Health Law


Laboratories of Exclusion: Medicaid, Federalism, & Immigrants

Medha D. Makhlouf

Medicaid’s cooperative federalism structure gives states significant discretion to include or exclude various categories of noncitizens. This has created extreme geographic variability in noncitizens’ access to health coverage. This Article describes federalism’s role in influencing state policies on noncitizen eligibility for Medicaid and its implications for national health policy. Although there are disagreements over the extent to which public funds should be used to subsidize noncitizen health coverage, this Article reveals that decentralized policymaking on noncitizen access to Medicaid has weakened national health policy by increasing wasteful spending and exacerbating inequities in access to healthcare. It has failed to incentivize the type of state policy experimentation and replication that justifies federalism arrangements in other contexts. Rather, federalism has (1) enabled states to enact exclusionary policies that are ineffective and inhumane and (2) created barriers for states to enact inclusionary policies that advance the normative goals of health policy. This Article concludes that noncitizen access to health coverage is best addressed through centralized policymaking.

This Article contributes to scholarly conversations about federalism and healthcare by providing a case study to test the efficacy of federalism arrangements in achieving equity for those who were left behind by health reform. More broadly, it adds to the federalism literature by synthesizing insights from three fields that rarely comment on one another: health law, immigration law, and federalism theory.

Racial Disparities in Maternal Mortality

Khiara M. Bridges

Racial disparities in maternal mortality have recently become a popular topic, with a host of media outlets devoting time and space to covering the appalling state of black maternal health in the country. Congress responded to this increased societal awareness by passing the Preventing Maternal Deaths Act at the tail end of 2018. The law provides states twelve million dollars annually, for five years, to fund maternal mortality review commissions—interdisciplinary collections of experts that evaluate and investigate the causes of every maternal death in a jurisdiction. Fascinatingly, although activists, journalists, politicians, scholars, and other commentators understand that the maternal health tragedy in the United States is a racial tragedy, the Preventing Maternal Deaths Act completely ignores race. Indeed, the term “race” does not appear anywhere in the text of the statute. The irony is striking: An effort to address a phenomenon that has become salient because of its racial nature ignores race entirely.

The racial irony embodied by the Preventing Maternal Deaths Act serves as an invitation to investigate not only the Act itself, but the national conversation that is currently taking place about racial disparities in maternal deaths. Indeed, in important respects, if the general discourse that surrounds racial disparities in maternal mortality is impoverished, then we should expect that the solutions that observers propose will be impoverished as well. This is precisely what this Article discovers. The analysis proceeds in four Parts.

Part I provides an overview of racial disparities in maternal mortality, identifying the various elements that have made pregnancy, childbirth, and the postpartum period much more dangerous for black women than their white counterparts in the United States. Part II then offers critiques of the national conversation around racial disparities in maternal mortality and warns of both the marginalizing effects it may have on black women and the possibility that it will lead to blaming black women for dying on the path to motherhood.

Part III describes the Preventing Maternal Deaths Act in some detail. Part IV follows with a critique of the Act, identifying three deficiencies. First, it notes the racial erasure contained in the Act—the fact that the Act nowhere mentions the racial dimensions of the nation’s maternal health debacle. It then observes the predicament created by the fact that erasing race likely was essential to the very passage of the Act. Second, it notes that because the Act does not direct the state maternal mortality review commissions to investigate the structural and institutional forces that produce excess maternal deaths in the United States, it leaves space for maternal mortality review commissions to simply blame the dead for dying. Third, it notes that the Act does no more than fund the gathering of more data about pregnancy-related deaths. However, it observes that there is a strong argument to be made that we do not need more data. We already know why women are dying, and we already know how to save them. In this way, the tragedy of maternal mortality in the United States is not a problem of information; it is a problem of political will. To the extent that Congress chose to intervene in the maternal health debacle not with policy changes, but rather with an attestation that we need more information, the Preventing Maternal Deaths Act demonstrates that we still lack the political will to make the concrete changes that will make pregnancy and childbirth safe.

Mismanaged Care: Exploring the Costs and Benefits of Private vs. Public Healthcare in Correctional Facilities

Micaela Gelman

Administering healthcare in prisons and jails has been an exceptionally difficult task for state, county, and city governments for decades. Facing the unprecedented rise in the correctional population, governments began contracting with private correctional healthcare companies in the 1980s for cheaper, higher-quality care. However, in practice, private correctional healthcare companies have been disastrous for inmate-patients and their families. This Note examines the structural deficiencies in the privatization of correctional healthcare, and argues that the market factors required for successful privatization, including choice, competition, and responsiveness to consumer preferences, are absent in the correctional healthcare sector. In addition, the lack of meaningful oversight, protective contractual provisions, and legal hurdles facing prospective litigants compound these structural problems and leave the companies unaccountable for their misconduct. This Note proposes switching from these private companies to publicly-run options, such as government health agencies, partnerships with universities, and private non-profit organizations. These public models increase democratic accountability and transparency, lower costs, and more appropriately treat correctional health as the public health issue that it is. While administering healthcare services in correctional settings will always be challenging, switching to public models is the first step in improving care and treating inmate-patients with dignity.

The Medicare Innovation Subsidy

Mark A. Lemley, Lisa Larrimore Ouellette, Rachel E. Sachs

Policymakers on both ends of the political spectrum have been looking for ways to reduce prescription drug prices. Democrats have also been working on expanding healthcare coverage, including different versions of Medicare for All. All these proposals have been framed as issues of access and spending. If innovation incentives come up at all, it has primarily been because pharmaceutical companies claim that reducing drug prices will threaten innovation by lowering the returns from their patents. 

In fact, however, pharmaceutical access and innovation incentives are intimately related. Health insurance can change the structure of market demand. And Medicare in particular does so in a way that gives a very large subsidy to patented drugs, such that current U.S. pharmaceutical profits are often higher than they would be in an unsubsidized market. Medicare reimbursement rules thus can lead to greater-than-monopoly pricing of patented drugs, dramatically expanding the incentive U.S. policy provides to pharmaceutical companies. By not recognizing the Medicare innovation subsidy, policymakers have ignored one of the largest sources of innovation incentives. That extra incentive might be a good thing or a bad thing, depending on how much incentive pharmaceutical developers need. It may well be good for some classes of drugs and bad for others. But it is important for policymakers to understand how access policies like Medicare also serve as innovation incentives. This extra innovation subsidy may open the policy space for hybrid proposals that combine expanded government insurance like Medicare for All with lower drug prices while preserving or even increasing current returns to innovation. 

The False Promise of Health Data Ownership

Jorge L. Contreras

In recent years there have been increasing calls by patient advocates, health law scholars, and would-be data intermediaries to recognize personal property interests in individual health information (IHI). While the propertization of IHI appeals to notions of individual autonomy, privacy, and distributive justice, the implementation of a workable property system for IHI presents significant challenges. This Article addresses the issues surrounding the propertization of IHI from a property law perspective. It first observes that IHI does not fit recognized judicial criteria for recognition as personal property, as IHI defies convenient definition, is difficult to possess exclusively, and lacks justifications for exclusive control. Second, it argues that if IHI property were structured along the lines of traditional common law property, as suggested by some propertization advocates, prohibitive costs could be imposed on socially valuable research and public health activity and IHI itself could become mired in unanticipated administrative complexities. Third, it discusses potential limitations and exceptions on the scope, duration, and enforceability of IHI property, both borrowed from intellectual property law and created de novo for IHI.

Yet even with these limitations, inherent risks arise when a new form of property is created. When owners are given broad rights of control, subject only to enumerated exceptions that seek to mitigate the worst effects of that control, constitutional constraints on governmental takings make the subsequent refinement of those rights difficult if not impossible, especially when rights are distributed broadly across the entire population. Moreover, embedding a host of limitations and exceptions into a new property system simply to avoid the worst effects of propertization begs the question whether a property system is needed at all, particularly when existing contract, privacy, and anti-discrimination rules already exist to protect individual privacy and autonomy in this area. It may be that one of the principal results of propertizing IHI is enriching would-be data intermediaries with little net benefit to individuals or public health. This Article concludes by recommending that the propertization of IHI be rejected in favor of sensible governmental regulation of IHI research coupled with existing liability rules to compensate individuals for violations of their privacy and abusive conduct by data handlers.

Incentivizing Pharmaceutical Testing in an Age of Off-Label Promotion

Ryan Sila

In 2012, the Second Circuit held that under the First Amendment, pharmaceutical manufacturers have a right to promote their drugs for uses for which that they have neither been clinically tested nor FDA-approved. Weighing heavily in the Second Circuit’s analysis was the argument that the FDA’s prohibition on so-called “off-label speech” inhibited physicians’ access to complete information, thereby harming public health. That line of reasoning has also created skepticism within Congress of the FDA’s policy. Others argue that the prohibition on off-label speech is necessary in order to incentivize manufacturers to clinically test their drugs for all intended uses—a process that not only allows the FDA to certify the drug as safe and effective in each of its uses, but also creates a larger data set about a drug’s effects before it begins to be marketed and prescribed. If manufacturers can market their pharmaceutical products for unapproved uses, they have reduced incentives to seek FDA approval, especially because the required clinical tests are extremely costly. Whatever one believes about a policy of permitting off-label promotion, it is clear that it not only creates benefits, but it also creates costs. This Note considers regulatory and common-law tools to reduce those costs. It rejects available regulatory tools, because either they are too weak to change manufacturers’ incentives to conduct clinical tests, or they suffer from the same constitutional questions that troubled the Second Circuit. Instead, this Note argues that courts can hold manufacturers to a common-law duty to test their drugs for each use for which they market them, and it outlines what such a duty might entail. Such a solution, if properly implemented, would not only mitigate the concerns about the liberalization of off-label promotion, but it would also be supported by modern products liability doctrine.

Deterring Fraud: Mandatory Disclosure and the FDA Drug Approval Process

Liora Sukhatme

The valuation of a pharmaceutical company often depends on its ability to bring a drug to market, making information about the likelihood of Food and Drug Administration (FDA) approval critical to investors and a highly sensitive issue for the company. Since the FDA drug approval process is not public, investors must rely on company disclosures to evaluate the likelihood of FDA approval. Currently, the FDA will not disclose the content of action letters sent to sponsor companies, giving company executives dangerous discretion over whether to disclose the information and how to present it. This discretion, coupled with a lack of oversight over the content of the disclosures, has resulted in several recent cases of fraud among pharmaceutical companies. As a way to curb such company discretion and prevent future fraud, this Note proposes mandatory public disclosure of action letters sent by the FDA to sponsor companies.

A Child’s Expertise: Establishing Statutory Protection for Intersexed Children Who Reject Their Gender Assignment

Emily A. Bishop

Intersexed children are born with genitalia and/or reproductive organs that do not look like those of most biological males or females. Doctors and parents usually assign an intersexed child a gender at birth or during early childhood. Occasionally, an individual will reject his or her gender of assignment and will want to take on a different gender role. Some clinicians and intersex advocates instruct parents to accept an intersexed child’s expressions of gender identity and to support the child’s gender role change. There is a risk, however, that parents may resist or prevent a child’s gender transition due to their own discomfort with the idea or based on a physician’s recommendation. A statutory framework that allowed intersexed minors to complete a “social gender transition,” coupled with a provision equating parental interference with this transition with actionable neglect, would protect intersexed children’s autonomy and prevent the trauma that can result from a forced existence in a gender role with which a child does not identify. The proposed framework would likely survive a constitutional challenge by the parents of an intersexed child because the harm caused by the parental decision to interfere with a child’s gender expression removes such interference from the realm of constitutionally protected parental decisionmaking.

Unintended Side Effects: Arbitration and the Deterrence of Medical Error

David Shieh

As many as 98,000 people die each year as a result of medical error. According to law and economics scholars, the solution to this problem is straightforward: When calibrated correctly, medical malpractice liability will force healthcare providers to internalize the cost of their negligence, incentivizing improvements to patient safety that will reduce medical error. Debate has raged for decades over the coherence of deterrence theory, but little attention has been paid to the erosion of one of its bedrock assumptions: that the procedural mechanism through which claims are to be resolved is litigation. Arbitration has become pervasive in the healthcare context, but its effects on medical malpractice liability’s ability to deter medical error have been largely overlooked by public health and legal scholars. This Note argues that the adoption of arbitration will not, as law and economics scholars assume, improve the medical malpractice regime’s ability to deter error. In addition to drawing on existing law and economics and public health scholarship to advance this descriptive claim, this Note studies the experience of Kaiser Permanente, the nation’s largest integrated healthcare consortium, in using arbitration to resolve medical malpractice disputes with its seven million members in California.

Prison Health Care after the Affordable Care Act: Envisioning an End to the Policy of Neglect

Evelyn Lia Malave

Inadequate prison health care has created a health crisis for reentering prisoners and their communities—a crisis that is exacerbated by barriers to employment and other collateral consequences of release. This Note will first examine how current Eighth Amendment doctrine has failed to sufficiently regulate prison health care so as to have any significant effect on the crisis. Next, it will argue that the Affordable Care Act (ACA) alters the Eighth Amendment analysis by triggering a change in the “evolving standards of decency” that guide the doctrine. Specifically, this Note will argue that, after the passage of the ACA, releasing sick, Medicaid-eligible prisoners without enrolling them in the federal benefits program violates the Eighth Amendment.