Comment on CMS-2026-1256-0002

Summary: The Biotechnology Innovation Organization (BIO) opposes the proposed repeal of the New Technology Add-on Payment (NTAP) alternative pathway, arguing it will create barriers to patient access for innovative therapies and increase costs for manufacturers. They also request that CMS develop new mechanisms, such as unbundling drugs or creating a low-volume/orphan drug add-on payment, to ensure sustainable reimbursement for rare disease treatments within the MS-DRG structure.