Coverage with Evidence Development

CMS released an updated guidance document on August 7, 2024 that describes coverage with evidence development (CED). CMS, as part of the national coverage determination (NCD) may determine coverage of an item or service only in the context of a clinical study. The NCDs requiring CED are listed to the left - clicking on an NCD will lead to a listing of approved clinical studies for that specific NCD. Each NCD contains information on the status of CED.

A CED cycle is considered completed when CMS completes a reconsideration of the CED coverage decision and removes the requirement for the study participation as a condition of coverage. As with any NCD, any member of the public may request to reopen the NCD that requires CED. CMS prospectively plans to re-examine the published evidence at a date tied to completion of a CMS-approved CED study or other available evidence. CMS retains the right to reconsider an NCD at any time. CMS will review the evidence resulting from the CED studies as well as any other available evidence. The NCD process is described in the Federal Register (78 Fed. Reg. 48164).

The most recent CED Guidance is located here:  Coverage with Evidence Development