The 340B Drug Pricing Program provides significant savings for covered entities, but with those savings comes strict compliance requirements. Pharmacy software plays a critical role in maintaining 340B compliance and maximizing program benefits.
Understanding the 340B Program
The 340B program requires drug manufacturers to provide outpatient drugs at significantly reduced prices to eligible healthcare organizations (covered entities).
Who Qualifies as a 340B Covered Entity?
- Federally Qualified Health Centers (FQHCs)
- Ryan White HIV/AIDS Program grantees
- Disproportionate Share Hospitals (DSH)
- Children's hospitals
- Critical Access Hospitals
- Sole Community Hospitals
- Rural Referral Centers
- Free-standing cancer hospitals
340B Savings Potential
| Drug Category | Typical 340B Discount | |---------------|----------------------| | Brand Name Drugs | 25-50% off AWP | | Specialty Drugs | 30-60% off AWP | | Generic Drugs | 15-30% off AWP |
Critical 340B Compliance Requirements
1. Patient Eligibility
A 340B-eligible prescription requires:
- Patient is registered at the covered entity
- Prescriber is employed/contracted by the covered entity
- Drug is for outpatient use
- Prescription is related to covered entity visit
2. Prohibition on Duplicate Discounts
The same drug cannot receive both:
- 340B pricing AND Medicaid rebate
- Must have systems to prevent duplicate discounts
3. Prohibition on Diversion
340B drugs must only be dispensed to eligible patients at the covered entity or its contract pharmacy.
4. Audit Requirements
Covered entities must maintain records for:
- Patient eligibility verification
- Prescription-to-dispense tracking
- Inventory separation (physical or virtual)
- Manufacturer compliance
Essential 340B Software Features
1. Split Billing Capabilities
Split billing is crucial for 340B compliance:
Virtual Inventory Model:
- Single physical inventory
- Software tracks 340B vs. non-340B accumulator
- Replenishment triggers based on 340B dispensing
Physical Inventory Model:
- Separate 340B and non-340B stock
- Software tracks which inventory is used
- Requires more space but cleaner separation
Key Software Requirements:
- Real-time accumulator tracking
- Replenishment order generation
- Inventory reconciliation reports
- Audit trail for all transactions
2. Patient Eligibility Verification
Software should verify eligibility at point of sale:
- Patient registration status at covered entity
- Prescriber affiliation verification
- Relationship between Rx and CE visit
- Real-time eligibility decision
Integration Points:
- EMR/EHR integration for patient data
- Prescriber database synchronization
- Visit history verification
- Insurance carve-out identification
3. Contract Pharmacy Management
For contract pharmacy arrangements:
- Covered entity data integration
- Third-party administrator (TPA) connectivity
- Claims submission to 340B TPA
- Reconciliation reporting
4. Medicaid Carve-Out/Carve-In
Prevent duplicate discount violations:
Carve-Out States:
- Dispense 340B drugs to Medicaid patients
- Bill Medicaid, no manufacturer rebate claimed
- Track carve-out claims separately
Carve-In States:
- Do NOT use 340B for Medicaid patients
- Bill Medicaid, manufacturer claims rebate
- Software must prevent 340B dispensing
5. Audit Trail and Documentation
Comprehensive record-keeping:
- Every 340B determination recorded
- Eligibility verification documented
- Prescription-to-dispense chain maintained
- Exception handling logged
- Adjustment documentation
340B Software Comparison
| Feature | Basic PMS | 340B-Enabled PMS | Dedicated 340B Solution | |---------|-----------|------------------|------------------------| | Split Billing | No | Yes | Yes | | Eligibility Verify | Manual | Automated | Automated | | Accumulator | No | Basic | Advanced | | Contract Pharmacy | No | Limited | Full | | HRSA Integration | No | Some | Yes | | Audit Reports | No | Basic | Comprehensive | | Cost | $ | $$ | $$$ |
Top 340B Software Solutions
Dedicated 340B Management Platforms
Sentry Data Systems
- Comprehensive 340B management
- Split billing automation
- Contract pharmacy support
- Extensive reporting
Apexus (340B Prime Vendor)
- Owned by HRSA
- Contract pricing assistance
- Compliance resources
- Educational support
Verity Solutions
- End-to-end 340B management
- Claims management
- Contract pharmacy administration
- Audit support
Pharmacy Software with 340B Features
PharmaPOS by MedSoftwares
PharmaPOS supports 340B program management for covered entities:
- Split billing with virtual inventory
- Patient eligibility tracking
- Prescriber affiliation verification
- Accumulator management
- Audit-ready reporting
Learn More About PharmaPOS 340B Features
PioneerRx
- 340B module available
- Split billing support
- Third-party integrations
- Claims processing
PrimeRx
- 340B tracking capabilities
- Contract pharmacy support
- Reporting tools
- Integration options
Implementing 340B Software
Step 1: Assess Current State
Before implementation:
- Current 340B volume
- Contract pharmacy relationships
- Existing software capabilities
- Staff 340B knowledge
- Audit history
Step 2: Choose the Right Solution
Consider:
- Size of 340B program
- In-house vs. contract pharmacy
- Budget constraints
- Integration requirements
- Vendor 340B expertise
Step 3: Configure and Test
Implementation steps:
- Configure patient eligibility rules
- Set up prescriber database
- Define split billing logic
- Establish accumulator thresholds
- Create reporting templates
- Test with sample transactions
Step 4: Train Staff
Critical training topics:
- 340B program basics
- Software operation
- Eligibility determination
- Exception handling
- Documentation requirements
Step 5: Monitor and Audit
Ongoing compliance:
- Regular self-audits
- Monthly reconciliations
- Annual program review
- HRSA audit preparation
Preparing for 340B Audits
HRSA Audit Focus Areas
Audits typically examine:
- Eligibility: Are patients actually eligible?
- Diversion: Are drugs staying within the program?
- Duplicate Discounts: Any Medicaid violations?
- GPO Prohibition: Are you following hospital rules?
- Orphan Drug Rules: Correct for SCH/RRC/CAH?
Software Audit Support
Your software should provide:
- Patient eligibility reports
- Prescription-to-dispense audit trails
- Accumulator reconciliation reports
- Medicaid claims carve-out reports
- Exception documentation
Audit-Ready Checklist
- [ ] All transactions documented
- [ ] Eligibility verification recorded
- [ ] Split billing reconciled
- [ ] Medicaid carve-out documented
- [ ] Contract pharmacy agreements current
- [ ] Staff training records maintained
Common 340B Compliance Pitfalls
1. Eligibility Creep
Problem: Dispensing 340B drugs to ineligible patients Solution: Rigorous eligibility verification at point of sale
2. Inadequate Documentation
Problem: Can't prove compliance during audit Solution: Comprehensive software audit trails
3. Accumulator Mismatch
Problem: Physical inventory doesn't match virtual accumulator Solution: Regular reconciliation and adjustment
4. Prescriber Issues
Problem: Dispensing for non-affiliated prescribers Solution: Real-time prescriber verification
5. Medicaid Duplicate Discounts
Problem: Using 340B for Medicaid in carve-in states Solution: Software carve-in/carve-out logic
Future of 340B and Technology
Regulatory Changes
The 340B program continues to evolve:
- Increased HRSA oversight
- Manufacturer restrictions on contract pharmacies
- New reporting requirements
- State-level regulations
Technology Trends
- Real-time eligibility APIs
- Blockchain for drug tracking
- AI for compliance monitoring
- Cloud-based 340B platforms
Conclusion
Effective 340B program management requires robust pharmacy software with specialized compliance features. The right system helps covered entities maximize savings while maintaining strict compliance.
Whether you're a hospital outpatient pharmacy or contract pharmacy, investing in 340B-capable software is essential for program success.
Contact MedSoftwares to discuss 340B software solutions for your covered entity.
