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On December 29, 2025, a federal court in Maine halted HRSA’s planned 340B manufacturer rebate pilot. After presumably realizing it did not have a strong case, HHS dropped its appeal and has started to work on a new version of the rebate pilot.
For now, the decision preserves the status quo. Covered entities (CEs) can continue accessing 340B priced drugs through upfront discounts, avoiding the operational and cash-flow disruption rebates would have introduced. But the ruling was narrow. It did not question HRSA’s authority to pursue a rebate-based model, leaving open the possibility that rebates could still take effect through a revised approach. Indeed, we have since seen HRSA signal renewed commitment to implementing a rebate model, releasing both a Request for Information and an Information Collection Request in February. Both requests seek comment from stakeholders on operationalizing a new 340B rebate pilot program, including feedback on financial impacts, proposed data collection requirements, and estimates of associated burden.
If anything is certain, it’s that manufacturers’ motivation to control access and expand data collection remains undeterred. For CEs, this moment should not be viewed as a reprieve, but as an opportunity to prepare for a future defined by greater scrutiny, variability, and downstream complexity. That preparation does not begin with rebates – it begins with pricing.
Pricing Integrity Is the First Line of Defense
At its core, the 340B program is about access to a specific drug price. Everything else – claims capture, replenishment, audit readiness, and even rebates – exists in service of 340B price availability.
Yet, pricing is increasingly difficult to monitor and manage. Maintaining the right 340B price at the right time, in the right channel, for the right patient and location is no longer a “set it and forget it” exercise. It depends on clean and timely data, accurate eligibility determinations, reliable accumulators, consistent NDC mapping, and close coordination across wholesalers, split-billing platforms, contract pharmacies, and internal finance and compliance teams.
When any link in that chain breaks or when policies shift midstream, the consequences are familiar and painful: missed savings, inventory imbalances, retroactive adjustments, disputes with manufacturers or vendors, and heightened compliance risk.
And critically, pricing failures are silent. No alerts are provided to CEs when they receive the wrong price. Issues typically surface only after the financial impact has already occurred, whether that be when purchases process at the wrong price, claims test incorrectly, or reconciliation reveals unexplained gaps. At that point, recovery depends on credits, rebills, or disputes that may or may not be successful.
Why the Rebate Pause Raises the Stakes
The pause in the rebate pilot does not reduce pricing risk. In many ways, it increases pressure on pricing accuracy. With no formal mechanism to prevent MFP and 340B duplicate discounts, manufacturers are turning to “alternative methods” to identify 340B claims – processes that remain opaque and undefined. This lack of transparency shifts additional burden onto CEs, which must now monitor all claims and dispute those inaccurately identified as 340B and therefore excluded from MFP rebates.
Manufacturers may also capitalize on these gaps by imposing broader pricing restrictions. Eli Lilly is the first of the major brand name drug companies to do so, announcing new in-house claims reporting requirements effective February 1. Novo Nordisk has now followed suit, announcing similar requirements that go into effect April 1. Others will likely continue to emerge.
As a result, the injunction should be viewed not as a resolution, but as a temporary hold that introduces new complexity. It does not lessen the need for CEs to prepare for continued evolution in how 340B pricing is delivered, tracked, and validated – if anything, it reinforces that need.
How Proximity Approaches Pricing
Proximity’s platform treats pricing as a living system, not a static reference file.
Pricing data is unified across wholesalers, TPAs, and transactional activity, then continuously evaluated for variance. The platform identifies inconsistencies whether they originate in catalog configuration, purchase execution, or claim-level application.
Crucially, this analysis is performed across every single claim, not just sampled subsets or aggregate summaries. The goal is not retrospective discovery, but early detection: surfacing issues before they quietly compound into significant financial impact.
This capability is valuable regardless of whether rebates are active. In periods of uncertainty, it becomes foundational.
Using the Time We’ve Been Given
The rebate pause has created space. How that space is used will matter.
In this new phase of 340B management, proactive CEs will be best served by strengthening governance and controls around pricing-adjacent processes now, not later. Organizations that invest in data integrity, monitoring, and cross-functional alignment will be better positioned to withstand future policy changes, whether those take the form of rebates or continued pressure on the existing discount model.
Proximity provides the foundation for success by identifying pricing issues across every transaction, restoring visibility where failures are silent, and giving CEs a more controlled footing as the program continues to evolve.
Scott Johnsen is founder and CEO of Proximity. For questions, please email scott@proximityhealth.com.
