Coverage with Evidence Development
Guidance for updated guidance document 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.
Final
Issued by: Centers for Medicare & Medicaid Services (CMS)
Issue Date: January 30, 2020
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
HHS is committed to making its websites and documents accessible to the widest possible audience, including individuals with disabilities. We are in the process of retroactively making some documents accessible. If you need assistance accessing an accessible version of this document, please reach out to the guidance@hhs.gov.
DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.