Medicare to Cover Transcatheter MV Repair, Requires Registry

August 08, 2014

BALTIMORE, MD — Transcatheter mitral-valve repair (TMVR) is to be covered under Medicare for the treatment of significant symptomatic degenerative mitral regurgitation (MR), the Centers for Medicare & Medicaid Services (CMS) announced yesterday[1]. The decision document outlines conditions for coverage that appear mostly to replicate those laid out in its May 15, 2014 proposed decision memo[2].

Coverage applies to TMVR using any device approved for the indication, which for now means only the the MitraClip (Abbott Vascular), which the FDA approved in late 2013 for patients with significant symptomatic MR (at least grade 3+) considered too high risk for surgery.

In one substantive difference between the proposed and final conditions, the new document states that "TMVR must be performed by an interventional cardiologist or a cardiothoracic surgeon," or the two can collaborate on the procedure as needed. That contrasts with the proposed language, which had stipulated that "the heart team's interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TMVR."

The final document follows a June 13, 2014 letter from the Society for Cardiovascular Angiography and Interventions (SCAI) to the acting director of the CMS Coverage and Analysis Group, Dr Tamara Syrek Jensen, posted on the SCAI website[3], that responds to several proposed conditions for coverage. Among those was the required "joint participation" of the cardiologist and surgeon; the letter argues for the change that the agency ultimately made to its proposed conditions.

"We fear hospitals may be less inclined to offer repair through use of the mitral-valve clip (or comparable device) if a federal mandate for joint intraoperative care is universally imposed and increases costs to an unsustainable level," the SCAI letter stated.

Both the proposal and final decision call for all cases of patients undergoing TMVR using approved devices from any manufacturer to be entered into a "prospective, national, audited registry" that tracks outcomes of each patient for at least one year.

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