Comment on CMS-2026-1256-0002

Summary: The Personalized Medicine Coalition (PMC) provides a mixed response to the proposed rule, supporting the continuation of MS-DRG 018 for CAR T-cell therapies and the expansion of high NTAP percentages for sickle cell disease treatments. However, the organization opposes the proposal to eliminate the fast-track NTAP alternative pathway for breakthrough devices and urges CMS to create a formal reimbursement solution for high-cost rare disease treatments.