Sep 15, 2023 Medha Makhlouf
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!
Aug 4, 2023 Nadia Sawicki
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.
Jul 7, 2023 Zack Buck
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.
Jun 5, 2023 Carl Coleman
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.
May 4, 2023 Trudo Lemmens
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.
Apr 14, 2023 André den Exter
Most lawyers will not be acquainted with the concept of Health Technology Assessment (HTA), although it is now considered a key instrument in health policy decision-making in Europe. It is also a potentially controversial concept as it reviews the cost-effectiveness of health technologies taking into account resource constraints. HTA has been defined as “a multidisciplinary process that uses explicit methods to determine the value of health technology at different points in its lifecycle.” Its purpose is “to inform decision-making to promote an equitable, efficient, and high-quality health system.”
HTA can be used as a policy instrument to decide whether a social insurance policy will cover a new health technology—whether a therapy, medicine, or device. HTA is not restricted to Europe. It has been applied in other parts of the world and is supported by the World Health Organization. One may ask, what’s in it for lawyers? Since HTA decision-making has health policy implications concerning the availability and accessibility of new medical technologies for all, it has human rights implications with respect to the right to health care.
This dissertation questions the role of law and the right to health care. It is grounded in the idea that international law regarding rights to health care can contribute to formulating standards for implementing health policies. The author argues that the role of law is not restricted to procedural issues such as transparency, but also more substantive criteria, including non-discrimination, maximum available resources, progressive realization, and international cooperation. Bottini Filho describes this as “applying the human rights-based approach” (HRBA) in HTA decision-making. The result of that approach, according to the author “should be an accountable process not only to distribute resources but also to create them and thus avoid unnecessary [health care] rationing.” For those who believe health care rationing is inappropriate and that health care is not a social good, a rather bizarre outcome.
Part One of the volume explains the concepts of HTA, its legal relevance, and the meaning of the right to health care in international law. Here, the focus of HTA is on macro-level deliberation from a centralized or governmental position to assess whether the health package should cover a medical technology. However, HTA can also be applied on micro-level, at the bedside. Interpreting the right to health care, the author refers to article 12 of the International Covenant of Economic, Social and Cultural Rights (ICESCR) and General Comment no. 14 defining several State obligations related to the right to health care.
Part Two applies the theoretical concepts by formulating a harmonized set of rules that will steer fair decisions related to resource distribution, and regulate standards in the criteria of HTA. These rules are based on human rights principles: progressive realization, maximum available resources, and the reasonableness standard, as well as the non-discrimination principle and the application of the role of international cooperation.
Part Three presents Brazil as a case study of the substantive policies and legal issues of HTA deliberations grounded in a socio-economic rights framework in international law. Brazil is for several reasons an interesting selection: it is a country with a constitutional right to health; HTA is regulated through law and institutionalized through a public agency; data and reports issued through this process are publicly available; and, finally, there is a large body of literature on the right to health in Brazil, also connected with HTA. As the author explains, however, the human rights dimension in HTA decision-making remains largely absent in practice.
The added value of this dissertation is conceptualizing the human rights-based approach in HTA decision-making processes. Apart from clinical effectiveness and cost considerations, improving the decision-making process requires the use of clear procedures, substantive human rights considerations, and public participation in deliberations. The author has made an important effort to contribute to that deliberative process.
Cite as: André den Exter,
Health Care Decision-Making and the Law, JOTWELL
(April 14, 2023) (reviewing Luciano Bottini Filho,
Health Technology Assessment and the International Right to Health: Interpreting State Obligations in Resource Distribution and Mobilisation (Ph.D. diss., University of Bristol Law School, 2022)),
https://health.jotwell.com/health-care-decision-making-and-the-law/.
Apr 3, 2023 Emma Cave
The International Committee of Medical Journal Editors (ICMJE) has set out guidance on the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals since 1978. The 2022 version recognises that “authorship confers credit and has important academic, social and financial implications” as well as implying “responsibility and accountability for published work.”
In Misuse of Co-authorship in Medical PhD Theses in Scandinavia: A Questionnaire Survey, published in the Journal of Academic Ethics, Gert Helgesson, Søren Holm, Lone Bredahl, Bjørn Hofmann and Niklas Juth survey the experiences and attitudes to authorship in Ph.D. theses in Denmark, Norway and Sweden. The article makes difficult but important reading. It points to a high level of acceptance and support for the ICMJE recommendations but a perpetuation of poor authorship practices.
Though the study focuses on scientific authorship, it is important reading for health lawyers for two principal reasons.
- As initiatives to foster interdisciplinary research proliferate, we might hope for greater consistency in the norms guiding co-authorship. Until that happens, academic health lawyers publishing co-authored work in biomedical journals or working with clinicians to publish in law journals must understand relevant norms or risk the misappropriation of both benefits and responsibilities.
- There are common themes that apply in relation to all academic co-authorship that are drawn out in this piece. One is that the risks of inappropriate co-authorship attribution are particularly high when there is an imbalance of power between co-authors. In the humanities and social sciences, where guidance on how to establish co-authorship is less clear and established than is the case in medicine, the risks of misuse may be accentuated. It is increasingly the norm in the social sciences and humanities for work to be co-authored. And emphasis on publication and citations play a burgeoning role in grant application success, promotion, and reputation across all academic areas.
The Committee on Publication Ethics is an international organisation that produces guidance cutting across academic fields. It recognises variation across disciplines on the norms governing authorship and, as consistency is too much to hope for, it calls for journal editors to put in place clear guidance. However, as Helgesson et al demonstrate, even when the norms are understood and supported, they are not consistently upheld.
The researchers collected quantitative and qualitative data from 287 questionnaires returned by medical Ph.D.s from faculties in Scandinavian universities in the second half of 2020. They report that nearly half of the respondents did not consider the authorship criteria set out by the ICMJE to have been respected. The failures involved inclusion of author/s who had not
- made a substantial contribution to the work (34.4%)
- drafted or critically revised the paper (32.6%)
- given final approval of the submitted paper (10.5%)
A further 24.4% reported that in at least one paper for their degree, the authorship order did not reflect the authors’ expectations given their relative contributions. Women were more likely to make this complaint than men.
As for the reasons for circumventing the guidelines, the authors give several examples of inappropriate exclusions and inclusions. Regarding the latter there were cases
by supervisors and others making sure they end up on papers they have power over, or because departments have such a policy; by influential researchers including friends or distributing benefits for pragmatic reasons, such as making sure PhD students get the final paper needed to defend their thesis.
The article contrasts the results of similar surveys in 2009 and 2016 and depressingly finds no meaningful differences, notwithstanding increased attention to the teaching and promulgation of authorship guidance and norms in medicine. The incentives to breach the guidelines are high and educational efforts alone are unlikely to resolve the issues. As methods of health research change to incorporate co-produced research, the issues intensify.
Equitable academic co-writing and co-authorship are goals we can all endorse but power differentials, incentives and unclear and inconsistent guidance across disciplines frequently frustrate.
Cite as: Emma Cave,
Ethical Co-Authorship, JOTWELL
(April 3, 2023) (reviewing Gert Helgesson, Søren Holm, Lone Bredahl, Bjørn Hofmann & Niklas Juth,
Misuse of Co-authorship in Medical PhD Theses in Scandinavia: A Questionnaire Survey,
J. of Acad. Ethics (2022)),
https://health.jotwell.com/ethical-co-authorship/.
Mar 28, 2023 Maya Manian
David S. Cohen, Greer Donley & Rachel Rebouché,
Abortion Pills, 76
Stan. L. Rev. __ (forthcoming 2024), Mar. 15, 2023 draft available at
SSRN.
In countries around the globe that have long criminalized abortion, women and pregnant people have been using abortion pills for decades to end their pregnancies. Public health research has shown that abortion pills are safe and effective for terminating a pregnancy, even when people access pills and self-manage abortions outside the formal health care system. Since the decision in Dobbs v. Jackson Women’s Health Organization, which overturned Roe v. Wade and permitted states to broadly restrict access to abortion care at any stage of pregnancy, abortion foes and abortion advocates have been engaged in a pitched battle over access to abortion pills. The majority of abortions in America are now managed through pills rather than a procedure. Given this reality, the legal battles over abortion pills could determine who has access to abortion care on the ground not only in red states, but even in blue states where many people presume (incorrectly) that their access to comprehensive reproductive health care is safe.
In their aptly titled draft article, Abortion Pills, David Cohen, Greer Donley, and Rachel Rebouché tackle the complicated legal terrain on which the abortion pills war is currently being waged. The authors argue that the battles over abortion pills will transform public contestation about government regulation of abortion going forward. The article provides a much-needed overview for scholars and advocates struggling to keep up with the barrage of litigation and legislation governing abortion pills post-Dobbs. Even more importantly, the authors crystallize the consequences of these legal battles for access to care nationwide. As with this trio’s previous article, The New Abortion Battleground, which was cited by the dissenting opinion in Dobbs and predicted much of the legal fallout from that decision, Abortion Pills is an important contribution to the rapidly growing literature on the impact of overturning Roe.
The bulk of the article maps out the landscape of legal battles about medication abortion currently raging in the courts, state legislatures, and the Food and Drug Administration (FDA), as well as the consequences of those battles for the availability of abortion pills. This mapping out is no easy feat—the article deftly examines a broad array of legal maneuvers from constitutional law claims on preemption, to health law issues relating to telemedicine, to the intricacies of administrative law in the context of FDA regulation. The article analyzes the strengths and weaknesses of anti-abortion strategies to shut down access to abortion pills, as well as abortion advocates’ push back to expand access to medication abortion. Several key themes emerge from the authors’ thorough analysis. First, the article highlights how the fight over pills will determine access to abortion care nationwide—women and pregnant people in blue states cannot count on access to the gold standard of abortion care in their home states. A second theme arises from the authors’ apt analogy to the War on Drugs. Although there are obvious differences, the analogy works to highlight how the war on abortion pills—like the war on drugs—will fail to stop illicit access to pills and will have a discriminatory impact on communities of color and low-income communities.
In the first part of the article, the authors provide an overview of anti-abortion strategies to erect barriers to widespread abortion pill access. As the article emphasizes, “how revolutionary abortion pills are cannot be understated,” since pills allow for safe, effective abortion care even in states that ban it. (P. 12.) Due to the relative ease of access to abortion that these pills allow, anti-abortion strategists are deploying a multitude of legal tools to tamp down on medication abortion. Most notably, a federal lawsuit in Texas seeks to remove mifepristone from the market nationwide. Mifepristone is the first drug in the two-drug protocol approved by the FDA for medication abortion and is also used for miscarriage management. The second drug, misoprostol, is more readily available—and is also safe and effective for abortion care on its own. However, since abortion using misoprostol alone has more side effects, the two-drug protocol is generally preferred in the U.S. Although the Texas lawsuit has received outsized media attention, the authors importantly argue that even an adverse ruling from the Texas courts need not stop all medication abortion nationwide.
In addition to examining the Texas lawsuit, the article also explores numerous other tactics to restrict abortion pills, including: reviving the Comstock Act, a long dormant nineteenth century federal statute, in order to ban the mailing of abortion pills; redefining the location of abortion care to prosecute out-of-state travel for abortion pills; targeting information about abortion pills and promoting misinformation online; threatening those in the abortion pills supply chain with civil lawsuits or criminal prosecution; and criminalizing women and pregnant people themselves for use of abortion pills. The authors emphasize that this list is not exhaustive and that creative new strategies targeting abortion pills are on the horizon. The landscape is so rapidly shifting that the draft article does not yet reflect a new civil lawsuit filed by a man in Texas that will likely have a chilling effect on access to abortion pills. This Texas suit for wrongful death seeks $1 million in damages against each of three women who helped the man’s ex-wife gain access to abortion pills to terminate her pregnancy. As the article points out, anti-abortion lawyers do not need to win these lawsuits to impede access to abortion pills, because “ambiguity breeds confusion and chills care.” (P. 24.)
The next part of the article investigates the counter-offensive, a multi-pronged effort to increase access to abortion pills through state legislation, federal court litigation, and administrative advocacy. The authors describe these various efforts and set forth arguments for further expanding the availability of abortion pills both through telehealth and self-managed abortion care outside the formal health care system. For example, the article outlines how state legislatures could enact more expansive shield laws, which would protect health care providers from liability for providing telehealth abortion care to patients located in abortion ban states. Health care providers could also increase access to abortion pills by prescribing pills without a known pregnancy, using the centuries old practice of “menstrual regulation,” also called missed period pills. (Pp. 33-34.) In addition, the article argues in favor of state legislatures permitting pharmacists to prescribe abortion pills in order to increase access, especially along the borders of red and blue states.
Finally and perhaps most importantly, the article examines the ongoing battle surrounding the FDA’s approval of abortion pills, which will impact access to abortion medications nationwide. In an inverse of the Texas lawsuit seeking to ban mifepristone nationwide, a federal court case filed by a manufacturer of abortion pills argues that FDA regulation of mifepristone preempts state abortion bans. If successful, this litigation could protect access to abortion pills nationwide even in abortion ban states. The FDA could also expand access to abortion pills by removing administrative restrictions under its REMS program or changing its labelling requirements for mifepristone—or under a Republican President the FDA could do the opposite and further restrict access to abortion pills nationwide. In particular, the FDA could make it easier (or harder) to access abortion pills via telehealth, removing (or adding) obstacles to abortion care that flow from medically unnecessary mandates to visit a physician in-person in order to receive abortion pills.
The last section of the article sketches out the normative implications of the simultaneous explosion in both abortion bans and abortion pills. The authors argue that increased use of abortion pills, especially earlier in pregnancy, may transform how abortion is understood and debated by the public. For example, the authors highlight how abortion pills bring to the fore definitional blurriness between abortion and other less stigmatized forms of health care, such as miscarriage management and treatment for life-threatening ectopic pregnancies. They contend that, among other factors, the broader health care implications of banning abortion and the reality of increasing criminalization of pregnant women and people themselves for using abortion pills could undermine abortion stigma. Whether or not abortion pills can help to destigmatize abortion seems the least predictable part of the article’s analysis. Criminalization and the resulting increased secrecy surrounding abortion could also lead to further stigma, especially since people criminalized for pregnancy outcomes are disproportionately racial minorities and low-income. The authors fully recognize the discriminatory impacts of criminalizing pregnant people. As they succinctly summarize their argument: “The lesson for the War on Abortion Pills from the War on Drugs is clear: invasive, punitive state action will not stop abortion. Rather, it will harm public health, hurt those most vulnerable to state power, and incentivize informal networks to operate.” (P. 5.)
While providing a thorough snapshot of the current legal landscape on abortion pills, the article acknowledges that the law is fast-changing and that the future is uncertain. Abortion Pills is an essential read for those who want to understand the shape of the battles to come and the implications for health equity in abortion access nationwide. Pills cross borders much more easily than people—and thus will continue to be a prime target for abortion foes and a prime source of hope for abortion access.
Feb 20, 2023 Myrisha Lewis
As scholars and the public consider the extensive consequences of the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, Professor Khiara Bridges’ article, The Dysgenic State: Environmental Injustice and Disability-Selective Abortion Bans, published shortly before Dobbs was released, adds another important lens to that analysis. Her article identifies and explains the “dysgenic state.” While the eugenic state was motivated by a desire to eradicate what it classified as “disability,” the dysgenic state fails to protect its citizenry from environmental toxins and compels its citizens to give birth to children whose health is impaired by those toxins. Further, environmental toxins have disproportionate impacts on people of color and individuals of lower socioeconomic status, and after controlling for socioeconomic status or class, “people of color are more likely to be exposed to environmental harms in their communities.”
There is significant scholarship on the impacts of abortion restrictions, especially scholarship emphasizing its restrictions on low-income individuals and people of color. Professor Bridges discusses these hurdles and abortion restrictions more broadly, as well as adds an additional perspective on these matters. The Article focuses on the role of reason-based abortion bans specifically, namely race-selective, sex-selective, and disability-selective bans.
The first part of the article provides background on the eugenics movement and environmental injustice. The Article is animated by three frameworks: (1) critical disability studies, (2) reproductive justice, and (3) environmental justice. She explains the relationship that already exists between the environmental justice and reproductive justice frameworks: environmental justice is already part of the reproductive justice framework as the harms of environmental degradation can negatively impact one’s ability to reproduce. Bridges’ analysis also celebrates the role of disability in society as well as acknowledges the difficulties of disabilities for many who may be harmed by its medicalization or the lack of societal accommodation for a disability.
While acknowledging the uncertainty of science, Bridges provides extensive citations from multiple literatures. Another important point includes noting that many environmental toxins can cause fetal death, which could lead to an undercounting of the extent of fetal harm that may result from environmental degradation as some environmental toxins lead to pregnancy loss (miscarriage or stillbirth) instead of the birth of a child with “a structural or functional birth defect.”
Part III of the article focuses on “reasons-based abortion bans,” in general, including the “entire premise of the genetic counseling industry…[which] is that parents have a legitimate interest in avoiding the birth of a health-impaired child.” It additionally raises several other issues such as how reason-based abortion bans operate with specific legislative exceptions for abortions in the case of fetal impairment. It addresses reasons-based abortion laws and other restrictions on abortion access such as the Hyde Amendment. As the article considers legislative and public views on the acceptability of reason-based abortions, it also analyzes other restrictions on abortion access in the United States. For example, while most states follow the Hyde Amendment’s funding scheme, which generally prohibits the spending federal Medicaid funds on abortions with exceptions for abortions for the patient’s life or for terminating pregnancies due to rape or incest, some states affirmatively permit spending state Medicaid funds for abortions in case of fetal impairment. This exception is notable considering the many restrictions on state-funded abortions.
Part IV focuses on disability-selective abortion bans and explains why society may disfavor regulating disability-selective abortions. It investigates the motivations of those who support disability-selective abortion bans and those who oppose them. Part IV also discusses criticism of Justice Thomas’ concurrence in Box v. Planned Parenthood of Indiana and Kentucky, Inc. In his concurrence, Thomas wrote that Indiana’s sex-selective and disability abortion ban and similar laws “promote a state’s compelling interest in preventing abortion from becoming a tool of modern-day eugenics.” There is growing attention to Thomas’ concurrence in Box, as well as significant push-back. For example, Bridges notes that some critics of Thomas’ concurrence have pointed out that those who terminate a pregnancy because of fetal impairment do not make that decision because they are concerned about the country’s gene pool, a concern that motivated eugenicists in the early 20th century (many of whom were also opposed to abortion). Others note that individuals interested in furthering disability-selective abortion bans seem to show no similar concern for existing people with disabilities or the individuals who gestate fetuses in general.
Ultimately, Part V of the article explains that the dysgenic and eugenic states produce societies with “virtually indistinguishable results,” as “impairments are concentrated among those who are nonwhite or poor, while wealthier white people remain comparatively free of impairments.” Thus, “[w]hile the dysgenic state appears to be the inverse of the eugenic state, it actually functions to produce results that are virtually indistinguishable from the goals of the eugenic state” by concentrating impairments in low income or nonwhite individuals.
Professor Bridges’ article, The Dysgenic State: Environmental Injustice and Disability-Selective Abortion Bans, was important reading before the Supreme Court’s decision in Dobbs. In the aftermath of the Supreme Court’s decision in Dobbs and the many environmental injustices that persist and continue to arise, Professor Khiara Bridges’ article is even more necessary.
Jan 19, 2023 Jessica Lind Mantel
Jaime S. King, Alexandra D. Montague, Daniel Arnold & Thomas L. Greaney,
Antitrust’s Healthcare Conundrum: Cross-Market Mergers and the Rise of the System of Power, __
Hastings L. J. __ (forthcoming 2023) available at
SSRN.
In Antitrust’s Healthcare Conundrum: Cross-Market Mergers and the Rise of the System of Power, Jamie King, Alexandra Montague, Daniel Arnold, and Thomas Greaney highlight a significant gap in federal and state antitrust enforcement policy─the growing market power of healthcare systems than span multiple local geographic markets. Although antitrust enforcers have long assumed that mergers and acquisitions among providers competing in different geographic markets pose little threat to competition, the authors persuasively argue that this assumption is wrong. To support antitrust enforcement in this area, the article proposes an initial framework for cross-market merger analysis that draws upon the insights from antitrust caselaw, guidance documents from American and European Union antitrust agencies, and economic and legal scholarship.
In their review of lessons learned from conglomerate mergers outside of the health care context, the authors identify two key factors suggestive of anticompetitive effects. First, the merger creates linkages between the markets served by the merging entities when their products or services are related or complementary and can be packaged together for sale to a common customer. Second, when significant, those linkages can generate pricing power that allows one or more of the merged entities to raise prices. The article then examines how cross-sector health mergers across geographic markets can create linkages that satisfy these conditions.
As for the first factor, the authors build on a key insight of modern horizontal merger guidelines for health care providers—that bargaining between payors and providers, and not competition for individual patients, largely determines health care prices. They explain that insurers create linkages across provider geographic markets by packaging health care services into provider networks, with these networks then marketed to employers with employees spanning multiple geographic areas. In addition, health systems create linkages between distinct local markets when, in their negotiations with insurers or employers, they tie the sale of services in one provider market to the insurer or employer also purchasing services in other markets.
The second half of the article explores these linkages in greater depth and discusses when they create opportunities for health systems to raise prices. Because antitrust enforcement requires a strong underlying economic theory backed by empirical evidence, Part IV provides an overview of the economic literature on cross-market health care mergers. It begins by highlighting several economic studies that provide credible evidence that cross-market health care mergers can result in higher prices. Part IV then discusses the economic theories that may explain these empirical findings. Of key importance are two factors that give a health system greater leverage in its price negotiations with the insurer. First, the health system can use its market power in one market (the tying market) to increase its bargaining position in a second market (the tied market) by linking its sales in the former with the later. For example, a health system with a “must-have” hospital can engage in all-or-nothing negotiations that require the insurer needing the must-have hospital in its provider network to also contract with all of the system’s facilities, including a newly acquired hospital. Second, when employers with employees across multiple geographic areas desire health plans that can insure an entire workforce, this can give a multimarket health system negotiating leverage if its exclusion from a plan’s provider network creates gaps that would make the plan unattractive to these employers.
Parts V and VI build on Part IV’s economic discussion and describe various legal avenues for challenging prospective cross-market health care mergers under section 7 of the Clayton Act. The authors contend that antitrust enforcers could challenge a cross-market merger where the health system can tie their facilities together and coerce payers into higher prices and/or foreclose lower-priced facilities from payers’ networks. For example, as described above, a large multi-hospital system that pre-merger included one or more “must-have” hospitals can extract price increases for a newly acquired facility in a different market by linking the hospitals together in its negotiations with insurers. The authors also identify several helpful factors relevant to the analysis or whether a cross-market merger would in fact enhance the potential for tying.
Next, the authors suggest that antitrust enforcers consider whether the elimination of competition between the merging parties substantially lessens competition due to the merged entities having greater negotiating leverage with insurers. Specifically, they argue that “in some cases market demand may support defining a cluster market for certain buyers that extends beyond the local boundaries traditionally assumed to delimit horizontal competition among hospitals,” namely when certain customers are willing to pay a premium to purchase health care services in a group. The authors then identify several scenarios where this may occur.
First, within a geographic area, a merger between health systems could lead to higher prices if some insurers or employers are willing pay a premium to have access to the merged system’s complex tertiary and quaternary care services. If so, this could support a broader, multi-regional geographic market for tertiary and quaternary services, as distinct from the narrower geographic markets antitrust enforcers use for secondary care. Alternatively, the cluster of services desired by insurers or employers may include the full spectrum of inpatient care, which would support an all-inclusive market in a broad geographic area that includes secondary, tertiary, and quaternary care.
Second, a cluster market may exist for multimarket health systems. The authors identify two groups of customers who may be willing to pay a premium for a multimarket health system─insurers serving regional and national employers that must build multimarket provider networks, and employers with geographically dispersed employees. The authors identify several reasons why these customer groups may prefer contracting with large cross-market health systems, such as lower transaction costs from negotiating with a single health system (versus multiple hospitals), and avoiding inconsistencies and incompatibilities among network providers (e.g., promoting standardized electronic medical records and patient interface technologies).
Having identified potential cluster markets for highly specialized care, an all-inclusive market, and multimarket health systems, the authors then explain how antitrust enforcers could apply traditional horizontal merger principles to evaluate a cross-sector merger’s anticompetitive effects in a cluster market. The authors note, however, that the modelling tools currently used in horizontal merger analysis would need to be modified to fit the cross-sector health merger context and provide some helpful suggestions for doing so.
The article concludes with instructive suggestions for a research agenda that would increase our collective understanding of cross-sector health mergers and enhance future antitrust enforcement of these mergers when anticompetitive.
In sum, the authors convincingly show that the failure of antitrust enforcers to challenge cross-market consolidation among health care providers has significantly harmed health care markets. Antitrust enforcers would be wise to heed the authors’ recommendations and expand the scope of antitrust enforcement to include cross-sector health mergers.
Cite as: Jessica Lind Mantel,
Challenging Anticompetitive Cross-Market Health Mergers, JOTWELL
(January 19, 2023) (reviewing Jaime S. King, Alexandra D. Montague, Daniel Arnold & Thomas L. Greaney,
Antitrust’s Healthcare Conundrum: Cross-Market Mergers and the Rise of the System of Power, __
Hastings L. J. __ (forthcoming 2023) available at SSRN),
https://health.jotwell.com/challenging-anticompetitive-cross-market-health-mergers/.
