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Focus on Regulation

MEDCAC Discusses Future of Coverage with Evidence Development

The Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) held a day-long meeting on May 16, 2012 to discuss Coverage with Evidence Development (CED). This meeting is part of a larger effort by CMS to reconsider its use of CED, a Medicare policy in which an item or service that would not otherwise be considered “reasonable and necessary” is covered while evidence is gathered on the item or service through clinical trials or registries. CED is intended to reduce barriers to innovative care and provide CMS with more data to support coverage decisions. CMS has applied CED in several coverage determinations over the past decade. 

In 2006, CMS issued a guidance document describing use of CED.  In November 2011, CMS withdrew that guidance document from its website and requested comments on implementation of CED through the national coverage determination (NCD) or other avenues under Part A and Part B; potential impact of CED on the Medicare program and its beneficiaries; and suggested approach to CED to maximize benefit to Medicare beneficiaries.  The Administration’s “National Bioeconomy Blueprint,” released in April 2012, explained that CMS plans to “implement the next phase of CED by better defining the parameters and guidance for CED so it can be used more widely and effectively as a driver of innovation.”  

The MEDCAC meeting’s agenda focused on discussion of evidentiary thresholds for invoking or terminating CED. Nine public speakers and four invited guest speakers addressed a series of questions about definition of an evidentiary threshold. Although the panel struggled to define “evidentiary threshold,” the panel members agreed that such a threshold should be defined before applying CED to an item or service, and that application of the threshold could be affected by numerous factors, such as the safety profile of the technology, the severity of disease being treated, the availability of alternative treatments, off-label use of the technology, and whether the item or service is diagnostic or therapeutic.  The panel members also agreed with the public speakers that CMS’s use of CED must be transparent and predictable, and should involve extensive stakeholder input.

CMS staff indicated that the agency will issued a revised draft of the guidance document on CED.