Corrective Action Plan (CAP)
Definition
When HRSA identifies compliance deficiencies during an audit, it may require the covered entity to submit a Corrective Action Plan (CAP). The CAP documents the specific actions the entity will take to address each finding, the timeline for implementation, and the controls that will be put in place to prevent recurrence.
CAPs are reviewed and approved by HRSA. The entity must implement the plan within the agreed timeline and may be subject to follow-up review to verify that corrective actions have been completed. Depending on the nature and scope of the findings, the CAP may also include a repayment component for improperly obtained 340B savings.
Receiving an HRSA finding and submitting a CAP is a significant compliance event. It creates a documented record of prior findings, which may influence future audit selection and scrutiny. Covered entities that have received CAPs should treat them as a serious signal to invest in comprehensive compliance program improvements.
Frequently Asked Questions
Why Corrective Action Plan (CAP) Matters
A CAP is not just a paperwork exercise—it is a formal commitment to HRSA that identified problems will be fixed. Failing to implement a CAP as agreed can escalate enforcement consequences. More importantly, the findings that triggered the CAP represent real compliance vulnerabilities that must be genuinely remediated.
How Virtue 340B Uses It
Virtue 340B helps covered entities develop and implement CAPs following HRSA findings, ensuring that remediation is substantive, well-documented, and genuinely reduces the risk of recurrence. We also work with entities that have prior CAP history to strengthen their overall compliance posture.