CMS Opens a Review of Coverage for Transcatheter Mitral Valve Repair

The Centers for Medicare & Medicaid Services (CMS) is seeking input on whether to expand coverage for transcatheter mitral valve repair (TMVR) to include patients with significant symptomatic functional mitral regurgitation (MR). The agency formally opened its coverage review last week and is seeking public comment.

The existing national coverage determination (NCD) for TMVR, adopted 5 years ago after the initial approval of the MitraClip (Abbott), provides reimbursement only when it is used to treat patients with significant symptomatic degenerative MR.

But there is now strong evidence to support use of the MitraClip—which remains the only TMVR device approved by the US Food and Drug Administration—in patients with functional MR. In the COAPT trial, patients with heart failure and severe functional MR who were treated with the MitraClip on top of guideline-directed medical care had significant reductions in heart failure rehospitalizations (primary endpoint) and all-cause mortality (secondary endpoint) at 2 years. Those findings, however, were at odds with the neutral results from the MITRA-FR trial, released a month earlier.

COAPT supported the FDA’s decision in March to expand MitraClip’s indication to include functional MR.

Seeking to harmonize the reimbursement criteria for TMVR and the FDA-approved indications for MitraClip, the Society of Thoracic Surgeons, the American College of Cardiology, the American Association for Thoracic Surgery, and the Society for Cardiovascular Angiography and Interventions sent a formal request to CMS to reconsider its NCD.

CMS obliged, and the agency will be collecting public comments regarding coverage of TMVR for significant symptomatic functional MR through September 13, 2019, through its website.

“In addition, we are reviewing the NCD requirement for randomized controlled trials of non-FDA approved indications and considering if it should be changed to reduce burden and encourage innovation in this space,” CMS said. “We are also considering revising the title of the NCD to ‘Transcatheter Mitral Valve Interventions’ so that we may consider potential coverage pathways for other transcatheter mitral valve treatments under this NCD as this field continues to evolve in the future.”

According to its tracking sheet, CMS plans to have a proposed decision memo by February 14, 2020, and to complete its analysis by May 14, 2020.