CMS will now cover transcatheter aortic valve replacement (TAVR) for Medicare patients under certain conditions.

Aortic valve replacements are used in patients whose aortic heart valves are damaged, causing the valve to narrow – a condition known as “aortic stenosis.” Once patients experience symptoms of aortic stenosis, treatment is critical to improve their chances of survival.  Until recently, aortic stenosis has been treatable only through invasive surgery. In contrast, TAVR allows doctors to replace a patient’s aortic valve through a small opening in the leg. This less invasive procedure gives patients who cannot undergo open heart surgery a new way to repair their damaged heart valve.

This final national coverage decision is one of the first coverage decisions completed under a mutual memorandum of understanding between CMS and the FDA, a joint effort aimed at getting sometimes lifesaving, new technology to patients sooner.

Because this technology is still relatively new, it is important that these procedures are performed by highly trained professionals in optimally equipped facilities.  Therefore, this decision uses “coverage with evidence development,” which, as a condition of coverage, will require certain provider, facility, and data collection criteria to be met.  Such requirements are important to ensure beneficiaries receive the safest and most appropriate care.