Healthcare is one of the most heavily regulated industries in the United States because organizations handle sensitive health information, receive substantial public funding, make decisions affecting patient safety, and operate within complex relationships among physicians, hospitals, insurers, pharmaceutical companies, device manufacturers, laboratories, contractors, and government programs. For managers, compliance is therefore not merely a legal department responsibility. It is an enterprise governance function that influences strategy, revenue, contracting, technology, workforce management, mergers and acquisitions, clinical operations, and organizational reputation.
Regulatory & Compliance in Healthcare is an advanced Junior MBA course designed to develop practical managerial judgment in navigating this environment. Rather than repeating introductory healthcare law or basic compliance concepts, the course focuses on how senior leaders build effective compliance systems, identify risk before it becomes misconduct, structure business arrangements appropriately, govern billing and reimbursement, protect patient information, manage third parties, respond to investigations, and integrate regulation into enterprise strategy.
A major emphasis is placed on the difference between knowing a rule and managing an organization so that the rule is followed in practice. HHS OIG’s current General Compliance Program Guidance describes core compliance-program infrastructure and identifies seven elements commonly used to structure healthcare compliance programs; OIG also emphasizes that its guidance is voluntary and nonbinding, while healthcare entities remain responsible for applicable legal requirements.
The course therefore trains students to think like executives who must ask: Where could our organization create compliance exposure? Who owns the control? What data would reveal a problem? How do compensation arrangements affect risk? Are our billing practices defensible? Are vendors creating exposure on our behalf? What happens when a violation is discovered? And how should regulatory risk influence a strategic decision before the organization commits capital?
Course Objectives
By the end of this course, students will be able to:
• Analyze healthcare regulation from an executive and enterprise-risk perspective.
• Understand the architecture of healthcare compliance programs.
• Distinguish among major federal fraud-and-abuse risks affecting healthcare organizations.
• Evaluate physician compensation, referral, contracting, and ownership arrangements for compliance risk.
• Understand the managerial implications of the physician self-referral law.
• Recognize Anti-Kickback Statute risk in common healthcare business relationships.
• Understand False Claims Act exposure associated with billing, coding, reimbursement, and certifications.
• Evaluate healthcare billing and documentation controls.
• Understand privacy and security governance surrounding protected health information.
• Develop compliance systems for employees, contractors, vendors, and other third parties.
• Analyze compliance implications of mergers, acquisitions, joint ventures, and affiliations.
• Evaluate pharmaceutical, device, laboratory, and provider-specific compliance risks.
• Understand exclusion screening and federal healthcare program participation risks.
• Assess conflicts of interest and organizational ethics.
• Build monitoring, auditing, reporting, investigation, and corrective-action systems.
• Understand when self-disclosure and government engagement may become relevant.
• Evaluate compliance risks associated with value-based care and emerging business models.
• Integrate healthcare compliance with board governance, enterprise risk management, and corporate strategy.
• Build a culture in which compliance supports operational integrity rather than functioning only as a defensive legal mechanism.
