Decision Memo for Transcatheter Mitral Valve Repair (TMVR)

The Centers for Medicare & Medicaid Services (CMS) covers transcatheter mitral valve repair (TMVR) under Coverage with Evidence Development (CED) with the following conditions: 

TMVR is covered for the treatment of significant symptomatic degenerative mitral regurgitation when furnished according to an FDA approved indication and when all of the following conditions are met.

1. The procedure is furnished with a complete transcatheter mitral valve repair system that  has received FDA premarket approval (PMA) for that system’s FDA approved indication.  

2. Both a cardiothoracic surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease have independently examined the patient face-to-face and evaluated the patient’s suitability for mitral valve surgery and determination of prohibitive risk; and both physicians have documented the rationale for their clinical judgment and the rationale is available to the heart team.

3. The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multi-disciplinary, team of medical professionals.  The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care. 


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