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CMS has received a formal complete request for a national coverage determination (NCD) for a Transcatheter Mitral Valve Repair (TMVR) device. This new technology involves clipping together a portion of the mitral valve leaflets as a treatment for reducing mitral regurgitation (MR) with the intended outcomes to improve recovery of the heart from overwork, improve function and potentially halt the progression of heart failure. The TMVR procedure is typically performed under general anesthesia via a percutaneous transvenous approach with echocardiographic and fluoroscopic guidance. The heart beats normally during the procedure, and heart-lung bypass support should generally not be required.
MR is the most common type of heart valve insufficiency. The condition occurs when the leaflets of the mitral valve do not close completely, thereby allowing retrograde (backward) blood flow from the left ventricle into the left atrium.
CMS is opening this national coverage analysis (NCA) to determine if this TMVR technology is reasonable and necessary. The scope of our review does not include coverage of mitral valve balloon annuloplasty or commissurotomy.
November 18, 2013
CMS initiates this NCA for Transcatheter Mitral Valve (TMV). 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 comments that include published clinical studies and other scientific information that provide evidence for improvement in short and long term outcomes related to this technology.
Instructions on submitting public comments can be found at http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html. You can also submit a public comment by clicking on the highlighted word comment in the title bar at the top of this page. We strongly urge that all public comments be submitted through this website. Please do not submit personal health information in public comments. Comments with personal health information may not be posted to the website.
May 15, 2014
August 7, 2014