Medicaid Drug Rebate Program Data
Product Data for Drugs in the Medicaid Drug Rebate Program
The rebate drug product data file [ZIP] 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. All drugs are identified by National Drug Code (NDC), unit type, units per package size, product name, Food and Drug Administration (FDA) approval date, the date the drug entered the market, plus indicators to show whether the drug is an innovator or non-innovator drug; whether it is available by prescription or over-the-counter (OTC); the FDA therapeutic equivalency code; and the Drug Efficacy Study Implementation (DESI) rating and termination date, if applicable. Please check on the link to access the web file the web file structure and data definitions for the drug product data file [PDF].
Starting with the 3Q2014 drug product data file that will be posted in early November 2014, the file format for the drug product data file will be changed to include new FDA Application Number/OTC Monograph Number and Reactivation Date fields and to replace the Drug Efficacy Study Implementation (DESI) rating with the Covered Outpatient Drug (COD) status. Please note that the COD status and corresponding FDA Application Number/OTC Monograph Number field will contain blanks for those NDCs for which the manufacturers have not yet reported those fields to CMS. You may refer to the data definitions for more information regarding the valid values for each of these fields.” Please click on the link to access the web file structure and data definitions for the drug product data file for 3Q2014 and later [PDF].
The drug product data file contains individual files for the current quarter plus the previous eight quarters. Please save and archive these files, including the file formats, for any future use you may have as we do not archive these files once posted and cannot honor individual requests for regenerated files. (Note: Only active drugs and drugs with a termination date on or after the last processed quarter are included in the file).
If you have any questions, please contact us at MDROperations@cms.hhs.gov.
Products In The Medicaid Drug Rebate Program That Are Not Listed With FDA
In Manufacturer Release #84 issued in July 2012, we strongly encouraged all manufacturers to review the Food and Drug Administration’s (FDA) comprehensive NDC Structured Product Labeling (SPL) Data Elements file (NSDE) to ensure that all manufacturer NDCs that are in the Medicaid Drug Rebate Program (MDRP) are listed electronically with FDA. As we explained in that release, CMS uses listing information to help verify which drug products are eligible for coverage under the MDRP.
We generated a list of NDCs in the MDRP that are not listed with FDA, by matching the NDCs at the 9-digit level that are in the second quarter 2014 MDRP drug product data file [ZIP] against FDA’s NSDE file to identify products that have been reported to CMS for inclusion in the MDRP but that are not listed with FDA. The drug products listed in MDRP, sorted by NDC, that are currently not listed with FDA as of 09/30/2014 [ZIP] includes NDCs with no termination date and NDCs with future termination dates.
We believe that it’s important that all drugs be listed with FDA. Therefore, we strongly encourage manufacturers to review this list to identify any NDCs under their labeler code(s) which are not currently listed electronically with FDA and list those drugs with FDA promptly. If a review of this list identifies any NDC(s) that you believe should not be included in the MDRP, please contact us immediately at RxDrugPolicy@cms.hhs.gov.
We would like to remind manufacturers that they are responsible for correctly reporting their covered outpatient drugs (CODs) to the MDRP via the Drug Data Reporting for Medicaid (DDR) system. Because the MDRP only covers products that meet the COD definition, CMS is currently reviewing the MDR system to ensure that only products that meet the COD definition are in the rebate program.
If you have any questions or comments regarding this topic, please email us at RxDrugPolicy@cms.hhs.gov.
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 Medicaid Drug Rebate Program 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 Medicaid Drug Rebate Program. 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 [ZIP]. This file contains the active drugs that have been submitted as of the most recent reporting period under the Medicaid Drug Rebate Program, 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 National Drug Code (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.
State Utilization Data
Drug utilization for States are available for covered outpatient drugs paid for by State Medicaid agencies since the start of the Medicaid Drug Rebate Program. For the web file structure and definitions without the new Record ID field, please click here [PDF]. For the web file structure and definitions with the new Record ID field, please click here [PDF].
Please note that this format includes two new fields: Medicaid Amount Reimbursed and Non-Medicaid Amount Reimbursed. The sum of these two fields should generally equal the Total Amount Reimbursed on an NDC by NDC basis; however, these new fields were implemented beginning with the fourth quarter of 2007 and are optional for the states to report prior to that time. Therefore, for quarters earlier than fourth quarter 2007, there may be some large discrepancies between the Total Amount Reimbursed and the sum of the Medicaid Amount Reimbursed and the Non-Medicaid Amount Reimbursed because the Non-Medicaid Amount Reimbursed is often not present for those earlier quarters. Should you notice apparent discrepancies in an individual state's utilization data, your questions should be directed to that state's Technical Contact.
How often are the State Utilization Data and the National Summary Utilization Data updated and posted to the website?
1st Quarter (plus 5 preceding years of data): August (includes data received from States through the end of June)
2nd Quarter (plus 5 preceding years of data): November (includes data received from States through the end of September)
3rd Quarter (plus 5 preceding years of data): February (includes data received from States through the end of December)
4th Quarter (plus 5 preceding years of data): May (includes data received from States through the end of March)
State utilization data older than the current quarter plus five previous years of data are updated annually and posted to the website during the month of February (the data posted includes utilization information received from States through the end of December). The national summary utilization data are aggregate data by NDC-11.
Last Update: November 2013 Cycle - 2nd Quarter (plus 5 preceding years of data):
Questions about the Medicaid Drug Rebate Program's data? Email MDRUtilization@cms.hhs.gov.
Page Last updated on November 18, 2014