Health Law and Policy Commons^™

The Affordable Care Act And Competition: Antidote Or Placebo?, Thomas L. Greaney

All Faculty Scholarship

In the run-up to its enactment, the Patient Protection and Affordable Care Act (ACA) elicited howls of protest from opponents who claimed the federal government was, “taking over,” the American healthcare system, “micromanaging,” medicine, and generally exposing the nation to the bête noire of, “socialized medicine.” Hyperbole, misrepresentation and chauvinism aside, these sound bites suffer from a deeper flaw: They mischaracterize the fundamental thrust of the new law. Though the law establishes significant new regulatory authority, this is neither a new development (indeed it can be faulted for preserving pre-existing regulatory regimes) nor does it impair market competition. To the …

Regulating To Promote Competition In Designing Health Insurance Exchanges, Thomas L. Greaney

All Faculty Scholarship

Many of the most contentious issues in the debate over health reform concerned the performance and competitiveness of private health insurance including abusive and unfair practices such as denying coverage to individuals with pre-existing conditions; the impact of dominant insurers serving individual and small group markets; and purportedly excessive profits of the insurance industry and lavish salaries of their executives. A key component of the Affordable Care Act for implementing and overseeing reforms directed at these problems is the establishment of market-making entities, health insurance exchanges. These state-run entities will certify insurers’ compliance with regulations, monitor their performance, and take …

The Vulnerabilities Of The Patient Protection And Affordable Care Act And The Tragedy Of Repeal, Susan A. Channick

Faculty Scholarship

No abstract provided.

End-Of-Life Decision-Making In Canada: The Report By The Royal Society Of Canada Expert Panel On End-Of-Life Decision-Making, Udo Schuklenk, Johannes J. M. Van Delden, Jocelyn Downie, Sheila Mclean, Ross Upshur, Daniel Marc Weinstock

Reports & Public Policy Documents

This report on end-of-life decision-making in Canada was produced by an international expert panel and commissioned by the Royal Society of Canada. It consists of five chapters: Chapter 1 reviews what is known about end-of-life care and opinions about assisted dying in Canada, Chapter 2 reviews the legal status quo in Canada with regard to various forms of assisted death, Chapter 3 reviews ethical issues pertaining to assisted death. The analysis is grounded in core values central to Canada’s constitutional order, Chapter 4 reviews the experiences had in a number of jurisdictions that have decriminalized or recently reviewed assisted dying …

Four Constitutional Limits That The Minimum Coverage Provision Respects, Neil S. Siegel

Faculty Scholarship

Opponents of the minimum coverage provision in the Affordable Care Act charge that if Congress can require most people to obtain health insurance or pay a certain amount of money, then Congress can impose whatever mandates it wishes - or, at least, whatever purchase mandates it wishes. This Essay refutes that claim by identifying four limits on the Commerce Clause that the minimum coverage provision honors. Congress may not use its commerce power: (1) to regulate noneconomic subject matter; (2) to impose a regulation that violates constitutional rights, including the right to bodily integrity; (3) to regulate at all, including …

Smoking Restrictions In Bars And Bartender Smoking In The Us, Christopher (Kitt) Carpenter, Marianne P. Bitler, Madeline Zavodny

Vanderbilt Law School Faculty Publications

Objective The present work is an analysis of whether adoption of state clean indoor air laws (SCIALs) covering bars reduces the proportion of bartenders who smoke primarily by reducing smoking among people already employed as bartenders when restrictions are adopted or by changing the composition of the bartender workforce with respect to smoking behaviours.

Methods Logistic regressions were estimated for a variety of smoking outcomes, controlling for individual demographic characteristics, state economic characteristics, and state, year, and month fixed effects, using data on 1380 bartenders from the 1992–2007 Tobacco Use Supplement to the Current Population Survey combined with data on …

Defense Of The Constitutionality Of Health Care Reform, Gillian E. Metzger

Faculty Scholarship

Along with the others, I want to thank David for organizing this panel. The great advantage of going last is that the terms of the debate over the Affordable Care Act's constitutionality have been established by the other panelists. As a result, I am going to target my remarks on a few key points, rather than walk through a full dress review of some of the arguments. Like the others, my focus is on existing doctrine. I completely agree with Dean Chemerinsky in thinking that the Supreme Court is not going to change the key parameters of existing analysis, but …

Symposium On Commercial Speech And Public Health, Jonathan H. Adler

Faculty Publications

Does the constitutional protection of commercial speech impair the government's ability to protect and promote public health? Or does the commercial speech doctrine itself enhance consumer education and harness market competition to advance public health? Do First Amendment limitations on regulation of commercial messages unduly retard governmental efforts to safeguard consumers? Or do they properly constrain illiberal paternalism? If the Court has been over-protective of health-related commercial speech, is there a principled place to redraw the line? And how should those governmental agencies entrusted with the power to protect public health and welfare respond to these constitutional constraints?

The editors …

An Institutionalization Effect: The Impact Of Mental Hospitalization And Imprisonment On Homicide In The United States, 1934-2001, Bernard E. Harcourt

Faculty Scholarship

Previous research suggests that mass incarceration in the United States may have contributed to lower rates of violent crime since the 1990s but, surprisingly, finds no evidence of an effect of imprisonment on violent crime prior to 1991. This raises what Steven Levitt has called “a real puzzle.” This study offers the solution to the puzzle: the error in all prior studies is that they focus exclusively on rates of imprisonment, rather than using a measure that combines institutionalization in both prisons and mental hospitals. Using state-level panel-data regressions over the 68-year period from 1934 to 2001 and controlling for …

Electronic Medical Records: A Prescription For Increased Medical Malpractice Liability?, Blake Carter

Vanderbilt Journal of Entertainment & Technology Law

The cost and quality of health care is and most likely will continue to be one of the most important issues that the United States faces in the coming decade. Although no powerful antidote exists to cure this industry of all of its ailments, one potential suggestion to treat some of the symptoms is the introduction of electronic medical records (EMRs).

Members of the medical community, patients, and even politicians all agree that EMRs offer promising opportunities to improve the overall quality of health care. However, lost in the discussion of these opportunities, is a consideration of the potential side …

There Will Be Blood ... Testing: The Intersection Of Professional Sports And The Genetic Information Nondiscrimination Act Of 2008, Jesse A. Bland

Vanderbilt Journal of Entertainment & Technology Law

Genetic testing, professional baseball, and employment discrimination seldom intersect. This Note changes that. Thanks to scientific breakthroughs in genetic research over the past half-century, genetic testing is a powerful tool for producing rich, individualized information. Progress comes at a price, however. As genetic testing has advanced and become more prevalent, so too has the potential misuse of genetic information. A recently enacted federal law--the Genetic Information Nondiscrimination Act of 2008 (GINA)--seeks to eliminate one such threat by prohibiting the improper use of genetic information in employment decisions. While the law gained congressional momentum after tales of abuse in blue-collar industries, …

Happy 65th Birthday: What Now?, Peter J. Strauss

Articles & Chapters

No abstract provided.

A Major Step On Medicaid, Arthur S. Leonard

Other Publications

No abstract provided.

Exceptions: The Criminal Law's Illogical Approach To Hiv-Related Aggravated Assaults, Ari Ezra Waldman

Articles & Chapters

This Article identifies logical and due process errors in HIV-related aggravated assault cases, which usually involve an HIV-positive individual having unprotected sex without disclosing his or her HIV status. While this behavior should not be encouraged, this Article suggests that punishing this conduct through a charge of aggravated assault - which requires a showing that the defendant’s actions were a means likely to cause grievous bodily harm or death - is fraught with fallacies in reasoning and runs afoul of due process. Specifically, some courts use the "rule of thumb" that HIV can possibly be transmitted through bodily fluids as …

Three Statutory Regimes At Impasse: Reverse Payments In Pay-For-Delay Settlement Agreements Between Brand-Name And Generic Drug Companies, Rudolph J.R. Peritz

Articles & Chapters

No abstract provided.

The Patient Protection And Affordable Care Act Of 2010: Rulemaking The Shadow Of Incentive-Based Regulation, Sam F. Halabi

Faculty Publications

While legislators, scholars and mainstream observers are focused on the intense debates surrounding the constitutionality of the Patient Protection and Affordable Care Act’s individual mandate, the Department of Health and Human Services and other agencies are proceeding apace in promulgating rules to implement the law’s other requirements. Congress’s substantial delegation of administrative authority to HHS and other agencies will provide a second key area for constitutional challenges after the U.S. Supreme Court resolves the initial lawsuits based on the individual mandate. Between facial constitutional challenges to the Affordable Care Act and lawsuits based on defects in agency rules or the …

A Cautious Path Forward On Accountable Care Organizations, Barak D. Richman, Kevin A. Schulman

Faculty Scholarship

The wave of new Accountable Care Organizations (ACOs), spurred by financial incentives in the Affordable Care Act, could become the latest chapter in the steady accumulation of market power by hospitals, health care systems, and physician groups. The main purpose behind forming many ACOs may not be to achieve cost savings but instead to strengthen negotiating power over purchasers in the private sector. This would be an unfortunate sequel to the waves of mergers in the 1990s when health care entities sought to counter market pressure from managed care organizations. The possibility that ACOs might further concentrate health care markets …

Refractory Pain, Existential Suffering, And Palliative Care: Releasing An Unbearable Lightness Of Being, George P. Smith Ii

Scholarly Articles

Since the beginning of the hospice movement in 1967, “total pain management” has been the declared goal of hospice care. Palliating the whole person’s physical, psycho-social, and spiritual states or conditions is central to managing the pain which induces suffering. At the end-stage of life, an inextricable component of the ethics of adjusted care requires recognition of a fundamental right to avoid cruel and unusual suffering from terminal illness. This Article urges wider consideration and use of terminal sedation, or sedation until death, as an efficacious palliative treatment and as a reasonable medical procedure in order to safeguard the “right” …

Indonesia’S Refusal To Share Influenza Virus Specimens With The World: Reviving The Arguments For Justice In Influenza Pandemic Preparedness, Meena Krishnamurthy, Matthew Herder

Articles, Book Chapters, & Popular Press

Indonesia’s December 2006 decision to stop sending influenza virus specimens to the World Health Organization’s Global Influenza Surveillance Network (GISN) captured international attention. At the time, the H5N1 subtype of influenza A virus was predicted to be the basis for the next pandemic. While many accused Indonesia - the country most afflicted by the virus - of putting the rest of the world in peril by withholding virus samples, Indonesia maintained that GISN was unjust for failing to ensure equitable access to vaccines developed using those samples. The H5N1 pandemic threat eventually waned, yet international negotiations to create a just …

Restorative Justice, Euthanasia, And Assisted Suicide: A New Arena For Restorative Justice And A New Path For End Of Life Law And Policy In Canada, Jennifer Llewellyn, Jocelyn Downie

Articles, Book Chapters, & Popular Press

This article examines the current Canadian legal approach to euthanasia and assisted suicide, highlights some of the problems with it, and offers a novel alternative to the current traditionally criminalized prohibitive regime. The authors first describe a restorative justice approach and explain the differences between such an approach and the traditional approach currently in use. They then explain how a restorative justice approach could be implemented in the arena of assisted death, acknowledging the potential challenges in implementation. The authors conclude that taking a restorative justice approach to euthanasia and assisted suicide could enable movement in the seemingly intractable public …

Access To Information On Safe Abortion: A Harm Reduction And Human Rights Approach, Joanna Erdman

Articles, Book Chapters, & Popular Press

With convergence-divergence as an organizing theme, this Article explores harm reduction and human rights as conceptual approaches to and discourses about unsafe abortion. The vehicle for this exploration is access to safer-use information on medication abortion, namely women’s self-administration of the drug misoprostol. More specifically, this Article focuses on the Sanitary Initiative Against Unsafe Abortion (“the Uruguay Model”) as an actualized model or prototype of access to information through physician-patient consultation in restrictive legal environments. On convergence, this Article seeks to test the claim that international human rights law imposes government obligations to provide, and to refrain from interfering with …

Are Canadians Providing Advance Directives About Health Care And Research Participation In The Event Of Decisional Incapacity?, Gina Bravo, Marie-France Dubois, Carole Cohen, Sheila Wildeman, Janice Graham, Karen Painter, Suzanne Bellemare

Articles, Book Chapters, & Popular Press

Objective: Advance planning for health care and research participation has been promoted as a mechanism to retain some control over one’s life, and ease substitute decision making, in the event of decisional incapacity. Limited data are available on Canadians’ current advance planning activities. We conducted a postal survey to estimate the frequency with which Canadians communicate their preferences about health care and research should they become incapacitated. Method: We surveyed 5 populations (older adults, informal caregivers, physicians, researchers in aging, and research ethics board members) from Nova Scotia, Ontario, Alberta, and British Columbia. We asked respondents whether they had expressed …

Restorative Justice, Euthanasia, And Assisted Suicide: A New Arena For Restorative Justice And A New Path For End Of Life Law And Policy In Canada, Jennifer Llewellyn, Jocelyn Downie

Articles, Book Chapters, & Popular Press

This article examines the current Canadian legal approach to euthanasia and assisted suicide, highlights some of the problems with it, and offers a novel alternative to the current traditionally criminalized prohibitive regime. The authors first describe a restorative justice approach and explain the differences between such an approach and the traditional approach currently in use. They then explain how a restorative justice approach could be implemented in the arena of assisted death, acknowledging the potential challenges in implementation. The authors conclude that taking a restorative justice approach to euthanasia and assisted suicide could enable movement in the seemingly intractable public …

Confusion Worse Confounded: A Comment On 'Withdrawl Of Clinical Trials Policy By Canadian Research Institute Is A 'Lost Opportunity For Increased Transparency', Jocelyn Downie, Francoise Baylis

Articles, Book Chapters, & Popular Press

According to a recent BMJ article on CIHR's decision to "disappear" its policy on clinical trial registration, "Ian Graham, CIHR's vice president Knowledge Translation and Public Outreach, stated the CIHR policy was removed 'as the overlap [with Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2)] will cause confusion and inconsistent application of the requirements.'"

Ironically, this explanation is itself confusing and inconsistent with previous decisions made by CIHR. There are at least three areas in which CIHR policy/guidelines overlapped with TCPS 2 (registration and results disclosure of trials, research involving Aboriginal People, and research involving human pluripotent …

Reverse Settlements As Patent Invalidity Signals, Gregory Dolin

All Faculty Scholarship

Over the last decade a new type of settlements, commonly referred to as “reversed payment settlements” or simply “reverse settlements,” emerged in litigation over patents covering pharmaceutical products. What differentiates these new settlements from their traditional counterparts is that whereas traditionally, the alleged trespasser on someone else's rights pays the rights-holder to settle the litigation, in these new settlements it is the rights holder that pays the alleged trespasser. These settlements are a direct consequence of the various incentives provided by the Hatch-Waxman Act - an Act designed to increase competition between brand name and generic manufactures of pharmaceutical products. …

Is Ze An American Or A Foreigner? Male Or Female? Ze's Trapped!, Annette De La Torre

Cardozo Journal of Equal Rights & Social Justice

The note argues that the legal and medical frameworks governing the treatment of transgender and transsexual immigrant detainees in U.S. Immigration and Customs Enforcement (ICE) facilities are inadequate, leading to violations of their Eighth Amendment rights. It contends that the legal system's reliance on narrow medical definitions and outdated gender roles fails to protect these detainees from unsafe and inhumane conditions. The analysis emphasizes the need for comprehensive reforms to address housing, medical care, and staff training to ensure dignity and safety for transgender detainees.

Protecting The Right To Choose: Regulating Conscience Clauses In The Face Of Moral Obligation, Huseina Sulaimanee

Cardozo Journal of Equal Rights & Social Justice

No abstract provided.

The Provider-Monopoly Problem In Health Care, Clark C. Havighurst, Barak D. Richman

Faculty Scholarship

Although federal judges have resisted giving due effect to standard antitrust principles in scrutinizing mergers of nonprofit hospitals, the presence of health insurance makes it especially important to oppose monopoly in health services markets. U.S.-style health insurance gives monopolist providers extraordinary pricing freedom, thus exacerbating monopoly’s usual redistributive effects. Significant allocative inefficiencies - albeit not the kind generally associated with monopoly - also result when the monopolist is a nonprofit hospital. Because it is probably impossible to undo past hospital mergers creating undue market power, we suggest some alternative remedies. One is to apply antitrust rules against "tying" arrangements so …

Who Pays? Who Benefits? Unfairness In American Health Care, Clark C. Havighurst, Barak D. Richman

Faculty Scholarship

American-style health insurance greatly amplifies price-gouging opportunities for health care providers, who inflate prices both to enrich themselves and to subsidize and expand the nation’s health care enterprise. To the extent that lower- and middle-income Americans with private health coverage pay premiums that go to support and expand the system, they are subject to an unfair (regressive) “head tax” levied by unaccountable entities for ostensibly public but also private purposes. Lower-income premium payers also often pay for costly health coverage designed to suit the economic interests and values of professional and other elites rather than their own. They also appear …

American Vertigo: Dual Use, Prison Physicians, Research, And Guantanamo, George J. Annas

Faculty Scholarship

Physicians can be used by governments for nonmedical purposes, and physician acceptance of their nonmedical use is usually denoted as "dual loyalty, " although it is more analytically helpful to frame it "dual use. " Dual use of physicians has been on display at Guantanamo where physicians have consistently been used to break hunger strikes as part of the military security mission in ways that directly violate medical ethics. Guantanamo itself has also been seen worldwide as a uniquely horrible prison, which can tell us little about other American prisons. The contrary seems to be true: Guantanamo, and the use …