HRSA 340B Audits

Preparing Covered Entities for 340B Program Requirements

With the passage of the 340B Drug Pricing Program by the Health Resources and Services Administration (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 (TPAs)
  • 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.


Get first-hand advice from your peers in our Guide to 340B HRSA Audits.

Are You Ready? Take Our HRSA Audit Readiness Quiz

Looking to take the extra step to prepare?
Take our HRSA Audit Readiness Quiz to see how prepared your organization is for an audit!

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.


Six-Point Compliance Approach to Capturing 340B Referrals

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


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.

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More Ways Cloudmed Supports 340B Compliance

Discover more great resources detailing how to optimize a 340B program in a compliance-first approach. Here you’ll find an in-depth take on the 340B Drug Discount Pricing Program, a CMS Memorandum for 2023, and more!

340B Program Compliance: The Patient Definition, Eligibility & Required Documentation


Meet 340B Compliance Standards With Cloudmed Referral Capture


340B Developments Resource Center


Our Team of 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 Cloudmed team makes HRSA audit readiness as worry-free as possible for our 340B clients.

Melissa Opraseuth, PharmD

SVP 340B Operations

Stephanie Caiazzo, MBA

VP, 340B Client Operations

Madison Moore, MPH, Sr. Manager 340B Operations

Madison Moore, MPH

Sr. Manager 340B Operations

Minh Hoang, PharmD

Director of 340B Hospital Operations

Berenys Polanco

Berenys Polanco, RCPhT

Sr. 340B Operations Lead

Yvonne Kohl

Yvonne Kohl, CPhT

Manager 340B Operations

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Connect with Our Experts

Our 340B experts are ready now to discuss any of your compliance needs or questions. Contact us now to find out more about 340B audit readiness and how the Cloudmed team can help!

The Cloudmed Difference

Cloudmed was the first in the industry to optimize 340B programs with our compliance-first technology built and backed by 340B experts.


in savings across 300+ CEs


verified claims since 2018


HRSA audit pass rate for clients

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