Health Law and Policy Commons^™

Fiscal Waivers And State "Innovation" In Health Care, Matthew B. Lawrence

Faculty Articles

This Article describes how the Department of Health and Human Services (HHS) has used fiscal waiver authorities—delegated power to alter federal payments to states under Medicaid and the Affordable Care Act (ACA)—to influence state health policy choices. It highlights how the agency uses its fiscal waiver authorities to shape which reforms states choose to pursue, in some cases inspiring genuine state innovation and in others encouraging states to adopt reforms favored by HHS or discouraging states from adopting disfavored reforms. Moreover, while HHS has sometimes influenced state policy making in ways that further the substantive goals of the ACA and …

Finding Parity Through Preclusion: Novel Mental Health Parity Solutions At The State Level, Ryan D. Kingshill

Dickinson Law Review (2017-Present)

Recently, the federal government has taken numerous steps to promote the equal treatment (also known as parity) of mental and physical health issues. The two most impactful actions are the Mental Health Parity and Addiction Act of 2008 and the Affordable Care Act. These acts focus on the traditional avenue for parity change—insurance regulation. While these acts have improved parity, major gaps in coverage and treatment between mental health/substance use disorder treatment and medical/surgical treatment persist. ERISA Preemption, evasive insurer behavior, lack of enforcement, and lack of consumer education continue to plague patients and healthcare professionals. On its own, federal …

The Fda’S Power Over Non-Therapeutic Uses Of Drugs And Devices, Patricia J. Zettler

Washington and Lee Law Review

Although we often—and rightly—think of the U.S. Food and Drug Administration (FDA) as regulating important therapies for patients, the agency also can regulate non-therapeutic uses of drugs and devices. The Federal Food, Drug, and Cosmetic Act defines drugs and devices as including not only products intended to address disease but also those intended to affect the structure or function of the body, such as cognitive enhancements, wrinkle removers, and recreational drugs. Indeed, if these broad definitions were read literally, many everyday consumer products—such as winter jackets intended to keep wearers’ warm—may be drugs or devices. Accordingly, Congress, courts, and the …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

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 …

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.

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 …

The Regulatory Production Of Vaccine Hesitancy, Eugene Mccarthy

Brooklyn Law Review

This article argues that U.S. vaccine law produces the “anti-vax” movement. The anti-vax movement is a growing problem, as more than half of American parents have concerns about vaccinating their children. Remarkably, these “vaccine-hesitant” individuals tend to be highly educated, wealthy, and experienced parents. Three legal structures cause vaccine hesitancy: strict immunization mandates, lax regulatory oversight, and blanket limited liability for vaccine manufacturers. The United States stands alone with regard to its vaccine mandates—no other developed democracy requires its citizens to receive such a large number of childhood vaccines. Meanwhile, the law permits financial conflicts of interest in vaccine approval …

Proposed Federal Osha Standards For Wildfire Smoke, Keenan Layton

Seattle Journal of Technology, Environmental, & Innovation Law

With the rise of global temperatures, climatologists predict a corresponding increase in the frequency and severity of wildfires in the Pacific Northwest. Rising temperatures are expected to create drier conditions in forests, thereby creating environmental conditions more prone to forest fires. Wildfires have become a common enough occurrence in the Pacific Northwest that summers have become synonymous with smoky conditions, but the issue is not constrained to this region. Though the Pacific Northwest has recently acted as a harbinger of increasing wildfires, environmental scientists forecast an increase in fire risk throughout the Western United States. The predicted rise in forest …

Splendid Isolation: Va’S Failure To Provide Due Process Protections And Access To Justice To Veterans And Their Caregivers, Yelena Duterte

Journal of Law and Policy

Imagine you are a spouse and caregiver of a severely injured post-9/11 veteran. Your spouse served in the Marine Corps, with several deployments to Iraq. During their last deployment, your spouse sustained a severe traumatic brain injury and suffers from post-traumatic stress disorder. Due to these injuries, they need consistent care throughout the day. Thankfully, upon their return, the VA provided a caregiver program that allowed you to step away from your job and focus on caring for your spouse full time. As part of this program, you received a caregiver stipend of $2,400 per month, healthcare, and support from …

Reforming And Strengthening The Centers For Disease Control And Prevention: Five Key Reforms To Renew The Agency’S Stature And Effectiveness, Lawrence O. Gostin, Sandro Galea

Georgetown Law Faculty Publications and Other Works

The US Centers for Disease Control and Prevention (CDC) is the world’s leading public health agency, so admired that whole regions and countries have borrowed its name—in Africa, Europe, even China. In past epidemics, CDC’s expertise was transformative, such as in AIDS, Ebola, Zika, and Influenza H1N1. If there ever were a moment for the CDC to show leadership domestically and globally, it was the COVID-19 pandemic. Yet, the CDC’s stature was diminished—not enhanced—in an administration that not only eschewed science and politically pressured the CDC, but also gave notice of withdrawal from the World Health Organization (WHO), where CDC …

Dispute Settlement Under The African Continental Free Trade Area Agreement: A Preliminary Assessment, Olabisi D. Akinkugbe

Articles, Book Chapters, & Popular Press

The African Continental Free Trade Area Agreement (AfCFTA) will add a new dispute settlement system to the plethora of judicial mechanisms designed to resolve trade disputes in Africa. Against the discontent of Member States and limited impact the existing highly legalized trade dispute settlement mechanisms have had on regional economic integration in Africa, this paper undertakes a preliminary assessment of the AfCFTA Dispute Settlement Mechanism (DSM). In particular, the paper situates the AfCFTA-DSM in the overall discontent and unsupportive practices of African States with highly legalized dispute settlement systems and similar WTO-Styled DSMs among other shortcomings. Notwithstanding the transplantation of …

“Waiving” Goodbye To Medicaid As We Know It: Modern State Attempts To Transform Medicaid Programs Through Section 1115 Waivers, Chandler Gray

Washington and Lee Law Review Online

This Note explores recent state efforts to reshape their respective Medicaid programs through Section 1115 waivers. Specifically, this Note looks at states that wish to convert their Medicaid program to a block grant through Section 1115 waivers. Examining the lawfulness of these waivers requires analyzing the language and application of both the Medicaid Act and the Administrative Procedure Act. This Note argues that any use of Section 1115 waivers to implement a block grant program would be a violation of the Medicaid Act and thus unlawful. Further, federal approval of such programs would be deemed arbitrary and capricious. To justify …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

California V. Texas: Brief For Jonathan H. Adler, Nicholas Bagley, Abbe R. Gluck, And Ilya Somin As Amici Curiae Supporting Petitioner, Nicholas Bagley

Appellate Briefs

Amici are experts in constitutional law, legislation, statutory interpretation, and administrative law. They disagree on many legal and policy questions concerning the Affordable Care Act (“ACA”), Pub. L. No. 111-148, 124 Stat. 119 (2010), including many questions about how to interpret it and whether the plaintiff States have standing in the present case. Yet they agree on this: even assuming the insurance mandate is unconstitutional, it is severable from the other provisions of the ACA. Any contrary conclusion would be inconsistent with settled law and Congress’s clearly expressed intent. Amici respectfully submit this amicus brief to explain this point.<\p>

Amici’s …

Shifting Public Perception: Climate Change Means Living With Fire And Smoke, Robert Froembling

Seattle Journal of Technology, Environmental, & Innovation Law

The urgency to prepare for the climate crisis has never been greater. We are currently living in the sixth mass extinction and the effects are only going to accelerate. We will inherit more wildfires, larger wildfires, and more frequent wildfires.

This piece is not meant to stoke fear in its readers or be depressing, but to shift public perception on what our future holds by evaluating the laws and science presented to us. This piece will look at regional and federal regulations and assess the increased rate of forest fires and the grave public health concerns from stagnant smoke specifically …

Environmental Justice In Little Village: A Case For Reforming Chicago’S Zoning Law, Charles Isaacs

Northwestern Journal of Law & Social Policy

Chicago’s Little Village community bears the heavy burden of environmental injustice and racism. The residents are mostly immigrants and people of color who live with low levels of income, limited access to healthcare, and disproportionate levels of dangerous air pollution. Before its retirement, Little Village’s Crawford coal-burning power plant was the lead source of air pollution, contributing to 41 deaths, 550 emergency room visits, and 2,800 asthma attacks per year. After the plant’s retirement, community members wanted a say on the future use of the lot, only to be closed out when a corporation, Hilco Redevelopment Partners, bought the lot …

Reflections On The Effects Of Federalism On Opioid Policy, Matthew B. Lawrence

Dickinson Law Review (2017-Present)

No abstract provided.

Mhpaea & Marble Cake: Parity & The Forgotten Frame Of Federalism, Taleed El-Sabawi

Dickinson Law Review (2017-Present)

No abstract provided.

State Regulatory Responses To The Prescription Opioid Crisis: Too Much To Bear?, Lars Noah

Dickinson Law Review (2017-Present)

In order to prevent further overuse of prescription opioids, states have adopted a variety of strategies. This article summarizes the growing use of prescription drug monitoring programs, crackdowns on “pill mills,” prohibitions on the use of particularly hazardous opioids, limitations on the duration and dosage of prescribed opioids, excise taxes, physician education and patient disclosure requirements, public awareness campaigns, and drug take-back programs. Although occasionally challenged on constitutional grounds, including claims of federal preemption under the Supremacy Clause, discrimination against out-of-state businesses under the dormant Commerce Clause doctrine, and interference with rights of commercial free speech, this article evaluates the …

The Opioid Litigation: The Fda Is Mia, Catherine M. Sharkey

Dickinson Law Review (2017-Present)

It is readily agreed that federal preemption of state tort law alters the balance between federal and state power. Federal preemption is a high-profile defense in almost all modern products liability cases. It is thus surprising to see how little attention has been given to federal preemption by courts and commentators in the opioid litigation. Opioid litigation provides a lens through which I explore the role of state and federal courts and the Food and Drug Administration (FDA) in striking the right balance of power. My purpose here is not to resolve the divide among the few courts that have …

Safe Consumption Sites And The Perverse Dynamics Of Federalism In The Aftermath Of The War On Drugs, Deborah Ahrens

Dickinson Law Review (2017-Present)

In this Article, I explore the complicated regulatory and federalism issues posed by creating safe consumption sites for drug users—an effort which would regulate drugs through use of a public health paradigm. This Article details the difficulties that localities pursuing such sites and other non-criminal-law responses have faced as a result of both federal and state interference. It contrasts those difficulties with the carte blanche local and state officials typically receive from federal regulators when creatively adopting new punitive policies to combat drugs. In so doing, this Article identifies systemic asymmetries of federalism that threaten drug policy reform. While traditional …

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.

Trump V. Commonwealth Of Pennsylvania: Brief For Nicholas Bagley And Samuel L. Bray As Amici Curiae Supporting Petitioners, Nicholas Bagley

Appellate Briefs

Amici curiae are professors of law who have expertise that bears directly on one of the questions before this Court: Whether the court of appeals erred in affirming a nationwide preliminary injunction barring implementation of the final rules challenged by respondents.<\p>

This case squarely raises the propriety of an accelerating trend in the lower federal courts issuing injunctions that extend beyond the parties to bar enforcement of a challenged federal law or policy across the Nation. These injunctions are variously called "national," "universal," or "nationwide." They are inconsistent with the proper role of the federal courts in our constitutional structure …

The Disability Dilemma: Difficulties Involving Erisa Claims For Subjective-Proof Diseases, Courtney D. Keeling

Oklahoma Law Review

No abstract provided.

Say “No” To Discrimination, “Yes” To Accommodation: Why States Should Prohibit Discrimination Of Workers Who Use Cannabis For Medical Purposes, Anne Marie Lofaso, Lakyn D. Cecil

Seattle University Law Review

This Article addresses the question of how the law should treat medical cannabis in the employment context. Using Colorado as a primary example, we argue that states such as Colorado should amend their constitutions and legislate to provide employment protections for employees who are registered medical cannabis cardholders or registered caregivers.

Part I briefly traces the legal regulation of cannabis from an unregulated medicine known as cannabis to a highly regulated illicit substance known as marijuana under the Controlled Substances Act. Our travail through this history reveals, unsurprisingly, an increasing demonization of cannabis throughout the twentieth century. That socio-legal demonization …

In Memory Of Professor James E. Bond, Janet Ainsworth

Seattle University Law Review

Janet Ainsworth, Professor of Law at Seattle University School of Law: In Memory of Professor James E. Bond.

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Regulatory De-Arbitrage In Twenty-First Century Cures Act's Health Information Regulation, Craig Konnoth

Publications

Health data regulation can be thought of at two levels. First, the micro- level of regulation has to do with Electronic Health Records (EHRs). Second, the macro-level concerns the networks on which EHRs are transmitted. The micro- and macro-levels of regulation interact. For example, EHRs need to be configured so that they can be transmitted on mandated networks. As a result, the lines do sometimes blur.

That said, the 21st Century Cures Act (Cures) clearly takes a dual approach to regulation. Cures was passed in December 2016 on a bipartisan basis. Its mandate was to address health data regulation at …

Examining Racial & Ethnic Disparities In The Reach Of The Medicare Shared Savings Program, Lindsey Arneson

Capstone Experience: Master of Public Health

It is important to understand the quality of health care for racial and ethnic minorities covered under the largest U.S. government-run insurance program, Medicare, because the demographics of the U.S. are becoming older and more diverse. A new value-based program under Medicare is the Shared Savings Program (MSSP), which creates incentives to improve care quality and health outcomes for Medicare beneficiaries with a specific focus on increasing the provision of preventive care services. This capstone project aims to understand the representation of racial/ethnic minority Medicare beneficiaries, namely African Americans/Blacks and Hispanics/Latinxs, that receive care from providers or facilities (i.e., Accountable …