Health Law and Policy Commons^™

The Disability Docket, Jasmine E. Harris, Karen M. Tani, Shira Wakschlag

American University Law Review

The monumental changes emanating from the contemporary Supreme Court have now generated abundant commentary—but it remains possible to glean new insights if we review the Court’s work from an alternative perspective, one that does not often inform mainstream accounts. Drawing on insights from Disability Legal Studies and other critical approaches to law, as well as from the trenches of disability advocacy and civil litigation, this Article applies a “disability lens” to the Supreme Court’s 2021 and 2022 Terms. Our review of the Court’s published decisions and broader docket suggests three themes. We highlight (1) the role of disability cases in …

Public Health Product Hops, Michael S. Sinha

American University Law Review

Pharmaceutical product hops are anticompetitive maneuvers that often represent a last-ditch effort by brand manufacturers to preserve market share in the face of generic competition. An integral part of product life cycle management strategies, product hops may offer marginal benefits to patients but can substantially increase costs to payers and patients alike. Industry advocates, however, maintain that product hops represent essential follow-on research and development, resulting in the development of novel products that would otherwise never reach the market.

Is there a middle ground between these two diametrically opposed views? Might certain product hops be considered beneficial, perhaps if they …

Buck As (Anti) Canon: The Misuse Of Eugenics Rhetoric In Selective-Abortion Jurisprudence And The Dangers For Tort Law, Samantha C. Smith

American University Law Review

America’s notorious eugenics case Buck v. Bell is being resurrected as anticanon in abortion jurisprudence. Buck became one of the Court’s worst decisions by upholding eugenic practices, but these recent anticanonical citations also prove harmful by misidentifying eugenics. This Article joins critics of this misuse of “eugenics” labeling and warns that the rhetorical use of Buck in abortion cases has dangerous implications for reproductive medicine. It draws on Buck as the leading precedent for eugenics under the law and demonstrates that selective-abortion cases are distinguishable because of two failures of the Buck Court: the failure to recognize state interference with …

Medicare Advantage? If You Say So. Fraud, Waste, And Abuse In Medicare Part C, John J. Locurto

Faculty Articles

Debates about health care often emphasize distributive justice. How should society allocate finite resources? Who will get access to them, who will not? Is the allocation fair? Who decides and by what standard? Answers to these questions rarely consider health care fraud, waste, and abuse. This is a material omission. Fraud alone costs the health care system billions of dollars annually, dissipating limited funds and degrading quality of care. This paper considers how fraud, waste, and abuse occur in Medicare Part C - better known as Medicare Advantage - an increasingly popular coverage option. Medicare Advantage experiences unique challenges that …

The Perils Of Privatization: Exploring The Side Effects Of Privatized Correctional Health Care In Favor Of A Public Delivery Model, Peyton Holahan

Washington and Lee Journal of Civil Rights and Social Justice

On July 16, 2020, Judge Roslyn Silver of the U.S. District Court for the District of Arizona set a trial between Arizona’s Department of Corrections and a class of Arizona’s prisoners alleging grossly inadequate health care in the state’s prison system. Arizona, like more than half of the states in the U.S., has outsourced prison health care to private correctional healthcare providers. While correctional healthcare providers win states over with promises of cost-effective care and limited liability, ever since the emergence of the correctional healthcare industry in the 1970s, problems with privatized health care in jails and prisons have persisted, …

Constitutional Law—Dobbs V. Jackson Women’S Health Organization Will Likely Have A Negative, Disproportionate Impact On Women Of Color And Reassert Inferiority, Makiya Turntine

University of Arkansas at Little Rock Law Review

No abstract provided.

Sb 140 - Treatment Of Gender Dysphoria In Minors, Kathleen Kassa, Alexander J. Merritt

Georgia State University Law Review

The Act adds two new subsections that prohibit licensed physicians, hospitals, and related institutions from performing or providing certain forms of gender‑affirming medical treatment, while also defining mechanisms for promulgating and enforcing new prohibitions and exceptions allowing such treatment.

Call Me, Beep Me, If You Want To Reach Me: Utilizing Telemedicine To Expand Abortion Access, Samantha A. Hunt

Vanderbilt Law Review

In June 2022, the Supreme Court handed down its decision in Dobbs v. Jackson Women’s Health Organization. The decision confirmed what the public already knew. An anonymously leaked draft version of what ultimately became Justice Samuel Alito’s majority opinion had braced the country for Dobbs’s keyholding. Overturning decades of precedent, the Court found that there is no right to abortion in the United States Constitution. Shortly thereafter, states began implementing restrictions and near-total bans on abortion. These laws had an immediate effect on the safety of pregnant people. In Tennessee, a state where abortion is now outlawed, one woman had …

Ai Regulation In Health Care: How Washington State Can Conquer The New Territory Of Ai Regulation, Natalie Shen

Seattle Journal of Technology, Environmental, & Innovation Law

1. The use of artificial intelligence both generally and in the health care field has exploded over the last decade. AI is now used in the health care field in areas like disease diagnostics, patient engagement, and administrative tasks. In disease diagnostics specifically, AI is being used to make life-altering diagnoses. This technology, however, does not come without its risks. Specifically, inherent bias is deeply rooted in the AI algorithms. This is because humans are inherently bias, and humans are the people creating the AI algorithms. The problem is, however, is that there are no federal regulations to mitigate the risks …

Universal Forms Of Influence: Support For Women On Boards, Cindy A. Schipani, Paula J. Caproni

Seattle University Law Review

There are various efforts underway to increase gender diversity on corporate boards, including legislation in California, a recent SEC approved comply or explain rule for companies listed on the Nasdaq stock exchange, and efforts by institutional investors such as State Street and BlackRock to recognize the value diversity brings to corporate decisionmaking. Although some of these efforts are being contested in the courts, many companies have begun to comply with these initiatives.

This Article is organized as follows. Part I provides an overview of several efforts to increase gender diversity on boards along with numerous research studies showcasing the benefits …

“Statistics Are Human Beings With The Tears Wiped Away”: Utilizing Data To Develop Strategies To Reduce The Number Of Native Americans Who Go Missing, Lori Mcpherson, Sarah Blazucki

Seattle University Law Review

On New Year’s Eve night, 2019, sixteen-year-old Selena Shelley Faye Not Afraid attended a party in Billings, Montana, about fifty miles west of her home in Hardin, Montana, near the Crow Reservation. A junior at the local high school, she was active in her community. The party carried over until the next day, and she caught a ride back toward home with friends in a van the following afternoon. When the van stopped at an interstate rest stop, Selena got out but never made it back to the van. The friends reported her missing to the police and indicated they …

Trust The Science But Do Your Research: A Comment On The Unfortunate Revival Of The Progressive Case For The Administrative State, Mark Tushnet

Indiana Law Journal

This Article offers a critique of one Progressive argument for the administrative state, that it would base policies on what disinterested scientific inquiries showed would best advance the public good and flexibly respond to rapidly changing technological, economic, and social conditions. The critique draws on recent scholarship in the field of Science and Technology Studies, which argues that what counts as a scientific fact is the product of complex social, political, and other processes. The critique is deployed in an analysis of the responses of the U.S. Centers for Disease Control and Food and Drug Administration to some important aspects …

Domestic Emergency Pretexts, Amy L. Stein

Indiana Law Journal

Whereas emergencies used to be the exception to the rule, they now seem to be the norm. Wildfires, hurricanes, flooding, and contagious diseases dominate our daily lives. Although these are not the traditional types of military emergencies of our past, these non-wartime emergencies can trigger some of the same emergency powers. And with their use comes some of the same concerns about abuses of such emergency powers. Much ink has been spilled analyzing the tradeoffs associated with necessary emergency powers and frequent abuses in the context of foreign threats—resulting in reduced privacy, civil liberties, and freedoms.

This Article is not …

Masking Vulnerability: Including Ppe As A Covered Service In Health Insurance, Mary Leto Pareja

Faculty Scholarship

The COVID-19 pandemic laid bare the shared vulnerability inherent in the human condition, prompting a collective recognition of our physical susceptibility to infectious diseases. While great strides have been made in combating COVID-19 through vaccinations and treatments, a portion of the population remains profoundly vulnerable due to health conditions that make the disease more dangerous, that limit vaccine efficacy, or that prevent vaccination altogether. This article explores a path forward by proposing a solution within health benefit plans—encompassing both private health insurance and public health benefits. Specifically, the article advocates for a coverage mandate for over-the-counter personal protective equipment (PPE) …

Experiential Education In Advocacy For Occupational Therapy Students: Didactic Approaches And Learning Outcomes, Aaron Bonsall, Rebecca L. Wolf, Abe Saffer

Journal of Occupational Therapy Education

Advocacy is a foundational value in occupational therapy, but uniformity in teaching and learning advocacy is lacking. This paper proposes and reports on the implementation of an advocacy course based on experiential education. The objective of the study was to evaluate student learning after an advocacy course with an experiential education component using an open-ended survey design. Participants were occupational therapy doctoral students, and the setting was a course taught in a health sciences university. Students voluntarily completed a four-item anonymous survey after participating in an experiential advocacy course. Written responses were coded into themes using an inductive approach. The …

Cryptic Patent Reform Through The Inflation Reduction Act., Arti K. Rai, Rachel E. Sachs, Price W. Nicholson

Articles

If a statute substantially changes the way patents work in an industry where patents are central, but says almost nothing about patents, is it patent reform? We argue the answer is yes — and it’s not a hypothetical question. The Inflation Reduction Act (“IRA”) does not address patents, but its drug pricing provisions are likely to prompt major changes in how patents work in the pharmaceutical industry. For many years scholars have decried industry’s ever-evolving strategies that use combinations of patents to block competition for as long as possible, widely known as “evergreening,” but legislators have not been receptive to …

‘A Most Equitable Drug’: How The Clinical Studies Of Convalescent Plasma As A Treatment For Sars-Cov-2 Might Usefully Inform Post-Pandemic Public Sector Approaches To Drug Development, Quinn Grundy, Chantal Campbell, Ridwaanah Ali, Matthew Herder, Kelly Holloway

Articles, Book Chapters, & Popular Press

Interventional clinical studies of convalescent plasma to treat COVID-19 were predominantly funded and led by public sector actors, including blood services operators. We aimed to analyze the processes of clinical studies of convalescent plasma to understand alternatives to pharmaceutical industry biopharmaceutical research and development, particularly where public sector actors play a dominant role. We conducted a qualitative, critical case study of purposively sampled prominent and impactful clinical studies of convalescent plasma during 2020-2021. We found that studies were mobilized and scaled at record pace due to well-connected investigators who engaged in widespread sharing of clinical trials resources, regulatory facilitators, and …

'More Of The Same, But Worse Than Before': A Qualitative Study Of The Challenges Encountered By People Who Use Drugs In Nova Scotia, Canada During Covid-19, Emilie Comeau, Matthew Bonn, Sheila Wildeman, Matthew Herder

Articles, Book Chapters, & Popular Press

Background

To learn about the experiences of people who use drugs, specifically opioids, in the Halifax Regional Municipality (HRM), in Nova Scotia, Canada during the COVID-19 pandemic through qualitative interviews with people who use drugs and healthcare providers (HCP). This study took place within the HRM, a municipality of 448,500 people. During the pandemic many critical services were interrupted while overdose events increased. We wanted to understand the experiences of people who use drugs as well as their HCPs during the first year of the pandemic.

Methodology

We conducted a qualitative study using semi-structured interviews with 13 people who use …

The Rise And Fall Of A Reproductive Right: Dobbs V. Jackson Women’S Health Organization, Carol Sanger

Faculty Scholarship

Although the phrase “Post-Roe Era” is still used by those who want to underscore the loss wrought last June by Dobbs v. Jackson Women’s Health Organization, it is only a matter of time before the present state of reproductive constitutionalism solidifies into the more authoritarian “Dobbs Era.” In these early days of transition, states are still figuring out what they want the legal status of abortion to be, ever since Dobbs overruled both Roe v. Wade and Planned Parenthood of Southeastern Pennsylvania v. Casey, thus tossing the issue of abortion’s legality back to the states for …

Public Health Law’S Digital Frontier: Addictive Design, Section 230, And The Freedom Of Speech, Matthew B. Lawrence

Faculty Articles

This Article argues that, even if courts are unpersuaded by the broadest arguments in favor of a public health approach to regulation of addictive design, they should nonetheless reject the platforms’ efforts to make addictive design a public-health-law-free zone. The public health and internet paradigms can be reconciled as a policy matter because addictive design threatens both public health and innovation online. The public health and internet paradigms can also be reconciled as a legal matter be-cause even strong theories of section 230 and the First Amendment, properly understood, leave states a safe harbor in which to regulate much addictive …

Climate Security Insights From The Covid-19 Response, Mark P. Nevitt

Faculty Articles

The climate change crisis and COVID-19 crisis are both complex collective action problems. Neither the coronavirus nor greenhouse gas (GHG) emissions respect political borders. Both impose an opportunity cost that penalizes inaction. They are also increasingly understood as nontraditional, novel security threats. Indeed, COVID-19’s human cost is staggering, with American lives lost vastly exceeding those lost in recent armed conflicts. And climate change is both a threat accelerant and a catalyst for conflict—a characterization reinforced in several climate-security reports. To counter COVID-19, the President embraced martial language, stating that he will employ a “wartime footing” to “defeat the virus.” Perhaps …

Addiction And Liberty, Matthew B. Lawrence

Faculty Articles

This Article explores the interaction between addiction and liberty and identifies a firm legal basis for recognition of a fundamental constitutional right to freedom from addiction. Government interferes with freedom from addiction when it causes addiction or restricts addiction treatment, and government may protect freedom from addiction through legislation empowering individuals against private actors’ efforts to addict them without their consent. This Article motivates and tests the boundaries of this right through case studies of emergent threats to liberty made possible or exacerbated by new technologies and scientific understandings. These include certain state lottery programs, addiction treatment restrictions, and smartphone …

Come As You Are?: Democratizing Healthcare Through Black Church - Telehealth Initiatives, Meighan Parker

Scholarly Works

Drawing from the phrase “come as you are,” which is frequently used in Black Churches to encourage and welcome people to church spaces for spiritual restoration and healing irrespective of their various social and economic dispositions, this Article aims to describe how telehealth partnerships with community organizations, such as Black Churches, can help democratize healthcare.

In this project, I develop two models for Black Church-Telehealth Initiatives—a Telehealth Clinic on the Church’s campus and a Designated Telehealth Space with the requisite technology to facilitate telehealth encounters—to argue that Black Church-Telehealth Initiatives can help address certain social determinants of health, such as …

Interagency Dynamics In Matters Of Health And Immigration, Medha D. Makhlouf

Faculty Scholarly Works

When Congress delegates authority to an executive agency, it tells us something important about the expertise that Congress wishes to harness in policymaking on an issue. In the legal literature on interagency dynamics and cooperation, issues at the nexus of health and immigration are largely understudied. This Article extends this literature by examining how delegations of authority on issues at the intersection of health and immigration influence policymaking. In an analysis of how administrative law models apply to three topics in the shared regulatory space of the Department of Health and Human Services (“HHS”) and the Department of Homeland Security …

Privacy For Student-Patients: A Call To Action, Stacey A. Tovino

Emory Law Journal

Consider a law student who has a mental or reproductive health issue that the student wishes to keep private. If the student seeks care at an off-campus health clinic that is not affiliated with the student’s law school or university, the student typically has a number of federally enforceable privacy rights. For example, the federal HIPAA Privacy Rule will typically apply and prohibit the clinic from disclosing the student’s protected health information to professors, parents, and other third parties without the student’s prior written authorization. The law student also will have the right to receive a notice of privacy practices, …

Renewing Faith In Antitrust: Unveiling The Hidden Network Behind Pharmaceutical Product Hopping, Victoria Field

Fordham Journal of Corporate & Financial Law

Patents grant time-limited market exclusivity to drug manufacturers, meaning that other companies are prohibited from copying and selling the patented pharmaceutical. This allows manufacturers to lawfully charge monopoly prices. Generic competition starts at the expiration of the patent. To maintain coveted monopoly power, manufacturers often release an alternative formulation of the drug with a fresh patent that enjoys continued market exclusivity. Manufacturers who can convert their consumer base to the new formulation can continue charging peak prices. This process, called “product hopping,” has been the target of significant antitrust inquiry, with mixed results.

A product hop may be the result …

Prescribing Exploitation, Charlotte A. Tschider

Faculty Publications & Other Works

Patients are increasingly reliant temporarily, if not indefinitely, on connected medical devices and wearables, many of which use artificial intelligence (“AI”) infrastructures and physical housing that directly interacts with the human body. The automated systems that drive the infrastructures of medical devices and wearables, especially those using complex AI, often use dynamically inscrutable algorithms that may render discriminatory effects that alter paths of treatment and other aspects of patient welfare.

Previous contributions to the literature, however, have not explored how AI technologies animate exploitation of medical technology users. Although all commercial relationships may exploit users to some degree, some forms …

Dobbsmacked By The Dobbs Decision: The Need For More Privacy Protection For Personal Health Information, Morgan Vanden Heuvel

Mitchell Hamline Law Review

No abstract provided.

The Surprising Harms Hidden Within The No Surprises Act, Madeleine Amick-Kehoe

Mitchell Hamline Law Review

No abstract provided.

Election Emergencies: Voting In Times Of Pandemic, Michael T. Morley

Washington and Lee Law Review

Over the past century, two global pandemics have struck during American elections—the Spanish Flu of 1918 and COVID-19 in 2020. The legal system’s responses to those pandemics, occurring against distinct constitutional backdrops concerning voting rights, differed dramatically from each other. These pandemics highlight the need for states to address the impact of election emergencies, including public health crises, on the electoral process. States should adopt election emergency laws that both empower election officials to modify an election’s rules as necessary to respond to such disasters and set forth “redlines” to identify certain policies that, even in a disaster, are too …