Risk Assessment (340B)
Definition
A 340B risk assessment is a systematic review of a covered entity’s program operations, documentation, and controls to identify where compliance risks are concentrated. It examines factors such as patient eligibility data quality, contract pharmacy controls, split-billing software configuration, OPAIS accuracy, Medicaid billing practices, vendor oversight, and policies and procedures currency.
The output of a risk assessment is a prioritized risk inventory that helps program managers and leadership understand where to focus remediation efforts. Risk assessments can be conducted as standalone exercises or as part of a broader audit or consulting engagement.
Risk assessments are most valuable when conducted regularly—at least annually—and updated whenever significant operational changes occur. They provide a structured, documented basis for compliance decision-making and demonstrate good-faith program oversight to HRSA.
Frequently Asked Questions
Why Risk Assessment (340B) Matters
Without a structured risk assessment, covered entities may not know where their compliance vulnerabilities lie until HRSA identifies them. A proactive risk assessment provides the roadmap needed to address gaps before they become findings.
How Virtue 340B Uses It
Virtue 340B conducts risk assessments as part of every audit and consulting engagement. We evaluate each covered entity's specific risk profile and provide a prioritized, actionable risk inventory that drives remediation planning.