Audits are one more opportunity to demonstrate the program is working well
We can only assume that audits were the focus of so much discussion at this year’s 340B Coalition Winter Conference because the changes that come with the installation of new government officials will inevitably lead to a fresh look at the 340B program. Audits serve as an opportunity to demonstrate full program compliance and transparency, as well as to disarm arguments of program opponents.
The good news overall? Adverse audit findings are trending downward because covered entities are becoming more knowledgeable about the 340B program and its operational requirements. A couple of interesting statistics were shared in a presentation by Matt Atkins, Manager at Draffin & Tucker, LLP, a corporate accounting firm that specializes in healthcare. Atkins noted that in 2015, 66% of errors were due to a lack of correct OPA registration, and 25% of errors were due to covered entities using “duplicate discounts,” or using 340B drugs to fill Medicaid claims.
In reviewing adverse audit findings, Atkins had three very specific recommendations for covered entities to help ensure full program compliance:
- All contract pharmacies and covered entities should review the language in their contracts to ensure that all requirements under HRSA guidelines are being met; and
- Covered entities must ensure their OPA registration is correct and up to date.
- Regardless of mandated audits, covered entities should be conducting annual independent audits (self-audits) to ensure proper oversight of contract pharmacies.
Another suggestion from conference speakers: take advantage of easily available educational tools such as the 340B Coalition Winter and Summer Conferences, and Apexus’ 340B University and 340B On Demand.
For its part, HRSA announced its goal is to have 200-300 audits (mostly hospitals) and four manufacturer audits in 2017. With this level of scrutiny, covered entities will be increasingly well-positioned to demonstrate that participants in the 340B program are compliant to program rules while delivering on the program’s mission: to stretch scarce Federal resources as far as possible to reach more eligible patients and provide more comprehensive services.
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