Law Commons^™

Evidence Supporting The Value Of Surgical Procedures: Can We Do Better?, Christopher Robertson, Jonathan Darrow, Willard S. Kasoff

Faculty Scholarship

There is an acknowledged need for higher-quality evidence to quantify the benefit of surgical procedures, yet not enough has been done to improve the evidence base. This lack of evidence can prevent fully informed decision-making, lead to unnecessary or even harmful treatment, and contribute to wasteful expenditures of scare health care resources. Barriers to evidence generation include not only the long-recognized technical difficulties and ethical challenges of conducting randomized surgical trials, but also legal challenges that limit incentives to conduct surgical research as well as market-based challenges that make it difficult for those funding surgical research to recoup investment costs. …

Desnatada: Latina Illumination Of Breastfeeding, Race, And Injustice, Jasmine Gonzales Rose

Faculty Scholarship

In Skimmed: Breastfeeding, Race, and Injustice, Andrea Freeman brilliantly explains how racism results in lower breastfeeding rates by Black mothers,¹ which in turn results in poorer health outcomes--including higher mortality rates--for Black babies.² She provides four primary reasons for this phenomenon: (1) the history and legacy of slavery, (2) the imposition of racist gender stereotypes on Black women, (3) racially-targeted formula promotion by manufacturers and hospitals, and (4) government benefits and employment policies that obstruct poor people's ability to breastfeed. The first two of these reasons are particularly devastating: the legacy of slavery and misogynoiristic³ stereotypes …

Paying For Unapproved Medical Products, Kelly Mcbride Folkers, Alison Bateman-House, Christopher Robertson

Faculty Scholarship

This symposium article examines the use of investigational (un-approved) medical products in the United States, with particular focus on who pays for this use. In the United States, the question of who pays for the use of approved medical products for their intended indications is complicated enough, with some expenses borne by private payers, some by public payers, some covered as charity care, and some paid out of pocket by patients. A separate question is off-label use, in which an approved medical product is used for an unapproved indication. In this article, we focus on a narrower issue: what entities …

The Limits Of Medical X-Pertise: Gender Markers In A Pandemic, Heron Greenesmith, Andy Izenson

Faculty Scholarship

The world changed drastically in 2020. The pandemic has far reaching consequences, and so too do the current civil rights movements and the struggle for gender justice and liberation. This Article seeks to describe a moment in time, a moment of doubt of how one 's gender and race will predict one 's ability to survive the pandemic-not simply COVID-19, but the pandemic writ-large and all the wrenches it has thrown into the health-care machine. How do those of us standing at the edge of a gender revolution navigate these waters? Will our health be the price we pay for …

Struggle For The Soul Of Medicaid, Nicole Huberfeld, Sidney Watson, Alison Barkoff

Faculty Scholarship

Medicaid is uniquely equipped to serve low-income populations. We identify four features that form the “soul” of Medicaid, explain how the administration is testing them, and explore challenges in accountability contributing to this struggle. We highlight the work of watchdogs acting to protect Medicaid and conclude with considerations for future health reform.

Social Solidarity In Health Care, American-Style, Erin C. Fuse Brown, Matthew B. Lawrence, Elizabeth Mccuskey, Lindsay F. Wiley

Faculty Scholarship

The ACA shifted U.S. health policy from centering on principles of actuarial fairness toward social solidarity. Yet four legal fixtures of the health care system have prevented the achievement of social solidarity: federalism, fiscal pluralism, privatization, and individualism. Future reforms must confront these fixtures to realize social solidarity in health care, American-style.

Setting The Standard: Multidisciplinary Hallmarks For Structural, Equitable And Tracked Antibiotic Policy, Kevin Outterson, Claas Kirchhelle, Paul Atkinson, Alex Broom, Komatra Chuengsatiansup, Jorge Pinto Ferreira, Nicolas Fortané, Isabel Frost, Christoph Gradmann, Stephen Hinchliffe, Steven J. Hoffman, Javier Lezaun, Susan Nayiga, Scott H. Podolsky, Stephanie Raymond, Adam P. Roberts, Andrew C. Singer, Anthony D. So, Luechai Sringernyuang, Elizabeth Tayler, Susan Rogers Van Katwyk, Clare I. R. Chandler

Faculty Scholarship

There is increasing concern globally about the enormity of the threats posed by antimicrobial resistance (AMR) to human, animal, plant and environmental health. A proliferation of international, national and institutional reports on the problems posed by AMR and the need for antibiotic stewardship have galvanised attention on the global stage. However, the AMR community increasingly laments a lack of action, often identified as an ‘implementation gap’. At a policy level, the design of internationally salient solutions that are able to address AMR’s interconnected biological and social (historical, political, economic and cultural) dimensions is not straightforward. This multidisciplinary paper responds by …

The Affordable Care Act: Up For A Final Vote?, Wendy K. Mariner

Faculty Scholarship

For more than a decade, the minimum essential coverage requirement, commonly known as the individual mandate, has been a key point of controversy over the ACA, symbolizing ideological and political disagreements over government assistance to low-income populations, federal regulation of private industry, and the legacy of President Obama. 26 U.S.C. §5000A(a) requires everyone (with exceptions) to be covered by a private or public health benefit program meeting ACA standards. 26 U.S.C. §5000A(b) requires those who are not so covered to pay a fee (“shared responsibility payment”) to the Treasury. 26 U.S.C. §5000A(c) sets forth the amount of that fee.

Introduction: Health And Human Rights, George J. Annas

Faculty Scholarship

The American health care industry is killing us, and the casualties are mounting daily. Instead of saving lives, it is more often taking them, and not only by failing to seriously confront the coronavirus pandemic and racism in the industry, but also by the way health care is financed.

Medicaid's Vital Role In Addressing Health And Economic Emergencies, Nicole Huberfeld, Sidney Watson

Faculty Scholarship

Medicaid plays an essential role in helping states respond to crises. Medicaid guarantees federal matching funds to states, which helps with unanticipated costs associated with public health emergencies, like COVID-19, and increases in enrollment that inevitably occur during times of economic downturn. Medicaid’s joint federal/state structure, called cooperative federalism, gives states significant flexibility within federal rules that allows states to streamline eligibility and expand benefits, which is especially important during emergencies. Federal emergency declarations give the secretary of Health and Human Services temporary authority to exercise regulatory flexibility to ensure that sufficient health care is available to meet the needs …

Have The Aca’S Exchanges Succeeded? It’S Complicated, Nicole Huberfeld, David Jones, Sarah Gordon

Faculty Scholarship

The fight over health insurance exchanges epitomizes the rapid evolution of health reform politics in the decade since the passage of the Affordable Care Act. The ACA's drafters did not expect the exchanges to be contentious; they would expand private insurance coverage to low- and middle-income individuals who were increasingly unable to obtain employer-sponsored health insurance. Yet, exchanges became one of the primary fronts in the war over Obamacare. Have the exchanges been successful? The answer is not straightforward and requires a historical perspective through a federalism lens. What the ACA has accomplished has depended largely on whether states were …

Genome Editing 2020: Ethics And Human Rights In Germline Editing In Humans And Gene Drives In Mosquitoes, George J. Annas

Faculty Scholarship

The moon landing, now more than a half century in the past, has turned out to be the culmination of human space travel, rather than its beginning. Genetic engineering, especially applications of CRISPR, now presents the most publicly discussed engineering challenges—and not just technical, but ethical as well. In this article, I will use the two most controversial genomic engineering applications to help identify the ethics and human rights implications of these research projects. Each of these techniques directly modifies the mechanisms of evolution, threatens to alter our views of ourselves as humans and our planet as our home, and …

What Federalism Means For The Us Response To Coronavirus Disease 2019, Sarah H. Gordon, Nicole Huberfeld, David K. Jones

Faculty Scholarship

The rapid spread of novel coronavirus disease 2019 (COVID-19) across the United States has been met with a decentralized and piecemeal response led primarily by governors, mayors, and local health departments. This disjointed response is no accident. Federalism, or the division of power between a national government and states, is a fundamental feature of US public health authority.¹ In this pandemic, US public health federalism assures that the coronavirus response depends on zip code. A global pandemic has no respect for geographic boundaries, laying bare the weaknesses of federalism in the face of a crisis.

Telehealth For An Aging Population: How Can Law Influence Adoption Among Providers, Payors, And Patients?, Tara Sklar, Christopher Robertson

Faculty Scholarship

Telehealth continues to experience substantial investment, innovation, and unprecedented growth. However, telehealth has been slow to transform healthcare. Recent developments in telehealth technologies suggest great potential for chronic care management, mental health services, and care delivery in the home—all of which should be particularly impactful for an aging population with physical and cognitive limitations. While this alignment of technological capacity and market demand is promising, legal barriers remain for telehealth operators to scale up across large geographic areas. To better understand how federal and state law can be reformed to enable greater telehealth utilization, we review and extract lessons from …

Floating Lungs: Forensic Science In Self-Induced Abortion Prosecutions, Aziza Ahmed

Faculty Scholarship

Pregnancy that ends in stillbirth or late miscarriage—particularly where a person gives birth outside of a hospital—raises the specter of criminal behavior. To successfully prosecute a person for the death of a child, however, requires proving that the child was born alive. Prosecutors mobilize forensic science as an objective way to determine life. This Essay focuses on one such forensic method: the hydrostatic lung test (“HLT”), also known as the floating lung test (“FLT”). Although there are debates about the “correct” way to perform the exam, in essence, the test requires that a forensic scientist take pieces of the lung …

Indemnifying Precaution: Economic Insights For Regulation Of A Highly Infectious Disease, Christopher Robertson, K Aleks Schaefer, Daniel Scheitrum, Sergio Puig, Keith Joiner

Faculty Scholarship

Economic insights are powerful for understanding the challenge of managing a highly infectious disease, such as COVID-19, through behavioral precautions including social distancing. One problem is a form of moral hazard, which arises when some individuals face less personal risk of harm or bear greater personal costs of taking precautions. Without legal intervention, some individuals will see socially risky behaviors as personally less costly than socially beneficial behaviors, a balance that makes those beneficial behaviors unsustainable. For insights, we review health insurance moral hazard, agricultural infectious disease policy, and deterrence theory, but find that classic enforcement strategies of punishing noncompliant …

How The Covid-19 Response Is Altering The Legal And Regulatory Landscape On Abortion, Aziza Ahmed

Faculty Scholarship

The CARES Act, a two trillion-dollar stimulus bill designed to fund the response to COVID-19 and address the many economic shortfalls created by the pandemic, offered the first arena for Democrats and Republicans to bring questions of abortion access into the COVID-19 response. Republicans successfully pushed for the application of the abortion restrictions to CARES Act funding vis-à-vis the Hyde Amendment. The Hyde Amendment was passed in 1976 as part of an appropriations bill and has been passed as a rider every year since. It prevents federal dollars from being used to access abortions except in cases where the life …

Fda In The Time Of Covid-19, Elizabeth Mccuskey

Faculty Scholarship

Over the past century, Congress has made the Food & Drug Administration (FDA) responsible for regulating the safety and efficacy of drugs and devices being deployed in the fight against the COVID-19 pandemic. The FDA’s regulatory infrastructure was built for public health threats and to combat manufacturers' misinformation about treatments.

This article spotlights the ways in which FDA has been adapting to a new challenge during the COVID-19 pandemic: combating misinformation emanating from within the executive branch.

Distinguishing Moral Hazard From Access For High-Cost Healthcare Under Insurance, Christopher Robertson, Andy Yuan, Wendan Zhang, Keith Joiner

Faculty Scholarship

Health policy has long been preoccupied with the problem that health insurance stimulates spending (“moral hazard”). However, much health spending is costly healthcare that uninsured individuals could not otherwise access. Field studies comparing those with more or less insurance cannot disaggregate moral hazard versus access. Moreover, studies of patients consuming routine low-dollar healthcare are not informative for the high-dollar healthcare that drives most of aggregate healthcare spending in the United States.

We test indemnities as an alternative theory-driven counterfactual. Such conditional cash transfers would maintain an opportunity cost for patients, unlike standard insurance, but also guarantee access to the care. …

First Man And Second Woman: Reflections On The Anniversaries Of Apollo 11 And Cruzan, George J. Annas

Faculty Scholarship

THE United States Supreme Court's decision in Cruzan v. Director, Missouri Department of Health marks its thirtieth anniversary in 2020.' This follows closely after the fiftieth anniversary of the Apollo 11 moon landing.² Anniversaries provide an opportunity for reflection and to gain perspective. We can, I suggest, gain deeper insights regarding human life and death by considering these two anniversaries together. Apollo 11 may seem far from Nancy Cruzan-but the discovery of disturbing details about the death of Neil Armstrong, the first man on the moon, is a productive introduction to the topic of death in a modern American …

Antibiotic Development & Economic, Regulatory And Societal Challenges, Kevin Outterson, Christine Årdal, Manica Balasegaram, Ramanan Laxminarayan, David Mcadams, John Rex, Nithima Sumpradit

Faculty Scholarship

Antibiotic resistance is undoubtedly one of the greatest challenges to global health, and the emergence of resistance has outpaced the development of new antibiotics. However, investments by the pharmaceutical industry and biotechnology companies for research into and development of new antibiotics are diminishing. The public health implications of a drying antibiotic pipeline are recognized by policymakers, regulators and many companies. In this Viewpoint article, seven experts discuss the challenges that are contributing to the decline in antibiotic drug discovery and development, and the national and international initiatives aimed at incentivizing research and the development of new antibiotics to improve the …

Pedagogy And Policy: A Tribute To Karen Rothenberg’S Contributions To Health Law, Michael Ulrich

Faculty Scholarship

Professor Karen Rothenberg has had a significant influence on my life, impacting my education, my career, and the way I think. Professor Rothenberg has been a pillar in the health law community, but perhaps her most lasting impact for myself was creating the health law program at the University of Maryland, Francis King Carey School of Law. This nationally recognized program grew from her passion, expertise, and recognition of the importance of health, and is the reason I chose to attend the University of Maryland. The curriculum, faculty, and experience made it one of the best decisions of my life …

Evaluating For-Profit Public Benefit Corporations As An Additional Structure For Antibiotic Development And Commercialization, Kevin Outterson, John H. Rex

Faculty Scholarship

While antibiotics are a key infrastructure underpinning modern medicine, evolution will continue to undermine their effectiveness, requiring continuous investment to sustain antibiotic effectiveness. The antibiotic R&D ecosystem is in peril, moving towards collapse. Key stakeholders have identified pull incentives such as Market Entry Rewards or subscription models as the key long-term solution. If substantial Market Entry Rewards or other pull incentives become possible, there is every reason to expect that for-profit companies will return to the antibiotic field. However, the political and financial will to develop such Market Entry Rewards or other similar incentives may be difficult to muster in …

Federalism Complicates The Response To The Covid-19 Health And Economic Crisis: What Can Be Done?, Nicole Huberfeld, Sarah Gordon, David K. Jones

Faculty Scholarship

Federalism has complicated the US response to the novel coronavirus. States’ actions to address the pandemic have varied widely, and federal and state officials have provided conflicting messages. This fragmented approach has cost time and lives. Federalism will shape the long-term health and economic impacts of COVID-19, including plans for the future, for at least two reasons: First, federalism exacerbates inequities, as some states have a history of underinvesting in social programs, especially in certain communities. Second, many of the states with the deepest needs are poorly equipped to respond to emergencies due to low taxes and distrust of government, …

Is Medicare For All The Answer? Assessing The Health Reform Gestalt As The Aca Turns 10, Nicole Huberfeld

Faculty Scholarship

As presidential candidates debate health reform, the expression “Medicare for All” (“M4A”) is on repeat, yet few appear to understand precisely what Medicare is or what M4A would mean. Even more striking is that Americans are vigorously debating health reform when the ACA – President Obama’s signature legislation and a health reform effort on a scale not seen in decades – turns 10 on March 23.

The ACA pioneered universal coverage, but it also ratcheted up health care complexity by building new scaffolding around an old foundation. This fragmented landscape has been exacerbated by a crazy quilt of implementation crafted …

A Public Health Law Path For Second Amendment Jurisprudence, Michael Ulrich

Faculty Scholarship

The two landmark gun rights cases, District of Columbia v. Heller and McDonald v. City of Chicago, came down in 2008 and 2010, respectively. In the decade that has followed, two things have become abundantly clear. First, these cases provide little clarity about the nature and scope of Second Amendment rights, resulting in chaos and circuit splits in the lower courts. Second, growing empirical evidence has revealed that, in the background of the debate on individual constitutional rights, a serious gun violence epidemic is intensifying around the country. In one corner, gun rights advocates worry that increased firearm regulation will …

Is Tort Law The Tool For Fixing Reproductive Wrongs?, Christopher Robertson

Faculty Scholarship

In his 2019 book, Birth Rights and Wrongs: How Medicine and Technology are Remaking Reproduction and the Law, Dov Fox offers a compelling argument for new torts allowing recovery for wrongful reproduction. These torts would include three sorts of cases, those where wrongdoing (whether negligent, reckless, or intentional) caused undesired reproduction; stymied desired reproduction; or confounded reproduction, causing birth of a child different than that intended by the parents. The likely defendants in these torts are gynecologists, urologists, sperm banks, and IVF clinics.

Federalism, Erisa, And State Single-Payer Health Care, Erin C. Fuse Brown, Elizabeth Mccuskey

Faculty Scholarship

While federal health reform sputters, states have begun to pursue their own transformative strategies for achieving universal coverage, the most ambitious of which are state-based single-payer plans. Since the passage of the Affordable Care Act in 2010, legislators in twenty-one states have proposed sixty-six unique bills to establish single-payer health care systems. This paper systematically surveys those state legislative efforts and exposes the federalism trap that threatens to derail them: ERISA's preemption of state regulation relating to employer-sponsored health insurance. ERISA's expansive preemption provision creates a narrow, risky path for state regulation to capture the employer health care expenditures crucial …