Journal of health law最新文献

Section 1011 of the 2003 Medicare Act authorized the disbursement of over one billion dollars to healthcare providers that provide uncompensated emergency medical care to undocumented immigrants. In 2005, the Centers for Medicare and Medicaid Services (CMS) issued its final interpretation of the statute. Despite previous statementsto the contrary, CMS conditioned eligibilityfor Section 1011 funds on the collection of certain immigration status-related information from patients seeking emergency care. Prior to the issuance of CMS' final guidance, the House defeated House Resolution 3722, which was substantially similar to the CMS final guidance. This Article argues that the House's rejection of H.R. 3722 renders CMS's final guidance invalid under the analysis set forth in Chevron, U.S.A. Inc. v. National Resources Defense Council, Inc.

This Article examines whether a participant in a clinical research trial for a drug obtains material nonpublic information about the drug and its manufacturer or licensor and, if so, whether the participant may lawfully trade securities based on that information. This issue has been noted but not examined in depth in several articles in recent years. After an introduction to the federal law of insider trading and a discussion of relevant aspects of a supervised research trial, the Article concludes that, absent an agreement to the contrary, the participant would be free to trade securities based on any material nonpublic information learned in the trial. The author evaluates the extent to which the information is material and nonpublic and then presents the policy issues surrounding whetherthe participantshould be precluded from trading when in possession of material nonpublic information gained as a result of participation in the trial. While not resolving the competing policy considerations, including the value of allowing participants to make disclosure of their experiences in the trial before publication of the results in a peer reviewed journal, the Article presents an approach for preventing the misuse of material nonpublic information gained in the clinical trial context, by obtaining an agreement from the participant, and an agreement from the limited circle of persons to whom the participant should be allowed to make disclosure in any event (such as his personal physician and family members), that would render any trading by them unlawful under the federal law of insider trading.

Abuses in labor practices affecting hospital housestaff (residents) have become better understood with the 2002 filing of a federal lawsuit challenging U.S. resident hiring practices. Other initiatives to redress residency employment abuses have included labor action (unionization) and legislative initiatives at both the state and federal levels. This Article suggests that all such initiatives are fated to have limited success because they fail to take into account the economics of the residency system. The author argues that, in several key respects, the U.S. residency employment system resembles the self-perpetrating bonded labor systems of rural Asia. Consequently the Article proposes a radical restructuring of U.S. housestaff employment.

Each year, five million senior citizens are the victims of abuse in our country-and that figure is a likely underestimate. In California alone, it is estimated that over 225,000 seniors are abused annually. Nursing home residents are particularly vulnerable to abuse, with one-fifth to one-third of these institutions cited for abusive activities that result in actual harm. Regular violations of minimum care regulations by nursing homes have been documented in every state. Despite legal protections, as a practical matter, the review, assessment, and investigation of nursing home care and potential senior abuse is the primary responsibility of voluntary ombudsmen. These volunteers are responsible for regular visits and determination of nursing home quality and resident treatment. This Article contends that, despite their commitment to the cause, voluntary ombudsmen are not a sufficient cure for the scourge of elder abuse. Rather, clinically-trained personnel with legal knowledge must assume the role that lay volunteer ombudsmen are inappropriately expected to play. Use of clinical case managers, who have expertise in assessing clinical factors and can be trained in legal matters, offers significant potential to assist in the detection, and, further, reporting and prosecution of elder abuse. The author concludes that only through use of those with appropriate training and knowledge can the epidemic of elder abuse be effectively addressed.

In designing and setting up a clinical trial, investigators and private sponsors must take into account what costs will or will not be covered by third-party insurers and government payment programs like Medicare and Medicaid. Failure to "cost out" the clinical trials accurately can yield one of two results: either third-party payors are billed improperly, or even illegally, for experimental care, or significant research-related care is not billed, with either the investigating institution, or the research subjects themselves, shouldering the cost. Unfortunately, because Medicare has established different coverage principles to be applied depending on the type of trial being conducted, costing out the trial is not an easy task. This Article looks at the various Medicare coverage principles as they apply to clinical trials, including the 2000 National Coverage Decision and the recent expansion in coverage for Class A Investigational Devices created by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. The Article then examines how the Medicare secondary payor rule, which states that providers may not bill Medicare for items or services when another party has primary responsibility for those services, relates to clinical trails in light of recent commentary. The Article concludes with the presentation of a general framework that investigators can use to establish a clinical trial budgeting and billing system.

Despite charges that it is at times ambiguous and overly burdensome, the Emergency Medical Treatment and Labor Act (EMTALA) remains an important protection for patients, and a valuable instrument for enforcing public policy goals in the area of emergency healthcare services. The 250 Yard Rule is a small but crucial part of EMTALA, extending the statute's protections to emergency patients who have narrowly failed to reach the hospital's entrance. Following recent revisions to EMTALA's implementing regulations, some health-care law practitioners and senior federal regulators have opined that enforcement of the 250 Yard Rule will be dramatically curtailed. This Article explores the legal and public policy origins of the 250 Yard Rule and their continuing applicability in the current regulatory environment. The Article concludes that the regulatory basis for the 250 Yard Rule remains intact and that the legislative intent behind EMTALA, as well as ongoing public policy goals, dictate that the 250 Yard Rule be preserved.

In the wake of the patient safety movement, there is a glaring disconnect between the increasing responsibilities placed on hospital board members and the limited accountability for those board members if they fail to meet their responsibilities. This Article discusses how the effectiveness of new patient safety laws is diminished by the lack of accountability of nonprofit board members. The Article suggests that an expanded notion of corporatefiduciary duties, enhanced by shifts in social norms, would contribute to patient safety reform.

This Article provides a detailed overview of the new National Response Plan (NRP) with a focus on its applicability to bioterrorism and other public health emergencies. The Article highlights critical policy and legal issues left unresolved by the NRP, and offers recommendations for the resolution of those issues. The author concludes that, although the NRP is not perfect, it represents a major advance in domestic incident management and provides regular opportunities for review and revision as we learn how to best coordinate the national response to major incidents. A close working relationship between the Departments of Health and Human Services and Homeland Security should enable a unified response to bioterrorism and other public health emergencies in support of state and local efforts.

In response to regulatory and financial pressures, entities participating in the healthcare industry have joined with others in order to maintain, even improve, their market positions. In the non-profit sector of the industry, partnerships, mergers, and acquisitions have included arrangements whereby some corporate partners have interlocking directors. After review of the fiduciary duties of care and loyalty owed by corporate board members, and their application to traditional performance and conflict of interest situations, the authors address two scenarios raising interlocking director issues.