Drug and Device Stakeholders Cite Concerns About CMS Coverage Guidance

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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and device industry stakeholders said they have numerous concerns about the Centers for Medicare & Medicaid Services' draft guidance on the use of coverage with evidence development (CED) for Medicare coverage decisions.

CMS released the draft guidance in November 2012 (10 PLIR 1534, 12/7/12). According to CMS, the draft guidance updates earlier guidance, first published in 2006, by broadening the potential use of CED.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Comments on the draft guidance were due Jan. 28.

Device Industry Concerns

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 CED.”

CMS in November 2011 asked for public input on improving its CED policy.


CMS should adhere to the principles governing the application of CED in its 2006 guidance document “because they were developed with extensive stakeholder input and continue to be relevant today.”  


--Thomas Novelli, MDMA

Branham also said the draft guidance “implies that the available evidence generated in order to achieve Food and Drug Administration (FDA) approval or clearance will rarely be sufficient for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 coverage.”

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:

• CMS should state its intent to consider CED at the outset of a national coverage analysis, if not sooner.

• CED 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.

• There should be a CED implementation steering committee with full stakeholder representation to develop key details of CED.

• CMS should adopt an interim coverage policy to ensure patient access while CED is being implemented.

• There should be clear timelines for completion of CED evidence generation and coverage reconsideration.


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.”

Adhere to 2006 Guidance

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.


“CMS should not second-guess the FDA's decisions by requiring additional post-approval studies of a drug or biological for its approved indications.”  


--Laurel L. Todd, Biotechnology Industry Organization

Novelli said MDMA urges CMS to adhere to those principles, which include the following:

• National coverage decisions (NCDs) requiring CED will occur within the NCD processes, which is transparent and open to public comment.

• CED will not be used when other forms of coverage are justified by the available evidence.

• CED will in general expand access to technologies and treatments for Medicare beneficiaries.

• CMS expects to use CED infrequently.

• CED will lead to the production of evidence complementary to existing medical evidence.

• CED will not duplicate or replace FDA's authority in assuring the safety, efficacy, and security of drugs, biological products, and devices.

• CED will not assume the National Institutes of Health's role in fostering, managing, or prioritizing clinical trials.

• Any application of CED will be consistent with federal laws, regulations, and patient protections.


“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,” Novelli said.

Use Caution Applying CED to Older Technologies

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.”

Off-Label Drug Uses

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 FDA-approved products.”

“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 clinician.

“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:

• when the alternative is national noncoverage based on limited evidence;

• when there is considerable noncoverage at the local level, creating a de facto national noncoverage policy;

• when the final NCD will be more restrictive than current use, as signaled by the draft NCD; or

• prior to removing coverage for an item or service that was previously covered by Medicare.


Eli Lilly Comments

The drug company Eli Lilly & Co. said in comments that the CED guidance should:

• reiterate the continuing relevance of the 2006 governing principles;

• identify specific measures CMS will take to avoid or limit the application of CED;

• clarify that CED may be implemented through NCDs or other avenues under Medicare Parts A or B;

• enumerate specific technologies, such as diagnostic radiopharmaceuticals, where CED will not apply;

• endorse the concept of coverage with research; and

• further 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.

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