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The regulatory landscape for the 340B drug pricing program is evolving rapidly. As scrutiny from the Health Resources and Services Administration (HRSA) and drug manufacturers intensifies, healthcare leaders and 340B teams face growing pressure to maintain airtight compliance while maximizing program value.
Today, most healthcare organizations rely on manual or sample-based audits, reviewing fewer than 25% of cases weekly or monthly (HPOR 2025). These limited spot checks are not only time-consuming and inefficient—they’re prone to errors and can overlook noncompliant claims, putting the entire program at risk.
Move from Reactive to Proactive with 100% 340B Transaction Audit
The solution? Implementing a continuous compliance approach with 100% claim-level audits.
By capturing every 340B-eligible transaction and flagging only valid exceptions, continuous compliance software with 100% audit is a must-have for safeguarding 340B programs. It empowers teams to focus where it matters most—correcting issues early, securing program savings, and maximizing revenue capture. Instead of searching for errors, 340B analysts can proactively address risks, ensuring stronger oversight and fewer missed opportunities.
We recently worked with an organization that implemented a 100% audit approach. With increased visibility, they identified a trend of violations where 340B outpatient dispenses were actually inpatient; they assumed this was an error. However, in reality, the inpatient department was incorrectly labeled as an outpatient department in their TPA. Because it was a small department, it never showed up on their sample audits. Because the site employed a 100% audit strategy, it brought visibility to this issue, allowing them to resolve it, update the outpatient department list in the TPA, and reclassify already processed claims.
*webinar limited to covered entities only
Operational Efficiency Through Automation
340B compliance software with automated workflows provides structure to the compliance process, replacing manual documentation and disconnected tasks with built-in alerts, task management, audit trails, and exception management. This automation drives:
- Faster issue resolution
- Greater accuracy and consistency
- More time for strategic program growth
Long-Term Value: Achieve Continuous Compliance and Maintain Audit Readiness
A 100%, continuous audit approach offers lasting value beyond operational efficiency. It helps covered entities:
- Maintain continuous program compliance
- Strengthen internal controls
- Ensure audit readiness with complete, traceable documentation
Unlike sample-based audits, which leave gaps and create risk, comprehensive audits capture every eligible transaction, ensuring that nothing is overlooked. Every claim, encounter, and prescription is audited, giving 340B teams the confidence to respond to HRSA or manufacturer audits.
Stay Ahead of the Curve
As HRSA audits and manufacturer challenges become more rigorous and frequent, partial oversight is no longer enough. Equip your team with a software-powered 100% audit tool to ensure your 340B program is compliant, efficient, and audit-ready – every single day.
To hear a real-world example of how Vernon Memorial Hospital is implementing 100% 340B transaction audit software, Register for our upcoming webinar with the site’s Pharmacy Manager, Melissa Stiles, PharmD.
*webinar limited to covered entities only
Sandy Still is Director of Clinical Strategy at Bluesight. She can be reached at hello@bluesight.com.
