Others titles
- Section 1927 of the Social Security Act
- Drug Manufacturers National Rebate Agreement
- Medicaid Drug Rebate Program Drugs Product Data
Keywords
- Medicare Rebate
- 340b Drugs
- Medicaid Gov
- CMS Company
- Drug Manufacturer
- Drug Rebates
- Drug Prices
- Drug Rebate Reports
CMS Drug Manufacturer Rebate Drugs
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.
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Description
“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.
About this Dataset
Data Info
Date Created | 2014-08 |
---|---|
Last Modified | 2022-03-11 |
Version | 2022-03-11 |
Update Frequency |
Quarterly |
Temporal Coverage |
1990 to 2021 |
Spatial Coverage |
N/A |
Source | John Snow Labs; Centers for Medicare & Medicaid Services; |
Source License URL | |
Source License Requirements |
N/A |
Source Citation |
N/A |
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 |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
Year | The year in which the data was submitted | date | - |
Quarter | The quarter of the year in which the data was submitted | integer | - |
Labeler_Name | Company associated with NDC 1 | string | - |
NDC | National drug code | integer | - |
Labeler_Code | First segment of National Drug Code that identifies the labeler | integer | level : Nominal |
Product_Code | Second segment of National Drug Code | integer | level : Nominal |
Package_Size_Code | Third segment of National Drug Code | integer | level : Nominal |
Drug_Category | Category of the drug | string | - |
Drug_Type_Indicator | Identifies a drug as a prescription (Rx) or Over-the-counter (OTC). | string | - |
Termination_Date | Date drug was withdrawn from market or the drug's last lot expiration date. | date | - |
Unit_Type | One of the 8 unit types by which the drug can be dispensed. | string | - |
Units_Per_Pkg_Size | Total number of units in the smallest dispensable amount for the 11-digit NDC | integer | level : Ratio |
FDA_Approval_Date | NDC or monograph approval date | date | - |
Market_Date | For 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_Code | Therapeutic Equivalence Code | string | - |
FDA_Product_Name | Drug name as approved by the FDA | string | - |
Is_Clotting_Factor_Indicator | Identifies a Single Source or Innovator Multiple Source drug as a clotting factor. | boolean | - |
Is_Pediatric_Indicator | Identifies 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_Date | The date the package size is first available on the market. | date | - |
Purchased_Product_Date | The date on which the company currently holding legal title to the NDC first markets the drug under this NDC | date | - |
COD_Status | Covered 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. | integer | level : Nominal |
FDA_Application_Number | FDA application number or OTC monograph number | string | - |
Reactivation_Date | The date on which the drug is reactivated | date | - |
Line_Extension_Drug_Indicator | Refers to the line extension drug indicator symbol. | string | - |
Data Preview
Year | Quarter | Labeler Name | NDC | Labeler Code | Product Code | Package Size Code | Drug Category | Drug Type Indicator | Termination Date | Unit Type | Units Per Pkg Size | FDA Approval Date | Market Date | FDA Ther Equiv Code | FDA Product Name | Is Clotting Factor Indicator | Is Pediatric Indicator | Package Size Intro Date | Purchased Product Date | COD Status | FDA Application Number | Reactivation Date | Line Extension Drug Indicator |
2019 | 3 | ELI LILLY AND COMPANY | 2120001 | 2 | 1200 | 1 | S | 1 | EA | 1000 | 2012-04-06 | 2012-05-01 | NR | AMYVID | False | False | 2012-05-01 | 3 | 202008 | N | |||
2019 | 3 | ELI LILLY AND COMPANY | 2143301 | 2 | 1433 | 1 | S | 1 | ML | 500 | 2014-09-18 | 2014-10-20 | NR | TRULICITY | False | False | 2014-10-20 | 2 | 125469 | N | |||
2019 | 3 | ELI LILLY AND COMPANY | 2143380 | 2 | 1433 | 80 | S | 1 | ML | 2000 | 2014-09-18 | 2014-10-20 | NR | TRULICITY | False | False | 2014-10-20 | 2 | 125469 | N | |||
2019 | 3 | ELI LILLY AND COMPANY | 2143401 | 2 | 1434 | 1 | S | 1 | ML | 500 | 2014-09-18 | 2014-10-20 | NR | TRULICITY | False | False | 2014-10-20 | 2 | 125469 | N | |||
2019 | 3 | ELI LILLY AND COMPANY | 2143480 | 2 | 1434 | 80 | S | 1 | ML | 2000 | 2014-09-18 | 2014-10-20 | NR | TRULICITY | False | False | 2014-10-20 | 2 | 125469 | N | |||
2019 | 3 | ELI LILLY AND COMPANY | 2143601 | 2 | 1436 | 1 | S | 1 | ML | 1000 | 2018-09-27 | 2018-10-08 | NR | EMGALITY | False | False | 2018-10-08 | 2 | 761063 | N | |||
2019 | 3 | ELI LILLY AND COMPANY | 2143611 | 2 | 1436 | 11 | S | 1 | ML | 1000 | 2018-09-27 | 2018-10-08 | NR | EMGALITY | False | False | 2018-10-08 | 2 | 761063 | N | |||
2019 | 3 | ELI LILLY AND COMPANY | 2144501 | 2 | 1445 | 1 | S | 1 | ML | 1000 | 2016-03-22 | 2016-04-15 | NR | TALTZ | False | False | 2016-04-15 | 2 | 125521 | N | |||
2019 | 3 | ELI LILLY AND COMPANY | 2144509 | 2 | 1445 | 9 | S | 1 | ML | 3000 | 2016-03-22 | 2016-04-15 | NR | TALTZ | False | False | 2016-05-03 | 2 | 125521 | N | |||
2019 | 3 | ELI LILLY AND COMPANY | 2144511 | 2 | 1445 | 11 | S | 1 | ML | 1000 | 2016-03-22 | 2016-04-15 | NR | TALTZ | False | False | 2016-04-15 | 2 | 125521 | N |