Why we’ve decided to file a lawsuit against HHS

Why we’ve decided to file a lawsuit against HHS
We believe recently announced policy changes harm the transparency, collaboration and ability to share data that are key to the long-term success of 340B

As a leading health tech innovator, Kalderos builds unifying technologies to address systemic challenges in healthcare. Our platform solutions make it easier for all stakeholders to participate transparently and compliantly in drug discount programs, including 340B.

On October 6, Kalderos filed suit against the U.S. Department of Health and Human Services (HHS) in regards to a change to longstanding policy in the 340B program. We would like to share our perspective on why this lawsuit is necessary to achieve our vision for a sustainable 340B program.

In May 2021, HRSA abruptly announced a blanket policy that no conditions—no matter how reasonable—could be imposed on the offer of a 340B price. This means that drug manufacturers may not request relevant claims data on 340B dispenses, despite the fact that such claims information is regularly supplied as standard industry practice throughout the healthcare industry whenever a price concession or payment is offered. HRSA announced this new policy in a series of letters issued to manufacturers on May 17, 2021.

The new policy represents a departure from the statute and HRSA’s prior guidance; HRSA’s 1994 guidance, issued soon after the founding of the program, allowed manufacturers to employ “customary business practices,” “request standard information,” and “adopt appropriate contract conditions.” HRSA did not provide an explanation for the change in policy communicated in the May 17 letters, and does not seem to have considered the broader implications.

As leaders and innovators in the 340B space, Kalderos has considered the implications, and we find them concerning. To solve the problems in 340B, all stakeholders must find a way to work together. Cooperation is intrinsic to delivering quality healthcare, and this is no different.

At Kalderos, we’ve built our tech solutions around the idea of collaboration and transparency. We believe better data is the best way to make 340B work fairly and equitably for everyone — so it can function in a way that meets the concerns of covered entities and manufacturers.

The platform technology we built enables covered entities to share a minimum number of data elements, such as the drug’s prescription number and the prescriber number, on utilization where they wish to request the statutory ceiling price from manufacturers. Using this small amount of information, our tech solution can ensure that covered entities receive the 340B price, while preventing duplicate discounts and errors.

Should HRSA’s new policy stand, it could prevent the exact type of information exchange that our technology was built to efficiently enable. This would make collaboration harder, not easier. It would eliminate transparency between parties. And it would further erode confidence in a program that needs mutual good faith to survive.

At Kalderos, we will continue to partner with covered entities, drug manufacturers and state Medicaid agencies alike, empowering these stakeholders with unifying technological solutions to ensure that drug discount programs work as intended.

Ultimately, we all do this work for the good of patients. Through this action, we hope to affirm the value of collaboration, transparency and shared data in empowering all stakeholders to support patient health.

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Article published
October 7, 2021