Law Commons^™

Following The Money: The Aca’S Fiscal-Political Economy And Lessons For Future Health Care Reform, William M. Sage, Timothy M. Westmoreland

Faculty Scholarship

It is no exaggeration to say that American health policy is frequently subordinated to budgetary policies and procedures. The Affordable Care Act (ACA) was undeniably ambitious, reaching health care services and underlying health as well as health insurance. Yet fiscal politics determined the ACA’s design and guided its implementation, as well as sometimes assisting and sometimes constraining efforts to repeal or replace it. In particular, the ACA’s vulnerability to litigation has been the price its drafters paid in exchange for fiscal-political acceptability. Future health care reformers should consider whether the nation is well served by perpetuating such an artificial relationship …

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. …

Medical Marijuana: Implications Of Evolving Trends In Regulation, Florence Shu-Acquaye

Faculty Scholarship

No abstract provided.

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 …

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.

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 …

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 …

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.

Keeping The Patient At The Center Of Machine Learning In Healthcare, Jessica Findley, Andrew Woods, Christopher Robertson, Marvin J. Slepian

Faculty Scholarship

Char et al. (2020) aspire to provide "a systematic approach to identifying ... ethical concerns" around machine learning healthcare applications (ML-HCAs), which includes artificial intelligence and big data. Their approach, styled around the development "pipeline" for new technologies, has valuable insights, but we think it over-emphasizes technical design questions and under-emphasizes core ethical questions. There is little ethical debate about whether to maximize accuracy, evaluation, and oversight, at reasonable cost. Of course those goals should be pursued, but these are design challenges about feasibility more than ethical concerns.

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 …

Kob Interviews Joshua Kastenberg About Constitutional Rights During Covid-19, Joshua Kastenberg, Brittany Costello

Faculty Scholarship

No abstract provided.

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 …

Border Babies — Medical Ethics And Human Rights In Immigrant Detention Centers, Sondra S. Crosby, George J. Annas

Faculty Scholarship

Providing decent medical care for families in U.S. detention centers near the Mexican border has become exceedingly difficult over the past 2 years. Trauma was inflicted on migrants to deter others from attempting to enter the United States. A cornerstone of deterrence was the “zero tolerance” policy that forcibly separated children from their parents at the border. Photographs of children confined in cages horrified Americans, who demanded that the policy be rescinded. It was, but family separations continue and have been made even worse by the Migrant Protection Protocol (MPP) — which the U.S. Supreme Court will most likely review …

Trade Mark Licensing And Covid-19: Why Fashion Companies Have A Duty To Comply With Their Legal Obligations, Irene Calboli

Faculty Scholarship

For the past several months, Covid-19 has dominated the intellectual property (IP) debate. Most discussions have focused on the implications of patent protection on access to treatments against the virus and a hopefully soon to be found vaccine. In these remarks, I would like to focus on another Covid-19 crisis making headlines across the world and partially related to IP: millions of workers in the garment industry in developing countries have been fired or furloughed as fashion companies have cancelled orders due to plunging sales since the pandemic’s beginning. Famous Western groups such as Inditex (Zara), C&A, Target, and Marks …

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 …

Rationing Crisis: Bogus Standards Of Care Unmasked By Covid-19, George J. Annas

Faculty Scholarship

After the spectacular failure to apply acceptable triage methods to evacuate patients from a flooded Memorial Hospital during Hurricane Katrina, preparedness planning was intensified (Fink Citation2013). Regarding physicians and hospitals, two approaches got the most attention: (1) diluting the legal “standard of care” for physicians and hospitals so they would be immune from lawsuit for negligent acts during a crisis (“crisis standards of care”); and (2) developing triage protocols for scarce resource allocation. Both can be considered crude works in process. Nonetheless, in the midst of the greatest national crisis since 9/11, I think it is time to declare …

Reconsidering The Rationale For The Duration Of Data Exclusivity, Jonathan Kimball, Srividhya Ragavan, Sophia Vegas

Faculty Scholarship

The paper’s focus is the singular one question of whether the 12-years of exclusivity that was needed in 2008 remains justified in 2019 given that technological advancement reduces the cost and the time for drug discovery? Basically, new and emerging technologies are deployed every day to enhance efficiencies and reduce the time it takes to bring a drug to the market. The paper asserts that as new technologies are adopted and advances in scientific understanding are leveraged, it results in shorter drug development timelines. This factum, the paper asserts should have a bearing to reduce the period of exclusivity granted …

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.

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 …

Why We (Probably) Must Deliberately Infect, Adam J. Kolber

Faculty Scholarship

No abstract provided.

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 …

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 …

Proposition 187 And The Legacy Of Its Law Enforcement Provisions, Huyen Pham

Faculty Scholarship

Passed by a wide margin of California voters in 1994, Prop. 187 is primarily remembered as a law that tried to deny state-funded health care and education to unauthorized immigrants. Far less attention has been paid to Section Four in Prop. 187 that required all law enforcement agencies (LEAs) in California to “fully cooperate” with federal immigration authorities. Specifically, these provisions required LEAs to verify the legal status of any arrestee “suspected” of being in the U.S. unlawfully, notify the arrestee of his/her unlawful status, and report the arrestee to state and federal immigration authorities.

Though never enforced, Section Four …

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. …

Can International Patent Law Help Mitigate Cancer Inequity In Lmics?, Srividhya Ragavan, Amaka Vanni

Faculty Scholarship

Although low- and middle-income countries (LMICs) bear 75% of the cancer burden globally, their available resources to treat cancer constitute less than 5% of global health resources. This inequity makes it imperative to take appropriate measures to treat and prevent cancer in LMICs, which should include consideration of trade and patent policies. This article highlights some impediments to effective use of existing policies to promote access to treatment and prevention measures in LMICs and offers recommendations about next steps.