Comment on CMS-2026-1256-0002
Shionogi Inc.OpposeBusiness
Summary: Shionogi Inc., a pharmaceutical company, opposes the proposed repeal of the alternative pathway for New Technology Add-on Payments (NTAP) for certain antimicrobial products. The company argues that the current pathway is necessary to address the public health threat of antimicrobial resistance and that the proposed requirements for "substantial clinical improvement" are difficult to meet due to the unique clinical trial designs required for antibiotics.
Shionogi appreciates the opportunity to provide comments on the Center for Medicare & Medicaid Services’ (CMS’s) proposed rule entitled, “Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2026 Rates; Requirements for Quality Programs; and Other Policy Changes” [CMS-1849-P]. Our comments are in regard to the proposed repeal the alternative pathway for New Technology Add-on Payments (NTAP) for Qualified Infectious Disease Products (QIDP) and Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) products. Our full comments are included in the attached file.