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August 29, 2019

CMS Initiates National Coverage Analysis for TMVR

August 30, 2019—The Centers for Medicare & Medicaid Services (CMS) initiated a national coverage analysis (NCA) for transcatheter mitral valve repair (TMVR) on August 14. The tracking sheet for the NCA, CAG-00438R, is available on the CMS website here.

CMS is soliciting public comment relevant to the request for coverage of TMVR for the treatment of significant symptomatic functional mitral regurgitation (MR). Additionally, CMS is seeking public comment relevant to the existing randomized clinical trial requirement for coverage of TMVR for uses that are not expressly listed as an FDA-approved indication. CMS is particularly interested in comments that include scientific evidence and that address the breadth of the request.

The initial 30-day public comment period began on August 14, when CMS posted the announcement, and ends after 30 calendar days from that day. CMS advised that it considers all public comments and is particularly interested in clinical studies and other scientific information relevant to the topic under review. Instructions on submitting comments can be found on the CMS website here.

The NCA is being conducted in response to a formal request from the Society of Thoracic Surgeons, American College of Cardiology, American Association for Thoracic Surgery, and Society for Cardiovascular Angiography and Interventions. The letter of request from April 29, 2019 is available on the CMS website here.

TMVR is used in the treatment of MR, of which there are two types: degenerative (primary) MR and functional (secondary) MR.

According to CMS, the National Coverage Determination (NCD; CAG-00438N) of August 2014 established coverage of TMVR under a Coverage With Evidence Development for the treatment of significant symptomatic degenerative MR. Although the existing NCD is specific to primary MR, this new analysis, the NCA of August 14, will primarily focus on TMVR for the treatment of significant symptomatic functional MR.

In addition, CMS is 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. It is also considering revising the title of the NCD to "Transcatheter Mitral Valve Interventions" so that the agency considers potential coverage pathways for other transcatheter mitral valve treatments under this NCD as this field continues to evolve in the future.

CMS noted that the only currently FDA-approved TMVR device is MitraClip (Abbott Structural Heart). In July 2019, FDA approved Abbott's fourth-generation MitraClip G4 heart valve repair device to treat MR.

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