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CMS Opens NCA for Transcatheter Mitral Valve Repair Procedures; Comments Due Dec. 18

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On Nov. 18, CMS opened a national coverage analysis (NCA) for Transcatheter Mitral Valve Repair (TMVR) devices.

The review was requested by The Society of Thoracic Surgeons, the American College of Cardiology, the Society for Cardiovascular Angiography and Interventions and the American Association for Thoracic Surgery, all of whom played a key role in shaping the recent Medicare coverage decision for Transcatheter Aortic Valve Replacement (TAVR) procedures. While the societies highlight the benefits of TMVR for the Medicare population in their detailed request letter, they encourage CMS to cover the device under their Coverage with Evidence Development (CED) program. Specifically, they asked CMS to require mandatory outcomes reporting into the TVT registry, the same registry CMS-approved for coverage of TAVR.

CMS is likely to closely consider the societies’ coverage recommendations in drafting its decision. The societies submitted a robust request letter, which outlines the specific coverage parameters they encourage CMS to employ in its coverage decision for TMVR. A similarly prescriptive request letter was put forth by the same societies for TAVR in 2011, and CMS largely adopted their recommendations. Each year, professional societies are playing a larger role in shaping Medicare coverage decisions by requesting NCAs and informing the content included in subsequent determinations. Since 2012, seven of the 13 NCAs reviewed by CMS were initiated by professional societies.

CMS is soliciting public comments to inform its draft decision until Dec. 18, noting its preferences for comments that include scientific evidence evaluating the short/long-term benefits of this technology. A proposed decision is expected by May 18, 2014.

More information on NCA and the official request letter can be found here.

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