AHA Urges HRSA to Block Eli Lilly’s Latest 340B Policy
- January 30, 2026
The American Hospital Association (AHA) is calling on the Health Resources and Services Administration (HRSA) to block a new 340B policy unveiled by Eli Lilly and Company (Lilly) that AHA said would “vastly increase the costs and burdens” on safety-net hospitals.
According to AHA, Lilly on January 15 issued a notice requiring 340B covered entities to submit claims-level data for all dispensations of its drugs, regardless of setting.
In a January 26 letter, AHA urged HRSA “to take immediate action to stop this policy from taking effect on February 1, including by assessing civil monetary penalties for intentionally overcharging 340B hospitals.”
The new policy is the latest in a string of efforts by drug companies to address concerns about 340B program abuses such as diversion and duplicate discounts. In July 2020, drug companies started limiting discounts under the 340B program to covered entities that use contract pharmacies to dispense prescriptions and attempting to impose additional claims-data submission requirements as well. Those changes sparked a slew of largely successful lawsuits that continue to play out in court.
More recently, a number of pharmaceutical manufacturers attempted to shift from providing upfront discounts to a rebate model for the 340B covered entities. That effort also was largely blocked in court, and a subsequent HRSA pilot to test a rebate model framework for 340B also seems to be headed back to the drawing board at this time.
AHA said Lilly’s latest “sweeping expansion of claims data demands” would “now reach in-house hospital pharmacies and apply to drugs directly administered to patients,” including both pharmacy and medical claims.
“At best, Lilly’s new requirements will be prohibitively costly for 340B hospitals. At worst, they will be unworkable. Either way, they will prevent hospitals from obtaining the 340B discounts they are owed by statute,” AHA’s letter to HRSA warned.
"Lilly’s change is part of our commitment to ensuring that the reduced prices offered through the 340B program help vulnerable patients and are not exploited by hospitals and their for-profit partners. The collection of claims data is intended to stop the rampant fraud, waste, and abuse in the 340B program that is harming employers, state and federal governments, and patients," the company said in response to AHA's letter.
Lilly maintained, in its own to letter to HRSA, that the company's policy change "is consistent with decades of agency guidance" and court rulings. "The collection of this data imposes no new burdens on 340B entities because it relies on data that is readily available and that those entities routinely collect and submit to insurers," it said.