Transcatheter Aortic Valve Replacement (TAVR) for Aortic Regurgitation (AR)

CMS NCA document | source_status=Open | review_type=3rd Recon | public_comment_open=True | document_id=CAG-00430R3

Issue: Transcatheter aortic valve replacement (TAVR) for Aortic Regurgitation is a technology for use in treating aortic stenosis (AS) and aortic regurgitation (AR). 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. The most recent update to that NCD was initiated in December 2025 and focused on severe AS. On September 10, 2026, CMS released the final NCD which updated the policy by 1) ending CED requirements for treatment of symptomatic severe AS; 2) expanding coverage for asymptomatic severe AS under CED; and 3) easing but not removing requirements related to pre-procedural patient assessments, intraoperative requirements, and operator and hospital procedural volume requirements. Simultaneously with the posting of the final NCD , CMS initiated this reconsideration of NCD 20.32 to review the evidence for TAVR for AR. CMS internally generated this reconsideration in response to public comments received during the prior reconsideration for AS and due to the March 2026 FDA approval of the first TAVR system for AR, the Trilogy Transcatheter Heart Valve system manufactured by JenaValve. Additionally, during the prior reconsideration for AS, commenters requested clarification on coverage of TAVR for AR, with some requesting that the final NCD address both AS and AR. Instead of expanding the scope of the prior analysis, we are opening a new reconsideration of the TAVR NCD to address coverage of AR. This NCA will only address indications for TAVR for AR. CMS is soliciting public comment. We are particularly interested in comments that include scientific evidence, specifically any peer-reviewed literature, that describes the role of TAVR for AR.