Expert Tip from Bluesight

With sweeping changes proposed in the latest presidential executive order, a surge in manufacturer-led audits, more states enacting provider reporting laws, and heightened scrutiny of 340B in Washington, D.C., the regulatory environment is more challenging and unpredictable than ever. Health systems and grantees must ensure their 340B programs are prepared for increased regulations and oversight.

In the face of a tumultuous legislative and regulatory landscape, Bluesight’s new 2025 Hospital Pharmacy Operations Report highlights the growing need for increased self-auditing of 340B transactions to safeguard organizations. Spot checks and sample audits may have been sufficient in the past, but they now leave 340B Covered Entities exposed to compliance risks, lost savings, and potential penalties.

Organizations must move beyond outdated, manual auditing strategies to protect their 340B program and ensure long-term sustainability. A 100% audit approach isn’t just ideal—it is essential. Relying on sample-based or periodic audits is demanding on resources, limits the team’s agility, and ultimately exposes teams to increased risk. A 100% audit empowers teams to identify issues in real time, take proactive action, and maintain confidence in program compliance, regardless of how the landscape evolves.

Simplify continuous compliance as your program grows and regulations become increasingly complex. Bluesight’s 340B Compliance Solution, 340BCheck, consolidates your 340B compliance into one location, providing hospitals and grantees with complete oversight and 100% auditing capabilities. Integrate disparate data sources, monitor compliance, and validate every transaction to stay HRSA audit-ready – all to scale your program and reduce financial risks.

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