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
AHASource packet
This story's primary source + 4 related tracked stories with theirs — one print-ready digest for your team or board packet.
Free — subscribes you to the weekly Intel Brief. Individual sources are always clickable above, no email needed.
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. Primary source: AHA. Retrieved July 28, 2026, from https://www.fqhctalent.com/intel/eli-lilly-novo-340b-claims-data-mandate-active-2026
More in Risk & Compliance
Jul 16
CMS and CDC reopen the CLIA regulations with a request for information — comments close September 14
Jul 10
Eli Lilly's 340B Termination Turns Into Litigation and Congressional Pushback — Tampa General Sues in Federal Court, 72 House Members Demand HHS Act
Jul 9
OIG declines to sanction an FQHC's produce-box and voucher program — a favorable outcome, but one that legally protects only the health center that asked
Jul 8
$3.3M California Billing-Fraud Settlement Turns on Rendering-Provider NPIs and Uncredentialed NPs/PAs — an Adjacent-Sector Warning FQHCs Should Read Closely