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 drug products and check to make sure that each one meets the definition of a covered outpatient drug as required by the Medicaid Drug Rebate Program. You should also verify that your drug products are listed (or de-listed if any have been discontinued) with the FDA on their website at:
http://labels.fda.gov. If you need to verify the status of your drug product listings, email the SPL Coordinator at the FDA at email@example.com. You should have at least one drug product listed with the FDA that CMS can review and verify before you submit your request for an official drug rebate agreement or if you have a drug product coming to market, please contact us before submitting an agreement. Otherwise, your product should be ready to market in the same quarter as your Optional Effective Date.
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.
In order to receive an agreement, your request should include:
• A contact name and mailing address
• Your manufacturer's FDA-assigned labeler code(s). Include the parent company and any other companies associated with the parent company along with their FDA assigned labeler code(s)
• A complete list of all NDCs (11-digit/package size level) for every labeler code. Include the drug name for each NDC
• The DESI Code, Drug Category (S/I/N), and Drug Type (Rx/OTC) for each 11-digit NDC
• The Market Date of the drug(s) (should be within the same quarter as the Optional Effective Date or earlier)
• The date the drug(s) were listed with the FDA
If any of the information above is missing, we will be unable to proceed with your request.
CMS Will Review Your Information
CMS will review your submission to ensure it is complete and check the NDCs you provide against the NDCs listed at http://labels.fda.gov. Please note that this is a manual process that takes time to complete, so please allow sufficient time to process your request.
Your Contact’s Mailing Address
The FDA requires that every labeler 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 either an office in the United States or 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.
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
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||November 1|
|2nd Quarter||January 30|
|3rd Quarter||May 1|
|4th Quarter||August 1|
Manufacturers are required to report initial product and pricing information on all NDCs within 30 days of the end of the month and quarter of the optional effective date. For every month and quarter thereafter, product and pricing data is due within 30 days of the end of each respective monthly and quarterly period.
Note: The “Sample” Medicaid Drug Rebate Agreement contained on this site is for informational purposes only. Get a copy of the
Page last updated on July 27, 2012