Healthcare Regulatory Compliance and Fraud, Waste and Abuse
The statutory backbone
Four statutes dominate: the False Claims Act, the Anti-Kickback Statute, the physician self-referral law (Stark), and the Civil Monetary Penalties Law. The False Claims Act imposes treble damages plus per-claim penalties for knowingly presenting false claims and permits qui tam relator suits; knowledge includes deliberate ignorance and reckless disregard, not just actual knowledge. The Anti-Kickback Statute prohibits remuneration intended to induce referrals of federally reimbursed items or services, requires intent, and is satisfied by the one-purpose test; its safe harbors provide protection only if every element is met. Stark is a strict-liability civil statute barring physician referrals of designated health services when a financial relationship exists, unless an exception applies; intent is irrelevant.
The ACA overpayment rule requires returning identified overpayments within 60 days of identification, with the corresponding claim report. Also know the OIG's seven elements of an effective compliance program: written standards and policies, compliance leadership and oversight, training and education, open lines of communication, internal monitoring and auditing, discipline for noncompliance, and prompt corrective action. Screen employees and vendors against the OIG List of Excluded Individuals and Entities and the SAM database before hiring and monthly thereafter.
Traps: applying a Stark intent analysis (there is none), treating a safe harbor as a defense that tolerates partial compliance, and measuring the 60-day clock from when a refund is issued rather than when the overpayment was identified.
Worked example: a hospital pays a referring cardiologist above fair market value for medical director services that are not documented. That is a Stark problem even without any improper motive, and it may also implicate the Anti-Kickback Statute.