Are there examples of Coverage with Evidence Development (“CED”) items, services, or treatments performed under an approved Medicare registry?
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