Transcatheter Aortic Valve Replacement (TAVR)

CMS covers TAVR for symptomatic aortic valve stenosis when performed per an FDA-approved indication using an FDA-PMA valve/system and when care is provided by a documented multidisciplinary heart team in a hospital meeting specified infrastructure and volume/practice requirements. Non–FDA-indicated uses are only covered within CMS-approved Coverage with Evidence Development (CED) clinical studies or registries that meet detailed scientific, human-subjects, registry enrollment, outcome-tracking, and public-reporting requirements; TAVR is not covered when comorbidities preclude expected benefit or when program, team, device, or documentation requirements are unmet.

"TAVR is covered for treatment of symptomatic aortic valve stenosis when furnished according to an FDA-approved indication and using a complete aortic valve and implantation system that has received..."