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When the Health Resources and Services Administration (HRSA)’s 340B Rebate Model Pilot Program was put on temporary pause by a federal court in the waning days of 2025, most of the covered entity (CE) community celebrated the delay thinking they had avoided the administrative burdens of reconciling payments in a manufacturer-aligned software system. While the pause did offer a reprieve from reconciling 340B rebates, the January 1 implementation of the Maximum Fair Price (MFP) negotiations under the Inflation Reduction Act means that pharmacies across the country are dealing with payments – and non-payments – from drug manufacturers. 340B teams across the country are being asked to work with their partners in retail pharmacies to ensure they are being properly paid. Even CEs that only have contract pharmacies need to be actively involved in managing this process.
For Entity-Owned Retail Pharmacies
Even though the 340B rebate model is paused, CEs that operate their own retail or specialty pharmacies need to establish processes to monitor and dispute MFP rebate requests which are denied by the manufacturers. Each manufacturer seems to be implementing their own approach to deduplicating the MFP refund payments from 340B purchases, and all seem to have their imperfections. The process is complex and requires collating data from a number of different systems including the Medicare Transaction Facilitator, Beacon MFP, wholesalers, and third-party administrators (TPAs). And different systems may use different identifiers which need to be cross walked to each other.
For Contract Pharmacies
Many CEs may have thought that they would not be affected by MFP since they only have contract pharmacies. (CP). However, even these CEs need to be engaged with their pharmacy partners to ensure an ongoing viable partnership. First, the CE and CP need to agree on whether the MFP products will continue to be considered eligible or if they will be carved out of the agreement. Many of the larger pharmacy chain are carving the products out, at least when it is a Medicare claim. CEs may still need to engage with their CP partners to ensure they have the data needed to dispute any non-payments of MFP refunds. Finally, CEs will need to monitor the viability of their CP partnerships to ensure they continue to be win-win arrangements.
Looking Ahead
With HRSA releasing a Request for Information on February 13 related to a future 340B Rebate Model Pilot, the payment reconciliation for MFP is likely a window into what the future of 340B rebates may hold. CEs should be learning from this process and using it to inform their responses to the proposal. Responses are due by April 20. HRSA needs to understand the administrative burden rebate reconciliation is causing CEs as they consider expanding it to even more claims.
How SpendMend Can Help
SpendMend has the knowledge, expertise and staff to help your team manage this process. From helping you design a process, to augmenting your staffing, or assisting with a response to the 340B rebate proposal, SpendMend’s team of experts can help you navigate these choppy waters. If you are already a valued SpendMend customer, just reach out to your favorite SpendMend team member. If you haven’t worked with us before, contact sales@spendmend.com to schedule a discussion.
Nick Gnadt is Director of Pharmacy Professional Services at SpendMend. He can be reached at ngnadt@spendmend.com.
