The Medicaid Drug Rebate Agreement contained on this site is for informational purposes only. Manufacturers can request an official agreement by emailing the Centers for Medicare & Medicaid Services (CMS) at DRUGREBATEAGREEMENT@CMS.HHS.GOV. In order to receive an agreement, you must include in your request:

• Mailing address
• 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 NDCs (11-digit/package size level) for every labeler code. Include the drug name.
• DESI Code, Drug Category (S/I/N) and Drug Type (Rx/OTC) for each 11-digit NDC
• A statement that the products will be marketed within the quarter in which your rebate agreement is effective (see dates below).

CMS will compare this data with the information the manufacturer supplied to the FDA to determine whether each product meets the definition of a covered outpatient drug as required by the Medicaid Drug Rebate Program (the Program) and that your drug data is consistent with the information you provided to the Food and Drug Administration. Please allow for sufficient lead time in providing your data to CMS for this process to be completed (the more NDCs the manufacturer has, the longer the process will take).

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. The Optional Effective Date coincides with the postmark date of a signed rebate agreement, and states can cover the manufacturer's drugs at their option any time between the start of the Optional Effective Date and the start of the Mandatory Effective Date. The Mandatory Effective Date is equal to the first day of the calendar quarter that begins more than 60 days after the date the agreement is entered into, and states must cover a manufacturer's drugs at the start of the Mandatory Effective Date (subject to the exceptions in section 1927 of the Social Security Act). An example of both a manufacturer's Optional and Mandatory Effective Dates follows:

• Manufacturer X submits a rebate agreement which is postmarked 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 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 to establish the mandatory state coverage date each quarter (in a non-leap year) is as follows:

In order for a Rebate Agreement to receive a a mandatory effective date of :

        1st Quarter
        2nd Quarter
        3rd Quarter
        4th Quarter

The Rebate Agreement must be received and accepted by CMS by:

        November 1
        January 30
        May 1
        August 1                                               

Downloads
View the Sample Agreement [PDF, 233KB] Contact Change Form [PDF, 99KB]
Related Links Inside CMS
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Related Links Outside CMS
Section 1927 of the Social Security Act

Page Last Modified: 09/03/2008 4:48:48 PM
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