The Next Chapter for 340B Starts with Claims Data
Court rulings, industry momentum and HRSA’s own pilot make one thing clear: claims collection is foundational to the future of 340B.
Court rulings, industry momentum and HRSA’s own pilot make one thing clear: claims collection is foundational to the future of 340B.
HRSA’s original 1994 guidance explicitly stated that manufacturers may include provisions in agreements that require “standard information.”
"HRSA’s initial guidance on implementation of the 340B indicated manufacturers could include provisions that address customary business practices, request standard information, or include other appropriate contract provisions."
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Multiple federal court decisions affirm that manufacturers can condition 340B pricing on the provision of claims data, and that doing so does not violate the 340B statute.
Two major rulings (Sanofi v. HHS and Novartis v. Johnson) have upheld the legality of manufacturer-imposed conditions, including claims data submission.
The courts concluded that requiring 340B claims data is consistent with the statute and imposes only a minimal burden on covered entities, which already collect this data in the normal course of business.
Without claims data, there’s no clear way to confirm eligibility, detect duplicate discounts or understand the program’s true impact.
Collecting claims data simplifies compliance, reduces waste and administrative burden and builds trust. That’s a winning combination for creating a healthier, more sustainable 340B program for everyone.
Reduced Compliance Risk – Verified claims help you detect and prevent duplicate discounts before they become costly disputes.
Simplified Operations - Minimize the need for good faith inquiries (GFIs), speed up dispute resolution and reduce administrative friction with covered entities (CEs).
Visibility - Claims data offers the most comprehensive view of 340B empowering stakeholders to make informed, data-driven decisions.
Stronger Partnerships – Transparency fosters collaboration and trust with manufacturers.
Simplified Compliance - Fewer audits, fewer disputes and faster resolution when issues arise.
340B Sustainability - Claims data fosters transparency, which is essential for the long-term sustainability of 340B and for safeguarding access for the communities it supports.
Here's why now is the time to build claims collection into your 340B approach
Truzo unites manufacturers and covered entities around accurate, validated data, creating transparency, resolving disputes faster and strengthening program integrity.
Policy Integration into Truzo:
The manufacturer’s updated claims collection policy is provided to Kalderos and processed into the Truzo platform.
CE Notification and Dedicated Support:
Kalderos CE Concierge team notifies CEs of policy changes. For CEs new to Truzo, the team provides onboarding support and ensures they are prepared to submit claims in line with the manufacturer’s policy.
Secure Claims Submission in Truzo:
Claims are submitted through Truzo, the industry’s only platform with SOC 1 and SOC 2 Type II compliance, aligned with leading security frameworks and moving toward HIPAA compliance by 2025, using standard .csv claim files.
Truzo Data Validation:
Once claims are uploaded, Truzo runs a series of data validation tests to ensure the claims are formatted correctly and notifies CEs of any issues. All submitted data is encrypted, access-controlled, minimized to what’s necessary, and any non-required data is securely discarded.
Eligibility Checks and Compliance Review:
Once submitted data is fully ingested and validated, Truzo runs eligibility checks on the claims to identify ineligible discounts, including cross-program duplicates, intra-program duplicates, and other discrepancies that may affect compliance.
CE Concierge Support and Issue Resolution:
If submissions do not comply with the manufacturer’s policy, the CE is notified and guided to provide the necessary information to validate the discount. The CE concierge team works closely with the CE throughout the process to ensure success and resolve any issues.
The result is a single source of truth that transforms fragmented data into actionable insights, preventing duplicate discounts, improving compliance and enabling data-driven decisions.
Kalderos is a healthcare technology company building the industry's only truly independent platform for drug pricing transparency and integrity.
Our platform, Truzo, enables manufacturers, providers, payers, and government entities to collaborate with confidence by delivering shared visibility, verified insights, and fully compliant pricing reconciliation that benefits the entire healthcare system.
Take the first step toward a more collaborative, compliant 340B program. Reach out to our team to get started.
