February 3rd, 2012
CMS Releases Details of Proposed National Coverage for TAVR
On Thursday the Centers for Medicare & Medicaid Services (CMS) released a memo containing details of its proposed Medicare coverage for transcatheter aortic valve replacement (TAVR). The memo is a response to a formal request for national coverage determination (NCD) from the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC). The memo will be open for public comment until March 3, after which a final determination will be made.
In the memo CMS proposes coverage for TAVR only if 5 conditions are met, including
- The use of an FDA-approved device for an FDA-approved indication,
- Evaluation of the patient by 2 cardiac surgeons,
- Performance of the procedure at an institution with sufficient surgical and interventional cardiology experience and expertise, including participation in a prospective national TAVR study and a commitment to the Heart Team concept,
- Performance by physicians with sufficient experience and expertise,
- The patient must be enrolled in, and the physician must participate in, a national TAVR registry that will track outcomes for at least five years after the procedure.
CMS also said it would provide coverage for patients enrolled in clinical trials that meet a long list of criteria. CMS recommended that coverage be denied for indications other than those specifically mentioned in the memo.