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CMS proposes coverage plan for TAVR

Issue: March/April 2012

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CMS has issued a proposed decision memo on the national coverage of transcatheter aortic valve replacement.

According to the memo, CMS stipulates that coverage of TAVR will be approved for the treatment of severe symptomatic aortic valve stenosis only when all of the following five conditions are met:

• The procedure is furnished for an FDA-approved indication, with a complete valve and implantation system that has received FDA premarket approval (PMA) for this indication.
• Two cardiac surgeons have, according to the pivotal PMA trial’s protocol, evaluated the patient’s suitability for open valve replacement surgery.
• The procedure is furnished in a facility that meets a determined criteria of experience performing TAVR and surgical aortic valve replacement.
• The procedure is performed by physicians with sufficient expertise and experience.
• The patient is enrolled in, and the treating physician is participating in, a national TAVR registry that tracks patient outcomes for at least 5 years following the procedure.

The proposal follows a formal request to CMS from the Society of Thoracic Surgeons and the American College of Cardiology for the development of a National Coverage Determination for TAVR procedures. After the release of the proposal, ACC and STS issued a joint statement supporting the proposed coverage.