Reflecting on 340B Audits: Trends and Key Takeaways (2020-2024)
Over the past five years, 340B program audits have continued to play a crucial role in ensuring compliance for participating covered entities. With increasing scrutiny from the Health Resources and Services Administration (HRSA), these audits provide insights into common pitfalls and areas of improvement. As a consulting firm dedicated to helping hospitals and health systems maximize their 340B opportunity while maintaining the highest level of compliance, Realistic Strategies LLC has analyzed audit trends from 2020 to 2024 to highlight key findings and offer mitigation strategies. Historical HRSA 340B audit results is considered public information and can be found on their website at: https://www.hrsa.gov/opa/program-integrity.
Introducing Our 340B Audit Series
Realistic Strategies LLC is excited to launch a new series focused on 340B audits. This series will dive deep into past audit results, exploring key findings and their implications for covered entities. More importantly, we will provide actionable strategies to help hospitals and health systems prepare for audits and achieve compliance success. Whether you are looking to strengthen your program or learn from past trends, our series will equip you with the knowledge needed to navigate the complexities of 340B audits with confidence.
Audit Results Overview
Between 2020 and 2024, a total of 873 340B audits were conducted. Of these audits:
- 357 audits (41%) resulted in no findings
- 516 audits (59%) had at least one finding
This data underscores the importance of strong compliance measures, as more than half of all audits revealed compliance issues.
Most Common 340B Audit Findings
Among the 705 total findings across all audits, the following categories emerged as the most frequent:
* Multiple audit findings occurred on some audits. These results were split out to unique findings per audit.
- Incorrect OPAIS Record (374 instances, 53%)
- Errors in the Office of Pharmacy Affairs Information System (OPAIS) continue to be the leading cause of audit findings. These inaccuracies often stem from outdated information regarding contract pharmacies, covered entity details, or incorrect Medicaid billing information.
- Duplicate Discount (237 instances, 34%)
- Compliance with the Medicaid Exclusion File remains a challenge. Incorrect coordination between Medicaid and 340B billing practices has led to duplicate discounts, which are strictly prohibited under the program.
- Diversion (83 instances, 12%)
- Dispensing 340B drugs to ineligible patients or for non-eligible services remains a common issue. This is often due to gaps in internal tracking systems and provider-based eligibility verification.
- Other Findings (11 instances, 1%)
- Findings related to ineligible entity participation, failure to maintain auditable records, and improper use of Group Purchasing Organization (GPO) pricing were less common but still present risks.
Mitigation Strategies for Common Findings
To reduce the risk of audit findings, covered entities should focus on the following key compliance strategies:
1. Maintain Accurate OPAIS Records
- Implement regular (quarterly) internal audits to verify that all contract pharmacy relationships, covered entity details, and Medicaid billing information are accurate.
- Assign a dedicated compliance officer or team to oversee OPAIS updates and ensure all changes are properly documented.
2. Strengthen Duplicate Discount Prevention Measures
- Develop a robust process for reviewing Medicaid billing to ensure no duplicate discounts occur.
- Utilize split-billing software to properly segregate 340B and non-340B purchases.
- Conduct regular internal reviews to cross-check Medicaid Exclusion File compliance.
3. Improve Diversion Controls
- Implement enhanced tracking and eligibility verification systems to ensure all 340B drugs are dispensed only to eligible patients.
- Train staff on 340B patient eligibility criteria and conduct routine spot checks on prescriptions.
- Use EMR and pharmacy software integrations to automate patient eligibility determinations.
4. Strengthen Auditable Recordkeeping
- Ensure documentation processes capture all required information, including NPI, patient encounter data, and prescription details.
- Maintain clear and easily accessible records for HRSA audits, with an emphasis on consistent, real-time documentation.
5. Avoid GPO Prohibition Violations
- Review purchasing policies regularly to ensure that 340B entities avoid acquiring outpatient drugs through GPOs.
- Conduct routine compliance audits to verify adherence to purchasing restrictions.
Looking Ahead: Preparing for Future 340B Audits
As HRSA audits continue to evolve, covered entities must take a proactive approach to compliance. By focusing on accurate recordkeeping, duplicate discount prevention, and eligibility verification, hospitals and health systems can strengthen their 340B programs and minimize audit risks.
At Realistic Strategies LLC, we specialize in providing expert guidance and tailored compliance solutions to help organizations navigate the complexities of 340B audits. Stay tuned for our next blog post in this series, where we will explore best practices for audit readiness and real-world case studies on successful 340B compliance programs.
For more insights and assistance with your 340B program, visit www.realisticstrategies.com.