The Riparian team was proud to participate in this year’s Medicaid Drug Rebate Program (MDRP) Summit, where four of our colleagues joined industry peers to share insights on evolving regulatory and operational challenges. Among these sessions, Justin Linder, Managing Director at Riparian, co-presented on one of the most pressing issues facing many manufacturers today: Maximum Fair Price (MFP) Effectuation Plans for Initial Price Applicability Year (IPAY) 2026 and beyond.
With the first round of MFP effectuation plans already submitted to CMS, Justin and fellow presenters provided a real-world look at how manufacturers can prepare for implementation and what lessons learned will mean for the next wave of affected products.
Early Preparation is Non-Negotiable
MFPs under the Medicare Drug Negotiation Program (Program) will take effect for certain Medicare Part D drugs on January 1, 2026. For manufacturers subject to MFP requirements, the burden of compliance is significant, and the timelines are unforgiving. Justin emphasized that preparing a strong MFP effectuation plan requires assembling an internal cross-functional team early. Organizing a team, engaging appropriate vendors, and confronting challenges early permits manufacturers to diligently address strategic and risk mitigation issues and avoid scrambling to meet deadlines.
Accelerated Timelines for IPAY 2027 Selected Drugs
The IPAY 2026 MFP Effectuation Plan requirements presented Selected Drug manufacturers with significant obstacles to timely submissions, and the IPAY 2027 cycle will accelerate certain manufacturer deadlines. For example, submission of a manufacturer’s communication plan, its approach to cash-constrained entities, and information about its plan to effectuate MFP refunds if it does not intend to use the Medicare Transaction Facilitator Payment Module that are due June 1, 2026, rather than September 1, 2026. Justin highlighted that regulatory ambiguity continues to pose challenges, with overlapping federal programs adding layers of uncertainty. Manufacturers should expect heightened scrutiny, shorter submission windows, and greater operational pressure.
Lessons Learned from the First Round
Riparian’s direct involvement in helping manufacturers draft and submit their MFP effectuation plans provided a window into the operational realities, along with valuable insights into addressing this moving forward:
- Build in more time than you think you need. Internal discussions, stakeholder approvals, and technical drafting took longer than expected.
- Clarify ownership early. Identifying the right stakeholders to assume accountability for regulatory, legal, finance, public affairs, and operations matters was essential.
- Expect to iterate. Plans often required multiple rounds of revision before submission, underscoring the importance of flexibility in both timelines and processes.
These insights offer critical guidance for manufacturers facing IPAY 2027 deadlines: start planning now, secure cross-functional engagement, and anticipate unexpected roadblocks.
As Justin addressed at MDRP, if your products are subject to MFP in 2027, it’s not too early to begin planning today. Riparian has been on the front lines of the inaugural MFP effectuation round, helping clients navigate ambiguity, assemble effective teams, and submit compliant plans.