The Vendor is required to provide conduct an independent annual audit of its Ryan white 340b program to ensure compliance with all applicable federal regulations and program requirements.
- Requirement:
1. Annual independent audit
• Provide an annual independent audit onsite or remote to include, but not limited to:
o Review current policies, procedures, and other 340b related documents.
o Review current 340b compliance strategies in place (or need to be in place) and quality assurance processes, and if available, current compliance with policies and procedures or verbalized processes.
• 340b compliance strategies include those related to:
o 340b diversion
o Duplicate discounts
o The GPO prohibition (if applicable)
o Auditable records
o OPAIS registration and information
o Other applicable 340b requirements
2. Recommendations
• Provide recommendations for policies, procedures, and other 340b related documents (e.g., audit guides and audit documentation forms) as needed to match OPA 340b program recommendations and requirements.
3. Audit activities (pre-work, post-work and on-site work
• Review 340b contract pharmacy prescriptions filled at contract pharmacies and in-house pharmacies (as applicable) for a six (6)-month window.
• Review 340b provider administered drug purchasing and utilization processes and samples.
• Review of clinic location 340b eligibility and contract pharmacies to determine if the prescriptions match with an encounter at eligible clinic.
• Medicaid and Medicaid managed care treatment for duplicate discount.
• Review physician list to ensure appropriate providers are listed.
• Provide a complete audit report with compliance gap analysis and action plan within twenty to thirty (20-30) business days of audit.
4. Ongoing compliance consulting
• 340b education (e.g., use of audit guides, purchasing)
• Corrective action plan creation and review
• 340b related contract review
• Discussions on 340b processes
• Q&A via email or phone
• Vendor process review
• 340b vendor calls (e.g., implementation, maintenance)
• 340b eligible location strategic planning and discussion
• Attendance of quarterly 340b
• Leadership team meeting.
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