The high cost of medication is a common challenge for many Americans. This is particularly true for patients served by Federally Qualified Health Centers (FQHCs) that often have low income and are medically vulnerable. In this article I discuss the history and purpose behind the creation of the 340B drug pricing program, legislation enacted to limit the cost of drugs used by patients covered by Medicaid that requires drug manufacturers to enter into discount agreements with the Health Resources and Services Administration (HRSA), and how for years this program has been used to finance health care provision for communities that use FQHCs as their source of primary care. Additionally, I will discuss the history behind the creation of FQHCs and how that mission is affected by litigation and proposed reforms that would limit the ability of FQHCs to leverage savings and revenue from the program to fund health services for their patient populations. I argue that reinforcement of existing discounting practices, along with limited reforms of the 340B program are necessary to avoid disruption of health care provision for patients of FQHCs and to ensure that the 340B program continues to perform as intended.
This article will focus on the use of AI tools in diagnosis and patient treatment in hospitals and health care systems. AI vendors promise efficiencies in workplaces: various forms of AI are already being developed to read x-rays and other medical scans, to diagnose a wide range of patient conditions, and to offer a partnership (or risk displacement) of physicians. AI is being pushed to transform medical diagnostics, care quality, patient safety, clinical experience, and efficiencies all over hospital operations. These AI technologies however are still novel and new, and studies proving efficacy or disclaiming it are often based on small scale studies or other limitations.I will take a quick look at the tools that comprise the use of AI in health care and the claims of effectiveness of AI alone or in partnership with physicians in making clinical decisions. I will then look at the ways in which AI can fail to meet its promises, causing serious harms. Finally, I will examine the prospects of a hybrid regulatory/liability model to regulate AI risks as hospitals and providers expand their uses of AI tools.
Despite the routine assessment of decisional capacity in the clinical context, the concept of capacity is contested, and its measurement is flawed. For example, scholars and clinicians disagree about the criteria for demonstrating capacity. There is further lack of consensus about whether some types of medical decisions should require more evidence of capacity. Moreover, there is robust literature demonstrating that formal capacity assessment instruments are not always valid and reliable. This Article focuses on these and other issues, namely the fact that (in)capacity as currently understood is often not viewed relationally and contextually. (In)capacity is viewed as a cognitive property of an individual - an individual has capacity or does not. However, properly conceived, (in)capacity is constituted in interaction with others (e.g., health care providers, family, friends) and one's environment, and mediated through one's body and experience of health, illness, or disability. When this reality is not acknowledged, clinicians, caregivers, family members, and others miss opportunities to strengthen patients' decisional capacity by modifying how they communicate with patients and by changing patients' environment to improve decision-making. In fact, not acknowledging the relational and contextual nature of (in)capacity likely leads to weakening of patients' decision-making abilities and the unnecessary disqualification of patients from contemporaneous decision-making, which subsequently negatively affects patient interests in maintaining autonomy and bodily integrity and experiencing wellbeing. This Article will foreground the relational and contextual nature of (in)capacity and address problems with capacity assessments for adult patients in the medical decision-making context, propose reforms to the capacity assessment process, and conclude by discussing the implications of these arguments in other decision-making contexts.
The use of AvertD, a genetic test to assess an individual's risk of developing opioid use disorder, will expose physicians to liability. Critics of the test argue that the test itself is unreliable, often resulting in false positives, which will lead to potential undertreatment of pain, and false negatives, which will lead to inappropriate opioid prescriptions. But if the test is available, physicians will use it. And often, due to a combination of genetic determinism and genetic illiteracy, physicians will rely on the test to make opioid prescription decisions without also looking to the environmental, socioeconomic, lifestyle, and other factors that contribute to an individual's opioid use disorder risk.Genetic test results that purport to predict opioid use disorder - or really, any behavioral or psychiatric trait or diagnosis - may have enormous consequences for individual lives. When patients are harmed by physicians' negligent clinical decision making, they can often turn to tort law for a remedy. This article covers various physician liability scenarios, from inappropriate prescribing based on genetic test results to failure to test and informed consent issues. Physicians could face liability for prescribing opioids after a positive test result, or for denying pain medication due to false positive test results, or for prescribing opioids to patients despite negative results that prove false, or for failing to administer the test at all. This article concludes that existing tort frameworks offer insufficient protection for patients and fail to ensure appropriate integration of these tests into clinical practice. And relying on tort law will not mitigate the individual and societal harms raised by the introduction of a polygenic risk score test for opioid use disorder.
With more than sixty percent of U.S. adults struggling with at least one diet-related health condition, the relationship between nutrition and public health has never been clearer. Indeed, for the first time in over a century, food has a prominent place on the national political stage and is one of the exceedingly few issues that has garnered bipartisan support. The recent rise in popularity of “Food Is Medicine” initiatives, which seek to provide medically tailored or healthy meals to vulnerable populations, underscores the critical importance of food to public health. Yet, while “Food Is Medicine” is shifting the insurance, business, and nutritional landscape, the Food and Drug Administration (“FDA”) — the primary regulator in charge of both food and drug safety — treats food as anything but medicine. Known and unknown food additives, color dyes categorically banned in other countries, chemicals leaching from paper and plastic, and environmental toxins and pathogens all contaminate our food and sicken children and adults alike. All the while, the FDA acts as if it were powerless to fulfill its mission of protecting the public from unsafe food. In a time when the political will to reform our food system and rid it of harmful chemicals and ingredients is high, this article offers a blueprint for how to do so in a scientifically grounded, legally consistent, and lasting manner. Starting from the basic premise that food can be medicine, the article explores ways to bring food safety review closer to the much more demanding safety process for pharmaceuticals. Part I defends the premise that food is every bit as important to human health as medicine — both for good and for ill — and posits that food safety should be regulated just as much as (even if not in identical ways to) the safety of medical drugs. Parts II and III offer a comparison between the rigors of drug safety review, albeit with its own set of problems, and the laxity and at times utter lack of food safety review. Finally, Part IV advances a comprehensive package of both legislative and regulatory reforms, all designed to shift the de facto burden of proving the safety of food ingredients from the overtaxed FDA and the overburdened consumers to food manufacturers.
Patients experiencing pregnancy complications have died after being denied emergency medical treatment in states with restrictive abortion laws even where the laws ostensibly allow pregnancy termination when necessary to save a patient's life. For patients experiencing miscarriage, premature rupture of membranes, placental abruption, severe hypertensive disorders, ectopic pregnancy, and other conditions, a treating physician's decision about whether their condition qualifies as an emergency under state law can mean the difference between life and death. Physicians who treat obstetric emergencies report being torn between delivering evidence-based care and protecting themselves from criminal prosecution. This article frames physician decision-making about emergency abortion within the larger institutional context in which those decisions arise, providing a taxonomy of the myriad hospital policies that impact physicians who treat obstetric emergencies. It evaluates these institutional procedures' efficacy with respect to the dual goals of protecting pregnant patients' health and limiting providers' exposure to legal risk. The article concludes that the optimal institutional approach grants full deference to physicians' clinical judgment while also providing robust institutional support in the form of comprehensive legal guidance and guaranteed legal representation for physicians who are prosecuted for making good faith medical judgments. It calls upon hospitals to re-commit to their primary mission of providing high quality patient care, and to dedicate resources to supporting physicians who deliver evidence-based care despite unrelenting legal and political pressures.
After Dobbs v. Jackson Women's Health Organization, the United States Supreme Court decision that overturned Roe v. Wade in 2022, OB/GYN residents' access to abortion training, which is required in all accredited programs, has come under pressure. To receive the foundational training doctors in the field need, many residents in ban states travel to out-of-state programs where abortion is legal. But demand is high, travel for multiple weeks is expensive, and the capacity to train at host sites is limited. Training by travel could have ripple effects for the quality of patient care. As the number of OB/GYNs continues to decrease, newly-trained providers will have different, and arguably diminished, skills in delivering not just elective but also medically necessary abortion care. And as exceptions for life and health become how legal, procedural terminations take place in one-third of the United States, there is no guarantee that the doctors in those states will feel comfortable providing that care. This article explores the residency training provided today, providers' and institutions' navigation of abortion bans, and what changes in residency programs might mean for patient care in the coming years. Part I surveys the landscape of abortion law after Dobbs; even the strictest bans contemplate instances when abortion is medically required and legally permitted. Part II summarizes the pre- and post-Dobbs expectations for abortion training for OB/GYN residents, describing how graduate medical education has changed for residents in ban states. Part III assesses shorter and longer-term effects of a system that relies on travel and simulation (the use of models) or is out of compliance with national accreditation standards. Part IV concludes with potential paths forward that depend on state and national organizations supporting and funding the networks of health care professionals that facilitate training across the country.
Financialization of healthcare drains our current system of resources it needs to provide care. It occurs when money is siphoned off for private profit through mechanisms such as rent seeking, gamesmanship, and exploitative price setting. This is not an ethically neutral activity, and the people profiting in this way ought to justify why they are entitled to this money, given the foreseeable negative effects what they are doing has on people's health. This important problem is masked by current accounting methods and healthcare billing methods, which need to be changed to allow for a more transparent assessment of what is really occurring.
The employment of people with disabilities lags significantly behind the employment of people without disabilities. This article addresses the traditional means for increasing the employment of people with significant disabilities, primarily through anti-discrimination law and affirmative action efforts. It then argues that another effective means for increasing such employment is to expand and modernize an existing federal program that designates certain federal procurement contracts to employers that hire a required percentage of people with significant disabilities.
This paper addresses the comprehensive regulation of artificial intelligence ("AI") across its entire lifecycle in the health care sector. It builds on a proposal for a True Lifecycle Approach ("TLA") to address governance gaps across three phases of AI and expands the framework with detailed practical insights for governing health care AI, drawing on pioneering examples from Qatar, Saudi Arabia, and the United Arab Emirates ("UAE") as models for global implementation. Beginning with the research and development phase, it highlights the urgent need for robust guidelines and certification processes to ensure that AI technologies are developed in compliance with ethical and safety standards. Moving into the approval stage, the discussion explores how AI systems can be effectively regulated under existing medical device frameworks, emphasizing the need for tailored regulations that consider the unique challenges posed by AI. Finally, the paper delves into the deployment of AI in clinical practice, examining the gaps in current laws and the need for a coherent and consistent regulatory framework that can adapt to AI advancements. The paper argues that the existing legal structures are inadequate, often inconsistent, and fail to address the complexities of AI in health care. It argues for a broader regulatory approach focused on patient safety throughout the AI lifecycle.
The American Law Institute (ALI) recently approved its first ever Restatement of Medical Malpractice law. One Restatement subsection embraces the position that an authoritative clinical practice guideline, if admissible and sufficiently relevant, can be prima facie evidence of a provider's compliance with the standard of care. This article responds to a forceful critique of that position by two of the Restatement's advisors, who are nationally esteemed members of the plaintiff's bar. They argue that caselaw does not support this provision, that it is unsound public policy, and that the provision is unfair because it does not afford the same prima facie proof status to plaintiffs' use of practice guidelines. This article addresses each of those critiques. It starts with the observation that, at bottom, this opposition is fundamentally at odds with the primary governing principle of professional liability, namely, that professional standards have greater force in medical liability cases than do industry standards in general negligence cases. Because professional standards determine professional negligence, a relevant clinical practice guideline that speaks with authority for a relevant segment of medical professionals, if admissible, should be sufficient to support a jury finding of non-negligence for a doctor who complies. The same conclusion does not apply, however, when a plaintiff presents a single relevant guideline that a physician failed to follow, for the simple reason that it is often the case that more than one approach can reasonably apply to a given clinical situation. Also, guidelines often set ideal rather than minimal standards. Thus, this provision's differential effect is not fundamentally unfair. Instead, it flows directly from a plaintiff's burden of establishing professional negligence, much like numerous other conventional legal rules can affect opposing sides of a case differently. As accomplished advocates, it is no surprise these authors have made the strongest possible case against any enhanced legal status for defensive use of exculpatory practice guidelines. Thoughtful inspection and reflection reveal, though, that their analysis significantly misstates or over-states the Restatement's position, and so their attacks are mostly misdirected. If this Restatement's position were truly as radical or poorly considered as these authors portray, the ALI likely would not have adopted it. Nevertheless, engaging with this critique can better elucidate reasons that courts might view this Restatement provision as well-considered.
Medicaid serves vulnerable populations that experience deep health inequities and significant health-related social needs. In recent years, reforms to Medicaid have sought to respond to those needs, with mixed results. Value based payment methods, which in theory link payment to outcome metrics, are emerging in commercial insurance markets and can be adapted to the needs of Medicaid programs and their beneficiaries. These methods seek to tie payment for services to the forging of connections between medical and social care including housing supports and nutrition services for vulnerable populations. This paper describes the merits and some pitfalls of the attempt to turn Medicaid from its roots as a medical insurance program to a broader health insurance program. It describes the benefits of employing community care hubs - intermediaries between community-based organizations and large payers and hospital systems - as a way to spur the move to social care in Medicaid. It also addresses some of the barriers to this move, including the perceived danger of "medicalizing" society's failures and the apparent turn by the current federal administration away from commitment to health equity.
The catchphrase "if you build it, they will come," from the movie "Field of Dreams," described an audacious plan to build a small baseball stadium in a remote cornfield. It could also describe the government infrastructure which has drawn in the ever-growing American health care business sector. A series of increasingly complex and expensive programs, first launched just after World War II, continue to provide essential funding and regulatory support for a multitude of private companies that have revolutionized medical care and, in the process, built an industry that represents more than 18% of the country's economy. This parade of programs includes the Hill-Burton Act of 1946, Medicare and Medicaid in 1965, the initiation of the Human Genome Project in 1990, and 2010's Patient Protection and Affordable Care Act, all of which created platforms on which private entities rely to provide medical services and products. In the process, these private entities have made and continue to generate substantial profits. And while many of them have improved public wellbeing dramatically, many have also degraded the system's integrity through fraud and anticompetitive behavior. In its role of keeping this huge and essential private enterprise on track, health law has become an indispensable part of the system, with health lawyers serving as the foundation of its effective operation.
This Article discusses the design of an innovative approach to the traditional medical-legal partnership. This potentially transformative service model proposes the use of unauthorized practice of law (UPL) reform to embed civil legal problem solving within a patient care setting. Unlike in the traditional medical-legal partnership - a service model which embeds lawyers within patient care settings to address patients' justice needs - we explore the promise of patient advocacy through community-based justice workers (CBJWs): members of the community who are not lawyers but who have specialized legal training and authorization to provide civil legal help to those who need it most. This work is the result of a partnership between Innovation for Justice, a social justice legal innovation lab housed at both the University of Arizona James E. Rogers College of Law and the University of Utah David Eccles School of Business, and University of Utah Health. The present framework for UPL-reform-based medical-legal partnerships was developed through robust community-engaged research and design work across the 2022-23 academic year. This article discusses the research findings and proposes a framework for replication in other jurisdictions.
Over the past three decades, the U.S. health care system has experienced numerous shortages of commonly-used older medicines that are both off-patent and inexpensive. Commentators seeking to explain shortages have often pointed to manufacturing quality and low profit margins as principal causes. These proximate causes, however, do not explain why there was a sudden and dramatic increase in shortages between 2007 and 2012, when shortages almost tripled from 154 to 456, or why they have persisted at similar levels into the 2020s despite repeated efforts to address them. This Article posits that low prices and quality problems derive from underlying shifts in the market environment, and that these shifts in turn are largely the result of Congressional legislation. The role of such well-intentioned legislation over the past fifty years is evaluated, including the 1984 Hatch-Waxman Act, the 2003 Medicare Modernization Act, the 2012 Generic Drug User Fee Act, and the 2015 Bipartisan Budget Act. The analysis reveals these laws have inadvertently squeezed profitability out of the generic drug market and thereby served as a true root cause of many drug shortages. Also considered are the potential effects on drug shortages of more recent legislation, including the 2021 American Rescue Act Plan and the 2022 Inflation Reduction Act.
This essay explores central aspects of the relationship between money and national health policy from the passage of Medicare in 1965 to the present, including the two most sweeping attempts at system reinvention during that period: the Patient Protection and Affordable Care Act of 2010 (ACA), and the failed Health Security Act of the early 1990s. Its point is not that ethical professionalism has prevailed, though it survives on the skill and dedication of nurses, physicians, and other health care workers. Rather, its point is that one should not criticize the morality of change without interrogating the morality of the status quo. In the 1990s, Jerome Kassirer wrote that "a system in which there is no equity is, in fact, already unethical." The same can be said for a system that overfunds medical care and underfunds other essential social investments, including education. A system that, moreover, cannot be justified by the limited morality of competition in the marketplace because it does not - and could not absent radical change - perform as a functioning market would. In terms of robust market competition with its winners and losers, U.S. health care has been, at worst, a sheep in wolf's clothing.
The Insular Cases, a relic of imperial-era judicial reasoning, have long dictated the political and constitutional status of U.S. territories. In United States v. Vaello-Madeo, Justice Neil Gorsuch's concurring opinion signaled a critical moment for reevaluating these precedents. This Note examines the enduring consequences of the Insular Cases, focusing on the Pacific Island Territory of Guam as a case study. Specifically, it explores how Guam's political subordination-rooted in the judicial distinction between incorporated and unincorporated territories-has led to disparities in federal Medicaid funding. By analyzing the relationship between territorial representation in Congress and the structural inequities in health care funding, this Note argues that the constitutional instability caused by the Insular Cases presents a ripe opportunity for legal challenge. Justice Gorsuch's opinion opens a path for reconsidering the Insular Cases, with federal Medicaid funding serving as a compelling vehicle for addressing the broader constitutional and democratic deficiencies imposed on U.S. territories.
This reflection article examines the trajectory of health law - using scholarly work by George Annas, Wendy Mariner, and Fran Miller as a platform.1 These three health law scholars have been analyzing the complications of health law in the U.S. economy for decades, and each of them has been prescient in anticipating what the future of health care delivery will look like and how we might improve it.
Medicaid has been called the “workhorse” of the American health care system, but one would hardly see that in the tenor of political debates. The Program perennially faces political headwinds that at times build to hurricane force with proposals for dramatic structural changes and spending cuts, most recently the draconian cuts enacted by Congress in 2025. In 2024, Medicaid covered more than seventy million Americans, and another ten million were covered by its companion program, the Children’s Health Insurance Program. As formidable as these numbers are, the Program’s impact runs much deeper, affecting the lives of almost everyone in the United States. It serves as an essential support for the entire health care system and, in doing so, helps to sustain almost every hospital, nursing home, and a range of other providers. This support, in turn, generates population-wide benefits that can be seen as public goods on which everyone relies, whether they realize it or not, that the private sector could not provide. These include peace of mind from knowing there is access to inpatient hospital care, emergency rooms, and long-term care when needed, protection from public health threats, improved health care based on continual innovation, greater social stability, enhanced economic productivity, and reduced health inequities. As devastating as proposals to shrink Medicaid would be for millions of low-income Americans who rely on it for access to health care, these repercussions would cause hardship for almost everyone. This article explains Medicaid’s role in sustaining the overall health care system, the nature of the public goods it produces in doing so, and the widespread harm that would be caused were these public goods to be diminished. By characterizing public debates in this way, the Program’s supporters could reframe political discourse as a matter of universal self-interest.
