Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER)

Tricuspid regurgitation (TR) occurs when the valve between the right atrium and right ventricle does not function properly and blood flows from the right ventricle back into the right atrium. TR can lead to symptoms of leg swelling, fluid accumulation in the abdomen, an enlarged spleen and liver, and heart failure. Transcatheter Edge-to-Edge Repair of the mitral valve is currently in use to treat mitral regurgitation, and T-TEER is a new application of similar technology for the treatment of TR. The T-TEER procedure is performed percutaneously using a catheter-based technology to pull together the leaflets of the native tricuspid valve with a clip device to reduce TR.

CMS received a complete, formal request to provide coverage for T-TEER. This is a Transitional Coverage of Emerging Technology (TCET) pilot. The manufacturer of this device tested the processes and concepts of TCET.

This NCA will focus on the clinical indications for use of T-TEER among Medicare beneficiaries. This NCA will analyze clinical evidence for characteristics or comorbidities that make patients more or less likely to benefit from the device and whether specific treatment conditions are necessary to achieve the outcomes demonstrated in clinical studies. Other outcomes of interest may include decreased mortality, decreased frequency of exacerbations requiring emergency room or hospital admission, improved function, and quality of life. The scope of this NCA is limited to T-TEER for TR.

CMS is soliciting public comment relevant to the request. We are particularly interested in comments that include scientific evidence, specifically any peer-reviewed literature, that describes the role of T-TEER. We are also interested in health disparities and equity aspects that should be considered in the review.

October 3, 2024