Health Law and Policy Commons^™

Criminal Laws On Sex Work And Hiv Transmission: Mapping The Laws, Considering The Consequence, Sienna Baskin, Aziza Ahmed, Anna Forbes

Faculty Scholarship

Lawmakers historically justify the mobilization of criminal laws on prostitution and HIV as a means of controlling the spread of disease. Over time, however, public health research has conclusively demonstrated that criminal laws on prostitution and HIV significantly impede the ability of sex workers to access services and to live without the stigma and blame associated with being a transmitter of HIV. In turn, mainstream public health approaches to sex work and HIV emphasize decriminalization as a way to improve the lives of sex workers in need of care, treatment, and services. Our current legal system, which criminalizes both prostitution …

An Assessment Of The Human Subjects Protection Review Process For Exempt Research, Jonathan D. Loe, Alex Winkelman, Christopher Robertson

Faculty Scholarship

Medical and public health research includes surveys, interviews, and biospecimens - techniques that do not present substantial risks to subjects. Consequently, this research is exempt from regulation under the Federal Common Rule. Nevertheless, at many institutions, exempt research is frequently subject to the same regulatory process that is required for non-exempt research, requiring the consumption of time and resources for review by Institutional Review Board members or staff. The federal government has indicated an intention to reform and centralize this system, but has not yet specified the form that it will use instead. By examining the policies of the top …

Law And Politics, An Emerging Epidemic: A Call For Evidence-Based Public Health Law, Michael Ulrich

Faculty Scholarship

As Jacobson v. Massachusetts recognized in 1905, the basis of public health law, and its ability to limit constitutional rights, is the use of scientific data and empirical evidence. Far too often, this important fact is lost. Fear, misinformation, and politics frequently take center stage and drive the implementation of public health law. In the recent Ebola scare, political leaders passed unnecessary and unconstitutional quarantine measures that defied scientific understanding of the disease and caused many to have their rights needlessly constrained. Looking at HIV criminalization and exemptions to childhood vaccine requirements, it becomes clear that the blame cannot be …

Instrumental And Transformative Medical Technologies, Nicole Huberfeld

Faculty Scholarship

This Article considers how medical technologies impact universality in health care. The universality principle, as embodied in the Patient Protection and Affordable Care Act (A CA), eliminated widespread discriminatory practices and provided financial assistance to those otherwise unable to become insured a democratizing federal act that was intended to stabilize health care policy nationwide. This Article posits that medical technology, as with all of medicine, can be universalizing or exclusionary and that this status roughly correlates to its being "instrumental technology" or "transformative technology." Instrumental technology acts as a tool of medicine and often serves an existing aspect of health …

Introduction To Thinking About A Post-Aca World: Litigation, Cost Shifting And Enforcement Of Statutory Rights, Maria O'Brien

Faculty Scholarship

At its annual gathering in 2016, members of the Employee Benefits and Executive Compensation and Law, Medicine and Healthcare Sections of the Association of American Law Schools (AALS) jointly sponsored a discussion of the future of the Affordable Care Act (ACA) following the Supreme Court's decision in King v. Burwell.' What follows are the papers generated for the panel discussion. The panelists² were asked to evaluate the future of the ACA from a distinct perspective.

After Tackett: Incomplete Contracts For Post-Employment Healthcare, Maria O'Brien

Faculty Scholarship

This paper examines the recent U.S. Supreme Court retiree health care decision in Tackett v. M & G Polymers and focuses, in particular, on the ostensibly odd silence with respect to a critical contract term — whether the parties in fact agreed that these benefits were vested. Although the union in Tackett insisted these welfare benefits were clearly intended to vest and the employer now asserts they can be modified at any time, the collective bargaining agreement and supporting documents are ambiguous on this question. This paper examines how and why this “silence” persisted for so many decades and concludes …

Scaling Cost-Sharing To Wages: How Employers Can Reduce Health Spending And Provide Greater Economic Security, Christopher Robertson

Faculty Scholarship

In the employer-sponsored insurance market that covers most Americans many workers are “underinsured.” The evidence shows onerous out-of-pocket payments causing them to forgo needed care, miss work, and fall into bankruptcies and foreclosures. Nonetheless, many higher-paid workers are “overinsured”: the evidence shows that in this domain, surplus insurance stimulates spending and price inflation without improving health. Employers can solve these problems together by scaling cost-sharing to wages. This reform would make insurance better protect against risk and guarantee access to care, while maintaining or even reducing insurance premiums.

Yet, there are legal obstacles to scaled cost-sharing. The group-based nature of …

The Picture Begins To Assert Itself: Rules Of Construction For Essential Health Benefits In Health Insurance Plans Subject To The Affordable Care Act, Wendy K. Mariner

Faculty Scholarship

As the ACA shifts the function of health insurance from voluntary contract to a means of financing health care, it poses some challenges to traditional doctrines for interpreting health plan provisions. This article explores whether and how the doctrine of reasonable expectations and rules of statutory interpretation might apply to Essential Health Benefits coverage. A functional approach linking the two into a doctrine of reasonable statutory expectations could move us toward developing more consistent rules of interpretation within a more realistic conception of contemporary health insurance.

What Will It Take To Address The Global Threat Of Antibiotic Resistance?, Kevin Outterson, Steven J. Hoffman

Faculty Scholarship

Antibiotic resistance is a global threat that may be beyond the capacity of any one country to address. We assess the three primary issues (access, conservation and innovation) and discuss which require higher levels of global coordination.

The Space Between Two Worlds: Forward To The Health Law, Elizabeth Mccuskey

Faculty Scholarship

This year's Law Review Symposium explored the modem state of health law under the heading, From Scalpel to Gavel. By situating its discussion in the space between the health sciences and law, this symposium embodied the inherently interdisciplinary nature of health law. The gathering of scholars, physicians, counsel, enforcers, and community groups bridged the spaces among numerous disciplines, promoting the exchange of empiricism, ideas, and experiences that have come to define health law.

Informed Decision Making On Abortion: Crisis Pregnancy Centers, Clinics, And The First Amendment, Aziza Ahmed

Faculty Scholarship

Shifting laws and regulations increasingly displace the centrality of women's health concerns in the provision of abortion services. This is exemplified by the growing presence of deceptive Crisis Pregnancy Centers alongside new informed consent laws designed to dissuade women from seeking abortions. Litigation on informed consent is further complicated in the clinical context due to the increased mobilization of facts - such as the gestational age or sonogram of the fetus - delivered with the intent to dissuade women from accessing abortion. In other words, factual information utilized for ideological purpose. To preserve a woman's autonomy and decision-making capacity, there …

An Empirical Perspective On Medicaid As Social Insurance, Nicole Huberfeld, Jessica L. Roberts

Faculty Scholarship

This paper is a contribution to the symposium entitled Scalpel to Gavel: Exploring the Modern State of Health Law. This essay quantifies and explores the central role Medicaid now plays in our health insurance system. For its first forty-nine years, Medicaid covered less than half of the nation’s poor. Today, one in five Americans have Medicaid coverage during the course of a year, and that number soon will increase to one in four given the insurance expansions enacted through the Patient Protection and Affordable Care Act. Medicaid now effectively functions as social insurance for many of its enrollees. In this …

Informed Consent And The First Amendment, Wendy K. Mariner, George J. Annas

Faculty Scholarship

For more than two decades, states have been adding to the things that physicians must say and do to obtain “informed consent” — and thereby testing the constitutional limits of states' power to regulate medical practice. In 1992, the Supreme Court upheld states' authority to require physicians to provide truthful information that might encourage a woman to reconsider her decision to have an abortion, finding that such a requirement did not place an “undue burden” on the woman.

Business Model Options For Antibiotics: Learning From Other Industries, Ella Jaczynska, Kevin Outterson, Jorge Mestre-Ferrandiz

Faculty Scholarship

As resistance to antibiotics continues to grow, there is a well-recognized misalignment between the clinical need for new antibiotics and the incentives for their development. The returns from investment in antibiotics research and development (R&D) are perceived as too small. Partly as a result, the number of large multinational companies researching antibiotics has fallen drastically in the past 20 years and few high-quality antibiotics have been developed.

In looking at the antimicrobial resistance (AMR) situation, we were aware that other industries have faced conceptually similar challenges and that they might offer helpful lessons and possible solutions that could be adapted …

Repairing The Broken Market For Antibiotic Innovation, Kevin Outterson, John H. Powers, Gregory W. Daniel, Mark B. Mcclellan

Faculty Scholarship

Multidrug-resistant bacterial diseases pose serious and growing threats to human health. While innovation is important to all areas of health research, it is uniquely important in antibiotics. Resistance destroys the fruit of prior research, making it necessary to constantly innovate to avoid falling back into a pre-antibiotic era. But investment is declining in antibiotics, driven by competition from older antibiotics, the cost and uncertainty of the development process, and limited reimbursement incentives. Good public health practices curb inappropriate antibiotic use, making return on investment challenging in payment systems based on sales volume. We assess the impact of recent initiatives to …

Trafficked? Aids, Criminal Law And The Politics Of Measurement, Aziza Ahmed

Faculty Scholarship

Since early in the HIV epidemic, epidemiologists identified individuals who transact sex as a high-risk group for contracting HIV. Where the issue of transacting sex has been framed as sex work, harm-reduction advocates and scholars call for decriminalization as a primary legal solution to address HIV. Where the issue is defined as trafficking, advocates known as abolitionists argue instead for the criminalization of the purchase of sex.

Global health governance institutions are porous to these competing ideas and ideologies. This article first historicizes the contestation between harm-reduction and abolition in global governance on health. The paper then turns to a …

Challenges For People With Disabilities Within The Health Care Safety Net, Michael Ulrich

Faculty Scholarship

Medicare and Medicaid were passed to serve as safety nets for the country's most vulnerable populations, yet, the disabled community continues to be one whose health care needs are not being met. This group is all too frequently left to suffer health disparities due to cultural incompetency, stigma and misunderstanding, and an inability to create policy changes that covers the population as a whole and their acute and long-term needs.

Will Uncooperative Federalism Survive Nfib?, Abigail Moncrieff, Jonathan Dinerstein

Faculty Scholarship

In October Term 2012, the Supreme Court decided two cases that are fundamentally at odds: NFIB v. Sebelius and Douglas v. Independent Living Center of Southern California. In NFIB, the Court held that the federal government, at least under some circumstances, may not use the threat of reduced funding in cooperative federalism programs to require states to comply with federal statutory requirements. In Douglas, however, the Court indicated that private litigants should sue federal agencies under the Administrative Procedure Act if those agencies refuse to enforce federal statutory requirements against the states. The problem is that the withdrawal of funding …

Should Patient Responsibility For Costs Change The Doctor-Patient Relationship?, Christopher Robertson

Faculty Scholarship

Copays, deductibles, coinsurance, and reference prices all now expose patients to increasingly larger shares of the costs of health care. Extant research on cost sharing has primarily focused on its impact on patients, their health care spending, and their health outcomes. Scholars have paid much less attention to the question of how patient exposure to health care costs may impact physicians and their relationships with their patients. This Essay is given on the occasion of a symposium motivated by two recent books by David Schenck, Larry Churchill, and Joseph Fanning that highlight the relational aspects of health care ethics. Accordingly, …

The Universality Of Medicaid At Fifty, Nicole Huberfeld

Faculty Scholarship

This essay, written for the Yale Law School symposium on The Law of Medicare and Medicaid at 50, explores how the law of Medicaid after the ACA creates a meaningful principle of universalism by shifting from fragmentation and exclusivity to universality and inclusivity. The universality principle provides a new trajectory for all of American health care, one that is not based on individual qualities that are unrelated to medical care but rather grounded in non-judgmental principles of unification and equalization (if not outright solidarity). This essay examines the ACA's legislative reformation, which led to universality, and its quantifiable effects. The …

Nfib V. Sebelius And The Right To Health Care: Government's Obligation To Provide For The Health, Safety, And Welfare Of Its Citizens, Jack M. Beermann

Faculty Scholarship

One of the most important roles government plays in contemporary society is protecting people from unsafe products and environmental conditions. Although the Supreme Court has rejected calls to read the Constitution of the United States to include positive rights, this article’s central claim is that the Supreme Court’s rejection of the Medicaid expansion in the Patient Protection and Affordable Care Act makes sense only if the Constitution is understood as requiring government to provide for the health, safety and welfare of its citizens. It’s not that Chief Justice Roberts intended this implication, but if states did not feel obligated to …

The Impact Of Law On The Right To Water And Adding Normative Change To The Global Agenda, Michael Ulrich

Faculty Scholarship

A resolution was passed at the United Nations Water Conference in 1977 to achieve universal access to sufficient water by 1990. This bar was lowered significantly as part of the Millennium Development Goals (MDGs). However, as the MDGs come to an end this year, even this reduced benchmark will not be reached. Water is inescapably intertwined with every other MDG, as well as the ability to exercise any human right. Consequently, the failure to achieve this goal implores an exploration of its causes. As the global community embarks on setting a new post-MDG agenda, one currently overlooked aspect is the …

Heterogeneity In Irb Policies With Regard To Disclosures About Payment For Participation In Recruitment Materials, Megan S. Wright, Christopher Robertson

Faculty Scholarship

Scholars have documented variation in the way local Institutional Review Boards differently adjudicate identical research proposals. It is unclear whether such heterogeneity is due to variation in positive policies, or variation in human processes of interpretation and enforcement. A particularly interesting question relates to whether investigators are allowed to provide truthful information about research opportunities to potential participants, which some IRBs seem to forbid. We investigated local IRB policies on disclosing the amount of compensation in recruitment materials by conducting a census of the top 100 institutions by receipt of NIH funding in 2012. We downloaded the relevant policies and …

A Randomized Experiment Of The Split Benefit Health Insurance Reform To Reduce High-Cost, Low-Value Consumption, Christopher Robertson, David V. Yokum, Nimish Sheth, Keith A. Joiner

Faculty Scholarship

Traditional cost sharing for health care is stymied by limited patient wealth. The “split benefit” is a new way to reduce consumption of high-cost, low-value treatments for which the risk/benefit ratio is uncertain. When a physician prescribes a costly unproven procedure, the insurer could pay a portion of the benefit directly to the patient, creating a decision opportunity for the patient. The insurer saves the remainder, unless the patient consumes. In this paper, a vignette-based randomized controlled experiment with 1,800 respondents sought to test the potential efficacy of the split benefit. The intervention reduced the odds of consumption by about …

Paternalism, Public Health, And Behavioral Economics: A Problematic Combination, Wendy K. Mariner

Faculty Scholarship

Some critiques of public health regulations assume that measures directed at industry should be considered paternalistic whenever they limit any consumer choices. Given the presumption against paternalistic measures, this conception of paternalism puts government proposals to regulate industry to the same stringent proof as clearly paternalist proposals to directly regulate individuals for their own benefit. The result is to discourage regulating industry in ways that protect the public from harm and instead to encourage regulating individuals for their own good -- quite the opposite of what one would expect from a rejection of paternalism. Arguments favoring "soft paternalism" to justify …

Crowdsourcing Public Health Experiments: A Response To Jonathan Darrow's Crowdsourcing Clinical Trials, Ameet Sarpatwari, Christopher Robertson, David Yokum, Keith Joiner

Faculty Scholarship

We are pleased to have this opportunity to respond to Jonathan Darrow's article, Crowdsourcing Clinical Trials (CCT).' We seek to highlight its important contributions and to commence debate over some of its arguments. In particular, we qualify the ethical arguments that characterize early clinical use of drugs as if they were research, and suggest instead that, in either domain, the ethical (and legal) analysis should remain focused on whether all material information is provided so patients may make informed decisions. We also highlight the limits of what can be gleaned from the observational data collection efforts envisioned by CCT.

Ultimately, …

Analytical Framework For Examining The Value Of Antibacterial Products, Kevin Outterson, Aylin Sertkaya, John T. Eyraud, Anna Birkenback, Calvin Franz, Nyssa Ackerley, Valerie Overton

Faculty Scholarship

Antibacterial resistance is a growing global problem. According to the most recent statistics from the Centers for Disease Control and Prevention (CDC), at least 2 million people acquire serious infections with bacteria that are resistant to one or more of antibacterial drugs designed to treat those infections in the United States alone. Of these, approximately 23,000 die as a result of drug-resistant infections. Even though estimates vary widely, the economic cost of antibacterial resistance in the United States could be as high as $20 billion and $35 billion a year in excess direct healthcare costs and lost productivity costs, respectively …

The Drug Quality And Security Act - Mind The Gaps, Kevin Outterson

Faculty Scholarship

After the compounding pharmacy disaster at New England Compounding Center, Congress had an opportunity to assure that all compounded medicines were safe and effective. The Drug Quality and Safety Act, despite its name, fell short of that mark.

Ahla Health Law Curriculum Manual, Kevin Outterson

Books

Despite being a significant segment of the economy, the discipline of health law is relatively new. This is particularly evident in many law schools where health law is still not represented by a full-time faculty member. Some of these schools either do not teach any courses in the area or rely primarily on adjuncts. For those unfamiliar with the discipline, it can be difficult to understand its content and breadth, which becomes a particular challenge to faculties that want to hire a health law professor for the first time, or for academic deans attempting to identify appropriately qualified adjuncts. Meanwhile, …

Allocating Responsibility For Health Care Decisions Under The United States Affordable Care Act, Wendy K. Mariner

Faculty Scholarship

This article summarizes the major elements of the ACA's insurance reforms and how they affect responsibility for making decisions about the health care that people receive. A key example of the difficulty of allocating decision making responsibility is the effort to define a minimum benefit package for insurance plans, called essential health benefits. While the ACA should achieve its goal of near-universal access to care, it leaves in place a multiplicity of processes and decision-makers for determining individual treatment. As a result, decisions about what care is provided are likely to remain, much as they are today, divided among government …