Kalderos’ Industry-Leading Push for Transparency in 340B Drug Pricing Program Validated by Federal Court Ruling; Continued Delay in Implementation Hampers Meaningful Progress

Stakeholders agree rebate model, reasonable conditions, would both enable much-needed transparency in growing program

Despite the U.S. District Court for the District of Columbia recently asserting that the 340B statute “explicitly contemplates” rebate models, those seeking to improve the 340B program’s transparency and ensure its efficacy remain in a holding pattern. This week, in response to years of efforts led by Kalderos and other 340B program stakeholders to implement a rebate model in the federal drug pricing program, the U.S. Department of Health and Human Services (HHS) submitted a proposed “340B Rebate Guidance” for review by the White House Office of Management and Budget. The substance of the proposed guidance was not shared publicly, meaning that all drug pricing stakeholders will need to wait up to 90 more days before getting much-needed clarity about the future integrity and sustainability of the 340B program.

Stakeholders agree that increased transparency is critical in the evolving drug pricing landscape, and the court acknowledged this need during a hearing. It is incumbent upon HHS to release a clear and transparent guidance for rebate model review and approval without further delay.

In addition to the court affirming the permissibility of a rebate model under the 340B program, it also reiterated that reasonable conditions, including the provision of claims data, for covered entities to purchase 340B-priced products are allowable. As a result of Kalderos’ years of work in this space and this decision, manufacturers and healthcare providers are one step closer to managing 340B and other drug pricing programs in a more transparent, data-driven way.

“We are pleased the court acknowledged that a rebate model is permissible under the 340B statute and hope HHS will soon move to allow a well-designed and administered rebate model to be implemented,” said Kalderos Chief Executive Officer Angie Franks. “We pioneered and fiercely advocated for a rebate model because transparency benefits all stakeholders. Kalderos will continue to harness our technology to support the transparency and integrity of drug pricing programs, like 340B, that allow patients to access the medications they need at an affordable price.”

The 340B drug pricing program is a vital lifeline for providers and patients, but lack of clear guidance and growing complexity have made compliance increasingly burdensome. For more than four years, Kalderos has led the movement towards a rebate model to better support the program’s sustainability and integrity by bringing stakeholders together to ensure the 340B price is provided as intended, transparently, and simply. Kalderos’ first-of-its-kind, end-to-end drug discount platform, Truzo, creates a streamlined way to manage prescription drug programs. It establishes a direct connection between healthcare providers and pharmaceutical manufacturers, making it easy to submit and manage claims.

Kalderos originally filed suit against HHS in October 2021. This was in response to the Health Resources and Services Administration (HRSA) departing from long-standing guidance that allowed manufacturers to employ customary business practices, request standard information, and adopt appropriate contract conditions. In November 2024, Kalderos amended its complaint in response to HHS taking additional actions to prevent manufacturers from adopting the Truzo platform.

“We are deeply concerned that the lack of oversight and layers of unnecessary complexity jeopardize the 340B program for all,” said Franks. “The court’s confirmation that reasonable conditions are allowable and its assertion that a rebate model is explicitly contemplated represent a step in the right direction to improve program integrity and transparency between stakeholders. Our efforts to bring transparency to the nation's second-largest federal drug program will continue.”

By facilitating a rebate model, Truzo will ensure that covered entities receive payments faster, giving them more control over program savings. Kalderos understands that the 340B program succeeds when covered entities and manufacturers are empowered to collaborate simply and efficiently. Truzo integrates seamlessly with covered entities' technology solutions and existing and upcoming drug pricing programs, so that covered entities can focus more on patient care and ensuring patients can access the drugs they need, at an affordable price.

For more information, head to: gotruzo.com.

About Kalderos

Kalderos is a technology company helping health care providers and manufacturers navigate the increasing complexity of the drug discount ecosystem by bringing the key stakeholders to the table to foster collaboration, build trust, and improve transparency and accountability. With Truzo, the end-to-end drug discount management platform, we are illuminating the path to a better system with a technology solution that promises to enhance compliance and visibility for stakeholders. More information can be found at gotruzo.com.

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Stakeholders agree that increased transparency is critical in the evolving drug pricing landscape, and the court acknowledged this need during a hearing.