CMS decision may expand use of Watchman device in the U.S.

After concerns from panels and advisory committees, the FDA approved the Watchman left atrial appendage closure device (Boston Scientific) last March. A recent reimbursement decision will likely make the Watchman available to many more people.

On Feb. 8, CMS released a national coverage determination for percutaneous left atrial appendage closure for non-valvular atrial fibrillation.

As of now, the Watchman is the only left atrial appendage closure device available in the U.S. The device is intended as an alternative to warfarin for patients with non-valvular atrial fibrillation who are at high risk.

The Star Tribune in Minneapolis reported that Medicare would pay hospitals an average of $16,720 for implanting the Watchman and up to more than $22,000 for patients with major complications or comorbidities.

Boston Scientific said some Blue Cross Blue Shield plans and other private payers already covered the Watchman. Still, the CMS decision was crucial because most patients who are suitable for the Watchman are older and have Medicare.

CMS said patients, providers and hospitals must meet numerous requirements before being considered for left atrial appendage closure devices. Interventional cardiologists, electrophysiologists or cardiovascular surgeons are required to have received training on how to use the device and have performed at least 25 interventional cardiac procedures that involve transeptal puncture through an intact septum.

Further, patients and hospitals are required to enroll in a registry that tracks annual outcomes for patients for at least four years after they undergo the procedure.

The Society for Cardiovascular Angiography and Interventions (SCAI) applauded CMS for its decision. In December, SCAI, the American College of Cardiology and Heart Rhythm Society sent a letter to CMS regarding the national coverage determination.

SCAI said that CMS adopted a few of its proposed changes, including not requiring hospitals to develop a control group of patients who were eligible for left atrial appendage but did not receive treatment. CMS also was more specific in its final ruling on patient eligibility for left atrial appendage closure devices.

“SCAI is pleased that CMS elected not to place extensive restrictions on patient access to this new therapy,” SCAI President James Blankenship, MD, FSCAI, said in a news release.

-Tim Casey
Executive Editor