Comment on CMS-2026-1256-0002

Summary: Envoy Medical, Inc. opposes the proposed wholesale repeal of the alternative pathway for New Technology Add-On Payments (NTAP) and the parallel outpatient device pass-through. The company argues that the repeal will stifle innovation and disproportionately harm manufacturers of Class III Breakthrough Devices, requesting instead that CMS retain the pathway for such devices or grandfather in those currently in pivotal clinical trials.