In 2021, CMS has established a resource mailbox MDRPChangeRequests@cms.hhs.gov to receive and respond to product and pricing change requests from manufacturers. Additionally, we consolidated our change request templates (see list below) into two new templates; one for change requests related to product data and the other for change requests to pricing data.
Medicaid Drug Rebate Program Change Request Process
Change Request Templates
- 5i Drug Indicator Change
- COD Status Change
- COD Status Change - Due to Narrow Exception
- Drug Category Change
- Drug Category Change - Due to Narrow Exception
- Drug Type Change
- FDA Approval Date Change
- FDA Approval Date Change for Previous Unapproved Product
- Line Extension Drug Indicator Change
- Market Date Change
- Unit Type Change
- Base AMP Change
- Base AMP Change - Due to Unit Type/UPPS Change
- Best Price Change after 12 quarters
- Best Price Change after 12 quarters - Due to Unit Type/UPPS Change
- Initial Drug for Line Extension Change
- Monthly AMP Change after 36 months
- Monthly AMP Change after 36 months - Due to Unit Type/UPPS Change
- Quarterly AMP Change after 12 quarters
- Quarterly AMP Change after 12 quarters - Due to Unit Type/UPPS Change
Process for Requesting a Change Request
Note: The process below must be followed and templates must be completed in full for them to be reviewed. A matrix for manufacturers to easily identify which fields are required for which type of change requests have been included within the available templates.
- The Product Template allows you to request up to 4 product changes for the same NDC-9 on the same product template (for example: Market Date, FDA Approval Date, Drug Category and COD status can all be requested on the same template now rather than having to submit multiple templates).
- The Pricing Template allows you to request all pricing changes for the same NDC-9 on the same product template (for example: Monthly AMP, Quarterly AMP, Base AMP and Best Price changes can now all be requested on the same template rather than submitting multiple templates).
- If requesting a change to Monthly AMP, Quarterly AMP or Best Price, a .txt or .csv file which contains the requested changes in the correct file format must accompany the pricing change request template.
- Manufacturers are to include only one drug (i.e., one NDC-9) on a template. If you have Market Date change requests for 5 different NDC-9s you need to complete 5 different templates.
- Each email should include templates related to only one drug (NDC-9).
- The Technical Contact must send the email requesting the changes or be copied on the email that includes the request. Additionally, the templates have a field requiring the technical contact to be identified.
- The subject line of the email should include the NDC-9, at least 3 letters of the drug’s name as well as the type of request(s) – for example: 12345-6789 ABC Market Date and Drug Category Change Request.
- Emails with attached templates must be sent to the MDRPChangeRequests@cms.hhs.gov resource mailbox.
- If an email is sent to the personal email box of a member of the Division of Pharmacy Staff, the email will not be processed.
- If an email is sent to Rxdrugpolicy@cms.hhs.gov resource mailbox, it will not be processed.
Best Practices in Completing a Change Request
Prior to submitting the change request, manufacturers should consider the following:
- Is the Technical Contact sending the email or is the Technical Contact copied on the email?
- Is the top portion of the template completed, including the name of the Technical Contact?
- Is there only 1 NDC-9 included on each template?
- Is there only 1 NDC-9 included for each email request?
- Has the manufacturer provided the fiscal impact? If not, has an explanation as to why there is no fiscal impact been provided?
- Has the manufacturer provided a detailed reason for requesting the change along with any required supporting information such as a reference NDC?
- If requesting a change to Monthly AMP, Quarterly AMP or Best Price, has a .txt or .csv file which contains the requested changes in the correct file format been provided with the pricing change request template?
REMINDER: If the template is missing any of this information, it will be sent back to the manufacturer for completion.
Disclaimer: Please note that the information provided on this web page does not bind or obligate the Centers for Medicare and Medicaid Services (CMS). The statements included on this web page are intended to provide information on Medicaid Drug Rebate Program Change Requests and do not in any way revise or modify the requirements set forth in Section 1927 of the Act, the national drug rebate agreement (NDRA), subsequent program releases, or regulations.
Page last updated on January 12, 2022