Drug Manufacturers Impose New 340B Data-Reporting Requirements, Prompting Objections

Hospitals and community health centers participating in the 340B Drug Pricing Program (also known as covered entities) are objecting to new data‑reporting requirements imposed by several drug manufacturers. On March 6, Novo Nordisk issued a notice that, effective April 1, covered entities must submit comprehensive claims-level data in order to continue receiving 340B discounts. Eli Lilly issued a similar notice in January 2026. Although these drug manufacturers claim their objective is to ensure appropriate discounts go to the correct providers and are not duplicated, covered entities contend that that the requirements are unlawful and will limit access to lower-priced drugs. In response to Eli Lilly’s actions, the American Hospital Association (AHA) sent a letter to the Health Resources Services Administration (HRSA), which oversees this 340B program, urging HRSA to take action to halt the new reporting mandates, which they consider to be onerous administrative burdens.