Health Law and Policy Commons^™

Follow The Leader?: Maryland's Response To The New Federal Stem Cell Guidelines, Michael Ulrich

Faculty Scholarship

Billions of dollars have been spent in search of cures for diseases such as cancer, muscular dystrophy, heart disease, diabetes, Alzheimer’s, and Parkinson’s. Medical research has consistently pushed the envelope to find new ways to tackle old problems, yet, the field of embryonic stem cell research, a field that many believe could be the key to providing new and effective treatments, remains relatively underfunded due to concerns over ethical considerations. This is largely because the biggest financial backer of scientific research is the federal government, and its desire to finance embryonic stem cell research has waxed and waned over the …

Higher First Amendment Hurdles For Public Health Regulation, Kevin Outterson

Faculty Scholarship

In 2007, Vermont enacted the Prescription Confidentiality Law, prohibiting pharmacies from selling “prescriber-identifiable” prescription information to data-mining companies such as IMS Health and Verispan. These companies aggregate such data and sell them to many groups, including drug companies, so when drug sales representatives visit a physician, they can know exactly what prescriptions the physician has written.

Smoking And The First Amendment, Kevin Outterson

Faculty Scholarship

On June 22, 2009, President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act into law. For the first time, Congress had given the Food and Drug Administration (FDA) authority to directly regulate tobacco products, with the aim of improving public health. And indeed, effective tobacco control would be a remarkable public health achievement — and might be possible if the law is allowed to stand. But on November 7, 2011, a federal judge in Washington, D.C., issued a preliminary injunction blocking some of its key provisions as unconstitutional restrictions on commercial speech, and the battle seems likely …

Improving Antibiotic Markets For Long Term Sustainability, Aaron S. Kesselheim, Kevin Outterson

Faculty Scholarship

The world faces a worsening public health crisis: A growing number of bacteria are resistant to available antibiotics. Yet there are few new antibiotics in the development pipeline to take the place of these increasingly ineffective drugs. We review a number of proposals intended to bolster drug development, including such financial incentives for pharmaceutical manufacturers as extending the effective patent life for new antibiotics. However, such strategies directly conflict with the clear need to reduce unnecessary antibiotic prescriptions and could actually increase prescription use. As an alternative, we recommend a two-prong, “integrated” strategy based on prizes administered through the insurance …

Hiv And Women: Incongruent Policies, Criminal Consequences, Aziza Ahmed

Faculty Scholarship

UN Women must take an aggressive role in the standardization of laws and policies at the global and national level where their incongruence has negative and often criminal consequences for the health and lives of women and girls. This article focuses in on three such examples: opt-out testing for HIV, criminalization of vertical transmission, and the new World Health Organization guidelines on breastfeeding.

Feminism, Power, And Sex Work In The Context Of Hiv/Aids: Consequences For Women's Health, Aziza Ahmed

Faculty Scholarship

This paper examines the involvement of feminists in approaches to sex work in the context of HIV/AIDS. The paper focuses on two moments where feminist disagreement produced results in favor of an "anti-trafficking" approach to addressing the vulnerability of sex workers in the context of HIV. The first is the UNAIDS Guidance Note on Sex Work and the second is the "anti-prostitution pledge" found in the Presidents Emergency Plan for AIDS Relief. This article also examines the anti-sex work position articulated by abolitionist feminists and demonstrates the unintended consequences of the abolitionist position on women's health. By examining the actual …

Guardianship And Its Alternatives: A Handbook On Maryland Law, Virginia Rowthorn, Ellen A. Callegary

Faculty Scholarship

No abstract provided.

Defense Of The Constitutionality Of Health Care Reform, Gillian E. Metzger

Faculty Scholarship

Along with the others, I want to thank David for organizing this panel. The great advantage of going last is that the terms of the debate over the Affordable Care Act's constitutionality have been established by the other panelists. As a result, I am going to target my remarks on a few key points, rather than walk through a full dress review of some of the arguments. Like the others, my focus is on existing doctrine. I completely agree with Dean Chemerinsky in thinking that the Supreme Court is not going to change the key parameters of existing analysis, but …

Reducing Mass Incarceration: Lessons From The Deinstitutionalization Of Mental Hospitals In The 1960s, Bernard Harcourt

Faculty Scholarship

In a message to Congress in 1963, President John F. Kennedy outlined a federal program designed to reduce by half the number of persons in custody. The institutions at issue were state hospitals and asylums for the mentally ill, and the number of such persons in custody was staggeringly large, in fact comparable to contemporary levels of mass incarceration in prisons and jails. President Kennedy's message to Congress – the first and perhaps only presidential message to Congress that dealt exclusively with the issue of institutionalization in this country – proposed replacing state mental hospitals with community mental health centers, …

Medical Malpractice Mediation: Benefits Gained, Opportunities Lost, Carol B. Liebman

Faculty Scholarship

In the past decade, the United States healthcare system has begun to use mediation to facilitate communication between patients and physicians after an adverse medical event, to ease tensions among members of care-giving teams, to resolve medical malpractice claims, and to help family members and medical professionals make awesome and wrenching decisions at the end of life. Implementation of the Patient Protection and Affordable Care Act of 2010 will produce new controversies and increase the need for mediation. Patients, families, physicians, nurses, other healthcare professionals, and administrators will require help managing the disagreements that arise as they adapt to the …

The Provider-Monopoly Problem In Health Care, Clark C. Havighurst, Barak D. Richman

Faculty Scholarship

Although federal judges have resisted giving due effect to standard antitrust principles in scrutinizing mergers of nonprofit hospitals, the presence of health insurance makes it especially important to oppose monopoly in health services markets. U.S.-style health insurance gives monopolist providers extraordinary pricing freedom, thus exacerbating monopoly’s usual redistributive effects. Significant allocative inefficiencies - albeit not the kind generally associated with monopoly - also result when the monopolist is a nonprofit hospital. Because it is probably impossible to undo past hospital mergers creating undue market power, we suggest some alternative remedies. One is to apply antitrust rules against "tying" arrangements so …

Who Pays? Who Benefits? Unfairness In American Health Care, Clark C. Havighurst, Barak D. Richman

Faculty Scholarship

American-style health insurance greatly amplifies price-gouging opportunities for health care providers, who inflate prices both to enrich themselves and to subsidize and expand the nation’s health care enterprise. To the extent that lower- and middle-income Americans with private health coverage pay premiums that go to support and expand the system, they are subject to an unfair (regressive) “head tax” levied by unaccountable entities for ostensibly public but also private purposes. Lower-income premium payers also often pay for costly health coverage designed to suit the economic interests and values of professional and other elites rather than their own. They also appear …

A Cautious Path Forward On Accountable Care Organizations, Barak D. Richman, Kevin A. Schulman

Faculty Scholarship

The wave of new Accountable Care Organizations (ACOs), spurred by financial incentives in the Affordable Care Act, could become the latest chapter in the steady accumulation of market power by hospitals, health care systems, and physician groups. The main purpose behind forming many ACOs may not be to achieve cost savings but instead to strengthen negotiating power over purchasers in the private sector. This would be an unfortunate sequel to the waves of mergers in the 1990s when health care entities sought to counter market pressure from managed care organizations. The possibility that ACOs might further concentrate health care markets …

Germ Shed Management In The United States, Kevin Outterson

Faculty Scholarship

The U.S. Medicare program reimburses only for discrete treatments of individuals with infections, but fails to pay for infection control or antibiotic stewardship more generally. By focusing solely on discrete hospitals and patients, Medicare ignores the larger epidemiological reality - that hospitals, nursing homes and other institutions operate within a germ shed. Under current Medicare rules, institutions that invest in infection control or antibiotic stewardship, may actually lose money and benefit rival firms in the market. In effect, current Medicare rules subsidize MRSA pollution. Worse yet, Medicare rules block potentially efficient Coasian contracts to promote private coordination within germ sheds.

American Vertigo: Dual Use, Prison Physicians, Research, And Guantanamo, George J. Annas

Faculty Scholarship

Physicians can be used by governments for nonmedical purposes, and physician acceptance of their nonmedical use is usually denoted as "dual loyalty, " although it is more analytically helpful to frame it "dual use. " Dual use of physicians has been on display at Guantanamo where physicians have consistently been used to break hunger strikes as part of the military security mission in ways that directly violate medical ethics. Guantanamo itself has also been seen worldwide as a uniquely horrible prison, which can tell us little about other American prisons. The contrary seems to be true: Guantanamo, and the use …

The Human Right To Health And Hiv/Aids: South Africa And South-South Cooperation To Reframe Global Intellectual Property Principles And Promote Access To Essential Medicines, Erika George

Faculty Scholarship

The HIV/AIDS pandemic has had a devastating and disproportionate impact in countries of the Global South. The experience of an individual infected with HIV in Africa is very different than that of an individual infected with HIV in America. Life expectancy varies sharply. The ability or inability to access medicines essential for treatment accounts for much of the variance. This article examines how the rhetoric of human rights used in the context of South Africa's AIDS crisis resonated across the Global South, resulted in a powerful social movement for access to medicines, and contributed to important changes in international intellectual …

Four Constitutional Limits That The Minimum Coverage Provision Respects, Neil S. Siegel

Faculty Scholarship

Opponents of the minimum coverage provision in the Affordable Care Act charge that if Congress can require most people to obtain health insurance or pay a certain amount of money, then Congress can impose whatever mandates it wishes - or, at least, whatever purchase mandates it wishes. This Essay refutes that claim by identifying four limits on the Commerce Clause that the minimum coverage provision honors. Congress may not use its commerce power: (1) to regulate noneconomic subject matter; (2) to impose a regulation that violates constitutional rights, including the right to bodily integrity; (3) to regulate at all, including …

Erisa & Uncertainty, Brendan S. Maher, Peter K. Stris

Faculty Scholarship

In the United States, retirement income and health insurance are largely provided through private promises made incident to employment. These “benefit promises” are governed by a statute called ERISA, which many healthcare and pension scholars argue is the cause of fundamental problems with our nation’s health and retirement policy. Inevitably, however, they advance narrowly tailored proposals to amend the statute. This occurs because of the widely-held view that reform should leave undisturbed the underlying core of the statute. This Article develops a theory of ERISA designed to illustrate the unavoidable need for structural reform.

Should The Patient Conquer?, William M. Sage

Faculty Scholarship

In 1596, Robert Bainbridge carved “The patient shall conquer” into the wall of his cell in the Tower of London. It is highly unlikely that Bainbridge was an early advocate for recipients of medical care, imprisoned perhaps by a cruel sheriff denied his payroll taxes or by a domineering barber refused his fee. But its unintended meaning would immediately provoke sympathy from many health care reformers. As we confront the critical challenges of implementing national health-care reform, however, whether the patient should conquer is a legitimate topic for debate. Does the patient’s conquest risk the collapse of the health-care system …

Health Insurance Politics In Federal Court, Wendy K. Mariner, George J. Annas

Faculty Scholarship

Having been outmaneuvered in Congress with the passage of the Patient Protection and Affordable Care Act (“Affordable Care Act,” or ACA), Republicans have taken their case to federal court, arguing that the law's key provision, the individual mandate to purchase health insurance, is unconstitutional. This argument has been made most prominently by attorneys general from 20 states in a Florida federal court and by the Commonwealth of Virginia in a Virginia federal court. In early August, federal district court judge Henry Hudson decided that the Virginia challenge deserves a hearing,1 thereby giving the constitutional argument an aura of respectability …

Gift Giving To Biobanks, Leonard H. Glantz, Patricia Roche, George J. Annas

Faculty Scholarship

We agree with Mark Rothstein's goal of giving tissue donors control over their donated tissues. But we think using the research model as the basis for attaining this goal, while widely employed and accepted, should be abandoned.

The research regulations were originally adopted to deal with interventions on living human beings, not on the tissue of human beings. The Nuremberg Code (a reaction to concentration camp experiments), the Willowbrook experiment, the Tuskegee syphilis experiment, and the other examples of the abuse of research subjects that provided the rationale for regulating research on human subjects clearly had nothing to do with …

Combating Antimicrobial Resistance: Regulatory Strategies And Institutional Capacity, William M. Sage, David A. Hyman

Faculty Scholarship

Amnesia is a common, important, but rarely noted side effect of antibiotics. Apart from medical historians, few recall the severe morbidity and mortality once associated with acute bacterial infection. However, decades of antibiotic overuse and misuse have compromised the long-term availability and efficacy of these life-saving therapies. If designed and implemented appropriately, regulation can reduce the risk of bacterial infection, reserve antibiotics for circumstances where they are necessary, and rationalize the use of the most powerful agents. Regulation of antibiotic resistance can be justified, and should be guided, by both efficiency and fairness. A range of regulatory options are available--some …

Introduction: Remembering Stephanie Feldman Aleong, Kathy L. Cerminara

Faculty Scholarship

Kathy Cerminara, Introduction: Remembering Stephanie Feldman Aleong, 34 Nova Law Review 565 (2010).

From Eugenics To The "New" Genetics: "The Play's The Thing", Karen H. Rothenberg

Faculty Scholarship

Genetics occupies a place in the public imagination with which few areas of science can compete. It is popularly understood to be the “science of life,” concerned with the essence of humanity: a subject that generates both awe and fear. These divergent emotions are encapsulated in the “promise versus peril” debate: the promise of an end to human disease is countered by the peril embodied in the discriminatory capacity of genetic essentialism. This debate has become ingrained in popular culture, and its dramatic potential has been effectively realized in theatre.

Plays have always been written and performed as expressions of …

Cognition-Enhancing Drugs: Can We Say No?, Frank Pasquale

Faculty Scholarship

Normative analysis of cognition-enhancing drugs frequently weighs the liberty interests of drug users against egalitarian commitments to a "level playing field." Yet those who would refuse to engage in neuroenhancement may well find their liberty to do so limited in a society where such drugs are widespread. To the extent that unvarnished emotional responses are world-disclosive, neurocosmetic practices also threaten to provide a form of faulty data to their users. This essay examines underappreciated liberty-based and epistemic rationales for regulating cognition-enhancing drugs.

Access To Medicine In An Era Of Fractal Inequality, Frank Pasquale

Faculty Scholarship

Those in the richest countries have far more income and wealth than those in poor countries. Moreover, the most fortunate in the richest countries – particularly those in the top centile of the income distribution – are far richer than those around them. Most dramatically, even within that top centile, the richest of the rich have far more resources than even their elite peers. Like fractals, the patterns of distribution repeat at various levels.

This pattern of fractal inequality ensures that spending that seems trivial to those at the top of an income distribution can overwhelm the purchasing power of …

La Caja De Pandora: Improving Access To Hospice Care Among Hispanic And African-American Patients, Kathy L. Cerminara, Alina M. Perez

Faculty Scholarship

Many patients clinging to hope in the form of potentially curative treatment could benefit from hospice services, but, for the most part, it is not until the patient accepts the finality of his or her condition that the physical, psychological and social benefits of hospice care become accessible to the patient and his or her family. Under current Medicare regulations and other health care payers’ policies, patients must abandon the hope of curative treatment before opting for hospice services. As a result, many terminally ill patients access the services late, sometimes a few hours before death. Scholars have proposed that …

Will Americans Embrace Single-Payer Health Insurance: The Intractable Barriers Of Inertia, Free Market And Culture, Susan A. Channick

Faculty Scholarship

In a country that prides itself on equality of opportunity, why is there so little equality when it comes to healthcare? Why does the value of equality of opportunity not translate into social solidarity? This Article seeks answers to these questions. Risking the label of socialist, I posit that the most cost-effective, efficacious, and efficient solution to the health care mess that the United States is in is universal single-payer reform with the federal government as that payer.

Part I examines the United States' current climate as it affects health care reform. In Part II, this Article scrutinizes recent state …

Regression By Progression Unleveling The Classroom Playing Field Through Cosmetic Neurology, Helia Garrido Hull

Faculty Scholarship

No abstract provided.

Scaling Up, Lourdes Hernández-Cordero, Susan P. Sturm, Kathleen Klink, Allan J. Formicola

Faculty Scholarship

Moments of crisis require big, bold ideas. In this chapter we will zoom out of our close examination of the Northern Manhattan Community Voices Collaborative experience to propose ways to scale up the things that worked for us in order to make them applicable at a national level. With this chapter we honor the intent of the W. K. Kellogg Foundation in its support of learning laboratories across the nation. Our goal is to contribute to the collective dialogue on how to improve the health care system. Specifically, we propose that making a healthier nation and reducing health care costs …