Angie examines the growing uncertainty surrounding the 340B program and explains why comprehensive reform remains unlikely in the near term. She argues that claims-level transparency must serve as the foundation for a sustainable path forward. She describes Truzo, Kalderos’ solution for manufacturers and covered entities to work in real time to gain visibility into 340B drug discounts.
To learn more, schedule a meeting with the Kalderos legal team.
Read on for Angie’s insights.
In an Uncertain 340B Environment, Kalderos Offers a Clear Path Forward
By Angie Franks, Chief Executive Officer, Kalderos
Entering 2026, the economic and policy environment around drug discounting remains as dynamic, nuanced, and complex as ever. Even as we adjust to the changes brought about by government-led initiatives like Most Favored Nation Agreements and the Max Fair Price effectuation plans, as well as continued pushback from PBMs on rebates and market interest in direct-to-consumer models, we are already encountering additional uncertainty due to litigation around the 340B program, especially the delay of the rebate pilot.
While these legal and policy battles continue to be fought, and a complete reform of the 340B program is unlikely to be in the cards anytime soon, how can the healthcare industry find firm footing and a solid path forward when it comes to prescription drug pricing? To do that, we have to start with what is clear, certain, and known.
A Path Forward Must Start with Transparency
If we look beyond the headlines, there are two things that we can count on.
The first certainty is, absent concrete action, the 340B program will continue to grow unchecked. As highlighted in Health Resources and Services Administration (HRSA) data released at the end of 2025, spending on 2024 340B purchases increased 23% year over year (compared to the 10.2% increase in drug purchases overall). While the rebate model has been one promising approach to addressing longstanding concerns about waste and abuse, it was never the only path forward.
At the heart of the now-delayed rebate pilot was a drive for transparency. Rebates presented a real opportunity to address structural issues with 340B by creating a clear, direct process for obtaining and analyzing data on 340B drug purchasing in a collaborative way. It gave a mechanism to bring both manufacturers and covered entities together around shared data, and while recent legal rulings have delayed this pilot, the drive to bring transparency to 340B data can not and should not be ignored.
This brings us to the second certainty: transparency must be at the core of any path forward to solve the challenges associated with 340B. Multiple courts have affirmed that drug manufacturers may require the submission of full claims data as a condition of accessing the 340B price, with some explicitly recognizing that transparency addresses the fundamental gaps that have plagued and undermined the program for years. The industry must stand firm on a simple, necessary idea: that claims-level transparency is not only permissible within 340B; it is essential if we are to restore and maintain the integrity 340B demands.
Without claims-level data, manufacturers cannot enforce pricing discipline, duplicate discounts and diversion persist, and policy debates are driven by anecdote rather than evidence. Claims-level transparency is critical and enables consistent program administration, defensible pricing strategies, and sustainable access for patients who need it most.
Regardless of the future of the rebate model, collecting claims data today will put the industry in a better position. Transparency is not a policy stance. It is an operational necessity protecting the interests of all stakeholders, including covered entities, patients, taxpayers, employers, and drug manufacturers.
Beyond Point Solutions
The moment we’re in underscores why the industry needs more than point solutions tied to a single policy construct. Solving these challenges requires an infrastructure designed to address the complex market and regulatory environment, one capable of scaling and adapting as rules, enforcement, and market dynamics change and evolve.
Truzo, Kalderos’ solution for manufacturers and covered entities to work in real time to gain visibility into 340B drug discounts, was purpose-built for exactly this environment. It is designed to flex with change while staying true to a simple mission: bringing integrity, transparency, and long-term sustainability to one of the most complex areas of healthcare.
Even without the rebate model, the industry can still make major strides towards transparency. Kalderos remains committed to bringing covered entities and drug manufacturers closer together around a shared source of truth for 340B utilization. Through Truzo, we offer the industry a clear, durable path forward that strengthens program integrity in the short term while preserving the ability to flex and scale with longer-term reform.
To learn more about how Kalderos is working to bring needed transparency to 340B and for a free, confidential analysis of what collecting 340B claims could look like with your policies, meet with the Kalderos legal team.
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