Yale Journal of Health Policy, Law, and Ethics

Current Issue: Volume 20, Issue 1

Health Care Sanctuaries

Medha D. Makhlouf

It is increasingly common for noncitizens living in the United States to avoid seeing a doctor or enrolling in publicly funded health programs because they fear surveillance by immigration authorities. This is the consequence of a decades-long shift in the locus of immigration enforcement activities from the border to the interior, as well as a recent period of heightened immigration enforcement. These fears persist because the law incompletely constrains immigration surveillance in health care.

This Article argues that immigration surveillance in health care is a poor choice of resource allocation for immigration enforcement because it has severe consequences for health and the health care system; additionally, it compromises the legitimacy of the state vis-à-vis its noncitizen residents. The consequences include public health threats, health care system inefficiency, ethical dilemmas, and increased vulnerability in immigrant communities. Laws permitting immigration surveillance in health care also create legitimacy harms by obstructing noncitizens’ access to health care and undermining their privacy and rights to public benefits. The COVID-19 pandemic starkly illustrates these dangers, but they exist even in the absence of a novel disease outbreak.

Health care access for noncitizens has largely been left to the vagaries of immigration policy. Immigration surveillance in health care should prompt us to consider the scope and limits of health law and the role of discretion in immigration law. Health care sanctuaries — durable legal protections against immigration surveillance in health care — recover some of the lost equilibrium between immigration enforcement and other goals and values of public policy.

Adding Principle to Pragmatism: The Transformative Potential of “Medicare-for-All” in Post-Pandemic Health Reform

William M. Sage

“Medicare-for-All” should be more than a badge of political identity or opposition. This Article examines the concept’s potential to catalyze policy innovation in the U.S. health care system. After suggesting that the half century of existing Medicare has been as much “Gilded Age” as “Golden Era,” this Article arrays the operational possibilities for a Medicare-for-All initiative. It revisits America’s recent history of pragmatic rather than principled health policy and identifies barriers to more sweeping reform. It then applies to Medicare-for-All four health policy insights not known when “single-payer” reform was debated a generation ago: simultaneous inefficiency and injustice in medical care, neglect of the social determinants of health, inertia resulting from the legal architecture of health care, and the latent power of generational change. It concludes by explaining how applying a Medicare-for-All frame to post-pandemic health reform might prompt ethical re-engagement by the medical profession and help the health care system take specific steps on a path to improvement.

No Parking Here: A Review of Generic Drug 180-Day Exclusivity and Recent Reform Proposals

Victor L. Van de Wiele, Jonathan J. Darrow, and Aaron S. Kesselheim

In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) to facilitate the market entry of generic drugs after brand-name drugs’ patent exclusivity ended. To incentivize generic manufacturers to challenge brand-name manufacturers’ patents, a 180-day exclusivity accrued to the first manufacturer to successfully litigate the validity or scope of a brand-name drug patent. However, brand-name and generic manufacturers have found ways to strategically “park” the 180-day exclusivity to delay generic entry and competitive drug markets. Congress revised the statute in 2003, but concerns continued. In 2019, three Congressional bills were introduced to further revise the 180-day exclusivity framework. This Article reviews the history of the 180-day provision, evaluates what types of strategic behavior remained after 2003, and considers whether the recent legislative proposals are likely to offer improvement.

“Everybody Knows I’m Not Lazy”: Medicaid Work Requirements and the Expressive Content of Law

Kristen Underhill

In a historic first for the Medicaid program, the Department of Health and Human Services under President Trump allowed states to establish work requirements for program participants who are considered “able-bodied adults.” These mandates were halted by litigation, and President Biden’s administration is now in the process of withdrawing the waivers. But early experiences with Medicaid work requirements suggested that they can produce widespread losses of benefits. In addition to affecting access, work requirements and other conditions on public benefits can serve an expressive purpose: they provide a source of information about a state’s values, goals, and beliefs about beneficiaries. Beneficiaries are one audience for this expressive message, but we know little about what they hear when their state makes benefits more difficult to access.

This Article presents an original empirical study of more than 9,000 Medicaid beneficiaries in the Commonwealth of Kentucky, the first state approved for a work requirement program. Using a mix of survey data and qualitative interviews, this Article demonstrates that Medicaid beneficiaries understand work requirements as providing information about the state’s values and priorities. But depending on their priors, beneficiaries interpreted these messages very differently. Many found work requirements unfair and expressive of disregard toward themselves and other beneficiaries; others believed, however, that the state had validated their identities as taxpayers.

This Article presents these findings and considers implications for expressive theories of law, shifting the paradigm to emphasize that the expressive impacts of law will depend on who is listening.

Pharmaceutical (Re)Capture

Liza Vertinsky

This Article makes the case that pharmaceutical companies, along with other powerful corporate actors in the pharmaceutical industry, are in effect designing their own markets, often at the expense of, rather than in pursuit of, public health. The influence exerted by these corporate actors extends beyond traditional forms of regulatory capture, rising to what this Article refers to as pharmaceutical capture—a concept that encompasses the exercise of holistic and systemic control over the operation of pharmaceutical markets and their regulation.

After developing a framework for thinking about pharmaceutical capture, this Article uses the evolution of the opioid epidemic as a case study of capture at work. It argues that the patterns of corporate influence highlighted in the case study are not unique to opioids, but rather are structural features of U.S. pharmaceutical markets.

A popular political response to concerns about the power exerted by corporate actors in the pharmaceutical industry has been to pin the blame on government regulation as impeding the discipline of the “free market.” But pharmaceutical markets rely on government regulations to function, and this push for deregulation is in many cases simply an effort to substitute one governance structure for another more favorable to incumbent corporate interests. This Article concludes that it is not deregulation, but rather a redesign of regulation, that is needed to improve the public health impact of the pharmaceutical industry. Drawing lessons from pharmaceutical capture, it suggests guidelines for a regulatory recapture.