Coverage with Evidence Development
CMS released an updated guidance document on November 20, 2014 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.
The NCDs requiring CED are listed to the left. Each NCD contains information on the status of CED.
A CED cycle is considered "completed" when CMS removes a requirement for study participation as a condition of coverage for one or more indications of an item or service. For CED under an NCD, the publication of the final decision is the effective date for the close of a CED cycle performed under that NCD.
The most recent CED Guidance is located here: Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development
Three proposed guidance documents have been posted and are open for public comment. Comment period: 6/22/23-8/21/23
Positron Emission Tomography (FDG) for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung, and Testicular Cancers (PDF)
National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage with Evidence Development - July 2006 (PDF)
Qs & As - Mandatory Reporting of Clinical Trial Identifier Numbers on Claims (PDF)
Positron Emission Tomography (FDG) for Solid Tumors (PDF)