Health Affairs January 1, 2025
Abstract
The Centers for Medicare and Medicaid Services (CMS) coverage with evidence development (CED) program provides coverage for items and services not meeting Medicare’s “reasonable and necessary” standard while requiring participation in clinical studies. As additional evidence is available, CMS may reconsider CED decisions. Of twenty-six items and services in the CED program since its 2005 inception, CMS has reconsidered coverage for ten (38 percent). Of 235 publications that CMS cited as evidence supporting reconsideration, 57 (24...