Law.com Subscribers SAVE 30%
Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.
Creating Private-Sector Standards of Conduct
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 Corporate Enforcement Policy: One Year Later
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.
Use of Deferred Prosecution Agreements In White Collar Investigations
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.
The DOJ's New Parameters for Evaluating Corporate Compliance Programs
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.
CLE Shouldn't Be the Only Mandatory Training for Attorneys
Each stage of an attorney's career offers opportunities for a curriculum that addresses both the individual's and the firm's need to drive success.
Discovery of Claim Construction and Infringement Analysis May be Compelled Prior to a Markman Hearing
A defendant in a patent infringement suit may, during discovery and prior to a <i>Markman</i> hearing, compel the plaintiff to produce claim charts, claim constructions, and element-by-element infringement analyses.