Journal of health law最新文献

The pharmaceutical industry has been receiving greater scrutiny lately due in large part to the many public and private legal enforcement actions taken against pharmaceutical manufacturers. These enforcement actions, along with legal developments such as the OIG Compliance Guidance for Pharmaceutical Manufacturers, the Sarbanes-Oxley Act's statutory guidelines for public corporations, the HIPAA privacy regulations, and the Medicare Modernization Act, have the potential to encourage the pharmaceutical industry to self-regulate beyond the bounds currently required by the law. After a brief overview of enforcement actions and compliance programs directed toward the pharmaceutical industry, this Article reviews a similar situation the hospital industry faced when Medicare promulgated major reimbursement modifications. The Article proposes that the pharmaceutical industry, in the face of such intense scrutiny and uncertainty, should implement more rigorous self-regulation. Without more stringent self-regulation, this intense interest in the pharmaceutical industry may result in a regulatory push that establishes unanticipated and cumbersome measures for the industry.

Last year's introduction of an exception to the Stark Regulations and a new Anti-Kickback safe harbor allows donors (mainly hospitals) to assist recipients (mainly physicians) with the establishment of electronic health records systems. This Article analyses the new regulations and makes the case that, among other negative effects, they will create an undesirable shift in physician referrals in the short term.

The authors analyze existing and developing trends in healthcare fraud litigation. They first review the traditional use of the Medicare-Medicaid Anti-Kickback Statute to prosecute such fraudulent activity. They then consider newer theories that have been employed, or may be employed, in cases involving payors, middlemen, agents, and fiduciaries. These include the use of the Civil False Claims Act, the Federal Travel Act, and the Public Contracts Anti-Kickback (sometimes incorporating violations under state commercial bribery and similar state legislation to form the basis of a federal claim or prosecution). The Article then turns to a discussion and warning of attorneys' potential liability for a client's kickback arrangements. Finally, the Article takes a very brief look at relationships under Medicare Part D that may well prove to be a fertile area of problematic conduct, public and congressional scrutiny, and prosecutions utilizing some of these theories.

In Caracci v. Commissioner, the Internal Revenue Service faced an important test in its application of Excess Benefit Taxes to disqualified persons of a nonprofit corporation that converted to for-profit status. This Article, written by the taxpayers' valuation expert, details the difficulties in the IRS case and demonstrates the reasons for the Fifth Circuit's reversal of the Tax Court's judgment in favor of the IRS. The author concludes with a number of lessons that taxpayers can take from Caracci.

As medicine's technical limits have become increasingly clear, Americans seem more willing to address end-of-life decisionmaking. A major development during the 1990s was physician assistance in dying: physician-assisted suicide in Michigan, Oregon's Death with Dignity Act, and developments in Europe, most notably The Netherlands. This evolution toward recognizing the appropriateness of assistance in dying raises legal and ethical issues for physicians and healthcare institutions such as nursing facilities and acute care hospitals. These issues include the effects on providers' values systems, the trust between patient and provider, and the "slippery slope" that voluntary, active assistance in dying will become involuntary, active assistance. This Article addresses the policy issues that institutions must confront in a changing environment.

This Article provides an analytical framework for assessing state regulation regarding lay ownership of healthcare entities. The author suggests there are three categories of state regulation restraining lay ownership, each focused on a particular stakeholder in healthcare transactions: provider, patient, and payor. These regulatory paradigms are analyzed through a discussion of three state approaches (California, Illinois, and Florida), each exemplifying a particular stakeholder schema. The Article then highlights shortcomings of the three schemas, pointing out formal frustrations, application inequities, and doctrinal flaws. The author concludes that any successful state regulation of lay ownership in healthcare should incorporate aspects of all approaches in pursuit of accommodating the needs of all three stakeholders.

In the wake of the Sarbanes-Oxley Act regulations that govern the public company sector, standards are emerging to assure that nonprofit corporate boards are maintaining appropriate levels of independence. This Article provides a summation of the current trends in the development of independence standards for nonprofit corporate governance, from both tax and corporate law perspectives. The authors consider independence standards for nonprofit boards of governance and discuss the evolution of independence standards as they relate to the duty of good faith, and the distinction between independence and conflicts of interest. The authors also seek to examine the evolution of current federal regulations and study state models that have been successfully implemented to insure the independence of nonprofit corporations. Finally, the authors propose a set of core guidelines to be considered when addressing board and committee independence issues.

The guidelines controlling the sentencing of organizations provide for the reduction in an entity's culpability score for self-reporting, cooperation, and acceptance of responsibility. What an organization must do in order to receive the reduction in culpability score changed dramatically in 2004 when additional language was added to Application Note 12 of the U.S. Sentencing Guidelines Manual Section 8C2.5(g) stating that "waiver of the attorney-client privilege and of work product protections is not a prerequisite to a reduction. ... However, in some circumstances waiver of the attorney-client privilege and of work product protections may be required in order to satisfy the requirements of cooperation." Following months of hearings and public comment, the United States Sentencing Commission reversed its position on whether a sentencing court should consider an organization's waiver of the attorney-client privilege and/or of the attorney work product protection in evaluating the organization's "cooperation" as a sentencing factor by proposing to retract the language added by the 2004 amendments. Although that proposal has become effective, it is yet to be determined what the response of the three branches of government will be on the issue of privilege waivers in the context of federal criminal law. This Article gives readers an overview of the development of the use of privilege waivers by organizations seeking credit for cooperation at the time of sentencing for federal crimes, the reaction of both corporations and their lawyers to the waiver issue, and the events leading up to the Commission's change of position.