Data / Federal rules / 2024-21254
Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program
The Centers for Medicare & Medicaid Services published this final rule in the Federal Register on September 26, 2024. It took effect on November 19, 2024.
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What the agency says
This final rule implements policies in the Medicaid Drug Rebate Program (MDRP) related to the new legislative requirements in the Medicaid Services Investment and Accountability Act of 2019 (MSIAA), which address drug misclassification, as well as drug pricing and product data misreporting by manufacturers. Additionally, we are finalizing several other proposed program integrity and program administration provisions or modifications in this final rule, including revising and finalizing key definitions used in the MDRP. This rule also finalizes a provision not directly related to MDRP that makes revisions to the third-party liability regulation due to amendments made by the Bipartisan Budget Act (BBA) of 2018. We also are finalizing our proposal to rescind revisions made by the December 31, 2020 final rule "Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements" ("the 2020 final rule") to the Determination of Best Price and Determination of Average Manufacturer Price (AMP) sections.
Key facts
- Document number
- 2024-21254
- Type
- Final rule
- Action
- Final rule
- Agency
- Health and Human Services Department; Centers for Medicare & Medicaid Services
- Published
- September 26, 2024
- Takes effect
- November 19, 2024
- Dates
- These regulations are effective on November 19, 2024.
- Docket
- CMS-2434-F
- Regulation ID (RIN)
- 0938-AU28
- Code of Federal Regulations
- 42 CFR 433; 42 CFR 438; 42 CFR 447
- Topics
- Accounting; Administrative practice and procedure; Child support; Citizenship and naturalization; Civil rights; Claims; Drugs; Grant programs-health; Health facilities; Health professions; Individuals with disabilities; Medicaid; Reporting and recordkeeping requirements; Rural areas; Sex discrimination
- Pages
- 66
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Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.