CMS Releases Proposed Decision Memo for Tricuspid TEER

The Centers for Medicare & Medicaid Services (CMS) has announced its proposed decision memo for the coverage of transcatheter edge-to-edge repair (TEER) for the treatment of symptomatic tricuspid regurgitation (TR).

In the memo, released Thursday, CMS proposes that TEER will be covered for patients with symptomatic TR despite optimal medical therapy who are considered appropriate candidates for valve repair by a heart team that includes a cardiac surgeon, an interventional cardiologist, and other specialists experienced in the care and treatment of TR.

As was the case with the recent final national coverage determination (NCD)  for transcatheter tricuspid valve replacement (TTVR), CMS is proposing that reimbursement for T-TEER only be provided under the coverage with evidence development process. This means that eligible cases must be performed in the context of a CMS-approved study with primary outcomes that include all-cause mortality, hospitalizations, or a composite of these, through a minimum of 24 months. Other requirements are an active comparator, a care management plan involving each member of the heart team, and a design allowing for various subgroup analyses.

Support for the NCD comes from the TRILUMINATE trials. T-TEER with TriClip (Abbott) was approved by the US Food and Drug Administration last year for use in patients with severe TR who are not candidates for surgery on the basis of TRILUMINATE. After 1 year, a primary composite outcome (all-cause death or tricuspid valve surgery, HF hospitalization, and improvement in quality of life) favored TEER over medical therapy alone.

The pivotal trial now has 2-year data showing that T-TEER with the TriClip device is associated with a 28% reduction in HF hospitalizations when compared with medical therapy alone.

CMS began its review of T-TEER in October 2024 following a formal request from Abbott to open a national coverage analysis. A second 30-day comment period has now begun and is scheduled to end on May 3, 2025, with a final decision memo anticipated by early July.