Comment on CMS-2026-1256-0002

Summary: The Alliance for Regenerative Medicine (ARM) opposes several key provisions of the proposed rule, specifically the repeal of the NTAP alternative pathway, the constriction of "commercial availability" delays, and the adoption of a cross-modality comparator approach for substantial clinical improvement. The organization argues that these changes would create significant barriers to patient access for cell and gene therapies (CGTs) and undermine the U.S. position in the regenerative medicine sector.