AHA Urges HRSA to Block Eli Lilly’s Expanded 340B Claims-Data Policy; Lilly Hits Back | iPharmaCenter
- Badari Andukuri
- 2 days ago
- 4 min read
Updated: 1 day ago
The American Hospital Association (AHA) has called on the Health Resources and Services Administration (HRSA) to stop a new Eli Lilly and Company policy that would expand claims‑data reporting requirements for 340B hospitals, warning that the change is unlawful, unworkable, and threatens patient access to discounted medicines.
On January 15, 2026, Lilly notified 340B covered entities that, effective February 1, all entity types will be required to submit claims‑level data (CLD) for every dispense and administration of every Lilly product purchased at 340B prices, across both pharmacy and medical claims, via the 340B ESP platform. Entities that fail to submit timely, complete, and accurate data risk losing access to 340B ceiling prices until data are provided.
What Lilly’s New 340B Claims-Data Policy Would Do
Under the updated policy, Lilly is extending its existing claims‑data requirements beyond contract pharmacies to reach in‑house hospital pharmacies and drugs administered directly to patients. The policy applies to Lilly’s entire portfolio under specified labeler codes and captures both pharmacy dispenses and medical claims, with tight timelines for reporting.
Lilly positions this expansion as an extension of its “long‑standing collection of claims data” and part of a broader effort to ensure that reduced 340B prices support vulnerable patients rather than being “exploited” by hospitals and their partners. The manufacturer states that CLD will be used to monitor for and avoid duplicate discounts and to support requests for audits, arguing that such data collection has become standard business practice in the industry over the past several years.
AHA’s Core Objections: Cost, Feasibility, and Legality
In a January 26 letter to HRSA Administrator Thomas Engels, the AHA describes Lilly’s new policy as a “sweeping expansion” of claims‑data demands that will impose unprecedented operational, financial, and technology burdens on 340B hospitals. The association highlights several specific concerns:
The “old” requirements tied to contract pharmacies already take weeks or months of hospital and third‑party administrator (TPA) effort to set up data feeds, and Lilly is now asking several additional categories of data that will be even more costly to implement.
For in‑house pharmacies, dispensing data are often spread across multiple record‑keeping systems, so reconciling and aligning those systems for CLD submission would add significant complexity and expense.
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Hospitals do not currently provide medical claims data to 340B ESP or other vendors; meeting Lilly’s specifications would require direct interfaces with electronic medical record systems or manual data transfer, raising serious resource, security, and privacy concerns.
The mandated use of the 340B ESP platform is itself problematic, as hospitals report incorrect pricing loads, unexplained claim denials, and substantial staff time spent resolving errors and ensuring accurate 340B pricing.
The AHA concludes that, “at best,” Lilly’s requirements will be prohibitively costly, and “at worst” they will be unworkable, effectively preventing hospitals from obtaining 340B discounts guaranteed by statute.
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Legally, AHA argues that the policy violates the 340B “must offer” provision, which requires manufacturers to offer covered outpatient drugs to each covered entity at or below the ceiling price if the drug is available to any other purchaser.
The letter also challenges Lilly’s characterization of CLD submission as a “standard business practice,” arguing that any such “standard” emerged only after manufacturers began demanding data in 2021 in connection with contract pharmacy restrictions. AHA urges HRSA to reaffirm what constitutes “standard information” under longstanding 1994 guidance, emphasizing that prior agency writings explicitly barred demands for “drug acquisition” and “purchase” information—the type of claims data Lilly is now seeking.
Program Integrity, Duplicate Discounts, and HRSA’s Role
Lilly justifies its policy as necessary to identify and prevent duplicate discounts, asserting that claims data have allowed it to uncover “countless” instances of Medicaid duplicate discounts.
AHA portrays Lilly’s new policy as unilateral attempt to circumvent HRSA’s oversight, following earlier moves such as 2021 contract pharmacy restrictions and a 2024 unilateral rebate proposal.
According to AHA, if Lilly’s approach becomes a template for other manufacturers, hospitals will be forced to divert resources from 340B‑supported services toward heightened administrative compliance, and patients may lose access to critical medicines, particularly in oncology and chronic disease areas where Lilly products play a central role.
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Lilly’s Public Response to AHA’s Criticism
In a January 29 statement, Lilly sharply rejected AHA’s characterization of the policy, framing the association’s objections as an attempt to “conceal” abuse in the 340B program. The company maintains that:
The expanded CLD collection for all pharmacy purchases is aimed at ensuring that 340B discounts reach vulnerable patients and are not captured by hospitals and for‑profit partners.
CLD requirements are consistent with agency guidance and federal appellate rulings that permit manufacturers to collect such data to detect fraud, waste, and unlawful duplicate discounts.
The policy does not impose new burdens because it relies on data that covered entities already collect and submit to payers as part of routine operations.
What’s Next fro AHA vs Lilly?
AHA is urging HRSA to use all available enforcement tools, including civil monetary penalties, to prevent Lilly’s policy from taking effect on February 1, arguing that continued overcharging of 340B hospitals would warrant such action.
For 340B stakeholders, the dispute raises immediate operational questions about how to respond to Lilly’s February 1 deadline, how to assess the technical and privacy implications of expanded CLD sharing through 340B ESP, and how potential HRSA or judicial interventions might reshape manufacturer data‑submission conditions going forward.