Do you need help preparing for your audit? HRSA Bizzell 340B Audits are the number one concern for Covered Entities participating in the program.  Without going through a formal audit previously, it can be hard to expect what auditors are going to look for and what the process may look like.  Prairie Health Ventures (PHV) manages and assists many rural clients through successful HRSA audits, below are some helpful Tips and Tricks to help your entity prepare for your eventual Bizzell Audit:

Contact your 340B Universe:

Reach out to every organization that plays a role in your 340B program and let them know about your audit.  This should be your Third Party Administrator (TPA), Contract Pharmacies, Independent Auditors/Consultants, Wholesalers, etc.  Regardless of which TPA you choose, they should help you in your data collection process.  Your Contract Pharmacies will play a role on the day of the audit as they will need to send hard copy scripts from your audit sample.

Find your EMR Super User:

During the audit, you will need to look up medical records for about 28 hospital charges and 30 contract pharmacy prescriptions.  Finding the person in your organization that knows your EMR inside and out will help speed up your audit as they will be able to find where some documentation or referral may be hidden.  Make sure this user has access to all departments that may have an auditable patient record.

Establish a Strong Foundation:

This is the most important step towards receiving a successful audit result.   Make sure your Policy & Procedures (P&P) are kept up-to-date with current rules and regulations.  Be sure to follow your self-audit and education P&P as neglecting them will lead to a finding.  Routinely, add and update your Policies with new additions or changes to your program.  This may include new contract pharmacy agreements, 340B team members and roles, referral captures, etc.

Create a 340B team within your entity and meet routinely to review your program and self-audit results.  This team should include your Authorizing Official and Primary contact listed on the Office of Pharmacy Affairs Information System (OPAIS), IT department, and staff members responsible for self-audits.  Your 340B team should receive routine 340B education to keep up-to-date on changing rules and regulations.

Develop open lines of communications with your Contract Pharmacies and TPA.  Your contract pharmacies play a key role in your program and community.  By developing a good relationship with your contracted pharmacies, they can help you build a solid 340B program that is compliant and can better serve your communities.  Don’t be afraid to reach out to your TPA for questions about your 340B program or education of their system.  They are there to help you understand your data and build a stronger 340B program.

Relax & Take a Breath:

Receiving a Bizzell Audit Notice can be stressful and send your team into a whirlwind of panic.  As with any stressful venture, just relax and take each part of the audit one step at a time.  Your 340B team and the strong foundation your organization has built will help you get through your audit.

PHV has over seven years of experience assisting rural hospitals get the most out of their 340B program while remaining compliant.  We can work with any TPA, so there is no obligation to switch. If you are having challenges building your 340B foundation or are looking to expand and optimize your 340B program, please reach out to our 340B Coordinator, Andrew Cross, at or 402-742-2211.

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