Law Commons^™

Site Visit To Richmond And Hampton Roads — Bon Secours Health System, Inc., Nora Super

National Health Policy Forum

The first in a series of three site visits leading to an April 27–28, 2000, conference in Annapolis, Maryland, on hospital-based health care systems in transition after the enactment of the Balanced Budget Act of 1997 (BBA) and the Medicare, Medicaid, SCHIP Balanced Budget Refinement Act of 1999 (BBRA). The site visit was designed to better understand how changing payment incentives — particularly the move to prospective payment systems for postacute services — has affected the ability to implement a continuum of care across delivery sites. It examined the Bon Secours Health System's operations in Virginia, which include four hospitals …

Improving Quality And Preventing Error In Medical Practice, Lisa Sprague

National Health Policy Forum

Drawing on the Institute of Medicine's report To Err Is Human, this issue brief looks at quality-improvement and error-reduction efforts at the institutional, regional, and state levels and analyzes the roles of government and the private sector in bringing such efforts into national focus. Questions considered include whether error reporting should be mandatory or voluntary, who should perform error analysis, and the role of the individual in an institutional accountability model.

Physician Connectivity: Electronic Prescribing, Robin J. Strongin

National Health Policy Forum

This issue brief focuses on physician connectivity — the electronic linking of physicians with online resources such as clinical databases and sophisticated formulary systems. As physician connectivity increasingly allows physicians to prescribe online via a handheld computer complete with formulary information as well as patient data and drug information, this issue brief examines the issues raised by this technological advance within the broader context of online prescribing.

The Gender Of Genetic Futures: The Canadian Biotechnology Strategy, Women And Health, Roxanne Mykitiuk, Fiona Miller, Lorna Weir

All Papers

No abstract provided.

Banning The Clone, Lori B. Andrews

All Faculty Scholarship

No abstract provided.

Site Visit To Arizona — Managed Medicaid: Arizona's Ahcccs Experience, Nora Super, Lisa Sprague, Judith D. Moore

National Health Policy Forum

This site visit featured a review of a unique Medicaid managed care system, the Arizona Health Care Cost Containment System (AHCCCS), which has operated as a research and demonstration waiver since its inception in 1982. Site visitors heard from speakers who provided historical and background information, a discussion of competitive bidding, contracting and performance management, and insights into the delivery of behavioral health under the mandatory AHCCCS program. The group also heard discussions about services to the uninsured and Arizona's safety net providers. Other topics covered during the visit included the state's KidsCare program under the State Child Health Insurance …

Reshaping Ahcs' Role In Biomedical Research, Karen Matherlee

National Health Policy Forum

This issue brief explores the reconfiguration of academic health centers (AHCs) in response to health marketplace and other pressures. It reviews four roles AHCs play in medical innovation: (a) development of new drugs, devices, diagnostic techniques, and therapeutic procedures; (b) adoption of new technologies, instruments, and drugs; (c) evaluation of new technologies; and (d) assessment of the need for new modalities and monitoring of their initial uses. The paper examines ways in which these roles are enhanced or threatened by evolving economic forces in the public and private sectors.

Adverse Drug Reactions: Harnessing Experiential Data To Promote Patient Welfare, Barbara A. Noah

Faculty Scholarship

Part I of this Article evaluates the pre-approval and post-approval regulatory framework governing prescription drugs, and the FDA's spontaneous reporting system for adverse events, as it contrasts that system with the regulatory mechanisms used to monitor risks associated with other products. Part II summarizes the recent series of prescription drug marketing withdrawals prompted by reports of unexpected adverse reactions. Finally, Part III offers some possible solutions designed to improve the efficiency of postapproval surveillance so that fewer patients will suffer the consequences of unexpected adverse drug reactions and interactions. This Article concludes that the existing regulatory system requires fundamental reprioritization …

Introduction: Fifteenth Anniversary Of The Edward V. Sparer Public Interest Law Fellowship Program, Elizabeth M. Schneider

Faculty Scholarship

No abstract provided.

Inverting The Viability Test For Abortion Law, Bruce Ching

Journal Articles

The abortion controversy is likely to become even more pressing with the development of technological advancements that enhance the chances for fetal survival of the abortion procedure. This essay explores the consequences of recognizing that keeping the fetus alive does not depend on keeping the fetus in utero.

., Administrative Channeling Under The Medicare Act Clarified: Illinois Council, Section 45(H), And The Application Of Congressional Intent, John Aloysius Cogan, Jr., Rodney A. Johnson

Faculty Articles and Papers

In non-legal terms, subject matter jurisdiction is much like your American Express card. You cannot "leave home without it." This is especially true if you represent a Medicare provider or supplier and intend to sue on a Medicare claim. To be sure, your well-pleaded complaint alleges several bases for the federal district court's subject matter jurisdiction, including, but not limited to, 28 U.S.C. § 1331 (federal question jurisdiction), 28 U.S.C. § 1346 (federal defendant jurisdiction), 28 U.S.C. § 1361 (mandamus), and 5 U.S.C. § 702 (the Administrative Procedures Act). Perhaps, your complaint is brought in the context of an adversary …

Mental Health Advance Directives: Having One's Say?, Justine A. Dunlap

Faculty Publications

First, this Article traces the extension of the right to refuse treatment to the psychiatric realm. Next, the Article addresses advance directives for health care and their utility for mental health issues. Then, the Article examines state statutory and judicial responses to mental health advance directives. Finally, the Article analyzes why the right to control future psychiatric treatment, including the right to refuse treatment, has been slow to gain acceptance. Although mental health advance directives present real challenges, legally and otherwise, this Article concludes that they are firmly rooted in the law and their rejection is, more often than not, …

Effect Of The 1996 Welfare And Immigration Reform Laws On Immigrants' Ability And Willingness To Access Medicaid And Health Care Services, George Washington University, Center For Health Services Research And Policy

Center for Health Policy Research

No abstract provided.

The Quiet Demise Of Deference To Custom: Malpractice Law At The Millenium, Philip G. Peters Jr.

Faculty Publications

According to conventional wisdom, tort law allows physicians to set their own standard of care. While defendants in ordinary tort actions are expected to exercise reasonable care under the circumstances, physicians traditionally have needed only to conform to the customs of their peers. However, judicial deference to physician customs is eroding. Gradually, quietly and relentlessly, state courts are withdrawing this legal privilege. Already, a dozen states have expressly rejected deference to medical customs and another nine, although not directly addressing the role of custom, have rephrased their standard of care in terms of the reasonable physician, rather than compliance with …

Is There A Doctor In The House? Using Failure-To-Warn Liability To Enhance The Safety Of Online Prescribing, Chester S. Chuang

Publications

This Note argues that manufacturers can satisfy the duty to warn that is owed to consumers who purchase prescription medications from Internet prescribing sites by contractually obligating the websites to implement comprehensive patient information systems. Analyzing these systems under a traditional failure-to-warn liability framework will allow reputable sites to mature into reliable sources of prescription medications for consumers, while cutting off the supply of drugs to fraudulent sites without resorting to increased government regulation. Ideally, this framework wiIl force manufacturers to weigh patients' health and safety with the commercial and practical advantages of Internet prescribing.

Part I of this Note …

Science Fact Or Science Fiction? The Implications Of Court-Ordered Genetic Testing Under Rule 35, Anthony S. Niedwiecki

Publications

This article proposes an analysis for courts to follow when faced with a Rule 35 motion to compel a party to undergo genetic testing or any other procedure that tests for a specific medical condition.

Part I explains the analysis courts generally conduct for a Rule 35 motion. Generally, courts make a factual inquiry into whether there is a need for the procedure and whether the examinee has placed his or her physical or mental condition in controversy. Rarely have courts examined the risks associated with ordering an examination. When courts do examine the risks, they continue to show a …

Criminal Penalties For Creating A Toxic Environment: Mens Rea, Environmental Criminal Liability Standards, And The Neurotoxicity Hypothesis, Colin Crawford

Publications

Recent research in brain biochemistry examining the likely neurological effects of exposure to toxic contaminants continues to demand legal consideration. In this Article, Professor Crawford evaluates the possible consequences of recent neurobiological studies-labeled "The Neurotoxicity Hypothesis" by researchers-for lawyers and the legal system. After summarizing the research, Professor Crawford suggests that as this (or similar) neurobiological research gains increased scientific acceptance, it will be necessary to reduce dramatically the acceptable levels of these toxic elements that can be discharged into the environment. He then examines the implications of such a result for establishing criminal liability under federal environmental statutes, focusing …

Law & Health Care Newsletter, V. 8, No. 1, Fall 2000

Law & Health Care Newsletter

No abstract provided.

Law & Health Care Newsletter, V. 7, No. 2, Spring/Summer 2000

Law & Health Care Newsletter

No abstract provided.

Science Fact Or Science Fiction? The Implications Of Court-Ordered Genetic Testing Under Rule 35, 34 U.S.F. L. Rev. 295 (2000), Anthony Niedwiecki

UIC Law Open Access Faculty Scholarship

No abstract provided.

Blood, Sweat, And Tears: Toward A New Paradigm For Protecting Donor Privacy, 7 Va. J. Soc. Pol'y & L. 141 (2000), Kevin Hopkins

UIC Law Open Access Faculty Scholarship

No abstract provided.

Note, Space-Age Medicine, Stone-Age Government: How Medicare Reimbursement Of Telemedicine Services Is Depriving The Elderly Of Quality Medical Treatment, Kristen Jakobsen Osenga

Law Faculty Publications

We have the technology. What is needed is government financial commitment, so argues Kristen Jakobsen in the following discussion of "telemedicine." The term refers to the delivery of health care services by means of modern telecommunications technology. According to Ms. Jakobsen, the telephone, the fax machine, the Internet, and interactive audio-visual transmissions hold the key to making medical care more accessible and less expensive. Potential beneficiaries include vast populations of elderly in rural areas, who tend to be remote from upscale health care facilities and in need of the wherewithal to reach them. Standing in the way, in Ms. Jakobsen's …

Current Issues In The Psychiatrist-Patient Relationship: Outpatient Civil Commitment, Psychiatric Abandonment And The Duty To Continue Treatment Of Potentially Dangerous Patients--Balancing Duties To Patients And The Public, Vanessa Merton, Linda C. Fentiman

Elisabeth Haub School of Law Faculty Publications

No abstract provided.

Erisa Health Plan Liability: Issues And Options For Reform, Karl Polzer

National Health Policy Forum

This background paper was written as congressional conferees faced the task of resolving differences between patient protection bills by the U.S. House of Representatives and U.S. Senate in late 1999. In order to discuss the principal issues facing policymakers and options for reform, it begins by describing problems raised by the federal law governing private-sector employee health plans (the Employee Retirement Income Security Act of 1974) from a consumer perspective. It then discusses approaches proposed by the Clinton administration and the House and Senate to give consumers greater ability to challenge health plan coverage decisions, focusing in particular on issues …

Beneficial And Unusual Punishment: An Argument In Support Of Prisoner Participation In Clinical Trials, Sharona Hoffman

Faculty Publications

Currently, approximately 1.8 million people are incarcerated in the United States at any given time. A disproportionately large percentage of the prisoner population has serious illnesses, such as AIDS and tuberculosis. Prisoners most often, however, are barred from participation in clinical trials, even when conventional therapy has failed, and experimental treatment might provide them with their only hope of survival.

Much of the reluctance to include prisoners in biomedical research is based on history. In the past, prisoners have been severely abused and even tortured in medical studies conducted in the Nazi death camps, Japanese prisoner camps, and correctional facilities …

The First Fifty Years: Health Law's Greatest Hit, Thomas Wm. Mayo

Faculty Journal Articles and Book Chapters

In honor of the Syracuse Law Review's 50th Anniversary, this article considers various developments in health law and concludes that the passage of the Medicare amendments to the Social Security Act has had the most significant impact on the field. The article discusses the impact of Medicare on the culture of hospitals and their medical staffs, on the development and dissemination of new technologies, and on restructuring and reforming the industry in key areas, including fraud and abuse, patient dumping, organ donation, advance directives, patients' rights, and other agencies' regulation of health care providers.

More Sorry Than Safe: Assessing The Precautionary Principle And The Proposed International Biosafety Protocol, Jonathan H. Adler

Faculty Publications

Part I of this paper provides a brief overview of the development of biotechnology, its regulation and its use, with a particular emphasis on agricultural biotechnology. Part II outlines the United Nations Convention on Biological Diversity, which provides an international legal framework for a biosafety protocol and summarizes the results of recent protocol negotiations, such as those conducted in Cartagena, Colombia in February 1999, which continued in Montreal in January 2000. Part III explains why the proposed protocol embodies a variant of the precautionary principle and why such policies may do more harm than good. This paper concludes with some …

Doubts About Daubert: Psychiatric Anecdata As A Case Study, Christopher Slobogin

Vanderbilt Law School Faculty Publications

In Daubert v. Merrell Dow Pharmaceuticals Inc., the Supreme Court sensibly held that testimony purporting to be scientific is admissible only if it possesses sufficient indicia of scientific validity. In Kumho Tire Co. v. Carmichael, the Court more questionably held that opinion evidence based on "technical" and "specialized" knowledge must meet the same admissibility threshold as scientific testimony. This Article addresses the implications of these two decisions for opinion evidence presented by mental health professionals in criminal trials.

Financing Clinical Research And Experimental Therapies: Payment Due, But From Whom?, Patricia C. Kuszler

Articles

This article will explore the realm of clinical research and the question of who should finance such research. The first part will define the various types and levels of clinical research in terms of the regulatory controls and oversight applied to such research. Then the article will summarize how the costs of clinical research and experimental therapies have been covered in the past. Finally, the article will evaluate the risks and benefits derived by the various stakeholders and propose a financing rationale for therapies that places the burden of cost squarely on the stakeholders most likely to benefit.

Symposium: Regulatory And Liability Considerations, Michael S. Baram, Ellen Flannery, Patricia Davis, Gary Marchant

Faculty Scholarship

You can tell from remarks by prior speakers that regulatory approvals and liability prevention are of critical importance to progress in biomaterials. Gene therapy trials and the tragic outcomes of some of those trials have raised the specter of government suspension of clinical studies, termination of funding, and potential liability for personal injury under malpractice or products liability doctrines. Regulatory requirements and the terms of research grants and contracts have to be very carefully addressed by organizations testing, developing, making, selling and using biomaterials, biotechnology, and medical devices. However, many regulatory requirements are incomplete, ambiguous and confusing because the agencies …