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Whether certain conduct is a crime depends on more than legislatures, judges, and juries. When prosecutors decide whether, whom, and what to charge, the policies underlying their decisions create operative standards of conduct. So, too, do those of agencies administering regulatory programs backed by criminal sanctions. But what about the private sector? Sensible standards of conduct articulated by trade associations can and should play a substantial role in drawing the line between acceptable business practices and bad conduct that can be subject to criminal sanctions.
A good example is the recent development of a Compliance Program Guidance for Pharmaceutical Manufacturers under the Medicare/ Medicaid anti-kickback statute, 42 U.S.C. ' 1320a-7b(b)(1)-(2), by the Office of the Inspector General (OIG) of the Department of Health and Human Services. In general, the anti-kickback statute prohibits the payment of any “remuneration” to a provider of health care to influence the provider's selection of any goods or services to be used in health-care covered by Medicare, Medicaid or another federal health care program. The statute has exceptions, 42 U.S.C. ' 1320a-7b(b)(3); and several safe harbors for specific kinds of arrangements have been created by regulation, 42 C.F.R. ' 1001.952. Nevertheless, there remains a large gray area, which makes it hard to know what is prohibited in many kinds of circumstances.
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.
When we consider how the use of AI affects legal PR and communications, we have to look at it as an industrywide global phenomenon. A recent online conference provided an overview of the latest AI trends in public relations, and specifically, the impact of AI on communications. Here are some of the key points and takeaways from several of the speakers, who provided current best practices, tips, concerns and case studies.
The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.