340B Termination Prevention Strategies
Protect your 340B eligibility with proven strategies to prevent Code 13 (Failure to Recertify) and Code 30 (DSH Percentage Below Minimum) terminations.
Prevention Strategies Overview
Learn how to implement systematic prevention strategies to protect your 340B eligibility
Most Common Termination
Failure to Recertify
Preventable
With proper systems
Months to Reinstate
Minimum timeline
Code 13: Failure to Recertify
The most common and most preventable termination reason. All 340B covered entities must recertify annually—missing the deadline results in automatic termination with no extensions.
Implementation:
- Create multiple reminder layers (not just one)
- Schedule reminders well before the deadline
- Use different reminder systems (calendar, email, task management)
Rationale: Multiple reminders create redundancy so that missing one reminder doesn't result in missing the deadline entirely.
Implementation:
- Identify and formally designate backup Authorizing Officials
- Ensure backup personnel have appropriate authority and access
- Train backup personnel on the recertification process
Rationale: Personnel changes, vacations, and unexpected absences can cause missed deadlines if only one person is responsible.
Implementation:
- Conduct quarterly reviews of contact information in 340B OPAIS
- Update immediately when personnel changes occur
- Whitelist HRSA email domains in spam filters
Rationale: HRSA sends recertification notifications via email. Outdated contact information or blocked emails mean missed notifications.
Implementation:
- Create centralized compliance calendar visible to key stakeholders
- Include all 340B-related deadlines (not just recertification)
- Assign ownership for each deadline
Rationale: A comprehensive calendar ensures recertification is viewed as part of ongoing compliance obligations.
Implementation:
- Schedule quarterly or semi-annual internal audits
- Review all 340B program requirements systematically
- Document findings and corrective actions
Rationale: The Authorizing Official must attest to compliance with all 340B program requirements during recertification. Regular audits ensure this attestation is accurate and that no compliance issues will prevent timely recertification.
If terminated due to Code 13, reinstatement requires:
- • Establishing systems to prevent future missed deadlines
- • Designating backup personnel for recertification
- • Implementing automated reminder systems
- • Ensuring current contact information in 340B OPAIS
Key Insight: The reinstatement path for Code 13 is "more straightforward" than other termination reasons, since it only requires better administrative systems, not fundamental operational changes.
Code 13 vs. Code 30: Key Differences
Understanding the distinctions helps prioritize prevention efforts
| Aspect | Code 13 (Failure to Recertify) | Code 30 (DSH Below Minimum) |
|---|---|---|
| Preventability | Entirely preventable through administrative systems | Partially preventable; some factors beyond hospital control |
| Prevention Focus | Administrative processes and reminders | Continuous monitoring and strategic planning |
| Time Horizon | Annual cycle with specific deadlines | Ongoing monitoring with annual calculation |
| Controllability | Fully within organization's control | Influenced by external factors (demographics, policy) |
| Reinstatement Path | "More straightforward" - requires better systems | Requires fundamental change in patient mix/DSH percentage |
| Prevention Strategies | 5 specific strategies detailed | General monitoring and documentation emphasized |
High Priority: Code 13 Prevention (Immediate)
Implement all five prevention strategies immediately. These are low-cost, high-impact administrative measures. Code 13 is the most common termination reason and prevention is entirely within your control.
Medium Priority: DSH Monitoring (Within 6 Months)
For DSH hospitals only: Establish quarterly DSH percentage calculations, create early warning thresholds, and document trends and contributing factors.
Ongoing: Comprehensive Compliance Program
Regular internal audits (supports Code 13 prevention), continuous monitoring of eligibility factors (supports Code 30 prevention), and documentation systems for all 340B requirements.
Need Help Implementing These Strategies?
Our compliance experts can help you establish robust prevention systems tailored to your organization.