assure that the topics studied are
those for which clinical research will provide
information of significant clinical value for
the Medicare population, e.g.

• Paucity of available effective treatment,

• Cost-effectiveness compared to available
treatments,

• Categories that do not ordinarily lend
themselves to rigorous methodology, e.g.
humanitarian use devices.

Medicare Coverage with Evidence Development

As AHIP recognizes that the proposed changes to
the Clinical Research Policy are linked to the
recent release of the guidance document on
Coverage with Evidence Development (CED) through
the coverage with study participation (CSP)
policy, we include our comments on this guidance
below.

We support CMS’s intent to ensure that all
patients receive the most effective and
appropriate treatments. AHIP believes CSP to be
an important and necessary step in expanding the
evidence base to study the safety and efficacy
of new interventions and treatments after
diffusion into the market, but there are some
concerns regarding the revised guidance
document.

• The guidance fails to present a clear and
transparent evidentiary standard by which
technologies will be judged eligible for CSP.
Without greater detail, there is a risk that new
technologies with only very preliminary evidence
of effectiveness may be considered for coverage
under CSP. In order to protect patients and
ensure value within the Medicare system, we
advocate that the guidance include or be linked
to separate guidance that can give a stronger
delineation of the evidentiary standards that
CMS will apply to ensure that only highly
promising new technologies receive coverage
under the CSP mechanism.

• The description of the process by which CSP
coverage decisions are reconsidered in light of
the further evidence developed through a CSP-
mandated registry or clinical trial lacks
specificity. We continue to be concerned about
the lack of explicit direction or indication on
how the collected data will be used to assess
current and future coverage policy decisions.

• Since the data resulting from CSP may not
always point to an obvious conclusion about the
true value of a new technology and/or the
applicable population, we believe it is very
important that CMS develop a clear and
transparent format for formal consideration of
how CSP data will be evaluated and used in the
reconsideration of the initial NCD. In
particular, we would welcome as part of this
guidance further clarity on whether a CSP
coverage decision will or will not automatically
revert to an “unlimited” coverage decision upon
the formal closing of the registry or clinical
trial linked to the coverage decision.

Thank you for the opportunity to comment on
these important issues.

Sincerely,

Carmella Bocchino
Executive Vice President,
Clinical Affairs and Strategic Planning