Regulatory and Legal Requirements (Fraud and Abuse, Privacy, Coding/Billing)
What this domain tests
Know the core federal frameworks at a conceptual level. False Claims Act: prohibits knowingly presenting false claims; includes qui tam relators and treble damages plus per-claim penalties; "knowingly" includes deliberate ignorance and reckless disregard. Anti-Kickback Statute: criminal prohibition on remunerating referrals of items or services payable by federal healthcare programs; intent-based; safe harbors provide protection. Stark Law: civil strict-liability prohibition on physician self-referral for designated health services with a financial relationship, unless an exception applies; no intent required. Civil Monetary Penalties Law and Exclusion authorities round out enforcement. HIPAA Privacy and Security Rules govern protected health information use, disclosure, minimum necessary, safeguards, breach notification, and business associate obligations.
Traps to expect
- Stark vs. AKS: Stark is strict liability and physician-focused; AKS is intent-based and covers any referral source. A question with "no intent to violate" points to Stark analysis.
- Safe harbor vs. exception: AKS has safe harbors; Stark has exceptions. Swapping terms is a common distractor.
- Minimum necessary does not apply to treatment disclosures.
- Upcoding vs. unbundling vs. medical necessity: match the described behavior to the correct term.
- Business associates must have written assurances and breach obligations.
Rule of thumb
Ask two questions: Is a federal program paying? (triggers AKS/Stark/FCA) and Is PHI involved? (triggers HIPAA). Then check whether an exception, safe harbor, or permitted disclosure applies.
Worked example
A physician owns the lab her group refers to and orders tests for Medicare patients. Even with no improper intent, Stark is implicated because a financial relationship exists and designated health services are involved; the analysis turns on whether an exception (e.g., in-office ancillary services) is satisfied. If the arrangement also involved payments per referral, AKS intent analysis would follow.