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Digital Reproductive Privacy in a Post-Dobbs World

Leah R. Fowler & Michael R. Ulrich, Femtechnodystopia, 75 Stan. L. Rev. 1233 (2023).

The first two sentences of the abstract for Leah R. Fowler’s & Michael R. Ulrich’s Femtechnodystopia are stunning but accurate: “Reproductive rights, as we have long understood them, are dead. But while history seems to be moving backward, technology moves relentlessly forward.” (P. 1233.)

The law often trails behind technology, especially reproductive technology. Femtechnodystopia focuses on fertility awareness-based contraception and proception apps and how these apps, which can enable users to take control over their reproductive lives, can, in a post-Dobbs world, be (legally) dangerous to users. After discussing the many benefits and perils of Femtech, Professors Fowler and Ulrich argue that there are three key criteria that Femtech must satisfy in order to avoid a potential dystopian future: “apps must be accurate, the data they contain must be kept private and secure, and the consumer must be aware of their risks and limitations.” (P. 1240.)

Part I of the article is divided into two sections. Part I.A discusses the lead-up to the Supreme Court’s decision in Dobbs v. Jackson Women’s Health. This section includes a discussion and analysis of cases related to many longstanding bioethical issues, including the reduced autonomy of pregnant people, fetal personhood, and reproductive rights more broadly. In addition to addressing the leadup to Dobbs, the article discusses potential future areas of litigation that have received attention lately, including the Comstock Act of 1873 and the Supreme Court’s increasing deference to religiously-based objections to the provision of healthcare. The authors write that “If Hobby Lobby walked so Zubik and Little Sisters of the Poor could run, Dobbs is sprinting to usher in an even more aggressive era of restrictions.” (P. 1247.)

Part I.B discusses the potential benefits of Femtech like fertility and period trackers, including their ability to enhance reproductive autonomy. The authors note that more individuals may turn to Femtech to meet menstrual and reproductive health needs as access to reproductive care declines in the U.S. This section also explains the U.S. Food and Drug Administration (FDA) regulatory scheme that applies to the apps. Notably, proceptive apps that “identify fertile days, so long as they do not claim the user can rely on this information from contraceptive purposes,” benefit from FDA enforcement discretion. (P. 1238.)

Part II, “Femtech’s Dystopia,” turns to the many perils of Femtech, including the possibility that the apps may be insecure or that the information shared with or generated by them may be introduced against users in civil and criminal legal proceedings. Moreover, Femtech apps, like many other apps, generate data that may be sold to other companies. One of the studies cited by the authors includes a 2014 estimate that “a pregnant person’s data are worth fifteen times that of the average person.” (Pp. 1265-66.

Beyond legal dangers, the apps themselves can be ineffective and lack extensive privacy protections. Additionally, many mobile health apps do not permit individuals to delete their data.

The authors note that individuals often find these apps through various sources, including magazine lists of the “best” tracker apps. While some of these sources discuss the apps’ limited effectiveness, they are far less likely to mention the privacy risks.

Ultimately, the authors do not recommend that users abandon these applications. Instead, Part III of the article provides many creative solutions to the issues facing period and fertility tracking apps after Dobbs. The authors acknowledge the limitations of their proposed solutions, including the practical difficulties Congress or administrative agencies like the FDA or the Federal Trade Commission would face in mandating changes. Rather than relying only on top-down changes, the authors identify options that app developers could implement themselves, along with an explanation as to why these changes would be helpful to users. They also alert readers to alternative apps, some of which were created abroad and have stronger privacy protections than some of the more well-known Femtech apps.

As technology permeates our lives, it is worth continually revisiting the authors’ caution: “Technology in a world with an anemic right to privacy endangers everyone.” (P. 1313.)

Cite as: Myrisha Lewis, Digital Reproductive Privacy in a Post-Dobbs World, JOTWELL (February 26, 2024) (reviewing Leah R. Fowler & Michael R. Ulrich, Femtechnodystopia, 75 Stan. L. Rev. 1233 (2023)), https://health.jotwell.com/digital-reproductive-privacy-in-a-post-dobbs-world/.

Rationing Healthcare Innovations

Leonard Fleck is a well-known philosopher and ethicist who has written extensively on various ethical issues in health care, including healthcare rationing. Although he writes from a moral perspective, the topic is also relevant to health lawyers. Healthcare rationing, interpreted as the denial or delay of necessary medical care for non-medical reasons, raises serious issues of equal access to health care as a human right, informed consent and shared decision-making (SDM), well-known concepts in contemporary legal doctrine. Long waiting times and delays in medical treatment, substantial co-payments, or restrictions in health insurance access can be considered a form of de facto rationing, challenging the right to health care as a human right.

Fleck’s Precision Medicine and Distributive Justice: Wicked Problems for Democratic Deliberation discusses healthcare rationing in the context of new pharmaceutical innovations, including  precision medicine, targeted cancer therapies and immunotherapies. These are highly promising but costly drugs (ranging from $100,000 to $475,000 in total costs per treatment) mainly used with metastatic cancer, a terminal illness. Most patients with access to these drugs will gain only a few extra weeks or months of life (P. 11.) Is society willing to pay for each patient’s life-prolonging targeted therapy with marginal gains at general public expense?

Although Fleck focuses on health ethics and policy (distributive justice), the central question of who will decide what treatment should be provided/reimbursed and based on what criteria also has legal implications. The law may set not only the decision-making procedures but also the substantive (medical, economic, ethical) criteria for selecting healthcare services for which we are willing to pay.

The book includes nine chapters, starting with a review of the medical literature regarding metastatic cancers and cutting-edge therapeutic interventions. From an economic perspective, none of these treatment options appear reasonably cost effective. This raises the notion of what Fleck calls wicked or “ragged edge” problems (P. 22). These are situations for which no ethical theory can provide a satisfactory answer and every proposed solution seems as problematic as the issues it is intended to solve.

Fleck argues that, because rationing is unavoidable, a respectful process of democratic deliberation is the only way to solve these problems of “rough justice” (P. 23.) From a legal perspective, notions like equal access to healthcare, non-discrimination, right to life, informed consent, shared decision-making, transparency and participation, and the need for legal remedies provide a valuable framework for thinking about the rationing issues generated by targeted therapies. A public debate addressing the abovementioned concepts would enable society to make more just choices on life-extending targeted therapies. A shared understanding of rationing or selection criteria at the policy level (severity of disease, clinical and cost-effectiveness, equal access, etc.) will help to formulate socially agreed-upon ideas about a threshold of basic healthcare and its limits. Ultimately, this will help physicians make more reasonable decisions on targeted therapies in individual cases.

 

Cite as: André den Exter, Rationing Healthcare Innovations, JOTWELL (January 23, 2024) (reviewing Leonard M. Fleck, Precision Medicine and Distributive Justice: Wicked Problems for Democratic Deliberation (2022)), https://health.jotwell.com/rationing-healthcare-innovations/.

Safeguarding the Healthcare System from Private Equity’s Potential Abuses

Erin C. Fuse Brown & Mark A. Hall, Private Equity and the Corporatization of Health Care, 76 Stan. L. Rev. __ (forthcoming, 2024); GSU L. Studies Rsch. Paper, available at SSRN.

The corporatization of medicine is not new. As Paul Starr masterfully documented in his historical account of American medicine, throughout the 20th Century various private organizations pursued bureaucratic control over the delivery of healthcare. Initially, the medical profession was largely successful in resisting efforts to corporatize healthcare. Several decades of mergers, acquisitions and corporate alliances, however, have firmly entrenched corporate ownership in American healthcare. In their article Private Equity and the Corporatization of Health Care, Erin Fuse Brown and Mark Hall explore the latest chapter of this trend—the acquisition of physician practices by private equity (PE) firms.

An aging population, advancements in medical technology and drug therapies, and other factors have fueled tremendous growth in the health care sector, which today comprises one-sixth of the U.S. economy. As the healthcare sector has expanded, private equity (PE) investors have recognized health care organizations as potential sources for profit-making. In Part I of their article, Fuse Brown and Hall explain that this PE incursion into health care is a particularly aggressive form of corporate investment. When PE firms target physician practices, they assume control over practices’ business strategies and downgrade physician ownership to minority status. This leaves acquired physician practices no longer governed by health professionals with ethical obligations that put patients’ medical needs before profits. Moreover, PE’s goal of boosting profitability leads to a focus on quick fixes and practices designed to maximize revenue rather than long-term operational changes that would enhance the quality and efficiency of care.

The authors identify several risks posed by the PE model. First, incremental acquisitions can result in horizontal market consolidation, which can increase prices, reduce the quality of medical care, and limit access. Second, astute PE investors have capitalized on various market inefficiencies for profit, such as exploiting billing loopholes, engaging in aggressive risk-coding, and steering patients to unnecessary or inefficient care. These practices in turn risk increasing overall healthcare spending without any corresponding improvements in quality. Third, PE control of physician practices threatens physicians’ clinical independence and can result in reduced staffing levels, potentially compromising the quality of patient care and physician morale. The authors also highlight several studies of PE in health care that support these concerns.

Fuse Brown and Hall convincingly argue that mitigating these risks requires an immediate and comprehensive policy response. The good news, as thoroughly covered in Part II of their article, is that existing legal tools under federal and state law can address many of the risks posed by PE investment in physician practices. These include antitrust laws that can target horizontal consolidation and fraud and abuse laws that police improper medical billing and self-referral. The authors also call for the revival of two policies that have fallen into disfavor, the corporate practice of medicine doctrine and state fee-splitting laws. In addition, employment laws can target PE practices that curtail physicians’ clinical and professional autonomy, such as non-compete, anti-disparagement, and non-disclosure provisions in physician employment contracts.

The article’s examination of existing legal tools provides a timely and indispensable roadmap for policymakers and legal practitioners seeking to safeguard the healthcare system from the adverse consequences of PE investment in physician practices. For example, regulators and qui tam litigators looking to curb PE-owned practices’ inappropriate billing and referral practices will benefit greatly from the authors’ in-depth analysis of fraud and abuse case law and regulations. Fuse Brown and Hall also discuss specific steps regulators can take to strengthen existing enforcement tools. For instance, antitrust regulators can increase their scrutiny of PE firms’ incremental acquisitions by lowering the mandatory reporting thresholds for pre-merger review and updating federal antitrust merger guidelines to address serial add-on acquisitions across broader geographic markets.

The authors’ meticulous analysis of existing laws, however, reveals a regulatory landscape that in many respects is ill-equipped to address the risks posed by PE investment in health care. To close these gaps, the authors propose various legislative actions designed to strengthen existing laws. For instance, states can amend their medical practice laws to eliminate loopholes that have allowed PE investors to circumvent the corporate practice of medicine prohibition. The authors also advocate for new legislation that would create additional policy tools for mitigating the risks of PE in healthcare, including closing Medicare billing loopholes, enhancing transparency in PE ownership and financial structures, and eliminating the tax advantages enjoyed by PE investors. Finally, in a nod to federalism, the authors stress the essential role played by states in responding to PE’s incursion into health care, both as co-enforcers of applicable federal law and overseers of medical practice laws that have no federal counterpart.

In sum, this provocative article is a must-read for anyone concerned with the continued march toward the corporatization of health care. While corporatization can support the shift to value-based care by providing needed capital, economies of scale, and innovation, its underlying profit motive also threatens medicine’s traditional professional values. Fuse Brown and Hall argue that with PE’s incursion into health care, the pendulum has swung too far in the direction of profiteering. Their article issues an urgent call to utilize existing policy levers to protect the healthcare system from the potential risks posed by PE. But Fuse Brown and Hall also caution that our existing legal tools are outdated and that legislative and regulatory action is needed to if we are to fully address the potential harms of PE investment in health care.

Cite as: Jessica Lind Mantel, Safeguarding the Healthcare System from Private Equity’s Potential Abuses, JOTWELL (December 8, 2023) (reviewing Erin C. Fuse Brown & Mark A. Hall, Private Equity and the Corporatization of Health Care, 76 Stan. L. Rev. __ (forthcoming, 2024); GSU L. Studies Rsch. Paper, available at SSRN), https://health.jotwell.com/safeguarding-the-healthcare-system-from-private-equitys-potential-abuses/.

Is the Health of the People Part of the Inner Morality of Law?

Wendy Parmet has a new book out, called Constitutional Contagion: COVID, the Courts, and Public Health. It is a long-awaited sequel of sorts to one of her earlier books, Populations, Public Health and the Law (2009). I mention this because, while COVID is the occasion for her argument, i.e., the circumstance that brings her point to the sharpest focus, the account is actually one she has been building for a long time, and its implications transcend the current crisis. At the most general level, Parmet argues for the health of the polity as not just one of but perhaps even the most central value that our laws exist to serve. In this newest volume, she surveys our Constitutional jurisprudence, re-centering our understanding of America’s foundational law in relation to its most fundamental material stakes.

Parmet’s argument proceeds with the sound, measured consideration that we know and trust from her body of work. Thus, she is perfectly within rights to distinguish her position from my maximalist gloss.  But as an intemperate enthusiast of the Parmet project, I view her work as teeing up the claim that population health is part of the inner morality of law. Just as Lon Fuller found reciprocity, human agency, and a certain formal integrity to inhere in law, Parmet finds an additional substantive morality at the ground level of law’s project. As she says in her first book, “[P]ublic health is not simply a norm, but also a legal norm that should be embraced by and incorporated into the legal system.” (P. 52.)

This understanding did not used to shock. It was a familiar feature of an older wisdom, the residue of which remains in common law and in the Latin phrase, salus populi suprema lex (“the health of the public is the supreme law.”). Only lately have we in our public law banished basic Hobbesian and Aristotelian insights, suppressing the recognition that bodily security and human flourishing—values inseparable from health—are the reasons for the constitution of the polity to begin with.

Chapters two and three of Parmet’s book reveal that it was not so long ago that our constitutional analysis reflected this basic health-centered wisdom through its police power jurisprudence. Parmet’s excavation of historical caselaw reveals that, in the 1800’s, “if a law appeared to be a health regulation, then the Court . . . would usually accept that it was an exercise of the police power and hence within the states’ prerogative.” (P. 34.) From the 19th century antebellum period into the early 20th century, before many of the Constitution’s individual rights were incorporated to apply to the states, individual rights-based reasoning played far less of a role in cabining the constitutional range of health protections we could pursue as a polity, which at that time consisted mostly of state efforts. Even when individual rights were invoked during that period, the prevailing view was that they “[E]xisted only in relation to the police power and the common good. Because individuals had no ‘right’ to endanger public health or safety, laws that aimed to protect those interests could not violate individual rights.” (P. 35.)

It was surprisingly late, not until after the New Deal, that courts “came to hold that even public health laws were only within the police power if they were reasonable or necessary to achieve their public health goal.” That phrase has since transmogrified into a turbocharged constitutional scrutiny to protect individualism and elevate a lopsided handful of health-harming negative rights, like religious liberty, commercial speech and gun possession. But Parmet cautions us not to naturalize this state of affairs and to remember the older wisdom of a more capacious liberty: “In this bygone world, the liberty that enabled people to stay healthy was recognized as one of the reasons we have governments.” (P. 29.)

Reading Parmet’s book all at once as I did (while recovering from COVID no less) is not for the fainthearted. The various doctrinal trendlines that constitute our unhealthy environment have closed in on us over time. She traces such strands as First Amendment speech and religious liberty rights insofar as they have diminished the scope of federal action; she recounts our anemic, retrogressive equality jurisprudence, and the role of qualified immunity as handmaiden to police violence; the sad recent histories of campaign finance law and receding protection for voting rights. She connects each of these developments to specific health-harming conditions. It was stomach-turning to see gathered in one place all the fronts of regressive Constitutional law converging to train harm on the targets of right-wing ire—including racial minorities and immigrants, women and gender minorities, and persons with pre-existing disabilities or health risks.

And here Parmet’s salus populi account links up with the bald truth of Ruth Wilson’s Gilmore’s famous definition of racism. Racism, Gilmore says in The Golden Gulag, is the “production and exploitation of group-differentiated vulnerability to premature death.” Our constitutional politics is functioning in precisely that manner—shaping, distributing, and patterning mortality, a necropolitics that is, as ever, cleft along old lines. Parmet’s book serves overwhelming evidence of how we have contorted our constitutive laws to thwart the common good. Can it truly be that we would forsake the good rather than hold it in common?

But her message is fundamentally a hopeful one insofar as she is pointing out the contingency of our current constitutional condition, the shallowness of the recent health-hostile stance of the courts, and the more deeply-rooted, pro-public health orientation that we could recuperate.

One final note about the resonance Parmet’s book has in our times: to the extent that Adrian Vermeule and others promote a substantive turn for law, they have typically proffered right wing theocratic candidates for the substantive good at stake. Their projects stall for many reasons, not least of which is the failure to counter Parmet’s case for health as an equally if not more plausible candidate. Her most recent book calls us to consider anew the deflection and distortion of purpose that has come to afflict the constitution of our corpus populi.

Cite as: Christina S. Ho, Is the Health of the People Part of the Inner Morality of Law?, JOTWELL (November 8, 2023) (reviewing Wendy E. Parmet, Constitutional Contagion: COVID, the Courts, and Public Health (2023)), https://health.jotwell.com/is-the-health-of-the-people-part-of-the-inner-morality-of-law/.

Freedom and Health Care

Valarie Blake, The Freedom Premium, WVU Coll. of L. Rsch. Paper, No. 2023-010 (forthcoming), available at SSRN (Mar. 13, 2023).

In the United States, universal health care is frequently derided as anti-American and liberty-infringing. In The Freedom Premium, Professor Valarie Blake turns this argument on its head by systematically exploring the ways in which our fragmented system of health care coverage influences the fundamental life choices of Americans – where and how much they work, when or if they marry or divorce, and where and with whom they live. Our current approach to health care coverage, she argues, unduly constrains these personal choices and, if freedom is a primary consideration, universal coverage is the answer.

To make this provocative argument, Professor Blake begins by establishing what she terms the “freedom premium” imposed by our system of health care finance, for both means-tested public programs and employer-sponsored insurance (ESI). The freedom premium refers to the incentives embedded in the eligibility provisions and coverage terms of a particular source of health care coverage that influence core social choices. Rather than relying solely on statutory terms to establish the relevant freedom premia, Blake interviews nearly two dozen individuals who have directly grappled with these and other trade-offs inherent in obtaining health coverage. Professor Blake finds, perhaps not surprisingly, that public programs tend to impose the most significant freedom premia on participants, primarily in the areas of work and marriage.

For example, an individual with a disability might decline employment opportunities because, even if their job came with ESI, that coverage would be unlikely to provide coverage for the types of services an individual with a disability requires. To maintain eligibility for Medicaid, the only type of coverage specifically designed to meet the needs of individuals with disabilities, the individual must limit their income and asset levels—for example, by self-employing and paying themselves below-market compensation, or by forgoing work altogether. For those considered categorically needy under Medicaid, income and asset thresholds are lower per person for a married couple than a single individual, creating a disincentive to marry for those who must rely on Medicaid to access health care. Unlike in many other areas of the law, Medicaid (by piggybacking on SSI provisions) actually allows the government to go a step further and treat individuals as married if they hold themselves out as married, creating an incentive not only to forgo legal marriage, but to forgo a committed relationship altogether.

While public programs most obviously impose freedom premia, so too does ESI. Professor Blake catalogs the well-known phenomenon of job lock (where individuals either pick jobs or stay at jobs for purposes of obtaining or retaining specific health insurance benefits), but also highlights less appreciated aspects of ESI’s impact on life choices. For example, as Americans increasingly delay childbearing into their thirties and forties, many workers have children who rely on them for health coverage well past normal retirement age. It is not uncommon, then, for workers otherwise eligible for Medicare to continue working in order to provide coverage for young adult children who can remain on the worker’s ESI through age twenty-five. While this incentive might not strike many as particularly problematic, it not only impacts a worker’s fundamental economic choice, but it also impacts the broader economy and labor market as individuals continue working past expected retirement age.

The solution, Professor Blake argues, is to uncouple eligibility for health benefits from “socially salient categories of work, poverty, and dependency and instead tie benefits to universal criteria like residency or citizenship.” (P. 9.) She works through some of the basic components of a universal system of coverage without getting too far into the weeds of system design. But the power of her argument does not depend on the particulars of a system of universal coverage. Rather, her argument’s power is in plainly stating the truth that the way we finance health care has a significant impact on how people structure their lives.

“Freedom” and “choice” are common buzzwords in debates about health care reform, but they are nearly always used in reference to the freedom to choose one’s own health plan or freedom to see the doctor of one’s choice. What Professor Blake argues is that we need to consider more fundamental personal freedoms—the freedom to marry or not and the freedom to structure one’s working life according to one’s personal and economic preferences—when we contemplate how health coverage should be arranged and financed. Not everyone will be swayed by the position put forward in The Freedom Premium, but the article caused me to think about our fragmented system of health finance in a new way, and I look forward to seeing where Professor Blake takes this line of inquiry in future work.

Cite as: Amy Monahan, Freedom and Health Care, JOTWELL (October 13, 2023) (reviewing Valarie Blake, The Freedom Premium, WVU Coll. of L. Rsch. Paper, No. 2023-010 (forthcoming), available at SSRN (Mar. 13, 2023)), https://health.jotwell.com/freedom-and-health-care/.

Addressing the Harms of Bureaucratization in the Public Home Care System

Yiran Zhang, The Care Bureaucracy, __ Indiana L.J. __ (forthcoming 2023), available at SSRN.

I’ll never forget my first Medicaid Fair Hearing as a legal aid attorney. The issue was whether my client, who was quadriplegic, was approved for sufficient Personal Care Attendant (PCA) time to chew his food. My client had recently been hospitalized for two months with aspiration pneumonia, a life-threatening condition caused by food entering the airway. His doctors advised him to eat slower, so he requested an additional 15 minutes of PCA assistance with eating per meal. The state Medicaid agency denied his request. The reason? They characterized the activity—waiting for my client to chew—as “supervision,” a non-covered service under the PCA program, rather than assistance with eating. My client and I found this reasoning absurd. At the hearing, we argued that waiting for a person to finish chewing is a natural and necessary component of feeding a person. Thankfully, we won, but that early experience of having to “fight” for every minute of PCA time for my client left me with an unfavorable impression of the home care bureaucracy.

I was reminded of this experience while reading Yiran Zhang’s forthcoming article, which focuses on subsidized home care in the United States. Professor Zhang describes the home care system’s origin in poverty law programs and its associated hyper-regulatory structure designed to combat fraud. Professor Zhang explores the administrative burdens that this structure places on both those who receive care as well as their caregivers, the latter of whom are disproportionately low-income women of color and immigrant women. She proposes an alternative structure for the public home care system modeled on the Department of Veterans Affairs’ caregiver programs for veterans with service-related disabilities.

The article begins with an overview of the U.S. home care system before turning to an important scholarly debate over care and the state: Are state interventions in family life too absent or too present? Professor Zhang contrasts the former perspective—which has urged state intervention to provide federal paid leave for caregiving duties and universal subsidized childcare—with the latter, which most notably includes critiques of the child welfare system and also cash assistance programs like Temporary Assistance for Needy Families that surveil and regulate poor families. This is a significant theoretical contribution that places Professor Zhang’s scholarship in conversation with leading scholars on care and the state.

In her discussion of the bureaucratization of home care, Professor Zhang highlights features of bureaucracies—task-based division of labor, quantification, and documentation among them—that clash with the actual provision of personal care. Such care does not always fit neatly into discrete categories that can be quantified and documented because it is “fundamentally relational and emotional.” As an example, Professor Zhang quotes a caregiver who describes her father’s refusal to wear his dentures to eat, requiring her to prepare and feed him specific soft foods. This task takes time that may not be allocated in his personal care plan and is therefore unpaid labor.

Professor Zhang then turns to the heart of her argument, linking the bureaucratization of home care to the political economy literature. She explains how poverty law programs influenced the development of the home care system, which, at its core, assumes that both care recipients and caregivers are untrustworthy and therefore must be heavily surveilled and audited. While identifying the current structure’s significant weaknesses (creating invisible bureaucratic work, leaving care gaps), Professor Zhang also acknowledges its strengths in preventing fraud and neglect and standardizing the provision of home care.

I encourage health law scholars to read this article to learn from Professor Zhang’s deep dive into an oft-overlooked component of subsidized health care. Given that the number of people needing long-term care is projected to increase rapidly in the years to come, home care is one of the fastest-growing industries, and Medicaid and other public programs are the major payors for home care, this article addresses a topic of significant political and economic importance. Congrats to Professor Zhang on authoring a timely and thought-provoking article!

Cite as: Medha Makhlouf, Addressing the Harms of Bureaucratization in the Public Home Care System, JOTWELL (September 15, 2023) (reviewing Yiran Zhang, The Care Bureaucracy, __ Indiana L.J. __ (forthcoming 2023), available at SSRN), https://health.jotwell.com/addressing-the-harms-of-bureaucratization-in-the-public-home-care-system/.

Pregnancy, Childbirth, Pain and…Silence

One of the most salient criticisms of the majority opinion in Dobbs v. Jackson Women’s Health Organization is its failure to give any consideration to the very real physical risks of pregnancy and childbirth. As Justices Breyer, Sotomayor, and Kagan’s dissent recognized, even the most uncomplicated pregnancies “impose[] significant strain on the body, unavoidably involving significant physiological change and excruciating pain.” The majority’s oversight of this critical fact is even more striking given that the rates of maternal morbidity and mortality in the U.S. are abysmal compared to other developed countries, and are furthermore inequitably distributed by race.

Francesca Laguardia’s excellent article, Pain That Only She Must Bear: On the Invisibility of Women in Judicial Abortion Rhetoric, offers an insightful perspective on this glaring omission of the lived reality of pregnancy in judicial rhetoric. In light of Laguardia’s findings, the approach taken in Dobbs must be viewed not as an anomalous oversight, but rather as a natural extension of a long history of judicial disregard for the physical consequences of pregnancy and childbirth. When courts in abortion cases weight the state’s interest in fetal life against a pregnant patient’s right to bodily autonomy, they inevitably express concern for fetal pain and dignity, but are notably silent about the physiological consequences and dangers of pregnancy – including preeclampsia, gestational diabetes, vaginal and perineal tearing, the pain of labor, hemorrhaging, and postpartum depression. For scholars seeking to understand how the rhetoric of abortion jurisprudence contributes to the erasure of women’s voices, Laguardia’s article is required reading.

The title of this article is a reference to a moving sentence from Planned Parenthood v. Casey: “The mother who carries a child to full term is subject to anxieties, to physical constraints, to pain that only she must bear.” Laguardia describes her analysis of federal and state cases on the constitutional right to abortion between 1974 and 2021 as “less an examination of rhetoric than an examination of a lack of rhetoric.” Her primary finding from a comprehensive review of 223 judicial opinions is that “the pain of pregnancy is articulated far less often than the (still hypothetical and vigorously debated) pain of the fetus.” She finds that courts discuss fetal pain “nearly nine times as often in just over twice as many opinions” than pregnancy- and childbirth-related pain, and discuss the abortion-related pain three times as often.

In the few opinions that do mention the risks of pregnancy and childbirth, “pain is discussed using euphemisms and vague language,” often focusing on the consequences of a woman’s emotional distress from unwanted pregnancy on her family. In contrast, references to fetal pain and the details of abortion procedures are frequent, explicit, and often graphic. Laguardia notes that in Carhart v. Ashcroft, for example, the Supreme Court devoted five pages a discussion of fetal pain and its legal implications.

One of the most fascinating pieces of Laguardia’s article is her consideration of possible reasons why judicial rhetoric in abortion cases ignores maternal physiology, and what impact this omission has.

It is clear why anti-abortion advocates pursuing litigation would want to emphasize the harmful consequences of abortion as compared to the harmful consequences of unwanted pregnancy. However, Laguardia notes that pro-choice attorneys may also have strategic reasons to “downplay the actual physical implications of pregnancy.” In particular, those advocating for freedom of choice may be concerned that “focus[ing] on women’s particular physical interests might be seen as opening the door to a balancing of interests, almost accepting the notion that a previable fetus might rise to the level of a protectable person whose interests could compete with the pregnant person.”

Laguardia further highlights the importance of legal rhetoric as a form of “strategic communication[], purposefully written in order to shape the behavior of other actors,” and argues that “the failure of judges to acknowledge the individual interests of pregnant women is both influenced by social rejection of that idea and influences that rejection.” Laguardia’s findings are a valuable contribution to the extensive body of scholarship that demonstrates the silencing of women’s voices within the legal system, as well as the consequences of that silencing from a broader societal perspective.

Cite as: Nadia Sawicki, Pregnancy, Childbirth, Pain and…Silence, JOTWELL (August 4, 2023) (reviewing Francesca Laguardia, Pain That Only She Must Bear: On the Invisibility of Women in Judicial Abortion Rhetoric, 9 J.L. & the Biosciences 1 (2022)), https://health.jotwell.com/pregnancy-childbirth-pain-and-silence/.

Health Care Fraud’s Next Frontier

Katrice Bridges Copeland, Telemedicine Scams, 108 Iowa L. Rev. 69 (2022).

As the Public Health Emergency triggered by the COVID-19 pandemic has come to an end, one wonders whether legal changes brought about by the pandemic—specifically, regulatory changes that have greatly impacted Americans’ health care access over the last three years—will endure. While the use of telemedicine—defined as “the delivery of healthcare from a distance using electronic information and technology”—during the pandemic greatly broadened access to important health care services for homebound patients, it also provided an opportunity for new ways to exploit the system and commit health care fraud. In her 2022 article Telemedicine Scams, Professor Katrice Bridges Copeland documents the fraudulent practices that impacted telemedicine and provides prescriptions for combatting it as we move into the post-pandemic future.

As the changes brought about by the last three years may lead to a permanent regulatory reorganization, Copeland’s observations are incisive and suggestions are vital. Indeed, as regulators seek to prioritize goals in a post-COVID era and providers and patients grapple with continued reliance on telemedicine to solve access challenges, the changes brought about in health care delivery are likely here to stay. As Copeland writes, “[o]nce the Public Health Emergency is over, it will be impossible to put telemedicine back into a box and shut the lid.”

Professor Copeland’s article—the first to address fraud in telemedicine—is a holistic and complete treatment of a pernicious problem in America’s health care system. She accomplishes her goals through four main sections.

In Part I, Copeland documents what telemedicine is and how it is “uniquely situated to address some of the most pressing problems in health care” by providing savings in time and cost to patients. Although state licensing laws and reimbursement uncertainty provide headwinds to its adoption, Medicare and Medicaid cover telemedicine and have established waivers through the duration of the Public Health Emergency (PHE) that have made it much easier for providers and patients to use. For instance, as part of the PHE, restrictions on the type of doctor that can rely on telemedicine, and the requirement of a preexisting doctor-patient relationship in order to utilize telemedicine, have been waived. In Part II, Copeland summarizes health care fraud efforts and the statutes—the False Claims Act and the Anti-Kickback Statute—that are the government’s chosen tools to go after telemedicine fraud.

In Part III, Professor Copeland walks through the structure of a typical telemedicine fraud scheme involving a marketing company, Medicare and Medicaid recipients, and a laboratory, durable medical equipment company, or telemedicine company. She provides examples of recent scams and investigations, including the “largest health care fraud takedown in [DOJ] history,” which resulted in charges against 345 defendants who collectively caused $6 billion in losses.

In discussing why some trusted employees end up succumbing to fraudulent schemes and others do not, Professor Copeland references the Fraud Triangle theory. This theory identifies three factors to explain and predict fraudulent behavior: incentives or pressure to commit fraud, a perceived opportunity, and a rationalization of the act. This theory can be used to explain why certain individuals—in the midst of a waiver of rules that makes telemedicine fraud more lucrative, and the calculation that detection is extremely low during the PHE—are attracted to fraudulent schemes. She uses the Fraud Triangle theory throughout her suggestions section to assess various policies’ likelihood of success.

Finally, in Part IV, Professor Copeland proposes policy measures to balance fraud prevention with the expanded access to care patients have seen with telemedicine services. She does not argue for any new criminal statute to go after fraud, but instead examines three types of potential preventative measures.

The first would be to reinstate the rule that requires a preexisting doctor-patient relationship as a condition of using telemedicine services. Noting that these types of limitations could potentially do more harm than good, she posits that an exception to protect rural and underserved communities in need of expanded health care access could be a solution.

The second measure would be to limit telemedicine reimbursement to providers in an accountable care relationship. While she believes that this approach could potentially hold promise, she dismisses a suggestion that telemedicine reimbursement should be limited to providers in advanced alternative payment models, citing concerns about its negative impact on access.

The third measure she considers is whether Medicare should add any new screening requirements regarding telemedicine in an effort to better limit fraud, such as patient verification and cross-checking requirements. She concludes that efforts like this may have some impact and should be pursued.

Professor Copeland’s important scholarly contributions in the area of health care fraud have all been impactful, and her newest piece is no exception. By adroitly focusing on the potential threats of a major new delivery mechanism such as telemedicine, she has made us aware of the next major frontier in health care fraud and abuse enforcement. In an area with such hope and promise in addressing America’s health care access challenges, and with the Public Health Emergency coming to an end, her warnings must be heeded to enable telemedicine to flourish while preventing the worst frauds from taking root.

Cite as: Zack Buck, Health Care Fraud’s Next Frontier, JOTWELL (July 7, 2023) (reviewing Katrice Bridges Copeland, Telemedicine Scams, 108 Iowa L. Rev. 69 (2022)), https://health.jotwell.com/health-care-frauds-next-frontier/.

Reforming the Law’s Treatment of Conscientious Objection in Medicine

Dov Fox, Medical Disobedience, __ Harvard L. Rev. __ (forthcoming 2023), available at SSRN (Feb. 14, 2023).

When health care practitioners (HCPs) assert conscience objections to performing medical interventions about which they have moral reservations, the law grants them a broad range of protections, including immunity from tort claims and, in some states, even crimes such as patient endangerment or abandonment. Yet, when HCPs appeal to their conscience as a basis for providing treatments that have been restricted by state laws or institutional policies, they can be fired, fined, suspended, or even imprisoned. Dov Fox’s persuasive new article, Medical Disobedience (forthcoming in the Harvard Law Review) forcefully challenges this legal asymmetry. In its place, he argues that the law should offer limited protections for both conscience-based denials and provisions of treatment, with safeguards designed to minimize any harms to third parties these objections may impose.

Fox begins by explaining why HCPs’ conscience-based decisions  should be entitled to legal protection in some situations. First, respecting HCPs’ conscience protects their agency and preserves their integrity. Second, giving HCPs room to assert conscientious objections reflects an “openness to debate and dissent that sustains a heterogeneous society and dynamic profession.” Noting that “[d]emocracy and medicine are marked by evolving norms and differences of opinion on hard moral questions,” Fox argues that “carve-outs for conscience can preserve objections as a repository for potentially worthy reforms in the future.” In addition, exemptions for conscience can help “achieve a pluralism that reflects a variety of values and backgrounds.”

Criticizing the lines drawn by existing legal doctrine, Fox argues that the “distinction between conscientiously denying care and delivering it” is fundamentally flawed. While he recognizes that “the act/omission distinction runs deep in our legal culture,” he argues that this distinction “has less purchase in medical contexts” because HCPs have an affirmative duty to promote their patients’ well-being. In light of this duty, HCPs have a “responsibility not merely to avoid doing [patients] undue harm, but also to keep such harm from being visited on them through their reckless or negligent indifference to standards of care.” He also challenges the assumption that accommodating requests to provide services is costly, while accommodating refusals is not. In many cases, HCPs will already have all the resources they need to provide the services in question. In contrast, when HCPs refuse to provide care, hospitals or states may be forced to pay more to recruit replacement staff or provide other alternatives.

Fox recognizes that, unlike the accommodation of conscientious refusals, allowing HCPs to provide otherwise prohibited care “undermine[s] the state’s judgment that people shouldn’t have access to [the disputed care] by designating incentives not to comply with the ban.” However, he maintains that denying any room for the conscientious provision of treatment comes at too great a cost, as it “strikes at [HCPs’s] fundamental charge to heal, to promote health, and to relieve suffering” and threatens to “erode the moral enterprise of medicine, and crowd out dissent crucial to sustaining a pluralistic profession.”

In place of the existing asymmetrical conscientious objection regime, Fox proposes legal reforms that would offer limited protections to both conscientious deniers and providers under specified circumstances. Under Fox’s proposed approach, HCPs would be permitted to refuse to provide treatments to which they have moral objections, but they would be required “to disclose their objections clearly upfront to employers as well as patients and pay a modest fee to offset the harms to both.” For HCPs who wish to provide otherwise prohibited treatment, Fox proposes that courts and/or legislators recognize a limited defense of “medical disobedience,” which would reduce—but not eliminate—the direct and collateral penalties associated with providing the disputed treatment. To qualify for this defense, HCPs would need to establish that they obtained competent consent for the treatment, that the treatment was clinically reasonable, and that they took steps to minimize the impact of the care on the availability of resources for others. As an example of this last point, Fox suggests that an HCP who provides treatment that is more expensive than its alternative might accept lower insurance reimbursement or pay a small fee. Conscientious refusals that would normally constitute malpractice or abandonment could qualify for similar treatment as long as they do not violate “non-negotiable duties,” including the duty not to engage in invidious discrimination, to obtain informed consent, and to stabilize patients in emergencies.

Fox has persuaded me that the law’s sharp distinction between conscience deniers and providers is ethically misguided. I also appreciated Fox’s nuanced approach to his proposed defense of medical disobedience, which recognizes that not all appeals to conscience deserve equal respect. For example, the criteria he proposes for applying the defense would probably protect a physician who defies a state prohibition on abortion to protect a patient who faces a risk of developing life-threatening complications but whose life is not immediately in danger. It would not, however, protect a physician who seeks to change a minor’s sexual orientation or gender identity in violation of accepted medical standards.

As states and health care institutions increasingly seek to limit physicians’ ability to practice in a manner consistent with medical standards, Fox’s article provides a roadmap for how judges and lawyers might begin to resist.

Cite as: Carl Coleman, Reforming the Law’s Treatment of Conscientious Objection in Medicine, JOTWELL (June 5, 2023) (reviewing Dov Fox, Medical Disobedience, __ Harvard L. Rev. __ (forthcoming 2023), available at SSRN (Feb. 14, 2023)), https://health.jotwell.com/reforming-the-laws-treatment-of-conscientious-objection-in-medicine/.

What Counts as Evidence? A Uniquely Valuable Analysis of a Belgian Criminal Case Involving Euthanasia

Marc De Hert, Sien Loos, Sigrid Sterckx, Eric Thys & Kristoff Van Assche, Improving Control Over Euthanasia of Persons With Psychiatric Illness: Lessons from the first Belgian Criminal Case Concerning Euthanasia, 13 Frontiers in Psychiatry (2022).

Determining what is reliable evidence seems particularly politicized and contentious in the context of physician-assisted-suicide [PAS] and euthanasia. In jurisdictions where its legalization is debated, opponents often illustrate critical interpretations of official, largely self-reported data with media-reported cases, which legalization advocates tend to trivialize as “anecdotes.”

Prior to Canada’s rapidly expanded euthanasia practice, data and media reports in Belgium and the Netherlands, which have euthanasia laws going back to 2002, used to be at the center of this debate. Official review committees in those countries rarely if ever identify serious problems with a practice that now involves around 3% (Belgium) to 5% (Netherlands) of overall deaths. Some legalization advocates see this as a confirmation of the practice’s safety. The “not-guilty” jury-verdict in the only Belgian criminal trial ever launched against doctors for their involvement in a reported euthanasia case could be seen as a vindication of the claim that even in the contentious context of mental illness, the system works. In Improving Control over Euthanasia of Persons with Psychiatric Illness: Lessons from the first Belgian Criminal Case Concerning Euthanasia, Belgian scholars Marc De Hert, Sien Loos, Sigrid Sterckx, Eric Thys and Kristoff Van Assche convincingly show us why this is wrong.

Their analysis is based on evidence presented during the trial, which took place in the Dutch-speaking region of Belgium, and on extensive Belgian media reports. In addition to analyzing the case, the article describes the Belgian euthanasia law and sketches the evolution of the “psychiatric euthanasia” practice in both Belgium and the Netherlands, which took off around 2010.

The case involved a young woman with a history of bipolar disorder who had, following her euthanasia request, been diagnosed with Asperger Syndrome [AS], and shortly after euthanized. The case provoked much debate about euthanasia for mental illness when it was first publicized in 2016. Criminal prosecution was launched against the attending and two consulting physicians only after media exposure and pressure by family members. The case was often invoked as an illustration of how euthanasia practices were going astray in Belgium. The “not-guilty” verdict by a jury in the Ghent Court of Assize seemed to undermine that claim, even though the Court of Cassation annulled part of the verdict as insufficiently motivated, and remanded the case against one physician to a civil court.

The article not only documents problems with the Belgian law and review system, but also illustrates some of the unique challenges of permitting euthanasia for mental illness. It further provides an interesting study of the importance of detailed and critical case analysis in contentious areas of policy making. The article should interest anyone working on end-of-life law and on mental health law, as well as those more broadly interested in the regulation of high-risk practices that leave much room for discretion to practitioners. Worth emphasizing is that in euthanasia and PAS cases, the party most directly harmed is dead, making complaints less likely and production of evidence uniquely complex. Family members may be traumatized, with mixed feelings, perhaps even of guilt, for not having resisted and done enough to save their loved ones. Institutions or providers may use privacy laws to shield them from scrutiny, as is happening in Canada. A critical analysis of the very few cases that go to court, as the authors did here, is therefore uniquely valuable.

The authors document remarkable procedural violations not caught or considered problematic by the Belgian federal review committee. For example, the attending physician, who performed the euthanasia, did not have the expertise to determine key access criteria under the law (including the nature of the illness and the presence of irremediable suffering), only met three times with the patient in person, and had virtually no medical documentation on the patient. The consulted psychiatrist, the authors note, was “among the psychiatrists generally most conducive” towards euthanasia for mental illness, since she was estimated to have been the consultant for one third to half of the psychiatric euthanasia requests in Belgium up to 2015. One can read in this factual statement a concern about forum-shopping and the overzealousness of some physicians.

The authors, who include two psychiatrists, also argue that basic standards of mental health care were not met. The article contains an interesting exploration of the challenge of determining the irremediability of mental illness. The authors discuss, for example, how “no evidence-based treatment whatsoever was tried for [AS],” notwithstanding an explicit legal duty to exhaust all available treatments in the Belgian and Dutch regimes. This should particularly interest Canadian readers. Indeed, Canada’s “medical assistance in dying” regime, which is scheduled to include mental illness only in the future, but already appears to have provided access to patients because of mental illness, lacks this basic safeguard. The authors reveal how sloppy practices can result in the ending of life of patients who more likely than not would have recovered if alternative treatments had been adequately explored.

The authors’ criticism of the federal review committee is short and to the point. Several of the authors wrote earlier a thorough critique of Belgium’s law and review system, a critique which I have also voiced. Here they briefly describe how the review system works, and then show how it concretely failed.

Perhaps a reflection of how challenging it is to fully step back, once a practice is introduced by law, is how the authors emphasize that “by no means do we want to suggest that the physicians involved should have been condemned for murder.” Physicians who violate the procedural requirements of the euthanasia act will, in the future, even less likely be receiving severe penalties. The Belgian Constitutional Court found recently, in response to a pre-judicial question in the ongoing civil procedure against one of the physicians, that the euthanasia law’s penalty for procedural violations, which is the same as for violating substantial requirements, is disproportionate and therefore unconstitutional. The authors further offer in their conclusion some examples of better clinical practice guidelines and better prior review, some of which have been developed by psychiatric associations in Belgium, which in their view could prevent such cases in the future.

Beyond documenting problems, the article provides a rebuttal to some of the claims about what counts as reliable evidence in this debate. When legalization of PAS was debated in Australia and New Zealand, one article supportive of legalization strategically advised to counter “media reports” from Belgium and to emphasize instead official data. Another article suggested that in contrast with media reports, court cases should be taken seriously; it placed the evidentiary value of court decisions based on adversarial presentation of evidence on par with the “gold standard” of medical evidence, i.e. at the top of the pyramid of evidence. This article documents how an official review system failed to identify even the most basic problems; how the family had difficulties in finding support for a criminal prosecution; how media reports can provide important information; and how, as anyone remotely familiar with the use of medical evidence in court already knows, meritorious claims often hit the wall, the quirks of the legal system being what they are.

The authors give us insight, based on the unique evidence of a specific case, into the shortcomings of a system that has inspired other jurisdictions, particularly Canada. Canadians will also be struck about the thoughtful discussion of how failures in mental health care arguably violated legal safeguards under the Belgian euthanasia law. In Canada, which went with its “medical assistance in dying” law in some crucial aspects beyond the Dutch and Belgian euthanasia laws, there would, remarkably, be no legal basis to find fault for failing to exhaust all standard treatments, prior to ending a life.

Cite as: Trudo Lemmens, What Counts as Evidence? A Uniquely Valuable Analysis of a Belgian Criminal Case Involving Euthanasia, JOTWELL (May 4, 2023) (reviewing Marc De Hert, Sien Loos, Sigrid Sterckx, Eric Thys & Kristoff Van Assche, Improving Control Over Euthanasia of Persons With Psychiatric Illness: Lessons from the first Belgian Criminal Case Concerning Euthanasia, 13 Frontiers in Psychiatry (2022)), https://health.jotwell.com/what-counts-as-evidence-a-uniquely-valuable-analysis-of-a-belgian-criminal-case-involving-euthanasia/.