Yes. All studies seeking Medicare coverage under CED should be registered with ClinicalTrials.gov. If the CED study is a registry, the study should be registered on AHRQ’s Registry of Patient Registries.
Yes. A Coverage with Evidence Development (“CED”) is considered completed when the Centers for Medicare and Medicaid Services (CMS”) removes the requirement for study participation as a condition of coverage for one or more indication of an item/service. The item/service is then designated as “covered” under the Medicare National Coverage Determination (“NCD”).
Yes, the following are examples of treatments covered only under CED: (Please click on the hyperlinks below to obtain further specific information such as decision memo, NCT#, Medicare approved registry and clinical study approvals).
Yes. As an example, Transaortic Valve Replacement (“TAVR”) involves a new technology for use in treating aortic stenosis. CMS issued a Medicare National Coverage Determination on May 1, 2012, which allows coverage of TAVR under Coverage with Evidence Development (“CED”) with certain conditions. As part of the CED, there is a Medicare approved registry which has been reviewed and determined to meet the requirements of coverage. For more information, please visit: please visit the https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/TAVR.html