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    MCD

    National Coverage Analysis (NCA) Tracking Sheet for Transcatheter Mitral Valve Repair (TMVR) (CAG-00438R)

    • Expand All All sections on the page are Expanded
    • Collapse All All sections on the page are Collapsed

    Collapse Issue

    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.

    Collapse Benefit Category

    Inpatient Hospital Services
    Physicians' Services

    Collapse Requestor Information

    Requestor Name(s):  The Society of Thoracic Surgeons (STS), the American College of Cardiology (ACC), the American Association for Thoracic Surgery (AATS), and the Society for Cardiovascular Angiography & Interventions (SCAI)
    Requestor Letter(s):  View Letter

    Collapse Important Dates

    Formal Request Accepted and Review Initiated:  08/14/2019
    Expected NCA Completion Date:  09/28/2020
    Public Comment Period:  08/14/2019 - 09/13/2019
    Proposed Decision Memo Released:  06/30/2020
    Proposed Decision Memo Public Comment Period:  06/30/2020 - 07/30/2020 
    Decision Memo Released:  01/19/2021
    Comments for this NCA:  View Public Comments

    Collapse Contacts

    Lead Analyst(s): 
    • Sarah Fulton, MHS
      sarah.fulton@cms.hhs.gov
      410-786-2749
    Lead Medical Officer(s): 
    • Steven Farmer, MD, PhD

    Collapse Actions Taken

    August 14, 2019

    CMS initiates this national coverage analysis for TMVR. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days. CMS 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 at: http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html.

    To submit a comment, please use the orange "Comment" button at the top of the page. Enter comments directly into the "Submit A Public Comment" webpage.

    February 18, 2020

    CMS will not be issuing a proposed National Coverage Determination on Transcatheter Mitral Valve Repair (TMVR) today, but a decision is forthcoming.

    June 30, 2020

    Posted proposed decision memo.

    January 19, 2021

    Posted final decision memo
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