Comment on CMS-2026-1256-0002

Summary: Medtronic opposes the proposed repeal of the New Technology Add-on Payment (NTAP) and Outpatient Prospective Payment System (OPPS) device pass-through alternative pathways for FDA-designated Breakthrough devices. The company argues that these pathways are essential for ensuring patient access to novel therapies and requests that CMS delay any repeal or instead issue a Request for Information (RFI) to collaborate on refinements.