A 340B Program Health Check reviews key areas to ensure compliance, accuracy, and audit readiness, including covered entity and child site eligibility, HRSA registration accuracy, patient definition and eligibility compliance, prevention of diversion and duplicate discounts, Medicaid billing and exclusion file alignment, purchasing and inventory management processes, split-billing and accumulator functionality, contract pharmacy oversight, and the strength of policies, procedures, staff training, and documentation to support ongoing compliance and successful HRSA audits.
Understanding a 340B Program Health Check
A 340B Program Health Check is a comprehensive evaluation of how a covered entity manages, documents, and monitors its 340B operations. It focuses on compliance, accuracy, and governance rather than punitive enforcement. The review typically includes policy assessments, data validation, and operational workflows. Unlike a HRSA audit, a health check is corrective and educational in nature. It helps organizations uncover vulnerabilities early and implement improvements. Ultimately, it serves as a preventative measure to strengthen the program.
Covered Entity Eligibility & HRSA Registration
This area reviews whether the organization and its child sites meet ongoing eligibility requirements under the 340B Program. It ensures that all eligible locations are properly registered and listed in the HRSA 340B database. Any outdated, missing, or inaccurate registrations can create compliance risks. The review also confirms that contract pharmacies are correctly registered and active. Maintaining accurate HRSA records is essential for audit defense. Errors in eligibility or registration are among the most common audit findings.
Patient Eligibility & Diversion Prevention
Patient eligibility is a core compliance requirement of the 340B Program. This review evaluates whether the organization’s patient definition aligns with HRSA guidance and is applied consistently. Dispensing practices are analyzed to ensure 340B drugs are only provided to eligible patients. Controls designed to prevent diversion are closely examined. Weak patient eligibility logic can expose covered entities to serious violations. A health check ensures patient qualification rules are clearly documented and operationalized.
Duplicate Discount Prevention & Medicaid Compliance
Preventing duplicate discounts is a critical responsibility of covered entities. This review assesses how Medicaid claims are billed and whether carve-in or carve-out decisions are correctly implemented. The accuracy of the Medicaid Exclusion File is carefully evaluated. Processes are reviewed to ensure manufacturers are not charged both a 340B discount and a Medicaid rebate. Any inconsistencies can result in compliance findings or financial penalties. Strong duplicate discount controls protect both the organization and manufacturers.
Purchasing & Inventory Management
Purchasing and inventory controls ensure that 340B drugs are ordered and replenished accurately. The health check reviews split-billing software configurations, accumulator logic, and replenishment methodologies. Mixed-use inventory handling is also evaluated to ensure proper segregation of 340B and non-340B drugs. Errors in purchasing workflows can lead to overuse or underutilization of 340B benefits. This review helps confirm that inventory practices match actual dispensing activity. Accurate purchasing safeguards both compliance and savings.
Contract Pharmacy Oversight
Contract pharmacies introduce additional compliance complexity and risk. This area reviews contract pharmacy agreements, roles, and responsibilities. Claims data is examined to ensure accurate dispensing and reimbursement. Oversight processes, including audits and monitoring reports, are evaluated for effectiveness. Covered entities remain responsible for compliance even when third parties are involved. Strong governance over contract pharmacies is essential to avoid audit findings. A health check ensures accountability and transparency across partnerships.
Policies, Procedures & Staff Training
Well-documented policies and procedures form the foundation of a compliant 340B program. This review evaluates whether written policies reflect current operations and HRSA guidance. Staff roles, responsibilities, and training programs are also assessed. Inconsistent knowledge among staff can lead to operational errors. Documentation practices are reviewed to ensure policies are accessible and enforced. Effective training and governance reduce reliance on individuals and strengthen program continuity.
Audit Preparedness & Ongoing Monitoring
Audit preparedness focuses on how well the organization can demonstrate compliance if reviewed by HRSA. Internal audits, monitoring tools, and corrective action processes are evaluated. The health check assesses whether issues are identified, documented, and resolved in a timely manner. Strong monitoring practices help organizations stay ahead of regulatory changes. This section ensures the program is defensible under audit conditions. Continuous oversight is key to long-term compliance success.
Why Regular 340B Program Health Checks Matter
Regular health checks reduce compliance risk by identifying issues before they escalate. They help organizations protect program savings and avoid repayment liabilities. Health checks also improve operational efficiency by streamlining workflows. Proactive reviews foster a culture of accountability and transparency. They support leadership decision-making with accurate data. Ultimately, they ensure the 340B Program continues to support patient care goals.
How NorthArc Health Strengthens 340B Compliance
NorthArc Health specializes in comprehensive 340B Program Health Checks tailored to each organization’s structure and risk profile. Their approach combines deep regulatory expertise with practical operational insight. NorthArc Health identifies compliance gaps, strengthens controls, and enhances audit readiness. They work collaboratively with internal teams to implement sustainable solutions. With ongoing monitoring and HRSA audit preparation support, they help covered entities protect both compliance and savings. Choosing NorthArc Health means confidence, clarity, and long-term program stability.
Comprehensive 340B Program Health Checks
NorthArc Health conducts in-depth 340B Program Health Checks tailored to each covered entity’s structure, contract pharmacy model, and risk exposure. Their reviews evaluate eligibility, patient definition compliance, diversion risks, and duplicate discount controls. This proactive assessment helps identify weaknesses before they become audit issues. Each check is aligned with current HRSA guidance and enforcement trends. The result is a clear, actionable compliance snapshot.
Regulatory Expertise with Practical Insight
NorthArc Health combines deep knowledge of 340B regulations with real-world operational experience. Their team understands how policy requirements translate into daily workflows across pharmacies, billing systems, and split-billing software. This balance ensures compliance recommendations are realistic and implementable. Clients receive guidance that supports both regulatory adherence and operational efficiency. It reduces confusion and strengthens internal accountability.
Identification and Mitigation of Compliance Gaps
Through detailed analysis, NorthArc Health identifies gaps in policies, procedures, and internal controls. They assess risks related to diversion, duplicate discounts, contract pharmacy oversight, and recordkeeping. Each gap is prioritized based on risk level and audit exposure. NorthArc Health then provides clear remediation steps to close these gaps efficiently. This structured approach minimizes long-term compliance risks.
Strengthening Internal Controls and Documentation
Strong internal controls are essential for 340B program integrity. NorthArc Health helps organizations design and refine policies, SOPs, and monitoring processes. They ensure documentation supports compliance during HRSA audits and manufacturer inquiries. Improved controls enhance transparency and consistency across departments. This foundation supports sustainable program management.
HRSA Audit Readiness and Ongoing Monitoring
NorthArc Health prepares covered entities for HRSA audits through mock audits, issue remediation, and documentation review. Their ongoing monitoring services help ensure continuous compliance as regulations and program structures evolve. Regular reviews reduce last-minute audit stress and costly findings. Clients remain confident in their audit posture year-round. This proactive model protects both compliance and savings.
Collaborative Implementation and Long-Term Stability
NorthArc Health works closely with internal teams to implement changes smoothly. They prioritize knowledge transfer, training, and process alignment. This collaborative approach ensures compliance improvements are sustainable over time. Organizations gain clarity, confidence, and long-term 340B program stability. NorthArc Health becomes a strategic partner, not just a consultant.
Conclusion
A 340B Program Health Check reviews every critical component of program compliance, from eligibility and patient definition to purchasing and contract pharmacy oversight. By addressing these areas proactively, covered entities reduce risk and strengthen governance. Regular health checks ensure audit readiness and financial integrity. They also help organizations maximize the program’s intended benefits. With expert support, healthcare organizations can maintain compliance while focusing on patient care. A structured health check is essential for long-term 340B success.
FAQs
1. How often should a 340B Program Health Check be conducted?
At least annually, or whenever there are major operational or regulatory changes.
2. Is a health check the same as a HRSA audit?
No, a health check is proactive and corrective, while a HRSA audit is regulatory and enforcement-based.
3. Who should perform a 340B health check?
Experienced 340B compliance experts or specialized third-party consultants.
4. What is the biggest risk identified in health checks?
Patient eligibility errors and duplicate discount issues are the most common risks.
5. Can a health check improve 340B savings?
Yes, by optimizing purchasing, inventory management, and operational controls.
