HRSA FY2025 340B Audit Results — 49% Adverse Findings, 75% OPAIS Errors, 50% Required to Repay Manufacturers
HRSA released full FY2025 340B program integrity audit results: 115 covered entities audited, 49% received adverse findings (improving from 64% in FY24 — still nearly 1 in 2). 75% of adverse-finding audits involved incorrect OPAIS records (master-data governance gap); 50% of adverse-finding entities required to repay manufacturers; 21% had site terminations.
The 68% re-audit failure rate signals that remediation is sticking poorly. ~90% of FY2025 audits are now risk-targeted (vs. random), elevating exposure for entities with tips, OPAIS anomalies, contract-pharmacy complexity, or prior findings.
Strategic implication: CA FQHCs running 340B contract pharmacy programs (often 30-50% of total revenue) face material exposure when OPAIS hygiene lapses.
The 'risk-targeted' shift means CFOs can no longer treat HRSA audits as random — prior findings, tips (incl. disgruntled-employee complaints common in the current layoff climate), and contract pharmacy complexity are the trigger profile. 50% repayment rate × typical CA FQHC 340B program ($5-20M/yr) = 7-figure exposure for poorly governed programs.
Pairs with already-tracked Lilly/Novo claims-data mandates and 4th Circuit contract pharmacy ruling.
Key takeaways
- 49% adverse findings (down from 64% FY24, still nearly 1 in 2 audited)
- 75% of adverse findings = incorrect OPAIS records (master-data governance gap)
- 50% required to repay manufacturers; 21% had site terminations; 68% re-audit failure rate
- ~90% of audits now risk-targeted — tips + prior findings + contract pharmacy complexity = trigger profile
Linked evidence
HRSA Office of Pharmacy AffairsSource packet
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FQHC Talent. (2026, May 15). HRSA FY2025 340B Audit Results — 49% Adverse Findings, 75% OPAIS Errors, 50% Required to Repay Manufacturers. Linked evidence: HRSA Office of Pharmacy Affairs. Retrieved September 11, 2026, from https://www.fqhctalent.com/intel/hrsa-fy25-340b-audit-results-49-percent-adverse-may-2026
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