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Full-Text Articles in Health Law and Policy

Humanizing Work Requirements For Safety Net Programs, Mary Leto Pareja Sep 2019

Humanizing Work Requirements For Safety Net Programs, Mary Leto Pareja

Faculty Scholarship

This Article explores the political and policy appeal of work requirements for public benefit programs and concludes that inclusion of such requirements can be a reasonable design choice, but not in their current form. This Article’s proposals attempt to humanize these highly controversial work requirements while acknowledging the equity concerns they are designed to address. Drawing on expansive definitions of “work” found in guidance published by the Centers for Medicare and Medicaid (“CMS”) and in various state waiver applications, this Article proposes that work requirements be approved for Medicaid (as well as other benefit programs) only if they encompass ...


Designing Development Programs For Non-Traditional Antibacterial Agents, Kevin Outterson, John Rex, Holly Fernandez Lynch, I. Glen Cohen, Jonathan Darrow Jul 2019

Designing Development Programs For Non-Traditional Antibacterial Agents, Kevin Outterson, John Rex, Holly Fernandez Lynch, I. Glen Cohen, Jonathan Darrow

Faculty Scholarship

In the face of rising rates of antibacterial resistance, many responses are being pursued in parallel, including ‘non-traditional’ antibacterial agents (agents that are not small-molecule drugs and/or do not act by directly targeting bacterial components necessary for bacterial growth). In this Perspective, we argue that the distinction between traditional and nontraditional agents has only limited relevance for regulatory purposes. Rather, most agents in both categories can and should be developed using standard measures of clinical efficacy demonstrated with non-inferiority or superiority trial designs according to existing regulatory frameworks. There may, however, be products with non-traditional goals focused on population-level ...


Legal Remedies To Address Stigma-Based Health Inequalities In The United States: Opportunities And Challenges, Valarie Blake, Mark L. Hatzenbuehler Jun 2019

Legal Remedies To Address Stigma-Based Health Inequalities In The United States: Opportunities And Challenges, Valarie Blake, Mark L. Hatzenbuehler

Faculty Scholarship

Stigma is an established driver of population-level health outcomes. Antidiscrimination laws can generate or alleviate stigma and, thus, are a critical component in the study of improving population health.


Currently, antidiscrimination laws are often underenforced and are sometimes conceptualized by courts and lawmakers in ways that are too narrow to fully reach all forms of stigma and all individuals who are stigmatized.


To remedy these limitations, we propose the creation of a new population-level surveillance system of antidiscrimination law and its enforcement, a central body to enforce antidiscrimination laws, as well as a collaborative research initiative to enhance the study ...


The Shadows Of Life: Medicaid's Failure Of Health Care's Moral Test, Barak D. Richman, Kushal T. Kadakia, Shivani A. Shah Jan 2019

The Shadows Of Life: Medicaid's Failure Of Health Care's Moral Test, Barak D. Richman, Kushal T. Kadakia, Shivani A. Shah

Faculty Scholarship

North Carolina Medicaid covers one-fifth of the state’s population and makes up approximately one-third of the budget. Yet the state has experienced increasing costs and worsening health outcomes over the past decade, while socioeconomic disparities persist among communities. In this article, the authors explore the factors that influence these trends and provide a series of policy lessons to inform the state’s current reform efforts following the recent approval of North Carolina’s Section 1115 waiver by the Centers for Medicare and Medicaid Services. The authors used health, social, and financial data from the state Department of Health and ...


Law, Technology And Patient Safety, Kathryn Zeiler, Gregory Hardy Jan 2019

Law, Technology And Patient Safety, Kathryn Zeiler, Gregory Hardy

Faculty Scholarship

Medical error is the third leading cause of death in the United States, In an effort to increase patient safety, various regulatory agencies require reporting of adverse events, but reported counts tend to be inaccurate. In 2005, in an effort to reduce adverse event rates, Congress proposed a list of “never events,” adverse events, such as wrong-site surgery, that should never occur in hospitals, and authorized CMS to refuse payment for care required following such events. CMS has since pushed for further regulation, “such as putting more payment at risk, increasing transparency, increasing frequency of quality data reviews, and stepping ...


A Black Box For Patient Safety?, Nathan Cortez Jan 2019

A Black Box For Patient Safety?, Nathan Cortez

Faculty Scholarship

Technology now makes it possible to record surgical procedures with striking granularity. And new methods of artificial intelligence (A.I.) and machine learning allow data from surgeries to be used to identify and predict errors. These technologies are now being deployed, on a research basis, in hospitals around the world, including in U.S. hospitals. This Article evaluates whether such recordings – and whether subsequent software analyses of such recordings – are discoverable and admissible in U.S. courts in medical malpractice actions. I then argue for reformulating traditional "information policy" to accommodate the use of these new technologies without losing sight ...


Insights Into Early Stage Of Antibiotic Development In Small And Medium-Sized Enterprises: A Survey Of Targets, Costs, And Durations, Kevin Outterson, Christine Ardal, Enrico Baraldi, Ursula Theuretzbacher, Francesco Ciabuschi, Jens Plahte, John-Arne Røttingen Apr 2018

Insights Into Early Stage Of Antibiotic Development In Small And Medium-Sized Enterprises: A Survey Of Targets, Costs, And Durations, Kevin Outterson, Christine Ardal, Enrico Baraldi, Ursula Theuretzbacher, Francesco Ciabuschi, Jens Plahte, John-Arne Røttingen

Faculty Scholarship

Antibiotic innovation has dwindled to dangerously low levels in the past 30 years. Since resistance continues to evolve, this innovation deficit can have perilous consequences on patients. A number of new incentives have been suggested to stimulate greater antibacterial drug innovation. To design effective solutions, a greater understanding is needed of actual antibiotic discovery and development costs and timelines. Small and medium-sized enterprises (SMEs) undertake most discovery and early phase development for antibiotics and other drugs. This paper attempts to gather a better understanding of SMEs’ targets, costs, and durations related to discovery and early phase development of antibacterial therapies.


Quarantine And The Federal Role In Epidemics, Wendy K. Mariner, Michael R. Ulrich Apr 2018

Quarantine And The Federal Role In Epidemics, Wendy K. Mariner, Michael R. Ulrich

Faculty Scholarship

Every recent presidential administration has faced an infectious disease threat, and this trend is certain to continue. The states have primary responsibility for protecting the public’s health under their police powers, but modern travel makes diseases almost impossible to contain intrastate. How should the federal government respond in the future? The Ebola scare in the U.S. repeated a typical response—demands for quarantine. In January 2017, the Department of Health and Human Services and the Centers for Disease Control and Prevention issued final regulations on its authority to issue Federal Quarantine Orders. These regulations rely heavily on confining ...


Structured Settlement Sales And Lead-Poisoned Sellers: Just Say No, Karen Czapanskiy Jan 2018

Structured Settlement Sales And Lead-Poisoned Sellers: Just Say No, Karen Czapanskiy

Faculty Scholarship

No abstract provided.


Removing Obstacles To A Peaceful Death, Kathy L. Cerminara, Barbara A. Noah Jan 2018

Removing Obstacles To A Peaceful Death, Kathy L. Cerminara, Barbara A. Noah

Faculty Scholarship

We all will die, but the American health care system often impedes a peaceful death. Instead of a quiet death at home surrounded by loved ones, many of us suffer through overutilization of sometimes-toxic therapeutic interventions long past the time when those interventions do more good than harm. This article proposes revisions to health professional training and payment policy to eliminate as much as possible physical and existential suffering while progressing through the terminal phase of illness. The solution lies in seamless progression from treatment with integrated palliative care to hospice before death, but provider attitudes and payor practices must ...


Brief Of Professor Ernest A. Young As Amicus Curiae In Support Of Plaintiff Appellant Urging Reversal, Ernest A. Young Jan 2018

Brief Of Professor Ernest A. Young As Amicus Curiae In Support Of Plaintiff Appellant Urging Reversal, Ernest A. Young

Faculty Scholarship

No abstract provided.


If We Pay Football Players, Why Not Kidney Donors, Philip J. Cook, Kimberly D. Krawiec Jan 2018

If We Pay Football Players, Why Not Kidney Donors, Philip J. Cook, Kimberly D. Krawiec

Faculty Scholarship

Ethicists who oppose compensating kidney donors claim they do so because kidney donation is risky for the donor’s health, donors may not appreciate the risks and may be cognitively biased in other ways, and donors may come from disadvantaged groups and thus could be exploited. However, few ethical qualms are raised about professional football players, who face much greater health risks than kidney donors, have much less counseling and screening concerning that risk, and who often come from racial and economic groups deemed disadvantaged. It thus seems that either ethicists—and the law—should ban both professional football and ...


Independence Is The New Health, Laura D. Hermer Jan 2018

Independence Is The New Health, Laura D. Hermer

Faculty Scholarship

Medicaid plays key roles in supporting our nation’s health. Under the Affordable Care Act, Medicaid took an even more central position in public health endeavors by extending coverage in all interested states to millions of adults who typically fell through the health care cracks. Nevertheless, the Trump administration is now undoing these gains by actively encouraging states to curtail access to Medicaid in key respects while using the rhetoric of health.

This article examines Trump administration efforts in two contexts: (1) state § 1115 waiver applications seeking to better align their Medicaid programs with cash welfare and food stamp programs ...


The Drug Debate: Data Exclusivity Is The New Way To Delay Generics, Srividhya Ragavan Jan 2018

The Drug Debate: Data Exclusivity Is The New Way To Delay Generics, Srividhya Ragavan

Faculty Scholarship

The article discusses the protection regime for clinical trial data internationally and outlines the applicable protection regime. In doing so, this article outlines how the data exclusivity regime can operate in parallel with the patent regime to add a layer of protection for the data. Such protection operates at a regulatory level to delay the entry of generic medications. Internationally, the data exclusivity regime, which has become an important contemporary tool in trade negotiations with poorer nations, works to detrimentally affect access to medication


Understanding The Failure Of Health-Care Exceptionalism In The Supreme Court's Obamacare Decision, Abigail Moncrieff Sep 2017

Understanding The Failure Of Health-Care Exceptionalism In The Supreme Court's Obamacare Decision, Abigail Moncrieff

Faculty Scholarship

On June 28, 2012, a mere century after the first presidential proposal for national health insurance, the Supreme Court issued a resounding victory for President Obama and for health-care reform generally, upholding the Patient Protection and Affordable Care Act against a serious constitutional challenge. Nevertheless, the Court also struck a potential blow to future health-care reform efforts. A majority of the Court refused to accept the Solicitor General’s argument that health care is a unique market with unique regulatory needs that justify special constitutional treatment. The failure of health-care exceptionalism in the Court’s opinion might render future reform ...


Marijuana Agriculture Law: Regulation At The Root Of An Industry, Ryan Stoa Mar 2017

Marijuana Agriculture Law: Regulation At The Root Of An Industry, Ryan Stoa

Faculty Scholarship

Marijuana legalization is sweeping the nation. Recreational marijuana use is legal in eight states. Medical marijuana use is legal in thirteen states. Only three states maintain an absolute criminal prohibition on marijuana use. Many of these legalization initiatives propose to regulate marijuana in a manner similar to alcohol, and many titles are variations of the "Regulate Marijuana Like Alcohol Act." For political and public health reasons the analogy makes sense, but it also reveals a regulatory blind spot. States may be using alcohol as a model for regulating the distribution, retail, and consumption of marijuana, but marijuana is much more ...


Assisted Reproduction Inequality And Marriage Equality, Seema Mohapatra Jan 2017

Assisted Reproduction Inequality And Marriage Equality, Seema Mohapatra

Faculty Scholarship

No abstract provided.


Beyond Canterbury: Can Medicine And Law Agree About Informed Consent? And Does It Matter?, 45 J.L. Med. & Ethics 106 (2017), Marc Ginsberg Jan 2017

Beyond Canterbury: Can Medicine And Law Agree About Informed Consent? And Does It Matter?, 45 J.L. Med. & Ethics 106 (2017), Marc Ginsberg

Faculty Scholarship

For those of us whose scholarship focuses on medico-legal jurisprudence, the law of informed consent is a gift. It has been a fertile topic of discussion for decades, with no end in sight. Although it is not difficult to acknowledge that patient autonomy is at the core of informed consent, the doctrine is not static - it has evolved in scope and continues to engage courts in thought provoking analysis.


Comparative Cannabis: Approaches To Marijuana Agriculture Regulation In The United States And Canada, Ryan Stoa Jan 2017

Comparative Cannabis: Approaches To Marijuana Agriculture Regulation In The United States And Canada, Ryan Stoa

Faculty Scholarship

The United States and Canada may be friends and allies, but the two countries' approaches to the regulation of marijuana agriculture have not evolved in tandem. On the contrary, their respective paths toward legalization and regulation of marijuana agriculture are remarkably divergent. In the United States, where marijuana remains a federally prohibited and tightly-controlled substance, legalization and regulation have remained the province of state legislatures and their administrative agencies for decades. In Canada, a succession of court cases paving the way toward medicinal marijuana use has prompted the federal government to develop a national framework committed to "legalize, regulate, and ...


Coverage In Transition: Considerations When Expanding Employer-Provided Health Coverage To Lgbti Employees And Beneficiaries, 24 Cardozo J. Equal Rts. & Soc. Just. 3 (2017), Kathryn J. Kennedy Jan 2017

Coverage In Transition: Considerations When Expanding Employer-Provided Health Coverage To Lgbti Employees And Beneficiaries, 24 Cardozo J. Equal Rts. & Soc. Just. 3 (2017), Kathryn J. Kennedy

Faculty Scholarship

The rights of transgender individuals has been in the headlines during 2017 - ranging from President Trump's tweet to announce a ban on transgender individuals from serving in the military due to the "tremendous medical costs" to a nationwide injunction imposed by a federal district court on the HHS regulations that prohibit health-care discrimination against transgender individuals under the Affordable Care Act (ACA). There are three important reasons why transgender rights are in the news. First, the Human Rights Campaign Foundation, designed to promote the lives of lesbian, gay, bisexual, and transgender (LGBT) people, scores employers in its Corporate Equality ...


Biotechnology And Consumer Decision-Making, Joanna K. Sax Jan 2017

Biotechnology And Consumer Decision-Making, Joanna K. Sax

Faculty Scholarship

Society is facing major challenges in climate change, health care and overall quality of life. Scientific advances to address these areas continue to grow, with overwhelming evidence that the application of highly tested forms of biotechnology is safe and effective. Despite scientific consensus in these areas, consumers appear reluctant to support their use. Research that helps to understand consumer decision-making and the public’s resistance to biotechnologies such as vaccines, fluoridated water programs and genetically engineered food, will provide great social value. This article is forward-thinking in that it suggests that important research in behavioral decision-making, specifically affect and ambiguity ...


The Gmo/Ge Debate, Joanna K. Sax Jan 2017

The Gmo/Ge Debate, Joanna K. Sax

Faculty Scholarship

The scientific community and the public sphere are having different debates about the application of genetic engineering to improve our food supply. Many that are deeply steeped in the science view genetically engineered food as a more precise way to accomplish what we have been doing for centuries, which is genetically modifying our food supply. Some members of the public view genetically engineered food with skepticism especially as it relates to health, safety and the environment. A disconnect between the scientific consensus and public perception is not a new phenomenon. This Article attempts to bridge this gap by explaining what ...


The Economics Of Healthcare Rationing, Michael D. Frakes, Matthew B. Frank, Kyle Rozema Jan 2017

The Economics Of Healthcare Rationing, Michael D. Frakes, Matthew B. Frank, Kyle Rozema

Faculty Scholarship

This article examines the economics of healthcare rationing. We begin with an overview of the various dimensions across which healthcare rationing operates, or at least has the potential to operate, in the first place. We then describe the types of economic analyses used in healthcare rationing decision-making, with particular reference to cost-benefit analysis and cost-effectiveness analysis. We also discuss healthcare rationing in practice, such as how economic analyses inform decisions regarding which services to cover, and conclude by discussing various practical and conceptual challenges that may arise with economic analyses and that span both economics and ethics.


N.C. Medicaid Reform: A Bipartisan Path Forward, Barak D. Richman, Allison Rice Jan 2017

N.C. Medicaid Reform: A Bipartisan Path Forward, Barak D. Richman, Allison Rice

Faculty Scholarship

The North Carolina Medicaid program currently constitutes 32% of the state budget and provides insurance coverage to 18% of the state’s population. At the same time, 13% of North Carolinians remain uninsured, and even among the insured, significant health disparities persist across income, geography, education, and race.

The Duke University Bass Connections Medicaid Reform project gathered to consider how North Carolina could use its limited Medicaid dollars more effectively to reduce the incidence of poor health, improve access to healthcare, and reduce budgetary pressures on the state’s taxpayers.

This report is submitted to North Carolina’s policymakers and ...


Unbefriended And Unrepresented: Better Medical Decision Making For Incapacitated Patients Without Healthcare Surrogates, Thaddeus Pope Jan 2017

Unbefriended And Unrepresented: Better Medical Decision Making For Incapacitated Patients Without Healthcare Surrogates, Thaddeus Pope

Faculty Scholarship

How should we make medical decisions for incapacitated patients who have no available legally-authorized surrogate decision maker? Because these patients lack decision making capacity, they cannot authorize treatment themselves. Because they lack a surrogate, nobody else can authorize treatment either. Clinicians and researchers have referred to these individuals as “adult orphans” or as “unbefriended,” “isolated,” or “unrepresented” patients. Clinicians and researchers have also described them as “unimaginably helpless,” “highly vulnerable,” and as the “most vulnerable,” because “no one cares deeply if they live or die.”

The persistent challenges involved in obtaining consent for medical treatment on behalf of these individuals ...


Changing The Tax Code To Create Consumer-Driven Health Insurance Competition, Regina Herzlinger, Barak D. Richman Jan 2017

Changing The Tax Code To Create Consumer-Driven Health Insurance Competition, Regina Herzlinger, Barak D. Richman

Faculty Scholarship

Because current tax laws exclude employer-paid health insurance premiums from employees’ taxable wages and income, employer-sponsored insurance remains the primary source of health insurance for most employed Americans. Economists have long blamed the employer-based insurance tax exclusion for inflating health care costs, and, more recently, for constraining income growth and exacerbating income inequality.

We execute a simulation to test the effect of permitting employees to receive their employers’ premium contribution directly and then purchase health insurance themselves, using tax-free funds. Employees could deduct for income tax purposes the amount used for insurance and, if they spend less than the amount ...


The Statutory Case Against Off-Label Promotion, Nathan Cortez Jan 2017

The Statutory Case Against Off-Label Promotion, Nathan Cortez

Faculty Scholarship

The Federal Food, Drug, and Cosmetic Act (FDCA) does not expressly prohibit companies from marketing or promoting drugs for unapproved, off-label uses. The FDA itself acknowledges that off-label promotion is not a prohibited act under the statute, or an element of any such act. Instead, the FDA uses off-label promotion as evidence of other statutory violations. This Article engages in perhaps the most thorough statutory construction analysis of the FDCA on this question, finding that the statute does support the FDA's functional ban on off-label promotion. Using various tools of construction, I find that several sections of the FDCA ...


The Abortion Closet (With A Note On Rules And Standards), David Pozen Jan 2017

The Abortion Closet (With A Note On Rules And Standards), David Pozen

Faculty Scholarship

This brief essay responds to Carol Sanger's book "About Abortion: Terminating Pregnancy in Twenty-First Century America." It draws out some implications of Sanger's arguments concerning abortion secrecy, abortion discourse, and the use of standards in constitutional abortion law.


Police Contact And Mental Health, Amanda Geller, Jeffrey Fagan, Tom R. Tyler Jan 2017

Police Contact And Mental Health, Amanda Geller, Jeffrey Fagan, Tom R. Tyler

Faculty Scholarship

Although an effective police presence is widely regarded as critical to public safety, less is known about the effects of police practices on mental health and community wellbeing. Adolescents and young adults in specific neighborhoods of urban areas are likely to experience assertive contemporary police practices. This study goes beyond research on policing effects on legal socialization to assess the effects of police contact on the mental health of those stopped by the police. We collected and analyzed data in a two wave survey of young men in New York City (N=717) clustered in the neighborhoods with the highest ...


Closets, Standards, Abortion: A Reply To Professor Pozen, Carol Sanger Jan 2017

Closets, Standards, Abortion: A Reply To Professor Pozen, Carol Sanger

Faculty Scholarship

I am grateful for David Pozen's thoughtful observations regarding About Abortion. They have sharpened my understanding of how to think about the problem of abortion – or more accurately, about how abortion is kept problematic – as a matter of law and of social practice. I invoke the word "problematic" to describe the cultural setting in which abortion sits: although the procedure is legal, common, and safe, it is often treated as though it were not legal, or barely so; not common, except perhaps for women and girls who have nothing to do with you; and not at all safe, but ...