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340B Audit Services | Mock HRSA & Compliance Audits

340B Audit Services: Compliance, Readiness, and Confidence

Strengthen Your 340B Program with Proven Audit Expertise

In the world of 340B program compliance, preparation is everything. Every covered entity—whether a hospital, health center, pharmacy, or government program—must ensure that its 340B operations meet HRSA’s rigorous standards. Yet, too many organizations only think about audits once the notice arrives.

At Cooper Strategy, we take a different approach. Our 340B Audit Services help covered entities anticipate, prepare, and excel in HRSA audits before they occur. Through comprehensive mock HRSA audits, program assessments, and continuous compliance monitoring, Cooper equips you with the confidence to face any 340B audit—knowing your documentation, policies, and data will stand up to scrutiny.

Contact our 340B audit consultants today to ensure your organization is audit-ready and compliant year-round.

What Is a 340B Audit?

The 340B Drug Pricing Program, administered by the Health Resources and Services Administration (HRSA), allows eligible healthcare organizations to purchase outpatient drugs at significantly reduced prices. These savings enable entities to expand services, improve patient care, and strengthen financial sustainability.

However, to maintain 340B eligibility, covered entities must demonstrate strict program compliance. HRSA conducts 340B audits to ensure adherence to patient eligibility, diversion prevention, and duplicate discount rules.

There are three main types of audits that covered entities may face:

  1. HRSA 340B Audits – Conducted by HRSA contractors to evaluate compliance with federal program requirements.

  2. Manufacturer Audits – Initiated by drug manufacturers when there’s concern about ineligible discounts or diversion.

  3. Internal or Mock Audits – Proactive reviews, often conducted by expert partners like Cooper Strategy, to identify and correct compliance issues before an official audit occurs.

A mock HRSA audit is one of the most powerful ways to prepare for the real thing. Cooper Strategy’s auditors replicate HRSA’s methodology—testing records, sampling transactions, and verifying eligibility—to reveal gaps before they become findings.

Why 340B Audit Readiness Matters

The stakes in a 340B audit are high. A single compliance finding can lead to repayments to manufacturers, program restrictions, or even disqualification from the 340B program. For safety-net providers and community health centers, those penalties can devastate operations.

Beyond the financial risks, audit readiness demonstrates your commitment to integrity and transparency. When your program is well-documented and compliant, you build trust with HRSA, manufacturers, and patients alike.

At Cooper Strategy, we’ve helped covered entities not only pass HRSA audits with zero findings but also optimize their 340B performance through smarter policies and proactive oversight. Our audits don’t just detect problems—they drive long-term improvement.

Common 340B Audit and Compliance Challenges

Even well-managed 340B programs face complexities that can lead to audit vulnerabilities:

  • Incomplete Documentation – Missing or inconsistent records linking patient encounters, prescriptions, and eligibility.

  • Inaccurate Patient Definition Application – Uncertainty around HRSA’s “patient” definition, especially for referred care or contract pharmacy claims.

  • Duplicate Discounts – Overlaps between Medicaid and 340B claims.

  • Diversion Risks – Dispensing 340B drugs to ineligible patients or prescriptions.

  • Contract Pharmacy Oversight – Lack of documentation or verification processes across multiple pharmacies.

  • Referral Capture Gaps – Failure to properly document care continuity on referred prescriptions, reducing 340B savings (see 340B Referral Capture).

Our consultants are deeply familiar with each of these pain points. By leveraging proprietary auditing tools and a detailed understanding of HRSA’s audit playbook, Cooper Strategy ensures that no vulnerability goes unnoticed.

Cooper Strategy’s 340B Audit Services

Mock HRSA Audits – Real-World Preparation for Covered Entities

Cooper Strategy’s mock HRSA audits replicate the full structure and rigor of HRSA’s official reviews. Our auditors evaluate the same data HRSA would—patient records, prescriptions, Medicaid carve-in/out documentation, and contract pharmacy activity—to determine your compliance posture.

Each audit engagement includes:

  • Pre-Audit Discovery: Review of policies, system setups, TPAs, and pharmacy networks.

  • Transaction Sampling: Random and targeted testing of 340B and non-340B claims to ensure correct patient eligibility.

  • Data Validation: Confirming accuracy between your EHR, pharmacy dispensing data, and third-party administrator records.

  • Compliance Documentation Review: Assessing policies, procedures, and staff training records.

  • Detailed Reporting: A comprehensive audit report highlighting findings, risk levels, and corrective recommendations.

  • Corrective Action Support: Step-by-step remediation plans with training, documentation templates, and follow-up validation.

Our audit team doesn’t just point out issues—they guide you through resolving them so your program is fully compliant before HRSA ever knocks on your door.

Ongoing 340B Compliance Audits and Monitoring

Beyond mock HRSA audits, Cooper Strategy offers continuous compliance auditing to help organizations maintain readiness throughout the year. This proactive service includes:

  • Quarterly mini-audits across locations and contract pharmacies.

  • Automated reporting dashboards highlighting real-time compliance metrics.

  • Quarterly policy reviews to ensure documentation reflects current HRSA guidance.

  • Staff re-training programs aligned with audit findings.

With this ongoing oversight, Cooper Strategy helps clients move from “audit panic” to “audit confidence.”

Customized Audit Services for Every Client Type

Cooper Strategy provides specialized 340B audit support tailored to each segment of the healthcare ecosystem:

For Hospitals and Health Centers

Learn more about 340B for Hospitals & Health Centers →

Hospitals and health centers face complex multi-site operations, large patient volumes, and contract pharmacy networks. We design audit processes that ensure system-wide consistency, reduce duplicate discounts, and enhance HRSA audit defensibility.

For Pharmacies

Explore 340B for Pharmacies →

We help retail and contract pharmacies implement robust 340B compliance controls, perform regular dispensing data validation, and maintain clean audit trails for every transaction.

For Government and Public Health Agencies

See 340B for Government →

From state health departments to local clinics, Cooper assists government programs in ensuring program integrity and public accountability through transparent 340B compliance reporting and audits.

For Third-Party Administrators (TPAs)

View 340B Assistance for TPAs →

We partner with TPAs to refine audit frameworks, validate data accuracy, and streamline compliance oversight across multiple covered entities. Cooper’s audit services help TPAs strengthen client trust and maintain adherence to HRSA expectations.

How Cooper Strategy Helps Clients Achieve Audit Success

Our experience speaks for itself. Cooper Strategy’s clients consistently outperform industry benchmarks in compliance, audit outcomes, and financial performance.

Case Study 1: $3 Million Annual Improvement Through Optimization

Seven affiliated Federally Qualified Health Centers (FQHCs) engaged Cooper Strategy for 340B program optimization and audit readiness.
Within one year, the group achieved over $3 million in additional annual revenue, half of which stemmed from improved compliance and enhanced referral capture through partnerships with major pharmacies.
These results demonstrate that compliance excellence and financial performance go hand in hand when your program is managed with precision and accountability.

Case Study 2: 52.5% Financial Improvement After Switching Providers

A consortium of 25 health centers in Florida transitioned from another 340B service provider to Cooper Strategy seeking better compliance oversight and audit support.
After Cooper’s comprehensive audit and referral program review, the group realized a 52.5% net financial improvement, equating to over $1 million in new funding per year to support patient programs and services.
Beyond the financial results, the organization’s HRSA audit readiness improved dramatically, with stronger documentation standards, consistent policies across sites, and measurable gains in program efficiency.

These case studies underscore how Cooper Strategy’s 340B audit and compliance consulting not only mitigate risk but also drive measurable operational and financial results.

The Cooper Strategy Audit Methodology

Our 340B audit process is guided by three principles: compliance, clarity, and continuous improvement.

  1. Compliance First: Every audit engagement is designed to align precisely with HRSA’s official audit methodology and documentation expectations.

  2. Clarity in Communication: Our audit reports are written in plain, actionable language that helps leadership and staff understand findings and solutions.

  3. Continuous Improvement: We view every audit as a learning opportunity. We don’t just close findings—we strengthen your systems, policies, and training to prevent recurrence.

Audit Technology & Tools

Cooper Strategy leverages advanced 340B analytics, including AI-assisted audit matching that cross-references EHR, pharmacy, and claims data to identify discrepancies automatically. This allows for a faster, more accurate audit experience with fewer manual errors.

Our proprietary dashboards provide a transparent view of your compliance status, showing which locations or pharmacies are performing best and where attention is needed most.

What to Expect from a Cooper Strategy 340B Audit

When you engage Cooper Strategy, you’ll experience a structured, transparent process:

  1. Initial Consultation: We assess your current 340B program and audit history.

  2. Pre-Audit Data Gathering: Our team collects necessary documents, policies, and sample data.

  3. On-Site or Remote Mock Audit: We conduct detailed testing, mirroring HRSA’s methods.

  4. Findings Presentation: Our auditors meet with your leadership team to discuss results.

  5. Corrective Action Plan: We provide step-by-step guidance to remediate risks.

  6. Ongoing Monitoring: Optional continuous audit support ensures long-term compliance.

With Cooper Strategy, every step of your audit journey is guided by experienced professionals who understand both the technical and operational sides of 340B compliance.

Why Choose Cooper Strategy for 340B Audit Services

  • Proven Expertise: Our audit team includes 340B Apexus Certified Experts (ACE), PharmDs, and former compliance officers with decades of experience.

  • National Reach, Local Focus: We’ve served hundreds of covered entities across the country, tailoring our approach to local operations and state regulations.

  • Zero Adverse Findings: Cooper clients have achieved perfect HRSA audit outcomes—with zero adverse findings—thanks to our proactive compliance approach.

  • Data-Driven Insights: Using AI and analytics, we identify compliance risks faster and more accurately than traditional manual audits.

  • End-to-End Support: From policy creation to staff training to HRSA representation, Cooper is your full-service audit partner.

When you work with Cooper Strategy, you gain more than auditors—you gain advisors dedicated to protecting your program’s integrity and sustainability.

Get Audit-Ready with Cooper Strategy

Whether you’re preparing for your first HRSA audit or need an independent assessment of your ongoing 340B compliance, Cooper Strategy delivers unmatched audit expertise.

Let our 340B auditors ensure your program meets every requirement, your documentation is airtight, and your leadership team is fully prepared.

Schedule a consultation today to learn how we can help your organization achieve complete compliance confidence.

👉 Contact Cooper Strategy to get started.

Frequently Asked Questions About 340B Audits

1. What is a 340B audit, and why does it matter?

A 340B audit is an official review conducted by the Health Resources and Services Administration (HRSA) to verify that a covered entity is complying with all requirements of the 340B Drug Pricing Program. These audits assess documentation, policies, and processes to ensure that 340B drugs are dispensed only to eligible patients, that no duplicate discounts occur, and that all program savings are used to support patient care. A successful audit confirms your organization’s integrity and commitment to compliance. Failing to prepare properly, however, can result in financial penalties, repayment demands, or even program termination. Partnering with experts like Cooper Strategy helps ensure full readiness and confidence before HRSA ever arrives.

2. What are the most common findings in 340B program audits?

The most frequent HRSA audit findings involve patient eligibility errors, diversion of 340B drugs to ineligible patients, duplicate discounts, and insufficient documentation to support claims. Another common pitfall is the lack of adequate oversight of contract pharmacies and third-party administrators (TPAs). These errors often stem from unclear policies or staff not fully understanding 340B rules. Cooper Strategy’s mock HRSA audits help covered entities identify and resolve these vulnerabilities before they become official findings. Our auditors replicate HRSA’s review process, testing claims, patient encounters, and referral documentation to ensure your program is fully compliant and defensible during a real audit.

3. How can a mock HRSA audit help my organization?

A mock HRSA audit serves as a proactive “dress rehearsal” for your real audit. Cooper Strategy’s mock audits mirror HRSA’s process in every detail—reviewing patient eligibility, transaction samples, pharmacy records, and policies to uncover any gaps or inconsistencies. The goal is to find and fix issues early, reducing the risk of HRSA findings or manufacturer disputes. Mock audits also train your staff to understand audit expectations, organize records efficiently, and respond confidently during an actual review. Many Cooper clients see long-term benefits beyond compliance: stronger documentation, better collaboration with pharmacies, and enhanced operational efficiency across their 340B programs.

4. How often should we perform internal 340B audits or reviews?

Best practice is to conduct quarterly internal audits and a comprehensive annual mock HRSA audit. Regular audits ensure continuous compliance, quickly detect documentation gaps, and confirm that new staff are following established procedures. Quarterly mini-audits can focus on high-risk areas—such as referral capture, Medicaid billing, or contract pharmacy oversight—while the annual review validates your overall program integrity. Cooper Strategy helps covered entities develop tailored audit schedules, using data analytics and risk assessments to prioritize focus areas. This proactive cadence not only keeps your organization HRSA-ready but also reinforces a culture of compliance and accountability throughout the year.

5. What happens if we fail a 340B audit or receive findings?

If HRSA identifies findings in your 340B audit, you’ll typically be required to submit a corrective action plan (CAP) and, in some cases, repay manufacturers for any identified ineligible discounts. The severity of findings determines the next steps—ranging from documentation corrections to potential program suspension. Cooper Strategy assists organizations at every stage, from analyzing findings to developing CAPs that satisfy HRSA’s requirements. Our auditors also provide training, revised procedures, and ongoing monitoring to prevent recurrence. In many cases, entities that initially struggled in audits have returned to full compliance—and even improved financial performance—through our structured, supportive remediation process.

Additional 340B Audit Resources by Cooper Strategy:

The Covered Entity’s Guide to 340B HRSA Audits: What to Expect and How to Prepare
10 Best Practices for Building a HRSA-Audit-Ready 340B Compliance Program
How to Write a Corrective Action Plan (CAP) for Your 340B Program