Which of the following is NOT a core element of a Corporate Integrity Agreement?

• A. Hire a compliance officer and appoint a compliance committee
• B. Develop written standards and policies
• C. Conduct an annual external audit
• D. Establish a confidential disclosure program

Answer: (C)

A Corporate Integrity Agreement centers on building an effective internal compliance program that enables a organization to prevent, detect, and remediate improper conduct. Hiring a compliance officer and forming a compliance committee establishes clear governance and accountability for the program, ensuring there is dedicated leadership to oversee compliance activities and escalate issues. Developing written standards and policies provides the rules, procedures, and expectations staff must follow, creating a consistent foundation for training, testing, and enforcement. Establishing a confidential disclosure program gives employees and others a safe way to report concerns or potential violations, which is crucial for uncovering problems early and taking corrective action. An annual external audit, while it may occur in some contexts, is not listed as a core element of the CIA itself. The emphasis is on building an internal program with governance, documented standards, and open reporting, rather than mandating a yearly external audit as part of the core agreement.