Transcatheter mitral valve repair (TMVR) is used in the treatment of mitral regurgitation (MR), abnormal blood flow back through the valve. There are two types of MR. Degenerative (primary) MR involves structural abnormality of the valve and functional (secondary) MR is a distinct condition that generally results from left ventricular dysfunction. Abbott Vascular's MitraClip®, is currently the only FDA-approved TMVR device. The procedure involves clipping together a portion of the mitral valve leaflets as a treatment for reducing MR to improve recovery of the heart from overwork, improve function and potentially halt the progression of heart failure.

The National Coverage Determination (NCD) (see NCD Manual, section 20.33) established coverage of TMVR under Coverage with Evidence Development (CED) for the treatment of significant symptomatic degenerative MR. While the existing NCD is specific to degenerative (primary) MR, this analysis will primarily focus on TMVR for the treatment of significant symptomatic functional MR.

In addition, we are reviewing the NCD requirement for randomized controlled trials of non-FDA approved indications and considering if it should be changed to reduce burden and encourage innovation in this space. We are also considering revising the title of the NCD to "Transcatheter Mitral Valve Interventions" so that we may consider potential coverage pathways for other transcatheter mitral valve treatments under this NCD as this field continues to evolve in the future.

CMS is soliciting public comment relevant to the request for coverage of TMVR for the treatment of significant symptomatic functional MR. We are also soliciting public comment relevant to the existing RCT requirement for coverage of TMVR for uses that are not expressly listed as an FDA approved indication. We are particularly interested in comments that include scientific evidence and that address the breadth of the request.