National Drug Rebate Agreement

How Do I Get A Medicaid Drug Rebate Agreement?

Prepare Your Information

Before you request a Medicaid Drug Rebate Agreement, you should make a list of all of your 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.  You should also verify that your 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.  If you need to verify the status of your drug listings, email the SPL Coordinator at the FDA at spl@fda.hhs.gov.  Your drugs should be ready to market in the same quarter in which you request a rebate agreement, if they are not marketed already. 

Submit A Request

Manufacturers can request an official drug rebate agreement by emailing the Centers for Medicare & Medicaid Services (CMS) at DrugRebateAgreement@CMS.HHS.gov.

Please use this Excel template to submit your information. 

In order to receive an agreement, your request should include:

  • A contact name, email address, and mailing address.
  • Your 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 any parent company and any other companies associated with the parent company along with their FDA-assigned labeler code(s).
  • A complete list of every NDC (11-digit/package size level) that meets the definition of a 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.)
  • The drug name, as it is listed with FDA, for each 11-digit NDC.
  • 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= 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    06= DESI 6* – LTE/IRS drug withdrawn from market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 URAs are calculated.
  • FDA approval number as appropriate; i.e., for drugs with COD Status 1-4 (NDA, ANDA, BLA), or for drugs with COD Status 9-10, provide the applicable OTC Monograph Part number.
  • The date that each 11-digit NDC was or will be first available for sale under your labeler code (should be no later than the end of the quarter in which the Optional Effective Date occurs). 
  • 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).
  • The date each drug was listed with FDA.
  • 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.

More information regarding the product information described above, including data definitions.

Please ensure your submission is complete; and verify that the information you submitted matches the information on the FDA listing website.  If any of the information above is missing, we will be unable to proceed with processing your request.

CMS Will Review Your Information

CMS will review your submission.  Please note that this is a manual review process that takes time to complete, so please allow sufficient time to process your request.

Phone Number and Mailing Address of Manufacturer's Contacts

The FDA requires that all manufacturers doing business in the United States have an office in the United States.  Therefore, if you want to enter into a rebate agreement, your company must have an office in the United States and an agent doing business on your behalf in the United States.  We do not email, mail, or call outside of the United States, and we do not require states to do so when contacting drug manufacturers about Medicaid Drug Rebate Program-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 they enter the Medicaid Drug Rebate Program: 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.

Reporting Requirements

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, they must also submit the drug to the Drug Data Reporting for Medicaid (DDR) system, ensuring that it is first electronically listed with FDA.

Note: The “Sample” Medicaid Drug Rebate Agreement contained on this site is for informational purposes only.  Get a copy of the Sample Medicaid Drug Rebate Agreement.

Page last updated on May 29, 2016