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Transcatheter Valve Coverage Proposal Reflects Stricter Medicare Environment

CMS’ proposed national coverage determination comes only three months after the approval and launch of Edwards Lifesciences’ Sapien, the first transcatheter aortic valve in the U.S. It restricts coverage to FDA-approved indications and includes a coverage-with-evidence-development provision.

CMS confirmed in a national coverage proposal released earlier this month its plans to keep tight controls over the long-term use of transcatheter aortic valves, reflecting what many say is a new reality of stricter evidence demands from the Medicare agency.

The draft policy, issued Feb. 2, tracks closely with last year’s coverage request by the American College of Cardiology and the Society of Thoracic Surgeons

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