Eli Lilly & Novo Nordisk Impose Universal 340B Claims Data Requirements — FQHCs Must Submit Data or Lose Pricing

For the first time, Eli Lilly (effective Feb 1, 2026) and Novo Nordisk (effective Apr 1, 2026) require all 340B covered entities — including FQHCs — to submit claims-level data for every in-house pharmacy and medical dispense, not just contract pharmacies. Lilly explicitly threatens to 'cancel 340B pricing' for non-compliant entities. AHA has urged HRSA to intervene, calling compliance costs unprecedented. HRSA has not responded. FQHCs dispensing Lilly or Novo products must build new data submission workflows immediately.