Frequently Asked Questions

What is the process for applying for Coverage with Evidence Development study approval?

To apply for CED approval the designated study sponsor (e.g. Principal Investigator, industry sponsor, or otherwise interested party) submits to the CMS Coverage and Analysis Group:

• His/her contact information
• Extensive study information (e.g. complete study protocol with protocol cites noting where relevant CMS research question(s) are addressed)
• A statement addressing how the study satisfies each of the standards of scientific integrity required by the CED.

The information submitted will be reviewed, and approved studies will be identified on the CMS Website. For further information regarding submission for CED, please see the following: https://www.cms.gov/Medicare/Coverage/Coverage-with-evidence-development/Downloads/HowToApplyforCMSApprovalofCEDStudy_prp.pdf

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