PBM audits extend beyond paperwork, assessing pharmacy operations, staff preparedness, SOPs, and compliance culture. Proactive strategies, training, and legal expertise ensure audit readiness.

PBM Audits: Strategies, Best Practices, and Expert Guidance

Beyond Documentation: What PBMs Evaluate During Audits

When pharmacies think of PBM audits, the focus often centers on assembling accurate documentation, from purchase records to signature logs. However, PBMs examine far more than just paperwork—they assess the fundamental operations of your pharmacy. Auditors are not only verifying records but also evaluating the systems and practices that generate them, determining whether compliance is woven into the fabric of your pharmacy’s day-to-day activities.

For instance, PBMs analyze how consistently your pharmacy handles exceptions, such as overrides for restricted medications. They also scrutinize whether inventory records align precisely with purchasing and dispensing data. Even seemingly minor discrepancies—like an incomplete inventory reconciliation—can prompt auditors to question the pharmacy’s overall operational integrity.

Additionally, PBM’s evaluation during an audit also extends to the pharmacy staff’s preparedness, training, and overall compliance. If employees struggle to locate records, auditors may interpret this as a lack of training—or worse, potential non-compliance. A pharmacy where staff confidently retrieve records, provide coherent explanations, and demonstrate uniform processes inspires trust in its compliance culture, even when minor errors are discovered.

PBMs want to see more than compliance on paper—they seek evidence of a pharmacy where adherence to regulations is second nature. Achieving this requires meticulous processes, a well-trained team, and a proactive operational culture focused on accuracy, consistency, and accountability.

Cultivating a Culture of Compliance

Building a pharmacy that successfully responds to PBM audits starts with investing in the pharmacy’s staff. While technology and internal computer systems play an essential role, the human element—the pharmacy staff’s actions and decisions—ultimately determines whether compliance becomes a priority within the pharmacy.

Establishing Consistency Through SOPs

Standard Operating Procedures (SOPs) are the backbone of compliance. Clear, actionable SOPs guide staff in managing critical tasks, such as logging overrides, reconciling inventory, addressing billing anomalies, and ensuring prompt claim reversals when necessary. Effective SOPs are living documents—regularly updated to reflect operational realities and regulatory changes—and should be actively used, not left to collect dust.

Moreover, ongoing training ensures that the pharmacy’s employees stay aligned with evolving regulatory changes and PBM expectations. Monthly refreshers, quarterly workshops, and hands-on sessions using real-world examples can help bridge the gap between theory and practice. Internal mock audits, in particular, allow staff to simulate the high-pressure scenarios of actual PBM audits, exposing gaps in processes and building the necessary knowledge and confidence.

Additionally, it is important to encourage a workplace culture where the staff feels comfortable raising concerns or reporting potential compliance risks without fear of reprisal. For example, if a pharmacy technician notices recurring billing discrepancies, they should have a clear path to report the issue for resolution. This transparency not only mitigates risks but reinforces the idea that compliance is a shared responsibility.

A cohesive, well-trained team equipped with actionable processes transforms compliance into an operational strength. It reduces audit-related stress, enhances efficiency, and positions your pharmacy as a trusted partner within PBM networks.

Leveraging Professional Expertise for Complex Challenges

Even the most prepared pharmacies can encounter situations where external expertise is invaluable. PBM audits can uncover challenges that surpass the capacity or knowledge of an internal team. Knowing when to engage legal counsel can mean the difference between swift resolution and prolonged disputes that may lead to network terminations.

Indeed, certain audit findings—such as those suggesting fraud waste and abuse and/or findings involving monetary clawbacks—demand immediate legal attention. Healthcare attorneys can interpret PBM contracts, challenge PBM audit findings, and negotiate more favorable outcomes. For example, if a pharmacy is accused of waiving patient copays without proper documentation, legal counsel can craft an appropriate response, compile necessary evidence, and effectively communicate with the PBMs.

Additionally, experienced healthcare attorneys specialize in identifying operational vulnerabilities and implementing best practices. Their services often include conducting comprehensive reviews of documentation and processes; developing tailored SOPs aligned with PBM requirements; and training staff on compliance standards and audit readiness.

Indeed, establishing relationships with legal professionals ensures that your pharmacy is prepared for PBM audits and any challenges associated with same. These trusted advisors can provide ongoing support, review PBM documentation, and offer insights into emerging audit trends thereby strengthening your pharmacy’s compliance framework and ensuring its continued network participation.

In sum, building a compliant and audit-ready pharmacy requires a comprehensive, proactive approach that integrates strong leadership, advanced technology, and expert legal guidance. Additionally, consistent staff training is essential to ensure a thorough understanding of PBM requirements and foster a culture of accountability where every team member actively supports the pharmacy’s compliance efforts. Likewise, clear, actionable SOPs are critical to maintaining consistency in handling key tasks, while internal self-audits are invaluable for identifying weaknesses and preparing staff for real-world scrutiny from PBMs and other regulatory bodies. Similarly, engaging experienced healthcare attorneys to address complex challenges and strengthen operational practices ensures the pharmacy is equipped to navigate PBM inquiries and audits more effectively.

Lastly, maintaining alignment with evolving PBM requirements involves ongoing updates to SOPs, continuous staff training, and regular reviews of the pharmacy’s records and operations. This iterative approach reinforces compliance as an integral part of daily operations.

Final Thoughts

While no pharmacy can avoid PBM scrutiny, adopting a proactive and holistic strategy transforms PBM audits from operational crises into manageable milestones. By prioritizing the pharmacy’s staff, streamlining processes, leveraging technology, and engaging legal support, your pharmacy can cultivate a robust compliance framework that not only withstands PBM audits but also drives operational excellence and positions your business for sustained success.

Frequently Asked Questions

Navigating PBM Audits in 2025: A Guide for Pharmacies

Navigate 2025 PBM audits confidently: Key triggers, trends, and preparation tips to protect your pharmacy.

Read More >>

Telehealth and Fraud Prevention: Protecting Your Practice

Address the increasing scrutiny telehealth providers face regarding potential fraud, waste, and abuse in virtual care. This article delivers expert insights into structuring telehealth practices to avoid fraud allegations, including strategies for compliance with the Anti-Kickback Statute, Stark Law, and other relevant regulations.

Read More >>

Telehealth in 2025: Medicare Providers Get Temporary Relief, But Uncertainty Remains

The American Relief Act, 2025, temporarily extends key Medicare telehealth flexibilities through March 31, 2025, preserving access to remote care for now but leaving providers and patients uncertain about the future. This update outlines what the extension covers, highlights permanent changes, and offers guidance to help providers prepare for potential disruptions.

Read More >>

Telehealth in 2025: What Medicare Providers Should Know

During COVID-19, Medicare expanded telehealth access by waiving geographic restrictions, broadening provider eligibility, and covering more services. These temporary flexibilities are set to expire at the end of 2024, requiring providers to adjust to stricter pre-pandemic rules unless Congress intervenes.

Read More >>