Health Law and Policy Commons^™

Medicare "Bankruptcy", Matthew B. Lawrence

Faculty Articles

Medicare, the social insurance program for the elderly and disabled, is once again facing insolvency. Spending from the program’s hospital insurance trust fund is predicted to exceed the accumulated payroll taxes and other revenues that support the fund within the next five years, leaving Medicare unable to honor some of its obligations. Yet, what happens if and when Medicare becomes insolvent has not previously been explored in legal scholarship and is not addressed in statute or regulation. This Article confronts for the first time the major legal questions that Medicare insolvency would present. It explains what policymakers could do to …

An Attempt To Bring Modern Workplace Realities To The Social Security Disability Adjudication System, Robert E. Rains

Dickinson Law Review (2017-Present)

No abstract provided.

A Proportionality-Based Framework For Government Regulation Of Digital Tracing Apps In Times Of Emergency, Sharon Bassan

Dickinson Law Review (2017-Present)

Times of emergency present an inherent conflict between the public interest and the preservation of individual rights. Such times require granting emergency powers to the government on behalf of the public interest and relaxing safeguards against government actions that infringe rights. The lack of theoretical framework to assess governmental decisions in times of emergency leads to a polarized and politicized discourse about potential policies, and often, to public distrust and lack of compliance.

Such a discourse was evident regarding Digital Tracing Apps (“DTAs”), which are apps installed on cellular phones to alert users that they were exposed to people who …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Table Of Contents

Seattle University Law Review

Table of Contents

Reforming Reimbursement For The Us Food And Drug Administration’S Accelerated Approval Program To Support State Medicaid Programs, Rachel Sachs, Julie M. Donohue, Stacie B. Dusetzina

Scholarship@WashULaw

Importance The US Food and Drug Administration (FDA) has an accelerated approval program that has become the subject of scholarly attention and criticism, not only for the FDA’s oversight of the program but also for its implications for payers.

Observations State Medicaid programs’ legal obligations to provide reimbursement for accelerated approval products have created fiscal challenges for Medicaid that have been exacerbated by industry’s changing use of the accelerated approval program over time. Although strategies for accelerated approval reforms have been proposed, most focus on reforming the FDA’s accelerated approval pathway and product regulation without taking into account the implications …

A Cost To Bear—Environmental Contamination And Eminent Domain, Evan C. Heaney

Seattle University Law Review

This Note advocates for Washington courts to adopt a system that universally allows evidence of environmental contamination on the private property taken in eminent domain proceedings. Part I of this Note discusses the history and progression of eminent domain and the broader constitutional roots of the Takings Clause. Part II explores Washington’s environmental remediation statute. Part III details the various approaches jurisdictions around the county have formulated to deal with this issue. Part IV argues Washington courts should adopt the inclusionary approach, which allows the introduction of environmental evidence in eminent domain proceedings.

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 …

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 …

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 …

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 …

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 …

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 …

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

Minnesota Journal of Law, Science & Technology

No abstract provided.

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 (1991 - )

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 (1991 - )

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 …

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 …

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.

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 …

Tobacco Reborn: The Rise Of E-Cigarettes And Regulatory Approaches, Daniel G. Aaron

Lewis & Clark Law Review

This Article examines e-cigarettes, FDA-regulated products which heat nicotine-containing fluid into an aerosol to be breathed into the lungs. Recent data show that e-cigarettes are used by about one-fifth of U.S. high school students. Given that we have, in the Surgeon General’s words, reached an epidemic of youth e-cigarette use, it is worth asking how a product within FDA jurisdiction became a serious threat to 3.6 million youth.

This Article reviews the law surrounding e-cigarettes and the history of FDA’s attempts to regulate them. Administrative law doctrines instruct us that increased presidential control will rein in misbehaving agencies by allowing …