The Office of Pharmacy Affairs (OPA) has issued potentially significant changes to the audit process for 340B covered entities, which includes Medicare/Medicaid disproportionate share hospitals, children’s hospitals, and other providers that fill a safety net role. Specifically, one of the changes covers the opportunities for correcting or otherwise addressing any findings on which the covered entities and auditors disagree.

Previously, after the onsite audit, OPA would issue a preliminary report and provide an opportunity for the covered entity to dispute findings and provide additional documentation prior to OPA’s issuance of its final report. Going forward, OPA will no longer issue preliminary reports. Instead, OPA will notify covered entities of the audit findings for the first time in the final report.  As described on OPA’s website, covered entities will still have an opportunity to disagree with the findings in the final report and submit additional supporting documentation, and OPA may make changes and reissue the final report.

OPA also states that an audit is not closed out until a covered entity attests that all repayment is resolved (when applicable) and that any corrective action plan has been fully implemented. In addition, covered entities whose findings involve repayment will be subject to an audit the following year.

Please see the audit update and related guidance for additional information.