New CMS Operational Documents for Medicare Transaction Facilitator MTF – Updates and User Agreements
Relevant to: Drug Pricing, Part D
Each week, we scan the latest CMS memos to find the most important ones that apply for PACE programs. Below is a summary of what you need to know.
Disclaimer: The content provided on this site is a summary for informational purposes only, and Grane PBM, Inc. assumes no liability for any errors or omissions in the site’s content. The information does not constitute legal or regulatory advice or replace the original CMS memo. Readers are advised to consult the CMS memo in its entirety and to verify information independently before making any decisions based on this information.
Introduction
CMS has released new operational documents essential for the development and implementation of the Medicare Transaction Facilitator, a key component of the Medicare Drug Price Negotiation Program. These documents, including the Information Collection Request (ICR) for 2026 and 2027, MTF User Agreements, and Technical FAQs, are now available for public access. These efforts aim to streamline processes and ensure compliance with the Inflation Reduction Act. Key stakeholders involved include drug manufacturers, dispensing entities, and other interested parties.
Key Dates and Deadlines
- 60-day public comment period concluded: December 27, 2024
- 30-day public comment period concluded: May 1, 2025
- Date of memo: May 15, 2025
- Begin onboarding for MTF Data and Payment Modules: June 2025
- Deadline for electronically signing final MTF agreements: during June 2025
- Effective date for negotiated MFPs for first ten drugs: January 1, 2026
PACE Compliance
This memo does not mention PACE directly or outline specific PACE compliance requirements related to Medicare drug price negotiations or the Medicare Transaction Facilitator. However, entities involved in PACE programs should remain informed about these developments as they could indirectly affect aspects of drug pricing and reimbursement, which may impact PACE participants.
Additionally, it is important to monitor any further guidance or amendments in line with CMS announcements to ensure that any changes affecting drug pricing could be incorporated into existing compliance activities and operational practices.
As information emerges around drug price negotiations facilitated by CMS (Centers for Medicare & Medicaid Services), ensure that your practices align with the finalized agreements and any related technical FAQs issued by the Medicare Drug Price Negotiation Program.
Required Actions
1. Access the Information Collection Request (ICR) for the Medicare Transaction Facilitator for 2026 and 2027 on the OMB’s website to review the finalized documents based on public comments.
2. Review the finalized Medicare Transaction Facilitator User Agreements available on CMS’ Medicare Drug Price Negotiation Program website and prepare for electronic signature during the MTF onboarding process in June 2025.
3. Visit CMS’s Medicare Drug Price Negotiation webpage to access the new Technical FAQs resource that addresses inquiries and provides additional operational details for the Medicare Drug Price Negotiation Program.
FAQs
- “What is the purpose of the Medicare Transaction Facilitator (MTF)?”
- “How can drug manufacturers access the new operational documents for the MTF?”
- “What are the key components included in the MTF User Agreements?”
- “How will the MTF support the Medicare Drug Price Negotiation Program?”
- “When will the negotiated maximum fair prices (MFPs) go into effect?”
