Mitral regurgitation (MR), also known as mitral insufficiency or mitral incompetence is a disorder in which the heart valve that separates the upper and lower chambers on the left side of the heart does not close properly. The Centers for Medicare & Medicaid Services (CMS) has issued a proposed decision memorandum this week covering the cost of transcatheter mitral-valve repair (TMVR) for the minimally invasive treatment of significant symptomatic mitral regurgitation. TMVR devices clip together a portion of the mitral valve leaflets to reduce MR, which if not treated, can lead to heart failure. CMS cited a study that estimates as many as 5 million people could suffer from the ailment by 2030, double the number of those who had the condition in 2000.
It was made clear that the scope of review in this proposed decision memo focuses on the only FDA-approved TMVR device, MitraClip. The memo focuses only on the repair of the mitral valve specifically by clipping the mitral-valve leaflets rather than by annular reduction or by chordal implantation [and] does not include mitral-valve balloon annuloplasty or commissurotomy.
CMS’ proposed approval under Coverage with Evidence Development (CED) does come with certain conditions that include:
- Mandatory FDA approval for the device.
- A cardiac surgeon experienced in mitral-valve surgery and a cardiologist experienced in mitral-valve disease must independently determine that traditional surgery would be too risky for a beneficiary.
- The procedure must be performed in a hospital that has an on-site heart-valve surgery program and a cardiac catheterization lab.
- Preoperatively and postoperatively, the patient is under the care of a patient-centered heart team, and the hospital has the appropriate infrastructure and heart-team members.
- The heart team’s interventional cardiologists and cardiac surgeon(s) must jointly participate in the intraoperative technical aspects of TMVR.
To cover TMVR for non–FDA-approved indications, the procedure must be part of an FDA-approved randomized clinical trial and meet 13 standards of scientific integrity and relevance to the Medicare population.
424.0 Mitral valve disorder
I34.1 Nonrheumatic mitral (valve) prolapse
The CMS is seeking comments from the public until June 15 regarding this proposed coverage of TMVR. After considering the public comments, the agency will make a final determination and issue a final decision memorandum.
According to Chuck Simonton, chief medical officer for Abbott Vascular, “Continued collaboration will also be important to establish appropriate physician and hospital reimbursement, so that Medicare beneficiaries have access to this breakthrough medical innovation”.