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.


Resources to help you prepare for HRSA audits

With the passage of the 340B Drug Pricing Program by the HRSA, covered entities (CEs) must maintain clear, accurate records documenting compliance with all program requirements. Here we outline the ins and outs of HRSA audits and how to ensure you are prepared.

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.

Are you ready? Take our HRSA Audit Readiness Quiz.

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.

Resources to help you prepare

HRSA Audit Checklist: 5 Tips for a Stress-Free Audit

Follow this five-part checklist, prepared by our team of 340B compliance experts, to avoid unnecessary stress and make HRSA audit prep a breeze.


Infographic: Six-Point Compliance Approach to Capturing 340B Referrals

Pharmacy professionals at Covered Entities rank 340B Program compliance as their primary concern.


Blog Post: 340B Policies and Procedures; the Keys to Compliant Savings

HRSA audits of 340B covered entities are a fact of life. Learn why 340B policies and procedures are the keys to proving compliance.


More ways R1 supports 340B compliance

Discover more great resources detailing how to optimize a 340B program in a compliance-first approach.

Pharmacy Drugstore: Beautiful Asian Pharmacist Uses Checkout Cou

The Patient Definition, Eligibility & Required Documentation

This white paper provides an overview of the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) 340B Drug Discount Pricing Program with a particular focus on aspects of legislation and regulation that impact patient definition and referral prescriptions.

African American male pharmacist using digital tablet during inventory in pharmacy.|

Meet 340B Compliance Standards with R1 Referral Capture

Maximize benefits and empower your covered entity and patients with much-needed funding through R1’s 40B referral capture. Our collective goal is to ensure that all claims qualified by our technology and review teams are fully compliant with 340B regulations, directing essential funding to the rightful 340B covered entity and its patients. Read our comprehensive guide today.

340B Referral Capture|

340B Developments Resource Center

R1 340B experts are here to help you stay well-informed of the critical developments that impact your organizations and 340B programs. Our 340B Developments Resource Center gives you a summary of all manufacturer exclusions to date.


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.

Connect with our 340B experts.