Health Law and Policy Commons^™

Ideology Meets Reality: What Works And What Doesn't In Patient Exposure To Health Care Costs, Victor Laurion, Christopher Robertson

Faculty Scholarship

U.S. policymakers, scholars, and advocates have long displayed an ideological commitment to exposing insured patients to substantial out-of-pocket expenses. These commitments derive from both overt political ideologies, which favor individual responsibility and oppose redistribution of wealth and risks, as well as more-subtle ideological commitments of academic economists, which link observed patterns of consumption to value-claims about welfare. In this symposium contribution, we document those ideological commitments and juxtapose them with a review of the scientific evidence about the actual effects of patient cost-sharing. We find, as economic theory predicts, that patients exposed to healthcare costs consume less healthcare. However, a …

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 …

Women’S Human Rights And Migration: Sex Selective Abortion Laws In The United States And India, Aziza Ahmed

Faculty Scholarship

In her compelling new book, Women's Human Rights and Migration, Sital Kalantry challenges the idea that a women's human rights framework offers a consistent and universal way to address complicated gender issues across countries. She is primarily concerned with the lives of migrant women in countries that respond to their social and cultural practices with harsh regulations designed to bring them in line with dominant ideas about gender equality. Kalantry focuses in on two issues in particular: sex-selective abortion and the veil as worn by Muslim women. Kalantry insightfully identifies a primary problem with these types of laws and …

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

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 …

Understanding The Failure Of Health-Care Exceptionalism In The Supreme Court's Obamacare Decision, Abigail Moncrieff

Faculty Scholarship

On June 28, 2012, a mere century after the first presidential proposal for national health insurance, the Supreme Court issued a resounding victory for President Obama and for health-care reform generally, upholding the Patient Protection and Affordable Care Act against a serious constitutional challenge. Nevertheless, the Court also struck a potential blow to future health-care reform efforts. A majority of the Court refused to accept the Solicitor General’s argument that health care is a unique market with unique regulatory needs that justify special constitutional treatment. The failure of health-care exceptionalism in the Court’s opinion might render future reform efforts more …

(Public) Health And Human Rights: Of Bridges And Matrixes, George J. Annas

Faculty Scholarship

Responding to President Trump's anti-Muslim executive order restricting immigration, the American Public Health Association (APHA) issued a press release recommitting the organization to human rights, noting that "health and human rights are inextricably linked." The organization underlined the basic human rights norm of nondiscrimination, noting that "all people should be valued equally, no matter their race, gender, sexual orientation, religion, immigration status, income or geographic region" and that whenever any groups of people are prevented from "experiencing basic human rights, all of our communities suffer" (APHA 2017). Human rights, especially the right to health, have also been at the core …

Frozen Ethics: Melting The Boundaries Between Medical Treatment And Organ Procurement, George J. Annas, Michael A. Grodin

Faculty Scholarship

When Renee Fox, medical sociologist and noted historian of organ transplantation, first learned of the proposal to use "non-heart-beating cadavers" as organ sources more than 25 years ago, she was appalled. She labeled the proposal "the most elaborately macabre scheme for obtaining organs that I have encountered," adding that "it borders on ghoulishness." She saw the procedure as "beyond the pale of the medically decent, morally allowable, and spiritually acceptable" (Fox 1993, 232). But medically decent has seldom gotten in the way of procuring organs for transplant, and we now seem to be on the verge of adopting an "uncontrolled" …

Informed Consent: Charade Or Choice, George J. Annas

Faculty Scholarship

The physicians of ancient Greece valued conversation with their patients. Conversation, however, did not apply to slaves, whose minds and opinions did not matter. More than 2000 years later, slavery has been abolished and the law has joined ethics in setting standards for the doctor-patient relationship. The most important doctrine, in both medical ethics and health law, is the doctrine of informed consent (better termed "informed choice"), including its corollary, the right to refuse treatment. Today this doctrine is under attack. The attack is direct from business models that see genuine doctor-patient conversations as inefficient (and a waste of time), …

Agency Imprimatur & Health Reform Preemption, Elizabeth Mccuskey

Faculty Scholarship

At this moment, there exists nearly unanimous agreement that the American health care system requires reform, but also vehement disagreements over what form regulation should take and who should be in charge of regulating—state or federal authorities. Preemption doctrine typically referees disputes between federal and state regulatory efforts, but it also exacerbates them. There exists nearly as unanimous opinion that preemption doctrine in health law is a mess. This Article identifies an inventive structure that may help defuse some preemption problems in health reform.

The Affordable Care Act’s (ACA) individual and employer mandates, health insurance exchanges, and insurance coverage standards …

Decreasing Smoking But Increasing Stigma? Anti-Tobacco Campaigns, Public Health, And Cancer Care, Kristen E. Riley, Michael Ulrich, Heidi A. Hamann, Jamie S. Ostroff

Faculty Scholarship

Public health researchers, mental health clinicians, philosophers, and medical ethicists have questioned whether the public health benefits of large-scale anti-tobacco campaigns are justified in light of the potential for exacerbating stigma toward patients diagnosed with lung cancer. Although there is strong evidence for the public health benefits of antitobacco campaigns, there is a growing appreciation for the need to better attend to the unintended consequence of lung cancer stigma. We argue that there is an ethical burden for creators of public health campaigns to consider lung cancer stigma in the development and dissemination of hard-hitting anti-tobacco campaigns. We also contend …

Patenting Frankenstein's Monster: Exploring The Patentability Of Artificial Organ Systems And Methodologies, Jordana Goodman

Faculty Scholarship

The conception of Frankenstein’s monster bridges the ever-narrowing divide between man and machine. Long before Congress codified Section 33(a) of the America Invents Act (“AIA”), Mary Shelley’s vague description of the monster’s creation has left people wondering: what defines a human organism? Through an analysis of patent law and scientific progress in the development of artificial organ systems, this paper explores the boundaries of patentable subject matter in the United States and attempts to clarify Congress’s determination that “no patent may issue on a claim directed to or encompassing a human organism.” Though patent law should incentivize development of artificial …

Teaching The Law Of American Health Care, Elizabeth Weeks, Nicole Huberfeld, Kevin Outterson

Faculty Scholarship

In writing our casebook, The Law of American Health Care, we started from scratch, rethinking the topics to include and themes around which to organize them. Like many health law professors, we were schooled in and continued to propound the traditional themes of cost, quality, access, and choice. While those concerns certainly pervade many areas of health care law, our casebook's overarching themes emphasize different issues, namely: federalism, individual rights, fiduciary relationships, the modem administrative state, and market regulation. These new themes, we believe, better capture the range of issues and topics essential forthe new generation of health lawyers. When …

Recognizing Women's Rights At Work: Health And Women Workers In Global Supply Chains, Erika R. George, Candace D. Gibson, Rebecca Sewall, David Wofford

Faculty Scholarship

The Guiding Principles mandate that businesses respect the human fights enshrined in the International Bill of Human Rights and in the International Labour Organization (ILO)'s Declaration on Fundamental Principles and Rights at Work. Due diligence processes and risk impact assessments are the main recommended means for ensuring compliance with companies' commitments to respect international human fights. Because OSH as a conceptual framework and regulatory order is not sufficient to identify the risk of health fights violations to women workers, we argue companies should not anchor their due diligence and risk assessment in OSH conventions and settle for a check-the-box solution …

Nfib V. Sebelius At 5, Nicole Huberfeld

Faculty Scholarship

Keeping up with health care reform is like running up a mountain of sand - every time you reach the top, -the terrain starts shifting. In this talk, I offer a snapshot of where we are in implementing the Patient Protection and Affordable Care Act ("ACA") to aid in understanding the significance of NFIB v. Sebelius' at five. I will situate the ACA2 within historical patterns in American health care reform. I have been asked to discuss the key points of the NFIB decision, after which I will share some of the research that I have performed for the past …

Abortion In A Post-Truth Moment: A Response To Erwin Chemerinsky And Michele Goodwin, Aziza Ahmed

Faculty Scholarship

In Abortion: A Woman’s Private Choice, Erwin Chemerinsky and Michele Goodwin respond to the crisis of abortion rights in our current political moment. While preserving the right to abortion is an ongoing challenge for reproductive-justice advocates and lawyers, the arrival of a new Republican administration led by Donald Trump and a Republican majority in the House and Senate heightens these concerns. In the face of ongoing and new threats to abortion access, Chemerinsky and Goodwin argue that abortion should be treated as a woman’s private choice. I agree with Chemerinsky and Goodwin, as all supporters of abortion rights should. …

Guardianship And Clinical Research Participation: The Case Of Wards With Disorders Of Consciousness, Megan S. Wright, Michael Ulrich, Joseph J. Fins

Faculty Scholarship

We review relevant federal law about research on human subjects and state laws on guardian authority to determine whether guardians can consent on behalf of their wards to participation in research. The Common Rule is silent on the issue as are most state guardianship laws. Our analysis shows significant variation in guardians’ decision-making authority in the states that do regulate wards’ participation in research. We consider how the appointment of guardians for patients with disorders of consciousness (DOC) impacts such patients’ access to research. We assert that it is important that such persons be permitted to participate in research, so …

Regulating Off-Label Promotion — A Critical Test, Christopher Robertson, Aaron S. Kesselheim

Faculty Scholarship

In 2012, the U.S. Court of Appeals for the Second Circuit handed down a landmark decision in the case of pharmaceutical sales representative Alfred Caronia. The Food and Drug Administration (FDA) had approved sodium oxybate (Xyrem) for treating narcolepsy, but Caronia promoted it for a wide range of nonapproved (off-label) indications, including insomnia, Parkinson’s disease, and fibromyalgia. Off-label use is common, especially in specialties such as oncology, in which it may even be considered the standard of care. However, surveys have revealed that supporting evidence is lacking for a majority of off-label uses of medical products.1 The uses Caronia …

Body Of Preemption: Health Law Traditions And The Presumption Against Preemption, Elizabeth Mccuskey

Faculty Scholarship

Preemption plays a prominent role in health law, establishing the contours of coexistence for federal and state regulatory authorities over health topics as varied as medical malpractice, insurance coverage, drug safety, and privacy. When courts adjudicate crucial preemption questions, they must divine Congress's intent by applying substantive canons of statutory interpretation, including presumptions against preemption.

This Article makes three main contributions to health law and preemption doctrine. First, it identifies a variant of the presumption against preemption that applies to health laws-referred to throughout as the "tradition presumption." Unlike the general presumption against preemption on federalism grounds, courts base this …

Delinking Investment In Antibiotic Research And Development From Sales Revenues: The Challenges Of Transforming A Promising Idea Into Reality, Kevin Outterson, Unni Gopinathan, Charles Clift, Anthony So, Chantal Morel, John-Arne Røttingen

Faculty Scholarship

1. The current business model for antibiotics is plagued by market failures and perverse incentives that both work against conservation efforts and provide insufficient rewards to drive the development of much-needed new treatments for resistant infection.

2. Many new incentive mechanisms have been proposed to realign incentives and support innovation and conservation over the long term. The most promising of these are based on the idea of delinking rewards from sales volume of the antibiotic — the notion of “delinkage.”

3. Some critical design issues for delinkage remain, such as how to secure access to badly needed new products when …

Funding Antibiotic Innovation With Vouchers: Recommendations On How To Strengthen A Flawed Incentive Policy, Kevin Outterson, Anthony Mcdonnell

Faculty Scholarship

A serious need to spur antibiotic innovation has arisen because of the lack of antibiotics to combat certain conditions and the overuse of other antibiotics leading to greater antibiotic resistance. In response to this need, proposals have been made to Congress to fund antibiotic research through a voucher program for new antibiotics, which would delay generic entry for any drug, even potential blockbuster lifesaving generics. We find this proposal to be inefficient, in part because of the mismatch between the private value of the voucher and the public value of the antibiotic innovation. However, vouchers have the political advantage in …

Ebola And Human Rights: Post-9/11 Public Health And Safety In Epidemics, George J. Annas

Faculty Scholarship

In public health practice, the concepts of health and safety are often conflated. However, protecting and promoting health is radically different from protecting and promoting safety. Since 9/11, the distinctions between health and safety have changed and are in the process of merging. In our terrorism-obsessed world, public health has been increasingly militarized and enlisted, often without protest, into the service of protecting the safety of the public and the security of the nation. But safety and security are the proper purposes of law enforcement and the military, not of public health. More importantly, using public health to combat terrorism …

Progress In The Fight Against Multidrug Resistant Bacteria?: A Review Of Fda-Approved Antibiotics 2010-2015, Dalia Deak, Kevin Outterson, John H. Powers, Aaron S. Kesselheim

Faculty Scholarship

A weak antibiotic pipeline and the increase in drug-resistant pathogens have led to calls for more new antibiotics. Eight new antibiotics were approved by the U.S. Food and Drug Administration (FDA) between January 2010 and December 2015: ceftaroline, fidaxomicin, bedaquiline, dalbavancin, tedizolid, oritavancin, ceftolozane-tazobactam, and ceftazidime-avibactam. This study evaluates the development course and pivotal trials of these antibiotics for their innovativeness, development process, documented patient outcomes, and cost. Data sources were FDA approval packages and databases (January 2010 to December 2015); the Red Book (Truven Health Analytics); Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (FDA); and supplementary information …

Vaccines And Airline Travel: A Federal Role To Protect The Public Health, Christopher Robertson

Faculty Scholarship

This Article explores two ways in which airline travel is an important vector for the spread of infectious disease, and argues that airlines have market-based and liability-based reasons to require that passengers be vaccinated. Going further, the Article explores whether the federal government has the legal and constitutional authority — especially under the Commerce Clause — to encourage or mandate that airlines implement such a vaccine screen. By disrupting the spread of disease at key network nodes where individuals interact and then connect with other geographic regions, and by creating another incentive for adult vaccination, an airline vaccine screen could …

Antibiotic Reimbursement In A Model Delinked From Sales: A Benchmark-Based Worldwide Approach, John H. Rex, Kevin Outterson

Faculty Scholarship

Despite the life-saving ability of antibiotics and their importance as a key enabler of all of modern health care, their effectiveness is now threatened by a rising tide of resistance. Unfortunately, the antibiotic pipeline does not match health needs because of challenges in discovery and development, as well as the poor economics of antibiotics. Discovery and development are being addressed by a range of public-private partnerships; however, correcting the poor economics of antibiotics will need an overhaul of the present business model on a worldwide scale. Discussions are now converging on delinking reward from antibiotic sales through prizes, milestone payments, …

An International Legal Framework To Address Antimicrobial Resistance, Steven J. Hoffman, Kevin Outterson, John-Arne Rottingen, Otto Cars, Charles Clift, Zain Rizvi, Fiona Rotberg, Göran Tomson, Anna Zorzet

Faculty Scholarship

Antimicrobial resistance is a growing threat to global health. Currently it accounts for approximately 700,000 deaths annually, but is predicted to cause as many as 10,000,000 deaths by 2050 if nothing is done to address it. To effectively deal with this problem three areas must be addressed simultaneously: access, conservation, and innovation. However, solving issues of access, conservation and innovation at the same time requires new coordination and financing mechanisms, some of which must be organized globally. This bulletin outlines the possible role that a binding international legal framework can play in the fight against antimicrobial resistance.

Reconsidering Constitutional Protection For Health Information Privacy, Wendy K. Mariner

Faculty Scholarship

What kinds of health information should be reported to government for civil purposes? Several competing trends encourage efforts to reassess the scope of constitutional protection for health information: the social and commercial value of health information; the amount of data held by third parties, from health care providers to internet servers; critiques of the third party doctrine exception to Fourth Amendment protection; and concerns about the loss of privacy. This article describes a variety of civil purposes for which health information is collected today. A close analysis of cases applying the third party doctrine, administrative search principles, and the special …

Health Care And The Myth Of Self-Reliance, Nicole Huberfeld, Jessica L. Roberts

Faculty Scholarship

Both pillars of the Affordable Care Act that are designed to facilitate universal coverage — the low-income tax subsidy and Medicaid expansion — have been subject to high-profile Supreme Court cases. While in King v. Burwell the Court saved the ACA’s low-income subsidy, in NFIB v. Sebelius the Court frustrated Medicaid expansion, at least temporarily. We argue that there is a deeper story about health care access for the poor. Drawing from the history of the American health care system, vulnerability theory, and demographic data, we demonstrate that all Americans lead subsidized lives and could find themselves quickly moving from …

Beyond Lifestyle: Governing The Social Determinants Of Health, Wendy K. Mariner

Faculty Scholarship

Non-communicable and chronic diseases have overtaken infectious diseases as the major causes of death and disability around the world. Despite recognition that reduction in the chronic disease burden will require governance systems to address the social determinants of health, most public health recommendations emphasize individual behavior as the primary cause of illness and the target of intervention. This Article argues that focusing on lifestyle can backfire, by increasing health inequities and inviting human rights violations. If States fail to take meaningful steps to alter the social and economic structures that create health risks and encourage unhealthy behavior, health at the …

International Cooperation To Improve Access To And Sustain Effectiveness Of Antimicrobials, Christine Årdal, Kevin Outterson, Steven Hoffman, Abdul Ghafur, Mike Sharland, Nisha Ranganathan, Richard Smith, Anna Zorzet, Jennifer Cohn, Didier Pittet, Nils Daulaire, Chantal Morel, Zain Rizvi, Manica Balasegaram, Osman Dar, David Heymann, Alison Holmes, Luke Moore, Ramanan Laxminarayan, Marc Mendelson, John-Arne Røttingen

Faculty Scholarship

Securing access to effective antimicrobials is one of the greatest challenges today. Until now, efforts to address this issue have been isolated and uncoordinated, with little focus on sustainable and international solutions. Global collective action is necessary to improve access to life-saving antimicrobials, conserving them, and ensuring continued innovation. Access, conservation, and innovation are beneficial when achieved independently, but much more effective and sustainable if implemented in concert within and across countries. WHO alone will not be able to drive these actions. It will require a multisector response (including the health, agriculture, and veterinary sectors), global coordination, and financing mechanisms …

Adjudicating Risk: Aids, Crime, And Culpability, Aziza Ahmed

Faculty Scholarship

The AIDS epidemic continues to pose significant public health challenges, especially given that the spread of the virus outpaces the AIDS response.¹ Importantly, HIV continues to disproportionately impact socially and economically marginalized communities. In countries with concentrated epidemics,² it is racial minorities, sex workers, men who have sex with men, and drug users who face the brunt of the epidemic.³ In the United States, the data is startling⁴ : 44% of new infections were among African-Americans, and among African-Americans contracting HIV, 57% were among gay and bisexual men.⁵ In 2016, the CDC found that one …