CMS expands coverage of T-TEER for TR treatment

CMS recently issued a final decision memo to formally expand Medicare coverage of transcatheter edge-to-edge repair (T-TEER) for the treatment of tricuspid regurgitation (TR).

The agency initiated a coverage analysis for T-TEER in late 2024 and set out to develop a National Coverage Determination (NCD) under coverage with evidence development (CED). The CED pathway allows Medicare to reimburse items and services furnished in the context of clinical studies or with the collection of additional clinical data.

T-TEER is covered when furnished according to an FDA market-authorized indication and certain patient, physician, and CED study criteria are met. First, despite optimal medical therapy, the patient must have symptomatic TR with tricuspid valve repair being considered as appropriate by a heart team. They must be under the care of this team in both pre-operative and post-operative settings.

At a minimum, the heart team must include the following specialists with experience in treating TR:

• Cardiac surgeon
• Interventional cardiologist
• Cardiologist with training and experience in heart failure management
• Interventional  echocardiographer

CMS-approved T-TEER studies must include several elements, such as specific primary outcomes, an active comparator, and a care management plan that reflects the experience and role of each expert on the heart team.

Throughout its analysis, CMS received a total of 93 comments from physicians, organizations, professional associations, and other industry stakeholders during two public comment periods. Of note, many commenters raised concerns over CMS’ proposal to require an electrophysiologist on the heart team. In response, the agency removed this criterion in its final decision.

T-TEER is not covered for patients outside of a CMS-approved study, and nothing in the NCD precludes T-TEER coverage through NCD 210.1 or the agency’s Investigational Device Exemption policy.