The Centers for Medicare & Medicaid Services (CMS) released its final national coverage determination on Feb. 8 for percutaneous left atrial appendage closure for non-valvular atrial fibrillation.
The decision made Boston Scientific’s Watchman left atrial appendage closure device immediately available for Medicare and Medicaid patients who fit a certain criteria. The FDA approved the Watchman in March to reduce the risk of stroke in patients with non-valvular atrial fibrillation who seek an alternative to warfarin or novel anticoagulants.
The Watchman is the first and only left atrial appendage closure device available in the U.S., although the FDA will likely approve other devices in the coming years.
CMS said patients must meet numerous requirements to be considered for left atrial appendage closure devices. Patients must have a CHADS2 score of 2 or higher, meet with a non-interventional physician to discuss oral anticoagulation and be deemed suitable for short-term warfarin therapy but unsuitable for long-term oral anticoagulation. Patients who are implanted with the Watchman device are required to take warfarin for 45 days following the procedure.
CMS also said that the procedure must be performed by interventional cardiologists, electrophysiologists or cardiovascular surgeons who have received training on how to use the device and performed at least 25 interventional cardiac procedures that involve transeptal puncture through an intact septum. The physicians are required to continue to perform at least 25 procedures over the following two years that involve transeptal puncture through an intact septum.
Patients and hospitals are also required to enroll in a prospective, national, audited registry that tracks annual outcomes for patients for at least four years after they undergo the procedure. The registry must track the following outcomes: operator-specific complications, device-specific complications, stroke adjudicated by type, transient ischemic attack, systemic embolism, death and major bleeding by site and severity.
In December, the American College of Cardiology launched a registry that will track data on left atrial appendage occlusion devices and serve as the FDA-mandated post-approval study for the Watchman.
Medicare beneficiaries represent a large majority of patients who may use the Watchman. Boston Scientific said in a news release that Blue Cross Blue Shield plans and other private payers also cover the device.