CMS notifies Merit that Wrapsody reimbursement requires further consideration

Merit Medical (MMSI) announced that the U.S. Centers for Medicare & Medicaid Services has notified Merit that its application for Transitional Pass-Through incremental payment for Wrapsody Cell-Impermeable Endoprosthesis procedures in the outpatient and ambulatory surgery center settings requires further consideration prior to CMS making a final decision. CMS notified Merit that it has deferred Merit’s application for the Wrapsody CIE to the Calendar Year 2027 Outpatient Prospective Payment System rule, making January 1, 2027, the earliest possible effective date. “While we are disappointed with the deferral of our application for TPT incremental payment, we believe this presents an opportunity for an important strategic pivot,” said Martha G. Aronson, Merit’s President and CEO. “Our efforts to secure incremental payment in the outpatient and ASC settings have impacted the pace of U.S. commercialization of our innovative solution for physicians treating hemodialysis patients suffering from venous outflow obstructions. We are enacting a new commercial strategy that increases patient access and optimizes adoption and utilization of our clinically superior technology. We expect this strategy to improve patient outcomes, reduce the cost of treating this large and growing patient population, and generate strong, margin-accretive revenue growth for Merit in the years to come. We have elected to withdraw our application for TPT incremental payment and intend to begin our full commercialization of the WRAPSODY CIE in the U.S. immediately.”