By Bronwyn Mixter
Drug and device industry stakeholders said they have numerous concerns about
the Centers for Medicare & Medicaid Services' draft guidance
on the use of coverage with evidence development (CED) for Medicare coverage
CMS released the draft guidance in November 2012 (10 PLIR 1534, 12/7/12).
According to CMS, the draft guidance updates earlier guidance, first published
in 2006, by broadening the potential use of CED. The draft also introduces
potential interactions between CMS and the Food and Drug Administration in
support of CED.
Comments on the draft guidance were due Jan. 28.
The Advanced Medical Technology Association (AdvaMed) has a number of
concerns with the draft CED guidance, Chandra N. Branham, vice president of
payment and health care delivery policy at AdvaMed, said in comments.
“When CMS solicited comments on CED in November of 2011, the Agency's stated
intent was to revise the existing CED guidance with an eye toward 'lessons
learned' in order to improve the application of CED,” Branham said. “We are
primarily concerned that the revised, draft document does not further this goal,
but rather creates more ambiguity than clarity regarding the application of
CMS in November 2011 asked for public input on improving its CED policy.
Branham also said the draft guidance “implies that the available evidence
generated in order to achieve Food and Drug Administration (FDA) approval or
clearance will rarely be sufficient for Medicare coverage, and coverage with
evidence development will become the more common pathway to attaining Medicare
Jeff Farkas, vice president of health policy and payment for device
manufacturer Medtronic Inc., said CMS should consider the following key points
as it finalizes the guidance:
should state its intent to consider CED at the outset of a national coverage
analysis, if not sooner.
should only be used to answer essential questions of “reasonable and necessary”
affecting the health of Medicare beneficiaries, and the CED study should be
specifically designed to answer these questions. These research questions should
be identified prospectively in the draft decision memo. Medtronic believes that
CED should only be applied when the alternative to the policy is national
noncoverage because of limited evidence of clinical benefit.
should be a CED implementation steering committee with full stakeholder
representation to develop key details of CED.
should adopt an interim coverage policy to ensure patient access while CED is
should be clear timelines for completion of CED evidence generation and coverage
The Medical Device Manufacturers Association (MDMA) “supports CMS's efforts
to improve the CED process to reduce barriers to innovation and improve health
outcomes for Medicare beneficiaries,” Thomas Novelli, vice president of
government affairs, MDMA, said. “Our primary concern is that such efforts do not
inadvertently limit patient access to advanced medical technologies.”
Novelli said CMS should adhere to the principles governing the application of
CED in its 2006 CED guidance document “because they were developed with
extensive stakeholder input and continue to be relevant today.”
“CMS includes in the CED Draft Guidance information related to goals,
history, and authority for CED; however, the agency fails to include principles
to guide the application of CED, such as those included in the 2006 CED guidance
document,” Novelli said. MDMA would like CMS to provide more discussion around
its decision to not include the principles in the draft guidance “so that MDMA
and other stakeholders can provide specific input to the agency on that
decision,” he said.
Novelli said MDMA urges CMS to adhere to those principles, which include the
coverage decisions (NCDs) requiring CED will occur within the NCD processes,
which is transparent and open to public comment.
will not be used when other forms of coverage are justified by the available
will in general expand access to technologies and treatments for Medicare
expects to use CED infrequently.
will lead to the production of evidence complementary to existing medical
will not duplicate or replace FDA's authority in assuring the safety, efficacy,
and security of drugs, biological products, and devices.
will not assume the National Institutes of Health's role in fostering, managing,
or prioritizing clinical trials.
application of CED will be consistent with federal laws, regulations, and
“By emphasizing that the use of CED will be limited, intended to expand
access, and not overlap with or duplicate the efforts of other regulatory
agencies, the principles simultaneously facilitate collection of data that helps
Medicare, as well as patients and providers, make better informed decisions
about current diagnostic and treatment options while also ensuring that the
collection of additional data does not impede medical technology innovation,”
The Biotechnology Industry Organization (BIO) also said that the principles
in the 2006 guidance should be included in the final guidance document. “BIO
strongly supports these principles because they protect beneficiary access to
appropriate care; encourage development of useful clinical evidence; ensure that
any applications of CED use the limited resources of CMS, providers and
manufacturers efficiently without unnecessary duplication of efforts; and were
developed with the support of a broad set of stakeholders,” Laurel L. Todd,
managing director of reimbursement and health policy, BIO, said in comments.
Todd also said that BIO urges CMS to “proceed cautiously” in applying CED to
older established technologies. “BIO is concerned that the application of CED to
older established technologies would create a less predictable coverage and
reimbursement environment, which can discourage continued innovation,” Todd
said. “Moreover, applying CED to older established technologies is unnecessary
since there is an evidence base on which to draw by virtue of these therapies
having been utilized over a period of time already.”
Additionally, Todd said BIO urges CMS to “state specifically that, with
regard to drugs and biologics, CED will be limited to off-label uses of
“Drugs and biologics are subject to a rigorous FDA review process, and their
approved prescribing information clearly describes the population for which each
therapy is approved and includes the data supporting each indication,” Todd
said. “CMS should not second-guess the FDA's decisions by requiring additional
post-approval studies of a drug or biological for its approved indications.”
Todd also said that CED should not be applied to premarket approval
(PMA)-approved diagnostic devices.
In her comments, Todd said CMS has previously recognized physician authority
to prescribe drugs off-label and should continue to rely on the judgment of the
“In general, BIO believes CMS should initiate CED only as an alternative to
otherwise limiting coverage,” Todd said. Specific circumstances under which BIO
believes CED may be appropriate include:
the alternative is national noncoverage based on limited evidence;
there is considerable noncoverage at the local level, creating a de facto
national noncoverage policy;
the final NCD will be more restrictive than current use, as signaled by the
draft NCD; or
to removing coverage for an item or service that was previously covered by
The drug company Eli Lilly & Co. said in comments that the CED guidance
the continuing relevance of the 2006 governing principles;
specific measures CMS will take to avoid or limit the application of CED;
that CED may be implemented through NCDs or other avenues under Medicare Parts A
specific technologies, such as diagnostic radiopharmaceuticals, where CED will
the concept of coverage with research; and
clarify the role of the federal Agency for Healthcare Research and Quality in
the CED process.
The draft guidance and comments are available at http://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=23.