HRSA Audit-Ready Resource Center
Preparing for HRSA 340B audits
The tools in our HRSA Resource Center will help you effectively prepare for a HRSA 340B audit. Contact our HRSA experts if you have any questions about 340B compliance or HRSA audits.
Why HRSA audits are necessary and inevitable
HRSA audits covered entities for compliance with the 340B Drug Pricing Program (340B Program) either by the manufacturer or the federal government. Entities that fail to comply with the audits risk being removed from the 340B Program or being held liable to manufacturers for refunds or discounts.
Any 340B-covered entity can be randomly selected for an audit at any time. Key indicators making a program more likely to undergo an audit include:
- A program’s overall complexity
- Number of third-party administrators
- Whether the program includes referral capture
- Recent changes and turnover to a program
Most 340B programs will fall under one of these categories, which is why proactively preparing for a HRSA audit should be a priority—and why it’s valuable for every 340B CE to have it on their radar.
Tips for a stress-free 340B HRSA audit
HRSA audits can be an inevitable part of life for many healthcare organizations, which is why proactively preparing for an audit will help keep you covered and compliant. Here are some tips you can follow to avoid unnecessary stress during HRSA audit prep.
Write all policies and procedures clearly for auditors but leave room to make small operational tweaks in the future. And don’t forget about your vendors. Ensure policies and procedures reflect the work they are doing on your behalf.
Conduct monthly practice audits. Routine self-audits help catch small non-compliance issues and proactively fix them. Additionally, a third-party partner can lead annual independent audits for you.
Organize all items your auditor will review; your documentation should always be easily accessible. For referral capture, consult notes are important for compliance.
Communicate with departments across your organization by notifying them of the impending audit. Inform them of the potential auditor and establish how you’ll communicate.
Partnering with 340B experts can bring enormous peace of mind. They can support you during a HRSA audit, streamline existing operations, and maximize the value of your 340B program.
Our team of 340B experts
We have a distinguished group of 340B and pharmacy experts who come with years of experience and revenue cycle heritage helping our providers navigate the complex 340B rules and regulations.
They are here to help you maximize your 340B program savings and keep you compliant and prepared for your next HRSA audit. From ensuring all claims meet compliance standards to reviewing all policies and procedures, the R1 team makes HRSA audit readiness as worry-free as possible for our 340B clients.
The R1 difference
$350M+
In savings across 400+ CEs
460K+
Verified claims since 2018
100%
HRSA audit pass rate for clients