CMS is revamping its coverage with evidence development
program with an eye to using its leverage more broadly to stimulate collection
of clinical data where innovations do not neatly fit into coverage mandates.
Coverage with evidence
development (CED) is a mechanism for CMS to grant conditional coverage
contingent on some form of clinical data collection. CED typically restricts
coverage to patients who are in a clinical trial, which is called "coverage
with study participation."