CMS Approves LAAO Registry

August 18, 2016—The American College of Cardiology (ACC) and the Society for Cardiovascular Angiography and Interventions (SCAI) advised that the LAAO Registry has been identified by the Centers for Medicare and Medicaid Services (CMS) as an approved registry to meet the requirements of the national coverage determination (NCD) for Medicare patients undergoing percutaneous left atrial appendage occlusion (LAAO) procedures. The NCD is available online here.

SCAI noted that physicians have been awaiting approval of this registry because Medicare coverage for the procedure is tied to participation in a CMS-approved registry. 

According to the ACC, this is first national registry capturing data on LAAO procedures to assess real-world procedural outcomes, short- and long-term safety, comparative effectiveness, and cost effectiveness.

Patient-level data will be submitted by participating hospitals on a quarterly basis to ACC’s National Cardiovascular Data Registry. Physicians and hospitals can use these data to support quality improvement efforts locally and monitor patterns of care. Registry data will be used to help develop clinical guidelines, leading to improved patient care. Ultimately, the registry will provide a better understanding of this population and emerging treatment options, noted the ACC.

The ACC, SCAI, and Heart Rhythm Society made recommendations for coverage to CMS at the time of the launch of the LAAO Registry in December 2015.