麻豆传媒

Medicare reimbursement for transcatheter mitral valve repair (TMVR) of functional (secondary) mitral regurgitation is on the table.

The Centers for Medicare & Medicaid Services (CMS) opening an analysis into extending the National Coverage Determination (NCD) beyond just its coverage of degenerative (primary) mitral regurgitation.

Abbott Vascular's MitraClip won an FDA indication for treating secondary MR in March, making it the sole TMVR device on the U.S. market.

Given the gap in coverage for the newly-approved procedure, revision of the NCD was requested by jointly The Society of Thoracic Surgeons, the American College of Cardiology, the American Association for Thoracic Surgery, and the Society for Cardiovascular Angiography & Interventions.

Their request letter cited the COAPT trial showing MitraClip's reductions in heart failure hospitalizations and mortality among patients with functional MR as evidence to support NCD coverage for this group. The MITRA-FR trial, on the other hand, was deemed "inconclusive" with the discrepancy in results in part attributed to "significant differences in trial inclusion/exclusion criteria and trial conduct."

"The four societies are working to review and update the current expert consensus document" on TMV repair and replacement, the formal request letter noted, but they advocated keeping the requirement for care from a multidisciplinary heart team and continuation of data collection under coverage with evidence development.

"Since FMR [functional mitral regurgitation] is a condition causing congestive heart failure, at least one team member should be focused on the clinical and medical aspects of the patient's heart failure," it added. "The success of the COAPT Trial was in large part due to optimization and maintenance of GDMT, appropriate patient selection, and post procedure management by this team member."

The agency also said it is considering renaming the NCD to "Transcatheter Mitral Valve Interventions" to cover both mitral valve repair and replacement, as well as approaches still under investigation such as direct and indirect annuloplasty and chordal implant.

Public comments can be submitted to CMS until mid-September.

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