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Defining Health Affordability, Govind C. Persad

Sturm College of Law: Faculty Scholarship

Affordable health care, insurance, and prescription drugs are priorities for the public and for policymakers. Yet the lack of a consensus definition of health affordability is increasingly recognized as a roadblock to health reform efforts. This Article explains how and why American health law invokes health affordability and attempts, or fails, to define the concept. It then evaluates potential affordability definitions and proposes strategies for defining affordability more clearly and consistently in health law.

Part I examines the role health affordability plays in American health policy, in part by contrasting the United States’s health system with systems elsewhere. Part II …

The Shared Ethical Framework To Allocate Scarce Medical Resources: A Lesson From Covid-19, Ezekiel J. Emanuel, Govind C. Persad

Sturm College of Law: Faculty Scholarship

The COVID-19 pandemic has helped to clarify the fair and equitable allocation of scarce medical resources, both within and among countries. The ethical allocation of such resources entails a three-step process: (1) elucidating the fundamental ethical values for allocation, (2) using these values to delineate priority tiers for scarce resources, and (3) implementing the prioritisation to faithfully realise the fundamental values. Myriad reports and assessments have elucidated five core substantive values for ethical allocation: maximising benefits and minimising harms, mitigating unfair disadvantage, equal moral concern, reciprocity, and instrumental value. These values are universal. None of the values are sufficient alone, …

Considering Vaccination Status, Govind C. Persad

Sturm College of Law: Faculty Scholarship

"This Article examines whether policies—sometimes termed “vaccine mandates” or “vaccine requirements”— that consider vaccination status as a condition of employment, receipt of goods and services, or educational or other activity for participation are legally permitted, and whether such policies may even sometimes be legally required. It does so with particular reference to COVID-19 vaccines.

Part I explains the legality of private actors, such as employers or private universities, considering vaccination status, and concludes that such consideration is almost always legally permissible unless foreclosed by specific state legislation. Part II examines the consideration of vaccination status by state or federal policy. …

Fair Domestic Allocation Of Monkeypox Virus Countermeasures, Govind C. Persad, R. J. Leland, Trygve Ottersen, Henry S. Richardson, Carla Saenz, G. Owen Schaefer, Ezekiel J. Emanuel

Sturm College of Law: Faculty Scholarship

Countermeasures for mpox (formerly known as monkeypox), primarily vaccines, have been in limited supply in many countries during outbreaks. Equitable allocation of scarce resources during public health emergencies is a complex challenge. Identifying the objectives and core values for the allocation of mpox countermeasures, using those values to provide guidance for priority groups and prioritisation tiers, and optimising allocation implementation are important. The fundamental values for the allocation of mpox countermeasures are: preventing death and illness; reducing the association between death or illness and unjust disparities; prioritising those who prevent harm or mitigate disparities; recognising contributions to combating an outbreak; …

Reserve System Design For Allocation Of Scarce Medical Resources In A Pandemic: Some Perspectives From The Field, Parag A. Pathak, Govind C. Persad, Tayfun Sönmez, M. Utku Unver

Sturm College of Law: Faculty Scholarship

No abstract provided.

A Multicenter Weighted Lottery To Equitably Allocate Scarce Covid-19 Therapeutics, Douglas B. White, Erin K. Mccreary, Chung-Chou H. Chang, Mark Schmidhoffer, J. Ryan Bariola, Naudia N. Jonassaint, Govind C. Persad, Robert D. Truog, Parag A. Pathak, Tayfun Sönmez, M. Utku Unver

Sturm College of Law: Faculty Scholarship

Shortages of new therapeutics to treat coronavirus disease (COVID-19) have forced clinicians, public health officials, and health systems to grapple with difficult questions about how to fairly allocate potentially life-saving treatments when there are not enough for all patients in need. Shortages have occurred with remdesivir, tocilizumab, monoclonal antibodies, and the oralantiviral Paxlovid.

Ensuring equitable allocation is especially important in light of the disproportionate burden experienced during the COVID-19 pandemic by disadvantaged groups, including Black, Hispanic/Latino and Indigenous communities, individuals with certain disabilities, and low-income persons. However, many health systems have resorted to first-come, first-served approaches to allocation, which tend …

Reforming Age Cutoffs, Govind C. Persad

Sturm College of Law: Faculty Scholarship

This Article examines the use of minimum age cutoffs to define eligibility for social insurance, public benefits, and other governmental programs. These cutoffs are frequently used but rarely examined in detail. In Part I, I examine and catalogue policies that employ minimum age cutoffs. These include not only Medicare and Social Security but also other policies such as access to pensions and retirement benefits, eligibility for favorable tax treatment, and eligibility for discounts on governmentally provided goods and services. In Part II, I examine different rationales underlying eligibility and discuss the imperfect fit between these rationales and the use of …

Fair Allocation Of Scarce Therapies For Coronavirus Disease 2019 (Covid-19), Govind C. Persad, Monica E. Peek, Seema K. Shah

Sturm College of Law: Faculty Scholarship

The US Food and Drug Administration (FDA) has issued emergency use authorizations (EUAs) for monoclonal antibodies (mAbs) for nonhospitalized patients with mild or moderate coronavirus disease 2019 (COVID-19) disease and for individuals exposed to COVID-19 as postexposure prophylaxis. EUAs for oral antiviral drugs have also been issued. Due to increased demand because of the Delta variant, the federal government resumed control over the supply and asked states to ration doses. As future variants (e.g., the Omicron variant) emerge, further rationing may be required. We identify relevant ethical principles (i.e., benefiting people and preventing harm, equal concern, and mitigating health inequities) …

Covid-19 Vaccine Refusal And Fair Allocation Of Scarce Medical Resources, Govind Persad, Emily A. Largent

Sturm College of Law: Faculty Scholarship

When hospitals face surges of patients with COVID-19, fair allocation of scarce medical resources remains a challenge. Scarcity has at times encompassed not only hospital and intensive care unit beds—often reflecting staffing shortages—but also therapies and intensive treatments. Safe, highly effective COVID-19 vaccines have been free and widely available since mid-2021, yet many Americans remain unvaccinated by choice. Should their decision to forgo vaccination be considered when allocating scarce resources? Some have suggested it should,while others disagree. We offer a framework for evaluating when it is ethical and briefly discuss its legality in American law.

Fair Access To Scarce Medical Capacity For Non-Covid-19 Patients: A Role For Reserves, Govind C. Persad, Parag A. Pathak, Tayfun Sönmez, M. Utku Unver

Sturm College of Law: Faculty Scholarship

As hospitals in the US and elsewhere fill again with patients with covid-19, discussions about how to fairly allocate scarce medical resources have come to the fore once again. One frequently voiced concern is that non-covid-19 patients with urgent health needs are facing indefinitely postponed surgeries, long-distance hospital transfers, or even are unable to access medical treatment. In our view, a reserve or categorised priority system could help. It could be used to fairly distribute scarce medical capacity—such as staffing, physical space, and medical treatments—between covid-19 and non-covid-19 patients, just as it has been used or proposed to allocate covid-19 …

Race-Specific, State-Specific Covid-19 Vaccination Rates Adjusted For Age, Elizabeth Wrigley-Field, Kaitlyn M. Berry, Govind C. Persad

Sturm College of Law: Faculty Scholarship

The authors provide the first age-standardized race/ethnicity-specific, state-specific vaccination rates for the United States. Data encompass all states reporting race/ethnicity-specific vaccinations and reflect vaccinations through mid-October 2021, just before eligibility expanded below age 12. Using indirect age standardization, the authors compare racial/ethnic state vaccination rates with national rates. The results show that white and Black state median vaccination rates are, respectively, 89 percent and 76 percent of what would be predicted on the basis of age; Hispanic and Native rates are almost identical to what would be predicted; and Asian American/Pacific Islander rates are 110 percent of what would be …

Equal Protection And Scarce Therapies: The Role Of Race, Sex, And Other Protected Classifications, Govind C. Persad

Sturm College of Law: Faculty Scholarship

The COVID-19 pandemic brought debates over the use of age in scarce resource allocation to the fore once again. Initially, particularly in developed countries, debates surrounded the use of older age as an exclusion or lower-priority criterion for receipt of scarce medical interventions such as ICU beds and ventilator therapy. Many advocacy groups for older adults argued that age should not be used as a criterion for access to such interventions.[1] In developed countries and in particular the United States, they were largely successful, at least with respect to formal policy, ensuring that resource allocation policies excluded or minimized the …

A Comprehensive Covid-19 Response—The Need For Economic Evaluation, Govind C. Persad, Ankur Pandya

Sturm College of Law: Faculty Scholarship

Recently, the World Health Organization has exhorted countries to fight the Covid-19 pandemic with other interventions in addition to vaccines. But for countries to mount a comprehensive and effective response, more than exhortation is needed. Policymakers must understand the benefits and burdens associated with various policy options. They also have to be equipped to rigorously and systematically compare these benefits and burdens, both when evaluating individual policies and when determining which policies to include in a legislative or regulatory package.

Errors In Converting Principles To Protocols: Where The Bioethics Of Us Covid‐19 Vaccine Allocation Went Wrong, William F. Parker, Govind C. Persad, Monica E. Peek

Sturm College of Law: Faculty Scholarship

For much of 2021, allocating the scarce supply of Covid-19 vaccines was the world's most pressing bioethical challenge, and similar challenges may recur for novel therapies and future vaccines. In the United States, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) identified three fundamental ethical principles to guide the process: maximize benefits, promote justice, and mitigate health inequities. We argue that critical components of the recommended protocol were internally inconsistent with these principles. Specifically, the ACIP violated its principles by recommending overly broad health care worker priority in phase 1a, using being at least seventy-five …

Letter In Reply To Bernard Prusak, Et Al., Govind C. Persad

Sturm College of Law: Faculty Scholarship

Scarce medical resource allocation should aim to prevent harm, especially to those who would be most disadvantaged if not helped. Bernard Prusak et al.’s letter reveals a narrow vision of which harms and disadvantages matter, one that overlooks opportunities to simultaneously prevent important harms and avoid exacerbating disadvantage.

Tailoring Public Health Policies, Govind Persad

Sturm College of Law: Faculty Scholarship

In an effort to contain the spread of COVID-19, many states and countries have adopted public health restrictions on activities previously considered commonplace: crossing state borders, eating indoors, gathering together, and even leaving one's home. These policies often focus on specific activities or groups, rather than imposing the same limits across the board. In this Article, I consider the law and ethics of these policies, which I call tailored policies.In Part II, I identify two types of tailored policies: activity-based and group-based. Activity-based restrictions respond to differences in the risks and benefits of specific activities, such as walking outdoors and …

Allocating Medicine Fairly In An Unfair Pandemic, Govind Persad

Sturm College of Law: Faculty Scholarship

America’s COVID-19 pandemic has both devastated and disparately harmed minority communities. How can the allocation of scarce treatments for COVID-19 and similar public health threats fairly and legally respond to these racial disparities? Some have proposed that members of racial groups who have been especially hard-hit by the pandemic should receive priority for scarce treatments. Others have worried that this prioritization misidentifies racial disparities as reflecting biological differences rather than structural racism, or that it will generate mistrust among groups who have previously been harmed by medical research. Still others complain that such prioritization would be fundamentally unjust. I argue …

Improving The Ethical Review Of Health Policy And Systems Research: Some Suggestions, Govind Persad

Sturm College of Law: Faculty Scholarship

Consistent and well-designed frameworks for ethical oversight enable socially valuable research while forestalling harmful or poorly designed studies. I suggest some alterations that might strengthen the valuable checklist Rattani and Hyder propose in this issue of Journal of Law, Medicine & Ethics Reference Rattani and Hyder for the ethical review of health policy and systems research (HPSR), or prompt future work in the area.

Pricing Drugs Fairly, Govind C. Persad

Sturm College of Law: Faculty Scholarship

Dissatisfaction with drug prices has prompted a flurry of recent legislation and academic research. But while pharmaceutical policy often regards fair pricing as a goal, the concept of fairness itself frequently goes undefined. Legal scholarship—even work ostensibly focused on fairness—has not defined and defended an account of fair pricing. Recent legislative proposals passed by the House and proposed by Sens. Ron Wyden and Chuck Grassley have similarly avoided a determinate position on fairness. This Article explains and defends an account of what makes a price for a drug fair that identifies fair price with social value, argues for implementing fair …

Fair Allocation At Covid-19 Mass Vaccination Sites, William F. Parker, Govind C. Persad, Monica E. Peek

Sturm College of Law: Faculty Scholarship

On February 26, 2021, the Federal Emergency and Management Agency (FEMA) announced 18 community vaccination centers in major cities capable of administering up to 6000 vaccines daily. Mass vaccination sites like these arrive amid staggering socioeconomic and racial disparities in COVID-19 vaccination. Black and Hispanic people are being vaccinated at less than half the rate of White people, despite being twice as likely to die of COVID-19. The wealth gap is similarly substantial, reaching up to a 65% difference between the wealthiest and poorest counties in Connecticut. The federal government is supporting mass vaccination sites, in part, to alleviate disparities, …

Choosing Affordable Health Insurance, Govind Persad

Sturm College of Law: Faculty Scholarship

The Affordable Care Act ("ACA") made health insurance accessible to many. Yet unaffordable insurance still abounds. This Article proposes a strategy for improving affordability that enables health insurance purchasers to choose, within reasonable limits, which treatments their insurance covers. After critiquing recently proposed strategies for improving affordability and reviewing past legal scholarship on content choice in health insurance, this Article introduces the "Affordable Choices" framework. This framework regulates choice in four ways. First, health plans should only exclude treatments whose merits are subject to reasonable disagreement among patients and physicians. Second, plans should appeal to purchasers' health-related values- values about …

Setting Priorities Fairly In Response To Covid-19: Identifying Overlapping Consensus And Reasonable Disagreement, David Wasserman, Govind C. Persad, Joseph Millum

Sturm College of Law: Faculty Scholarship

Proposals for allocating scarce lifesaving resources in the face of the Covid-19 pandemic have aligned in some ways and conflicted in others. This paper attempts a kind of priority setting in addressing these conflicts. In the first part, we identify points on which we do not believe that reasonable people should differ—even if they do. These are (i) the inadequacy of traditional clinical ethics to address priority-setting in a pandemic; (ii) the relevance of saving lives; (iii) the flaws of first-come, first-served allocation; (iv) the relevance of post-episode survival; (v) the difference between age and other factors that affect life-expectancy; …

The Case For Valuing Non-Health And Indirect Benefits, Govind Persad, Jessica Du Toit

Sturm College of Law: Faculty Scholarship

Health policy is only one part of social policy. Although spending administered by the health sector constitutes a sizeable fraction of total state spending in most countries, other sectors such as education and transportation also represent major portions of national budgets. Additionally, though health is one important aspect of economic and social activity, people pursue many other goals in their social and economic lives. Similarly, direct benefits—those that are immediate results of health policy choices—are only a small portion of the overall impact of health policy. This chapter considers what weight health policy should give to its “spill-over effects,” namely …

Expensive Patients, Reinsurance, And The Future Of Health Care Reform, Govind Persad

Sturm College of Law: Faculty Scholarship

In 2017, Americans spent over $3.4 trillion-nearly 18% of gross domestic product-on health care. This spending is unevenly distributed: Almost a quarter is spent on the costliest 1% of patients, and almost half on the costliest 5%. Most of these patients soon return to a lower percentile, but many continue or economic, analysis of existing and proposed options for sharing expensive patients' costs. Third, it bridges the disconnected literature on reinsurance, limit setting, and health care financing, identifying how proposals in these different areas intersect. to incur health care costs in the top percentiles year after year. This Article focuses …

Disability Law And The Case For Evidence-Based Triage In A Pandemic, Govind Persad

Sturm College of Law: Faculty Scholarship

This Essay explains why model policies proposed or adopted in response to the COVID-19 pandemic that allocate scarce medical resources by using medical evidence to pursue two core goals—saving more lives and saving more years of life—are compatible and consonant with disability law. Disability law, properly understood, permits considering medical evidence about patients’ probability of surviving treatment and the quantity of scarce treatments they will likely use. It also permits prioritizing health workers, and considering patients’ post-treatment life expectancy. These factors, when based on medical evidence and not inaccurate stereotypes, are legal to consider even if they disadvantage some patients …

Examining Pharmaceutical Exceptionalism: Intellectual Property, Practical Expediency, And Global Health, Govind Persad

Sturm College of Law: Faculty Scholarship

Advocates, activists, and academics have criticized pharmaceutical intellectual property ("pharma IP") rights as obstacles to access to medicines for the global poor. These criticisms of pharma IP holders are frequently exceptionalist: they focus on pharma IP holders while ignoring whether others also bear obligations to assist patients in need. These others include holders of other lucrative IP rights, such as music copyrights or technology patents; firms, such as energy companies and banks, that do not rely on IP; and wealthy private individuals. Their resources could be used to aid patients by providing direct medical assistance, funding prizes or biomedical research, …

Transparency Trade-Offs Priority Setting, Scarcity, And Health Fairness, Govind Persad

Sturm College of Law: Faculty Scholarship

This chapter argues that rather than viewing transparency as a right, we should regard it as a finite resource whose allocation involves tradeoffs. It then argues that those tradeoffs should be resolved by using a multi-principle approach to distributive justice. The relevant principles include maximizing welfare, maximizing autonomy, and giving priority to the worst off. Finally, it examines some of the implications for law of recognizing the tradeoffs presented by transparency proposals.

Justice And Public Health, Govind Persad

Sturm College of Law: Faculty Scholarship

This chapter discusses how justice applies to public health. It begins by outlining three different metrics employed in discussions of justice: resources, capabilities, and welfare. It then discusses different accounts of justice in distribution, reviewing utilitarianism, egalitarianism, prioritarianism, and sufficientarianism, as well as desert-based theories, and applies these distributive approaches to public health examples. Next, it examines the interplay between distributive justice and individual rights, such as religious rights, property rights, and rights against discrimination, by discussing examples such as mandatory treatment and screening. The chapter also examines the nexus between public health and debates concerning whose interests matter to …

Evaluating The Legality Of Age-Based Criteria In Health Care: From Nondiscrimination And Discretion To Distributive Justice, Govind Persad

Sturm College of Law: Faculty Scholarship

Recent disputes over whether older people should pay more for health insurance, or receive lower priority for transplantable organs, highlight broader disagreements regarding the legality of using age-based criteria in health care. These debates will likely intensify given the changing age structure of the American population and the turmoil surrounding the financing of American health care. This Article provides a comprehensive examination of the legality and normative desirability of age-based criteria. In the Article, I defend a distributive justice approach to age-based criteria. Rather than viewing age as a personal characteristic akin to race or religion, the distributive justice approach …

Paying Patients: Legal And Ethical Dimensions, Govind Persad

Sturm College of Law: Faculty Scholarship

This Article explores the implications for medical care of a debate that is more familiar in the law and ethics of human subjects research: whether people should be paid to receive or decline medical interventions, or to reach certain health objectives. It examines the legal and ethical issues such payments raise, and considers various actors who might make such payments, including governments, employers, insurers, care providers, and private parties. It argues for two interrelated conclusions: first, that these payments should not be subject to blanket normative condemnation, and, second, that payments made in different settings and contexts frequently share underlying …