CMS Releases Final Guidance On Coverage With Evidence Development

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By Nathaniel Weixel

Dec. 1 — The CMS in a recent final guidance said it is committed to a transparent, least burdensome approach to Medicare coverage with evidence development (CED) that will expand access to medical technologies for beneficiaries.

The final guidance, issued in late November, is principally intended to help the public understand the Centers for Medicare & Medicaid Services’ implementation of CED through the national coverage determination process. It broadens the potential use of CED and introduces potential interactions between the CMS and the Food and Drug Administration in support of CED.

CED is used in instances where there is some evidence of medical benefit but more data are needed before a coverage decision can be made. In making coverage decisions involving CED, the CMS said it decides after a formal review of the medical literature to cover an item or service only in the context of an approved clinical study or when additional clinical data are collected to assess the appropriateness of an item or service for use with a particular beneficiary.

The draft guidance, which updated a document published in 2006, was released in November 2012. 

Not Much Stakeholder Input?

The agency said it received 27 comments on the guidance from stakeholders. In general, the CMS said commenters were supportive of CED as a policy; however, there were particular aspects of the draft guidance with which stakeholders disagreed.

However, a consultant said the agency didn't take into account much of what the stakeholders were asking.

“Stakeholders wanted more predictability and detail around CED, particularly because this is a policy that Medicare is increasingly employing,” Jenny Gaffney, a director at Washington-based consulting firm Avalere Health, said in a Nov. 28 e-mail to Bloomberg BNA. “However, stakeholders did not get this in the final guidance. Medicare did not provide more detail around when it will invoke or end CED at the national level. Rather, Medicare expands the application of CED to the local level without providing any more detail.”

Prior to the release of the proposed guidance, Avalere in 2012 published an analysis of the comments received by the CMS in response to its request for input on the CED policy in general. Avalere found the top concern was whether CED should be applied in local coverage decisions as well as national ones.

Gaffney noted that many of the comments on the proposed guidance requested the agency limit CED to national coverage only. However, the CMS disagreed, and in the final guidance left the door open for CED to be used at a local level.

The CMS in the guidance said, “CED is accomplished through the coverage determination process,” which may occur within the national coverage determination process (NCD) or local coverage determination (LCD) process. The agency said it's working to create CED guidance specifically for Medicare Administrative Contractors to use in LCDs.

Devices Industry

Medical device stakeholders were cautious in responding to the final guidance. Don May, executive vice president, payment and health-care delivery policy at the Advanced Medical Technology Association (AdvaMed), said in an e-mail to Bloomberg BNA that the group thinks having a framework for CED “is good for industry, although we will be closely watching how CMS applies the guidance in practice.”

May said the agency responded to some requests, such as including seven of the eight principles from the original 2006 CED guidance document.

“CMS also agreed with our comment that CED should be used to expand access to coverage and patient access to new medical technologies,” May said. “While CMS did not incorporate other suggestions made by AdvaMed and other stakeholders, the agency discussed changes in the way CED is being used today. For example, the agency did not include the original principle that CED would be used infrequently, noting that technologies are being presented to CMS for coverage earlier in their lifecycle, and companies request CED in order to obtain some coverage rather than a non-coverage decision. Other provisions of the guidance also remain unclear, such as the role of Medicare Administrative Contractors and their ability to use CED in local coverage determinations.”

No Longer ‘Rarely' Applied

The CMS also said it no longer expects to use CED infrequently. However, the CMS said the change isn't because the agency “expects to issue a flood of CED decisions.”

Rather, the CMS said it is responding to the changing nature of NCD requests.

“Technology is being presented to the agency for coverage earlier in the technology lifecycle, and requesters more frequently ask CMS to consider using CED for their particular technology. With these changes, it is no longer appropriate to include as a guiding principle our expectation that CED will be used only ‘infrequently,'” the CMS said.

Some commenters also discussed concerns about patient access to technologies. For example, the Biotechnology Industry Organization (BIO) said CED shouldn't be applied to long-covered technologies, medically accepted indications or technologies under Food and Drug Administration postapproval studies.

The CMS disagreed. In a response, the CMS said “there are many standing NCDs for items and services for which evidence has never been established. CMS may find it appropriate to reconsider an NCD and require CED to fully consider the effectiveness of some of these technologies.”

BIO also urged the CMS to “state specifically that, with regard to drugs and biologics, CED will be limited to off-label uses of FDA-approved products.”

In the guidance, the agency responded to the concern. “CED can be applied to coverage of drugs and biologics. However, we do not contemplate the application of CED to drugs or biologics that have not been approved by FDA for at least one indication. Additionally, many drugs and biologics are self-administered, falling outside the scope of Medicare Part A and B, and therefore, outside the scope of CED,” the CMS said. Self-administered drugs are usually addressed under the scope of Medicare Part D, the CMS document said.

To contact the reporter on this story: Nathaniel Weixel in Washington at

To contact the editor responsible for this story: Brian Broderick at

The guidance is at

A CMS summary of the comments received is at