PBMs as De Facto Regulators: A 2025 Recap of PBM Audits and Their Growing Impact on Board of Pharmacy Enforcement

A 2025 Year-End Legal and Regulatory Recap for Independent Pharmacies

Introduction: A Clearer Regulatory Landscape Emerged in 2025

Pharmacy Benefit Managers have long operated as de facto regulators of pharmacies, but in 2025 their regulatory influence became more prevalent, more coordinated and more transparent. Through audits, reimbursement controls, network participation decisions and information sharing with government agencies, PBMs increasingly shaped pharmacy operations in ways that mirrored traditional regulatory oversight. While this reality presents meaningful challenges, it also brings clarity. Independent pharmacies that recognize this environment and respond with discipline, preparation and strategy are better positioned to protect their licenses, maintain network relationships and operate with confidence as enforcement expectations continue to evolve.

PBMs’ Regulatory Role Came Into Sharper Focus

For years, PBMs exerted operational control over pharmacies without formal regulatory authority. Audit programs expanded quietly, Provider Manuals grew longer and more complex, and network participation became increasingly conditional. In 2025, however, this influence became unmistakable.

PBM audits were no longer limited to reviewing individual claims. Instead, they examined broader operational practices such as purchasing sources, invoice timing, inventory controls and internal compliance processes. Pharmacies were asked not only whether a prescription was dispensed correctly, but how business decisions were made and documented.

This shift did not happen overnight, but 2025 marked the point at which PBM oversight began to resemble ongoing supervision rather than episodic review. For many independent pharmacies, this recognition prompted a necessary reassessment of how audits should be approached—not as isolated events, but as part of a larger compliance framework.

Audits Became More Frequent, but Also More Predictable

Another defining feature of 2025 was the increase in audit activity across multiple PBMs and audit programs. While higher audit volume created pressure, it also revealed patterns. PBMs repeatedly focused on the same categories: high-reimbursement drugs, diabetic testing supplies, specialty medications, GLP-1 products and controlled substances.

This predictability worked in pharmacies’ favor. Those that invested in internal review processes, strengthened documentation practices and aligned responses with applicable state pharmacy laws were often able to navigate audits more efficiently and with fewer downstream issues.

Importantly, pharmacies that treated audits as operational exercises rather than adversarial standoffs saw better outcomes. Consistent records, clear policies and measured responses reduced the likelihood of escalation and positioned pharmacies as responsible, compliant participants in the healthcare system.

PBM Audit Findings and Board of Pharmacy Awareness

One of the most notable developments in 2025 was the growing intersection between PBM audit activity and Board of Pharmacy enforcement priorities. While Boards remain independent regulators, PBM-generated data increasingly informed inspection focus areas and investigative inquiries.

From a regulatory standpoint, this development is understandable. PBM audits provide granular transaction-level data that can highlight trends or anomalies. When used responsibly, such information can help Boards allocate limited resources more effectively.

For pharmacies, this means that audit responses now carry broader implications. Statements, explanations and documentation provided during an audit may later be reviewed through a regulatory lens. Pharmacies that recognized this dynamic in 2025 adjusted accordingly.

This approach not only reduced regulatory exposure but also strengthened credibility with both PBMs and regulators.

Cross-Network Actions Reinforced the Need for Strategic Planning

In 2025, PBMs also relied more heavily on cross-network enforcement strategies, particularly when pharmacies shared ownership structures, management arrangements, or purchasing relationships. While this approach raised legitimate concerns, it also highlighted the importance of thoughtful organizational planning.

Independent pharmacies that proactively evaluated ownership disclosures, affiliation agreements and operational overlaps were better prepared to respond when questions arose. Clear documentation of corporate structure and compliance safeguards often helped limit broader network consequences.

This trend underscored a key lesson from 2025: transparency and preparation are assets. Pharmacies that understand how their business relationships may be perceived are better equipped to explain them when necessary.

Independent Pharmacies Demonstrated Resilience

Despite increased scrutiny, 2025 also demonstrated the resilience of independent pharmacies. Many successfully defended audit findings, avoided unwarranted terminations and maintained strong patient relationships throughout periods of review.

Several factors contributed to this resilience. Independent pharmacies are often closer to their operations, more agile in implementing changes and deeply invested in compliance. When supported by informed legal and compliance guidance, these strengths translated into effective audit and regulatory responses.

Rather than being overwhelmed by PBM oversight, many pharmacies used 2025 as an opportunity to strengthen internal systems, refine policies and elevate operational discipline.

A Constructive Outlook for 2026

Looking ahead to 2026, the regulatory environment is unlikely to become less complex but it is becoming more predictable. The increased visibility of PBM practices has prompted broader conversations among regulators, legislators and industry stakeholders. Transparency expectations are rising, and enforcement priorities are becoming more clearly defined.

For independent pharmacies, this presents opportunity. Those that invest in proactive compliance, maintain strong documentation practices and approach PBM interactions strategically will be well positioned to operate with stability and confidence.

Importantly, pharmacies no longer need to guess what PBMs are looking for. The patterns observed in 2025 provide a roadmap. Preparation, consistency and early engagement remain the most effective tools.

Conclusion

The lessons of 2025 are not cause for alarm, but for alignment. PBMs have long functioned as de facto regulators, and in 2025 that role became more visible and influential. Independent pharmacies that acknowledge this reality and adapt thoughtfully are not disadvantaged—they are empowered.

With the right strategies in place, pharmacies can continue to serve their communities, protect their licenses, and thrive in a regulatory environment that increasingly rewards preparation and professionalism.