Last year, and then again at the 340B Winter Coalition, HRSA announced that they planned on performing at least 200 340B audits by the end of 2015. According to the latest data, they had completed 33 as of January 13th. And according to Commander Pedley’s 340B Winter Coalition address (see highlights HERE), program integrity is OPA’s highest priority. So, if you haven’t received your 340B audit notification letter yet, be on the lookout.
How do you know if you might be selected for a 340B audit? Well we’ve put together a checklist of risk factors that might make you a candidate if you can answer yes to any of the following questions:
Have you been in the program for a long time?
Do you have around 50 or more contract pharmacies?
Do you have a long list of child sites (A-Z)?
Do you have a complex facility with multiple entities?
Do you belong to hospital system that is currently being audited?
Do you have a high 340B drug spend?
Have you signed on quite a few contract pharmacies at once?
Have you terminated quite a few contract pharmacies at once?
Have you changed or updated a lot of information at once on the OPA website that wasn’t done during annual recertification?
Have you reported yourself to HRSA through self-disclosure?
Has someone else reported you to HRSA?
Again, if you can answer yes to any of the questions above, chances are you may get that audit letter because you are a target. The more complex your facility is and the more you take on, the harder things are to control and this of course, makes you vulnerable for an audit. Commander Pedley also stated that random audits would be selected using a “risk stratification methodology” and those covered entities with higher risk factors like those we have listed above will have a higher chance of an audit.
You also become a target by putting yourself in the limelight. Anything that draws attention to your facility might put you at risk. Sometimes you won’t have a choice. If your state changes its Medicaid status from carve-out to carve-in, or carve-in to carve-out, this might drive some concern in the Medicaid duplicate discount area and cause HRSA to target some covered entities in your state.
Now that you are aware of some of the risk factors, stay tuned for future blogs that will contain things that you can do to be 340B audit ready and prepare your covered entity for audit. In addition, feel free to contact us if you would like to discuss factors specific to your organization and program. Please also feel free to comment if you have experienced additional risk factors or have been targeted in an audit situation so we can provide additional guidance.
READ MORE ON THE 340B DRUG PRICING PROGRAM AND SCA's 340B AUDIT AND COMPLIANCE SERVICES. ARE YOU 340B AUDIT READY?
