Health Law and Policy Commons^™

Why Govern Broken Tools?, Ryan Calo

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In Assessing the Governance of Digital Contact Tracing in Response to COVID-19: Results of a Multi-National Study, Brian Hutler et al. ably compare two approaches to the governance of digital contract tracing (DCT). In this brief essay, I want to examine to what extent governance actually played a meaningful role in the failure of DCT. If DCT failed primarily for other reasons, then the authors’ normative suggestion to pursue “a new governance approach … for designing and implementing DCT technology going forward” may be misplaced.

Exclusion Cycles: Reinforcing Disparities In Medicine, Ana Bracic, Shawneequa L. Callier, Nicholson Price

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Minoritized populations face exclusion across contexts from politics to welfare to medicine. In medicine, exclusion manifests in substantial disparities in practice and in outcome. While these disparities arise from many sources, the interaction between institutions, dominant-group behaviors, and minoritized responses shape the overall pattern and are key to improving it. We apply the theory of exclusion cycles to medical practice, the collection of medical big data, and the development of artificial intelligence in medicine. These cycles are both self-reinforcing and other-reinforcing, leading to dismayingly persistent exclusion. The interactions between such cycles offer lessons and prescriptions for effective policy.

Medicare Coverage Of Aducanumab - Implications For State Budgets, Rachel E. Sachs, Nicholas Bagley

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Aducanumab (Aduhelm), the controversial $56,000-per-year Alzheimer’s disease drug approved by the Food and Drug Administration (FDA) in June 2021, has the potential to cost the federal government many billions of dollars — more, by one estimate, than it spends on agencies such as the Environmental Protection Agency or the National Aeronautics and Space Administration. The drug’s extraordinary price tag helps explain why, soon after its approval, the Centers for Medicare and Medicaid Services (CMS) opened a national coverage determination to decide whether and under what circumstances Medicare would pay for it.1

Problematic Interactions Between Ai And Health Privacy, W. Nicholson Price Ii

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Problematic Interactions Between AI and Health Privacy Nicholson Price, University of Michigan Law SchoolFollow Abstract The interaction of artificial intelligence (AI) and health privacy is a two-way street. Both directions are problematic. This Essay makes two main points. First, the advent of artificial intelligence weakens the legal protections for health privacy by rendering deidentification less reliable and by inferring health information from unprotected data sources. Second, the legal rules that protect health privacy nonetheless detrimentally impact the development of AI used in the health system by introducing multiple sources of bias: collection and sharing of data by a small set …

Privacy As The Price Of Drug Access, Laura Karas

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In response to the recent increase in FDA-approved specialty drugs and escalating specialty drug prices, drug companies now offer patient support programs ("PSPs") for eligible patients prescribed a particular pharmaceutical drug. Such programs encompass both financial assistance for the purchase of a specialty drug and behavioral services, including nursing support and injection training, intended to improve drug adherence. Although ostensibly gratuitous, these programs have a steep and underappreciated cost: disclosure of protected health information. In effect, patient support programs compel patients to trade protected health information for drug access. This Article provides the first in-depth examination of the legal and …

California V. Texas — Ending The Campaign To Undo The Aca In The Courts, Nicholas Bagley

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On June 17, 2021, the U.S. Supreme Court, by a 7-to-2 vote, rejected what will probably be the last major case seeking to uproot the Affordable Care Act (ACA). Although skirmishes over the law and its implementation will persist, the Court’s decision most likely marks an end to Republicans’ efforts to achieve in the courts what they have been unable to achieve in Congress.

The Reincorporation Of Prisoners Into The Body Politic: Eliminating The Medicaid Inmate Exclusion Policy, Mira K. Edmonds

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Incarcerated people are excluded from Medicaid coverage due to a provision in the Social Security Act Amendments of 1965 known as the Medicaid Inmate Exclusion Policy (“MIEP”). This Article argues for the elimination of the MIEP as an anachronistic remnant of an earlier era prior to the massive growth of the U.S. incarcerated population and the expansion of Medicaid eligibility under the Patient Protection and Affordable Care Act of 2010. It explores three reasons for eliminating the MIEP. First, the inclusion of incarcerated populations in Medicaid coverage would signify the final erasure from the Medicaid regime of the istinction between …

Suicide Prevention And Mood Disorders: Self-Exclusion Agreements For Firearms As A Suicide Prevention Strategy, Melvin G. Mcinnis, Stephen B. Thompson, Sofia D. Merajver, Carl E. Schneider

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Suicide involves a complex set of behaviors and emotions that lead up to actions that may be based on planning and forethought or the result of impulse. While there are a host of antecedent circumstances the presence of a mood disorder, primarily depression, is the most common factor in suicide. While management of depression is recognized as important prevention strategy in depression, the means by which suicide occurs must be a critical element of prevention. Policies that lower access to the means for suicide will decrease the fatality. Guns are associated with half of suicides and the case fatality rate …

Equality And Sufficiency In Health Care Reform, Gabriel Scheffler

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Most Americans believe that health care is a right, not a privilege. Yet debates over health care reform frequently fail to distinguish between two distinct conceptions of the right to health care: one which focuses on sufficient access to health care-what I refer to as the Right to a Decent Minimum-and a second which focuses on equality in access to health care what I refer to as the Right to Equal Access. These two conceptions of the right to health care in turn support two distinct categories of proposals for expanding health insurance coverage. The Right to Equal Access justifies …

The New Eugenics, Samuel R. Bagenstos

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During the first third of the Twentieth Century, the eugenics movement played a powerful role in the politics, law, and culture of the United States. The fear of “the menace of the feebleminded,” the notion that those with supposedly poor genes “sap the strength of the State,” and other similar ideas drove the enthusiastic implementation of the practices of excluding disabled individuals from the country, incarcerating them in ostensibly beneficent institutions, and sterilizing them. By the 1930s, with the rise of Adolf Hitler in Germany, eugenic ideas had begun to be discredited in American public discourse. And after the Holocaust, …

How Much Can Potential Jurors Tell Us About Liability For Medical Artificial Intelligence?, W. Nicholson Price Ii, Sara Gerke, I. Glenn Cohen

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Artificial intelligence (AI) is rapidly entering medical practice, whether for risk prediction, diagnosis, or treatment recommendation. But a persistent question keeps arising: What happens when things go wrong? When patients are injured, and AI was involved, who will be liable and how? Liability is likely to influence the behavior of physicians who decide whether to follow AI advice, hospitals that implement AI tools for physician use, and developers who create those tools in the first place. If physicians are shielded from liability (typically medical malpractice liability) when they use AI tools, even if patient injury results, they are more likely …

Protecting Patients From Physicians Who Inflict Harm: New Legal Resources For State Medical Boards, Elizabeth Pendo, Tristan Mcintosh, Heidi A. Walsh, Kari Baldwin, James M. Dubois

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State medical boards (SMBs) protect the public by ensuring that physicians uphold appropriate standards of care and ethical practice. Despite this clear purpose, egregious types of wrongdoing by physicians are alarmingly frequent, harmful, and under-reported. Even when egregious wrongdoing is reported to SMBs, it is unclear why SMBs sometimes fail to promptly remove seriously offending physicians from practice. Legal and policy tools that are targeted, well-informed, and actionable are urgently needed to help SMBs more effectively protect patients from egregious wrongdoing by physicians.

Past reviews of SMB performance have identified features of SMBs associated with higher rates of severe disciplinary …

Substance Use Disorder Discrimination And The Cares Act: Using Disability Law To Inform Part 2 Rulemaking, Kelly K. Dineen, Elizabeth Pendo

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Substance use disorder (SUD) is a chronic health condition—like people with other chronic health conditions, people with SUDs experience periods of remission and periods of exacerbation or recurrence. Unlike people with most other chronic conditions, people with SUDs may be more likely to garner law enforcement attention than medical attention during a recurrence. They are also chronically disadvantaged by pervasive social stigma, discrimination, and structural inequities. The COVID-19 pandemic has had devastating consequences for people with SUDs, who are at higher risk for both contracting the SARS-CoV-19 virus and experiencing poorer outcomes. Meanwhile, there are early indications that pandemic conditions …

Pandemics And International Law: The Need To Strengthen International Legal Frameworks After The Covid-19 Global Health Pandemic [Sierra Leone], Charles C. Jalloh

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No abstract provided.

Opioid Settlement Funds: Do Not Neglect Patients With Pain, Mark C. Bicket, Barbara Mcquade, Chad M. Brummett

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The opioid crisis has escalated in the setting of the COVID-19 pandemic to new extremes and has claimed more than half a million lives in the US since 2000. Lawsuits to address the civil and criminal liability of drug companies and other groups have originated from federal, state, local, and tribal jurisdictions. When successful, there will likely be billions of dollars and significant discretion as to how these funds are spent. Several groups have produced reports with principles to address the toll of addiction using settlement funds. However, they lack actionable strategies to address the needs of patients with pain, …

Taxes As Pandemic Controls, Ashley C. Craig, James R. Hines Jr.

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Tax policy can play important roles in limiting the spread of communicable disease and in managing the economic fallout of a pandemic. Taxes on business activities that bring workers or customers into close contact with each other offer efficient alternatives to broad regulatory measures, such as shutdowns, that have been effective but enormously costly. Corrective taxation also helps raise the revenue required to cover elevated government expenditure during a pandemic. Moreover, the restricted consumer choice that accompanies a pandemic reduces the welfare cost of raising tax revenue from higher-income taxpayers, making it a good time for deficit closure. Current U.S. …

How The Covid-19 Pandemic Has And Should Reshape The American Safety Net, Gabriel Scheffler, Andrew Hammond, Ariel Jurow Kleiman

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No abstract provided.

What Will (Or Might?) Law School Look Like This Fall?: Teaching In The Midst Of A Pandemic, Ted Becker

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January 2020 marked the start of a new semester for Michigan law schools. There was little reason to suspect it wouldn’t be a semester like any other: for 3Ls, the start of the stretch run to graduation; for 1Ls, a chance to begin anew after the stress of their first set of law school final exams; for law school faculty, administrators, and staff, a return to the excitement and activity of crowded hallways and classrooms after the brief interlude of winter break. Classes began and proceeded as normal.

Covid-19, Single-Sourced Diagnostic Tests, And Innovation Policy, Deb Chaarushena, Osman Moneer, Nicholson W. Price Ii

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At the heart of the United States, disastrous response to the Covid-19 pandemic is a failure of diagnostic testing. That something so fundamental to medical care could be so botched evokes incredulity. From primary care offices to critical care settings, every patient encounter begins with a diagnostic workup. Diagnostic testing tools are key parts of the physician’s toolkit, and confirmatory testing is essential. But in the greatest public health challenge of the 21st century, the failures of diagnostic testing have been laid entirely bare.

What's Left Of The Affordable Care Act?, Helen Levy, Andrew Ying, Nicholas Bagley

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We assess the progress of the Affordable Care Act a decade after it became law. Although most of it remains intact, some parts have been repealed and others have not been implemented as expected. We review how and why the law has aged. Legal challenges have done less damage than is commonly appreciated, with the exception of the Supreme Court case that thwarted full expansion of Medicaid. Most of the important changes have other sources. Some parts were born to fail. Others were dismantled in response to interest-group pressure. Still others have failed to thrive for any number of reasons. …

The Neglect Of Persons With Severe Brain Injury To The United States: An International Human Rights Analysis, Tamar Ezer, Megan S. Wright, Joseph J. Wright

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Brain injury contributes more to death and disability globally than any other traumatic incident. While the past decade has seen significant medical advances, laws and policies remain stumbling blocks to treatment and care. The quality of life of persons with severe brain injury often declines with unnecessary institutionalization and inadequate access to rehabilitation and assistive technologies. This raises a host of rights violations that are hidden, given that persons with severe brain injury are generally invisible and marginalized. This article highlights the current neglect and experiences of persons with severe brain injury in the United States, analyzing the rights to …

Medical Marijuana, Taxation, And Internal Revenue Code Section 280e, Douglas A. Kahn, Howard J. Bromberg

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Congress enacted § 280E of the Internal Revenue Code in 1982 to punish businesses engaged in illegal drug trafficking, including marijuana. Section 280E denies all credits and deductions, including ordinary business expenses, from gross income of businesses illegally trafficking in a Schedule I or II controlled substance. This provision violates the principle that the tax code should foster a consistent treatment of income, regardless of source; and that the income tax is ill-used for punitive measures. Now that marijuana has been legalized in some form in at least 46 states for therapeutic purposes, this federal tax penalty transgresses principles of …

Who Gets The Ventilator? Disability Discrimination In Covid-19 Medical-Rationing Protocols, Samuel Bagenstos

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The coronavirus pandemic has forced us to reckon with the possibility of having to ration life-saving medical treatments. In response, many health systems have employed protocols that explicitly de-prioritize people for these treatments based on pre-existing disabilities. This Essay argues that such protocols violate the Americans with Disabilities Act, the Rehabilitation Act, and the Affordable Care Act. Such explicit discrimination on its face violates these statutes. Nor can medical providers simply define disabled patients as being “unqualified” because of disabilities that do not affect the ability to ameliorate the condition for which treatment is sought. A proper interpretation of the …

Importing Prescription Drugs From Canada — Legal And Practical Problems With The Trump Administration's Proposal, Rachel E. Sachs, Nicholas Bagley

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As Americans report ever-growing difficulty affording their prescription drugs, President Donald Trump has come under increasing pressure to act. To date, the Trump administration has attempted to advance a number of policy initiatives by means of executive action, but it has not yet adopted a program that would meaningfully assist patients. Most recently, the administration proposed a rule that, if finalized, would allow states to develop programs to import lower-priced prescription drugs from Canada, with the intent of reducing spending on drugs by U.S. patients and states and increasing access for patients.

The Coronavirus And The Risks To The Elderly In Long-Term Care, William Gardner, David States, Nicholas Bagley

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The elderly in long-term care (LTC) and their caregiving staff are at elevated risk from COVID-19. Outbreaks in LTC facilities can threaten the health care system. COVID-19 suppression should focus on testing and infection control at LTC facilities. Policies should also be developed to ensure that LTC facilities remain adequately staffed and that infection control protocols are closely followed. Family will not be able to visit LTC facilities, increasing isolation and vulnerability to abuse and neglect. To protect residents and staff, supervision of LTC facilities should remain a priority during the pandemic.

The Dynamism Of Health Law: Expanded Insurance Coverage As The Engine Of Regulatory Reform, Gabriel Scheffler

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Can law improve the delivery of health care? The predominant view is that law serves as a barrier to reforming the health care delivery system. Health law scholars of all stripes blame regulations for impeding innovation, limiting competition, and exacerbating fragmentation in health care.

I argue that this view neglects an important-but overlooked-feature of health law: the dynamic relationship between laws that expand health insurance coverage and laws that regulate the delivery of health care. By expanding health insurance coverage and increasing the demand for health care, laws such as Medicare, Medicaid and the Affordable Care Act catalyze policymakers to …

The Hidden Disability Consensus In The 2020 Campaign, Harold A. Pollack, Samuel R. Bagenstos

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At this writing, the final results of the Iowa caucuses remain unreported. No one yet knows which candidates did well and which did poorly. We do know that health policy is a defining cleavage between left and liberal Democrats this primary season. Much of the press coverage will naturally focus on the implications of this vote for Democrats’ commitment to an incremental public option or a full-throated single-payer plan.

Olmstead V. L.C.: The Supreme Court Case, Samuel R. Bagenstos, Irv Gornstein, Michael Gottesman, Jennifer Mathis

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You have an incredible luxury here at Georgetown Law. You have faculty who are engaged in the world like two of my colleagues on this panel. To my immediate left is Professor Michael Gottesman (Georgetown University Law Center) who argued the case on behalf of Lois and Elaine, and to my next far left, Professor Irv Gornstein (Georgetown University Law Center) who argued the case on behalf of the United States. Between them is Jennifer Mathis (The Bazelon Center for Mental Health Law) who has spent, I think, most of her career at the Bazelon Center litigating, and organizing, and …

Is Obamacare Really Unconstitutional?, Nicholas Bagley

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On December 18, 2019, just 3 days after the close of open enrollment on the exchanges and on the same day the House of Representatives impeached President Donald Trump, a conservative appeals court handed the President a major victory in his crusade against the Affordable Care Act (ACA). Over a stern dissent, the U.S. Court of Appeals for the Fifth Circuit declared that the law’s individual mandate is unconstitutional and that the entire rest of the law might therefore be invalid.

The Role Of Law And Policy In Achieving Healthy People’S Disability And Health Goals Around Access To Health Care, Activities Promoting Health And Wellness, Independent Living And Participation, And Collecting Data In The United States, Elizabeth Pendo, Lisa I. Iezzoni

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Ensuring that the almost 60 million Americans with disabilities live as healthy and independent lives as possible is an important goal for our nation. This evidence-based report highlights efforts to better use law and policy to support and protect people with disabilities. Specifically, it examines how existing federal laws and policies could be leveraged by states, communities, and other sectors to reduce barriers to primary and preventive care; reduce barriers to local health and wellness programs; increase access to leisure, social, or community activities (and indirectly, to religious activities) for individuals with disabilities; and generate better disability data needed to …