Medicaid National Drug Rebate Agreement
Actions Required by Participating Manufacturers
On March 22, 2018, the Centers for Medicare & Medicaid Services (CMS) put on display CMS-2397-FN, the final notice that announced changes to the Medicaid National Drug Rebate Agreement (NDRA) which will be applicable as of the March 23, 2018 publication in the Federal Register. The updated NDRA incorporates legislative and regulatory changes that have occurred since the NDRA was last published on February 21, 1991, and also makes editorial and structural revisions, such as references to the updated Office of Management and Budget (OMB)-approved data collection forms and electronic data reporting. Manufacturers with an existing active NDRA(s) as of the applicability date of the notice have until September 30, 2018 to complete (including the CMS-367d), sign and submit the updated NDRA in order to continue participation in the Medicaid Drug Rebate Program (MDRP).
How to Request a Medicaid National Drug Rebate Agreement?
Before requesting a Medicaid National Drug Rebate Agreement, make a list of all drugs and identify each one that meets the definition of a covered outpatient drug (COD) as defined in section 1927 of the Social Security Act and required by the Medicaid Drug Rebate Program (MDRP). Verify that drugs are listed (or de-listed if any have been discontinued) with the Food and Drug Administration (FDA) on their website at http://labels.fda.gov. Verify the status of drug listings, email the Structured Project Labeling (SPL) Coordinator at the FDA at firstname.lastname@example.org. Drugs should be ready to market in the same quarter in which a rebate agreement is requested, if not marketed already.
Prepare Information and Submit a Request
Manufacturers are able to request an official NDRA by emailing CMS at DrugRebateAgreement@CMS.HHS.gov.
Please use this Excel template to submit your information.
Before submitting a request, ensure that you have verified and compiled the following information:
- A contact name, email address, and complete mailing address. Please be advised that CMS does not email, mail, or call outside of the United States, and does not require states to do so when contacting drug manufacturers about MDRP-related issues as communications are time-sensitive. Please note that utilizing a call or email forwarding service is not acceptable.
- Manufacturer's FDA-assigned labeler code(s) as well as the name of the drug manufacturer as reported to the FDA. Include the name of all associated companies, along with their FDA-assigned labeler code(s).
- A complete list of every National Drug Code (NDC) (11-digit/package size level) that meets the definition of a Covered Outpatient Drug (COD) for each labeler code for which you are requesting a new agreement. This list should also include all NDCs that should be reported with a COD Status of “05” or “06”. (See below for the complete list of COD Status values). If there are NDCs reported to the FDA that your company has determined do/does not meet the definition of a COD, please also provide those NDCs along with the rationale for your company’s determination.
- The drug name, as it is listed with the FDA, for each 11-digit NDC
- FDA Approval Date (if COD status is 1-4; for COD status 5-13, input 09/30/1990)
- The COD Status for each NDC (this value should be the same for every package size of a 9-digit NDC). The COD Status is an indicator that identifies how a drug meets the statutory definition of a covered outpatient drug in accordance with section 1927of the Social Security Act. The following list identifies all COD Status values:
01= Abbreviated New Drug Application (ANDA)
02= Biological License Application (BLA)
03= New Drug Application (NDA)
04= NDA Authorized Generic
05= (Drug Efficacy Study Implementation) DESI 5* – LTE/IRS drug for all indications
06= DESI 6* – LTE/IRS drug withdrawn from market
07= Prescription Pre-Natal Vitamin or Fluoride
08= Prescription Dietary Supplement/Vitamin/Mineral (Other than Prescription Pre-Natal Vitamin or Fluoride)
09= OTC Monograph Tentative
10= OTC Monograph Final
11= Unapproved Drug – Drug Shortage
12= Unapproved Drug – Per 1927(k)(2)(A)(ii)
13= Unapproved Drug – Per 1927(k)(2)(A)(iii)
*NDCs with a COD Status of 05/06 (DESI 5/6) are not eligible for coverage or rebates under the Medicaid Drug Rebate Program. However, pricing is required and Unit Rebate Amounts (URA) are calculated
- FDA Application Number (for COD status 1-4) OR OTC Monograph Part number (for COD status 9-10), as appropriate
- The date that each 11-digit NDC was or will be first available for sale under your labeler code (this date should fall during or before the quarter in which a rebate agreement is requested)
- The date that the drug was first marketed by any labeler code. For drugs with COD Status 1-4, provide the date that the drug was first marketed under the NDA, ANDA, or BLA (NOTE: this is not always equivalent to the date that the NDC is first available for sale under your labeler code; rather, it is the date that the NDA, ANDA, or BLA was marketed by the manufacturer who first marketed a product under that application)
- Drug Type (i.e., Rx/OTC) for each 11-digit NDC (this value should be the same for every package size of a 9-digit NDC)
- Drug Category (i.e., Single Source/Innovator Multiple Source/Non-Innovator) for each 11-digit NDC (this value should be the same for every package size of a 9-digit NDC). Definitions of these terms may be found in Federal Regulations (42 CFR §447.502)
- Confirmation that NDC appears on FDA’s NSDE file
- The unit type that will be reported for each 9-digit NDC. The unit type should be the same for every package size of a 9-digit NDC and should be reported as one of the following values:
AHF = Injectable Anti-Hemophilic Factor
CAP = Capsule
SUP = Suppository
GM = Gram
ML = Milliliter
TAB = Tablet
TDP = Transdermal Patch
EA = Each
- The units per package size that will be reported for each 11-digit NDC. The units per package size should equal the total number of units in the smallest dispensable amount for the 11-digit NDC. For more information on this topic, please search the Manufacturer Releases for “units per package size” or “UPPS”.
- More information regarding the product information described above, including data definitions.
Please ensure the submission is complete; and verify that the information submitted matches the information on the FDA listing website. If any of the information above is missing, CMS will be unable to proceed with processing the request.
CMS Will Review the Information
CMS will review the submission. Please note that this is a manual review process that takes time to complete, so please allow sufficient time to process the request.
Phone Number and Mailing Address of Manufacturer's Contacts
The FDA requires that all manufacturers doing business in the United States (US) have an office in the US. Therefore, if entering into a rebate agreement, the company must have an office in the US and an agent doing business on the company's behalf in the US. CMS does not email, mail, or call outside of the United States, and does not require states to do so when contacting drug manufacturers about MDRP-related issues as communications are time-sensitive. Please note that utilizing a call or email forwarding service is not acceptable.
Manufacturer Effective Dates
Since 1999, new manufacturers have been given two effective dates under the law when entering the MDRP: an optional effective date and a mandatory effective date.
|Effective Date Type||Start Date||What It Means|
|Optional Effective Date||Starts on the postmark, fax, or email date on the signed rebate agreement||States can (at their option) cover the manufacturer's drugs as of this date|
|Mandatory Effective Date||Starts on the first day of the calendar quarter that begins more than 60 days after the date the agreement is entered into||States must generally cover a manufacturer's drugs as of this date (subject to the exceptions in section 1927 of the Social Security Act)|
Examples of Optional and Mandatory Effective Dates Once the Rebate Agreement Has Been Received and Accepted by CMS
Manufacturer X submits a rebate agreement which is postmarked, faxed, or emailed January 15th,
- The Optional Effective Date for Manufacturer X's rebate agreement is January 15th.
- The Mandatory Effective Date for Manufacturer X's rebate agreement is the first day of the calendar quarter that begins more than 60 days after the date the agreement is entered into. Sixty days after January 15th is March 16th and the next complete quarter that occurs after that date is the second quarter; therefore, the Mandatory Effective Date for Manufacturer X's rebate agreement is April 1st.
Generally, the last date on which a new manufacturer's rebate agreement can be postmarked, faxed, or emailed to establish the mandatory state coverage date each quarter (in a non-leap year) is as follows:
|For a Mandatory Effective Date of:||The Rebate Agreement Must Be Received And Accepted by CMS by|
|1st Quarter (i.e., January 1st)||November 1|
|2nd Quarter (i.e., April 1st)||January 30|
|3rd Quarter (i.e., July 1st)||May 1|
|4th Quarter (i.e., October1st)||August 1|
For information on new/reinstated and terminated labelers, please see the New/Reinstated & Terminated Labeler Information page.
Manufacturers are required to report initial product and pricing information on all CODs within 30 days of the end of the month and quarter of the optional effective date. For every month and quarter thereafter, pricing data are due within 30 days of the end of each respective monthly and quarterly period and updated as often as necessary. In addition, product data should be initially reported and/or updated as soon as it is available. When a manufacturer markets a new COD, the drug must also be submitted to the Drug Data Reporting for Medicaid (DDR) system, ensuring that it is first electronically listed with FDA.
Note: Visit the Federal Register for a copy of the Medicaid National Drug Rebate Agreement.
Page last updated on March 22, 2018