CMS Drug Manufacturer Rebate Drugs

$179 / year

The dataset consists of details of the most recent reports on covered outpatient active drugs by manufacturers participating in the Medicaid Drug Rebate Program of the Centers for Medicare and Medicaid Services (CMS) according to Section 1927 of the Social Security Act. The rebate drug product data file 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.

Complexity

“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.

Date Created

2014-08

Last Modified

2019-08-21

Version

2019-08-21

Update Frequency

Quarterly

Temporal Coverage

1990 to 2019-02

Spatial Coverage

N/A

Source

John Snow Labs; Centers for Medicare & Medicaid Services;

Source License URL

Source License Requirements

N/A

Source Citation

Centers for Medicare & Medicaid Service. Medicaid Drug Rebate Program. Published February, 2015. Accessed February 23, 2016. Wikipedia Medicaid Drug Rebate Program. https//en.wikipedia.org/wiki/Medicaid_Drug_Rebate_Program. Published November, 2013. Accessed February 23, 2016. Centers for Medicare & Medicaid Service. Drug Product Data Webfile Structure and Definitions. Published November, 2014. Accessed February 16, 2016.

Keywords

Medicare Rebate, 340b Drugs, Medicaid Gov, CMS Company, Drug Manufacturer, Drug Rebates, Drug Prices, Drug Rebate Reports

Other Titles

Section 1927 of the Social Security Act, Drug Manufacturers National Rebate Agreement, Medicaid Drug Rebate Program Drugs Product Data

NameDescriptionTypeConstraints
YearThe year in which the data was submitteddate-
QuarterThe quarter of the year in which the data was submittedinteger-
Labeler_NameCompany associated with NDC 1string-
NDCNational drug codeinteger-
Labeler_CodeFirst segment of National Drug Code that identifies the labelerintegerlevel : Nominal
Product_CodeSecond segment of National Drug Codeintegerlevel : Nominal
Package_Size_CodeThird segment of National Drug Codeintegerlevel : Nominal
Drug_CategoryCategory of the drugstring-
Drug_Type_IndicatorIdentifies a drug as a prescription (Rx) or Over-the-counter (OTC).string-
Termination_DateDate drug was withdrawn from market or the drug's last lot expiration date.date-
Unit_TypeOne of the 8 unit types by which the drug can be dispensed.string-
Units_Per_Pkg_SizeTotal number of units in the smallest dispensable amount for the 11-digit NDCintegerlevel : Ratio
FDA_Approval_DateNDC or monograph approval datedate-
Market_DateFor S and I drugs, the Market Date is the date the drug was first marketed by the original labeler. If the S/I drug was purchased or otherwise acquired from another labeler, the Market Date should be equal to the Market Date of the original product. For N drugs, the Market Date is the date the drug was first marketed under the labeler’s rebate agreement. If an N drug was purchased or otherwise acquired from another labeler, the Market Date should be equal to the Market Date of the original product, if that date is available.date-
FDA_Ther_Equiv_CodeTherapeutic Equivalence Codestring-
FDA_Product_NameDrug name as approved by the FDAstring-
Is_Clotting_Factor_IndicatorIdentifies a Single Source or Innovator Multiple Source drug as a clotting factor.boolean-
Is_Pediatric_IndicatorIdentifies a Single Source or Innovator Multiple Source drug approved by the FDA exclusively for pediatric indications for patients in the FDA-defined pediatric age group.boolean-
Package_Size_Intro_DateThe date the package size is first available on the market.date-
Purchased_Product_DateThe date on which the company currently holding legal title to the NDC first markets the drug under this NDCdate-
COD_StatusCovered outpatient drug status. Identifies whether or not a product meets the statutory definition of a covered outpatient drug. NDCs with a COD Status of DESI 5/6 are not eligible for coverage or rebates under the Medicaid Drug Rebate Program.integerlevel : Nominal
FDA_Appl_NoFDA application number or OTC monograph numberstring-
Reactivation_DateThe date on which a terminated product is re-introduced to the marketdate-
YearQuarterLabeler NameNDCLabeler CodeProduct CodePackage Size CodeDrug CategoryDrug Type IndicatorTermination DateUnit TypeUnits Per Pkg SizeFDA Approval DateMarket DateFDA Ther Equiv CodeFDA Product NameIs Clotting Factor IndicatorIs Pediatric IndicatorPackage Size Intro DatePurchased Product DateCOD StatusFDA Appl NoReactivation Date
20183ALLERGAN INC232181052321815Innovator multiple sourcePrescription DrugML50001993-01-201993-01-20NRACULAR .5% OPHTH. SOLUTIONFalseFalse1993-01-20319700
20183ALLERGAN INC233205032332053Single sourcePrescription DrugML25002010-08-312010-10-01NRLUMIGAN 0.01%FalseFalse2010-10-01322184
20183ALLERGAN INC233205052332055Single sourcePrescription DrugML50002010-08-312010-10-01NRLUMIGAN 0.01%FalseFalse2010-10-01322184
20183ALLERGAN INC233205082332058Single sourcePrescription DrugML80002010-08-312010-10-01NRLUMIGAN 0.01%FalseFalse2010-10-01322184
20183ALLERGAN INC233240012332401Non -Innovator multiple sourcennovator multInnovator multiple sourceple sourceOver-the-counter DrugML150002006-09-122006-09-12NROPTIVEFalseFalse2010-07-1510PART349
20183ALLERGAN INC2332401523324015Non -Innovator multiple sourcennovator multInnovator multiple sourceple sourceOver-the-counter DrugML150002006-09-122006-09-12NROPTIVEFalseFalse2006-09-1210PART349
20183ALLERGAN INC233348072333487Single sourcePrescription DrugEA10002009-06-172009-08-31NROZURDEXFalseFalse2009-08-31322315
20183ALLERGAN INC235858012358581Single sourcePrescription DrugEA10002015-02-262015-04-10NRLILETTA 52MGFalseFalse2016-08-302016-08-303206229
20183ALLERGAN INC2361423023614230Single sourcePrescription DrugCAP300002008-10-082009-03-20NRRAPAFLO 8 MGFalseFalse2018-05-142018-05-14322206
20183ALLERGAN INC2361429023614290Single sourcePrescription DrugCAP900002008-10-082009-03-20NRRAPAFLO 8 MGFalseFalse2018-06-262018-05-14322206