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.