Health Law and Policy Commons^™

Substance Use Disorder Discrimination And The Cares Act: Using Disability Law To Inform Part 2 Rulemaking, Kelly K. Dineen, Elizabeth Pendo

Articles

Substance use disorder (SUD) is a chronic health condition—like people with other chronic health conditions, people with SUDs experience periods of remission and periods of exacerbation or recurrence. Unlike people with most other chronic conditions, people with SUDs may be more likely to garner law enforcement attention than medical attention during a recurrence. They are also chronically disadvantaged by pervasive social stigma, discrimination, and structural inequities. The COVID-19 pandemic has had devastating consequences for people with SUDs, who are at higher risk for both contracting the SARS-CoV-19 virus and experiencing poorer outcomes. Meanwhile, there are early indications that pandemic conditions …

Pandemics And International Law: The Need To Strengthen International Legal Frameworks After The Covid-19 Global Health Pandemic [Sierra Leone], Charles C. Jalloh

Articles

No abstract provided.

Co-Opting Coronavirus, Assailing Asylum, Ashley B. Armstrong

Faculty Publications

The Centers for Disease Control (CDC) issued an Order on March 26, 2020, under Title 42, Section 265 of the Public Health Service Act, in the name of combatting the spread of coronavirus. The Order has been called the “Asylum Ban” because it effectively has sealed the southern border to protection-seekers, resulting in the pushback of nearly 400,000 asylees and unaccompanied children. This Article argues that the Trump administration has contravened the rule of law by using the coronavirus pandemic as a convenient pretext to end asylum in the U.S., and by violating the rights of protection-seekers. In doing so, …

Inherent Powers And The Limits Of Public Health Fake News, Michael Goodyear

Articles & Chapters

The world has changed dramatically over the past year. The COVID-19 pandemic has presented unprecedented challenges and has caused a catastrophic loss of over 300,000 U.S. lives. This crisis has been compounded by an infodemic, an effusion of misinformation and fake news about COVID-19. This incorrect information has flooded social media and online platforms, confusing and misleading the American public. Yet U.S. constitutional law largely upholds fake news as protected free speech under the First Amendment. This legal reality has significantly compounded the COVID-19 crisis.

But U.S. law is not limited to only constitutional enumerated powers. An underexamined approach to …

Opioid Settlement Funds: Do Not Neglect Patients With Pain, Mark C. Bicket, Barbara Mcquade, Chad M. Brummett

Articles

The opioid crisis has escalated in the setting of the COVID-19 pandemic to new extremes and has claimed more than half a million lives in the US since 2000. Lawsuits to address the civil and criminal liability of drug companies and other groups have originated from federal, state, local, and tribal jurisdictions. When successful, there will likely be billions of dollars and significant discretion as to how these funds are spent. Several groups have produced reports with principles to address the toll of addiction using settlement funds. However, they lack actionable strategies to address the needs of patients with pain, …

Ending The War On People With Substance Use Disorders In Health Care, Kelly K. Dineen, Elizabeth Pendo

All Faculty Scholarship

Earp et al. (2021) provide a robust justification for the decriminalization of drugs based on the systemic racism that fuels the “war on drugs” and the ongoing harms of drug policies to individuals. The authors’ call for decriminalization is a necessary but insufficient step in addressing the entrenched structural, institutional, and individual discrimination that leads to the inequitable and unjust treatment of people with substance use disorder (PWSUD). Nothing short of robust enforcement of existing legal protections and sweeping legal reforms in the regulation of addiction treatment, controlled substances, health care finance, and civil rights law will be adequate to …

Intellectual Property As A Determinant Of Health, Ana S. Rutschman

Vanderbilt Journal of Transnational Law

Public health literature has long recognized the existence of determinants of health, a set of socioeconomic conditions that affect health risks and health outcomes across the world. The World Health Organization defines these determinants as “forces and systems” consisting of “factors combin[ing] together to affect the health of individuals and communities.” Frameworks relying on determinants of health have been widely adopted by countries in the global South and North alike, as well as international institutional players, several of which are direct or indirect players in transnational intellectual property (IP) policymaking. Issues raised by the implementation of IP policies, however, are …

Re-Emphasizing African Bioethics In Light Of Potential Crispr-Based Treatment For Hiv And Sickle Cell Disease, Taylor Daniel

Vanderbilt Journal of Transnational Law

Recent genetic studies indicate that CRISPR-Cas9, a biological gene-editing mechanism derived from bacteria, may be capable of curing HIV and Sickle Cell Disease. Clinical research for HIV and SCD is prevalent in African nations because of the high incidence of those diseases in all forms. Because past research studies in Africa demonstrate how Western companies can abuse lax ethics regulations in developing African nations, ethics systems must prevent this new, potentially far-reaching CRISPR technology from being prematurely and unethically used on African research participants. In updating current international bioethics frameworks, drafters should pay particular attention to its application in African …

A World Of Their Own: Illiberal Religious Communities Struggle To Comply With Covid-19 Public Health Regulations, Shai Stern

Vanderbilt Journal of Transnational Law

The COVID-19 pandemic did not eliminate existing social tensions; rather, it at times intensified them. Thus, it is unsurprising that. the tension between the liberal state and illiberal religious communities likewise intensified, as those communities were late to comply with COVID-19 public health regulations issued by state authorities. This Article suggests that alongside the behavioral and psychological explanations for individual non-compliance, illiberal religious communities' late response to the COVID-19 threats stems out of these communities' unique characteristics and deeply held norms. It provides five explanations supporting this argument and argues that all result from the interventionist liberal-centric policies embraced by …

The Intellectual Property Of Covid-19, Ana Santos Rutschman

All Faculty Scholarship

The response to COVID-19 is indissolubly tied to intellectual property. In an increasingly globalized world in which infectious disease pathogens travel faster and wider than before, the development of vaccines, treatments and other forms of medical technology has become an integral part of public health preparedness and response frameworks. The development of these technologies, and to a certain extent the allocation and distribution of resulting outputs, is informed by intellectual property regimes. These regimes influence the commitment of R&D resources, shape scientific collaborations and, in some cases, may condition the widespread availability of emerging technologies. As seen throughout this chapter, …

Is There A Cure For Vaccine Nationalism?, Ana Santos Rutschman

All Faculty Scholarship

“[V]accine nationalism . . . should serve as a reality check for the status of global health cooperation in the twenty-first century.”

Systemic Racism, The Government’S Pandemic Response, And Racial Inequities In Covid-19, Ruqaiijah Yearby, Seema Mohapatra

All Faculty Scholarship

During the COVID-19 pandemic, the federal and state governments have ignored racial and ethnic minorities’ unequal access to employment and health care that results in racial inequities in COVID-19 infections and deaths. In addition, they have enacted laws that further exacerbate these inequities. Consequently, many racial and ethnic minorities are employed in low-wage essential jobs that lack paid sick leave and health insurance. This lack of benefits causes them to go to work even when they are sick and prevents them from receiving appropriate medical treatment. As a result, racial and ethnic minorities have disproportionately been infected and died from …

Lessons Learned: Strengthening Medicaid To Address Health And Economic Emergencies, Nicole Huberfeld, Sidney Watson

All Faculty Scholarship

COVID-19 has disproportionately harmed low-income people, especially Black and Latino populations, seniors, and people with disabilities. Medicaid plays an essential role in providing coverage and access to care for these populations. As COVID-19 disrupted employment, earnings, and insurance coverage, Medicaid enrollment increased, in part because Congress offered states increased Medicaid funding in return for maintaining eligibility and enrollment for the duration of the public health emergency (PHE). At the same time, many states expanded eligibility and streamlined enrollment to assure that people could secure and keep coverage. Such policies resulted in more than 5.3 million more Americans having Medicaid coverage …

Editor, Ethical Challenges In Discharge Planning: Stories From Patients, Elizabeth Pendo

All Faculty Scholarship

This symposium includes twelve personal narratives from patients and their caregivers who have navigated challenges in planning for discharge from the hospital and transition to care at home, a rehabilitation facility, long-term care facility, or hospice. Three commentaries on these narratives are also included, authored by experts and scholars in the fields of medicine, bioethics, and health policy with particular interest in vulnerable populations. The goal of this symposium is to call attention to the experiences of patients during transitions in care and to enrich discussions of ethical issues in discharge planning.

Covid-19 Employee Health Checks, Remote Work, And Disability Law, Elizabeth Pendo

All Faculty Scholarship

The Americans with Disabilities Act (ADA) prohibits discrimination against people with disabilities, about 61 million individuals in the U.S. The law’s protections in the workplace are especially important during COVID-19, which has worsened pre-existing disparities experienced by people with disabilities. The ADA also applies to new strategies to reduce the risk of COVID-19 infection in the workplace. This Chapter will focus on two strategies that impact individuals with and without disabilities – employee health screening, testing and vaccination policies, and new or expanded remote work programs.

Intellectual Property As A Determinant Of Health, Ana Santos Rutschman

All Faculty Scholarship

Public health literature has long recognized the existence of determinants of health, a set of socio-economic conditions that affect health risks and health outcomes across the world. The World Health Organization defines these determinants as “forces and systems” consisting of “factors combin[ing] together to affect the health of individuals and communities.” Frameworks relying on determinants of health have been widely adopted by countries in the global South and North alike, as well as international institutional players, several of which are direct or indirect players in transnational intellectual property (IP) policymaking. Issues raised by the implementation of IP policies, however, are …

Vaccine Clinical Trials And Data Infrastructure, Ana Santos Rutschman

All Faculty Scholarship

We find ourselves at a momentous turn in the history of vaccines. The COVID-19 pandemic triggered a quasi-global vaccine race that not only compressed vaccine research and development (R&D) timelines, but also paved the way for the administration of a new type of vaccine technology – mRNA vaccines, which work in substantially different ways from the vaccines in use before the pandemic.

While the process of bringing emerging COVID-19 vaccines to market has taken place in an unusually short timeframe, it was largely predicated on the same scientific and regulatory processes that govern the development, approval and deployment of new …

Social Media Self-Regulation And The Rise Of Vaccine Misinformation, Ana Santos Rutschman

All Faculty Scholarship

This essay examines the main characteristics and shortcomings of mainstream social media responses to vaccine misinformation and disinformation. Parts I and II contextualize the recent expansion of vaccine information and disinformation in the online environment. Part III provides a survey and taxonomy of ongoing responses to vaccine misinformation adopted by mainstream social media. It further notes the limitations of current self-regulatory modes and illustrates these limitations by presenting a short case study on Facebook—the largest social media vehicle for vaccine-specific misinformation, currently estimated to harbor approximately half of the social media accounts linked to vaccine misinformation. Part IV examines potential …

Property And Intellectual Property In Vaccine Markets, Ana Santos Rutschman

All Faculty Scholarship

As biopharmaceutical forms of technology, vaccines constitute one of the most important tools for the promotion and maintenance of public health. Tolstoy famously wrote that [h]appy families are all alike; every unhappy family is unhappy in its own way.¹ Vaccine markets offer perhaps one of the most extreme embodiments of Tolstoy's principle² in the field of biopharmaceutical innovation.

The Functional Operation Of Workers’ Compensation Covid Presumptions, Michael C. Duff

All Faculty Scholarship

During 2020, a number of U.S. states implemented workers' compensation COVID-19 presumptions. This short informal paper defines and explains legal presumptions generally and then discusses the workers' compensation presumptions. The paper contends that at this juncture it is not clear whether states intended to enact "Thayer-Wigmore" or "Morgan" presumptions; but if they operate as Thayer-Wigmore presumptions they will not do workers' compensation claimants much good in the context of non-jury proceedings presided over by administrative law judges.

Covid-19 And Digital Contact Tracing: Regulating The Future Of Public Health Surveillance, Divya Ramjee, Pollyanna Sanderson, Imran Malek

Cardozo Law Review de•novo

Digital surveillance tools are at the forefront of potential public health response strategies for the COVID-19 pandemic. The United States is in desperate need of a national-level contact tracing and exposure notification strategy to supplement traditional public health response efforts. This article addresses data privacy and security concerns, as well as epidemiological considerations, when developing digital contact tracing and exposure notification tools. It is both feasible and prudent that the United States establish a federal network for public health surveillance aided by digital tools, especially considering that waves of COVID-19 are expected to continue well into 2021 and while the …

Response To: A Telehealth Explosion: Using Lessons From The Pandemic To Shape The Future Of Telehealth Regulation, Joanna K. Sax

Faculty Scholarship

In A Telehealth Explosion: Using Lessons from the Pandemic to Shape the Future of Telehealth Regulation, published in the Texas A&M Law Review, Professor Deborah Farringer tackles the critical issue of the efficacy and implementation of telehealth, using our experience(s) of telehealth during the COVID–19 pandemic as the guide. This is important, as Professor Farringer acknowledges, because while telehealth advocates pre-date the pandemic, barriers prevented the implementation of telehealth in a widespread manner. These barriers included a concern about fraud and a question as to whether telehealth visits could provide effective outcomes compared to in-person visits. Professor Farringer …

Difficulty Of Care: Aligning Tax And Health Care Policy For Family Caregiving, Christine Speidel

Scholarly Articles in Law Reviews & Journals

In the United States millions of people live with disabilities, many of whom require assistance with activities of daily life to remain in their homes and communities. However, financial support for this assistance is limited. Many caregivers forgo working outside the home in order to provide care to a family member. And while state and federal programs provide some compensation for caregiving, caregivers frequently face problems including poverty, lack of health insurance, lack of Social Security and Medicare credits, and lack of retirement savings. Our nation’s paltry support for caregiving threatens the practical ability of people with disabilities to choose …

Ethical Challenges In The Middle Tier Of Covid-19 Vaccine Allocation: Guidance For Organizational Decision-Making, Nancy Berlinger, Matthew Wynia, Tia Powell, Aimee Milliken, Parinda Khatri, Fatma Marouf, Keisha Ray, Johanna Crane

Faculty Scholarship

This supplement to The Hastings Center’s “Ethical Framework” aims to help structure time-sensitive discussion of significant, foreseeable ethical concerns in responding to Covid-19 and to support collaboration across institutions throughout pandemic response and recovery. It is designed for use by county health systems and by hospitals, community health centers, and other health care organizations responsible for patient care or preventive health, including vaccine education, vaccine distribution, and vaccination. This document aims to support formal and informal convening and policy work within the same geographic region, such as a municipality, county, metropolitan area, state, or multistate area, led by public health …

Difficulty Of Care: Alligning Tax And Health Care Policy For Family Caregiving, Christine S. Speidel

Faculty Publications

In the United States millions of people live with disabilities, many of whom require assistance with activities of daily life to remain in their homes and communities. However, financial support for this assistance is limited. Many caregivers forgo working outside the home in order to provide care to a family member. And while state and federal programs provide some compensation for caregiving, caregivers frequently face problems including poverty, lack of health insurance, lack of Social Security and Medicare credits, and lack of retirement savings. Our nation’s paltry support for caregiving threatens the practical ability of people with disabilities to choose …

Identifying Meaningful Dietary Intake And Physical Activity Questions For Individual And Population Health, Jennifer Bennett Shinall, David G. Schlundt, Et Al.

Vanderbilt Law School Faculty Publications

We aimed to identify valid screening questions for adults regarding physical activity and dietary behaviours that (a) were correlated with BMI, (b) were deemed by patients and providers to be relevant to clinical care, and (c) have utility for longitudinal understanding of health behaviours in populations. The goal was to identify screening questions that could be implemented at annual health care visits. First, we identified dietary behaviour questions and solicited patient input. Next, we tested both physical activity and dietary behaviour questions in a large sample to test their potential utility. Finally, we used cognitive interviews with patients and physicians …

Encouraging Interagency Collaboration: Learning From Covid-19, Rachel Sachs

Scholarship@WashULaw

In the health innovation context, federal regulatory authority is sharply fragmented among different agencies. The National Institutes of Health, Food and Drug Administration, Centers for Medicare and Medicaid Services, and other agencies all share responsibilities in the development and dissemination of new healthcare technologies. Scholars have previously written about the importance of interagency collaboration both in the healthcare area and more generally, and about strategies for encouraging collaborative efforts to promote various policy goals. Under these accounts, a failure to collaborate between federal agencies may be unfortunate, but it does not typically result in or exacerbate a crisis. In the …

Recent Trends In Medicaid Spending And Use Of Drugs With Us Food And Drug Administration Accelerated Approval, Rachel Sachs, Kyle A. Gavulic, Julie M. Donohue, Stacie B. Dusestzina

Scholarship@WashULaw

State Medicaid programs have reported concerns about rising drug prices and spending, particularly regarding drugs entering the market through the accelerated approval program under the US Food and Drug Administration (FDA). The accelerated approval program enables the FDA to approve drugs on the basis of unverified surrogate end points, meaning that clinical benefits for these products are uncertain at the time of approval. However, state Medicaid programs are legally required to cover these drugs. Little is known about the set of products with accelerated approval over time, their use among Medicaid beneficiaries, or the magnitude of their financial influence on …

The Rhetorical Transformations And Policy Failures Of Prescription Drug Pricing Reform Under The Trump Administration, Rachel Sachs

Scholarship@WashULaw

Throughout his four years in office, President Trump made prescription drug pricing a focus of his policy agenda. President Trump not only used strong language to criticize the pharmaceutical industry and its practices but also introduced ambitious reform policies that had previously lacked acceptance among Republican policy makers. President Trump appears to have been successful in developing a new populist form of rhetoric that Republicans can use in support of novel drug pricing reforms such as the ones his administration considered. From a policy perspective, however, the Trump administration failed to implement any of their more ambitious reform ideas. This …

Is Germline Gene Editing Exceptional?, Myrisha S. Lewis

Faculty Publications

Advances in gene editing have recently received significant scientific and media attention. Gene editing, especially CRISPR-Cas9, has revived multiple longstanding ethical debates, including debates related to parental autonomy, health disparities, disability perspectives, and racial and economic inequalities. Germline, or heritable, gene editing generates several newer, neglected bioethical debates, including those about the shared human germline and whether there is a "line" that humans should not cross.

This Article addresses several interrelated ethical and legal questions related to germline gene editing. Those questions address why, if at all, germline gene editing needs to be regulated and, if germline gene editing needs …