As the Health Resources and Services Administration (HRSA) continues to increase their role in the 340B Program oversight, they have made three modifications which will certainly affect covered entities. Even though the overall procedure continues to be mostly unchanged, recently-announced improvements to post-audit procedures will impact how covered entities learn about and reply to audit results.

In a July 2014 update, HRSA announced that it will not issue preliminary reports to CEs after an audit. Instead, covered entities will learn of audit findings when HRSA provides its Final Report.

Furthermore, are presently obligated to present HRSA a letter describing findings related to diversion and/or duplicate rebates. This letter will be posted on the HRSA web site, in conjunction with the audit findings, and is intended to notify any affected suppliers and wholesalers of potential payment they might be due. Instances of letters are currently published along with FY12 audit findings on the HRSA website.

Finally, all CEs whose results include payment will promptly be subject to a follow-up audit the next year. As HRSA continues to enhance the audit process, they will likely publish additional updates here.

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