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Program Releases

The Centers for Medicare & Medicaid Services (CMS) issues program releases to states and drug manufacturers participating in the Medicaid Drug Rebate Program. To find prior releases by topic, please use the "Keyword Search" function below.

If you have any questions regarding the states and/or drug manufacturer releases, please email MDROperations@cms.hhs.gov.

Disclaimer: Please note that the information provided on this web page does not bind or obligate the Centers for Medicare and Medicaid Services (CMS).  The statements included on this web page are intended to provide information on Medicaid Drug Rebate Program Releases and do not in any way revise or modify the requirements set forth in Section 1927 of the Act, the national drug rebate agreement (NDRA), or regulations.

Page Last Updated on January 4, 2021 

Showing 1 to 10 of 321 results

Manufacturer Release 114

Date:
Type: Manufacturer Release
Keywords: Importation, Drug Importation, Covered Outpatient Drug, SIP Drugs, Prescription Drugs
Links: Manufacturer Release 114: Medicaid Drug Rebate Program (MDRP) Requirements and FDA Guidance on Importation of Certain Drugs under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act (FFDCA) ( PDF, 148.41 KB )

State Release 187

Date:
Type: State Release
Keywords: Importation, Drug Importation, Covered Outpatient Drug, SIP Drugs, Prescription Drugs
Links: State Release 187: CMS Guidance to the States on the FDA Final Regulation “Importation of Prescription Drugs” Related to Section 804 of the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Medicaid Drug Rebate Program ( PDF, 136.46 KB )

Manufacturer Release 113

Date:
Type: Manufacturer Release
Keywords: Manufacturer, Medicaid Drug Rebate Program
Links: Manufacturer Release 113: Compliance with Drug Pricing and Drug Product Information under the Medicaid Services Investment and Accountability Act of 2019 ( PDF, 143.27 KB )

Manufacturer Release 112

Date:
Type: Manufacturer Release
Keywords: Authorized generic, Average Manufacturer Price (AMP), Blended AMP, Manufacturer, Medicaid Drug Rebate Program, Wholesaler
Links: Manufacturer Release 112: Recommendations on Calculation of AMP of Brand Name Drug and Authorized Generic Drugs (resulting from statutory changes in Continuing Appropriations Act, 2020, and Health Extenders Act of 2019) ( PDF, 170.63 KB )

Manufacturer Release 111

Date:
Type: Manufacturer Release
Keywords: Authorized generic, Average Manufacturer Price (AMP), transfer sales
Links: Manufacturer Release 111: Changes to Calculation of AMP under MDRP for Authorized Generics (as required under the Pub. L. 116-59, the Continuing Appropriations Act, 2020, and Health Extenders Act of 2019) ( PDF, 120.09 KB )

Manufacturer Release 110

Date:
Type: Manufacturer Release
Keywords: Best Price, 5i Average Manufacturer Price (5i AMP), Average Sales Price (ASP), Medicare Advantage plans, Medicare Part B, Voluntary Termination of National Drug Rebate Agreement, Optional Effective Date, Mandatory Effective Date
Links: Manufacturer Release 110: Rebates Provided to Medicare Advantage for Part B Utilization; Manufacturer Voluntary Termination Notice of NDRA; NDRA Optional Effective Date (OED) and Mandatory Effective Date (MED) ( PDF, 143.67 KB )

State Release 186

Date:
Type: State Release
Keywords: Line Extension, Line Extension Drug, Line Extension Unit Rebate Amount, Unit Rebate Amount, Unit Rebate Offset Amount, URA, UROA, Affordable Care Act, Bipartisan Budget Act of 2018, BBA of 2018
Links: State Release 186: Revision to the Line Extension Unit Rebate Amount Calculation ( PDF, 203.03 KB )

Manufacturer Release 109

Date:
Type: Manufacturer Release
Keywords: Line Extension, Line Extension Drug, Line Extension Unit Rebate Amount, Unit Rebate Amount, Unit Rebate Offset Amount, URA, UROA, Affordable Care Act, Bipartisan Budget Act of 2018, BBA of 2018
Links: Manufacturer Release 109: Revision to the Line Extension Unit Rebate Amount Calculation ( PDF, 200.91 KB )

State Release 185

Date:
Type: State Release
Keywords: Accelerated Approval, Accelerated Approval Pathway, Section 506(c) of FFDCA, Covered Outpatient Drug, Medically Accepted Indication, Surrogate endpoint, Clinical endpoint
Links: State Release 185: State Medicaid Coverage of Drugs Approved by the FDA under Accelerated Approval Pathway; Background on FDA’s Accelerated Approval Program ( PDF, 112.47 KB )

Manufacturer Release 108

Date:
Type: Manufacturer Release
Keywords: National Drug Rebate Agreement, NDRA, Medicaid Rebate Agreement, Rebate Agreement, Updated Rebate Agreement, Updated NDRA
Links: Manufacturer Release 108: Action Required to Remain in Medicaid Drug Rebate Program: Updated National Drug Rebate Agreement ( PDF, 106.97 KB )
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