Top 10 Tips to Become 340B Audit-Ready

While Assent is readily available to help your organization prepare for its next audit, here are some action steps you can take in the meantime:

1 Evaluate your Policies and Procedures

It’s a good rule of thumb to not include anything in the document that is not actually being performed. There are general requirements by HRSA located on the sample data request on Apexus. These requirements apply to health centers and should be addressed.

2 Perform regular internal audits

HRSA expects covered entities to keep up with their 340B program compliance by performing internal self-audits. Covered entities should conduct monthly or quarterly self-audits of sample patient transactions in all areas where 340B drugs are used: outpatient areas, offsite clinics, in-house retail pharmacies and contract pharmacies.

3 Update your information on OPAIS

One requirement is that the covered entity’s information on OPAIS is accurate and up to date. Conduct a thorough review of your HRSA database records prior to your annual recertification as a 340B participant annually (at the very least).

4 Check Medicaid Exclusion File accuracy

OPAIS commonly finds that the Medicaid Exclusion File (MEF) is not accurate. Carve-in covered entities should be sure that Medicaid Provider Numbers (MPNs) and NPIs listed on OPAIS are the numbers used to bill at each site.

5 Conduct an external, independent audit

Though it’s not mandated by legislation, HRSA recommends that covered entities assemble an independent audit of their entire 340B program – preferably similar to a HRSA audit.

6 Develop a cross-functional 340B committee

It’s important for colleagues to work together to develop and drive 340B Program compliance. Ideally, your committee should include a multi-disciplinary team from various departments including pharmacy, materials management, IT, credentialing, finance/billing, compliance, legal and medical records.

7 Review contract pharmacy service agreements

Covered entities should ensure they have an agreement in place with all participating pharmacies registered on OPAIS, verify the name and address on the agreement match OPAIS records, and confirm they possess copies of all fully executed agreements.

8 Ensure you have your 340B eligibility documentation available

No one likes scrambling to find important documents at the last minute. Prepare your eligibility documentation ahead of time for peace of mind.

9 Know your 340B wholesalers and be able to locate your invoices and purchases

Staying organized throughout the year by keeping record of your invoices and purchases will come in handy when audit season rolls around. Try keeping a list of your wholesalers, along with records and invoices, in an easily accessible location.

10 Pay attention to clinic administered drugs (if applicable)

If you are billing Medicaid on an encounter basis and using 340B medications on a patient that you will bill Medicaid for, it is suggested that the covered entity carve-in.


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