Healthcare leaders are preparing for stricter oversight and tighter regulations across the board, including those surrounding 340B. Organizations that prioritize 340B program compliance today will be better positioned to navigate what comes next.
Strengthen 340B Program Compliance Amid Regulatory Shifts
340B programs aren’t just about savings, they’re about sustainability. But in 2025, manufacturer audits are on the rise, a trend accelerated by HRSA’s revision of the Alternative Dispute Resolution (ADR) process in 2024. Meanwhile, lawmakers and pharmaceutical companies are pushing for stricter enforcement of 340B program compliance. Adding to the complexity, over 50 active 340B-related court cases are currently in play, ranging from contract pharmacy arrangements to rebate models. This clearly signals that we’re in a regulatory flux and a reminder that policy can turn on a dime.
A recent Bluesight survey of professionals managing 340B program compliance emphasizes that compliance managers are aware of this flux, and they’re already feeling the pressure.
Specifically, 76% expect regulatory oversight to increase over the next 2–3 years. Not a single respondent expects oversight to decrease. Now, organizations are searching for better compliance strategies for managing this increased scrutiny. Currently, the same survey shows that:
- 50% of respondents audit claims only monthly
- 13% audit quarterly
- Most hospitals audit less than 25% of total transactions
But the reality is that you need to be conducting internal audits on a frequent and regular basis. Ask yourself: Do you have the right documentation, oversight, and systems in place to remain audit-ready no matter what changes come your way?
340B Best Practices for Creating Future-Proof Compliance Programs
To protect your 340B savings and minimize risk, 340B teams need to realize that spot audits and manual checks are no longer sufficient in a world where every transaction can be questioned. Here are the most important strategies that organizations should prioritize integrating into their 340B compliance program:
1. Validate Every Transaction
Relying on sample-based or periodic audits leaves too much to chance. To ensure you’re fully compliant, you need to validate every single transaction. A 100% audit approach allows you to uncover issues in real time, not months after they’ve impacted your program.
2. Focus Your Team Where It Matters
The process of auditing every transaction cannot be a manual one. Technology should take on the heavy lifting. Automating 100% audits increases compliance confidence and lets your analysts and pharmacy teams focus only on the true exceptions that require manual review.
3. Support Continuous Compliance
Your 340B program compliance should be ongoing and consistently enforced across every area:
- Eligibility: Ensure every patient and prescriber meets the 340B definition.
- Duplicate Discounts: Actively monitor to prevent Medicaid duplicate discounts.
- Diversion: Confirm that drugs are only dispensed to eligible patients in eligible settings.
4. Build the Right Operational Infrastructure
Creating policies and procedures that meet 340B program requirements is only part of the puzzle. You need to operationalize them through purpose-built tools that can scale with your program, adapt to changes, and ensure consistency across sites and teams.
5. Leverage Expert Guidance and Available Technology
Staying compliant isn’t a one-person, or even one-team, job. You need access to trusted experts who understand regulatory nuance and the technology to put that guidance into action. That combination is what future-proofs your 340B program.
Why Automated and Continuous 340B Program Compliance Is a Must-Have in 2025
If you’re still relying on partial audits, you’re exposed. A 100% audit approach to 340B compliance is no longer a nice-to-have, but rather a foundational requirement to remain in business. It’s how you:
- Achieve total confidence in the integrity of your program
- Catch compliance risks early, before they escalate
- Prepare for HRSA or manufacturer audits with complete, transaction-level documentation
- Preserve your 340B savings margin by addressing issues proactively
Don’t wait for the next audit or the next policy change to find out your program has blind spots. Learn how 340BCheck can help you future-proof your 340B program by seeing the software in action.