The 340B Drug Pricing Program allows eligible healthcare organizations to purchase medications at reduced prices, enabling them to stretch resources and provide more comprehensive care to underserved populations. Compliance is critical to ensure that the program is used appropriately, avoiding penalties and maintaining eligibility. My role involves monitoring program adherence, conducting audits, and ensuring that all transactions align with federal regulations. By maintaining compliance, we safeguard the program’s integrity and ensure it continues to benefit patients and institutions alike.

If non-compliance is identified, I would first conduct a thorough investigation to understand the root cause and scope of the issue. I would then work with the entity to develop a corrective action plan, ensuring they understand the violations and steps needed to rectify them. Communication with HRSA and other stakeholders would be transparent and timely. My goal is to resolve the issue while minimizing disruption to patient care and preventing future violations through enhanced training, process improvements, and ongoing monitoring.

To ensure compliance across multiple sites, I would establish a centralized compliance framework with standardized policies and procedures. Regular training sessions would be conducted to educate staff on program requirements and updates. I would also implement a robust auditing system, including internal and external audits, to identify and address potential issues proactively. Leveraging technology, such as compliance software, would streamline tracking and reporting. By fostering a culture of accountability and continuous improvement, I would ensure all sites adhere to 340B regulations consistently.

I stay informed by regularly reviewing updates from HRSA, attending industry conferences, and participating in professional networks focused on 340B compliance. I also subscribe to relevant newsletters and engage with legal and compliance experts to interpret new regulations. Within the organization, I ensure changes are communicated promptly through training sessions and updated policies. By proactively monitoring regulatory developments and fostering a culture of awareness, I ensure our organization remains compliant and adapts to evolving requirements effectively.

In a previous role, I identified discrepancies in drug pricing data that risked non-compliance. I collaborated with finance, pharmacy, and IT teams to trace the issue to a system integration error. We corrected the data, implemented additional validation checks, and provided targeted training to prevent recurrence. By addressing the issue promptly and transparently, we avoided penalties and strengthened our compliance processes. This experience highlighted the importance of cross-departmental collaboration and proactive problem-solving in maintaining 340B program integrity.