On Wednesday, July 30, 2020, HFSA submitted comments to the Centers for Medicare and Medicaid Services (CMS) regarding the proposed national coverage memorandum for Transcatheter Mitral Valve Repair (TMVR). The CMS proposed national coverage memo would drastically change Medicare’s approach to TMVR coverage, principally by eliminating the concept of “coverage with evidence development” (CED) for these procedures and relegating coverage policy for TMVR for degenerative mitral regurgitation (DMR) to local Medicare contractors, which could create variable coverage policies across the country.
HFSA weighed in to urge CMS to maintain coverage with evidence development (CED) for TMVR. Also, HFSA wrote in opposition to CMS’ proposal to remove the current CED for transcatheter edge-to-edge repair (TEER) for both DMR and FMR citing the risk to patient access and safety. CMS will now consider submitted comments and is required to respond to those public comments when it issues its final coverage decision memorandum.