Healthcare Law, Regulation, and Compliance
What to know
Know the major federal statutes shaping healthcare: HIPAA (privacy and security), EMTALA (emergency screening and stabilization), Stark (physician self-referral), the Anti-Kickback Statute (remuneration for referrals), and the False Claims Act (fraud). Understand fraud, waste, and abuse distinctions, the role of a compliance program (policies, training, auditing, hotlines), and corporate integrity agreements. Grasp consent, advance directives, and confidentiality basics, plus licensure, accreditation, and scope-of-practice concepts.
Traps
Questions often confuse Stark and the Anti-Kickback Statute: Stark is a strict-liability civil statute limited to physician referrals of designated health services to entities with a financial relationship; the Anti-Kickback Statute is a criminal intent-based statute covering remuneration for referrals of federally payable items. Another trap is assuming HIPAA prohibits all disclosures-treatment, payment, and operations exceptions exist. EMTALA applies to Medicare-participating hospitals with emergency departments.
Worked example
A hospital leases office space to a referring physician below fair market value. This implicates Stark (financial relationship plus referral of designated health services) and potentially the Anti-Kickback Statute. Rule of thumb: fair market value and commercially reasonable terms are the safe-harbor anchors.
Review compliance program elements and whistleblower protections, since scenario questions test reporting obligations.