The CMS has rendered a final coverage decision for left atrial appendage devices, a move driven largely by the successful Watchman PMA by Boston Scientific, which slogged through three FDA advisory committee hearings on its way to the CMS coverage analysis. The final decision memo included several important changes compared to the draft, including that the agency has dropped the demand for a contemporaneous set of patients on medical therapy, making the resulting study a simpler and less expensive one-arm registry study. Read More
