Health Law and Policy Commons^™

The Inclusion Of Pregnant Women In Clinical Research, Barbara A. Noah

Faculty Scholarship

In the past three decades, there has been unprecedented growth in medical research utilizing human subjects, with much promise for new treatments that extend life, improve quality of life, and prevent disease and disability. Safe prescribing of drug therapies requires that researchers design clinical trials to test products for the benefit of all persons who are likely to utilize them, not just a limited population. For this reason, it is essential that clinical trials include women, pregnant women, children, and racial minorities, as appropriate, because these populations sometimes exhibit different patterns of response or adverse reactions.

Despite some significant progress …

Aggressive Policing And The Mental Health Of Young Urban Men, Amanda Geller, Jeffrey Fagan, Tom Tyler, Bruce Link

Faculty Scholarship

Objectives: We provide the first population-based analysis of the health implications of contemporary policing. Many cities have adopted “proactive” policing models, which engage citizens – often aggressively – at low levels of suspicion. We survey young men on their experiences of police encounters and subsequent mental health. Methods: We conducted a population-based phone survey of 1,261 young men in New York City. Respondents reported how many times they were approached by New York Police Department (NYPD) officers, what these encounters entailed, any trauma they attributed to the stops, and their overall anxiety. Data were analyzed using cross-sectional regression. Results: Respondents …

The Mirror Image Of Asylums And Prisons, Sacha Raoult, Bernard E. Harcourt

Faculty Scholarship

This article analyzes trends in prison rates and mental hospital rates in France since the earliest available statistics. It shows that, on almost two centuries of data and amidst an agitated political history, every asylum trend in France is "countered" by an inverse prison trend, and vice-versa. Both trends are like a mirror image of each other. We reflect on the possible explanations for this intriguing fact and show that the most obvious ones (a population transfer or a building transfer) are not able to account for most of the relationship. After these explanations have been dismissed, we are left …

Comment On The Definition Of "Eligible Organization" For Purposes Of Coverage Of Certain Preventive Services Under The Affordable Care Act, Robert P. Bartlett, Richard M. Buxbaum, Stavros Gadinis, Justin Mccrary, Stephen Davidoff Solomon, Eric L. Talley

Faculty Scholarship

This comment letter was submitted by U.C. Berkeley corporate law professors in response to a request for comment by the Health and Human Services Department on the definition of "eligible organization" under the Affordable Care Act in light of the Supreme Court's decision in Burwell v. Hobby Lobby. "Eligible organizations" will be permitted under the Hobby Lobby decision to assert the religious principles of their shareholders to exempt themselves from the Affordable Care Act's contraceptive mandate for employees.

In Hobby Lobby, the Supreme Court held that the nexus of identity between several closely-held, for-profit corporations and their shareholders holding “a …

"Keep Government Out Of My Medicare": The Search For Popular Support Of Taxes And Social Spending, Gillian Lester

Faculty Scholarship

Despite the broad reach of the American welfare state, Americans continue to have conflicted and contradictory attitudes about the role of the state in mediating economic equality through both taxation and social spending. This chapter identifies several key themes that help explain these contradictions. Specifically, information about taxes and spending is complex and hard to understand, cognitive biases and limitations hamper people’s ability to process information in a way that is always consistent, and affective and symbolic factors influence social attitudes about taxes and government benefits. This chapter explores the implications of these insights for public policy, including the possibility …

On The Uneasy Relationship Between Medicaid And Charity Care, Laura D. Hermer, Merle Lenihan

Faculty Scholarship

Medicaid and charity care have a lengthy relationship fraught with complications. These complications will remain and in some respects become even more acute following the implementation of the Patient Protection and Affordable Care Act.

This article focuses on the uneasy relationship between Medicaid and charity care, one that becomes particularly acute in the context of Medicaid reimbursement. It traces the lineage of Medicaid in charity, and uses Medicaid reimbursement and supplemental payments as lenses through which to examine the relationship between Medicaid and charity care. The tension that we uncover will need to be resolved if Medicaid is to come …

The Burden Of Deciding For Yourself: The Disutility Caused By Out-Of-Pocket Healthcare Spending, Christopher Robertson, David Yokum

Faculty Scholarship

As part of a larger "consumer-directed healthcare movement," cost-sharing mechanisms, such as copays and deductibles, cause patients to pay out of pocket for a portion of the costs of the healthcare they consume. Cost sharing is intended to reduce costs by changing consumption behavior, and it has been shown to be an effective though incomplete solution to the problem of unsustainable cost growth. It is controversial nonetheless. This Essay distinguishes three different normative problems with cost sharing (including underinsurance, deterrence of high-value care, and a tax on sickness), which can all be fixed through more precision in the design of …

The Presumption Against Expensive Health Care Consumption, Christopher Robertson

Faculty Scholarship

This essay, as part of a symposium in honor of Professor Einer Elhauge, starts with his recognition that, for both epistemic and normative reasons, it remains profoundly difficult to regulate particular uses of medical technologies on the basis of their cost-benefit ratios. Nonetheless, this essay argues in favor of a general regulatory presumption against consumption for the most expensive medical technology usages, which drive most of aggregate healthcare spending. This essay synthesizes twelve facts about the ways in which medical technologies are produced, regulated, studied, and consumed to suggest that it is quite unlikely that the most expensive usages of …

Money, Sex, And Religion – The Supreme Court's Aca Sequel, George J. Annas, Theodore W. Ruger, Jennifer Prah Ruger

Faculty Scholarship

The Supreme Court decision in the Hobby Lobby case is in many ways a sequel to the Court's 2012 decision on the constitutionality of the Affordable Care Act (ACA). The majority decision, written by Justice Samuel Alito, is a setback for both the ACA's foundational goal of access to universal health care and for women's health care specifically. The Court's ruling can be viewed as a direct consequence of our fragmented health care system, in which fundamental duties are incrementally delegated and imposed on a range of public and private actors. Our incremental, fragmented, and incomplete health insurance system means …

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 …

Hiv, Violence Against Women, And Criminal Law Interventions, Aziza Ahmed

Faculty Scholarship

The growing calls for the “securitization of body and property,”[ii] documented by Jonathan Simon in his book Governing Through Crime, illustrates a deep tension in our understanding of the role of criminal law as a tool for societal transformation.[iii] For some, including communities of color, the criminal legal system is a place where inequality flourishes;[iv] for others, including those feminists who have support criminal law interventions, it has become a tool to realize equality.[v] The Trafficking Victims Protection Act, reauthorized in 2013 as an amendment to the Violence Against Women Act (VAWA),[vi] relies heavily on the criminal law to obtain …

Hiv Infrastructure Study Columbia, Sc, Susan S. Reif, Elena Wilson, Carolyn Mcallaster

Faculty Scholarship

No abstract provided.

Rationalizing Home And Community-Based Services Under Medicaid, Laura Hermer

Faculty Scholarship

This article examines efforts states are making to expand access to community-based services for elderly and disabled Medicaid beneficiaries and suggests several options that might improve such access nationally. Like much of Medicaid, Medicaid long term services and supports (LTSS) have developed through a complex process of accretion. Policymakers appear only rarely to have considered an overarching view of such services and the needs of those who require them. Rationalizing Medicaid LTSS will accordingly require not only additions but also substantial pruning, and may even warrant a reconsideration of who should have ultimate authority to develop and direct such services. …

Redescribing Health Privacy: The Importance Of Information Policy, Frank Pasquale

Faculty Scholarship

No abstract provided.

The Hidden Costs Of Health Care Cost-Cutting: Toward A Postneoliberal Health-Reform Agenda, Frank Pasquale

Faculty Scholarship

No abstract provided.

Health Insurance Is Dead; Long Live Health Insurance, Wendy K. Mariner

Faculty Scholarship

Today, health insurance is no longer simply a class of insurance that covers risks to health, and it has not been so for many years. Health insurance has become a unique form of insurance — a mechanism to pay for healthcare that uses risk spreading as one of several pricing methods. The Affordable Care Act builds on this important payment function to create a complex social insurance system to finance healthcare for (almost) everyone. This article examines how the ACA draws on various conceptions of insurance to produce a quasi-social insurance system. This system poses new challenges to laws governing …

A Role For Law In Preparing For Death, Barbara A. Noah

Faculty Scholarship

This Article discusses the limits of how end of life law can address threats to patient autonomy. The reluctance of physicians, patients and family to discuss end of life matters and to confront the certainty of death, together with a culture that actively denies the aging process itself, interferes with a patient’s ability to exercise choice as death approaches. Thus, patients often suffer needlessly from the continuation of treatments and life-supportive measures that they would choose to decline if better informed about their choices and the importance of choosing. Advance directives, as a legal mechanism, often fail fully to protect …

Hiv Infrastructure Study Baton Rouge, Susan S. Reif, Elena Wilson, Carolyn Mcallaster, Casteel Scherger

Faculty Scholarship

No abstract provided.

Beyond Title Vii: Rethinking Race, Ex-Offender Status, And Employment Discrimination In The Information Age, Kimani Paul-Emile

Faculty Scholarship

More than sixty-five million people in the United States—more than one in four adults—have had some involvement with the criminal justice system that will appear on a criminal history report. A rapidly expanding, for-profit industry has developed to collect these records and compile them into electronic databases, offering employers an inexpensive and readily accessible means of screening prospective employees. Nine out of ten employers now inquire into the criminal history of job candidates, systematically denying individuals with a criminal record any opportunity to gain work experience or build their job qualifications. This is so despite the fact that many individuals …

Medicaid Expansion As Completion Of The Great Society, Nicole Huberfeld, Jessica L. Roberts

Faculty Scholarship

A state’s decision whether to expand Medicaid has become a highly politicized issue, spawning countless news stories and on-going debate. However, this Essay takes a step back from that highly charged discourse and situates Medicaid expansion in its historical context. We reveal that this latest change universalizes the program, holding the power to finally realize President Johnson’s vision for the Great Society, almost fifty years later. Medicaid can be understood as a universal program for three reasons: (1) the percentage of thepopulation of children, pregnant women, and non-elderly adults it covers; (2) the degree to which Medicaid funds long-term care …

The Tobacco Diaries: Lessons Learned And Applied To Regulation Of Dietary Supplements, Joanna K. Sax

Faculty Scholarship

This Article examines the future role of the FDA in the regulation of the dietary supplement industry. To address the role of the FDA in the twenty-first century with respect to the dietary supplement industry, Part I of this Article begins by describing the dietary supplement industry and the role of the FDA in this industry. In Part II, this Article provides a brief exposé of the tactics used by the tobacco industry to evade regulation. The purpose of Part II is to provide insight into the tobacco industry’s ability to manipulate consumers and discount scientific proof of the harmful …

Reflections On The Cost Of "Low-Cost" Whole Genome Sequencing: Framing The Health Policy Debate, Timothy Caulfield, Jim Evans, Amy Mcguire, Christopher Mccabe, Tania Bubela, Robert Cook-Deegan, Jennifer Fishman, Stuart Hogarth, Fiona A. Miller, Vardit Ravitsky, Barbara Biesecker, Pascal Borry, Mildred K. Cho, June C. Carroll, Holly Etchegary, Yann Joly, Kazuto Kato, Sandra Soo-Jim Lee, Karen H. Rothenberg, Pamela Sankar, Michael J. Szego, Pilar Ossorio, Daryl Pullman, Francois Rousseau, Wendy J. Ungar, Brenda Wilson

Faculty Scholarship

The cost of whole genome sequencing is dropping rapidly. There has been a great deal of enthusiasm about the potential for this technological advance to transform clinical care. Given the interest and significant investment in genomics, this seems an ideal time to consider what the evidence tells us about potential benefits and harms, particularly in the context of health care policy. The scale and pace of adoption of this powerful new technology should be driven by clinical need, clinical evidence, and a commitment to put patients at the centre of health care policy.

Dynamic Expansion, Nicole Huberfeld

Faculty Scholarship

Nearly one in four Americans will have medical care and costs covered by the Medicaid program when it has been expanded pursuant to the Patient Protection and Affordable Care Act (the ACA). National media outlets have been reporting that only about half of the states are participating in the Medicaid expansion; if the reports were true, millions of Americans would be left without insurance coverage, and many of the nation’s medically fragile citizens would not have access to consistent healthcare. Contrary to these reports, most states will participate in the Medicaid expansion in the near future. This claim is not …

Approval And Withdrawal Of New Antibiotics And Other Antiinfectives In The U.S., 1980-2009, Kevin Outterson, John H. Powers, Enrique Seoane, Rosa Rodriguez-Monguio, Aaron S. Kesselheim

Faculty Scholarship

Concerns about a dearth of antibiotic innovation have spurred calls for incentives to speed the development of new antibiotics. Our data demonstrates that many of the new molecular entity (NME) antibioticsintroduced in the last 3 decades were withdrawn from the market, at more than triple the rate of other drug classes. Adjusted for these withdrawals, the net introduction of NME antibiotics is not as troubling of a trend. The reduction in NME antibiotics was partially offset by a surge in the introduction of NME antiretrovirals for HIV/AIDS and other drug classes (such as cardiovascular drugs) posted similar declines.

These data …

Reverse Payments, Perverse Incentives, Murat C. Mungan

Faculty Scholarship

Issuing and enforcing prescription drug patents requires courts and legislatures to strike a delicate balance. A patent gives drug manufacturers a legal, if temporary, monopoly on sales of a drug; this encourages manufacturers to engage in costly research and development of new medicines. But not all patents issued by the Patent Office are ultimately deemed valid – generic drug manufacturers can infringe the patent, and, when sued, attack its validity in court on a variety of grounds, including obviousness. In recent years, patent holders have begun to settle these suits (which they initiated) by paying the alleged infringer. Not surprisingly, …

Legally Blind: The Therapeutic Illusion In The Support Study Of Extremely Premature Infants, George J. Annas, Catherine L. Annas

Faculty Scholarship

Physician-researchers follow a protocol to generate generalizable knowledge; physicians have a duty to treat patients in ways they and their patients think best. In both activities, research and treatment, physicians often see themselves simply as physicians, practicing medicine. Sick people have similar perception difficulties, and prefer to think of their physician-researcher simply as their physician, even when their treatment is ² determined by a protocol or the flip of a coin. Almost 20 years ago, in this Journal, one of us suggested that at least some researchers use language "to obscure; to blur or eliminate the distinctions between research …

Not The Power To Destroy: An Effects Theory Of The Tax Power, Robert D. Cooter, Neil S. Siegel

Faculty Scholarship

The Supreme Court’s “new federalism” decisions impose modest limits on the regulatory authority of Congress under the Commerce Clause. According to those decisions, the Commerce Clause empowers Congress to use penalties to regulate interstate commerce, but not to regulate noncommercial conduct. What prevents Congress from penalizing non-commercial conduct by calling a penalty a tax and invoking the Taxing Clause? The only obstacle is the distinction between a penalty and a tax for purposes of Article I, Section 8. In National Federation of Independent Business v. Sebelius (NFIB), the Court considered whether the minimum coverage provision in the Patient Protection and …

The New Textualism, Progressive Constitutionalism, And Abortion Rights: A Reply To Jeffrey Rosen, Neil S. Siegel

Faculty Scholarship

In this Essay, I offer a few thoughts in response to Jeffrey Rosen's contribution to this symposium on Jack Balkin's "Living Originalism". I will first focus on what he writes about the "new textualism." I will then reply to what he intimates about the continuing validity of Roe v. Wade. In short, I will argue that Rosen offers progressives little reason to accept the new textualism or to reject Roe in the name of legal fidelity.

If the abortion right is ultra vires because a lack of decisive warrant in text, structure, and history trumps mediating equality principles and legal …

Limiting “Sugary Drinks” To Reduce Obesity — Who Decides?, Wendy K. Mariner, George J. Annas

Faculty Scholarship

When a judge struck down the New York City Board of Health's partial ban on selling “sugary drinks” in containers of more than 16 fluid ounces, the reaction was swift. The Portion Cap Rule was widely viewed as a signature accomplishment of Mayor Michael Bloomberg's third term as the “public health mayor,” and he vowed to appeal, saying, “I've got to defend my children, and yours, and do what's right to save lives. Obesity kills.” But the question before the judge was not about the health risks posed by obesity or even the relationship between obesity and access to large …

Equality Arguments For Abortion Rights, Neil S. Siegel, Reva B. Siegel

Faculty Scholarship

Roe v. Wade grounds constitutional protections for women’s decision wheth­er to end a pregnancy in the Due Process Clauses. But in the four decades since Roe, the U.S. Supreme Court has come to recognize the abortion right as an equality right as well as a liberty right. In this Essay, we describe some distinctive features of equality arguments for abortion rights. We then show how, over time, the Court and individual Justices have begun to employ equal­ity arguments in analyzing the constitutionality of abortion restrictions. These arguments first appear inside of substantive due process case law, and then as claims …