On May 1 the Centers for Medicare and Medicaid Services (CMS) announced approval of a National Coverage Determination (NCD) of transcatheter aortic valve replacement (TAVR). The announcement follows an analysis based on an NCD request from the American College of Cardiology (ACC) and The Society of Thoracic Surgeons (STS) in late 2011.

TAVR is a technology for patients with severe aortic valvular stenosis who are either high-risk candidates or inoperable for surgical aortic valve replacement. Since its approval by the Food and Drug Administration (FDA) in November 2011, interest in the procedure has quickly grown among cardiologists and heart surgeons as well as patients, prompting efforts by professional medical societies to identify institutional and physician credentialing criteria for performing the procedure.

The NCD covers TAVR when performed with a FDA-approved device consistent with labeled indications and any other FDA requirements. In addition, it permits Medicare coverage only in facilities meeting certain requirements. The NCD also requires all patients to be included in a national TAVR registry. Medicare coverage will be available for non-FDA-approved indications when performed in a CMS-approved clinical study.

“The American College of Cardiology commends CMS on its decision and its comprehensive approach to the introduction of TAVR. This means that this transformative technology will be available to Medicare patients who do not have other options for treating severe, debilitating aortic stenosis,” said ACC President William A. Zoghbi, MD, FACC. “We agree with CMS’s decision to structure the NCD in a manner that supports access to TAVR while ensuring that services are performed by the best qualified team of physicians and hospitals. The ACC hopes this NCD proves to be a successful model for providing rapid access to promising new technologies for Medicare beneficiaries while focusing on patient safety, quality care and outcome.”

The ACC and STS believe that an NCD is necessary to ensure nationally uniform coverage for Medicare patients who can benefit from TAVR. In addition, an NCD ensures national standards for facilities and physicians performing TAVR and that data are collected to enable ongoing analysis of outcomes.

NCDs are policies issued by CMS under Section 1869(f) of the Social Security Act to determine whether or not a particular item or service should be covered nationally by Medicare. The NCD grants, limits, or excludes Medicare coverage. NCDs are binding on all Medicare carriers, fiscal intermediaries, quality improvement organizations, health maintenance organizations, competitive medical plans, and health care prepayment plans.

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