Drug Label Anti-Fraud Provisions Solidified in Medicaid Proposal

A proposal to enforce stricter regulations on the way pharmaceutical companies label drugs and set prices in Medicaid’s drug rebate program aims to clarify the impact of litigation in a drug misclassification case involving Mylan Inc.'s EpiPen, attorneys say.

The proposed rule (RIN 0938-AU28) would overhaul the Medicaid Drug Rebate Program by addressing significant issues, such as drug misclassification, opacity in pharmacy benefit managers’ pricing, and concerns regarding whether or not drug companies were offering the statutorily required lowest drug prices for Medicaid.

The program overseen by the Centers for Medicare and Medicaid Services requires manufacturers to ...