Regulatory Compliance and Ethical Standards
The anti-kickback statute and Stark law
Candidates must distinguish the Anti-Kickback Statute (AKS), which prohibits remuneration for referrals of federally payable items, from the Physician Self-Referral Law (Stark), which prohibits physician referrals to entities with which they have a financial relationship, absent an exception. A trap is assuming a discount or free equipment is harmless; anything of value tied to referrals is suspect. Safe harbors and exceptions exist but must be met precisely.
False Claims Act and compliance programs
Know that the False Claims Act imposes liability for knowingly submitting false claims, and that whistleblower (qui tam) actions are common. A robust compliance program-written standards, a compliance officer, training, auditing, and a hotline-is a mitigating factor. Questions often test whether a supplier must self-report an overpayment; the answer is generally yes, within a defined period.
HIPAA and patient privacy
Understand minimum necessary use, safeguards for electronic protected health information, and the requirement to report breaches. A trap is sharing patient information with a marketing partner without authorization.
Accreditation and supplier standards
Medicare requires suppliers to meet enrollment standards and, for certain items, accreditation. Know that a supplier must be enrolled, bonded where required, and compliant with the supplier standards (e.g., no unsolicited contact, honoring warranties).
Ethical decision rule
If a marketing arrangement pays a referral source per patient, stop and analyze it under AKS before signing. Document the analysis. Rule of thumb: if the payment varies with the volume or value of referrals, it likely needs a safe harbor.