“The Medicaid Drug Rebate Program is a program that includes CMS, State Medicaid Agencies, and participating drug manufacturers that helps to offset the Federal and State costs of most outpatient prescription drugs dispensed to Medicaid patients. Approximately 600 drug manufacturers currently participate in this program.” (1) “It requires that drug manufacturers have a national rebate agreement with the Secretary of the Department of Health and Human Services (HHS) in order for states to receive Federal Medicaid coverage of their products.”(2) In the present data set drugs are presented with their National Drug Code, FDA product name, date of introduction to the market, among other details regarding the introduction and current status of the drug. It’s important to notice that “if a Market Date falls on a date that is earlier than 9/30/1990, CMS will change it to 9/30/1990 in both the Medicaid Drug Rebate (MDR) system and the Drug Data Reporting for Medicaid (DDR) system since dates earlier than the start of the Drug Rebate Program have no bearing on this aspect of the program.”(3)
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.
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).
All drugs in the dataset 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.