The Centers for Medicare & Medicaid Services (CMS) released a proposed National Coverage Determination (NCD) Tuesday that would provide for Medicare and Medicaid coverage of transcatheter edge-to-edge mitral valve repair to treat functional mitral regurgitation (MR).
CMS has provided coverage for transcatheter mitral valve repair to treat degenerative MR since 2014.
Edge-to-edge repair would be covered to treat moderate-to-severe or severe MR when the patient remains symptomatic despite maximally tolerated guideline-directed medical therapy (GDMT). Eligible patients would also need to meet all of the following criteria:
- ischemic or non-ischemic cardiomyopathy,
- left ventricular (LV) ejection fraction of 20% to 50%,
- New York Heart Association functional class II, III or IVa (ambulatory),
- LV end-systolic dimension £70 mm, and
- The local heart team would have to determine that mitral valve surgery is not a treatment option for the patient.
These are the same criteria used in the COAPT trial, which showed that at 2-year follow-up, patients who were treated using the MitraClip plus maximally tolerated GDMT had a significantly lower all-cause mortality rate than patients treated with medical therapy alone (29.1% vs. 64.1%; HR 0.62; 95% CI 0.46-0.82; p<0.001).
The NCD also sets requirements for hospitals where the procedure would be performed. The program must meet the following criteria to start a new program, or to maintain an existing program:
- ³40 mitral valve surgeries the year before initiating the program, at least 20 of which were mitral valve repairs;
- ³2 physicians with cardiac surgery privileges experienced in valvular surgery;
- ³1 physician with interventional cardiology privileges; and
- ³300 percutaneous coronary interventions per year.
The FDA approved the MItraClip (Abbott Vascular) to treat significant symptomatic degenerative MR (grade ³3+) in 2013. In March 2019, a few months after the results of the COAPT trial were released, the FDA expanded the indication for MitraClip to include treatment of patients meeting the COAPT criteria.
The MITRA-FR trial showed no benefit for MitraClip over medical therapy, but some of those patients had worse heart failure (ejection fraction 15% to 40%) and less MR.
CMS is seeking public comments on the proposed NCD, and the public comment period will be open for 30 days. After that period closes, CMS will issue a final NCD within 60 days.