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September 14, 2026
CMS Initiates NCA on TAVR for Aortic Regurgitation
KEY TAKEAWAYS
- CMS initiated an NCA to reconsider Medicare coverage of TAVR for aortic regurgitation.
- The review follows public comments on the previous NCA on TAVR coverage for aortic stenosis and the FDA approval of the JenaValve Trilogy TAVR system for aortic regurgitation.
- CMS is accepting public comments on the NCA through October 10, 2026, with particular interest in peer-reviewed scientific evidence.
September 14, 2026—The Centers for Medicare & Medicaid Services (CMS) has initiated a national coverage analysis (NCA; CAG-00430R3) for transcatheter aortic valve replacement (TAVR) to treat aortic regurgitation (AR). Simultaneously, CMS posted the final National Coverage Determination (NCD) on TAVR focused on severe aortic stenosis (AS), which is covered separately in Cardiac Interventions Today.
CMS advised that during the reconsideration for AS, commenters requested clarification on coverage of TAVR for AR, with some requesting that the final NCD address both AS and AR. However, instead of expanding the scope of the previous analysis, CMS opened the new reconsideration of the NCD 20.32 for TAVR to address coverage of AR, stated the agency.
CMS further noted that this reconsideration was internally generated by the agency in response to public comments received during the reconsideration for AS as well as FDA approval of the first TAVR system for AR, the Trilogy transcatheter heart valve system (JenaValve), announced in March 2026.
CMS is soliciting public comments and is particularly interested in comments that include scientific evidence, specifically any peer-reviewed literature, that describe the role of TAVR for AR. The 30-day public comment period on the new NCA focused on TAVR for AR is September 10 to October 10, 2026.
The proposed decision memo due date is March 10, 2027, advised CMS.
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