Boston Scientific announced the 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 (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," said Mike Mahoney, president and chief executive officer, Boston Scientific.
"The final decision reflects more than a decade of robust clinical evidence and will facilitate additional data collection via a prospective national registry."
The WATCHMAN Device, the first and only percutaneous LAAC therapy approved by the U.S. Food and Drug Administration (FDA) in March 2015, 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 now cover the WATCHMAN Device.
The WATCHMAN LAAC Device is a catheter-delivered heart implant designed to close the left atrial appendage (LAA) in order to prevent the migration of blood clots from the LAA, and thus, reduce the incidence of stroke and systemic embolism for higher risk patients with non-valvular AF.
The LAA is a thin, sack-like appendix arising from the heart and is believed to be the source of >90 percent of stroke-causing clots that come from the left atrium in patients with non-valvular AF.