Comment on CMS-2026-1256-0002

Summary: NeuroPace, a medical device company, opposes the proposed elimination of the Alternative Pathway for New Technology Add-on Payment (NTAP) and Transitional Pass-through (TPT) for FDA Breakthrough Devices. They argue that the repeal is an abrupt policy shift that disrupts clinical trial designs and request a delay or grandfathering of existing devices to allow for further analysis and stakeholder input.