Comment on CMS-2026-1256-0002

Summary: The Pharmaceutical Research and Manufacturers of America (PhRMA) opposes the proposed rule, specifically arguing that the CJR-X initiative exceeds CMS's statutory authority and raises constitutional concerns. They also urge CMS to reject the repeal of NTAP alternative pathways and the revision of the NTAP newness period, arguing these changes will hinder access to innovative antimicrobial treatments and penalize manufacturers for commercial delays.