Comment on CMS-2026-1256-0002

Summary: The Medical Device Manufacturers Association (MDMA) opposes the proposal to eliminate the Alternative Pathways for NTAP and TPT payments for Breakthrough Devices, arguing it creates acute disruption for manufacturers who have relied on these pathways. They also urge CMS not to eliminate the conditional approval policy for NTAP, suggesting instead that it be expanded to include breakthrough devices to improve patient access.