Manufacturers are no longer treating claim-level data as solely a contract pharmacy issue. It is becoming a system-wide expectation. The most immediate example is Eli Lilly and its updated 340B Distribution Program policy, which requires claim-level data for all in-house pharmacy dispenses beginning February 1, 2026, with submission through the 340B ESP platform. Several other manufacturers have already conditioned access to 340B pricing or contract pharmacy participation on the timely submission of claim data through designated platforms.
These developments make claim integrity and clear submission workflows critical for covered entities and their pharmacy partners. Covered entities and contract pharmacies should understand the current manufacturer-driven data requirements and take practical steps now to protect compliant access to 340B drugs.
The New Data Landscape for 340B Drugs
Manufacturer policies now expect covered entities to furnish timely, accurate, and standardized claim-level data regardless of where a dispense occurs. Eli Lilly’s notice requires claims data for all 340B dispenses at in-house pharmacies and for medical claims, not only for contract pharmacy activity. The policy covers Lilly’s full portfolio under specific labeler codes 00002, 00077, and 66733. For most products, covered entities must submit data to 340B ESP within 45 days of the dispense date. For certain products administered in clinical settings (including Alimta, Amyvid, Cyramza, Erbitux, Kisunla, Omvoh, Portrazza, and Tauvid), the submission window is 60 days from administration. Lilly states that the 340B ESP platform is the only channel for compliance, and that failure to submit complete and timely data can result in loss of access to 340B pricing until the deficiency is resolved.
Other manufacturers have taken similar steps. Exelixis requires claims data for all 340B dispenses, including in-house pharmacy activity, with limited exceptions for federal grantees, and it relies on 340B ESP for submissions. Alkermes and Puma have shifted contract pharmacy designations and claims data collection to Kalderos’s Truzo platform, with firm timelines for submissions tied to designated contract pharmacy dispenses. Although platform details and product scope differ, the common thread is straightforward. Access to discount pricing is increasingly conditioned on the ability to produce verified claim-level data on schedule and through a specified portal.
Importantly, Lilly’s policy also includes defined carve-outs ostensibly based on state-level legislation. Covered entities located in Colorado, Maine, Nebraska, North Dakota, Oregon, Rhode Island, South Dakota, Tennessee, Vermont, or West Virginia are exempt from the claims data requirement at this time. Federally qualified health centers and look-alike entities in New Mexico are also exempt. Lilly reserves the right to change exemptions, so entities should memorialize any reliance on an exemption and check for policy updates.
The Legal Landscape
The legality of these manufacturer data demands is unsettled. Section 340B of the Public Health Service Act (42 U.S.C. § 256b) requires manufacturers to “offer each covered entity covered outpatient drugs for purchase at or below the applicable ceiling price if such drug is made available to any other purchaser at any price,” but it does not expressly authorize manufacturers to condition that obligation on claim-level data submission. HRSA has historically maintained that manufacturers bear an unconditional obligation to offer ceiling prices to registered covered entities, and in May 2021, sent violation letters to six manufacturers, including Eli Lilly, declaring that their restrictions on contract pharmacy access violated the statute. Of note, no court has yet addressed whether a manufacturer may suspend 340B pricing specifically for failure to submit claims data through a manufacturer-designated platform.
Covered entities that lose 340B pricing as a result of these policies should look first to HRSA’s 340B Administrative Dispute Resolution (ADR) process. ADR decisions are binding, and manufacturers that knowingly overcharge may face civil monetary penalties of up to $5,000 per instance under 42 C.F.R. § 10.11. Because the U.S. Supreme Court has held that there is no private right of action under the 340B statute, the ADR process is the principal federal mechanism for covered entities to enforce their pricing rights. Claims must be filed within three years and require documentation of good faith efforts to resolve the dispute beforehand. Covered entities and associations may also file joint claims, which can reduce the burden on individual entities.
Many states have enacted laws prohibiting manufacturers from restricting 340B access through contract pharmacy arrangements, and the Eighth Circuit upheld the constitutionality of Arkansas’s 340B nondiscrimination statute in PhRMA v. McClain, No. 22-3675 (8th Cir. 2024), finding the law “assists in fulfilling the purpose of 340B” rather than creating an obstacle to federal compliance. The Supreme Court declined to review that decision in December 2024. Lilly’s own exemptions for entities in ten states reflect the practical force of these laws.
What This Means for Covered Entities
For covered entities, the first question is readiness. Pharmacy, revenue cycle, and compliance teams should be able to connect each dispense to a qualifying encounter, a prescriber, and a clearly identified payor, then furnish those data elements in the format and cadence the manufacturer requires. Medicaid duplicate discount risk is front and center. Entities need accurate carve-in and carve-out indicators, consistent use of National Council for Prescription Drug Programs fields, and reliable mapping across fee-for-service Medicaid, managed Medicaid, and commercial programs that may feed state rebate processes. The goal is to be able to show, for any sampled claim, why it qualifies and how it was excluded from rebates when appropriate.
Covered entities should limit disclosures to the minimum necessary fields, transmit only over secure channels, and bind any business associates or split-billing vendors to written controls that address access rights, retention, and secondary use. As a practical compliance standard, an entity should be able to document who requested the data, precisely what was transmitted, when the transmission occurred, and the legal or contractual authority supporting it. Absent that audit trail, the entity’s position will be materially weakened in any audit or administrative review.
What This Means for Contract Pharmacies
Contract pharmacies frequently generate the core data elements necessary to complete manufacturer submissions and to reconcile a covered entity’s 340B accumulators. Even when a manufacturer directs its policy to the covered entity, pharmacies should anticipate being asked to compile or validate claim-level data. Operationally, pharmacies should confirm that required data fields are captured accurately at the point of sale, that outbound file layouts conform to the platform’s technical specifications, and that transmissions can occur through secure, auditable channels without reliance on manual workarounds.
A clear understanding between the pharmacy and the covered entity about who is responsible for what will prevent operational headaches and reduce audit risk. Pharmacies should prepare in advance for who is responsible to compile and transmit the data, how eligibility disputes will be handled, and how quickly rejected or incomplete submissions will be corrected. If a manufacturer limits contract pharmacy participation or moves to a single pharmacy designation, as seen in recent policy updates from Pfizer that appear to direct covered entities to one contract pharmacy, pharmacies should notify the covered entity and legal counsel as soon as any notice is received. Early coordination helps protect patient access, maintain compliant dispensing arrangements, and prepare for any new reporting or data requirements tied to the change.
How New Policies Work in Practice
These updated manufacturer 340B distribution program policies are now a concrete requirement rather than a suggested best practice. The notices state that failure to submit complete and accurate data will result in a pause in access to 340B pricing until the missing data are received. Operationally, when a submission touches Medicaid claims, the file should align with the entity’s carve-in or carve-out status and with state exclusion file practices. A short, plain-language guide for internal staff can reduce errors. It should explain which claims are in scope for each manufacturer, if applicable, where the data live in the pharmacy system, what to do if a key field is missing, and who to contact for exceptions.
If a covered entity encounters an improper denial of access to 340B pricing despite timely and complete submissions, the covered entity should escalate with a well-documented record and ask the manufacturer to review its decision. If that fails, with the help of counsel, HRSA offers a 340B Administrative Dispute Resolution process for manufacturer-related disputes.
How Frier Levitt Can Help
Our team advises hospitals, health systems, federally qualified health centers, and specialty and retail pharmacies on the full spectrum of 340B issues, including responding to manufacturer data requests, structuring compliant in-house and contract pharmacy operations, and litigating or negotiating access restoration where restrictions threaten patient care. We help clients map claim-level data to eligibility, payors, and accumulators, design privacy-preserving disclosure protocols, and document governance decisions that withstand audit and dispute.
If you have received updated communications from a drug manufacturer that appear to limit contract pharmacy options to a single pharmacy or limit your access to 340B drugs, we are ready to assist.
