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Scientific Deception
Regulators are increasingly becoming concerned about pharmaceutical companies that offer financial and other incentives to physician-researchers, reasoning that the incentives may affect the physicians' judgment when they make treatment decisions for beneficiaries of health care programs. They think that this can result in increased costs being passed on to the federal government. In the worst-case scenario, such incentives could cause medically unnecessary items and services to be provided, and patients to be harmed.
Because the health care industry is so highly regulated, many health care transactions may draw government scrutiny. Clinical research is not immune from such scrutiny, particularly with the ever-increasing amounts of money, both public and private, being funneled into these activities. The main federal laws addressing financial arrangements between physicians and potential referral sources are the Ethics in Patient Referrals Act, more commonly called the Stark Law (42 U.S.C. ' 1395nn), the Medicare and Medicaid Antikickback Statute (42 U.S.C. ' 1320a-7b) and the False Claims Act (the civil False Claims Act is codified at 31 U.S.C. ' 3729, while the criminal False Claims Act is codified at 18 U.S. C. ' 387). The first two of these laws require physicians who enter into financial arrangements with potential referral sources for which claims for items or services may be presented to federal health benefit programs to try to structure their affairs to fall within one of the narrow statutory or regulatory exceptions or safe harbors the False Claims Act provisions essentially require persons who cause claims to be submitted to the federal government for reimbursement to do so in an honest manner.
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.
How AI Has Affected PR
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 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.