Defining Health Affordability

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 then reviews and categorizes approaches to affordability in American health law. It highlights how conceptions of affordability are woven into the Affordable Care Act’s premium assistance tax credits for marketplace buyers and how the American Rescue Plan and Inflation Reduction Act have implicitly shifted the definition of affordability. It also discusses how rulemaking around the “affordability guardrail” for state waivers of ACA provisions has prompted contestation between presidential administrations over the place of health equity and racial justice. After discussing these federal provisions, it identifies the role of affordability definitions in recent state-level innovations, such as affordability standards for health insurance and pharmaceutical affordability boards. The latter two Parts situate these legal enactments within a cohesive framework and make recommendations. Part III categorizes existing or proposed definitions of health affordability according to their normative commitments, drawing on sociological and philosophical scholarship. Part IV then evaluates potential approaches to defining affordability. Options include continuing to leave affordability undefined, rejecting affordability as a cornerstone of health law, or replacing affordability with some of its constituent concepts. Rather than these alternatives, I propose a hybrid definition that combines different definitions discussed in Part III. It proposes that health spending is affordable if it delivers value for money without worsening access to basic needs or a reasonable opportunity range

Risk, Everyday Intutions, and the Institutional Value of Tort Law

This Note offers a normative critique of cost-benefit analysis, one informed by deontological moral theory, in the context of the debate over whether tort litigation or a non-tort approach is the appropriate response to mass harm. The first Part argues that the difference between lay and expert intuitions about risk and harm often reflects a difference in normative judgments about the existing facts, rather than a difference in belief about what facts exist, which makes the lay intuitions more defensible. The second Part considers how tort has dealt with this divergence between lay and expert perspectives. It also evaluates how tort\u27s approach has differed from that of public law approaches to accident law, such as legislative compensation and risk regulation by administrative agencies. Ultimately, tort\u27s ability to recognize the value of lay intuitions supports retaining the tort perspective as part of our societal arsenal of responses to risk and harm. This ability can also support a pro-tort perspective in two practical debates in the arena of tort law: that over preemption of tort law by administrative agency judgments, and that over access to tort recovery as part of a no-fault system. © 2010 by the Board of Trustees of the Leland Stanford Junior University

Risk, Everyday Intuitions, and the Institutional Value of Tort Law

This Note offers a normative critique of cost-benefit analysis, one informed by deontological moral theory, in the context of the debate over whether tort litigation or a non-tort approach is the appropriate response to mass harm. The first Part argues that the difference between lay and expert intuitions about risk and harm often reflects a difference in normative judgments about the existing facts, rather than a difference in belief about what facts exist, which makes the lay intuitions more defensible. The second Part considers how tort has dealt with this divergence between lay and expert perspectives. It also evaluates how tort's approach has differed from that of public law approaches to accident law, such as legislative compensation and risk regulation by administrative agencies. Ultimately, tort's ability to recognize the value of lay intuitions supports retaining the tort perspective as part of our societal arsenal of responses to risk and harm. This ability can also support a pro-tort perspective in two practical debates in the arena of tort law: that over preemption of tort law by administrative agency judgments, and that over access to tort recovery as part of a no-fault system

Considering Vaccination Status

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. It concludes that such consideration is similarly allowed at the state level unless expressly foreclosed, and is allowed at the federal level if appropriately supported by federal regulatory authority. Part III examines what may be a future front in these debates: whether policies considering vaccination status may be required rather than merely permitted, just as some courts have found that mask requirements may be federally required in certain circumstances

Letter in reply to Bernard Prusak, et al.

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

Pricing Drugs Fairly

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 pricing through a price ceiling grounded in social value, and examines how the proposed price ceiling could overcome legal and political obstacles. By focusing on fairness, this Article pursues a goal that complements, rather than duplicates, recent legal scholarship on pharmaceutical pricing. This Article makes three contributions. First, it identifies, makes explicit, and categorizes the most prominent conceptions of fairness in drug pricing. Second, it advances an account of fair pricing that centers on a drug’s value to society. Third, it proposes that fair pricing be implemented via a price ceiling that ensures that the price of a drug does not exceed its value to society, and explains how this price-ceiling approach would address a variety of legal and political obstacles. In Part I, the Article categorizes conceptions of fair pricing. It first considers procedural fairness, and critically evaluates the view that any price reached in a procedurally fair negotiation is substantively fair. It then reviews four comparators used for assessing substantive fairness: (a) the cost of developing the drug, (b) the drug’s affordability to patients, (c) the drug’s customary price, and (d) the drug’s social value. Part I concludes that social value should be used to identify when a price is unfair, although the other factors can indicate procedural unfairness or serve to justify other policies, such as subsidized insurance. Part II then takes on the task of defining social value. It explains how cost-effectiveness analysis could be used to define social value, and argues that cost-effectiveness analysis should be modified to incorporate factors other than overall costs and health benefits, such as fairness to patients with preexisting disabilities and reduction of health disparities, but should not be modified to provide greater incentives to treat rare diseases or diseases lacking other treatments. Part III turns to implementation, arguing that fair pricing can best be achieved through a price ceiling that tracks social value. It explains how such a price ceiling could incentivize the production of socially valuable treatments, and describes the legal, ethical, and political advantages of price ceilings over other options such as reimbursement ceilings. In particular, the availability of treatments whose price exceeds the reimbursement ceiling will lead to administrators enforcing the reimbursement ceiling being blamed when patients die or suffer illness. In contrast, while price ceilings may discourage the development of costly drugs, they do not require families or payers to say no to identifiable patients who could benefit from existing treatments. Price ceilings also avoid the legal limitations that private and public insurers face when they attempt to deny coverage for expensive treatments. Part IV identifies potential legal obstacles to the implementation of a price ceiling and explains how to avoid them. Some, like preemption and the Dormant Commerce Clause, apply only to state-level efforts. Others, such as the Takings Clause and a potential revival of Lochner-era freedom of contract, also apply to federal initiatives

Equal Protection and Scarce Therapies: The Role of Race, Sex, and Other Protected Classifications

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 role of age-based prioritization that might work to the disadvantage of older adults. Some of these groups argued that the use of age would constitute “unlawful age discrimination

A Comprehensive Covid-19 Response—The Need for Economic Evaluation

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

The Shared Ethical Framework to Allocate Scarce Medical Resources: A Lesson from COVID-19

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, and their relative weight and application will vary by context. In addition, there are procedural principles such as transparency, engagement, and evidence-responsiveness. Prioritising instrumental value and minimising harms during the COVID-19 pandemic led to widespread agreement on priority tiers to include health-care workers, first responders, people living in congregate housing, and people with an increased risk of death, such as older adults and individuals with medical conditions. However, the pandemic also revealed problems with the implementation of these values and priority tiers, such as allocation on the basis of population rather than COVID-19 burden, and passive allocation that exacerbated disparities by requiring recipients to spend time booking and travelling to appointments. This ethical framework should be the starting point for the allocation of scarce medical resources in future pandemics and other public health conditions. For instance, allocation of the new malaria vaccine among sub-Saharan African countries should be based not on reciprocity to countries that participated in research, but on maximally reducing serious illness and deaths, especially among infants and children

The ethics of expanding access to cheaper, less effective treatments

This article examines a fundamental question of justice in global health. Is it ethically preferable to provide a larger number of people with cheaper treatments that are less effective (or more toxic), or to restrict treatments to a smaller group to provide a more expensive but more effective or less toxic alternative? We argue that choosing to provide less effective or more toxic interventions to a larger number of people is favored by the principles of utility, equality, and priority for those worst-off. Advocates are mistaken to demand that medical care provided in low-income and middle-income countries should be the same as in high-income countries