340B Mock Audit Best Practices for Covered Entities

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The federal government’s 340B Drug Pricing Program aims to help participating healthcare providers, also known as covered entities, stretch their federal dollars further by giving them access to discounted prescription medications. To ensure compliance, audits are part of the equation. Covered entities are encouraged to conduct mock audits in preparation for the real thing.

Mock audits are most productive when they are conducted according to industry best practices. A properly conducted mock audit will reveal deficiencies, some of which can be corrected prior to a real audit conducted by either government agencies or for pharmaceutical companies. Here are the most common best practices for 340B mock audits:

1. Create and Stick to a Schedule

Program requirements do not force covered entities to conduct mock audits. As a general rule, mock audits are conducted annually, in preparation for real audits. Industry best practices suggest multiple mock audits per year – usually conducted quarterly – based on an established schedule.

All of this is to say that covered entities are better off when they create and stick to a 340B mock audit schedule. Establishing and sticking to a schedule takes the ambiguity out of the process. Everyone knows when the next mock audit is coming. There is plenty of time to prepare.

This is a good thing in the sense that quarterly mock audits make audit preparation routine. Doing it four times annually goes a long way toward ensuring that a covered entity is fully prepared for the real thing.

2. Put Together an Audit Team

Mock audits need to be conducted by people who know what they are doing. Likewise for audit preparation. Whether a covered entity conducts mock audits in-house or hires a third-party consultant, an audit team should be created to handle preparation. The team should consist of ranking members from a variety of departments including billing, HR, and executive management.

At least one member of the team should have direct knowledge of OPAIS. Ideally, that individual would be the primary OPAIS contact. They have the required knowledge to bridge the gap between audits and reporting requirements.

3. Identify Documents for Review

Preparing for a mock audit requires identifying the documents that will be reviewed. Every document a covered entity creates will not be audited. But the most critical documents will be. So it is important that teams identify those documents, followed by examining each one in fine detail. The team should be looking for anything and everything that could raise a red flag.

4. Bring in a Third-Party Auditor

Finally, industry best practices dictate bringing in a third-party auditor to handle mock audits. In-house teams can and should prepare, but 340B compliance consultants like Ravin Consultants should be given the actual task of conducting the audit. Why? Because the point of 340B mock audits is to get ready for the real thing. A third-party auditor can look at things with an unbiased eye.

Bringing in a third-party also takes any and all emotion out of the audit. Third-party auditors have no attachment to the covered entities they work with. Not only that, but it is also in their best interests to ensure that mock audits are as unbiased as possible. That is the way to keep clients happy. That’s the way to ensure that clients actually pass their real audits.

340B mock audits are a valuable tool to help cover entities maintain compliance with the federal drug program. Though they are not mandated by law, a covered entity would be foolish to not take advantage of them. Failing to conduct mock audits means going into the real thing blind.