Health Law and Policy Commons^™

... Because "Yes" Actually Means "No": A Personalized Prescriptive To Reactualize Informed Consent In Dispute Resolution

Marquette Law Review

None.

Health Care Referrals Out Of The Shadows: Recognizing The Looming Threat Of The Texas Patient Solicitation Act And Other Illegal Remuneration Statutes, Trenton Brown

St. Mary's Law Journal

Abstract forthcoming

Drug Approval In A Learning Health System, W. Nicholson Price

Articles

The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA—and the health system generally—should gather information after drugs are approved to learn how well they work and how safe they are. This is hard to do. FDA has its own surveillance systems, but those systems face substantial limitations in practical use. Drug companies can also conduct their own studies, but have little incentive to do so, and often fail to fulfil study commitments made to FDA. Proposals to improve this dynamic often suggest gathering more …

Alienage Classifications And The Denial Of Health Care To Dreamers, Fatma E. Marouf

Fatma Marouf

In the Affordable Care Act (“ACA”), passed in 2010, Congress provided that only “lawfully present” individuals could obtain insurance through the Marketplaces established under the Act. Congress left it to the Department of Health and Human Services (“HHS”) to define who is “lawfully present.” Initially, HHS included all individuals with deferred action status, which is an authorized period of stay but not a legal status. After President Obama announced a new policy of Deferred Action for Childhood Arrivals (“DACA”) in June 2012, however, HHS amended its regulation specifically to exclude DACA recipients from the definition of “lawfully present.” The revised …

Reform At Risk — Mandating Participation In Alternative Payment Plans, Scott Levy, Nicholas Bagley, Rahul Rajkumar

Articles

In an ambitious effort to slow the growth of health care costs, the Affordable Care Act created the Center for Medicare and Medicaid Innovation (CMMI) and armed it with broad authority to test new approaches to reimbursement for health care (payment models) and delivery-system reforms. CMMI was meant to be the government’s innovation laboratory for health care: an entity with the independence to break with past practices and the power to experiment with bold new approaches. Over the past year, however, the Department of Health and Human Services (HHS) has quietly hobbled CMMI, imperiling its ability to generate meaningful data …

Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox

Michigan Telecommunications & Technology Law Review

Biologic drugs offer major advancements over small-molecule drugs when it comes to treating serious diseases. Biosimilars, which mimic innovative biologic drugs, have the potential to further revolutionize the practice of medicine. States now have decades of experience regulating the substitution of generic, small-molecule drugs for their brand-name equivalents. But the complexities of biologic drugs and biosimilars force states to confront novel scientific and legal issues. Many states have begun tackling those issues by passing laws that regulate when pharmacists may substitute biosimilars for their corresponding biologic drugs. Other states have yet to do so. This Note surveys five provisions common …

Informing Consent: Medical Malpractice And The Criminalization Of Pregnancy, Laura Beth Cohen

Michigan Law Review

Since the early 1990s, jurisdictions around the country have been using civil child abuse laws to penalize women for using illicit drugs during their pregnancies. Using civil child abuse laws in this way infringes on pregnant women’s civil rights and deters them from seeking prenatal care. Child Protective Services agencies are key players in this system. Women often become entangled with the Child Protective Services system through their health care providers. Providers will drug test pregnant women without first alerting them to the potential negative consequences stemming from a positive drug test. Doing so is a breach of these providers’ …

Mid-Atlantic Ethics Committee Newsletter, Spring 2018

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Healthcare In Appalachia And The Role Of The Federal Government, Robert R. Davis, Shelly Cole

West Virginia Law Review

No abstract provided.

Are Medicaid Work Requirements Legal?, Nicholas Bagley

Articles

On January 12, 2018, the Centers for Medicare & Medicaid Services (CMS) approved a waiver allowing Kentucky to impose a work requirement on some nondisabled Medicaid beneficiaries. Similar waivers are sure to follow. Supporters see work requirements as a spur to force the idle poor to work; opponents see the requirements as a covert means of withholding medical care from vulnerable people. Setting the policy debate aside, however, are work requirements legal?

The New Health Care Federalism On The Ground, Nicole Huberfeld, Abbe Gluck

Faculty Scholarship

This essay, part of a symposium investigating methods of empirically evaluating health policy, focuses on American health care federalism, the relationship between the federal and state governments in the realm of health care policy and regulation. We describe the results of a five year study of the implementation of the Patient Protection and Affordable Care Act (ACA) from 2012-2017. Our study focused on two key pillars of the ACA, which happen to be its most state-centered — expansion of Medicaid and the implementation of health insurance exchanges — and sheds light on federalism in the modern era of nationally-enacted health …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Katharine Van Tassel

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

The Burden Of A Good Idea: Examining The Impact Of Unfunded Federal Regulatory Mandates On Medicare Participating Hospitals, Rachel Juhas Suddarth

Law Faculty Publications

Health care costs are on the rise. In 1960, the United States spent $9 billion on hospital care. Since then, hospital related spending has grown exponentially. In 2015, the United States spent over $1 trillion on hospital care, with $359.9 billion of those payments coming from the federal Medicare program for the aged and disabled. Researchers have long tried to understand the exact causes of rising health care costs. While many have closely examined the costs associated with population demographics, medical innovation, prescription drug costs, overutilization of services, and fraud or abuse, there is one driving force that does not …

The International Right To Health Care: A Legal And Moral Defense, Michael Da Silva

Michigan Journal of International Law

In the following, I outline the case against the international right to health care and explain why recognition of such a right is still necessary. The argument is explicitly limited to international human rights law and is primarily descriptive in nature, but I go on to explain the moral reasons to accept this account. Both the positive law and moral reasoning could be used in other health rights debates, but I do not attempt to make such claims here.

The structure of my work is as follows. I first outline three problems with recognizing an international right to health care. …

Make America Discriminate Again? Why Hobby Lobby's Expansion Of Rfra Is Bad Medicine For Transgender Health Care, Alexis M. Florczak

Health Matrix: The Journal of Law-Medicine

The article highlights the implications of the U.S. Supreme Court's decision in "Burwell v. Hobby Lobby Stores, Inc." which held for-profit corporations could be exempt from the Affordable Care Act's (ACA)contraceptive mandate because of their sincerely held religious beliefs. Topics discussed include ACA Nondiscrimination or Civil Rights provision provides valuable protections to transgender individuals; and Department of Health and Human Services' further guidance on the ACA's provision.

Witch Doctors, Zombies, And Oracles: Rethinking Health In America, Ali S. Khan

Health Matrix: The Journal of Law-Medicine

To the extent we can even refer to an American healthcare "system," it functions brilliantly ... to make money. The system is designed to reward executives or major shareholders of pharmaceutical & health insurance companies, healthcare facilities, and related entities. With a rapidly aging population, healthcare will soon surpass a fifth of our economy. Of course, the American healthcare system does not function brilliantly when one considers the perspective of patients and over-extended primary care providers. Prices are growing faster than inflation or wages, healthcare is twice as costly as other comparable nations, and one third is a result of …

Medicalization Of Rural Poverty: Challenges For Access, Elizabeth Weeks

Scholarly Works

This article was prepared for a live conference, on “The Medicalization of Poverty,” held at the University of Illinois College of Law, and a symposium to be published in the Journal of Law, Medicine & Ethics. My piece focuses on a constellation of challenges for health care delivery and access to care in rural areas. Discussions regarding health and poverty often seem to focus on the admittedly persistent and multilayered problems of the urban poor: unemployment, substandard and unaffordable housing, violent crime, nutrition and “food desserts,” recreation and safe outdoor spaces, and under-resourced public schools, to name a few. While …

Researching Colorado Health Law, Kerri Rowe

Publications

No abstract provided.

The New Health Care Federalism On The Ground, Nicole Huberfeld, Abbe Gluck

Faculty Scholarship

This essay, part of a symposium investigating methods of empirically evaluating health policy, focuses on American health care federalism, the relationship between the federal and state governments in the realm of health care policy and regulation. We describe the results of a five year study of the implementation of the Patient Protection and Affordable Care Act (ACA) from 2012-2017. Our study focused on two key pillars of the ACA, which happen to be its most state-centered — expansion of Medicaid and the implementation of health insurance exchanges — and sheds light on federalism in the modern era of nationally-enacted health …

Can Rationing Through Inconvenience Be Ethical?, Nir Eyal, Paul Romain, Christopher Robertson

Faculty Scholarship

In this article, we provide a comprehensive analysis and a normative assessment of rationing through inconvenience as a form of rationing. By “rationing through inconvenience” in the health sphere, we refer to a non-financial burden (the inconvenience) that is either intended to cause or has the effect of causing patients or clinicians to choose an option for health‐related consumption that is preferred by the health system for its fairness, efficiency, or other distributive desiderata beyond assisting the immediate patient. We argue that under certain conditions, rationing through inconvenience may turn out to serve as a legitimate and, compared to direct …

Medical Necessity: A Higher Hurdle For Marginalized Taxpayers?, Julie Furr Youngman, Courtney D. Hauck

Loyola of Los Angeles Law Review

Civil rights protection for transgender people—and in particular access to affordable health care—is currently the subject of intense political scrutiny, with a hostile administration chipping away at legal protections. Among other setbacks, a federal district court enjoined regulatory guidelines that were issued in 2016 to clarify that the federal prohibition on sex discrimination in health insurance applies to discrimination on the basis of gender identity and transgender status, and the promulgating agency itself is now reconsidering the guidelines. Without explicit federal protections against discrimination by health insurers and in the face of uneven state law protections, the ability to deduct …

An Assessment Of Advance Directives In China: The "Coming Of Age" For Legal Regulation?, Yue An, Mimi Zou

Marquette Benefits and Social Welfare Law Review

Advance directives (AD) are playing an increasingly important role in end-of-life medical care and treatment in ageing societies. A growing number of jurisdictions have introduced AD-related laws as a component of their medical and health care regulatory frameworks. This article presents an analytical account of why specific regulation on ADs has yet to develop in China, the most populous ageing society in the world. We argue that the regulatory vacuum to date can be partly explained by limited public demand, which can be further accounted by relatively low public awareness as well as the influence of traditional views on life-and-death …