Compliance and Ethics: Program Elements, Statutes, and Judgment Calls
Start with the framework
Every candidate should be able to recite the seven elements of an effective compliance program without notes: written policies and procedures; a designated compliance officer and compliance committee with defined authority; effective training and education; open lines of communication (including anonymity and non-retaliation); internal monitoring and auditing; enforcement and discipline; and prompt corrective action and prevention. Questions often test the function of an element rather than its name - a hotline employees are afraid to use fails the communication element even though the hotline exists.
Statutes you must keep straight
- False Claims Act: liability for knowingly submitting false claims; "knowingly" includes deliberate ignorance and reckless disregard, so no proof of specific intent is required.
- Anti-Kickback Statute: criminal, intent-based, covers remuneration to induce referrals for items or services payable by a federal health care program; the "one purpose" rule applies.
- Stark: civil, strict liability, no intent needed; it reaches physician referrals of designated health services to entities with which the physician has a financial relationship unless an exception fits.
- Exclusion and the LEIE: screening employees and vendors against the OIG List of Excluded Individuals/Entities is a recurring exam point.
Traps
Assuming the compliance officer should report to the CFO (independence matters); treating a signed code of conduct as sufficient training; forgetting expected board oversight; and answering "Anti-Kickback" when the scenario describes a strict-liability physician self-referral problem.
Rule of thumb
If you would have to explain why an arrangement is fair, get a documented compliance review before the money moves. Keep the analysis, not just the conclusion.