Comment on CMS-2026-1256-0002

Summary: SI-BONE, Inc., a medical device manufacturer, opposes the proposed repeal of the Breakthrough Device Designation (BDD) "alternative pathway" for New Technology Add-on Payments (NTAP). They argue that the repeal would create a structural bias against 510(k)-cleared devices, reduce Medicare beneficiary access to innovative technologies, and undermine the goals of the 21st Century Cures Act. Additionally, the company opposes proposed changes to the NTAP newness criterion, arguing that narrowing the window would limit the data available for accurate DRG weight recalibration and harm technologies currently in development.