Medicare officials have released a coverage proposal for transcatheter aortic valve replacement 3 months after the procedure was approved in the United States.
The Centers for Medicare and Medicaid Services’ proposal restricts the procedure’s coverage where all of the following five criteria are met:
• The procedure meets Food and Drug Administration–approved criteria, and an FDA-approved device is used.
• Two cardiac surgeons evaluate the patient’s suitability for open valve replacement surgery.
• The procedure is performed in a facility that meets a certain level of experience. The document breaks down the criteria by centers with or without previous transcatheter aortic valve replacement (TAVR) clinical trial experience. All centers are required to participate in a prospective national TAVR study, and be committed to the Heart Team concept.
• The cardiac surgeon and interventionalist meet certain qualifications and levels of experience.
• The patient is enrolled in the prospective national registry for TAVR. The treating physician team also needs to be participating in the national registry.
The memo arrived ahead of its March 28 due date.
It also comes just days after four leading cardiovascular societies issued a document providing detailed guidance on TAVR implementation in centers across the United States.
Heart Teams, a national registry, and careful evaluation and selection of patients are also among the societies’ consensus document highlights.
In the United States, the first valve to be used for TAVR (the Edwards Lifesciences Sapien valve) was approved in November 2011. The valve is currently approved for use in inoperable patients with severe aortic stenosis. Other use of the Sapien valve is limited to clinical trials. Medtronic’s CoreValve is also in being studied in large U.S. trials.
In a joint statement, the Society of Thoracic Surgeons and the American College of Cardiology said they were pleased with CMS’s comprehensive approach to the coverage of TAVR, balancing the patients’ needs while stressing measures that would ensure quality of care. “This coverage analysis achieves these goals through the use of specialized centers with multidisciplinary heart teams and registry enrollment,” said STS President Dr. Jeffrey B. Rich, in a statement.
“We are especially please to that CMS has proposed to provide a smooth path to Medicare coverage as the technology continues to evolve and improve,” said ACC President Dr. David R. Holmes, in a statement.
CMS opened the national coverage determination analysis in September, before Sapien was even approved, in response to a request from the the two organizations to establish the criteria for national Medicare coverage of the minimally invasive valve procedure.
The CMS proposal is a step in the national coverage analysis process, in which the agency decides whether an item or service is covered by Medicare.
The CMS coverage proposal is open for comment until March 3. The agency is expected to make a final decision by May of this year.