CV societies ‘very concerned’ about proposed coverage changes for MR therapy

Four leading cardiovascular societies have shared a new comment letter in response to the CMS proposal that would cover transcatheter edge-to-edge repair (TEER) of the mitral valve for patients with functional mitral regurgitation (FMR).

The American College of Cardiology (ACC), Society of Thoracic Surgeons (STS), American Association for Thoracic Surgery (AATS) and Society for Cardiovascular Angiography and Interventions (SCAI) all worked together on the letter, describing the idea of expanding coverage for FMR as “an important advancement for patient care.”

However, the societies wrote, they “are very concerned” about specific details of the proposed national coverage determination (NCD). For instance, CMS wants to stop data collection under coverage with evidence development (CED) for MR therapy, believing that enough evidence has already been gathered. The societies disagree, noting that “important information to ensure quality and improve care should still be collected and monitored through continued CED.”

“The decision to eliminate CED for TEER in the proposed NCD has substantial, negative ramifications for the management and safety of patients with significant symptomatic MR, whether degenerative or functional, and the societies strongly urge CMS to reconsider this proposal,” according to the comment letter.

The societies also urged CMS to reconsider its proposal to bifurcate coverage for MR therapy, addressing FMR in its updated NCD while leaving degenerative mitral regurgitation (DMR) coverage to “local coverage” at the discretion of Medicare Administrative Contractors. Going down this route, they wrote, could put some FMR patients at risk.

“Dividing coverage in this manner is confounded by the fact that there is often significant difficulty in the medical community differentiating DMR from FMR,” according to the comment letter. “In fact, 15% of patients currently entered into the TVT Registry are classified as “mixed” disease. To leave these coverage decisions to local contractors would create needless confusion in determining patient coverage.”

The full comment letter, signed by the presidents of the ACC, STS, AATS and SCAI, includes other key concerns and recommendations related to the proposed NCD. It can be read in full here.

July 30 was the final day for comments to be submitted to CMS. A final decision is expected by Sept. 28.

Earlier Cardiovascular Business coverage of the CMS proposal is available here. To read the full proposal, first published on June 30, click here.

Michael Walter
Michael Walter, Managing Editor

Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.

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