The 340B Program in 2025: What Covered Entities Need to Know
As healthcare costs continue to rise, the 340B program remains a vital resource for hospitals, Federally Qualified Health Centers (FQHCs), and contract pharmacies. In 2025, the program continues to help safety-net providers stretch scarce federal resources, but new challenges and updated Health Resources and Services Administration (HRSA) guidance have made compliance more complex than ever.
HRSA Audit Findings: What We’re Seeing in 2025
In 2024, HRSA conducted over 200 audits of covered entities, and early 2025 trends suggest the agency is increasing its focus on contract pharmacy arrangements and duplicate discount prevention. According to HRSA’s Program Integrity Updates, the most common findings include:
Inadequate tracking of 340B inventory across multiple contract pharmacies.
Failure to maintain auditable records of eligibility determinations.
Gaps in policies and procedures that align with 340B requirements.
For covered entities, these findings highlight the need for robust audit-readiness processes, not just annual reviews.
Changes in OPAIS Registration
The Office of Pharmacy Affairs Information System (OPAIS) remains the central platform for 340B program enrollment and oversight. In 2025, HRSA updated OPAIS to improve transparency and accountability. Covered entities now face:
Stricter quarterly registration deadlines.
Enhanced data verification processes for child sites and contract pharmacies.
Increased penalties for late or inaccurate submissions.
Failure to keep OPAIS data up-to-date can jeopardize program participation, creating significant financial and compliance risks.
Industry Trends: Why Compliance Is More Complex Than Ever
Beyond HRSA updates, industry-wide shifts are shaping the 340B landscape:
Rising Drug Costs: According to the American Hospital Association, prescription drug costs continue to rise faster than inflation, increasing reliance on 340B savings.
Contract Pharmacy Restrictions: Several drug manufacturers continue to limit 340B pricing through contract pharmacies, forcing covered entities to reassess their distribution strategies.
Technology Adoption: Covered entities are turning to compliance software solutions to track eligibility, manage inventory, and prepare for audits with real-time dashboards.
How Compliance Software Helps
Manual compliance processes are no longer enough. Platforms like Halo340B™ empower covered entities to:
Conduct independent eligibility validation to recover missed claims.
Maintain TPA relationships while reducing dependency on third parties.
Access real-time financial dashboards for transparency.
Strengthen audit defense with automated, HRSA-ready reporting.
With these tools, covered entities can move from reactive compliance to proactive risk management.
The 340B landscape is evolving quickly — and audit readiness is no longer optional.
→ Request a Demo to see how Halo340B™ prepares you for your next HRSA audit and ensures you maximize program savings while staying fully compliant.
