CMS guidance outlines more flexible CED program

CMS released draft guidance that would give the agency greater flexibility to apply its coverage with evidence development (CED) mechanism. CMS uses CED to provide conditional coverage for items and services contingent on some form of clinical data collection in the Medicare population. In the guidance, which will update 2006 guidance on the topic, CMS removed a section that called for the agency to use CED "infrequently," as well as a section that restricted CED to the National Coverage Determination (NCD) process.

CMS also removed one of the two types of CEDs -- coverage with appropriateness determination, in which the agency provides coverage if specific data are submitted to a registry. The agency said the other type of CED -- coverage with study participation, where CMS covers a drug, device or procedure only if the patient is enrolled in a prespecified clinical trial -- is more "consistent with the current conceptualization of CED." CMS said it will continue to consider public comments, which are due by Jan. 28 (see BioCentury, April 9). ...