Transcatheter Aortic Valve Replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) is a technology for use in treating aortic stenosis (AS). A bioprosthetic valve is inserted via transfemoral, transapical, or transaortic approaches using a catheter and implanted in the opening of the native aortic valve or in failed surgical bioprosthetic aortic valves.

Section 20.32 of the Medicare National Coverage Determinations (NCD) Manual states conditions of coverage for TAVR for AS. In 2012, the Centers for Medicare & Medicaid Services (CMS) established coverage of TAVR under Coverage with Evidence Development (CED). In 2019, coverage requirements were updated following a reconsideration of the TAVR NCD. The NCD contains requirements including specific procedural volumes for heart teams and hospitals as well as participation in a prospective, national, audited registry. The NCD requires TAVR procedures for uses that are not expressly listed as an FDA-approved indication to be performed in clinical studies that meet certain requirements and are approved by CMS.

CMS received a complete, formal request to initiate a reconsideration of the TAVR NCD.

This NCA will focus on coverage of TAVR for AS in symptomatic and asymptomatic patients. This NCA will analyze clinical evidence for characteristics or comorbidities that make patients more or less likely to benefit from the device and whether specific treatment conditions are necessary to achieve the outcomes demonstrated in clinical studies.

CMS is soliciting public comment relevant to the request. We are particularly interested in comments that include scientific evidence, specifically any peer-reviewed literature, that describes the role of TAVR for AS.

December 15, 2025