CMS Issues New Guidance to Manufacturers

Yesterday, the Centers for Medicare & Medicaid Services (CMS) released guidance to manufacturers through Manufacturer Release #102 to clarify how CMS intends to verify if a drug is an abuse-deterrent formulation, and thus be excluded from the definition of line extension for purposes of the Medicaid Drug Rebate (MDR) program. This Manufacturer Release is available for download at the following link: https://www.medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Benefits/Prescription-Drugs/Program-Releases.html