The Medicaid Drug Rebate Agreement contained on this site is for informational purposes only.  Manufacturers can request an official agreement by emailing CMS at drugrebateagreement@cms.hhs.gov. 

Get a copy of the Sample 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) on the FDA’s National Drug Code Directory (old NDC directory and new NDC directory).  If you need to verify the status of your drug product listings, email the SPL Coordinator at the FDA at spl@fda.hhs.gov.

Submit A Request

Manufacturers can request an official drug rebate agreement by emailing 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)
• The date the drug(s) were listed with the FDA

CMS Will Review Your Information

We will contact the FDA to confirm the data you provided to us.  This is a manual process that takes time to complete (the more NDCs that you have, the longer the process may take), so please allow us sufficient time.

Your Contact’s Mailing Address

The FDA requires that every drug manufacturer doing business in the United States have an office in the United States.  Therefore, if you want to enter into a national 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 when they enter the Medicaid Drug Rebate Program: an Optional Effective Date and a Mandatory Effective Date.

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 this manufacturer's rebate agreement is January 15th
• The Mandatory Effective Date for this manufacturer'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 calendar 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: