The word “audit” may invoke many emotions and sentiments of anxiety, assurance, stress, disapproval, shame, elation, nervousness, guilt and more. Not knowing when an audit will occur may invoke the negative responses on a continual basis.
Before I share information regarding the concept of an audit, I felt it would be helpful to provide a definition so that we are moving forward with a basic and common understanding. You will recognize throughout my blog posts that I will often cite sources of truth to not only promote credibility, but also provide a measure of confidence and point of reference for the readers.
Per Wikipedia, historically, the word ‘auditing’ has been derived from Latin word “audire” which means “to hear”. Traditional auditing can be understood as an examination of accounting records undertaken with a view to establishing whether they completely reflect the transactions correctly for the related purpose. Also, the auditor may express an opinion of whether the records portray a true and fair picture. The term most commonly refers to audits in accounting, internal auditing, and government auditing.
When we hear the words, “340B Audit”, the emotional response as mentioned above, is often the same. Also, the unknown, can be very daunting and many emotions that may have been harbored, continue to swell and can cause physical disturbance, inner turmoil or external disorder. For some, the emotions may stem from being ill-prepared, they may feel solely responsible for the status of their program, they could feel angst based on the future results of an audit, and they may even have a belief that a loss may occur in the event that adverse findings surface,
If you or those who play a role in your 340B program have these feelings, it may be helpful to know that others feel these same emotions as well. Those who have been successful in minimizing the negative feelings are typically those who have taken a proactive approach to move their 340B program towards being compliant with the rules and guidelines of the program. My goal in the future blog posts will be to illustrate tools and techniques that can be employed to support you as you build an “Audit Ready” 340B Audit and Compliance program.
As you move forward, I will look to support your needs by providing tools and techniques that have been proven and successful and can be useful to lessen the negative emotional response, when and if you receive an audit notice by (HRSA) or a manufacturer (I used to just say “if”). Over time, I have gained a vast amount of knowledge related to 340B Compliance and Auditing and my objective is to share this with you. Most recently, I supported a customer who received an audit notice from Health Resources and Service Administration (HRSA). This particular audit was of great value and provided many takeaways and experiences that can be useful to those who are in the elementary or late phases of building a 340B audit program. Another thing to keep in mind is that while only HRSA is privy to their audit planning, we have heard from multiple sources that the chance of being audited is much greater than in prior years and the number of audits that will be conducted has grown exponentially.