340B Program Audits

Advanced 340B Compliance Protection for Healthcare Organizations

The 340B Drug Pricing Program creates significant financial opportunities for covered entities—but it also introduces substantial compliance obligations. Increased oversight from the Health Resources and Services Administration (HRSA), manufacturer-driven audits, and evolving regulatory interpretations have made proactive compliance more important than ever.

A single compliance failure can lead to repayment demands, corrective action plans, manufacturer disputes, reputational damage, or removal from the 340B program altogether. Safe Harbor Group helps healthcare organizations identify vulnerabilities before regulators do.

Our team includes former government prosecutors, certified healthcare compliance professionals, auditors, investigators, and healthcare regulatory specialists who understand exactly how enforcement agencies evaluate 340B compliance.

Why 340B Program Audits Matter More Than Ever

Regulatory scrutiny surrounding the 340B program continues to intensify nationwide. HRSA audits frequently uncover findings related to diversion, duplicate discounts, contract pharmacy oversight, and documentation deficiencies.

Today’s covered entities face growing pressure to demonstrate:

• Accurate patient eligibility determinations
• Effective diversion prevention controls
• Compliant contract pharmacy oversight
• Reliable Medicaid duplicate discount prevention processes
• Accurate OPAIS registration and recertification data
• Well-maintained policies and procedures
• Strong audit readiness and defensible documentation

Organizations operating without ongoing compliance oversight are increasingly vulnerable to HRSA findings, manufacturer repayment demands, and operational disruption.

Comprehensive 340B Audit Services

Safe Harbor Group delivers comprehensive 340B audits designed to evaluate every phase of your program operations. Our methodology mirrors real-world regulatory investigations and HRSA audit protocols.

Independent Annual 340B Audits

HRSA strongly recommends independent annual audits, particularly for organizations utilizing contract pharmacy arrangements. Our audits provide objective third-party validation that demonstrates proactive compliance efforts and good-faith oversight.

Contract Pharmacy Compliance Reviews

Contract pharmacy oversight remains one of the most scrutinized areas of 340B compliance. We evaluate:

• Ship-to-bill accuracy
• Dispensing workflows
• Prescriber eligibility
• Patient qualification standards
• Inventory management controls
• Third-party administrator (TPA) configurations
• Claims reconciliation processes

Duplicate Discount Prevention Audits

Duplicate discounts continue to represent one of the highest-risk areas within the 340B program. We conduct advanced reconciliation between 340B utilization data and Medicaid claims activity to identify vulnerabilities before regulators or manufacturers do.

Diversion Risk Assessments

Drug diversion findings can trigger severe consequences, including repayment obligations, corrective action plans, and potential program termination. Our auditors perform detailed transactional testing to confirm medications are dispensed only to eligible patients at qualified locations.

340B Policies & Procedures Development

Generic compliance manuals are no longer sufficient. We help healthcare organizations develop customized policies and procedures aligned with actual operational workflows, current HRSA guidance, and evolving enforcement trends.

OPAIS & Recertification Reviews

Errors within the Office of Pharmacy Affairs Information System (OPAIS) can create unnecessary audit exposure. We verify entity registrations, provider eligibility, site information, and associated data accuracy.

Who We Serve

Safe Harbor Group supports covered entities nationwide across a wide range of healthcare environments, including:

• Disproportionate Share Hospitals (DSH)
• Children’s Hospitals
• Critical Access Hospitals (CAH)
• Federally Qualified Health Centers (FQHCs)
• FQHC Look-Alikes
• Ryan White Clinics
• Rural Health Clinics
• Independent Healthcare Systems
• Specialty Healthcare Providers

Our team understands the unique compliance challenges associated with each entity type, including GPO prohibition requirements, referral loop compliance, telehealth eligibility, and payer-specific billing risks.

The Safe Harbor Group Audit Methodology

Phase 1: Data Collection & Integrity Validation

We analyze data from your 340B software platforms, electronic health records, dispensing systems, and billing systems to identify inconsistencies and risk indicators.

Phase 2: Transactional Testing

Using statistically valid sampling methodologies, we trace medication utilization from acquisition through dispensing to verify patient eligibility, provider qualification, and encounter compliance.

Phase 3: Root Cause Analysis

Our audits go beyond identifying problems. We determine the underlying operational, workflow, training, or technology issues contributing to compliance gaps.

Phase 4: Corrective Action Planning

We deliver actionable remediation plans designed to strengthen compliance infrastructure, reduce future exposure, and improve audit defensibility.

Why Healthcare Organizations Choose Safe Harbor Group

Former Government Investigators & Prosecutors

Our team understands how regulators build cases, evaluate evidence, and assess organizational risk. That insight allows us to help clients proactively address vulnerabilities before they become enforcement actions.

Healthcare Compliance Specialists

We are not general consultants. Our focus is healthcare regulatory compliance, investigations, auditing, and risk mitigation.

Customized Compliance Solutions

Every healthcare organization operates differently. We tailor our audits and compliance strategies to your workflows, provider structure, specialty, and operational realities.

National Experience

Safe Harbor Group supports healthcare organizations nationwide and has extensive experience working with medical practices, pharmacies, hospitals, and healthcare attorneys across the United States.

Frequently Asked Questions

How often should a 340B audit be performed?

Most covered entities should conduct independent annual audits. Organizations with multiple contract pharmacies or higher prescription volume may benefit from additional interim reviews.

What is a duplicate discount?

A duplicate discount occurs when a manufacturer provides a 340B discount on a drug that also generates a Medicaid rebate, which is prohibited under federal law.

Can Safe Harbor Group help during an active HRSA audit?

Yes. We provide HRSA audit defense support, document preparation assistance, corrective action guidance, and ongoing compliance consultation throughout the audit process.

Do telehealth visits qualify for 340B eligibility?

Telehealth encounters may qualify when specific HRSA patient definition criteria are satisfied. Proper documentation and provider oversight are essential.

How long does a 340B audit take?

Most audits are completed within four to eight weeks, depending on organizational size, number of contract pharmacies, and data complexity.

Protect Your 340B Program Before Regulators Identify the Risk

The cost of proactive compliance is significantly lower than the cost of enforcement actions, repayment obligations, or program removal.

Safe Harbor Group helps healthcare organizations strengthen compliance infrastructure, reduce exposure, and confidently navigate the complexities of the 340B Drug Pricing Program.

Contact Safe Harbor Group today to schedule a confidential 340B compliance assessment.