National Coverage Analysis (NCA) Tracking Sheet

Transcatheter Mitral Valve Repair (TMVR)

CAG-00438R

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.

Benefit Category

Inpatient Hospital Services
Physicians' Services

Requestor Information

Requestor NameRequestor Letter
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) View Letter

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

Contacts

Lead Analysts
Sarah Fulton, MHS
sarah.fulton@cms.hhs.gov
410-786-2749
Lead Medical Officers
Steven Farmer, MD, PhD

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

January 19, 2021