EVALUATING U.S. FRAUD AND ABUSE COMPLIANCE CONTROLS, INCLUDING CORPORATE INTEGRITY AGREEMENT PROVISIONS, FOR A GLOBAL ANTICORRUPTION COMPLIANCE PROGRAM

• Published in: The Health Lawyer 2016-08, Vol.28 (6), p.25-35
• Main Authors: Partridge, John D W, Chung, Daniel P, Sucherman, Micah
• Format: Article
• Language: English
• Subjects: Bribery; Compliance; Corruption; Enforcement; Foreign subsidiaries; Fraud; Health care; Marketing; Settlements & damages
• ISSN: 0736-3443

To the contrary, the DOJ and the U.S. Securities and Exchange Commission ("SEC") - and foreign regulators - have admonished that companies should adopt risk-based FCPA compliance programs with certain core elements. Because CIAimposed obligations often go much further than the core compliance elements recommended by the DOJ and the SEC - and also may not match a company's risk profile overseas - a full-scale export of a company's CIAimposed obligations is unlikely to be necessary or practical. [...]the DOJ routinely demands, as a condition of settlement, that companies implement the following pillars of a compliance program: * High-level commitment to compliance; * Policies and procedures addressing specified risk areas and financial and accounting controls; * Periodic risk assessments; * Senior-level responsibility for the compliance program; * Training and guidance; * Internal reporting and investigation; * Enforcement and discipline; * Due diligence and compliance requirements relating to third-party relationships; * Policies and procedures for mergers and acquisitions; and * Monitoring and testing.42 These high-level elements (derived from DOJ, SEC, and OIG guidance and the terms of FCPA resolutions) are the core pillars of an FCPA- or AKS-focused compliance program.43 However, U.S. regulators generally recognize that companies must tailor their compliance programs to their "specific needs, risks, and challenges," focusing on, among other factors, the territories in which they operate, the size and scope of their operations, and their business models.44 Because they recognize that compliance programs should be tailored to a company's specific risks, U.S. regulators (with the notable exception of the OIG) rarely prescribe specific compliance controls that companies can implement to operationalize the high-level elements of an effective compliance program. [...]to flesh out the fundamental elements of a global anti-corruption compliance program with practicable, pragmatic internal controls, U.S. healthcare companies generally must look elsewhere for guidance.45 Risk-Based Compliance Controls As detailed below, there are several critical areas of risk that healthcare companies must address to comply with the AKS and the FCPA. [...]Party Agents, Consultants, Distributors, and Joint-Venture Partners Both the AKS and the FCPA's anti-bribery provisions encompass direct and indirect corrupt payments. [...]financial relationships with third-party agents, consul