PYA Oncology Business Resources | Page 19

340B Assessments

Managing risk while ensuring pharmaceutical program compliance and maximizing cost savings
Challenges
• Increased regulatory oversight of 340B activities
• Limited resources and expertise
• High penalties for improper maintenance of 340B Program documentation
Benefits
• Optimize 340B Program participation
• Meet HRSA recommendation for independent audits
• Demonstrate and ensure compliance
• Reduce pharmaceutical expenses with lower drug pricing
• Maximize revenue stream
• Share cost savings with patients
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• Annual independent audits
• Mock “ HRSA audit readiness ” reviews
• Internal audit work plan design
• Periodic compliance testing
• Reimbursement and cost-reporting assistance
• Mega-guidance impact analysis
• Policy and procedure development and testing
• Covered entity eligibility determination 19