Health Law and Policy Commons^™

When Is Competition Not Competition: The Curious Case Of Medicare Advantage, Robert A. Berenson

Saint Louis University Journal of Health Law & Policy

Policymakers routinely assume that Medicare Advantage plans and the traditional Medicare program compete for beneficiaries. Yet the District of Columbia federal district court blocked the proposed Aetna and Humana merger, finding that for purposes of antitrust analysis Medicare Advantage plans and traditional Medicare are effectively in different product markets. That is, they do not compete. This article reviews the basis for the court decision, which relied to a large extent on information that Medicare beneficiaries select their insurance coverage based on durable preferences either for the Medicare Advantage or the traditional Medicare option.

The article explores whether the apparently durable …

Taking Quality Of Health Care Seriously In Provider Merger Analysis, Kent Bernard

Saint Louis University Journal of Health Law & Policy

Traditionally, antitrust analysis had no method to quantify the benefits of better health care outcomes from a potential merger to balance them against the potential for increased costs. However, a branch of health care economics allows for that calculation. This approach has not been used in antitrust analysis to date, but United States law is flexible enough to allow such an approach, and the 2010 Horizontal Merger Guidelines contemplate it in Section 5. It enables us to use established procedures to put quality of care into health care merger analysis.

Avoiding Sticker Shock: Legislative Approaches To Protect Consumers From Surprise Medical Bills, Merlow M. Dunham

Saint Louis University Journal of Health Law & Policy

Consumers are increasingly receiving surprise medical bills, where an insured patient is unexpectedly billed directly for medical services received at an in-network health care facility from an out-of-network provider. These situations often arise in emergency rooms, operating rooms, and delivery rooms, despite the efforts of patients to receive care only from in-network providers. Surprise medical bills commonly leave consumers on the hook for thousands of dollars for out-of-network services that they had no opportunity to refuse. This article explores how the steady rise of narrow provider network health plans and the often-corresponding lack of transparency regarding which providers are included …

Working Well(Ness): The Impact Of The Ada Final Rule On Wellness Program Regulation And A Proposal For A Zero-Incentive Rule, Stefanie Brody

Saint Louis University Journal of Health Law & Policy

The Equal Employment Opportunity Commission (EEOC) recently amended wellness program regulation under 29 C.F.R. § 1630.14 of the Americans with Disabilities Act (ADA). Amidst criticism of the new rule, this article proposes the EEOC return to a zero-incentive policy for voluntary wellness programs that include disability-related inquiries or medical examinations. First, it reviews existing literature on wellness programs and the ADA, highlighting the legal and ethical challenges facing American workers with disabilities. Then, it explores the latest case law, illustrating the effects of the new rule compared to the proposal. By eliminating the thirty percent incentive limit and redefining “voluntary” …

The Abortion Closet (With A Note On Rules And Standards), David E. Pozen

Faculty Scholarship

An enormous amount of information and insight is packed into Carol Sanger's About Abortion: Terminating Pregnancy in Twenty-First Century America. The book is anchored in post-1973 American case law. Yet it repeatedly incorporates examples and ideas from popular culture, prior historical periods, moral philosophy, feminist theory, medicine, literature and the visual arts, and more.

The Limits Of Reading Law In The Affordable Care Act Cases, Kevin C. Walsh

Law Faculty Publications

One of the most highly lauded legacies of Justice Scalia's decades-long tenure on the Supreme Court was his leadership of a movement to tether statutory interpretation more closely to statutory text. His dissents in the Affordable Care Act cases- National Federation of Independent Business v. Sebelius and King v. Burwell- demonstrate both the nature and the limits of his success in that effort.

These were two legal challenges, one constitutional and the other statutory, that threatened to bring down President Obama's signature legislative achievement, the Patient Protection and Affordable Care Act. Both times the Court swerved away from a direct …

Closets, Standards, Abortion: A Reply To Professor Pozen, Carol Sanger

Faculty Scholarship

I am grateful for David Pozen's thoughtful observations regarding About Abortion. They have sharpened my understanding of how to think about the problem of abortion – or more accurately, about how abortion is kept problematic – as a matter of law and of social practice. I invoke the word "problematic" to describe the cultural setting in which abortion sits: although the procedure is legal, common, and safe, it is often treated as though it were not legal, or barely so; not common, except perhaps for women and girls who have nothing to do with you; and not at all …

Police Contact And Mental Health, Amanda Geller, Jeffrey Fagan, Tom R. Tyler

Faculty Scholarship

Although an effective police presence is widely regarded as critical to public safety, less is known about the effects of police practices on mental health and community wellbeing. Adolescents and young adults in specific neighborhoods of urban areas are likely to experience assertive contemporary police practices. This study goes beyond research on policing effects on legal socialization to assess the effects of police contact on the mental health of those stopped by the police. We collected and analyzed data in a two wave survey of young men in New York City (N=717) clustered in the neighborhoods with the highest rates …

Regulatory Obstacles To Harm Reduction: The Case Of Smoking, Jonathan H. Adler

Faculty Publications

The inability of many smokers to quit is a significant public health problem. The demand for a product that can help smokers kick the habit is an entrepreneurial opportunity. In surveys, a majority of smokers express concern for their health and a desire to kick the habit.

Electronic cigarettes (“e-cigarettes” or “e-cigs”) appear to be the most promising smoking alternative to enter the market to date. E-cigarettes have the potential to satisfy smokers’ craving for nicotine in a less dangerous way. The available evidence suggests e-cigarettes expose smokers (and others) to a fraction of the health risks posed by combustible …

The Process Of Reclaiming Tribal Sovereignty Through Healthcare Autonomy, Karolina A. Serhan

Honors Theses

This honors thesis explores the complex interplay between health status, healthcare, and tribal sovereignty among native communities in the United States. These relationships are explored through analyzing the paradoxical and condescending nature of the Federal Trust Responsibility in relation to government-organized healthcare programs for natives. In establishing this relationship, the thesis goes on to illustrate how native communities have effectively fought to regain sovereignty through reclaiming autonomy of their healthcare systems through the use of the 1975 Indian Self-Determination and Education Assistance Act. The impact of tribal-led healthcare systems is further explored through an in-depth case study conducted regarding the …

A Global Vaccine Injury Compensation System, Sam F. Halabi, Saad B. Ommer

Faculty Publications

Vaccines are extremely safe and harm is rare. Worldwide, more than 30000 vaccine doses are delivered per second through routine immunization programs, which, in turn, prevent an estimated 2 million to 3 million deaths annually. Yet the specter of vaccine injury plays a central role in vaccine access and will continue to do so as vaccine technologies evolve.

Zika, Pregnancy, And The Law, Sam F. Halabi

Faculty Publications

This Essay situates a crucial component of the public health response to Zika - the effort to develop a safe and effective vaccine - within the broader literature. It does so in an effort to highlight the need to revisit the relationship between law and pregnancy - not only in the areas legal scholars have prioritized so far, but also in the context of routine and emergency maternal health, which has heretofore been largely assumed to be governed by straightforward norms and practices based on medical evidence and physician ethics. In fact, whereas the current literature tends to assume or …

Unbefriended And Unrepresented: Better Medical Decision Making For Incapacitated Patients Without Healthcare Surrogates, Thaddeus Pope

Faculty Scholarship

How should we make medical decisions for incapacitated patients who have no available legally-authorized surrogate decision maker? Because these patients lack decision making capacity, they cannot authorize treatment themselves. Because they lack a surrogate, nobody else can authorize treatment either. Clinicians and researchers have referred to these individuals as “adult orphans” or as “unbefriended,” “isolated,” or “unrepresented” patients. Clinicians and researchers have also described them as “unimaginably helpless,” “highly vulnerable,” and as the “most vulnerable,” because “no one cares deeply if they live or die.”

The persistent challenges involved in obtaining consent for medical treatment on behalf of these individuals …

Medical Board Of California, Kayla Watson, J. D. Fellmeth

California Regulatory Law Reporter

No abstract provided.

A Deliberate Departure: Making Physician-Assisted Suicide Comfortable For Vulnerable Patients, Browne C. Lewis

Law Faculty Articles and Essays

This Article is divided into four parts. Part I discusses the history and evolution of the "right to die movement" in the United States. The current legal landscape in the United States is examined in Part II. In Part III, I analyze some of the relevant ethical concerns caused by the availability of physician-assisted suicide. My analysis primarily focuses on the Oregon statutes because it is the oldest physician-assisted suicide law in the United States and has served as a model for laws in the United States and abroad. For example, Lord Falconer's Bill, which was defeated by the British …

Health Law, Public Law, And Social Justice, Sidney D. Watson

Saint Louis University Law Journal

I have taught Health Law for almost three decades. In the early years, the course was primarily about private law, the application of contract and tort principles in the context of health insurance coverage and medical care. Federal law of Medicare, Medicaid, EMTALA, and federal civil rights laws always made an appearance. Other federal statutes were added as they came along: HIPAA, the Americans with Disabilities Act, and GINA. Over the years, the course focused more and more on federal statutes until the passage of the Affordable Care Act (“ACA”) in 2010 completed the transition

Health law is now a …

Remedying Stigma-Driven Health Disparities In Sexual Minorities, Valarie K. Blake

Law Faculty Scholarship

No abstract provided.

Physician Encounters With Human Trafficking: Legal Consequences And Ethical Considerations, Jonathan Todres

Faculty Publications By Year

There is growing recognition and evidence that health care professionals regularly encounter - though they may not identify - victims of human trafficking in a variety of health care settings. Identifying and responding appropriately to trafficking victims or survivors requires not only training in trauma-informed care but also consideration of the legal and ethical issues that arise when serving this vulnerable population. This essay examines three areas of law that are relevant to this case scenario: criminal law, with a focus on conspiracy; service provider regulations, with a focus on mandatory reporting laws; and human rights law. In addition to …

Consumer Financial Protection In Health Care, Erin C. Fuse Brown

Faculty Publications By Year

There are inadequate consumer protections from harmful medical billing practices that result in unavoidable, unexpected, and often financially devastating medical bills. The problem stems from the increasing costs shifting to patients in American health care and the inordinate complexity that makes health care transactions nearly impossible for consumers to navigate. A particularly outrageous example is the phenomenon of surprise medical bills, which refers to unanticipated and involuntary out-of-network bills in emergencies or from out-of-network providers at in-network facilities. Other damaging medical billing practices include the opaque and à la carte nature of medical bills, epitomized by added “facility fees,” as …

The Indirect Consequences Of Expanded Off-Label Promotion, Patricia J. Zettler

Faculty Publications By Year

The U.S. Food and Drug Administration’s (FDA) policies have been a battleground for litigation about First Amendment protections for commercial speech. In the last five years, the FDA’s position that “off-label” promotion of approved prescription drugs—when a manufacturer promotes a drug for a use for which the FDA has not approved it—leads to violations of the Federal Food, Drug, and Cosmetic Act has been subject to successful legal challenges. Although the merits of these off-label promotion decisions are well traversed in the literature, this Article explores the potential indirect consequences of recently-recognized protections for off-label promotion. This Article demonstrates that—as …