Covered entities no longer have the luxury of waiting to see whether manufacturer claims-data mandates will hold up. To date, Eli Lilly has already suspended 340B pricing for hospitals that did not comply with its in-house claims-data policy. In response, covered entity Tampa General Hospital has sued Lilly over the resulting price increases. And most recently, a bipartisan group of seventy-two members of Congress has written to the Department of Health and Human Services (HHS) and the Health Resources and Services Administration (HRSA) asking them to intervene. Other manufacturers, including Novo Nordisk, Novartis, Sanofi, GSK, Sobi, and Boehringer Ingelheim, have followed with claims-data policies of their own. For covered entities still deciding how to respond, the question is no longer whether these policies are worth taking seriously, but what to actually do about them.
Manufacturer 340B Claims-Data Mandates Are Expanding
Manufacturer claims-data mandates are not a new concept, but they have expanded considerably over the past year. While manufacturers have demanded claims data as a condition for contract pharmacy access for several years, Exelixis was among the first manufacturers to condition 340B pricing for in-house pharmacy dispensing on the submission of claims data.
Eli Lilly followed with an expanded policy in January 2026 that reached beyond contract pharmacy activity to cover in-house dispensing and provider-administered drugs across its full portfolio, requiring claims data to be submitted through its 340B ESP platform within forty-five days of dispensing, or sixty days for certain specialty and provider-administered products, and taking the step of threatening to terminate access if such data was not supplied.
When a subset of covered entities did not comply, Lilly followed through in June 2026, directing wholesalers to stop honoring 340B pricing for many hospitals. Since then, several other manufacturers, including Novo Nordisk, have similarly warned that failure to submit timely, complete, and accurate claims-level data may result in suspension of access to 340B pricing. Other manufacturers have since layered on their own versions of the requirement, each with different scopes, timing, and state carve-outs, leaving covered entities to track a fragmented and expanding set of manufacturer-specific rules rather than a single uniform standard.
Respond Before 340B Pricing Is Suspended
Not every covered entity that wants to comply is currently able to produce every data field a manufacturer requests, particularly where legacy dispensing systems, multiple electronic health record platforms, or contract pharmacy relationships complicate data capture. A covered entity that engages early and explains, in specific and documented terms, what data it can provide now and what will require additional system work may be able to negotiate a phased submission schedule that preserves 340B pricing while the entity builds out its reporting capability. This approach works best when the covered entity documents its outreach, keeps a written record of what was requested and what was offered, and follows through on the timeline it commits to. A partial solution obtained early is almost always preferable to a suspension of pricing followed by a fight to get it reinstated.
When a covered entity believes a manufacturer’s data mandate exceeds what the 340B statute permits, it should consider stating its position in writing before pricing is cut off rather than after. Section 340B requires manufacturers to offer covered outpatient drugs to covered entities at or below the applicable ceiling price. It does not explicitly authorize a manufacturer to condition that pricing on the submission of claims-level data, and HRSA has previously taken the position, including in its review of Lilly’s contract pharmacy restrictions, that manufacturer-imposed conditions of this kind can result in prohibited overcharges. A written objection accomplishes two things:
- It puts the manufacturer on notice of the covered entity’s legal position, which may be important if the dispute later proceeds to HRSA’s administrative dispute resolution (ADR) process or to litigation.
- It creates a contemporaneous record, distinct from any informal phone calls or emails, showing that the covered entity raised the issue before losing access to pricing rather than only after the fact.
Document Pricing Denials and Preserve Available Remedies
Where a manufacturer suspends 340B pricing or a wholesaler stops honoring it, the covered entity should treat every resulting purchase at a non-340B price as a documented overcharge. That documentation gives the covered entity a factual record it can bring to HRSA to seek enforcement action, including possibly civil monetary penalties, against manufacturers that condition 340B pricing on data submission. It may also support a formal overcharge claim through the 340B ADR process, which remains the primary statutory mechanism for a covered entity to seek repayment when a manufacturer has charged above the ceiling price.
Where the facts support it, as Tampa General Hospital’s July 2026 lawsuit against Eli Lilly illustrates, that documentation may also support a direct legal claim, particularly where the covered entity can show a specific, quantifiable increase in what it is now paying for medically necessary drugs. That case, Florida Health Sciences Center, Inc. v. Eli Lilly and Company, was filed on July 2, 2026, in the U.S. District Court for the Middle District of Florida and remains in its early stages. Tampa General Hospital pleads a Florida Deceptive and Unfair Trade Practices Act claim and seeks an injunction ending Lilly’s ESP claims-data condition plus damages for the 25-50% price increases it has incurred since Lilly cut off its 340B pricing on June 18, 2026. As of this article, the court has not ruled on the merits of the hospital’s claims.
The covered entities in the best position today are those that treated manufacturer data mandates as both an operational and a legal issue as soon as the policies were announced, rather than waiting until a wholesaler actually stopped honoring 340B pricing. That means confirming, in writing, exactly what each manufacturer’s policy requires and by when, assessing honestly whether the covered entity’s claims data infrastructure can meet that requirement, and deciding, with counsel, whether the appropriate posture is negotiated partial compliance, a formal written objection, or both. It also means training pharmacy and revenue cycle staff to flag the moment a manufacturer denies 340B pricing so the covered entity can begin building its record of potential overcharges immediately, rather than discovering the denial weeks later in a reconciliation report.
How Frier Levitt Can Help
Our team advises hospitals, health systems, federally qualified health centers, and specialty and retail pharmacies on the full range of 340B compliance and enforcement issues, including manufacturer claims-data mandates. We help covered entities evaluate a manufacturer’s data policy against the requirements of the 340B statute, negotiate phased or partial compliance where full compliance is not immediately achievable, and prepare the written record needed to support a HRSA ADR claim or, where appropriate, litigation. We also assist clients in coordinating with trade associations and congressional offices to ensure that documented instances of potential overcharging are brought to the attention of appropriate policymakers and regulators.
If your organization has received a manufacturer claims-data mandate, has had 340B pricing suspended or denied, or is unsure whether its current data submission workflow satisfies a manufacturer’s requirements, contact Frier Levitt to discuss your options.
