CMS introduces new Medicare coverage requirements for TAVR

CMS recently announced that it updated the national coverage policy for transcatheter aortic valve replacement (TAVR), requiring covered hospitals and physicians to begin or maintain a TAVR program and adhere to updated volume requirements.

TAVR is a procedure used to treat aortic stenosis, a condition in which the heart valve that pumps blood from the heart to the rest of the body narrows. A team of cardiologists, cardiac surgeons, imaging specialists, and other specialists work together to perform this open-heart procedure.

The new national coverage policy will continue to cover TAVR under coverage with evidence development (CED) when it is performed in accordance with an FDA-approved indication. However, under the updated policy, CMS requires hospitals and physicians to establish or maintain a TAVR program that meets updated volume requirements.

To begin a TAVR program, a hospital without TAVR experience must have:

• At least 50 open heart surgeries in the year preceding TAVR program initiation
• At least 20 aortic valve-related procedures in the two years preceding TAVR program initiation
• At least two physicians with cardiac surgery privileges, including one with interventional cardiology privileges
• Delivered at least 300 percutaneous coronary interventions (PCI) per year

To continue a TAVR program, a hospital with TAVR experience must maintain:

• At least 50 aortic valve replacements per year, including at least 20 TAVR procedures in the prior year; or, deliver 100 or more aortic valve replacements every two years, including 40 TAVR procedures in the prior two years
• The same physician requirements and PCI volume requirements listed above for hospitals without TAVR experience

The finalized national coverage policy with additional details on coverage requirements is available on the CMS website.