Health Law and Policy Commons^™

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 …

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 …

Changing The Culture Of Nurse Practitioners: Incorporating Medical Billing And Coding To Prevent Fraud, Waste And Abuse, Tralissa Morrow

DNP Research Projects

Medical coding and billing errors are avoidable problems that have afflicted practitioners for decades. Correct coding and billing are required for reimbursement of healthcare services. Fraud, waste and abuse increase healthcare costs, reduce the quality of care provided and directly impact costs to patients. This pilot study was intended to evaluate the impact of an educational webinar on medical billing and coding, fraud, waste and abuse on nurse practitioner (NP) knowledge using a pretest posttest design. Mean scores increased from 58.4% to 76.4%. Test reliability was low at 0.477 (pretest) and 0.142 (posttest) with two questions that were unable to …

J Mich Dent Assoc January 2021

The Journal of the Michigan Dental Association

Every month, The Journal of the Michigan Dental Association brings news, information, and features about Michigan dentistry to our state's oral health community and the MDA's 6,200+ members. No publication reaches more Michigan dentists!

In this issue, the reader will find the following original content:

• A cover story on “The Dentist’s Role in Recognizing Sleep-Disordered Breathing in Children”.
• A feature article, “Dental Sleep Medicine Education: Do You Want a Nap or a Full Night’s Sleep?”.
• The feature article, “In-office Plans: Where Are We Now? What Have We Learned?”
• News you need, Editorial and regular department articles on MDA Foundation activities, …

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.

Legislative Options To Address Institutional Objections To Voluntary Assisted Dying In Australia, Ben P. White, Lindy Willmott, Eliana Close, Jocelyn Downie

Articles, Book Chapters, & Popular Press

Voluntary assisted dying is being considered by parliaments and law reform bodies across Australia. Although individual conscientious objection is routinely considered in these deliberations, an institution’s desire to object to providing voluntary assisted dying has received very little attention. After briefly considering the concept of institutional objection in voluntary assisted dying, this article examines the available (albeit limited) Australian evidence on this practice. Institutional objection is happening in Victoria (where voluntary assisted dying is lawful) and is likely to occur in other Australian states. The article proposes that regulation is needed and presents three models for parliaments and law reformers …

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 …

Environmental Law, Disrupted By Covid-19, Rebecca Bratspies, Vanessa Casado Peréz, Robin Kundis Craig, Lissa Griffin, Sarah Krakoff, Keith Hirokawa, Katrina Kuh, Jessica Owley, Melissa Powers, Shannon Roesler, Jonathan Rosenbloom, J. B. Ruhl, Erin Ryan, David Takacs

Publications

For over a year, the COVID-19 pandemic and concerns about systemic racial injustice have highlighted the conflicts and opportunities currently faced by environmental law. Scientists uniformly predict that environmental degradation, notably climate change, will cause a rise in diseases, disproportionate suffering among communities already facing discrimination, and significant economic losses. In this Article, members of the Environmental Law Collaborative examine the legal system’s responses to these crises, with the goal of framing opportunities to reimagine environmental law. The Article is excerpted from their book Environmental Law, Disrupted, to be published by ELI Press later this year.

Put More Women In Charge And Other Leadership Lessons From Covid-19, Peter H. Huang

Publications

COVID-19 teaches us lessons about leadership, the most important of which is to put more women in charge. This Article provides an interdisciplinary analysis of these lessons, which come at the very high price of many forever disrupted and lost human lives. COVID-19 is a global tragedy. COVID-19 can also be a cruel, relentless and unforgiving teacher of valuable lessons about leadership. During COVID-19, leaders had to quickly mobilize many resources and convince many people to change their established behaviors and familiar routines. Leaders had to rely on effective and persuasive communication to achieve buy-in and voluntary compliance by a …

Antibiotic Development Incentives That Reflect Societal Value Of Antibiotics, Helen Boucher, Thomas M. File, Vance Fowler, Amanda Jezek, John Rex, Kevin Outterson

Faculty Scholarship

TO THE EDITOR—Rome and Kesselheim [1] claimed that rewarding developers of novel antibiotics with transferable exclusivity vouchers is an expensive approach to promoting antibiotic development. This analysis is incomplete as it focuses only on the cost of bringing new antibiotics to market without acknowledging their societal value. The authors also did not suggest an alternative approach. With patients running out of treatment options for resistant infections, failing to strengthen the antibiotic pipeline is not a reasonable option.

The Future Of Facts: The Politics Of Public Health And Medicine In Abortion Law, Aziza Ahmed

Faculty Scholarship

While a great deal of public scrutiny has focused on how information circulates through online outlets including Twitter and Facebook, less attention has been devoted to how more traditional institutions traffic in factual assertions for the sake of setting a particular distributional agenda into motion.[1] Of these more traditional institutions, courts play a central role in legitimating legal and factual claims in the process of applying and clarifying legal rules. In public health-related adjudication, courts play at least two important roles: first, judges and juries make decisions between competing sets of public health and medical claims and second, courts …

A Code Of Ethics For Gene Drive Research, George J. Annas, Chase L. Beisel, Kendell Clement, Andrea Crisanti, Stacy Francis, Marco Galardini, Roberto Galizi, Julian Grunewald, Greta Immobile, Ahmad S. Khalil, Ruth Muller, Vikram Pattanayak, Karl Petri, Ligi Paul, Luca Pinello, Alekos Simoni, Chrysanthi Taxiarchi, J. Keith Joung

Faculty Scholarship

Gene drives hold promise for use in controlling insect vectors of diseases, agricultural pests, and for conservation of ecosystems against invasive species. At the same time, this technology comes with potential risks that include unknown downstream effects on entire ecosystems as well as the accidental or nefarious spread of organisms that carry the gene drive machinery. A code of ethics can be a useful tool for all parties involved in the development and regulation of gene drives and can be used to help ensure that a balanced analysis of risks, benefits, and values is taken into consideration in the interest …

The Covid-19 Pandemic And The Technology Trust Gap, Johanna Gunawan, David Choffnes, Woodrow Hartzog, Christo Wilson

Faculty Scholarship

Industry and government tried to use information technologies to respond to the COVID-19 pandemic, but using the internet as a tool for disease surveillance, public health messaging, and testing logistics turned out to be a disappointment. Why weren’t these efforts more effective? This Essay argues that industry and government efforts to leverage technology were doomed to fail because tech platforms have failed over the past few decades to make their tools trustworthy, and lawmakers have done little to hold these companies accountable. People cannot trust the interfaces they interact with, the devices they use, and the systems that power tech …

Vaccination And The Child’S Right To An Open Future, Elias Feldman

Lewis & Clark Law Review

States commonly require the vaccination of children through their parens pa- triae and police powers. But many states also allow parents to opt for non- medical exemptions from these vaccination requirements, contributing to the emergence of a national vaccine hesitancy crisis. By permitting parents not to vaccinate their children, do states that grant these exemptions violate children’s rights? This Article posits that children may indeed have a right to be vac- cinated and thus protected against contracting a disease for which there is a scientifically proven vaccine. This Article examines this question through the lens of Joel Feinberg’s theory of …

Avoiding The Second Assault: A Guidebook For Trauma-Informed Prosecutors, Eric M. Werner

Lewis & Clark Law Review

Many victims in the criminal justice system have already survived at least one traumatic experience, but too often the process of prosecuting their case exacerbates that trauma instead of healing it. This Article discusses how trauma may impact a victim of crime on a behavioral and neurobiological level, and how prosecutors can re-orient their interactions with victims in a way that helps victims regain their voice, choice, and sense of community. Section I describes the necessity for prosecutors to be trauma-informed and what that means in the context of the criminal justice system. Section II seeks to inform prosecutors and …

Paying Americans To Take The Vaccine - Would It Help Or Backfire?, Christopher Robertson, Daniel Scheitrum, K. Aleks Schaefer, Trey Malone, Brandon R. Mcfadden, Kent D. Messer, Paul J. Ferraro

Faculty Scholarship

This research investigates the extent to which financial incentives (conditional cash transfers) would induce Americans to opt for vaccination against COVID-19. We performed a randomized survey experiment with a representative sample of 1,000 American adults in December 2020. Respondents were asked whether they would opt for vaccination under one of three incentive conditions ($1,000, $1,500, or $2,000 financial incentive) or a no-incentive condition. We find that—without coupled financial incentives—only 58% of survey respondents would elect for vaccination. A coupled financial incentive yields an 8-percentage-point increase in vaccine uptake relative to this baseline. The size of the cash transfer does not …

Litigation As Education: The Role Of Public Health To Prevent Weaponizing Second Amendment Rights, Michael Ulrich

Faculty Scholarship

Tobacco litigation was unquestionably successful, but it is dangerous to expect that it can be easily duplicated. An unrealistic reliance on litigation as a regulatory measure can blind public health advocates to other mechanisms of change. And that includes litigation as a means of enabling actual regulation. Firearms and the gun violence epidemic provides a useful case study. The Protection of Lawful Commerce in Arms Act (PLCAA) essentially bars litigation as a regulatory tool for firearms. This legislation means every time someone pulls the trigger, they become the party to blame. Soto v. Bushmaster Firearms presents a rare exception based …

One Child Town: The Health Care Exceptionalism Case Against Agglomeration Economies, Elizabeth Weeks

Scholarly Works

This Article offers an extended rebuttal to the suggestion to move residents away from dying communities to places with greater economic promise. Rural America, arguably, is one of those dying places. A host of strategies aim to shore up those communities and make them more economically viable. But one might ask, “Why bother?” In similar vein, David Schleicher’s provocative 2017 Yale Law Journal article, Stuck! The Law and Economics of Residential Stagnation urged dismantling a host of state and local government laws operating as barriers to migration by Americans from failing economies to robust agglomeration economies. But Schleicher said little …

Health Reform Reconstruction, Lindsay F. Wiley, Elizabeth Y. Mccuskey, Matthew B. Lawrence, Erin C. Fuse Brown

Faculty Articles

This Article connects the failed, inequitable U.S. coronavirus pandemic response to conceptual and structural constraints that have held back U.S health reform for decades and calls for reconstruction. For more than a half-century, a cramped “iron triangle” ethos has constrained health reform conceptually. Reforms aimed to balance individual interests in cost, quality, and access to health care, while marginalizing equity, solidarity, and public health. In the iron triangle era, reforms unquestioningly accommodated four legally and logistically entrenched fixtures — individualism, fiscal fragmentation, privatization, and federalism — that distort and diffuse any reach toward social justice. The profound racial disparities and …

Jacobson 2.0: Police Power In The Time Of Covid-19, James R. Steiner-Dillon

Akron Law Faculty Publications

The COVID-19 pandemic has become a legal, as well as a public health, crisis. In response to the pandemic, state and municipal governments have imposed unprecedented constraints on Americans’ daily activities. These restrictions provoked a wave of constitutional challenges that have revealed the antiquated doctrinal foundations of states’ police power in the area of public health. It has been over a century since the Supreme Court, in Jacobson v. Massachusetts, articulated a broadly deferential approach to constitutional review of state orders issued in response to a public health emergency. The constitutional order has changed since Jacobson was decided; many provisions …

A Virtuous Circle: How Health Solidarity Could Prompt Recalibration Of Privacy And Improve Data And Research, Nicolas P. Terry, Christine Coughlin

Oklahoma Law Review

No abstract provided.

Protecting Patients From Physicians Who Inflict Harm: New Legal Resources For State Medical Boards, Elizabeth Pendo, Tristan Mcintosh, Heidi A. Walsh, Kari Baldwin, James M. Dubois

Articles

State medical boards (SMBs) protect the public by ensuring that physicians uphold appropriate standards of care and ethical practice. Despite this clear purpose, egregious types of wrongdoing by physicians are alarmingly frequent, harmful, and under-reported. Even when egregious wrongdoing is reported to SMBs, it is unclear why SMBs sometimes fail to promptly remove seriously offending physicians from practice. Legal and policy tools that are targeted, well-informed, and actionable are urgently needed to help SMBs more effectively protect patients from egregious wrongdoing by physicians.

Past reviews of SMB performance have identified features of SMBs associated with higher rates of severe disciplinary …

A Model For Defunding: An Evidence-Based Statute For Behavioral Health Crisis Response, Taleed El-Sabawi, Jennifer J. Carroll

Faculty Publications

Too many Black persons and other persons of color are dying at the hands of law enforcement, leading many to call for the defunding of police. These deaths were directly caused by excessive use of force by police officers, but were also driven by upstream and institutional factors that include structural racism, institutional bias, and a historic culture of racialized violence. Public outcry against racial inequities has increased as the authority of police departments has expanded to include not only the authority to respond to and investigate criminal activity, but also to respond to calls regarding behavioral health issues and …

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 …

Put More Women In Charge And Other Leadership Lessons From Covid-19, Peter H. Huang

FIU Law Review

No abstract provided.

Foreward, Cesare P.R. Romano, Jessica Almqvist, Andrea Boggio, Timo Faltus, Kerry Lynn Macintosh, Scott J. Schweikart

Loyola of Los Angeles International and Comparative Law Review

No abstract provided.

A Human Rights Approach To Risk: The Case Of Human Germline Editing, Jessica Almqvist

Loyola of Los Angeles International and Comparative Law Review

No abstract provided.