The Centers for Medicare & Medicaid Services (CMS) today issued its national coverage decision (NCD) for transcatheter aortic valve replacement (TAVR). As expected, CMS will offer reimbursement for TAVR, but only if a number of criteria are first met. The NCD was initially requested by the American College of Cardiology and the Society of Thoracic Surgeons, responding to concerns that TAVR approval might lead to a stampede of implantations as cardiologists, surgeons, and hospitals sought to stake a claim in a major new territory.
The NCD decision memo outlines a series of conditions that must be met for CMS reimbursement:
- 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. (The memo provides details on two sets of qualifications: one for hospitals without previous TAVR experience and the second for hospitals with TAVR experience.)
- Performance by physicians with sufficient experience and expertise.
- The patient must be enrolled in, and the physician must participate in a national TAVR registry.
CMS also said it would provide coverage for patients enrolled in clinical studies for new indications, as long as the trials meet a long list of criteria. CMS said that coverage would be denied for indications other than those specifically mentioned in the memo.
[…] defining criteria for TAVR programs and operators. These documents were largely accepted by CMS when it issued a National Coverage Decision for TAVR. Later in the year the FDA extended the indication for TAVR to include high risk patients who […]