Compliance
Regulatory landscape
Compliance means following laws, regulations, and payer rules. Key statutes: HIPAA/HITECH for privacy and security, False Claims Act for fraud and qui tam actions, Anti-Kickback Statute for remuneration for referrals in federal programs, Stark for physician self-referral, EMTALA for emergency screening, CLIA for laboratories, OSHA for workplace safety, and Medicare Conditions of Participation. The Joint Commission adds accreditation standards.
Compliance program
The seven elements are written policies, a compliance officer and committee, training and education, communication lines, auditing and monitoring, discipline, and corrective action. Perform risk assessments, coding audits, and security risk analyses, and monitor the OIG Work Plan, LEIE exclusions, and RAC audits.
Fraud versus abuse
Fraud is intentional deception; abuse is inconsistent with accepted practices and may be unintentional. Waste is unnecessary resource use. Reporting is often mandatory when a violation is known, and retaliation is prohibited.
Trap
Stark and Anti-Kickback are not the same: Stark is a strict-liability physician self-referral prohibition with exceptions; Anti-Kickback requires intent and covers remuneration broadly.
Rule of thumb
Document the what, who, when, and why of every compliance investigation, and preserve confidentiality and legal privilege.