340BRight

Audit-Ready Is Not Optional: If You’re Scrambling, You’re Already Behind

Apr 21, 2025

The Reality of 340B Compliance in 2025

For covered entities participating in the 340B Drug Pricing Program, compliance is no longer a theoretical exercise or a check-the-box requirement. It is a daily operational standard, and the bar continues to rise. HRSA audits are more frequent, more detailed, and more likely to result in findings that can carry significant financial and reputational consequences.

The days of last-minute preparations and reactive responses are over. If your organization is scrambling when an audit notice arrives, you are already behind. The expectation is clear: audit-ready is the baseline, not a best-case scenario.

HRSA’s Scrutiny Is Real—and Growing

HRSA continues to enforce program integrity through rigorous audit activity. In recent years, the agency has conducted more than 200 audits per year on average, with a consistent focus on areas such as:

  • Patient eligibility
  • Contract pharmacy oversight
  • Duplicate discount prevention
  • Accurate child site registration
  • Documentation of 340B-related savings use

Findings are common. According to HRSA’s public data, roughly 80 percent of audited entities have at least one finding. The message is clear: compliance cannot be an afterthought. It must be embedded in daily operations.

Systems, Not Shortcuts

Many covered entities fall into the trap of viewing 340B compliance as a series of forms to fill out, spreadsheets to maintain, and reports to pull when the audit arrives. This approach is not sustainable—and it is not enough.

A truly compliant 340B program requires a systems-based approach that includes:

  • Clear policies and procedures that align with HRSA guidance
  • Routine internal audits that mirror HRSA’s audit focus areas
  • Integrated tracking systems that capture dispensing data, eligibility checks, and financial records in real time
  • Regular training for staff at all levels, from pharmacy technicians to leadership, ensuring that everyone understands their role in maintaining program integrity
  • Documentation that tells the full story—not just numbers on a page, but narratives that demonstrate how your program benefits patients and the community

Without these systems in place, your 340B program is operating on borrowed time.

The Cost of Falling Behind

Scrambling to prepare for an audit creates unnecessary risk. Gaps in documentation, incomplete data, and inconsistent practices are not only harder to fix under pressure—they are also more likely to result in HRSA findings that require costly repayments, program changes, or, in the worst case, loss of 340B eligibility.

Beyond the immediate financial risks, there are reputational consequences. The 340B program is under intense scrutiny from policymakers, the pharmaceutical industry, and the public. Covered entities must be able to demonstrate compliance, transparency, and responsible stewardship of the program’s benefits. If you cannot tell that story confidently and consistently, you will find yourself at a disadvantage in the broader debate about the program’s future.

A Call to Action for Covered Entities

If you are reading this and feeling a sense of urgency—that is good. It means you recognize that 340B compliance is not optional. It is a core competency for any organization that relies on the program to support patient care.

The next step is to take ownership. Ask yourself:

  • Do we have a documented, up-to-date compliance plan?
  • Are we conducting regular self-audits that mirror HRSA’s audit process?
  • Can we clearly demonstrate how 340B savings are used to support our mission?
  • Are we training our team—not just the pharmacy staff, but finance, compliance, and leadership—on 340B requirements and expectations?
  • If HRSA called tomorrow, could we provide complete documentation without scrambling?

If the answer to any of these questions is no, now is the time to act.

Conclusion

The 340B program remains a vital resource for hospitals and health centers serving patients who face significant barriers to care. But with that resource comes responsibility. The expectation is no longer that you are audit-prepared once a year, or when a notice arrives. The expectation is that you are audit-ready, every day.

There are no shortcuts. There is only the discipline of doing the work—building systems, embedding compliance into operations, and holding your team accountable. That is the price of participation in 340B today. And it is a price worth paying to ensure that the program continues to serve the patients and communities who need it most.