‍The 340B program plays a vital role in supporting hospital operations—but many covered entities are finding that staying compliant doesn’t always mean they’re operating efficiently.

In a landscape shaped by shifting policies, evolving manufacturer requirements, and increased scrutiny, it’s not uncommon for even well-managed programs to develop operational gaps that impact savings, oversight, and audit readiness.

At RxTrail, we work with hospitals and health systems across the country to identify areas where programs are technically compliant but underperforming. In many cases, the missed opportunities come down to limited visibility, outdated processes, or assumptions about TPAs.

1. Compliance Isn’t the Same as Optimization

While meeting HRSA expectations is foundational, covered entities often overlook areas where internal systems aren’t aligned, or where external partners (like TPAs or contract pharmacies) may be missing eligible claims.

Common examples include:

• Inconsistent flagging of Medicaid managed care claims
• Manual processes for ESP submissions or data configuration
• Gaps in tracking drug replenishment by contract pharmacy
• Inaccurate or missing encounter feeds and/or settings results in unclaimed 340B savings on eligible WAC-purchased drugs

These issues rarely trigger compliance concerns—but they often have a direct financial impact.

2. Limited Oversight Creates Long-Term Risk

Executives and compliance officers frequently lack consolidated reporting that brings together internal pharmacy data, TPA performance, contract pharmacy trends, and 340B claim outcomes.

Without centralized oversight, key questions go unanswered:

• Are all eligible claims being captured and classified correctly?
• Are our systems set up to respond to manufacturer policies and reporting requests?
• Do we have a clear escalation process for blocked claims or ESP disputes?

Small oversights often compound over time—making periodic reviews essential.

3. Operational Gaps Can Be Costly

Hospitals that are technically compliant but operationally limited can miss out on substantial savings—especially if:

• Replenishment logic is misaligned with current inventory practices
• ESP configurations are not kept up to date
• In-house pharmacies aren’t properly set up to capture MCO claims
• Carve-in decisions are not accurately reflected in OPAIS

These challenges aren’t always easy to spot internally—especially when third-party systems mask the root causes.

4. Proactive Management Matters More Than Ever

As state-level policies evolve (e.g., Kentucky DMS) and manufacturers continue to refine restrictions, covered entities must be prepared to adapt quickly. A proactive approach now can prevent issues later—both financially and operationally.

Programs that routinely assess their internal structure, reporting tools, and partner performance are better positioned to:

• Capture full savings potential
• Respond effectively to audit requests
• Adapt to evolving manufacturer data demands
• Maintain compliance across multiple payers and systems

Strong 340B programs don’t just meet requirements—they are actively monitored, clearly documented, and regularly optimized. By building visibility into your program now, you can minimize risk, uncover additional value, and ensure your hospital is well-positioned for whatever comes next.

Looking to strengthen oversight and performance in your 340B program?

RxTrail offers a personalized approach to help hospitals evaluate operations, align systems, and optimize savings—while maintaining full audit readiness. Contact us today to learn more.

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