CMS Will Cover Boston Scientific's Watchman LAAC Device

February 8, 2016—Boston Scientific Corporation announced that the US Centers for Medicare and Medicaid Services (CMS) will cover percutaneous left atrial appendage closure (LAAC) therapy under specific criteria, as outlined in the agency’s final National Coverage Determination. This decision, effective immediately, provides consistent and uniform access to Boston Scientific’s Watchman LAAC device as a nonpharmacologic treatment option for stroke risk reduction for appropriate Medicare beneficiaries. 

The National Coverage Determination states that CMS will cover percutaneous LAAC therapy when specific conditions are met. CMS adopted the majority of physician and professional medical society feedback received in the 30-day public comment period, specifically as it relates to patient coverage criteria and future data collection requirements. 

Boston Scientific advised that the Watchman device, which was approved by the US Food and Drug Administration (FDA) in March 2015, is indicated for patients with nonvalvular atrial fibrillation who are at high stroke risk, suitable for warfarin, and are seeking an alternative to long-term warfarin therapy. The Watchman device is the only LAA occlusion device that has been approved by the US Food and Drug Administration. CMS issued the proposed decision memo, CAG-00445N, for percutaneous LAAC therapy on November 13.

According to Boston Scientific, Medicare beneficiaries account for the overwhelming majority of patients deemed candidates for the Watchman device. The remaining population is represented by private payers. Before the CMS final decision, a number of private payers, including several Blue Cross Blue Shield plans, have updated their policies to now cover the Watchman device.

The Society for Cardiovascular Angiography and Interventions (SCAI) issued a statement noting that CMS dropped the proposed requirement that hospitals develop a control group of patients eligible for LAA procedures but treated medically. Additionally, as SCAI had requested in December, the National Coverage Determination was more specific as to patient eligibility based on stroke risk and suitability of oral anticoagulation. In addition, the National Coverage Determination leaves open the opportunity for future FDA-approved devices that will appear on the LAA occlusion landscape.

The determination is also aligned with the recent multisocietal consensus document on operator and institutional requirements on LAA occlusion. Specifically, the National Coverage Determination incorporates society-crafted recommendations on volume requirements for institutions and proceduralists to initiate and maintain an LAA occlusion program. Additionally, it mandates the involvement of multidisciplinary team with shared decision making and participation in a registry to track safety and efficacy metrics, advised SCAI.