Health Law and Policy Commons^™

The Personal Responsibility Pandemic: Centering Solidarity In Public Health And Employment Law, Lindsay F. Wiley, Samuel R. Bagenstos

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Our nation’s response to the coronavirus pandemic has revealed fundamental flaws in our legal regimes governing both public health and employment. Public health orders have called on individuals to make sacrifices to protect society as a whole. Simple fairness dictates that the burdens should be shared as widely as the benefits. And the case for burden-sharing does not rest on fairness alone. Public health measures are more likely to succeed when those who are subject to them understand them as fair1 and when their cooperation is supported. 2 Predictably, our pandemic response has placed disproportionate burdens on those who are …

Sex-Based Discrimination In Health Care Under Section 1557: The New Final Rule And Supreme Court Developments, Brietta R. Clark, Elizabeth Pendo, Gabriella Garbero

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One of the primary goals of the Patient Protection and Affordable Care Act (PPACA) has been the reduction and elimination of health disparities, generally defined as population-level health differences that adversely affect disadvantaged groups, including disparities associated with sex and gender. Many of PPACA’s general provisions — expanded access to public and private insurance coverage, guarantee issue and pricing reforms, and coverage mandates — were expected to reduce barriers and eliminate discriminatory practices targeting or disproportionately impacting women and transgender individuals. Provisions like the Women’s Health Amendment, which mandated women’s preventive healthcare to be covered without cost sharing, and the …

Resolving Tensions Between Disability Rights Law And Covid-19 Mask Policies, Elizabeth Pendo, Robert Gatter, Seema Mohapatra

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As states reopen, an increasing number of state and local officials are requiring people to wear face masks while out of the home. Grocery stores, retail outlets, restaurants, and other businesses are also announcing their own mask policies, which may differ from public policies. Public health measures to stop the spread of the coronavirus such as wearing masks have the potential to greatly benefit millions of Americans with disabilities, who are particularly vulnerable to the impact of COVID-19. But certain disabilities may make it difficult or inadvisable to wear a mask.

Mask-wearing has become a political flashpoint, putting people with …

Regulatory Responses To Medical Machine Learning, Timo Minssen, Sara Gerke, Mateo Aboy, W. Nicholson Price Ii, Glenn Cohen

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Companies and healthcare providers are developing and implementing new applications of medical artificial intelligence, including the artificial intelligence sub-type of medical machine learning (MML).MML is based on the application of machine learning (ML) algorithms to automatically identify patterns and act on medical data to guide clinical decisions. MML poses challenges and raises important questions, including (1) How will regulators evaluate MML-based medical devices to ensure their safety and effectiveness? and (2) What additional MML considerations should be taken into account in the international context? To address these questions, we analyze the current regulatory approaches to MML in the USA and …

Addiction-Informed Immigration Reform, Rebecca Sharpless

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Immigration law fails to align with the contemporary understanding of substance addiction as a medical condition. The Immigration and Nationality Act regards noncitizens who suffer from drug or alcohol substance use disorder as immoral and undesirable. Addiction is a ground of exclusion and deportation and can prevent the finding of "good moral character" needed for certain immigration applications. Substance use disorder can lead to criminal behavior that lands noncitizens, including lawful permanent residents, in removal proceedings with no defense. The time has come for immigration law to catch up to today's understanding of addiction. The damage done by failing to …

Potential Liability For Physicians Using Artificial Intelligence, W. Nicholson Price Ii, Sara Gerke, I Glenn Cohen

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Artificial intelligence (AI) is quickly making inroads into medical practice, especially in forms that rely on machine learning, with a mix of hope and hype. Multiple AI-based products have now been approved or cleared by the US Food and Drug Administration (FDA), and health systems and hospitals are increasingly deploying AI-based systems. For example, medical AI can support clinical decisions, such as recommending drugs or dosages or interpreting radiological images.2 One key difference from most traditional clinical decision support software is that some medical AI may communicate results or recommendations to the care team without being able to communicate the …

Medical Ai And Contextual Bias, W. Nicholson Price Ii

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Artificial intelligence will transform medicine. One particularly attractive possibility is the democratization of medical expertise. If black-box medical algorithms can be trained to match the performance of high-level human experts — to identify malignancies as well as trained radiologists, to diagnose diabetic retinopathy as well as board-certified ophthalmologists, or to recommend tumor-specific courses of treatment as well as top-ranked oncologists — then those algorithms could be deployed in medical settings where human experts are not available, and patients could benefit. But there is a problem with this vision. Privacy law, malpractice, insurance reimbursement, and FDA approval standards all encourage developers …

Pharmaceutical Industry Funding To Patient-Advocacy Organization: A Cross-National Comparison Of Disclosure Codes And Regulation, Laura Karas, Robin Feldman, Bai Ge, So Yeon Kang, Gerard F. Anderson

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Transparency has become one of the primary themes in health care reform efforts in the United States and across the world. In the face of exorbitant drug prices, high levels of patient cost-sharing, and pharmaceutical expenditures that consume a growing proportion of public sector budgets, much attention has been drawn to the pharmaceutical industry. Congressional investigations, academic publications, and news articles have endeavored to reveal the extent of drug and device industry influence on health care actors. In response, several nations, including the United States, have passed legislation mandating disclosure of drug company payments to physicians. In the United States, …

Artificial Intelligence In The Medical System: Four Roles For Potential Transformation, Will Nicholson Price Ii

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Artificial intelligence (AI) looks to transform the practice of medicine. As academics and policymakers alike turn to legal questions, a threshold issue involves what role AI will play in the larger medical system. This Article argues that AI can play at least four distinct roles in the medical system, each potentially transformative: pushing the frontiers of medical knowledge to increase the limits of medical performance, democratizing medical expertise by making specialist skills more available to non-specialists, automating drudgery within the medical system, and allocating scarce medical resources. Each role raises its own challenges, and an understanding of the four roles …

Deploying Mindfulness To Gain Cognitive Advantage: Considerations For Military Effectiveness And Well-Being, Amishi P. Jha, Scott L. Rogers, Eric Schoomaker, Edward Cardon

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Mindfulness involves paying attention to present moment experience without discursive commentary or emotional reactivity. Mindfulness training (MT) programs aim to promote this mental mode via introduction to specific mindfulness exercises, related in-class discussion, and ongoing engagement in mindfulness exercises. MT is being increasingly offered to high-demand, high-stress military/uniformed and civilian cohorts with a wide array of reported benefits. Herein, we begin by discussing recent theoretical models regarding MT’s mechanisms of action from a cognitive training/cognitive neuroscience perspective, which propose that MT engages and strengthens three key processes [e.g., 1]. These are: 1) attentional orienting, which is the ability to select …

Cannabis For Medical Use: Fda And Dea Regulation In The Hall Of Mirrors, Rebecca S. Eisenberg, Deborah B. Leiderman

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A majority of Americans now live in states that purport to authorize medical use of cannabis, although federal law continues to prohibit both recreational and medical use. The current legal regime for cannabis is unstable and may be more effective at deterring research than it is at deterring medical use. Lack of data on medical cannabis products poses public health risks as well as policy and legal challenges. Modified regulatory approaches for other kinds of products provide alternative models for encouraging safety and effectiveness research and providing better information about cannabis products already in clinical use.

Artificial Intelligence In The Medical System: Four Roles For Potential Transformation, W. Nicholson Price Ii

Articles

Artificial intelligence (AI) looks to transform the practice of medicine. As academics and policymakers alike turn to legal questions, including how to ensure high-quality performance by medical AI, a threshold issue involves what role AI will play in the larger medical system. This Article argues that AI can play at least four distinct roles in the medical system, each potentially transformative: pushing the frontiers of medical knowledge to increase the limits of medical performance, democratizing medical expertise by making specialist skills more available to non-specialists, automating drudgery within the medical system, and allocating scarce medical resources. Each role raises its …

Occupational Licensing And The Limits Of Public Choice Theory, Ryan Nunn, Gabriel Scheffler

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No abstract provided.

The Costs Of Uncertainty: The Doj’S Stalled Progress On Accessible Medical Equipment Under The Americans With Disabilities Act, Elizabeth Pendo

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Imagine seeking medical care for serious pressure sores for a year, but your doctor never examining the sores because you could not get on the examination table in her office. Or imagine going more than fifteen years without an annual well-woman examination for the same reason, or your doctor guessing at the right dosage for a prescription because there was no scale that she could use to weigh you.

Although these scenarios may be difficult for many to imagine, they are common experiences for individuals with mobility disability. The Trump administration’s attacks on the Patient Protection and Affordable Care Act …

Unlocking Access To Health Care: A Federalist Approach To Reforming Occupational Licensing, Gabriel Scheffler

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No abstract provided.

Permitted Incentives For Workplace Wellness Plans Under The Ada And Gina: The Regulatory Gap, Elizabeth Pendo

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Although workplace wellness plans have been around for decades, they have flourished under the Patient Protection and Affordable Care Act (“PPACA”) into a $6 billion-dollar industry. Under PPACA, a “wellness plan” is a program of health promotion or disease prevention offered by an employer that is designed to promote health or prevent disease and which meets the other applicable requirements of that subsection. Employers look to these programs to promote healthy lifestyles, improve the overall health of employees and beneficiaries, and reduce rising healthcare costs.

PPACA’s amendments to the Health Insurance Portability and Accountability Act (“HIPAA”) permit employers to offer …

Shadow Health Records Meet New Data Privacy Laws, W. Nicholson Price Ii, Margot E. Kaminski, Timo Minssen, Kayte Spector-Bagdady

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Large sets of health data can enable innovation and quality measurement but can also create technical challenges and privacy risks. When entities such as health plans and health care providers handle personal health information, they are often subject to data privacy regulation. But amid a flood of new forms of health data, some third parties have figured out ways to avoid some data privacy laws, developing what we call “shadow health records”—collections of health data outside the health system that provide detailed pictures of individual health—that allow both innovative research and commercial targeting despite data privacy rules. Now that space …

Privacy In The Age Of Medical Big Data, W. Nicholson Price Ii, I. Glenn Cohen

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Big data has become the ubiquitous watch word of medical innovation. The rapid development of machine-learning techniques and artificial intelligence in particular has promised to revolutionize medical practice from the allocation of resources to the diagnosis of complex diseases. But with big data comes big risks and challenges, among them significant questions about patient privacy. Here, we outline the legal and ethical challenges big data brings to patient privacy. We discuss, among other topics, how best to conceive of health privacy; the importance of equity, consent, and patient governance in data collection; discrimination in data uses; and how to handle …

Health Reform And Higher Ed: Campuses As Harbingers Of Medicaid Universality And Medicare Commonality, Sallie Thieme Sanford

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Between 2010 and 2016, the percentage of uninsured higher education students dropped by more than half. All the Affordable Care Act’s key access provisions contributed, but the most important factor appears to be the Medicaid expansion. This article is the first to highlight this phenomenon and ground it in data. It explores the reasons for this dramatic expansion of coverage, links it to theoretical frameworks, and considers its implications for the future of health reform.

Drawing on Medicaid universality scholarship, I discuss potential consequences of including the educationally privileged in this historically stigmatized program. Extending this scholarship, I argue that …

Nobody Knew How Complicated: Constraining The President's Power To Re(Shape) Health Reform, Sallie Thieme Sanford

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Beginning on inauguration day, President Trump has attempted an executive repeal of the Affordable Care Act. In doing so, he has tested the limits of presidential power. He has challenged the force of institutional and non-institutional constraints. And, ironically, he has helped boost public support for the ACA’s central features. The first two sections of this article respectively consider the use of the President’s tools to advance and to subvert health reform.

The final two sections consider the forces constraining the administration’s attempted executive repeal. I argue that the most important institutional constraint, thus far, is found in multifaceted actions …

Note: The Prisoner’S Dementia: Ethical And Legal Issues Regarding Dementia And Healthcare In Prison, David M. N. Garavito

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This Note will give an overview of the political and legal issues that lead to the underdiagnosing of dementias in prison populations and the problems associated with such underdiagnosing. Part I will discuss various forms of dementia that place the prison population at risk, providing general information about both pathology and symptomology of these disorders. Part II will provide an overview of the laws and policies surrounding the healthcare of prisoners and how these policies could lead to underdiagnosing problems specifically with neurological problems like dementia. Part III will describe how the symptomology of dementia, especially for those who remain …

Limiting State Flexibility In Drug Pricing, Nicholas Bagley, Rachel E. Sachs

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Throughout the United States, escalating drug prices are putting immense pressure on state budgets. Several states are looking for ways to push back. Last year, Massachusetts asked the Trump administration for a waiver that would, among other things, allow its Medicaid program to decline to cover costly drugs for which there is limited or inadequate evidence of clinical efficacy. By credibly threatening to exclude such drugs from coverage, Massachusetts hoped to extract price concessions and constrain the fastest-growing part of its Medicaid budget.

Drug Approval In A Learning Health System, W. Nicholson Price

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The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA—and the health system generally—should gather information after drugs are approved to learn how well they work and how safe they are. This is hard to do. FDA has its own surveillance systems, but those systems face substantial limitations in practical use. Drug companies can also conduct their own studies, but have little incentive to do so, and often fail to fulfil study commitments made to FDA. Proposals to improve this dynamic often suggest gathering more …

Reform At Risk — Mandating Participation In Alternative Payment Plans, Scott Levy, Nicholas Bagley, Rahul Rajkumar

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In an ambitious effort to slow the growth of health care costs, the Affordable Care Act created the Center for Medicare and Medicaid Innovation (CMMI) and armed it with broad authority to test new approaches to reimbursement for health care (payment models) and delivery-system reforms. CMMI was meant to be the government’s innovation laboratory for health care: an entity with the independence to break with past practices and the power to experiment with bold new approaches. Over the past year, however, the Department of Health and Human Services (HHS) has quietly hobbled CMMI, imperiling its ability to generate meaningful data …

Are Medicaid Work Requirements Legal?, Nicholas Bagley

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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 …