Eli Lilly is not simply asking 340B covered entities for more data. It is tying access to 340B pricing to the submission of that data.
In January 2026, Lilly announced an expanded claims-data policy covering pharmacy dispenses and medical claims. The policy may include in-house pharmacy transactions and provider-administered drugs. Lilly warns that covered entities that do not comply with the policy may lose access to 340B pricing. In June 2026, Lilly notified some covered entities that it could direct wholesalers to stop extending 340B pricing when required data remained outstanding and cut off 340B pricing to certain hospitals. The question is whether a manufacturer may condition the statutory 340B price on compliance with a manufacturer-created claims-data program.
Why Lilly Wants the Data
Lilly says the information is needed to identify duplicate discounts, diversion and other program-integrity concerns. Those are real compliance issues. The 340B statute prohibits a covered entity from obtaining a 340B discount and a Medicaid rebate on the same drug unit, and it prohibits transferring a 340B drug to an individual who is not a patient of the covered entity.
Those obligations do not resolve who may control the compliance system. The harder question is whether each manufacturer may set its own data requirements, procedures and penalties, then enforce them by removing 340B pricing.
A Broader Policy Than Contract Pharmacy Data
Manufacturer claims-data requirements are not new. For years, manufacturers have required certain covered entities to submit contract pharmacy claims data as a condition of receiving 340B pricing through those arrangements. Lilly’s policy is broader because it may require data from in-house pharmacies, hospital systems, infusion centers and other sites where Lilly products are dispensed or administered. It may also reach medical claims.
That scope creates a different operational problem. A medical claim may involve an electronic health record, hospital billing platform, administration record, split-billing system and wholesaler account. Those systems do not always use the same identifiers or timing rules. A medical claim may identify a drug through a billing code, while the purchasing system uses a National Drug Code. Units billed may not match package sizes, and corrected claims, reversals, wastage and inpatient-versus-outpatient status can further complicate the analysis.
Producing a file is therefore not the same thing as producing an accurate file. Covered entities should understand both the request and the limitations of the systems from which the data will be drawn.
The Legal Issue Remains Unsettled
Section 340B requires participating manufacturers to offer covered outpatient drugs to covered entities at or below the ceiling price. The statute also addresses diversion, duplicate discounts, manufacturer audits and administrative dispute procedures, but it does not expressly establish a manufacturer-controlled claims-data system.
Covered entities argue that Lilly is adding a new prerequisite to the statutory price. Under that view, a manufacturer cannot turn its interest in program integrity into an independent power to suspend 340B pricing whenever a covered entity declines to participate in its preferred reporting process.
Lilly’s position is that the requirement is a reasonable condition designed to verify compliance with existing obligations. The issue may turn on the scope and burden of the request, the sensitivity of the information, and the consequences of an incomplete or inaccurate submission. Manufacturers have prevailed in federal appellate cases involving 340B contract pharmacy restrictions. Those decisions generally rejected the argument that the statute requires manufacturers to deliver discounted drugs through every contract pharmacy arrangement selected by a covered entity.
Those decisions matter, but they do not resolve Lilly’s current policy. The earlier cases focused primarily on contract pharmacy distribution, while Lilly’s policy may reach in-house pharmacies and provider-administered drugs. Limiting contract pharmacy arrangements is also different from suspending a covered entity’s access to 340B pricing because it did not submit broad claims data.
Privacy, Contracts and Data Accuracy
Lilly has characterized the requested data as de-identified. Covered entities should verify that conclusion based on the fields being submitted because removing a patient’s name does not necessarily make a data set de-identified under HIPAA.
HIPAA is not the only issue. A claims submission may implicate state privacy laws, payer and PBM contracts, contract pharmacy agreements, business associate agreements, vendor restrictions and information security requirements.
Covered entities should determine what information is being disclosed, who controls it, what permits the disclosure, what the recipient may do with it and whether it may later be used in an audit, pricing decision, rebate dispute or contract pharmacy restriction. Accuracy creates a risk. Claims files contain reversals, rebills, corrected payer information, retroactive Medicaid eligibility, partial fills and other transactions that can create false matches. Medical claims add complications involving billing units, discarded quantities, administration dates and National Drug Code conversions.
If those issues are not addressed, a submission intended to demonstrate compliance may instead create the appearance of a duplicate discount or diversion problem. Acceptance by a data platform establishes only that the file was accepted, not that it is correct.
What Covered Entities Should Do Now
1. Confirm the Current Requirements
Covered entities should collect the latest data specifications, deadlines, product scope, reporting periods, correction procedures and enforcement notices. They should confirm which accounts, locations and entity types are affected rather than relying on an older notice or vendor summary.
2. Map the Organization’s Exposure
The organization should identify Lilly products purchased, administered or dispensed through the 340B program. The review should separate in-house pharmacy, contract pharmacy, specialty pharmacy, infusion, clinic-administered and other medical benefit transactions, and identify the wholesaler accounts and service lines affected by a pricing change.
3. Identify and Validate the Data
Covered entities should determine where the requested information resides and who is responsible for extracting, validating, correcting and transmitting it. Sample files should be reconciled to source systems, with attention to reversals, Medicaid transactions, medical claims, wastage as well as differences among dispensing, administration, billing, purchasing and replenishment dates.
4. Review Disclosure Authority
The organization should evaluate privacy requirements, payer and PBM contracts, business associate agreements, contract pharmacy agreements and vendor restrictions. It also should consider whether requested fields can be narrowed or masked and whether limits should apply to retention, redistribution and secondary use.
5. Prepare for a Pricing Interruption
Covered entities should establish a process for monitoring wholesaler accounts and identifying changes in 340B pricing. The plan should address internal escalation, continuity of care, additional acquisition costs, restoration of pricing and whether higher-priced purchases can be corrected.
6. Preserve the Record
Manufacturer notices, wholesaler communications, data specifications, vendor correspondence, submission files, validation results, internal analyses and evidence of financial impact should be retained. The record should show what was requested, what the covered entity did, why it did it and what happened next.
The Bottom Line
Lilly’s claims-data policy has moved the 340B debate beyond contract pharmacy restrictions. The immediate issue is no longer simply whether a covered entity will submit data, but whether failure to do so will change the price available through the wholesaler. The law remains unsettled. Manufacturers have legitimate program-integrity concerns, but existing contract pharmacy decisions do not necessarily authorize every data condition or pricing suspension.
For covered entities, the sound response is neither automatic refusal nor blind compliance. It is a documented, fact-specific decision made before the wholesaler account changes.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
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