The Future of 340B: Policy, Technology, and the Road Ahead

The 340B landscape is evolving quickly — and covered entities must adapt. With new policy debates, heightened HRSA scrutiny, and advancing technology, 2025 marks a pivotal year for hospitals, FQHCs, and contract pharmacies striving to protect both compliance and savings.

Upcoming Policy Shifts
Lawmakers and regulators continue to review the scope of the 340B program. According to 340B Health, discussions around contract pharmacy restrictions and program transparency are likely to intensify in the coming year. Proposed changes may include:

• More stringent reporting requirements for covered entities.

• Adjustments to contract pharmacy eligibility under manufacturer pressure.

• Expanded HRSA oversight and enforcement authority.

Increasing Audit Scrutiny
The Health Resources and Services Administration (HRSA) has already stepped up audits, with more than 200 conducted in 2024 alone. Trends for 2025 point to:

• Greater focus on duplicate discount prevention.

• Heightened review of contract pharmacy compliance.

• Stronger enforcement of OPAIS accuracy and timely reporting.

The Government Accountability Office (GAO) underscores that audit readiness is essential for maintaining program integrity.

The Role of Modern Technology
Manual processes can no longer keep pace with 340B complexity. According to the American Hospital Association (AHA), the rising cost of prescription drugs makes maximizing 340B savings a financial imperative. Technology platforms like Halo340B help covered entities:

• Independently validate claims to recover up to 20% more eligible revenue.

• Automate HRSA-ready audit documentation.

• Provide real-time dashboards for CFO-level transparency.

• Predict savings with AI-driven analytics to support long-term financial planning.

Halo340B is designed to help covered entities navigate the challenges of 2025 and beyond. By combining AI-powered claim validation with transparent dashboards and audit-ready documentation, Halo340B ensures organizations are both compliant and financially resilient.