Health Law and Policy Commons^™

Contours Of Gmo Regulation And Labeling, Joanna K. Sax

Faculty Scholarship

No abstract provided.

Hiv/Aids Care And Prevention Infrastructure In The U.S. Deep South, Susan S. Reif, Kristen Sullivan, Elena Wilson, Miriam Berger, Carolyn Mcallaster

Faculty Scholarship

No abstract provided.

Firearm Legislation And Firearm Mortality In The Usa: A Cross-Sectional, State-Level Study, Bindu Kalesan, Matthew Mobily, Olivia Keiser, Jeffrey Fagan

Faculty Scholarship

In an effort to reduce firearm mortality rates in the USA, US states have enacted a range of firearm laws to either strengthen or deregulate the existing main federal gun control law, the Brady Law. We set out to determine the independent association of different firearm laws with overall firearm mortality, homicide firearm mortality, and suicide firearm mortality across all US states. We also projected the potential reduction of firearm mortality if the three most strongly associated firearm laws were enacted at the federal level.

Law In The Shadow Of Violence: Can Law Help To Improve Doctor-Patient Trust In China?, Benjamin L. Liebman

Faculty Scholarship

Can law help to address the lack of trust in doctor-patient relationships in China? This essay examines the role that law, on the books and in practice, has played in the rise and resolution of patient-doctor disputes and conflict in China. Law has generally played a secondary role in medical disputes: most patient claims never make it to court, and there is little evidence that negotiated outcomes are influenced by legal standards. Yet a legal framework weighted in favor of hospitals and doctors almost certainly exacerbated doctor-patient conflict in the 2000s. Patients facing legal procedures and rules that appeared to …

We Have The Tools To End Hiv: Benefits, Barriers, And Solutions To Expanded Utilization Of Pre-Exposure Prophylaxis (Prep) In The Us Deep South, Jason Ervin, Allison Weller Tikare, Carolyn Mcallaster

Faculty Scholarship

No abstract provided.

On The Expansion Of “Health” And “Welfare” Under Medicaid, Laura Hermer

Faculty Scholarship

Medicaid was intended from its inception to provide financial access to health care for certain categories of impoverished Americans. While rooted in historical welfare programs, it was meant to afford the "deserving" poor access to the same sort of health care that other, wealthier Americans received. Yet despite this seemingly innocuous and laudable purpose, it has become a front in the political and social battles waged over the last several decades on the issues of welfare and the safety net. The latest battleground pits competing visions of Medicaid. One vision seeks to transform Medicaid from a health care program into …

International Cooperation To Improve Access To And Sustain Effectiveness Of Antimicrobials, Christine Årdal, Kevin Outterson, Steven Hoffman, Abdul Ghafur, Mike Sharland, Nisha Ranganathan, Richard Smith, Anna Zorzet, Jennifer Cohn, Didier Pittet, Nils Daulaire, Chantal Morel, Zain Rizvi, Manica Balasegaram, Osman Dar, David Heymann, Alison Holmes, Luke Moore, Ramanan Laxminarayan, Marc Mendelson, John-Arne Røttingen

Faculty Scholarship

Securing access to effective antimicrobials is one of the greatest challenges today. Until now, efforts to address this issue have been isolated and uncoordinated, with little focus on sustainable and international solutions. Global collective action is necessary to improve access to life-saving antimicrobials, conserving them, and ensuring continued innovation. Access, conservation, and innovation are beneficial when achieved independently, but much more effective and sustainable if implemented in concert within and across countries. WHO alone will not be able to drive these actions. It will require a multisector response (including the health, agriculture, and veterinary sectors), global coordination, and financing mechanisms …

Avoiding Overtreatment At The End Of Life: Physician-Patient Communication And Truly Informed Consent, Barbara A. Noah, Neal R. Feigenson

Faculty Scholarship

This Article considers how best to ensure that patients have the tools to make informed choices about their care as they near death. Informed decision making can help reduce excessive end-of-life care and unnecessary suffering, and result in care that aligns with patients’ well-considered values and preferences. The many factors that contribute to dying patients receiving too much therapy and life-prolonging care include: the culture of denial of death, physicians’ professional culture and attitudes toward treatment, physicians’ fear of liability, physicians’ avoidance of discussions about prognosis, and the impact of payment incentives that encourage overutilization of medical technologies.

Under the …

After Tackett: Incomplete Contracts For Post-Employment Healthcare, Maria O'Brien

Faculty Scholarship

This paper examines the recent U.S. Supreme Court retiree health care decision in Tackett v. M & G Polymers and focuses, in particular, on the ostensibly odd silence with respect to a critical contract term — whether the parties in fact agreed that these benefits were vested. Although the union in Tackett insisted these welfare benefits were clearly intended to vest and the employer now asserts they can be modified at any time, the collective bargaining agreement and supporting documents are ambiguous on this question. This paper examines how and why this “silence” persisted for so many decades and concludes …

Beyond Lifestyle: Governing The Social Determinants Of Health, Wendy K. Mariner

Faculty Scholarship

Non-communicable and chronic diseases have overtaken infectious diseases as the major causes of death and disability around the world. Despite recognition that reduction in the chronic disease burden will require governance systems to address the social determinants of health, most public health recommendations emphasize individual behavior as the primary cause of illness and the target of intervention. This Article argues that focusing on lifestyle can backfire, by increasing health inequities and inviting human rights violations. If States fail to take meaningful steps to alter the social and economic structures that create health risks and encourage unhealthy behavior, health at the …

Adjudicating Risk: Aids, Crime, And Culpability, Aziza Ahmed

Faculty Scholarship

The AIDS epidemic continues to pose significant public health challenges, especially given that the spread of the virus outpaces the AIDS response.¹ Importantly, HIV continues to disproportionately impact socially and economically marginalized communities. In countries with concentrated epidemics,² it is racial minorities, sex workers, men who have sex with men, and drug users who face the brunt of the epidemic.³ In the United States, the data is startling⁴ : 44% of new infections were among African-Americans, and among African-Americans contracting HIV, 57% were among gay and bisexual men.⁵ In 2016, the CDC found that one …

Criminal Laws On Sex Work And Hiv Transmission: Mapping The Laws, Considering The Consequence, Sienna Baskin, Aziza Ahmed, Anna Forbes

Faculty Scholarship

Lawmakers historically justify the mobilization of criminal laws on prostitution and HIV as a means of controlling the spread of disease. Over time, however, public health research has conclusively demonstrated that criminal laws on prostitution and HIV significantly impede the ability of sex workers to access services and to live without the stigma and blame associated with being a transmitter of HIV. In turn, mainstream public health approaches to sex work and HIV emphasize decriminalization as a way to improve the lives of sex workers in need of care, treatment, and services. Our current legal system, which criminalizes both prostitution …

An Assessment Of The Human Subjects Protection Review Process For Exempt Research, Jonathan D. Loe, Alex Winkelman, Christopher Robertson

Faculty Scholarship

Medical and public health research includes surveys, interviews, and biospecimens - techniques that do not present substantial risks to subjects. Consequently, this research is exempt from regulation under the Federal Common Rule. Nevertheless, at many institutions, exempt research is frequently subject to the same regulatory process that is required for non-exempt research, requiring the consumption of time and resources for review by Institutional Review Board members or staff. The federal government has indicated an intention to reform and centralize this system, but has not yet specified the form that it will use instead. By examining the policies of the top …

Introduction To Thinking About A Post-Aca World: Litigation, Cost Shifting And Enforcement Of Statutory Rights, Maria O'Brien

Faculty Scholarship

At its annual gathering in 2016, members of the Employee Benefits and Executive Compensation and Law, Medicine and Healthcare Sections of the Association of American Law Schools (AALS) jointly sponsored a discussion of the future of the Affordable Care Act (ACA) following the Supreme Court's decision in King v. Burwell.' What follows are the papers generated for the panel discussion. The panelists² were asked to evaluate the future of the ACA from a distinct perspective.

Law And Politics, An Emerging Epidemic: A Call For Evidence-Based Public Health Law, Michael Ulrich

Faculty Scholarship

As Jacobson v. Massachusetts recognized in 1905, the basis of public health law, and its ability to limit constitutional rights, is the use of scientific data and empirical evidence. Far too often, this important fact is lost. Fear, misinformation, and politics frequently take center stage and drive the implementation of public health law. In the recent Ebola scare, political leaders passed unnecessary and unconstitutional quarantine measures that defied scientific understanding of the disease and caused many to have their rights needlessly constrained. Looking at HIV criminalization and exemptions to childhood vaccine requirements, it becomes clear that the blame cannot be …

Instrumental And Transformative Medical Technologies, Nicole Huberfeld

Faculty Scholarship

This Article considers how medical technologies impact universality in health care. The universality principle, as embodied in the Patient Protection and Affordable Care Act (A CA), eliminated widespread discriminatory practices and provided financial assistance to those otherwise unable to become insured a democratizing federal act that was intended to stabilize health care policy nationwide. This Article posits that medical technology, as with all of medicine, can be universalizing or exclusionary and that this status roughly correlates to its being "instrumental technology" or "transformative technology." Instrumental technology acts as a tool of medicine and often serves an existing aspect of health …

G2i Knowledge Brief: A Knowledge Brief Of The Macarthur Foundation Research Network On Law And Neuroscience, David L. Faigman, Anthony Wagner, Richard J. Bonnie, Bj Casey, Andre Davis, Morris B. Hoffman, Owen D. Jones, Read Montague, Stephen J. Morse, Marcus E. Raichle, Jennifer A. Richeson, Elizabeth S. Scott, Laurence Steinberg, Kim Taylor-Thompson, Gideon Yaffe

Faculty Scholarship

Courts are daily confronted with admissibility issues – such as in cases involving neuroscientific testimony – that sometimes involve both the existence of a general phenomenon (i.e., “G”) and the question of whether a particular case represents a specific instance of that general phenomenon (i.e., “i”).

Unfortunately, courts have yet to carefully consider the implications of “G2i” for their admissibility decisions. In some areas, courts limit an expert’s testimony to the general phenomenon. They insist that whether the case at hand is an instance of that phenomenon is exclusively a jury question, and thus not an appropriate subject of expert …

Does Medical Malpractice Law Improve Health Care Quality?, Michael D. Frakes, Anupam B. Jena

Faculty Scholarship

Despite the fundamental role of deterrence in justifying a system of medical malpractice law, surprisingly little evidence has been put forth to date bearing on the relationship between medical liability forces on the one hand and medical errors and health care quality on the other. In this paper, we estimate this relationship using clinically validated measures of health care treatment quality constructed using data from the 1979 to 2005 National Hospital Discharge Surveys and the 1987 to 2008 Behavioral Risk Factor Surveillance System records. Drawing upon traditional, remedy-centric tort reforms — e.g., damage caps — we estimate that the current …

Contract Development In A Matching Market: The Case Of Kidney Exchange, Kimberly D. Krawiec, Wenhao Liu, Marc L. Melcher

Faculty Scholarship

We analyze a new transplant innovation — Advanced Donation, referred to by some as a kidney “gift certificate,” “layaway plan,” or “voucher — as a case study offering insights on both market and contract development. Advanced Donation provides an unusual window into the evolution of the exchange of a single good — a kidney for transplantation — from gift, to simple barter, to exchange with a temporal separation of obligations that relies solely on trust and reputational constraints for enforcement, to a complex matching market in which the parties rely, at least in part, on formal contract to define and …

Funding The Costs Of Disease Outbreaks Caused By Non Vaccination, Robert L. Schwartz

Faculty Scholarship

While vaccination rates in the United States are high – generally over 90 percent – rates of exemptions have been going up, and preventable diseases coming back. 2014 is shaping to be one of the worst years for measles since 1994, with outbreaks generally starting from unvaccinated individuals and affecting primarily the unvaccinated. While pertussis is a more complex story, communities with high rates of exemptions are more vulnerable to outbreaks. Aside from their human cost and the financial cost of treatment imposed on those who become ill, outbreaks impose financial costs on an already burdened public health system, diverting …

When Biopharma Meets Software: Bioinformatics At The Patent Office, Saurabh Vishnubhakat, Arti K. Rai

Faculty Scholarship

Scholars have spilled much ink questioning patent quality. Complaints encompass concern about incoming applications, examination by the U.S. Patent and Trademark Office (“USPTO”), and the USPTO’s ultimate output. The literature and some empirical data also suggest, however, that applications, examination, and output may differ considerably based on technology. Most notably, although definitions of patent quality are contested, quality in the biopharmaceutical industry is often considered substantially higher than that in information and communications technology (ICT) industries.

This Article presents the first empirical examination of what happens when the two fields are combined. Specifically, it analyzes the creation and early history …

Dualism And Doctrine, Alex Stein, Dov Fox

Faculty Scholarship

No abstract provided.

False Framings: The Co-Opting Of Sex-Selection By The Anti-Abortion Movement, Seema Mohapatra

Faculty Scholarship

No abstract provided.

The Picture Begins To Assert Itself: Rules Of Construction For Essential Health Benefits In Health Insurance Plans Subject To The Affordable Care Act, Wendy K. Mariner

Faculty Scholarship

As the ACA shifts the function of health insurance from voluntary contract to a means of financing health care, it poses some challenges to traditional doctrines for interpreting health plan provisions. This article explores whether and how the doctrine of reasonable expectations and rules of statutory interpretation might apply to Essential Health Benefits coverage. A functional approach linking the two into a doctrine of reasonable statutory expectations could move us toward developing more consistent rules of interpretation within a more realistic conception of contemporary health insurance.

What Will It Take To Address The Global Threat Of Antibiotic Resistance?, Kevin Outterson, Steven J. Hoffman

Faculty Scholarship

Antibiotic resistance is a global threat that may be beyond the capacity of any one country to address. We assess the three primary issues (access, conservation and innovation) and discuss which require higher levels of global coordination.

Scaling Cost-Sharing To Wages: How Employers Can Reduce Health Spending And Provide Greater Economic Security, Christopher Robertson

Faculty Scholarship

In the employer-sponsored insurance market that covers most Americans many workers are “underinsured.” The evidence shows onerous out-of-pocket payments causing them to forgo needed care, miss work, and fall into bankruptcies and foreclosures. Nonetheless, many higher-paid workers are “overinsured”: the evidence shows that in this domain, surplus insurance stimulates spending and price inflation without improving health. Employers can solve these problems together by scaling cost-sharing to wages. This reform would make insurance better protect against risk and guarantee access to care, while maintaining or even reducing insurance premiums.

Yet, there are legal obstacles to scaled cost-sharing. The group-based nature of …

Compelling Interests And Contraception, Neil S. Siegel, Reva Siegel

Faculty Scholarship

On the eve of Griswold v. Connecticut’s fiftieth anniversary, employers are bringing challenges under the Religious Freedom Restoration Act (RFRA) to federal laws requiring them to include contraception in the health insurance benefits that they offer their employees. In Burwell v. Hobby Lobby Stores, five Justices asserted that the government has compelling interests in ensuring employees access to contraception, but did not discuss those interests in any detail. In what follows, we clarify those interests by connecting discussion in the Hobby Lobby opinions and the federal government’s briefs to related cases on compelling interests and individual rights in the areas …

Time To Lift The Veil Of Inequality In Health Care Coverage: Using Corporate Law To Defend The Affordable Care Act, Seema Mohapatra

Faculty Scholarship

No abstract provided.

Informed Consent And The First Amendment, Wendy K. Mariner, George J. Annas

Faculty Scholarship

For more than two decades, states have been adding to the things that physicians must say and do to obtain “informed consent” — and thereby testing the constitutional limits of states' power to regulate medical practice. In 1992, the Supreme Court upheld states' authority to require physicians to provide truthful information that might encourage a woman to reconsider her decision to have an abortion, finding that such a requirement did not place an “undue burden” on the woman.

The Space Between Two Worlds: Forward To The Health Law, Elizabeth Mccuskey

Faculty Scholarship

This year's Law Review Symposium explored the modem state of health law under the heading, From Scalpel to Gavel. By situating its discussion in the space between the health sciences and law, this symposium embodied the inherently interdisciplinary nature of health law. The gathering of scholars, physicians, counsel, enforcers, and community groups bridged the spaces among numerous disciplines, promoting the exchange of empiricism, ideas, and experiences that have come to define health law.