2020 Update to the DOJ's Evaluation of Corporate Compliance Program Guidance

• Published in: Journal of Health Care Compliance 2020-09, Vol.22 (5), p.17-61
• Main Authors: Faget, Kyle Y, Shalom, Allie
• Format: Article
• Language: English
• Subjects: COVID-19; Employees; Medical equipment; Telephone hotlines
• ISSN: 1520-8303

An effective compliance program also guards such compa-nies against civil and/or criminal liability for fraudulent activities.1 When a company engages in fraud, the U.S. Department of Justice (DOJ) may prosecute such conduct as a corporate crime.2 In doing so, the DOJ promotes a variety of public interest, including: "(1) protecting the integrity of our economic and capital markets by enforcing the rule of law; (2) protecting consumers, investors, and business entities against competitors who gain unfair advantage by violating the law; (3) preventing violations of environmental laws; and (4) discouraging business practices that would per-mit or promote unlawful conduct at the expense of the public interest. According to the United States Sentencing Commission (USSC), there were 425 health care fraud offenders in 2018.4 On June 1, 2020, the DOJ published an update to its Evaluation of Corporate Compliance Program Guidance (the "2020 Update").5 The DOJ first pub-lished its Evaluation of Corporate Compliance Program Guidance in February 2017 (the "2017 Guidance") and subsequently updated it in April 20196 (the "2019 Update," collectively with the 2020 Update and the 2017 Guidance, the "Guidance"). [...]the nature of some crimes may be such that national law enforcement policies mandate prosecutions of corpora-tions notwithstanding the existence of a compliance program.7 Although the DOJ Justice Manual pro-vides some guidance to prosecutors on how to evaluate a corporate compliance program, the Guidance provides addi-tional insight and criteria for prosecu-tors when they are deciding whether or not to prosecute or resolve an offense, what monetary penalties to impose, and ongoing compliance obligations to include in a criminal resolution.8 As such, the Guidance also provides companies with helpful insight into the DOJ priorities and serves as a useful guidepost for com-panies that are designing, implementing, and updating their corporate compliance programs. Specifically, prosecutors should give weight to how a corporation tailors its compliance program based on a variety of factors, including but not limited to: * the company's size, * industry, * geographic footprint, * regulatory landscape, and * other factors, both internal and external to the company's operations.12 For example, a company looking to commercialize a pharmaceutical product for the first time may have a core scalable compliance program, whereas a multi-product commercial-stage pharmaceutical