Since implementing the audit process in 2012, HRSA has audited over 1,058 Covered Entities. The number of audits conducted has increased each year, and audits are expected to increase in 2021 and beyond.  When HRSA selects your program, will you be prepared?

Who is being audited?

Disproportionate Share Hospitals, Critical Access Hospitals and Community Health Centers have accounted for over 83% of the audited Covered Entities. Of the Covered Entities selected, 81% had one or more child sites and 82% had one or more contract pharmacies. It is acknowledged that Covered Entities with multiple child sites and contract pharmacies are increasingly likely to be selected for an audit.

What are the chances that instances of noncompliance are uncovered with my program?

Nearly 71% of the audits conducted by HRSA have resulted in findings, with over 38% identifying two or more findings. Over half of the audits by HRSA have resulted in the Covered Entity incurring sanctions potentially requiring repayment to manufacturers with the corresponding corrective action.

What can I do?

A system of best practices for a Covered Entity should include a process of self-assessment and/or internal audit of your 340B processes and procedures. Another best practice should be to engage an expert in conducting an independent assessment of your program’s compliance. This allows you to identify weaknesses in your program and address them on your own terms.

How can we help?

Our 340B compliance audit program aligns with the audit process employed by HRSA. We will work with you to assess the processes and procedures in place for compliance, and assist in remediating process and control weaknesses. In addition, we will assess the effectiveness and efficiency of the operation of your program to ensure you are maximizing the program’s benefits.

* 340B report is reflective of activity through April 30, 2019