Health Law and Policy Commons^™

Be Not Afraid Of Change: Time To Eliminate The Corporate Practice Of Medicine Doctrine, Nicole Huberfeld

Faculty Scholarship

This article argues that the corporate practice of medicine doctrine is a physician-centric, guild type doctrine that is misplaced in the present incarnation of the American healthcare system and that does nothing to improve quality, efficiency, or accountability. The paper focuses on three key reasons that the corporate practice of medicine doctrine should be laid to rest. First, the motives for creating the corporate practice of medicine doctrine are long gone, as physicians have not been able to operate as a guild of autonomous providers of healthcare for quite some time. Second, it is disingenuous to pretend that physicians are …

Bioethical Malpractice: Risk And Responsibility In Human Research, Barbara A. Noah

Faculty Scholarship

This Article provides an overview of Institutional Review Board (IRB) operations, reviews the sources of regulatory guidance, and examines the weaknesses of the existing system for the protection of human research subjects. It then discusses the scant case law relating to IRB negligence in the protection of human research subjects and explores some hypothetical circumstances under which it may be appropriate to hold a board accountable for injuries to clinical trial participants. Finally, this Article considers the potential consequences of expanded IRB liability, concluding that tort lawsometimes may serve an important function as a catalyst to regulatory reform when professional …

Politicizing The End Of Life: Lessons From The Schiavo Controversy, Barbara A. Noah

Faculty Scholarship

The case of Theresa Marie Schiavo raises challenging legal and ethical issues, although the events of the case are not entirely novel. It is a well-settled principle under Florida law that individuals have a right to refuse life-sustaining medical treatment. After years of litigation, numerous courts have confirmed that removal of life support is legally appropriate under the facts of this case. Nevertheless, six days after Theresa's feeding tube was removed, the Florida legislature
opted to intervene in the final judicial decision by granting the Governor the authority to overrule the court's decision and to order the tube reinserted. These …

Can Consumer-Choice Plans Satisfy Patients? Problems With Theory And Practice In Health Insurance Contracts, Wendy K. Mariner

Faculty Scholarship

Much scholarship has considered whether health care - and insurance - should be distributed by voluntary contract or subject to government standards or regulation. Contracts will likely play a key distributive role in any future health care system. Yet we do not fully understand where private contracting does and does not work to further the goals of equitable access to affordable care. This article examines the role of health insurance policies in defining and enforcing access to medical care, focusing on private employment-based group health benefit plans. It describes models of consumer choice health plans and critiques their capacity for …

Finding Cures For Tropical Diseases: Is Open Source An Answer?, Stephen M. Maurer, Arti K. Rai, Andrej Sali

Faculty Scholarship

Only about 1% of newly developed drugs are for tropical diseases, such as African sleeping sickness and dengue fever. While patent incentives and commercial pharmaceutical companies have made Western health care the envy of the world, the commercial model works only if companies can sell enough patented products to cover their R&D costs. The model thus fails for diseases found largely in the developing world, where markets for patented products are tiny. Any solution to the problem of tropical diseases must recognize the need for rigid cost-containment. An open source approach to identifying promising drug candidates would keep costs down …

Introduction: The New Economy And The Unraveling Social Safety Net, Elizabeth M. Schneider

Faculty Scholarship

No abstract provided.

Forcible Medication For Courtroom Competence: The Case Of Charles Sell, George J. Annas

Faculty Scholarship

The right to refuse treatment is firmly recognized in U.S. law. Competent persons have the legal right to refuse treatment, even life-sustaining treatment, and incompetent patients can also refuse treatment through an advance directive, by naming a health care agent to make decisions for them or by having a person who knows their wishes express them.

Politics, Morals And Embryos, George J. Annas, Sherman Elias

Faculty Scholarship

Bioethics in the United States reflects US culture and tends to be pragmatic, market-oriented and insular. Add embryo politics to this mix and, over the past few years, the result has been a bioethics that has become so narrow and selfabsorbed as to be virtually irrelevant to the rest of the world. Not all the blame for this can be placed on President George W. Bush’s political agenda for his President’s Council on Bioethics, now in its third year of operation, but much can. The council has made public bioethics the servant of politics by pursuing a narrow, embryo-centric agenda. …

Parks As Gyms? Recreational Paradigms And Public Health In The National Parks, Jay D. Wexler

Faculty Scholarship

When scholars and policymakers think about the relationship between public health and environmental law and policy, they likely think first about controlling pollution and other toxic substances. As other articles have amply demonstrated, water pollution, air pollution, and other environmental toxins can have significant deleterious effects on the public's health. Scholars rightly pay serious attention to these relationships, and policymakers wisely devise methods and strategies to ameliorate the public health risks posed by these polluting substances.

Although pollution control might be the most obvious and important intersection between environmental policy and public health, legal and policy decisions regarding the management …

Finding Cures For Tropical Diseases: Is Open Source An Answer?, Stephen M. Maurer, Arti K. Rai, Andrej Sali

Faculty Scholarship

No abstract provided.

Monopsony As An Agency And Regulatory Problem In Health Care, Peter J. Hammer, William M. Sage

Faculty Scholarship

The article is organized as follows. Part I returns to the source, explaining the controversy in Kartell, examining Breyer's opinion, and summarizing its impact on other courts. Part II looks at Kartell through the lens of classic monopsony theory involving suppliers, producers, and consumers, and focuses on the opinion's oversimplification of the relationship between health insurers and insured individuals. It further considers whether lower input prices result in lower consumer prices in the endproduct market, and, therefore, whether monopsony power can be welfare-enhancing. Part III evaluates Kartell's disregard of other important principal-agent problems in health care that arguably influence the …

Managed Care’S Crimea: Medical Necessity, Therapeutic Benefit, And The Goals Of Administrative Process In Health Insurance, William M. Sage

Faculty Scholarship

This Essay explores the concept of medical necessity as it has evolved in the judicial and administrative oversight of managed care. The goals of the Essay are to illustrate the range of plausible rationales for establishing administrative procedures to govern medical necessity disputes, and to demonstrate the difficulty of incorporating into those procedures the most important professional and social responsibilities of managed care in today’s health care system. Part I of the Essay explains the ideological and practical significance of medical necessity as managed care has evolved. Part II examines medical necessity as a legal problem, and questions whether current …

Bodily Integrity And Informed Choice In Times Of War And Terror, George J. Annas

Faculty Scholarship

Law is the dominant force behind American medical ethics, and has been for at least the past half-century. That ' lawyers and judges, rather than physicians, have set the agenda for medical ethics in the United States is a bit surprising to many in the field of medical ethics, but it should not be. Medicine has historically been based on paternalism. The Hippocratic physician was obligated to act in the best interests of the patient-as the physician judged those interests-and to "do no harm." American law, on the other hand, is based on liberty and justice, principles that, among other …

A Matter Of Priority: Transplanting Organs Preferentially To Registered Donors, Adam Kolber

Faculty Scholarship

No abstract provided.

Achieving The Right Balance In Oversight Of Physician Opioid Prescribing For Pain: The Role Of State Medical Boards, Diane E. Hoffmann, Anita J. Tarzian

Faculty Scholarship

No abstract provided.

Can't We All Get Along? The Case For A Workable Patent Model, Srividhya Ragavan

Faculty Scholarship

The global move towards a trade regime has been impeded by challenges of poverty and health crisis for the developing nations. Until now, the developed nations have touted the establishment of a trade regime as envisaged under TRIPS as the solution for the national challenges. This paper examines the effectiveness of TRIPS as a mechanism to move towards a trade regime. It argues that the patent policy in TRIPS cannot gear the world towards patent harmonization but can potentially adversely impact the developed nations and the post-world war trade structure. The impediments affecting the effectiveness of TRIPS as a harmonizing …

Navigating Uncharted Waters: Intellectual Property Rights Surrounding Genomics Research & Development Information, Lawrence M. Sung

Faculty Scholarship

No abstract provided.

What Makes Genetic Discrimination Exceptional?, Deborah Hellman

Faculty Scholarship

No abstract provided.

Arbitrage, Bioethics, And Cloning: The Abcs Ofgestating A United National Cloning Convention, Rosario M. Isasi, George J. Annas

Faculty Scholarship

America's inability to craft a regulatory ethics of abortion has led to a
/="/">wild west of unregulated research with human embryos and pregnant
/="/">women by our private infertility industry. Because of an "all or nothing"
/="/">research mentality, it is becoming increasingly impossible to suggest
/="/">outlandish and reckless reproductive research possibilities without seeing
/="/">them actually pursued. And if even the wild west seems a bit inhospitable
/="/">to particular research goals, such as cloning to produce the genetic duplicate
/="/">of an existing person, media darlings like Severino Antinori and Zavos
/="/">Panos, and even members …

Midwifery: Strategies On The Road To Universal Legalization, Laura Hermer

Faculty Scholarship

Multiple studies have shown that direct-entry midwifery is just as safe, if not safer than, medical care in low-risk childbirth. Most births using direct-entry midwives require fewer interventions than those attended by physicians, yet yield excellent results. The results of these studies indicate that we should return to midwifery for normal births, rather than continuing to rely primarily on medicine. This option, however, has been significantly curtailed by many state legislatures and courts, despite decades of attempts to make incursions on the traditional paradigm of hospital births attended by obstetricians. As a result, where midwifery is more readily available, it …

Disasters First: Rethinking Environmental Law After September 11, Michael B. Gerrard

Faculty Scholarship

Many environmental statutes were enacted, or at least spurred along, in direct response to disasters. The Federal Water Pollution Control Act of 1972 followed from the Santa Barbara Oil Spill; the Emergency Planning and Community Right-to-Know Act (EPCRA) resulted from the chemical gas disaster in Bhopal, India; the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) was sparked by the Love Canal incident; and the Oil Pollution Acte was a reaction to the Exxon Valdez oil spill.

The terrorist attacks of September 11, 2001 have led to the Homeland Security Act and to several other enactments. The collapse of the …

Hipaa Regulations: A New Era Of Medical-Record Privacy?, George J. Annas

Faculty Scholarship

The new privacy regulations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) become effective April 14, 2003. This article outlines the implications of the new policy for practicing physicians. The regulations will affect virtually every physician, because they apply to any health care provider who conducts any business electronically, including billing. The regulations require health care providers to provide patients with a privacy notice that informs them who will have access to their records without their explicit consent and about patients' rights to inspect and amend their own records.

Privatization As Delegation, Gillian E. Metzger

Faculty Scholarship

Recent expansions in privatization of government programs mean that the constitutional paradigm of a sharp separation between public and private is increasingly at odds with the blurred public-private character of modern governance. While substantial scholarship exists addressing the administrative and policy impact of expanded privatization, heretofore little effort has been made to address this disconnect between constitutional law and new administrative reality. This Article seeks to remedy that deficiency. It argues that current state action doctrine is fundamentally inadequate to address the constitutional challenge presented by privatization. Current doctrine is insufficiently keyed to the ways that privatization involves delegation of …

Puppy Love: Bioterrorism, Civil Rights, And Public Health, George J. Annas

Faculty Scholarship

Florida has been the state humorists most like to make fun of since the 2000 presidential election, especially when it comes to politics. And humorists are almost the only commentators who can be counted on to tell us the truth about the state of American politics today. When Californians decided to recall their Governor, for example, Conan O'Brien observed: "Yesterday Arnold Schwarzenegger announced he would run for governor of California. The announcement was good news for Florida residents, who now live in the second-flakiest state in the country."' And when more than 200 people filed to run for Governor, Jay …

Blinded By Bioterrorism: Public Health And Liberty In The 21st Century, George J. Annas

Faculty Scholarship

In Blindness, Nobel Prize laureate Jos6 Saramago chronicles the quarantining of the first victims of a plague of blindness.1 We meet many people who become blind in Saramago's novel, including an opthamologist, a one-eyed man with an eye patch, and a man born blind. Saramago reminds us that we are all blind in one way or another, and that there are many things about ourselves and our society that we can't or won't see. The quarantine itself turns out to be isolating, inhumane, and degrading; the interred blind being portrayed by themselves and others as pigs, dogs, and "lame crabs." …

The Right To Health And The Nevirapine Case In South Africa, George J. Annas

Faculty Scholarship

Thanks to activists in South Africa, the right to health as a human right has returned to the international stage, just as it was being displaced by economists who see health through the prism of a globalized economy and by politicians who see it as an issue of national security or charity. The current post-apartheid debate in South Africa is not about race but about health, and in this context, the court victory by AIDS activists in the nevirapine case has been termed not only, as stated in one British newspaper, “the greatest defeat for [President Thabo] Mbeki's government” but …

Independent External Review Of Health Maintenance Organizations' Medical-Necessity Decisions, Wendy K. Mariner

Faculty Scholarship

States may have more freedom to regulate the practices of managed-care organizations than many observers previously believed. In the absence of congressional action on the federal Bipartisan Patient Protection Act, the primary source of patient-protection legislation remains at the state level. Nevertheless, the federal Employee Retirement Income Security Act (ERISA) of 19742restricts state regulation of health maintenance organizations (HMOs) that serve private employee group health plans. On June 20, 2002, the U.S. Supreme Court, in Rush Prudential HMO, Inc. v. Moran, upheld an Illinois state law that requires binding independent external review when an HMO disagrees with the …

A Jurisprudential Analysis Of Government Intervention And Prenatal Drug Abuse, Susan Saab Fortney

Faculty Scholarship

This article addresses the serious public health problem of substance abuse among pregnant women. Part I of this article introduces the national problem of prenatal drug abuse. Part II discuses the appropriateness of government intervention. The article explains the medical consequences of prenatal drug abuse, and then, describes the justification of government intervention. The article details both existing criminal law and new legislation regarding prenatal drug abuse. Part III addresses constitutional concerns and the conflict between a woman’s right on the one hand and the state interest and “fetal rights” on the other. Part IV considers the moral and legal …

A Copernican View Of Health Care Antitrust, William M. Sage, Peter J. Hammer

Faculty Scholarship

Sage and Hammer use the analogy of Copernican astronomy to suggest that understanding the dramatic change wrought by managed care requires a conceptual reorientation regarding the meaning of competition in health care and its appropriate legal and regulatory oversight. Both share the belief that misperceiving the world limits potential for technical and social progress.

Whose Duty Is It Anyway?: The Kennedy Krieger Opinion And Its Implications For Public Health Research, Diane E. Hoffmann, Karen H. Rothenberg

Faculty Scholarship

In this article, the authors discuss the Maryland Court of Appeals decision in the case of Grimes v. Kennedy Krieger Institute, Inc. and its implications for the tort duty owed by researchers, in particular public health researchers, to their subjects. The Opinion resulted from two lawsuits alleging lead poisoning of children enrolled in a study conducted by the Kennedy Krieger Institute, a world renown pediatric research and treatment facility. The opinion shocked the research establishment with its scathing characterization of researchers and its apparent holding that in Maryland a parent cannot consent to the participation of a child in "nontherapeutic …