Health Law, Regulation, and Compliance
What to know
This domain covers the legal and regulatory framework governing healthcare. Candidates must know the major fraud and abuse laws: the False Claims Act (including qui tam provisions), the Anti-Kickback Statute (knowingly offering remuneration for referrals), the Stark Law (physician self-referral for designated health services), and the Civil Monetary Penalties Law. Understand EMTALA (emergency screening and stabilization), HIPAA (privacy and security rules), the HITECH Act, and antitrust basics.
Compliance program elements are heavily tested: written policies, a compliance officer and committee, training, communication lines, internal monitoring and auditing, enforcement and discipline, and response and prevention. Know the seven elements framework and the role of the compliance committee reporting to the board.
Also know licensure, credentialing, informed consent, mandatory reporting, and corporate negligence/vicarious liability concepts.
Traps
A frequent trap is confusing Stark (strict liability, physician self-referral, designated health services) with the Anti-Kickback Statute (intent-based, broader remuneration). Another is assuming HIPAA prohibits all disclosures - permitted disclosures for treatment, payment, and operations exist. Watch for EMTALA questions that confuse transfer stabilization with admission.
Worked example / rule of thumb
Rule of thumb: Stark = self-referral, no intent needed; AKS = remuneration for referrals, intent needed. If a physician refers to a lab they own without an exception, Stark applies regardless of intent. For compliance programs, remember the seven elements start with policies and end with response and prevention.