Law Commons^™

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

Faculty Scholarship

No abstract provided.

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

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 …

Our 'Patchwork' Health Care System: Melodic Variations, Counterpoint, And The Future Role Of Physicians, William M. Sage

Faculty Scholarship

This Foreword to a forthcoming symposium on the "patchwork" health care system to be published in the Houston Journal of Health Law & Policy considers whether current reactions to fragmentation in health care represent minor variations on a longstanding theme in US health policy or offer a more substantial counterpoint to that theme. The theme is this: that perfect physicians should be allowed to control health care even if safeguards are needed in practice because real physicians are not perfect. The Foreword previews four scholarly articles featured in the published symposium. It concludes that, while all the articles present original …

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 …

Themes, Doctrine, And Pedagogy In The 2013-2014 National Health Law Moot Court Competition Problem, Anita Bernstein

Faculty Scholarship

No abstract provided.

Themes, Doctrine, And Pedagogy In The 2013-2014 National Health Law Moot Court Competition Problem, Anita Bernstein

Faculty Scholarship

No abstract provided.

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 …

Private Certifiers And Deputies In American Health Care, Frank Pasquale

Faculty Scholarship

No abstract provided.

Putting Insurance Reform In The Aca's Rear-View Mirror, William M. Sage

Faculty Scholarship

This Commentary acknowledges and applauds efforts to understand the mechanisms of insurance reform contained in the ACA and to evaluate their success or failure. But the Commentary’s principal purpose is to examine the pros and cons of connecting insurance reform to health care and health—the pen and the french fry—and to convey the importance to the country of moving beyond insurance reform as quickly as possible. The Commentary begins by describing the potential synergies among the three health policy domains and offering reasons why the ACA sought to make simultaneous changes. It then identifies the vulnerabilities that are revealed in …

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 Affordable Care Act, Remedy, And Litigation Reform, Brendan S. Maher

Faculty Scholarship

The Patient Protection and Affordable Care Act of 2010 (“ACA”) rewrote the law of private health insurance. How the ACA rewrote the law of civil remedies, however, is — to date — a question largely unexamined by scholars. Courts everywhere, including the United States Supreme Court, will soon confront this important issue.

This Article offers a foundational treatment of the ACA on remedy. It predicts a series of flashpoints over which litigation reform battles will be fought. It identifies several themes that will animate those conflicts and trigger others. It explains how judicial construction of the statute’s functional predecessor, the …

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.

Protecting Health Privacy In An Era Of Big Data Processing And Cloud Computing, Frank Pasquale, Tara Adams Ragone

Faculty Scholarship

No abstract provided.

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

Faculty Scholarship

No abstract provided.

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 …

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 …

Setting The Stage: Enhancing Understanding Of Bioethical Challenges With Theatre, Karen H. Rothenberg

Faculty Scholarship

Theatre provides a dynamic platform to reflect upon the ethical, legal, and social implications of medical innovations and the powerful impact on personal and professional relationships. This article explores the last four to five decades of theatre, which coincide with the evolution of the formal discipline of bioethics and the field of medical humanities, to aid in the understanding of the bioethical challenges we face today and to place them in an historical and societal context. Four plays are discussed that reflect the ethical and legal context of their eras and reveal significant ethical challenges for us to consider.

Probiotics: Achieving A Better Regulatory Fit, Diane E. Hoffmann, Claire M. Fraser, Francis Palumbo, Jacques Ravel, Virginia Rowthorn, Jack Schwartz

Faculty Scholarship

In 2007, the National Institutes of Health (NIH) launched the Human Microbiome Project (HMP), a $150 million initiative to characterize the microbial communities found at several different sites on the human body and to analyze the role of these microbes in human health and disease. Many lines of research have demonstrated the significant role of the microbiota in human physiology. The microbiota is involved, for example, in the healthy development of the immune system, prevention of infection from pathogenic or opportunistic microbes, and maintenance of intestinal barrier function. The HMP findings are helping us understand the role and variation of …

Private Certifiers And Deputies In American Health Care, Frank A. Pasquale

Faculty Scholarship

So-called “public programs” in U.S. health care pervasively contract with private entities. The contracting does not merely involve the purchase of drugs, devices, information technology, insurance, and medical care. Rather, government agencies are increasingly outsourcing decisions about the nature and standards for such goods and services to private entities. This Article will examine two models of outsourcing such decisions. In private licensure, firms offer a stamp of approval to certify that a given technology or service is up to statutory or regulatory standards. Via deputization, firms can pursue a regulatory or law enforcement role to correct (and even punish) providers …

Redescribing Health Privacy: The Importance Of Health Policy, Frank A. Pasquale

Faculty Scholarship

Current conversations about health information policy often tend to be based on three broad assumptions. First, many perceive a tension between regulation and innovation. We often hear that privacy regulations are keeping researchers, companies, and providers from aggregating the data they need to promote innovation. Second, aggregation of fragmented data is seen as a threat to its proper regulation, creating the risk of breaches and other misuse. Third, a prime directive for technicians and policymakers is to give patients ever more granular methods of control over data. This article questions and complicates those assumptions, which I deem (respectively) the Privacy …

Perspectives On Outpatient Commitment, Richard C. Boldt

Faculty Scholarship

No abstract provided.

Protecting Health Privacy In An Era Of Big Data Processing And Cloud Computing, Frank A. Pasquale, Tara Adams Ragone

Faculty Scholarship

This Article examines how new technologies generate privacy challenges for both healthcare providers and patients, and how American health privacy laws may be interpreted or amended to address these challenges. Given the current implementation of Meaningful Use rules for health information technology and the Omnibus HIPAA Rule in health care generally, the stage is now set for a distinctive law of “health information” to emerge. HIPAA has come of age of late, with more aggressive enforcement efforts targeting wayward healthcare providers and entities. Nevertheless, more needs to be done to assure that health privacy and all the values it is …

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 …

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. …

"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 …

Fertility Preservation For Medical Reasons And Reproductive Justice, Seema Mohapatra

Faculty Scholarship

No abstract provided.

Using Egg Freezing To Extend The Biological Clock: Fertility Insurance Or False Hope?, Seema Mohapatra

Faculty Scholarship

No abstract provided.

Medicaid Expansion As Completion Of The Great Society, Nicole Huberfeld

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 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

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 …