Medicaid Drug Misclassification Proposed Rule Summary

On May 26, 2023, CMS published in the Federal Register a proposed rule entitled “Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program” (88 FR 34238-34296). The rule proposes to implement policies in the Medicaid Drug Rebate Program (MDRP) related to legislative requirements addressing drug misclassification, as well as drug pricing and product data misreporting by manufacturers. Several other program integrity and program administration provisions are proposed for MDRP. The public comment period will end on July 25, 2023 (60-day comment period).