The U.S. Centers for Medicare and Medicaid Services (CMS) announced that it will now reimburse mitral valve repair performed with the MitraClip (Abbott) for patients with functional mitral regurgitation (MR).
Previously, MitraClip procedures for degenerative MR, but not functional MR, were eligible for reimbursement.
CMS’s decision, announced Tuesday, comes nearly 2 years after the U.S. Food and Drug Administration expanded the indication for MitraClip as treatment for functional MR and nearly 7 months after CMS first proposed a National Coverage Determination (NCD) for this indication.
The final NCD contains some changes from the proposal, which was issued June 30. For example, the proposed NCD said that the heart team caring for the patient must consist of a cardiac surgeon, interventional cardiologist, interventional echocardiographer and providers from other physician groups, as well as advanced patient practitioners, nurses, research personnel and administrators.
The final NCD adds “heart failure cardiologist experienced in treating patients with advanced heart failure” to the required heart team members caring for functional MR patients.
Hospital volume requirements were also adjusted. The proposed NCD said that a hospital program must have performed at least 40 mitral valve surgeries in the year before the program started, at least 20 of which were mitral valve repairs; have at least two physicians with cardiac surgery privileges experienced in valvular surgery; have at least one physician with interventional cardiology privileges; and perform at least 300 percutaneous coronary interventions (PCIs) per year.
The final NCD changed the first of these volume requirements to at least 20 mitral valve surgical procedures for severe MR per year or at least 40 over 2 years, of which at least 10 (or 20 over 2 years) must be mitral valve repairs.
MitraClip was the subject of mixed studies for functional MR. The MITRA-FR study, published in the Dec. 13, 2018 issue of The New England Journal of Medicine, found that the device plus medical therapy did not significantly lower the primary outcome rate (a composite of all-cause mortality or unplanned heart failure hospitalization at 1 year) in comparison with medical therapy alone.
However, the COAPT study, published in the same issue of The New England Journal of Medicine, found that patients treated MitraClip plus maximally tolerated guideline-directed medical therapy (GDMT) had significantly lower rates of heart failure hospitalizations and mortality from any cause at 2 years in comparison with the GDMT-alone group.
A consensus has emerged in the more than 2 years since those studies’ results were released that the COAPT trial enrolled patients with more severe MR, less-pronounced left ventricular remodeling, lower pulmonary pressure and better right ventricular function as compared with patients in the MITRA-FR trial.
The NCD requires that patients with functional MR closely resemble those enrolled in the COAPT trial. In response to public comments encouraging that more a broader set of patients be included, CMS said in part that “the COAPT study excluded patients with a range of clinical conditions that commonly occur together with moderate-to-severe or severe MR.”
“CMS has determined that there is insufficient evidence to conclude that TEER is reasonable and necessary for the treatment of patients specifically excluded from the COAPT study,” the NCD says.
Both the proposed and final NCD replaced the term “transcatheter mitral valve repair (TMVR)” with mitral valve “transcatheter edge-to-edge repair (TEER).” TEER applies to treatment of both functional (also known as secondary) MR and degenerative (also known as primary) MR.
“Secondary mitral regurgitation generally impacts older individuals suffering from heart failure who rely on Medicare for their healthcare coverage,” said Neil Moat, MD, chief medical officer of Abbott’s structural heart business, in a Wednesday news release announcing CMS’s decision. “CMS’ decision to expand coverage for MitraClip marks a pivotal moment for people seeking a minimally invasive option that reduces mitral regurgitation and significantly improves their quality of life and chances of survival.”