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Product Data for Drugs in the Medicaid Drug Rebate Program
The rebate drug product data contains the active drugs that have been reported by participating drug manufacturers as of the most recent rebate reporting period under the Medicaid Drug Rebate Program (MDRP). All drugs are identified by the following data fields:
- Labeler Name
- National Drug Code (NDC)
- Drug Category (to identify whether a drug is an innovator or non-innovator)
- Drug Type (to identify whether a drug is available by prescription or over-the-counter (OTC))
- Termination Date (if applicable)
- Unit Type
- Units Per Package Size
- Food and Drug Administration (FDA) Approval Date
- Market Date
- FDA Therapeutic Equivalency Code
- Product Name
- Clotting Factor/Exclusively Pediatric Indicator
- Package Size Introduction Date
- Purchased Product Date
- Covered Outpatient Drug (COD) status (which replaces the Drug Efficacy Study Implementation (DESI) rating)
- FDA Application Number/OTC Monograph Number
- Reactivation Date (if applicable)
- Line Extension Drug Indicator
You may refer to the data definitions for more information regarding the definition valid values for each of these fields.
(Note: Only active drugs and drugs with a termination date within or after the last processed quarter are included in the file).
Quarterly Average Manufacturer Price (AMP) Data for Drugs in the Medicaid Drug Rebate Program: Reported or Not Reported
In accordance with the terms of the National Drug Rebate Agreement and section 1927(b)(3)(A) of the Social Security Act (the Act), drug manufacturers participating in the MDRP are required to report AMP information to the Centers for Medicare & Medicaid Services (CMS) each quarter. A quarterly AMP must be reported for each active drug that the manufacturer has reported for inclusion in the MDRP. Failure to submit the required AMP data may result in penalties, such as the drug manufacturer’s termination from the rebate program or the issuance of civil monetary penalties by the Office of the Inspector General.
In an effort to improve the timeliness of the data CMS receives from drug manufacturers each quarter, CMS is posting the quarterly AMP reported or not reported file. This file contains the active drugs that have been submitted as of the most recent reporting period under the MDRP, along with an indication of whether or not the required AMP was reported for each drug. All drugs are identified in the file by the 11-digit NDC, product name, labeler name, and reported (R) or not reported (NR). Please note that, due to confidentiality provisions found in section 1927(b)(3)(D) of the Act, this file does not contain actual AMP values; rather, it simply notes whether or not CMS received an AMP for each drug included in the file. Further, the file only reflects AMP data that was received at the time that Medicaid drug rebates were calculated for the most recent reporting period. Finally, the only terminated drugs included in this file are those that are being terminated within the quarter represented in the file, or those with a termination date in the future.
Legend to the Newly Reported Drugs in the Medicaid Drug Rebate Program files above can be accessed at the following link: data definitions
If you have any questions, please contact us at 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 Data 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), subsequent program releases, or regulations.
Page last updated on May 06, 2024