The Anti-Kickback Statute (AKS) and Stark Law are two of the most critical laws governing financial relationships in healthcare. These laws impose strict limitations on physician referrals and financial arrangements to prevent fraud, abuse, and conflicts of interest in Medicare and Medicaid reimbursement. Violations can lead to severe civil and criminal penalties, including exclusion from federal healthcare programs, heavy fines, and imprisonment.
This course provides an in-depth legal analysis of AKS and Stark Law compliance, regulatory interpretations, safe harbors, enforcement actions, and best practices for structuring legally compliant financial relationships in healthcare. Students will gain expertise in navigating complex regulatory requirements, structuring business arrangements to avoid violations, and responding to government investigations.
Course Objectives
By the end of this course, students will:
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Understand the Legal and Regulatory Framework of the Anti-Kickback Statute (AKS) and Stark Law – Analyze the purpose, scope, and enforcement mechanisms of these laws.
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Examine the Differences Between AKS and Stark Law – Learn how these statutes apply to different types of financial relationships and transactions.
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Evaluate Safe Harbors and Exceptions That Allow Legal Financial Arrangements – Study when and how certain financial relationships are permissible under the law.
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Analyze Case Law and DOJ/OIG Enforcement Actions – Review key legal precedents and settlements involving Stark Law and AKS violations.
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Assess the Legal and Compliance Risks of Physician Referrals and Financial Incentives – Investigate high-risk areas, including physician ownership in healthcare entities, joint ventures, and marketing arrangements.
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Explore Corporate Compliance Programs and Internal Auditing Strategies – Develop best practices for preventing violations and ensuring regulatory adherence.
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Identify Strategies for Responding to Investigations and Government Enforcement Actions – Learn how to manage audits, subpoenas, and whistleblower allegations effectively.
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Prepare for Future Regulatory Changes and Evolving Compliance Risks – Examine trends in healthcare fraud enforcement, proposed legislative changes, and new regulatory guidance.
