The Centers for Medicare and Medicaid Services (CMS) on Feb. 2 released its proposed National Coverage Determination (NCD) Analysis of transcatheter aortic valve replacement (TAVR).

Under the proposal, Medicare would cover all Food and Drug Administration (FDA)-labeled indications when procedures are performed at facilities by physicians who meet specified criteria outlined by specialty societies. In addition, all patients would have to be enrolled in a prospective national registry, like the STS/ACC TVT RegistryTM and tracked for five years. Off-label use would only be covered through approved clinical studies.

“This is great news for Medicare beneficiaries,” says ACC President David Holmes, Jr., MD, FACC. “The ACC is pleased that the NCD balances the critical need to provide access to this important, innovative service with the need to ensure that care is provided in qualified facilities by highly skilled heart care teams and the need to collect data on experience with the device and procedure in the real world. We are especially pleased that CMS has proposed to provide a smooth path to Medicare coverage as the technology continues to evolve and improve.”

The NCD analysis is the result of a request from the American College of Cardiology (ACC) and The Society of Thoracic Surgeons (STS) in late 2011. The request asked CMS to cover TAVR when performed with an FDA-approved device consistent with labeled indications and any other FDA requirements. The request also asked that CMS permit Medicare coverage only in facilities meeting requirements as recommended by professional societies, and that coverage with evidence development be allowed for patients participating in qualified prospective clinical studies. The ACC and STS also requested that CMS require all patients to be included in a national registry.

The ACC has been working closely with the FDA, industry, CMS and its partner societies on the rollout of TAVR. Most recently the College released an Expert Consensus Document on TAVR and took part in an SCAI-led Specialty Society Statement on Credentialing Criteria for Institutions and Physicians for TAVR.

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