Health Law and Policy Commons^™

Planetary Ethics: Russell Train And Richard Nixon At The Creation, George J. Annas

Faculty Scholarship

This piece offers a retrospective review of a plenary speech at the 1969 Annual Meeting of the American Public Health Association by the leading environmentalist of the Nixon administration, attorney and judge Russell Train. Train's talk, titled “Prescription for a Planet,” can be seen as an early argument for uniting environmental health and public health as the two main determinants of both individual and population health and for the inclusion of these fields in the then-new field of “bioethics.”

The Folly Of Credit As Pandemic Relief, Pamela Foohey, Dalié Jiménez, Christopher K. Odinet

Faculty Scholarship

Within weeks of the coronavirus pandemic appearing in the United States, the American economy came to a grinding halt. The unprecedented modern health crisis and the collapsing economy forced Congress to make a critical choice about how to help American families survive financially. Congress had two basic options. It could enact policies that provided direct and meaningful financial support to people, without the necessity of later repayment. Or it could pursue policies that temporarily relieved people from their financial obligations, but required that they eventually pay amounts subject to payment moratoria later.

In passing the CARES Act, Congress primarily chose …

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.

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

Faculty Scholarship

No abstract provided.

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 …

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 …

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 …

Cares Act Gimmicks: How Not To Give People Money During A Pandemic And What To Do Instead, Pamela Foohey, Dalié Jiménez, Christopher K. Odinet

Faculty Scholarship

The coronavirus pandemic upturned Americans’ lives. The profound financial effects caused by even a few weeks of the coronavirus’ upheaval spurred Congress to pass the CARES Act, which purported to provide economic relief to individuals and businesses. For individuals, the CARES Act includes five provisions that were effectively designed to provide people money. Chief among those provisions are a direct payment in the form of a tax rebate and enhanced employment benefits.

Ultimately, this financial support will prove to be shockingly minimal. The direct payments represent a fraction of the average American households’ monthly budget. The unemployment benefits, while providing …

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.
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/="/">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 …

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.

The Pandemic Paradox In International Law, Peter G. Danchin, Jeremy Farrall, Shruti Rana, Imogen Saunders

Faculty Scholarship

No abstract provided.

The Great American Health Care System And The Dire Need For Change: Stark Law Reform As A Path To A Vital Future Of Value-Based Care, Marilyn Uzdavines

Faculty Scholarship

No abstract provided.

Today’S Crusades: A Therapeutic Jurisprudential Critique Of Faith-Based Civil Rights In Health Care, Kathy Cerminara

Faculty Scholarship

No abstract provided.

Contractual Incapacity And The Americans With Disabilities Act, Sean M. Scott

Faculty Scholarship

The doctrine of contractual incapacity allows people with mental disabilities to avoid their contractual liability. Its underlying premise is that the law has an obligation to protect people with such disabilities both from themselves and from unscrupulous people who would take advantage of them; mental incapacity provides this protection by rendering certain contracts unenforceable. The Disability Rights Movement ("DRM"), however, has challenged such protective legal doctrines, as they rest on outmoded concepts about people with mental disabilities.

This essay argues that the mental incapacity doctrine undermines the goals of the DRM and the legislative goals of the Americans with Disabilities …

Nothing Generic About It: Promoting Therapeutic Access By Overcoming Regulatory And Legal Barriers To A Robust Generic Medical Device Market, Megan S. Wright, Zachary Shapiro, Adam Pan, Keturah James, Joseph Fins

Faculty Scholarship

This Article addresses a paradox in American healthcare technology: a thriving market for generic drugs but a paucity of generic medical devices. Despite the success of generic pharmaceuticals in reducing healthcare costs, no analogous market exists for generic medical devices. This plays a part in keeping prices high while limiting access to affordable therapies. In this Article, we highlight the regulatory and legal barriers currently impeding the development of a generic medical device market in the United States. We explore differences between generic drugs and generic devices in FDA regulation, products liability, and patentability, all of which contribute to the …

Kidney Donation And The Consent Of The Poor, Philip J. Cook, Kimberly D. Krawiec

Faculty Scholarship

In "Consentability," Nancy Kim tackles an important and current topic—in an age of increasing options about how to live, die, and procreate, what limits, if any, should the law place on those choices? "Consentability" is a valuable resource for scholars and policymakers alike, summarizing the arguments for and against government intrusion on the choices of consenting adults with encyclopedic thoroughness. After weighing the arguments, Kim proposes that “bodily integrity exchanges” be permitted, subject to limitations. Although we agree with the general conclusion that bodily integrity exchanges should be permitted, we disagree with the specific limitations that treat the decisions of …

Decarcerating New York City: Lessons From A Pandemic, Nicole Smith Futrell

Faculty Scholarship

Over the last decade, long before the sweeping impact of COVID-19, the criminal legal system in New York City has been on a halting path toward decarceration. Set against the national backdrop of declining crime rates and a reckoning with the economic, social, and racial costs of mass criminalization and incarceration, elected officials in New York City and State have acknowledged that a shift toward reducing the number of people held in New York City jails is long overdue. Particular attention has been focused on Rikers Island, the notoriously violent, sprawling jail complex, which has been regarded as one of …

Covid-19 And Prisoners’ Rights, Gregory Bernstein, Stephanie Guzman, Maggie Hadley, Rosalyn M. Huff, Alison Hung, Anita N.H. Yandle, Alexis Hoag, Bernard E. Harcourt

Faculty Scholarship

As COVID-19 continues to spread rapidly across the country, the crowded and unsanitary conditions in prisons, jails, juvenile detention, and immigration detention centers leave incarcerated individuals especially vulnerable. This chapter will discuss potential avenues for detained persons and their lawyers seeking to use the legal system to obtain relief, including potential release, during this extraordinary, unprecedented crisis.

Covid-19 And Lgbt Rights, Suzanne B. Goldberg

Faculty Scholarship

Even in the best of times, LGBT individuals have legal vulnerabilities in employment, housing, healthcare and other domains resulting from a combination of persistent bias and uneven protection against discrimination. In this time of COVID-19, these vulnerabilities combine to amplify both the legal and health risks that LGBT people face.

This essay focuses on several risks that are particularly linked to being lesbian, gay, bisexual, or transgender, with the recognition that these vulnerabilities are often intensified by discrimination based on race, ethnicity, age, disability, immigration status and other aspects of identity. Topics include: 1) federal withdrawal of antidiscrimination protections; 2) …

Driver For Contactless Payments, Ronald J. Mann

Faculty Scholarship

As a consumer, my primary experience with cash before the virus was standing in checkout lines observing the sluggish pace of cash transactions in front of me. Like so many things in our lives, the advent of the virus has changed the situation markedly. From the earliest days of infection, it has been far more unsettling to observe cash transactions knowing that the virus persists on paper and metal surfaces for days.

The dynamic that has driven the choices merchants offer in face-to-face retail transactions will change as well. Driven by the private exigencies of the retail environment, the last …

Privacy And Pandemics, Clarisa Long

Faculty Scholarship

The beginning of 2020 marked an unexpected turn for the world, the global pandemic of COVID-19 has affected every aspect of life. It has also created an unprecedented opportunity for governments to justify the expansion of their surveillance and collection of data. The foregoing essay, which was first published in Faculty Publications at Scholarship Archive of the Columbia Law School focuses on two types of data collection – governmental mass collection of nonanonymized location data and state-collected nonanonymized data on people's health and immunity status. Several countries have applied one or both practices and it is relevant to look into …

Covid-19 And The Law: Elections, Richard Briffault

Faculty Scholarship

With one Supreme Court decision, lower federal and state court decisions, pending litigation, and proposals around the country for major changes in how elections are conducted, COVID-19 has already had and likely will continue to have a significant impact on election law.

The discussion that follows proceeds in two parts. The first addresses the initial consequences of COVID-19 as an electoral emergency. Voters were due to go to the polls in states around the country just as the pandemic was gathering force and governors and mayors were calling on people to stay at home and avoid large gatherings – which, …

Child Welfare And Covid-19: An Unexpected Opportunity For Systemic Change, Jane M. Spinak

Faculty Scholarship

The COVID-19 pandemic has already wrecked greater havoc in poor neighborhoods of color, where pre-existing conditions exacerbate the disease’s spread. Crowded housing and homelessness, less access to health care and insurance, and underlying health conditions are all factors that worsen the chances of remaining healthy.Workers desperate for income continue to work without sufficient protective measures, moving in and out of these neighborhoods, putting themselves and their families at risk. During periods of greater disruption, tensions are heightened and violence more prevalent. Already some experts are warning of an onslaught of child maltreatment cases, citing earlier examples of spikes in foster …

The Problems With Decision-Making, Joanna K. Sax

Faculty Scholarship

Our society faces major challenges in numerous areas, including climate change and healthcare. Addressing these problems with technological advances are of great importance. Increasingly, however, consumers are resisting or rejecting such technological interventions based on inappropriate assignment of risk. In other words, the consumer assessment of risk is not in line with evidence-based assessment of risk. This article focuses on two controversial areas, vaccines and genetically engineered food, as examples in which consumers assign a high risk despite an evidence-based assessment of low risk. This article describes how empirically tested decision-making theories explain why consumers inappropriately assign risk. While these …

Dementia, Autonomy, And Supported Healthcare Decisionmaking, Megan S. Wright

Faculty Scholarship

Healthcare providers often rely on surrogates to decide on behalf of their patients with dementia who are deemed incapable of exercising autonomy. There is a longstanding debate about the appropriate standard of surrogate healthcare decisionmaking for these patients. Many influential scholars argue that the precedent autonomy of the person with dementia should be respected, and healthcare decision-making laws generally reflect this principle. These laws direct surrogate decisionmakers to follow instructions in living wills or to decide on the basis of the wishes and values of the person before the onset of dementia.But other prominent scholars have questioned whether surrogates should …

Covid-19 Business Interruption Insurance Losses: The Cases For And Against Coverage, Christopher French

Faculty Scholarship

The financial consequences of the government-ordered shutdowns of businesses across America to mitigate the COVID-19 health crisis are enormous. Estimates indicate that small businesses have lost $255 to $431 billion per month and more than 44 million workers have been laid off. When businesses have requested reimbursement of their business interruption losses from their insurers under business interruption policies, their insurers have denied the claims. The insurance industry also has announced that business interruption policies do not cover pandemic losses, so they intend to fight COVID-19 claims “tooth and nail.” More than 450 lawsuits throughout the country already have been …