Eli Lilly + Novo Nordisk 340B Claims-Data Mandates Now Live, FQHCs Must Submit Within 45 Days or Risk Losing 340B Access
Issue
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 points
- 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
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Part of
- 340B drug pricing
Manufacturer restrictions and data demands
FQHC 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. Source: AHA. Retrieved October 6, 2026, from https://www.fqhctalent.com/intel/eli-lilly-novo-340b-claims-data-mandate-active-2026
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