Administrative Law Commons^™

Eksistensi Perlindungan Paten Atas Vaksin Covid-19, Adzhani Tharifah, Agus Sardjono

Jurnal Hukum & Pembangunan

The Covid-19 vaccine is expected to be a solution to return to normal life. However, the need for vaccines that are global in nature raises several questions in the community, especially regarding the existence of patent protection. For this reason, this paper will answer these questions by discussing the patentability of the Covid-19 vaccine as well as how to implement patent protection in the midst of a pandemic and public concerns about limited access to vaccines. The research method used in the writing of this thesis is normative juridical with a qualitative approach where the data comes from literature studies …

Health Insurance And Bankruptcy Risk: Examining The Impact Of The Affordable Care Act, Philip M. Pendergast, Michael D. Sousa, Tim Wadsworth

Brooklyn Law Review

The passage of the Patient Protection and Affordable Care Act (“ACA”) in 2010 represented a watershed moment for healthcare in the United States. As is well-noted, the federal courts are still wrangling over the constitutionality of the law, and there is significant uncertainty regarding the extent to which the ACA will survive these legal battles. Unquestionably, the ACA has expanded access to health insurance for many millions of Americans. Prior to the advent of the ACA, Medicaid income eligibility for adults without dependents was approximately 61 percent of the Federal Poverty Line. Empirical studies since the advent of the ACA …

Structured To Fail: Lessons From The Trump Administration’S Faulty Pandemic Planning And Response, Alejandro E. Camacho, Robert L. Glicksman

Michigan Journal of Environmental & Administrative Law

The Trump Administration’s response to the COVID-19 pandemic is a stark reminder that poorly designed government can be a matter of life and death. This article explains how the Administration’s careless and delayed response to the crisis was made immeasurably worse by its confused and confusing reallocation of authority to perform or supervise tasks essential to reducing the virus’s ravages.

After exploring the rationale for and impact of prior federal reorganizations responding to public health crises, the article shows how a combination of unnecessary and unhelpful overlapping authority and a thoughtless mix of centralized and decentralized authority contributed to the …

Regulating New Tech: Problems, Pathways, And People, Cary Coglianese

All Faculty Scholarship

New technologies bring with them many promises, but also a series of new problems. Even though these problems are new, they are not unlike the types of problems that regulators have long addressed in other contexts. The lessons from regulation in the past can thus guide regulatory efforts today. Regulators must focus on understanding the problems they seek to address and the causal pathways that lead to these problems. Then they must undertake efforts to shape the behavior of those in industry so that private sector managers focus on their technologies’ problems and take actions to interrupt the causal pathways. …

Held V. State, Alec D. Skuntz

Public Land & Resources Law Review

On March 13, 2020, a group of 16 Montana children and teenagers filed a complaint in the First Judicial District, Lewis and Clark County against the State of Montana and several state agencies. These young Plaintiffs sought injunctive and declaratory relief against Defendants for their complicity in continuing to extract and release harmful amounts of greenhouse gases which contribute to climate change. Plaintiffs premised their argument on the Montana Constitution’s robust environmental rights and protections. The Defendants filed a motion to dismiss which the District Court granted in-part and denied in-part. Held provides a roadmap for future litigation by elucidating …

Osha’S Comprehensive Failure To Protect Workers During The Covid-19 Pandemic, Nancy M. Modesitt

Dickinson Law Review (2017-Present)

Under the Trump Administration, the Occupational Safety and Health Administration (“OSHA”), failed to protect workers from COVID-19, which has led to deadly workplace outbreaks of the virus. OSHA’s failures began when it refused to produce legally-binding rules, known as emergency temporary standards, that would mandate the most basic step of requiring masks in the workplace to protect workers from the risks of infection on the job. In addition, while OSHA did produce non-binding guidance for employers, that guidance was unclear and fundamentally deficient in failing to require masks in all workplaces and failing to require recordkeeping that would identify potential …

Freedom Without Opportunity: Using Medicare Policy And Cms Mechanisms To Anticipate The Platform Economy’S Pitfalls And Ensure Healthcare Platform Workers Are Fairly Paid, Kim A. Aquino

Brooklyn Law Review

The rapidly aging population, along with the demand for innovative Medicare delivery models such as bundled payment programs have incentivized the use of technology in healthcare because of its potential to cut costs and improve quality of care. Like many industries embracing technological strides to automate and digitize services, the healthcare industry has welcomed new labor markets like the platform economy to facilitate connections between patients and workers with ease. Along with streamlining connections, the platform economy also promises workers flexibility and autonomy over their own schedule. The platform economy’s promise of freedom, however, is not enough to prevent the …

The Rise Of Ada Title Iii: How Congress And The Department Of Justice Can Solve Predatory Litigation, Sarah E. Zehentner

Brooklyn Law Review

The Americans with Disabilities Act (ADA) was enacted in 1990 to afford equal opportunities for individuals with disabilities. Title III of the ADA, specifically, was enacted to afford disabled individuals equal access to places of public accommodation. When the ADA was enacted, the internet was still in its infancy and Congress did not contemplate the need for governing accessibility to websites of public accommodations. Today, the internet has become embedded in virtually every aspect of our lives, yet there are still millions of disabled individuals who are unable to equally access the websites of American businesses. With the ADA being …

Shifting Antitrust Laws And Regulations In The Wake Of Hospital Mergers: Taking The Focus Off Of Elective Markets And Centering Health Care, Maya Inka Ureño-Dembar

Brooklyn Law Review

Access to health care requires access to a care center and access to comprehensive health care services. Rampant hospital mergers are uniquely poised to reduce both the number of hospitals, requiring patients to travel further, and the services provided within a newly merged hospital, namely reproductive health services. This phenomenon is clearly seen through the merging of secular and nonsecular hospitals, which often result in patients being forced to travel much further for reproductive health care. In the United States’ current model, health care is not a right, but is treated as a commodity. As such, it is governed by …

Due Process And Administrative Hearings In The Time Of Covid-19: Help, I Need Somebody!, Leslie Birnbaum

Journal of the National Association of Administrative Law Judiciary

The COVID-19 pandemic has caused the reinvention of the administrative hearing process in a virtual or hybrid setting. Since March 2020, administrative forums have experienced continuances, backlogs, and the digital divide. The purpose of this paper is to examine the effects of COVID-19 on procedural due process and administrative hearings, and to address some of the problems and unanswered questions about the new normal. Part I presents background information about the virus and a brief history of pandemics. Part II examines past and present case law, and the NAALJ and National Conference of Administrative Law Judges' national survey. Part III …

Reimagining Exceptional Events: Regulating Wildfires Through The Clean Air Act, Emily Williams

Washington Law Review

Wildfires are increasing in both frequency and severity due to climate change. Smoke from these fires causes serious health problems. Land managers agree that prescribed burns help mitigate these negative consequences. Prescribed burns are lower-intensity fires that are intentionally ignited and managed for an ecological benefit. They reduce the amount of smoke produced and limit wildfire damage to natural systems and human property.

The Clean Air Act (CAA) is designed to regulate air pollution to protect public health, yet it exempts wildfire smoke through the exceptional events designation while imposing strict regulations on prescribed burns. Congress and the Environmental Protection …

Health Care Fraud Means Never Having To Say You're Sorry, Jacob T. Elberg

Washington Law Review

For decades, the Department of Justice (DOJ) has issued a steady flood of press releases announcing False Claims Act (FCA) settlements against health care entities and extolling the purportedly sharp message sent to the industry through these settlements about the consequences of engaging in wrongdoing. The FCA is the primary mechanism for government enforcement against health care entities engaged in wrongdoing, and it is expected to be DOJ’s key tool for addressing fraud arising out of government programs in response to the COVID-19 pandemic. DOJ has pointed to three key goals of its enforcement efforts (deterrence, incentivizing cooperation, and building …

Covid-19: A Crisis And An Opportunity To Improve The Emergency Use Authorization Process, Daniel Walsh, Ph.D

Minnesota Journal of Law, Science & Technology

No abstract provided.

The U.S. Department Of Agriculture As A Public Health Agency? A "Health In All Policies" Case Study, Lindsay F. Wiley

Journal of Food Law & Policy

The "war on obesity" is now well into its second decade. What began as an effort to encourage medical doctors to screen and treat patients whose weight put them at risk for health problems has transformed into a much broader public health campaign to address the root causes of obesity. A growing number of state, territorial and local health departments are currently exploring new ways to promote healthy eating and physical activity. At the federal level, the U.S. Centers for Disease Control and Prevention (CDC) has made "nutrition, physical activity and obesity" a top priority.

Medical Volunteers During Pandemics, Disasters, And Other Emergencies: Management Best Practices, John I. Winn, Seth Chatfield, Kevin H. Govern

Seattle Journal of Technology, Environmental & Innovation Law

How best to utilize volunteers^[1] during medical emergencies is an essential part of hospital compliance planning. Onboarding recruited and spontaneous volunteers during crisis situations require careful consideration of multiple legal issues. Volunteer planning becomes more complex if volunteers move across state lines because applicable tort immunity statutes,^[2] compensation limits,^[3]and workers compensation regimes vary significantly from one jurisdiction to another. Effective planning for volunteers requires these and other issues to be addressed well in advance of actual emergencies. Although predicting the scope or severity of any future crisis is impossible, the provided checklist of management best practices …

Environmental Justice Class Action Rises Above The Rubbish: The Third Circuit Revives Common-Law Nuisance Remedies In Baptiste V. Bethlehem Landfill Co., Kyra G. Bradley

Villanova Environmental Law Journal

No abstract provided.

Don't You Know That You're Toxic? Cercla Section 113(H) Challenges, Sovereign Immunity, And Perfluoroalkyl Substances In Pennsylvania Drinking Water In Giovanni V. Navy, Stephanie J. Oppenheim

Villanova Environmental Law Journal

No abstract provided.

Out Of Sight, Out Of Mind: Analyzing Inhumane Practices In Mississippi’S Correctional Institutions Due To Overcrowding, Understaffing, And Diminished Funding, Ariel A. Williams

Honors Theses

The purpose of this research is to examine the political, social, and economic factors which have led to inhumane conditions in Mississippi’s correctional facilities. Several methods were employed, including a comparison of the historical and current methods of funding, staffing, and rehabilitating prisoners based on literature reviews. State-sponsored reports from various departments and the legislature were analyzed to provide insight into budgetary restrictions and political will to allocate funds. Statistical surveys and data were reviewed to determine how overcrowding and understaffing negatively affect administrative capacity and prisoners’ mental and physical well-being. Ultimately, it may be concluded that Mississippi has high …

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

William & Mary Law Review

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 …

Hubungan Keuangan Pemerintah Pusat Dan Daerah Dalam Penyelenggaraan Jaminan Kesehatan Nasional, Amelia Martira

"Dharmasisya” Jurnal Program Magister Hukum FHUI

Indonesia's National Health Security (NHS) has begun since 2014 which give a lot of benefits to people in Indonesia. Access to health care become more easier without giving financial hardship. However, there are some obstacles that Indonesia NHS facing, which one is deficit in pool funding that is not enough to pay the benefits. One of newer solution to overcome this problem is by activating the resources from local government, especially from the funding. Basically, decentralization is the framework of the central and local government relation in Indonesia, by transferring power, authority and financial of health functional assignment to local …

European Union Food Law Update, Nicole Coutrelis

Journal of Food Law & Policy

On March 31, 2006, the European Commission published Council Regulation (EC) No. 510/2006 On the Protection of Geographical Indications and Designations of Origin for Agricultural Products and Foodstuffs. This new regulation repealed Council Regulation (EEC) No. 2081/92 On the Protection of Geographical Indications and Designations of Origin for Agricultural Products and Foodstuffs mainly to bring Community law into conformity with the World Trade Organization (WTO) agreements and the findings of a recent WTO panel. Under the new Regulation, persons in third countries (non-European Union members) are entitled to address applications for the protection of geographic names and statements of objection …

United States Food Law Update, Michael Tingey Roberts, Margie Alsbrook

Journal of Food Law & Policy

This update summarizes some of the significant changes and developments in food law over the first half of 2006. Not every change in food law is included; instead, this update provides a starting point for scholars, practitioners, food industry members, and policymakers determined to understand the shaping of food law in modern society. Tracing the development of food law through these updates, which appear in each issue of the Journal of Food Law & Policy, also provides historical context for the development of significant food law issues over time. New developments in state law, while certainly important and deserving in …

Creating Balance: Problems Within Dshea And Suggestions For Reform, Jennifer Akre Hill

Journal of Food Law & Policy

The Dietary Supplement Health and Education Act of 1994 (DSHEA) was signed into law on October 25, 1994. At the signing, President Clinton endorsed the "intense efforts" of manufacturers and legislators to change the "treatment of dietary supplements under regulation and law." Further, the bill was signed with the hope that it would benefit consumers by permitting more access to dietary supplements and more choices for consumer directed healthcare. In support, politicians on both sides of the aisle claimed the DSHEA as a victory for consumer freedom, populist protection, and preventative medicine.

The 21st Century Cures Act: A Patient's Miracle Or Demise?, Brittaney N. Edwards

Journal of the National Association of Administrative Law Judiciary

The 21st Century Cures Act is designed to expedite the FDA’s approval of pharmaceutical and medical device applications in order to increase patient access to innovative therapies. However, many experts claim that the Act’s Title III provisions promote evidentiary “‘shortcuts’” that eviscerate the safety and efficacy standards of the FDA approval process. For new drugs, Title III permits surrogate endpoints and real-world evidence in lieu of more rigorous scientific data. For new medical devices, Title III requires the FDA to exempt certain Class I and II devices from any kind of safety or efficacy evaluation. Moreover, Title III forces the …

Revolving Doors - We Got It Backwards, Hadar Yoana Jabotinsky Dr.

University of Cincinnati Law Review

The revolving door phenomenon, in which senior public officials transfer from the public service to the private sector after finishing their term as public officials, and vice versa, is widespread. This gives rise to concern of regulatory capture, which happens when the regulators respond to the wishes of strong interest groups, such as the regulated industry, instead of protecting the interests of the general public. The solution is usually found in conflict-of-interest rules which set cooling-off periods for individuals moving from the public to the private sector. This paper proposes that although revolving doors do incur some costs, they also …

United States Food Law Update: The Fda Food Safety Modernization Act, Obesity And Deceptive Labeling Enforcement, A. Bryan Endres, Nicholas R. Johnson

Journal of Food Law & Policy

The long-awaited enactment of the FDA Food Safety Modernization Act (FSMA), the most significant amendment to the Federal Food, Drug, and Cosmetic Act in several decades, provides the Food and Drug Administration (FDA) with significantly enhanced jurisdiction to close some of the gaps in the domestic food safety system. The enhanced FDA authority, however, will have little impact on the shared governance system at the federal level that involves multiple agencies, as the Act does not address the U.S. General Accounting Office's (GAO) repeated calls for consolidation of the fragmented federal food safety system. Rather, the Act perpetuates the division …

Workers' Comp And Contagious Disease: History And Future, Kate E. Britt

Law Librarian Scholarship

Modern workers’ compensation schemes set out to provide financial relief to employees who contract an occupational disease during employment, like miners contracting black lung or contractors exposed to asbestos. Certain professions are understood to stand a particular risk of exposure to contagious diseases. Health-care workers interact with persons carrying contagious disease as a matter of course. What workers’ compensation does not cover are diseases which are so prevalent they are considered an “ordinary disease of life.” These diseases, like the common cold, influenza, or pneumonia, could be contracted by persons regardless of their profession, and workers’ compensation acts generally limit …

Little Sisters Of The Poor V. Pennsylvania: The Not So Little Effect Of Interfering With The Aca's Contraceptive Mandate, Sabrina Rubis

Women, Leadership & Equality

No abstract provided.

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 …

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 …