Comment on CMS-2026-1256-0002

Summary: The Massachusetts Medical Device Industry Council (MassMEDIC) opposes the proposed repeal of the alternative NTAP and OPPS TPT pathways for FDA-designated Breakthrough Devices. They argue that these pathways are essential for providing predictable reimbursement for innovative technologies, and that an abrupt repeal will stifle investment, harm small manufacturers, and delay patient access to life-saving treatments.