Health Law and Policy Commons^™

Should Canada Adopt Managed Access Agreements In Canada For Expensive Drugs?, Melanie Mcphail, Tania M. Bubela

Office of the Provost

Drugs are increasingly authorized based on less mature evidence, leaving payors faced with significant clinical and cost-effectiveness uncertainties. As a result, payors must often choose between reimbursing a drug that may not turn out to be cost-effective (or may even be unsafe) or delaying the reimbursement of a drug that is cost-effective and offers clinical benefit to patients. Novel reimbursement decision models and frameworks, such as managed access agreements (MAAs), may address this decision challenge. Here, we provide a comprehensive overview of the legal limitations, considerations, and implications for adopting MAAs in Canadian jurisdictions. We begin with an overview of …

Genetic Technologies: Patent Protections & The Case For Technology Transfer, Smitha Gundavajhala

Washington Journal of Law, Technology & Arts

Genetic technologies range in scope from agricultural to medical applications. Most recently, during the COVID-19 pandemic, companies like Moderna developed and patented genetic technologies for diagnostic and therapeutic purposes, like the mRNA vaccine. However, patent protection provides these companies with a monopoly that ultimately limits domestic production of generic versions, thus limiting access to life-saving diagnostics and therapeutics. When a company located in one country files a patent for recognition in another country, it effectively places a hold on production of any technologies covered by that patent’s reach, whether that patent is enforced or not. However, the TRIPS Agreement, the …

“Tiktok Told Me I Have Adhd”: Regulatory Outlook For The Telehealth Revolution, Kaitlin Campanini

Washington Journal of Law, Technology & Arts

Telehealth’s expansion during the COVID-19 pandemic has drastically changed the approach to healthcare in the United States. This is particularly true in the behavioral health sector where several behavioral telehealth companies have emerged to treat Attention-Deficit/Hyperactivity Disorder (“ADHD”). These companies utilize a direct-to-consumer (“DTC”) model with a virtual platform that connects subscribing patients to medical providers who can treat them for ADHD. Although this telemedicine model emphasizes convenience and efficiency, the reality is that those benefits come at the cost of patient care. The federal regulations promulgated in the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 to curtail …

The Origins Of Covid-19 — Why It Matters (And Why It Doesn’T), Lawrence O. Gostin, Gigi K. Gronvall

Georgetown Law Faculty Publications and Other Works

When Health emergencies arise, scientists seek to discover the cause — such as how a pathogen emerged and spread — because this knowledge can enhance our understanding of risks and strategies for prevention, preparedness, and mitigation. Yet well into the fourth year of the Covid-19 pandemic, intense political and scientific debates about its origins continue. The two major hypotheses are a natural zoonotic spillover, most likely occurring at the Huanan Seafood Wholesale Market, and a laboratory leak from the Wuhan Institute of Virology (WIV). It is worth examining the efforts to discover the origins of SARS-CoV-2, the political obstacles, and …

The Shared Ethical Framework To Allocate Scarce Medical Resources: A Lesson From Covid-19, Ezekiel J. Emanuel, Govind C. Persad

Sturm College of Law: Faculty Scholarship

The COVID-19 pandemic has helped to clarify the fair and equitable allocation of scarce medical resources, both within and among countries. The ethical allocation of such resources entails a three-step process: (1) elucidating the fundamental ethical values for allocation, (2) using these values to delineate priority tiers for scarce resources, and (3) implementing the prioritisation to faithfully realise the fundamental values. Myriad reports and assessments have elucidated five core substantive values for ethical allocation: maximising benefits and minimising harms, mitigating unfair disadvantage, equal moral concern, reciprocity, and instrumental value. These values are universal. None of the values are sufficient alone, …

Three New Actions Enter Legal Landscape, Lance Plunkett Jd, Llm

The New York State Dental Journal

Latest legal maneuvers cover a variety of fronts with potential impact on dental practices.

A Pandemics Treaty: A Boon For Africa, Kafumu Kalyalya

Southern African Journal of Policy and Development

This article illustrates the weaknesses of the current global health framework. It highlights two pillars a new treaty regime ought to be built upon. The analysis seeks to establish how these pillars could have helped Africa during the pandemic and can indeed help Africa in future pandemics. The analysis suggests the need for a unified global health regime or pandemics’ treaty that promotes a level legal and political playing field regarding future pandemics. The treaty could focus on coordination of research and development; build a stronger global framework that reinforces legal obligations and norms; provide for universal access to medicines, …

Ella P. Stewart And The Benefits Of Owning A Neighborhood Pharmacy, Randall K. Johnson

Faculty Works

This Essay is the first to explain how and why Ella P. Stewart, who was among the first Black women to earn a doctoral degree in Pharmacy, used her status as a small business owner to protect the limited set of legal rights that were available to African-Americans in the twentieth century. It also describes how Stewart’s early personal and professional experiences informed her subsequent public service career. Additionally, this Essay highlights the various ways that Stewart expanded the real freedoms that Black Americans enjoyed by guaranteeing they received a fair share of public goods or services. It concludes by …

Public Health Law—Punishing Pain: Why Treating Chronic Pain With Opioids Needs A New Standard Of Care, Robert Stodola

University of Arkansas at Little Rock Law Review

No abstract provided.

Staff Matters: Which Of Our Staff Are Hourly Vs. Salaried?, Jodi Schafer Sphr, Shrm-Scp

The Journal of the Michigan Dental Association

This article addresses the classification of employees as hourly (non-exempt) or salaried (exempt) in the context of dental practices. It outlines the Fair Labor Standards Act (FLSA) rules, including the current minimum salary threshold of $684 per week and the potential for changes in overtime regulations. The article also discusses the duties tests for various white-collar exemptions and provides guidance on correctly classifying common dental practice positions to ensure compliance with the law.

Interview: Dr. Eric Knudsen 2023-24 Mda President, David Foe Ma

The Journal of the Michigan Dental Association

Dr. Eric Knudsen, the 2023-24 MDA President, brings a wealth of experience and dedication to his new role. Hailing from the Upper Peninsula and a family of dentists, he discusses his goals for the year, including addressing access to dental care, promoting member assistance and well-being programs, and advocating for new dentists. He also shares insights on rural dentistry, community involvement, and increasing member participation in organized dentistry.

President’S Address: Dr. Vince Benivegna, Vince Benivegna Dds

The Journal of the Michigan Dental Association

Dr. Vince Benivegna, the outgoing President of the Michigan Dental Association, addressed the House of Delegates, emphasizing the significant progress in enhancing Adult Dental Medicaid coverage and reimbursement in Michigan. He thanked the dedicated individuals who supported him during his tenure and shared his journey. Dr. Benivegna lauded Michigan's accomplishments in reducing opioid prescribing and highlighted the MDA's role as a model state society in advocacy, leadership, mentorship, continuing education, diversity, equity, and inclusion. He praised Michigan's achievements in improving Adult Dental Medicaid, encouraging Michigan dentists to participate and help address oral health disparities. Dr. Benivegna underscored how this aligns …

Erisa’S Fiduciary Fantasy And The Problem Of Mass Health Claim Denials, Katherine T. Vukadin

University of Richmond Law Review

Over 100 million Americans face healthcare debt. Most of those in debt have health insurance, with the debt often springing from services people thought were covered. Before and even after receiving care, those seeking coverage must run a gauntlet of obstacles such as excessive pre-authorization requests, burdensome concurrent review of care, and retrospective review, which claws back payment after a treatment is pre-authorized and payment made. Increasingly, this procedural tangle leaves people with unwarranted and unexpected medical bills, quickly spiraling them into debt.

Who polices health insurers’ claims practices? What keeps insurance companies from designing overly burdensome pre-authorization requirements or …

Going The Extra Mile: Expanding The Promoting Affordable Housing Near Transit Act, Emily R. Casey

University of Richmond Law Review

The Promoting Affordable Housing Near Transit Act (“Act”), introduced in Congress in June 2021 and signed into law six months later, proposes a goal of balancing the disproportionately-high costs of housing and transportation felt by lower-income families by combining these resources in one project: transit-oriented housing developments. Middle-income and wealthy suburbanites have ready access to cities by car, but lower-income urbanites lack access to the suburbs without a private vehicle. While the goal of the Act recognizes this disparate outcome, the Act’s failure to include expansion of mass transit into the suburbs will continue to restrict low-income minorities to urban …

N Y State Dent J June-July 2023

The New York State Dental Journal

In the June-July 2023 issue, the reader will find the following feature articles:

• Understanding Persistent Bleeding in Children
• Sinus Tract vs. Fistula: There is a Difference
• What is the Prevalence of Temporomandibular Joint (TMJ) Condylar Osteoarthritis in an Asymptomatic Oral and Maxillorfacial Surgery Department Population?

This issue includes regular columns with regional news impacting the New York membership including: editorial and perspectives columns, legal, association activities, component news, continuing education opportunities, and classifieds.

Developing Ethics And Equity Principles, Terms And Engagement Tools, Ellen W. Clayton, Rachele Hendricks-Sturrup, Shilo Anders, Et Al.

Vanderbilt Law School Faculty Publications

Background:

Artificial intelligence (AI) and machine learning (ML) technology design and development continues to be rapid, despite major limitations in its current form as a practice and discipline to address all sociohumanitarian issues and complexities. From these limitations emerges an imperative to strengthen AI and ML literacy in underserved communities and build a more diverse AI and ML design and development workforce engaged in health research.

Objective:

AI and ML has the potential to account for and assess a variety of factors that contribute to health and disease and to improve prevention, diagnosis, and therapy. Here, we describe recent activities …

When Patients Are Assailants: Valuing Occupational Risks, W. Kip Viscusi, Elissa P. Gentry

Vanderbilt Law School Faculty Publications

Intentional violence against healthcare workers inflicts a physical and mental toll, motivating legislative proposals to better regulate these occupational risks. This article uses this context to address two novel issues for benefit assessment raised by injuries from assailants: potential heterogeneity in valuation based on the context of the injury risk and possible reductions in self-reported valuations when the exposed population has been trained to feel responsible for the risk. This article presents experimental evidence on workers’ preferences over the form of intervention: protection (risk reduction) or insurance (cost-sharing). The experiment also elicits worker valuations of occupational health care risks, calculating …

Considerations In Selecting Venues For The American Thoracic Society International Conference: Balancing Competing Priorities Of The Society's Diverse Membership, Gregory P. Downey, M. Patricia Rivera, Lynn M. Schnapp, Irina Petrache, Jesse Roman, Karen J. Collishaw

Division of Pulmonary, Allergy, and Critical Care Medicine Faculty Papers

No abstract provided.

Why Punish Pharma For Making Medicine? Preserving Patent Protections And Cutting Consumer Costs, Alex Wharton

Vanderbilt Journal of Entertainment & Technology Law

The push to lower pharmaceutical drug prices has taken a stronger foothold in legislative and executive actions in recent years. With average prices rising continuously over the past decade, many consumers struggle to pay for the medications they need-—insulin being the most often cited example. Accordingly, a variety of solutions have been suggested. Some solutions support reducing barriers for generic drugs to provide competition to the big brands, others push for greater regulation of manufacturers’ ability to price their drugs, and some proposals seek greater transparency to promote price negotiations, especially when compared to prices abroad. Most concerningly, however, one …

Dentistry And The Law: Accessing/Disclosing Prescription Information On Software Platforms, Dan Schulte Jd

The Journal of the Michigan Dental Association

This article discusses the access and disclosure of prescription information on software platforms like eScribe and MAPS. It highlights that HIPAA regulations govern such access, and as long as the information is obtained through business associate agreements and used for treatment purposes, specific patient consent may not be necessary. The article also mentions that the Michigan Automated Prescription System (MAPS) allows prescribers to access controlled substance prescription information without requiring patient consent.