CMS Seeks Comments on Proposed Decision Memo for TTVR Coverage

January 7, 2025—The Centers for Medicare & Medicaid Services (CMS) is seeking comments on its proposed decision memo for a national coverage determination (NCD) for transcatheter tricuspid valve replacement (TTVR).

The public comment period is open through January 18, 2025. The proposed decision memo, which was released on December 19, 2024, is available online here and includes a function to submit comments.

The expected completion date of the national coverage analysis (CAG-00467N) is March 19, 2025.

As noted in the document, CMS proposes to cover TTVR under Coverage with Evidence Development (CED) for the treatment of symptomatic tricuspid regurgitation (TR) graded as at least severe. The coverage criteria are for TTVR when furnished with an FDA-approved complete TTVR system and when all provisions (patient criteria, physician criteria, CED study criteria, which are detailed in the memo) are met.

The CMS webpage for the national coverage analysis stated that the review for an NCD was initiated by a request from Edwards Lifesciences in a letter dated February 20, 2024. Edwards announced FDA approval of its Evoque TTVR system for the treatment of TR on February 2, 2024.