Health Law and Policy Commons^™

For Whom The Bell (Equitably) Tolls: Erisa Compliance And Denial Of Benefits Notices Circuit Split, Sarah Smith

Akron Law Review

The circuit courts are split as to how a plan administrator of an ERISA-governed employee benefit plan must notify a claimant of a time limitation placed on a claimant’s ability to seek judicial review of an adverse benefit decision. Some courts indicate that inclusion of this time limitation in the Summary Plan Description is sufficient to notify a claimant. Other courts have held that the time period must specifically be included in adverse determination notices, which are documents notifying claimants of the denial of their claim and the right to judicial review. Much of the debate among courts concerns the …

From Guns That Do Not Shoot To Foreign Staplers: Has The Supreme Court’S Materiality Standard Under Escobar Provided Clarity For The Health Care Industry About Fraud Under The False Claims Act?, Deborah R. Farringer

Brooklyn Law Review

In June of 2016, the U.S. Supreme Court issued an opinion in the case of Universal Health Services, Inc. v. United States ex rel. Escobar, in order to resolve a circuit split regarding the viability of the “implied false certification” theory of liability under the False Claims Act (FCA). This article examines what has happened in the twelve months since the Escobar opinion by observing the reaction and subsequent arguments arising out of the Department of Justice and exploring the analyses of district courts and courts of appeals in trying to apply a new and more demanding materiality standard as …

Health Data And Privacy In The Digital Era, Lawrence O. Gostin, Sam F. Halabi, Kumanan Wilson

Georgetown Law Faculty Publications and Other Works

In 2010, the social networking site Facebook launched a platform allowing private companies to request users’ permission to access personal data. Few users were aware of the platform, which was integrated into Facebook’s terms of service. In 2014, Cambridge Analytica, a UK-based political consulting firm, developed a data-harvesting app. That app prompted Facebook users to provide psychological profiles, including responses such as “I get upset easily” and “I have frequent mood-swings” as part of a “research project.”

The Facebook platform allowed users to share their friends’ data as well, enabling Cambridge Analytica to access tens of millions of personal profiles, …

Dying To Be Fresh And Clean? Toxicants In Personal Care Products, The Impact On Cancer Risk, And Epigenetic Damage, Katherine Drabiak

Pace Environmental Law Review

The FDA does not conduct pre-market review of chemicals contained in cosmetics—which encompasses not only makeup but also numerous personal care products including shampoo, lotion, perfume, aftershave, and shaving cream. Every day, consumers use cosmetic products that contain a variety of synthetic ingredients, none of which the FDA has approved for safety but each of which are being ingested, absorbed, and inhaled into our bodies and accumulating in our tissue. Many of these products contain endocrine disrupting chemicals (“EDCs”), which emerging research links to an increased risk of cancer as well as immune and neurological dysfunction. This Article examines how …

New Ebola Outbreak In Africa Is A Major Test For The Who, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

On May 8, the Democratic Republic of Congo (DRC) notified the World Health Organization (WHO) of a confirmed outbreak of Ebola in Bikoro, on the shores of Lake Tumba in Équateur Province. Ebola in the DRC is not unexpected. The first-ever identified Ebola outbreak occurred in the DRC—then Zaire—in 1976. This is the ninth of DRC’s outbreaks, which until now have been confined mainly to rural areas. With high fatality rates, earlier outbreaks quickly burned out due to the natural firewall of remoteness.

Bikoro and a nearby village, Ikoko-Impenge, are rural, but on May 16, the WHO confirmed spread to …

Law & Health Care Newsletter, Summer 2018

Law & Health Care Newsletter

No abstract provided.

Where's Dad? The Importance Of Integrating Fatherhood And Parenting Programming Into Substance Use Treatment For Men, Carla Smith Stover, Melissa Carlson, Sarika Patel, Raquel Manalich

Mental Health Law & Policy Faculty Publications

Large numbers of men enter substance use disorder treatment each year, yet very little attention is paid to the fatherhood and parenting status of these men. Substance use treatment programmes for men rarely incorporate a parenting component into their treatment planning, despite the increased success of women's treatment programmes that focus on gender and motherhood. This paper provides: (1) a review of the literature on the fathering of substance‐using men, what has been learned from substance use disorder treatment for mothers, and the implications for children and families; (2) pilot quantitative and qualitative outcomes resulting from the implementation of a …

The Global Person: Pig-Human Embryos, Personhood, And Precision Medicine, Yvonne Cripps

Indiana Journal of Global Legal Studies

Chimeras, in the form of pig-human embryos engineered by CRISPR-Cas9 and other biotechnologies, have been created as potential sources of organs for transplantation. Against that background, and in an era of "precision medicine," this Article examines the concept of the global genetically modified person and asks whether humanness and personhood are being eroded, or finding new boundaries in intellectual property and constitutional law.

Healthcare Law, Kathryn S. Dunnam

Mercer Law Review

This Article serves as a review of significant healthcare developments in the United States Court of Appeals for the Eleventh Circuit over the last two years and builds upon Mercer Law Review's last Healthcare Article in Volume 65. Specifically, this Article will cover cases dealing with physician speech, the False Claims Act, and the Medicare Secondary Payer Act.

Rural Health, Universality, And Legislative Targeting, Nicole Huberfeld

Faculty Scholarship

Health disparities are persistent and worsening for rural communities, which have smaller patient populations with higher rates of uninsurance and greater incidence of the diseases and deaths of despair. Hospital closures and provider shortages are more common than in urban areas, also contributing to worsening population health and crises in maternal and infant health. This paper posits that these disparities are tied to the unique rural features of space and population. Efforts to address persistent problems in health care through universal legislation, such as the ACA, have given rural communities important tools to address some long-standing health problems by improving …

End Of Life And Autonomy: The Case For Relational Nudges In End-Of-Life Decision-Making Law And Policy, Megan S. Wright

Maryland Law Review

Autonomy is a central principle in many areas of health law. In the case of end-of-life decision-making law and policy, however, the principle of autonomy requires revision. On the whole, law conceptualizes autonomy at the end of life as an individual making private, personal decisions based solely on their interests and values, and independent of others. But ordinary people understand autonomous decisionmaking at the end of life differently, in a way that acknowledges the importance of their interpersonal relationships. Social science research has documented that strengthening relationships with others, sharing responsibility in the decision-making process with healthcare providers, and taking …

Investment Spending And Gdp, Kevin Zaldivar

Celebration of Learning

This study's mission is to give a modern day analysis to investment spending and to provide insight to the degree of impact certain investments have on our GDP. This should interest local,state,and federal policy makers as well as anyone who practices their civic duty.

Crispr/Cas-9 Technologies: A Call For A New Form Of Tort, Kendall Lovell

San Diego International Law Journal

Once relegated to the domains of science fiction, modern day scientists and researchers are poised on the precipice of making genome editing clinically available. Once introduced into a clinical setting the effects of an off-target mutation or germline edit will remain largely unknown until health issues arise later in life or in the following generation. The novelty of the injuries that will arise require a system that is able to balance the interests of physicians with single and multi-generational plaintiffs, while providing a realistic framework for courts to follow. This comment offers a brand-new context that accounts for these needs …

Strike Down Obamacare, Says Justice Department, Saikrishna B. Prakash, Neal Devins

Popular Media

No abstract provided.

Environmental Health Regulation In The Trump Era: How President Trump’S Two-For-One Regulatory Plan Impacts Environmental Regulation, Elizabeth Ann Glass Geltman

University of Michigan Journal of Law Reform

This Article explores the Trump regulatory reform agenda and its potential impact on environmental determinants of health. The Article begins with a discussion of the Department of Commerce’s (DOC or Commerce) initial fact-finding investigation to evaluate the impact of federal regulations on domestic manufacturing. The Article next presents an overview of the Trump administration’s regulatory reform formula as announced in E.O. 13771 and the interim guidance explaining E.O. 13771 and E.O. 13777 (the executive order announcing the Trump administration’s plans to enforce the regulatory reform plan announced in E.O. 13771). The Article then examines the federal agency initiatives undertaken in …

Needles, Haystacks, And Next-Generation Genetic Sequencing, Teneille R. Brown

Utah Law Faculty Scholarship

Genetic testing is becoming more frequent and the results more complex. Not infrequently, genetic testing conducted for one purpose reveals information about other features of the genome that may be of clinical significance. These unintended findings have been referred to as “incidental” or “secondary” findings. In 2013, the American College of Medical Genetics (“ACMG”) recommended that clinical laboratories inform people if their genetic analyses indicate that they have certain secondary mutations. These mutations were selected because they probably cause a serious disease, which is treatable, and may go undetected. The ACMG’s recommendations galvanized critical responses by the genetics and ethics …

Cold Genocide: Falun Gong In China, Maria Cheung, Torsten Trey, David Matas, Richard An

Genocide Studies and Prevention: An International Journal

The article explores patterns of a cold genocide in the eradication campaign against Falun Gong. Falun Gong is a spiritual practice that has been targeted for eradication by the Chinese regime since 1999. In comparison to the documented cases of genocide, the genocide of Falun Gong stands out as anomalous because it is virtually ignored. The article seeks to elucidate the multi-faceted nature of this concealed genocide from an interdisciplinary perspective encompassing social work, medicine and law, In particular, the article demonstrates that the eradication campaign against Falun Gong is distinguishable as a cold genocide as it is: (1) multi-dimensional …

Securing The Internet Of Healthcare, Scott J. Shackelford, Michael Mattioli, Steve Myers, Austin Brady

Minnesota Journal of Law, Science & Technology

No abstract provided.

What Is Federalism In Health Care For?, Nicole Huberfeld

Faculty Scholarship

The Affordable Care Act offers a window on modern American federalism—and modern American nationalism—in action. The ACA’s federalism is defined not by separation between state and federal, but rather by a national structure that invites state-led implementation. As it turns out, that structure was only a starting point for a remarkably dynamic and adaptive implementation process that has generated new state-federal arrangements. States move back and forth between different structural models vis-à-vis the federal government; internal state politics produce different state choices; states copy, compete, and cooperate with each other; and negotiation with federal counterparts is a near-constant. These characteristics …

Passing The Baton: The Effect Of The International Olympic Committee's Weak Anti-Doping Laws In Dealing With The 2016 Russian Olympic Team, Saroja Cuffey

Brooklyn Journal of International Law

Following the investigation of a Russian state-sponsored doping ploy prior to the Olympic Games in Rio 2016; the International Olympic Committee (IOC) decided against a blanket ban of the Russian Olympic team. Instead; it allowed athletes’ individual international federations to decide whether Russian athletes could compete. In following the various anti-doping laws in place; the IOC sought to protect and give justice to clean athletes around the world. This Note argues that they did not achieve this result; due to the anti-doping laws in place and the actors applying these laws. It suggests that there should be a universal anti-doping …