Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement
Pharmacy Times
JUNE 23, 2025
This pathway’s expanded use and shifting Centers for Medicare & Medicaid Services (CMS) policies are reshaping reimbursement practices and therapeutic equivalence standards for 505(b)(2) drugs. Based on this ruling, 505(b)(2) drugs that are not therapeutically interchangeable should be considered sole-source drugs.
Let's personalize your content