Mr. Aspinwall presents a comprehensive overview of the anti-kickback statute to show how Congress enacted the legislation to prevent inappropriate utilization and to reduce the ambiguity of the anti-kickback prohibitions by adding a knowing and willful requirement to the standard of intent. He discusses the different lines of caselaw on the anti-kickback standard of intent, and closely examines the standard endorsed by the OIG. He proposes adopting a standard of reasonableness modeled after the rule of reason from antitrust law, using cost-effectiveness as the primary criterion. He argues that a cost-benefit outcomes-based approach to the anti-kickback statute would better serve the public interest.

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