Journal of health law最新文献

This Introduction provides a broad overview of the new Emergency Medical Treatment and Labor Act (EMTALA) regulations and the changes they effected. The three Articles that follow discuss various aspects of the regulations in much greater detail. Health Lawyers Teleconference: EMTALA Update provides a commentary on the regulations from the perspective of representatives of the Centers for Medicare & Medicaid Services and the Department of Health and Human Services, followed by a critique of the regulations from a practitioner's standpoint. EMTALA: Dedicating an Emergency Department Near You analyzes the provisions of the regulations in detail and discusses their implications for hospitals and their counsel. Finally, The New EMTALA Regulations and the On-Call Physician Shortage: In Defense of the Regulations analyzes the on-call provisions of the regulations in light of the current shortage of on-call physicians.

On September 16, 2003, the American Health Lawyers Association's (Health Lawyers) Regulation, Accreditation, and Payment Practice Group and its Liability Practice Group sponsored a teleconference entitled EMTALA: Finally Final Regulations. During that Teleconference, Messrs. Barker and Urbanowicz, from the perspective of their positions at Centers for Medicare & Medicaid Services and the Department of Health and Human Services, gave an informal overview of the Emergency Medical Treatment and Labor Act (EMTALA) final regulations that were unveiled a week earlier. Ms. Joy critiqued the regulations from the practitioner's standpoint, followed by questions from the teleconference off-site participants. This Article is a transcript of that teleconference, modified by the addition of endnotes and slight editing for publication.

This Article explores the intersection between quality of care and healthcare fraud by examining the extent to which quality-related fraud settlements benefit patients. The author argues that, although the protection of beneficiary health and welfare often is invoked by the federal government as one of the reasons for undertaking anti-fraud efforts, such considerations do not appear to play a large role in many of the settlements that are negotiated. While returning funds to the federal Treasury helps to ensure that the federal healthcare programs remain solvent and continue to serve beneficiaries in the aggregate, it may not adequately address harm to individual patients. Thus, the author concludes it may be time to explore new models of fraud settlements that can provide adequate compensation to the patients who may have suffered harm.

The growth of the Internet pharmacy industry is challenging the ethical and regulatory systems that govern the sale and distribution of prescription drugs. New forms of regulation are necessary to prevent abuse and minimize mistakes by consumers, doctors, and pharmaceutical companies. Unfortunately, the mercurial nature of the Internet makes trying to regulate it "like trying to nail Jell-O to a wall." Effective regulation will require greater coordination among state, national, and international regulatory bodies. In addition, consumereducation programs are necessary to inform the public of the problems that are caused by the impersonal and commercial nature of marketing drugs over the Internet. At a minimum, the author suggests that states should uniformly adopt laws that prohibit a physician from prescribing drugs without any face-to-face communication between the physician and the patient, and the United States should work to make this a uniform international standard.

Human subjects research has been the focus of numerous controversies over the years. The dilemma lies between the potential harm to individuals who participate in research and the knowledge to be gained from the research study that might benefit society. When research is conducted in developing countries by researchers and sponsors from the United States and other industrialized countries, differences in history, culture, politics, wealth, and power between the countries give rise to unique challenges. In this Article, the author identifies several ethical issues to be considered when research is conducted in developing countries and provides the legal and ethical framework for their resolution.

The year preceding June 30, 2004, was one of the most active periods in the development of health policy and health law in a generation. Against the odds, President Bush delivered on his promise of a prescription drug benefit for Medicare beneficiaries. As with all momentous legislation, the prescription drug benefit was accompanied by legislative changes both large and small, affecting virtually every sector of the healthcare community. In addition to new legislation, the Bush administration continued to release regulations deemed vitally important by those regulated. The Joint Commission on Accreditation of Healthcare Organizations pursued new standards and processes to improve patient safety, and the courts dealt with a myriad of health law issues.

Congress enacted the Emergency Medical Treatment and Labor Act (EMTALA) in 1986 to prohibit patient dumping. Subsequent to its passage, however, issues concerning the application of EMTALA have vexed hospitals, patients, regulators, and courts. In an attempt to clarify these issues, the Centers for Medicare & Medicaid Services (CMS) recently promulgated new EMTALA regulations. This Article reviews the basic requirements of EMTALA and highlights the statutory definitions critical to its proper interpretation and application. The article then analyzes the impact of the new regulations, particularly in five major areas: where and when the statute applies, on-call physician requirements, hospital-owned ambulances, managed care, and bioterrorism. It concludes with a discussion of the implications of the new regulations for hospitals and their counsel.

Nearly thirty years ago, Congress amended the National Labor Relations Act (Act) and provided employees of healthcare institutions with the right to strike and picket. At the same time, Congress added a new Section 8(g) requiring a labor organization to provide a healthcare institution with ten days' notice before engaging in various types of concerted activity--primarily strikes and picketing--against the institution. Thus, Section 8(g) is an important statute for healthcare employers. But since the time Congress added Section 8(g), the National Labor Relations Board has taken various views on Section 8(g) and whether "ten days" is really ten days. This Note explores the purposes of Section 8(g), as well as the reach and limits of its language, noting areas in which the board may wish to reconsider its application of the statute. Ultimately, the Note provides a checklist for healthcare employers to keep in mind with respect to Section 8(g).

The application of the federal privacy regulations promulgated pursuantto the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to employer benefit plans is arguably the most conceptually difficult area of a complex law. A purely textual reading of the Rule, when applied to employer plans, results in varying interpretations on some significant issues and puzzling results on others. This Article offers a practical approach for interpreting the rule when clear-cut answers are not provided by the text and DHHS guidance is nonexistent or unclear. In addition, this approach can be applied to the interpretation of other statutes and regulations.