Health Law and Policy Commons^™

Are Medicaid Work Requirements Legal?, Nicholas Bagley

Articles

On January 12, 2018, the Centers for Medicare & Medicaid Services (CMS) approved a waiver allowing Kentucky to impose a work requirement on some nondisabled Medicaid beneficiaries. Similar waivers are sure to follow. Supporters see work requirements as a spur to force the idle poor to work; opponents see the requirements as a covert means of withholding medical care from vulnerable people. Setting the policy debate aside, however, are work requirements legal?

Innovative Contracting For Pharmaceuticals And Medicaid’S Best-Price Rule, Nicholas Bagley

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In recent years, drug manufacturers and private payers have expressed interest in novel pricing models that more closely link a drug’s price to its value. Indication-based pricing, outcome-based pricing, drug licenses, and drug mortgages have all been discussed as alternatives to paying strictly for volume. Manufacturers and payers have complained, however, that Medicaid’s “best-price rule” inhibits their ability to enter into these newpricing arrangements. This article examines the best-price rule and assesses to what extent, if any, it might frustrate the goal of paying for value. We conclude that the best-price rule is not as serious a problem as it …

Big Data: Destroyer Of Informed Consent, A. Michael Froomkin

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The 'Revised Common Rule' took effect on January 21, 2019, marking the first change since 2005 to the federal regulation that governs human subjects research conducted with federal support or in federally supported institutions. The Common Rule had required informed consent before researchers could collect and use identifiable personal health information. While informed consent is far from perfect, it is and was the gold standard for data collection and use policies; the standard in the old Common Rule served an important function as the exemplar for data collection in other contexts. Unfortunately, true informed consent seems incompatible with modern analytics …

Strategic Litigation To Advance Public Health, Tamar Ezer, Priti Patil

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The HIV movement has relied on strategic litigation as an important tool to develop and enforce legal protections critical to health. This experience contains lessons on the potential of strategic litigation to advance public health more generally. Beyond impacting laws and policies, strategic litigation can change practice, breathing life into existing legal rules never implemented. While cases may target a particular law, policy, or practice, indirect impacts beyond a particular court decision on future cases, other branches of government, and the public record may be just as important. Each case is only one step towards change, and a judgment can …

Risk And Resilience In Health Data Infrastructure, W. Nicholson Price Ii

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Today’s health system runs on data. However, for a system that generates and requires so much data, the health care system is surprisingly bad at maintaining, connecting, and using those data. In the easy cases of coordinated care and stationary patients, the system works—sometimes. But when care is fragmented, fragmented data often result. Fragmented data create risks both to individual patients and to the system. For patients, fragmentation creates risks in care based on incomplete or incorrect information, and may also lead to privacy risks from a patched together system. For the system, data fragmentation hinders efforts to improve efficiency …

Artificial Intelligence In Health Care: Applications And Legal Implications, W. Nicholson Price Ii

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Artificial intelligence (AI) is rapidly moving to change the healthcare system. Driven by the juxtaposition of big data and powerful machine learning techniques—terms I will explain momentarily—innovators have begun to develop tools to improve the process of clinical care, to advance medical research, and to improve efficiency. These tools rely on algorithms, programs created from healthcare data that can make predictions or recommendations. However, the algorithms themselves are often too complex for their reasoning to be understood or even stated explicitly. Such algorithms may be best described as “black-box.” This article briefly describes the concept of AI in medicine, including …

Small Change, Big Consequences — Partial Medicaid Expansions Under The Aca, Adrianna Mcintyre, Allan M. Joseph, Nicholas Bagley

Articles

Though congressional efforts to repeal and replace the Affordable Care Act (ACA) seem to have stalled, the Trump administration retains broad executive authority to reshape the health care landscape. Perhaps the most consequential choices that the administration will make pertain to Medicaid, which today covers more than 1 in 5 Americans. Much has been made of proposals to introduce work requirements or cost sharing to the program. But another decision of arguably greater long-term significance has been overlooked: whether to allow “partial expansions” pursuant to a state Medicaid waiver. Arkansas has already submitted a waiver request for a partial expansion, …

Tort Reform Through The Back Door: A Critique Of Law And Apologies, Yonathan A. Arbel, Kaplan, Yotam Kaplan, Yotam

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In this Article, we show how the biggest tort reform of the last decade was passed through the back door with the blessing of its staunchest opponents. We argue that the widely-endorsed "apology law" reform-a change in the national legal landscape that privileged apologies-is, in fact, a mechanism of tort reform, used to limit victims' recovery and shield injurers from liability. While legal scholars overlooked this effect, commercial interests seized the opportunity and are in the process of transforming state and federal law with the unwitting support of the public.

The Dubious Empirical And Legal Foundations Of Wellness Programs, Adrianna Mcintyre, Nicholas Bagley, Austin Frakt, Aaron Carroll

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The article offers information on the dubious empirical and legal foundations of workplace wellness programs in the U.S. Topics discussed include enactment of Affordable Care Act for expanding the scope of incentives availas; analysis of financial incentives offered to the employees for encouraging their participation in wellness programs; and targeting incentives specifically toward individuals diagnosed with chronic diseases.

Anti-Homosexual Legislation And Hiv-Related Stigma In African Nations: What Has Been The Role Of Pepfar?, Amy Hagopian, Deepa Rao, Aaron Katz, Sallie Sanford, Scott Barnhart

Articles

Background: Gay men and other men who have sex with men are disproportionately burdened by HIV infection. Laws that penalize same-sex intercourse contribute to a cycle of stigma, homonegativity and discrimination. In many African nations, laws criminalizing homosexuality may be fueling the epidemic, as they dissuade key populations from seeking treatment and health care providers from offering it.

Objectives: We analyzed the ways in which policies and practices of the US President’s Emergency Plan for AIDS Relief (PEPFAR) program addressed pervasively harsh anti-homosexuality laws across Africa. Given the aim of the US PEPFAR program to reduce stigma surrounding HIV, we …

The Eeoc, The Ada, And Workplace Wellness Programs, Samuel R. Bagenstos

Articles

It seems that everybody loves workplace wellness programs. The Chamber of Commerce has firmly endorsed those progarms, as have other business groups. So has President Obama, and even liberal firebrands like former Senator Tom Harkin. And why not? After all, what's not to like about programs that encourage people to adopt healthy habits like exercise, nutritious eating, and quitting smoking? The proponents of these programs speak passionately, and with evident good intentions, about reducing the crushing burden that chronic disease places on individuals, families, communities, and the economy as a whole. What's not to like? Plenty. Workplace wellness programs are …

Federalism And The End Of Obamacare, Nicholas Bagley

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Federalism has become a watchword in the acrimonious debate over a possible replacement for the Affordable Care Act (ACA). Missing from that debate, however, is a theoretically grounded and empirically informed understanding of how best to allocate power between the federal government and the states. For health reform, the conventional arguments in favor of a national solution have little resonance: federal intervention will not avoid a race to the bottom, prevent externalities, or protect minority groups from state discrimination. Instead, federal action is necessary to overcome the states’ fiscal limitations: their inability to deficit-spend and the constraints that federal law …

Circumcision: Immigration, Religion, History, And Constitutional Identity In Germany And The U.S., David Abraham

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A four-year-old Muslim boy was brought to a local Cologne emergency room by his mother, who was concerned about minor bleeding around the site of a circumcision. A District Court there found that circumcision, notwithstanding parental consent or religious motivation, constituted a criminal bodily injury and child abuse. Ultimately, on July 19, 2012 the Bundestag resolved that "Jewish and Muslim religious life be viable in Germany," and in December a bill was passed that legislatively overrode the ruling of the District Court and recognized circumcision as a non-punishable undertaking when undertaken for religious reasons by someone professionally trained. Two years …

Medical-Legal Partnerships With Communities: Legal Empowerment To Transform Care, Tamar Ezer

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Medical-legal partnerships (MLPs) integrate legal services into health care settings to provide holistic care and address the social determinants of health. This article brings a legal-empowerment lens to MLP work, arguing for a stronger focus on communities. It examines the application to MLPs of bringing services to communities, investing in rights literacy, and partnering with community-based paralegals. It then outlines the potential for a transformation in health and legal services to a rights - rather than needs-based framework where communities are active partners in program design and development.

Contemporary Practice Of The United States Relating To International Law, January 2017, Daugirdas Kristina, Julian Davis Mortenson

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In this section: • Congress Overrides Obama’s Veto to Pass Justice Against Sponsors of Terrorism Act • U.S. Federal Court of Appeals Upholds United Nations’ Immunity in Case Related to Cholera in Haiti • U.S.-Russian Agreements on Syria Break Down as the Syrian Conflict Continues • Russia Suspends Bilateral Agreement with United States on Disposal of Weapons-Grade Plutonium • The United States Makes Payment to Family of Italian Killed in CIA Air Strike • United States Ratifies Hague Convention on the International Recovery of Child Support and Other Forms of Family Maintenance

Regulating Secrecy, W. Nicholson Price Ii

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Inventors face a stark choice between two intellectual property systems of protecting innovative ideas: patents and trade secrecy. But accounts of this choice underexplore the role of the regulators that dominate some areas of innovation. Regulation interacts with intellectual property exclusivity in socially problematic ways by encouraging secrecy at the expense of innovation, efficiency, and competition. This Article theorizes how regulation empowers intellectual property generally, explains why this strengthening is problematic for trade secrecy but not for patents, and offers the solution of regulator-enforced disclosure. When a regulator defines a product or a process, it becomes much harder to successfully …

Trouble On The Exchanges — Does The United Owe Billions To Health Insurers?, Nicholas Bagley

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Yet another bruising fight has erupted over health care reform. On September 9, 2016, the Obama administration offered to open settlement negotiations with health insurers that have sued the United States to recover billions of dollars that they claim they are owed. Congressional Republicans are incensed, believing that any settlement would illegally squander taxpayer dollars in a lastgasp effort to save the Affordable Care Act (ACA).

Big Data, Patents, And The Future Of Medicine, W. Nicholson Price Ii

Articles

Big data has tremendous potential to improve health care. Unfortunately, intellectual property law isn’t ready to support that leap. In the next wave of data- driven medicine, black-box medicine, researchers use sophisticated algorithms to examine huge troves of health data, finding complex, implicit relationships and making individualized assessments for patients. Black-box medicine offers potentially immense benefits, but also requires substantial high investment. Firms must develop new datasets, models, and validations, which are all nonrivalrous information goods with significant spillovers, requiring incentives for welfare-optimizing investment. Current intellectual property law fails to provide adequate incentives for black- box medicine. The Supreme Court …

A Liberal Dilemma: Respecting Autonomy While Also Protecting Inchoate Children From Prenatal Substance Abuse., Andrew J. Weisberg, Frank E. Vandervort

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Substance abuse is a significant social problem in America. It is estimated that some eighteen million Americans have an alcohol abuse problem and that almost five million have a drug abuse problem. According to the National Institute on Drug Abuse, substance abuse costs some $700 billion per year Substance abuse is a major contributor to child maltreatment. It is estimated that between one- and two-thirds of cases in which children enter foster care are linked to parental substance abuse. Unfortunately, this may be an underestimate as recent research suggests that many cases, particularly cases in which children have been exposed …

Monitoring Hiv And Aids Related Policy Reforms: A Road Map To Strengthen Policy Monitoring And Implementation In Pepfar Partner Countries, Jeffrey Lane, Andre Verani, Mai Hijazi, Erin Hurley, Amy Hagopian, Nicole Judice, Ron Macinnis, Sallie Sanford, Sarah Zelek, Aaron Katz

Articles

Achieving an AIDS-free generation will require the adoption and implementation of critical health policy reforms. However, countries with high HIV burden often have low policy development, advocacy, and monitoring capacity. This lack of capacity may be a significant barrier to achieving the AIDS-free generation goals. This manuscript describes the increased focus on policy development and implementation by the United States President’s Emergency Plan for AIDS Relief (PEPFAR). It evaluates the curriculum and learning modalities used for two regional policy capacity building workshops organized around the PEPFAR Partnership Framework agreements and the Road Map for Monitoring and Implementing Policy Reforms. …

Legal Limits And The Implementation Of The Affordable Care Act, Nicholas Bagley

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Accusations of illegality have dogged the Obama Administration's efforts to implement the Affordable Care Act (ACA), the most ambitious piece of social legislation since the advent of Medicare and Medicaid. Some of the accusations have merit; indeed, it would be surprising if they did not. Even as the ACA's rollout has exposed unanticipated difficulties in the statutory design, congressional antipathy to health reform has precluded looking to the legislature to iron out those difficulties. To secure his principal achievement, President Obama has repeatedly tested the limits of executive authority in implementing the ACA. Six years after its enactment and two …

Deference To Claims Of Substantial Religious Burden, Caroline Mala Corbin

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No abstract provided.

Transparency And The Supreme Court—Can Employers Refuse To Disclose How Much They Pay For Health Care?, Nicholas Bagley, Christopher Koller

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For decades, the prices that hospitals and physicians charge private insurers have been treated as trade secrets. Even though inflated prices are an enormous reason why health care is so much more expensive in the United States than in other countries, we have only a hazy picture of what those prices actually are.

Three Words And The Future Of The Affordable Care Act, Nicholas Bagley

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As an essential part of its effort to achieve near universal coverage, the Affordable Care Act (ACA) extends sizable tax credits to most people who buy insurance on the newly established health care exchanges. Yet several lawsuits have been filed challenging the availability of those tax credits in the thirty-four states that refused to set up their own exchanges. The lawsuits are premised on a strained interpretation of the ACA that, if accepted, would make a hash of other provisions of the statute and undermine its effort to extend coverage to the uninsured. The courts should reject this latest effort …

Diagnostics Need Not Apply, Rebecca S. Eisenberg

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Diagnostic testing helps caregivers and patients understand a patient's condition, predict future outcomes, select appropriate treatments, and determine whether treatment is working. Improvements in diagnostic testing are essential to bringing about the long-heralded promise of personalized medicine. Yet it seems increasingly clear that most important advances in this type of medical technology lie outside the boundaries of patent-eligible subject matter. The clarity of this conclusion has been obscured by ambiguity in the recent decisions of the Supreme Court concerning patent eligibility. Since its 2010 decision in Bilski v. Kappos, the Court has followed a discipline of limiting judicial exclusions from …

Protection Or Harm? Suppressing Substance-Use Data, Austin B. Frakt, Nicholas Bagley

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What if it were impossible to closely study a disease affecting 1 in 11 Americans over 11 years of age — a disease that’s associated with more than 60,000 deaths in the United States each year, that tears families apart, and that costs society hundreds of billions of dollars? What if the affected population included vulnerable and underserved patients and those more likely than most Americans to have costly and deadly communicable diseases, including HIV–AIDS? What if we could not thoroughly evaluate policies designed to reduce costs or improve care for such patients?

No Good Options: Picking Up The Pieces After King V. Burwell, Nicholas Bagley, David K. Jones

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If the Supreme Court rules against the government in King v. Burwell, insurance subsidies available under the Affordable Care Act (ACA) will evaporate in the thirty-four states that have refused to establish their own health-care exchanges. The pain could be felt within weeks. Without subsidies, an estimated eight or nine million people stand to lose their health coverage. Because sicker people will retain coverage at a much higher rate than healthier people, insurance premiums in the individual market will surge by as much as fifty percent. Policymakers will come under intense pressure to mitigate the fallout from a government loss …

Predicting The Fallout From King V. Burwell - Exchanges And The Aca, Nicholas Bagley, David K. Jones, Timothy Stoltzfus Jost

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The U.S. Supreme Court's surprise announcement on November 7 that it would hear King v. Burwell struck fear in the hearts of supporters of the Affordable Cara Act (ACA). At stake is the legality of an Internal Revenue Service (IRS) rule extending tax credits to the 4.5 million people who bought their health plans in the 34 states that declined to establish their own health insurance exchanges under the ACA. The case hinges on enigmatic statutory language that seems to link the amount of tax credits to a health plan purchased "through an Exchange established by the State." According to …

The Struggle To Bury Pre-Existing Condition Consideration, Sallie Thieme Sanford [email protected]

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As of January 1, 2014, applicants for comprehensive health insurance do not face questions about their health history. The ACA prohibits health insurers from considering an individual’s health history in determining whether to sell that person a comprehensive health insurance policy, the policy’s price, or its coverage terms. Pre-existing condition (PEC) consideration is, in this crucial context, dead. Few will mourn its passing. This legislative milestone marks a significant step towards the goal of a healthier population. While celebrating this achievement, however, in this article I argue that we ought to recall the context of PEC consideration, its practical application, …

What Patients With Disability Teach Us About The Everyday Ethics Of Healthcare, Elizabeth Pendo

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In Healers: Extraordinary Clinicians at Work, by David Schenck and Dr. Larry Churchill, and in What Patients Teach: The Everyday Ethics of Health Care, their follow-up with Joseph Fanning, the authors look at the everyday experience of health care and the relationships that shape it. They call attention to the ethical dimensions of the clinical encounter and the hope for, and desirability of, a genuine human engagement between the clinician and the patient. In their view, healers are clinicians who cultivate a therapeutic relationship with their patients. They identify a set of skills that accomplish this, including welcoming …