CMS Initiates National Coverage Analysis on TAVR for Asymptomatic and Symptomatic Aortic Stenosis

December 24, 2025—The Centers for Medicare & Medicaid Services initiated a National Coverage Analysis (NCA) to reconsider the National Coverage Determination (NCD) on transcatheter aortic valve replacement (TAVR) that will focus on coverage of TAVR for aortic stenosis (AS) in symptomatic and asymptomatic patients. The NCA (CAG-00430R2) and related documents are available on the CMS website here.

According to CMS, 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 received a complete formal request, submitted by Edwards Lifesciences in July, to initiate a reconsideration of the TAVR NCD.

As stated in the NCA, CMS is soliciting public comment relevant to the request, particularly comments that include scientific evidence, specifically peer-reviewed literature that describes the role of TAVR for AS. The public comment period opened December 15, 2025, and will close January 14, 2026. The due date of the proposed decision memo is June 15, 2026, and the expected completion date for the NCA is September 13, 2026. Instructions on submitting comments can be found here.

The NCA advised that the conditions of coverage for TAVR for AS are stated in Section 20.32 of the Medicare NCD manual. CMS established coverage of TAVR under Coverage with Evidence Development in 2012. Further, coverage requirements were updated in 2019 after 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.