CMS Agrees to Reimburse Transcatheter Tricuspid Valve Replacement

The US Centers for Medicare & Medicaid Services (CMS) has finalized its national coverage determination (NCD) for transcatheter tricuspid valve replacement (TTVR) when used to treat patients with symptomatic tricuspid regurgitation (TR).

According to the final decision memo posted March 19, 2025, CMS will cover TTVR when used for a US Food and Drug Administration-approved indication in patients who have symptoms despite use of optimal medical therapy and in whom a heart team considers tricuspid valve replacement to be an appropriate option.

The heart team overseeing patient care should include—at a minimum—a cardiac surgeon, an interventional cardiologist, a cardiologist with training and experience in heart failure management, an electrophysiologist, multimodality imaging specialists, and an interventional echocardiographer. All must have experience in treating TR.

Importantly, reimbursement for TTVR will only be provided under the coverage with evidence development (CED) process, meaning eligible cases must be performed in the context of a CMS-approved study. That study must have primary outcomes that include all-cause mortality and/or hospitalizations; a minimum follow-up of 24 months; an active comparator; a care management plan involving each member of the heart team; and a design allowing for various subgroup analyses.

According to the CMS tracking sheet, the agency started its review of TTVR in June 2024 after Edwards Lifesciences requested coverage for its Evoque system, which became the first TTVR system cleared by the FDA in February 2024. CMS made its final determination after two public comment periods and the release of a proposed decision memo in December.

The bulk of the supporting evidence came from two pivotal trials of the Evoque system—the single-arm TRISCEND study and the randomized TRISCEND II trial. The latter showed that compared with optimal medical therapy alone, the addition of TTVR with Evoque led to the “near elimination” of TR and significantly improved symptoms, function, and quality of life at 1 year among patients with symptomatic severe TR, with numerically fewer deaths and hospitalizations for heart failure.