CMS wants to shake up how it covers transcatheter aortic valve replacement (TAVR). The agency is proposing to drop the evidence development requirement for symptomatic aortic stenosis patients while expanding coverage — with conditions — to asymptomatic patients. The plan also loosens procedural and staffing requirements, sparking both praise and concern from medical societies.
CMS has proposed a significant update to its national coverage policy for transcatheter aortic valve replacement (TAVR), the first major revision since 2019. The proposal would eliminate the longstanding Coverage with Evidence Development (CED) requirement for patients with symptomatic severe aortic stenosis — effectively recognizing TAVR as a mature, proven therapy — while extending Medicare coverage to asymptomatic severe aortic stenosis patients, albeit with a CED requirement tied to enrollment in a CMS-approved study.
The proposal also streamlines procedural requirements: heart teams could triage patients via chart review, only one in-person evaluation by a TAVR operator is required, and the mandate for both a cardiac surgeon and interventional cardiologist to co-operate during the procedure is eliminated. Hospital-level volume thresholds would also be removed. The changes follow the FDA's 2025 approval of Edwards Lifesciences' Sapien 3 for asymptomatic patients and the landmark EARLY TAVR trial showing better outcomes with preemptive valve replacement.
Key Takeaways:
Why it matters: This overhaul could significantly expand patient access to TAVR — particularly for asymptomatic patients who currently have limited coverage options — while also reshaping how heart teams are structured and how procedures are reimbursed across the U.S.
