The US Centers for Medicare and Medicaid Services (CMS) are to cover percutaneous left atrial appendage closure (LAAC) therapy under specific criteria, as outlined in the agency’s final National Coverage Determination (NCD). This decision, effective immediately, provides consistent and uniform access to the Watchman LAAC Device as a non-pharmacological treatment option for stroke risk reduction for appropriate Medicare beneficiaries.
“We are very pleased CMS has established national coverage for this life-changing therapy for Medicare beneficiaries who have a reason to seek an alternative to long-term anticoagulation,” says Mike Mahoney, president and chief executive officer, Boston Scientific.
The Watchman device, the first and only percutaneous LAAC therapy approved by the US Food and Drug Administration (FDA), is indicated for patients with non-valvular atrial fibrillation (AF) who are at high stroke risk, suitable for warfarin, and are seeking an alternative to long-term warfarin therapy.
According to the NCD, 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.
Medicare beneficiaries account for the overwhelming majority of patients deemed candidates for the Watchman device. The remaining population is represented by private payers. Prior to the CMS final decision, a number of private payers, including several Blue Cross Blue Shield plans, have updated their policies to cover the Watchman Device.