Health Law and Policy Commons^™

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 …

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

Faculty Scholarship

No abstract provided.

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 …

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.

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." …

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.

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 …

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 …

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 …

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 …

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 …

Antitrust, Health Care Quality, And The Courts, Peter J. Hammer, William M. Sage

Faculty Scholarship

Antitrust law represents the principal legal tool that the United States employs to police private markets, yet it often relegates quality and nonprice considerations to a secondary position. While antitrust law espouses the belief that vigorous competition will enhance quality as well as price, little evidence exists of the practical ability of courts to deliver on that promise. In this Article, Professors Hammer and Sage examine American health care as a vehicle for advancing understanding of the nexus among competition, quality, and antitrust law. The Article reports the results of a comprehensive empirical review of judicial opinions in health care …

Road Warriors: Two Parents' Perspective On Getting Services For Children With Special Needs, Teresa K. Lamaster, John J. O'Brien

Faculty Scholarship

No abstract provided.

Before It's Too Late- Addressing Fear Of Genetic Information, Karen H. Rothenberg, Sharon F. Terry

Faculty Scholarship

No abstract provided.

New Death Penalty Debate: What's Dna Got To Do With It, James S. Liebman

Faculty Scholarship

The nation is engaged in the most intensive discussion of the death penalty in decades. Temporary moratoria on executions are effectively in place in Illinois and Maryland, and during the winter 2001 legislative cycle legislation to adopt those pauses elsewhere cleared committees or one or more houses of the legislature, not only in Connecticut (passed the Senate Judiciary Committee) and Maryland (where it passed the entire House, and the Senate Judiciary Committee) but in Nevada (passed the Senate) and Texas (passed committees in both Houses). In the last year, abolition bills have passed or come within a few votes of …

The Invisible Patient (Reviewing Sally Satel, How Political Correctness Is Corrupting Medicine (2000)), Barbara A. Noah

Faculty Scholarship

Despite the fact that African-Americans suffer from a variety of health problems at disproportionately higher rates than whites, inequities in the medical system make access to care more difficult for minorities. The problem of racial disparities in health care encompasses more than problems of access or payment, however. Communication difficulties between physician and patient and disparate provision of services covered by insurance also may contribute substantially to health disparities between the races. This review canvasses some of the evidence of differential medical treatment and offers some suggestions that may improve the quality of communication between physicians and patients. In addition …

Protecting The Endangered Human: Toward An International Treaty Prohibiting Cloning And Inheritable Alterations, George J. Annas, Lori B. Andrews, Rosario M. Isasi

Faculty Scholarship

We humans tend to worry first about our own happiness, then about our families, then about our communities. In times of great stress, such as war or natural disaster, we may focus temporarily on our country but we rarely think about Earth as a whole or the human species as a whole. This narrow perspective, perhaps best exemplified by the American consumer, has led to the environmental degradation of our planet, a grossly widening gap in living standards between rich and poor people and nations and a scientific research agenda that focuses almost exclusively on the needs and desires of …

Bioterrorism, Public Health, And Civil Liberties, George J. Annas

Faculty Scholarship

The prospect of having to deal with a bioterrorist attack, especially one involving smallpox, has local, state, and federal officials rightly concerned. Before September 11, most procedures for dealing with a bioterrorist attack against the United States were based on fiction. Former President Bill Clinton became engaged in the bioterrorism issue in 1997, after reading Richard Preston's novel The Cobra Event. In Tom Clancy's 1996 Executive Orders, the United States is attacked by terrorists using a strain of Ebola virus that is transmissible through the air. To contain the epidemic, the President declares a state of emergency, orders that …

Medical Privacy And Medical Research: Judging The New Federal Regulations, George J. Annas

Faculty Scholarship

Americans support both protecting the privacy of medical records and encouraging medical research. Thus, it is not surprising that a move to change practices in these two areas has generated attention and comment. The new federal regulations, promulgated under the authority of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), were adopted to protect the privacy of medical records. They were not specifically designed to facilitate or limit medical research. Nonetheless, the regulations have prompted strong objections from the biotechnology industry and from academic medicine. The Association of American Medical Colleges and the Biotechnology Industry Organization have argued …

Cloning And The U.S. Congress, George J. Annas

Faculty Scholarship

In the immediate aftermath of the birth of Dolly the sheep, the national debate over the banning of human cloning focused almost exclusively on the issue of safety. President Bill Clinton's National Bioethics Advisory Commission, for example, recommended in 1997 that Congress impose a five-year moratorium on attempts to clone a human because of the likely physical harm to the cloned infant. Congress did not act on this suggestion, but even if it had, that moratorium would already be almost over. Cloning is now back on the congressional agenda, with a new focal point: the creation of cloned embryos for …

Moral Progress, Mental Retardation, And The Death Penalty, George J. Annas

Faculty Scholarship

Two major aspects of the death penalty in the United States directly involve physicians: how the death penalty is carried out and who is subject to execution. As a matter of constitutional law, both are governed by the prohibition against “cruel and unusual” punishment in the Eighth Amendment. The meaning of “cruel and unusual,” unlike every other part of the U.S. Constitution, is determined by public opinion as it reflects society's evolving standards of decency. With regard to how the death penalty is carried out, the role of physicians in capital punishment has been controversial for more than two decades. …

Two Concepts Of Immortality: Reframing Public Debate On Stem-Cell Research, Frank Pasquale

Faculty Scholarship

No abstract provided.