Eli Lilly + Novo Nordisk 340B Claims-Data Mandates Now Live — FQHCs Must Submit Within 45 Days or Risk Losing 340B Access
Eli Lilly (effective February 1) and Novo Nordisk (effective April 1) both implemented policies requiring all 340B covered entities, including FQHCs, to submit claims-level data for every drug dispense within 45 days or risk losing 340B access. The AHA has urged HRSA to use civil monetary penalties to halt both policies, but HRSA has not acted. FQHCs with high GLP-1/diabetes (Mounjaro, Trulicity, Ozempic, Fiasp) and insulin utilization face the greatest immediate risk. This is a separate compliance burden from the rebate model pilot fight.
Key takeaways
- FQHCs using Novo Nordisk or Eli Lilly drugs under 340B must submit claims data within 45 days of each dispense — pharmacy directors must implement tracking now
- Non-compliance risks losing 340B access to high-utilization GLP-1s and insulin products — financial impact could be significant for FQHCs with large diabetic panels
Primary source
AHAFQHC Talent. (2026, April 1). Eli Lilly + Novo Nordisk 340B Claims-Data Mandates Now Live — FQHCs Must Submit Within 45 Days or Risk Losing 340B Access. Primary source: AHA. Retrieved April 28, 2026, from https://www.fqhctalent.com/intel/eli-lilly-novo-340b-claims-data-mandate-active-2026
More in Risk & Compliance
Jul 5
Section 1557 Language Access Annual Notice Year 1 Anniversary — July 5, 2026 Compliance Window
May 11
URGENT: HHS Section 504 WCAG 2.1 AA Digital Accessibility Deadline Hits FQHCs May 11, 2026 — 3 Weeks Away
Apr 27
HRSA 340B Rebate Model ICR Burden Comment Window Closes April 27 — Second Window for FQHCs After April 20 Main Deadline
Apr 22
Section 504 / WCAG 2.1AA 'Red Alert' — Enforcement Interpretation May Be Contested in Final Weeks Before May 11