Kathleen M. Boozang

“Monitoring” Corporate Corruption: DOJ's Use of Deferred Prosecution Agreements in Health Care

The Department of Justice (DOJ) has added another weapon to its enforcement arsenal in its ongoing battle against corporate corruption, generally referred to as the pretrial diversion process. With increased frequency, especially in the health care arena with respect to both domestic and international fraud allegations, DOJ agrees to defer or not pursue a criminal prosecution, in exchange for the subject company paying significant fines, entering into a deferred or non-prosecution agreement, expanding its ethical and legal compliance programming, and, in some cases, agreeing to the appointment of a corporate monitor. Considered a less onerous alternative to a federal criminal indictment, this enforcement approach has been adopted with the aim of punishing and eliminating corporate corruption and reforming corporate ethos. While having the immediate benefit of avoiding a potentially fatal corporate criminal indictment and trial with the attendant exclusion from Federal Health Care Programs, this approach is not without considerable financial and operational consequences for the subject companies. Further, the effectiveness of this enforcement approach in achieving the DOJs ultimate goal of eliminating corporate corruption, whether within a company or an entire industry, is wholly unknown. More to the point, there are no established metrics by which to measure the respective costs and benefits of this enforcement approach. Of additional concern to the reform effort is the lack of transparency in an area with vague statutory requirements and little case law. This article examines the DOJs enforcement approach to corporate corruption and whether its working and suggests that, given the tremendous costs involved, a measured analysis of respective costs and benefits is warranted. It also concludes that reform efforts are likely to be enhanced by greater transparency at all stages of the enforcement process, beginning with pre-settlement and continuing through an actual monitorship.

National policy on CAM: the White House Commission Report.

n March 2000, President William Clinton signed Executive Order 13,147, establishing the White House I Commission on Complementary and Alternative Medicine, to develop public policy proposals geared toward maximizing “the benefits to Americans of complementary and al te r n a t i ve m ed ic i n e . ” I Disconcert i n gl y, the Commission’s charge presumed the safety and efficacy of complementary and alternative medicine (CAM). In so doing, it placed the proverbial cart before the horse by setting the Commission on a mission to “address education and training of health care practitioners in CAM; [coordinate] research to increase knowledge about CAM products; [provide] reliable and useful information on CAM to health care professions, and [provide] guidance on the appropriate access to and delivery of CAM.”z The Commission’s final report (“Commission Report”), issued in March 2002, similarly skirts the fundamental question of whether evidence exists that CAM interventions are safe or offer sufficient benefit to justify their proliferation. Admittedly, answering this question is extremely problematicbecause of the wide range of therapies that can be included within the CAM rubric. Nonetheless, a commission established to guide the nation on how to proceed in resolving the myriad public policy questions raised by CAM’s popularity must at least first identify what comprises CAM, and address whether -so identified CAM is safe and effective. Despite this oversight, the Commission makes several dramatic recommendations to propel the integration of CAM practitioners and practices into the health care delivery system, to expand access to CAM modalities, and to expend sigruficant research dollars to fill the tremendous void of information about CAM’s safety, efficacy, and cost-effectiveness.