As the Health Resources and Services Administration (HRSA) carries on to improve their function in the 340B drug pricing program administration, they have crafted three modifications which will affect covered entities. While the overall process continues to be mostly unchanged, recently-announced improvements to post-audit procedures will most likely effect how covered entities learn about and react to audit findings.
In a July 2014 update, HRSA stated that it will not release preliminary reports to CEs after an audit. Rather, covered entities will learn of audit results the moment HRSA provides its final 340B audit Report. Furthermore, covered entities are currently required to present HRSA a letter detailing results related to diversion and/or duplicate rebates. This notice will be uploaded on the HRSA website, alongside the audit results, and is aimed to alert any affected manufacturers and wholesalers of possible payment that they may be due. Examples of letters are currently posted along with FY12 340B audit findings on the HRSA web site.
Lastly, all CEs whose results include repayment will promptly undergo a follow-up audit the next year.
As HRSA proceeds to enhance the audit process, they will likely post additional updates here.