CMS Invites Comments on Proposed Decision Memo for TAVR

June 18, 2026—The Centers for Medicare and Medicaid Services (CMS) released a proposed decision memo (CAG-00430R2) focused on coverage of transcatheter aortic valve replacement (TAVR) in the treatment of aortic stenosis (AS) in symptomatic and asymptomatic patients.

CMS stated it is seeking public comments on the proposed decision memo and will respond to comments in a final decision memorandum. The CMS website’s National Coverage Analysis (NCA) TAVR page provides a function for submitting public comments. The public comment period is June 15 to July 15, 2026.

As stated in its summary of the proposed decision memo, CMC proposes to (1) cover TAVR for symptomatic severe AS without the coverage with evidence development (CED) requirement; (2) expand coverage of TAVR to asymptomatic severe AS with CED; and (3) revise coverage criteria related to preprocedural patient assessment, intraoperative requirements, and operator and hospital procedural volume requirements.

Additionally, CMS proposes that TAVR for severe AS is covered when furnished with a complete aortic valve and implantation system that has FDA premarket approval for that system’s FDA-approved indication, and when patient, physician and heart team, hospital, and CED study criteria are met. The specific conditions and criteria are outlined in the full proposed decision memo.

In December 2025, CMS announced the initiation of a National Coverage Analysis (NCA) to reconsider the National Coverage Determination (NCD) on TAVR in this indication.

According to CMS, this NCA analyzed 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 from Edwards Lifesciences in July 2025 to initiate a reconsideration of the TAVR NCD.

On June 16, 2026, Society for Cardiovascular Angiography & Interventions (SCAI) President J. Dawn Abbott, MD, discussed key changes in the proposed decision memo in relation to feedback received from SCAI members and discussed next steps in the process.