Sharona Hoffman, What Genetic Testing Teaches About Predictive Health Analytics Regulation
, __ N.C. L. Rev.
__ (forthcoming), available at SSRN
Professor Sharona Hoffman is one of our most prominent health law scholars. She is particularly interested in the intricacies of health privacy and quality in the context of pervasive healthcare technologies such as electronic health records and big data. Her expertise extends to a deep understanding of the Genetic Information Nondiscrimination Act of 2008 (GINA) and the scope of the Americans with Disabilities Act (ADA). In her excellent article, What Genetic Testing Teaches about Predictive Health Analytics Regulation, Hoffman neatly combines these interests, providing a thoughtful critique of predictive health analytics founded on a detailed description of our legal and policy experiences with genetic testing. The comparison is particularly pertinent because, to an extent, algorithmic medicine is stepping into a space that many had hoped would by now be occupied by precision medicine.
Hoffman identifies the policy and regulatory issues raised by both genetic testing and what she labels as long-term predictive analytics as “clinical validity and accuracy, privacy and discrimination, and psychological harms.” (P. 14.) At root, these raise the question of what Jessica Roberts and Elizabeth Weeks call “healthism,” “[p]ermitting—and even encouraging—discriminatory treatment based on an individual’s health status.”
Hoffman’s position is that, while we have taken a “relatively cautious approach to genetic testing,” the approach to predictive health analytics has been “more cavalier.” (P. 3.) To a large extent this is likely because the publicly-funded human genome project featured (as Hoffman notes) a concomitant Ethical, Legal and Social Implications Research Program (ELSI). In contrast (and at least in the U.S.), most predictive health analytics projects are in the hands of private actors such as Alphabet’s Verily or IBM Watson (even if some of their products eventually may receive reimbursement from public funds). A lack of social inquiry or concern with regard to the latter also may be attributable to different media and public perceptions. Cracking our genetic code was big news, regularly reported on. In contrast, analysis of predictive health analytics, while of interest to economists is more likely to be subsumed under broader, frequently dystopian visions about the very future of mankind or at least its impact on employment.
Hoffman correctly views the risks such as breach of privacy or discrimination associated with health analytics as amplified by the inclusion of non-traditional data sources and the products such as health scores offered by businesses such as data-brokers. Those observations also inform the regulatory problems she identifies. For example, while GINA would regulate many of these activities if they involved genetic information the same cannot be said of predictive health analytics. Similarly, as Hoffman points out, other regulatory models struggle here. Thus, the HIPAA Privacy Rule falls down when data is in the hands of persons who are not covered entities or their business associates while the Food and Drug Administration’s jurisdiction maps poorly to these products and the risks they pose (notwithstanding the agency’s recent discussion paper on healthcare AI).
As a result and as Hoffman terms it, this “article is a call to action.” (P. 32.) First, she argues that the scientific community must “carefully consider the benefits and risks of predictive health analytics and implement safeguards to address its hazards… and develop oversight mechanisms to safeguard the quality of predictive models.” (P. 4.) Second:
Data subjects should enjoy rights that give them a degree of control over their data including predicted health outcomes. They should have an expanded right to consent to disclosure of their health information a right to discover who has seen their health data and a right to sue for privacy breaches that harm them and for discrimination based on disease predictions.
(P. 4.) This second group of recommendations inevitably leads to a call for changes to the HIPAA rules and the ADA, the former extending the reach of “covered entity” and “health information.” Here I part company somewhat, as I remain unconvinced that HIPAA can be usefully extended much beyond its current scope. I go further (accepting the inevitable accusation of political naïvety) arguing that when looking at regulatory options for healthcare AI we should go big or go home.
Hoffman’s “call to action” deserves immediate attention. So far the public debate in the U.S. has been muted, limited to the technocratic musings of the Obama Administration’s Artificial Intelligence Automation, and the Economy report to the more jingoistic proposals of the Trump Administration’ Artificial Intelligence for the American People. Our friends in Europe seem be further along the regulatory path, benefiting from perceptive reports from both the House of Lords in the UK and the European Commission’s Ethics Guidelines For Trustworthy AI.
Professor Hoffman is on solid ground in arguing that now is the time for action. As she argues, “many more minds must tackle the challenges of predictive health analytics and develop mechanisms to enhance the integrity and benefits of this technology.” (P. 39.) To do otherwise would be “imprudent and could cost society dearly.” (P. 39.) Highlighting those perils with her perceptive and apposite comparisons to the risks associated with genetic testing and the appropriate legal and policy steps that followed will be the lasting message of this excellent article.
Allison K. Hoffman, Health Care’s Market Bureaucracy
, 66 UCLA Law Rev.
__ (forthcoming, 2019), available at SSRN
Nearly all politically viable solutions for the health system’s ills over the last four decades have been market-based solutions aimed at harnessing the competitive pressures of the market to produce better outcomes at lower cost while preserving individual choice. In Health Care’s Market Bureaucracy, Professor Allison Hoffman reviews the empirical evidence of the effectiveness of such policies in three primary areas – the market for health insurance, the market for medical care from the patient/demand-side, and the market for medical care from the provider/supply-side. She then systematically breaks down both the costs of insisting on a market-based approach to health care and the illusory nature of individual choice within such approaches.
There are, of course, many health law and policy scholars who believe a market-based health system is not a normatively desirable approach to health care. But what makes this article so powerful is that it takes on market-based theorists on their own terms, analyzing the evidence of whether and to what extent the market has delivered desired results. The article is valuable, in part, simply because it takes a holistic view of market-based health policy. But more specifically, it makes three important contributions to the literature. First, it brings attention to the enormous costs associated with a commitment to maintaining health care markets, both in terms of financial costs and policy bandwidth. Second, it provides a clear-eyed examination of what individual choice can and cannot accomplish in a market-based health system. And finally, it acknowledges that relying on market-based solutions allows all of us to avoid the hard choices we know must be made in allocating scarce health care resources.
The article’s title phrase, “market bureaucracy,” is a reference to the enormous financial costs and government infrastructure that have resulted from our commitment to health care markets. The ACA individual insurance markets provide a timely example of this phenomenon. Instead of directly providing health insurance in one form or another to the target uninsured population, the ACA has required a massive investment of time, infrastructure, and money, while delivering coverage to a relatively small percentage of the population. The federal government spent nearly $5 billion on state grants to establish the state exchanges, and spends $1 – $2 billion a year to operate healthcare.gov, the federally-funded exchange. States spend additional, significant amounts each year, all to maintain health insurance markets that sell largely standardized plans. And here Professor Hoffman makes a powerful point: the market-based policy of the ACA likely created more bureaucracy than a more direct approach to expanding access would have and arguably makes consumers worse off at the same time.
Creating this significant bureaucracy would not necessarily be a bad thing if, in fact, the system were welfare maximizing. But as Professor Hoffman’s review of consumer choice in the market for health insurance suggests, the available choice in our market-based system provides little apparent benefit. The ACA’s state-based markets are regulated to provide relatively standardized offerings. All plans are supposed to offer a nearly identical package of benefits at standardized actuarial values. Plans, then, should compete on limited and productive bases: provider networks, premiums, cost-sharing structure, and maybe insurer reputation. Yet numerous studies of consumer choice in ACA markets are reviewed in this article, nearly all of which strongly suggest that “[c]onsumers left to their own devices seem to make large errors when choosing health insurance…and they seem to be unaware of their failure.” (P. 32.) Professor Hoffman suggests that we might be better off if we simply handed the best available health plan to individuals or, as she notes more controversially, if we denied coverage for medical care with low or no value.
The article not only pushes against assumptions about the ways markets function and the benefits they deliver, but also reminds us that being able to claim that the market will maximize welfare allows us to shirk our responsibility to make the hard decisions: who gets health care and how much? But Professor Hoffman is realistic about this last issue. She acknowledges that it’s possible that a market-based approach might be the best we can do – that the social and political costs of having these harder conversations may simply be too high – although she does offer some suggestions about paths forward for collective decisionmaking around these issues.
Professor Hoffman does not hide that part of the article’s purpose is to encourage health law and policy scholars to spend less time obsessing over reforms that improve in some marginal way the function of health care markets. I consider myself part of the target audience for this call to action and I found it to be a truly helpful and challenging reminder that there are other paths forward that are worth the same careful thought as market-based solutions. She encourages us to “put down the technocratic tools” and “let go of the false hope that market-based solutions will solve U.S. health care woes.” (P. 87.)
Discussions of limits on women’s reproductive choice these days most often focus on legislative efforts to curtail that choice by narrowly limiting abortion access. Sofia Yakren’s new article reminds us that medical malfeasance in failing to provide accurate information about the fetus may also limit a woman’s choice regarding her pregnancy. Yakren’s article considers how tort law’s existing remedy for that malfeasance—the “wrongful birth” cause of action—is anti-therapeutic, harming the woman who seeks redress (and potentially her child) and stigmatizing people with disabilities. Drawing on legal scholarship, disability studies, feminist theory, psychological research, and journalistic accounts, the article is an important read for those interested in bioethics, torts, and feminist or disability studies.
Reproductive torts are sometimes characterized as embodying an inevitable tension between the interests of a disabled child (and disability advocates more broadly) and the interests of a woman (and feminists more broadly), but Yakren resists that smooth path. Her article criticizes how existing wrongful birth jurisprudence requires a mother to claim in court that, had she received accurate information from her doctor prenatally, she would have terminated her pregnancy. According to Yakren, this requirement leads to mothers being blamed and shamed—by courts and the media—for cold-heartedly rejecting their disabled children and being criticized—by disability advocates—for stigmatizing disabled lives as harmful. Yakren’s goal is to “shift blame from mothers to the legal system.” (P. 583.) In other words, the problem is not that mothers are cold-hearted, it is that the legal system forces them to act that way to recover resources needed for child rearing. To accomplish this goal, she offers a nuanced and contextual consideration of the emotional and financial experiences of plaintiff-mothers.
Central to Yakren’s understanding of plaintiff-mothers in wrongful birth lawsuits is an acceptance of their ambivalent feelings about mothering a child whose impairment was negligently undisclosed during pregnancy. According to Yakren, it is unsurprising that a woman bringing a wrongful birth suit may simultaneously love her child but resent or even hate the many difficulties associated with raising a child with extensive health and social needs in a society providing few supports. The article supplies rich support for “embracing the paradox” of a mother’s loving her disabled child, even if she might have terminated the pregnancy had she known of the disability.
Yakren deftly employs the work of feminist psychotherapist Roszika Parker regarding maternal ambivalence and journalistic accounts of plaintiffs in wrongful birth suits. She also makes good use of the extensive accounts of parenting a child with a disability that Andrew Solomon offers in his interview-based book Far from the Tree. In doing so, Yakren makes a powerful case that a mother’s ambivalence associated with raising a child with a disability that she would have chosen to avoid does not truly differ in kind from the emotional experience of mothering any child, though it may differ in degree. Unlike societal portrayals of the idealized, perfect mother, real mothers normally experience complex and paradoxical feelings towards their children. As Yakren puts it: “For parents bringing wrongful birth claims, as for all parents to one degree or another, love and labor go hand in hand.” (P. 615.)
After making the case that current wrongful birth jurisprudence is anti-therapeutic, Yakren explores how changing law and practice might mitigate existing harms. One change would entail courts’ accepting a more expansive understanding of the emotional distress for which successful plaintiffs can recover, thereby normalizing maternal ambivalence. The article suggests doctrinal strategies for accomplishing that expansion. Another key change is to shift how the law describes the wrong suffered by the mother, from the birth of a disabled child to the deprivation of her reproductive control. That shift that could affect how damages are assessed. Yakren acknowledges that this shift may be largely semantic, but it is important to her overarching thesis: “[T]he rhetorical shift from a flawed child who should have been aborted to disappointed parental expectations could well improve plaintiff-mothers’ emotional experience and reduce the stigma of disability.” (P. 624.)
Yakren’s final suggestion is that lawyers representing plaintiff-mothers should be aware of the particular emotional toll that pursuing a wrongful birth claim can take on their clients. By being accepting of maternal ambivalence in counselling those clients, lawyers can decrease the negative impact of the judicial system. The article’s treatment of this point is brief, but it raises a concern deserving fuller consideration. How tort litigation, and particularly the assessment of damages, routinely serves to devalue disabled life by asserting its tragic nature is an important question largely unexplored by legal scholars. This concern looms particularly large in reproductive tort litigation, where the very existence of a child with some kind of impairment is often a central aspect of the injury alleged. Effective client-centered representation in cases seeking compensation for disability requires sensitivity to the tension between maximizing the client’s (and thus attorney’s) financial recovery and minimizing the psychic harm potentially associated with proclaiming the client’s degraded quality of life.
Yakren’s article offers readers a vision of how to transform existing “wrongful birth” jurisprudence so as to respect women’s reproductive autonomy and deter medical malfeasance. Most valuably, the article honors the complex mixture of love, resentment, joy, and depletion that can accompany parenting a child with a disability in our society and demands that the law acknowledge that complexity.
Cite as: Mary Crossley, Righting Wrongful Birth
(April 12, 2019) (reviewing Sofia Yakren, “Wrongful Birth” Claims and the Paradox of Parenting a Child with a Disability
, 87 Fordham L. Rev.
593 (2018)), https://health.jotwell.com/righting-wrongful-birth/
Charles Silver, David A. Hyman, & Bernard Black, Fictions and Facts: Medical Malpractice Litigation, Physician Supply, and Health Care Spending in Texas Before and After HB 4
, __ Tex. Tech. L. Rev.
__ (forthcoming), available at SSRN
It is difficult to convene a discussion of cost containment in health care without someone calling for tort reform. In the view of many in the medical community and the general public, malpractice suits play a key role in driving up health care costs. Litigation is expensive, and the threat of being sued causes doctors to order lots of unnecessary tests—the defensive medicine problem. Tort reform also is popular with elected officials. Most states have caps on damages; pre-trial medical review panels are common too.
But the gap between the theory and reality of malpractice reform is large. Confirming findings from earlier studies, Silver, Hyman, and Black report in their careful analysis of Texas data that tort reform fails to deliver on its promises. Moreover, it may be causing significant harm.
In 2003, Texas passed HB4, a major tort reform bill that included a range of procedural and substantive provisions and featured a $250,000 cap on non-economic damages. Proponents of HB4 said the legislation was necessary to stem a surging tide of malpractice lawsuits, reverse an exodus of physicians from the state, and bring down health care spending by relieving the pressure for defensive medicine. It turns out that none of those assertions was accurate. Moreover, it appears that the tort reform law may have worsened things for patients by weakening the deterrence of liability.
In enacting its statute, the Texas legislature cited an inordinate increase in malpractice claims during the previous eight years. The data set used by Silver, Hyman, and Black included malpractice claims for which a payment was made to the plaintiff. While such claims had increased over the eight-year period that worried legislators, increases also occurred in the number of Texans and the number of physicians. Once the claims data were adjusted for the changes in population and practicing physicians, the data actually showed a decline in paid claims before tort reform was enacted. There also had not been an increase in the size of payments made to plaintiffs.
Texas tort reform also was supposed to address a physician-shortage problem. According to advocates of reform, liability concerns were driving physicians out of Texas in general, and particularly from high-risk specialties or rural parts of the state. In fact, both before and after enactment of tort reform, there was steady growth in the number of physicians practicing in the state, with no discernible effect on the rate of growth from the reform legislation. There also was no effect on trends for physicians in high-risk specialties or rural areas.
What about tort reform and health care costs? Did Texans see a reduction in spending because physicians did not have to order unnecessary laboratory tests or imaging studies to protect against the risk of liability? No. As with data elsewhere, the Texas data showed no decline in health care spending from tort reform. Indeed, if there was an effect, it went in the other direction. Tort reform might actually have led to an increase in spending, perhaps because physicians were more willing to provide care to high-risk patients.
All in all, Texas tort reform was based on faulty premises and mostly faulty predictions about its benefits. It did deliver on one promise—it led to decreases in paid claims and malpractice premiums, though more of the savings in premiums went to the insurance companies than physicians. Of course, the decrease in malpractice payments could reflect undercompensation of injured patients rather than correction of overcompensation.
The most troubling impact of Texas tort reform was on patient safety. A key reason for tort liability is to deter negligent practices, and relaxing tort liability might make physicians less likely to take steps that would protect patients from harm. Unfortunately, the Texas data alone, and in combination with that of other tort reform states, suggest that tort reform may weaken the deterrence of malpractice liability. After tort reform was enacted, patient safety scores deteriorated in tort reform states such as Texas.
As policymakers develop their proposals for cost containment in health care, they can be confident that tort reform should not play a role. There are important measures needed to slow spending, and they are elsewhere than in the tort system.
Cite as: David Orentlicher, The Myths and Reality of Tort Reform
(March 11, 2019) (reviewing Charles Silver, David A. Hyman, & Bernard Black, Fictions and Facts: Medical Malpractice Litigation, Physician Supply, and Health Care Spending in Texas Before and After HB 4
, __ Tex. Tech. L. Rev.
__ (forthcoming), available at SSRN), https://health.jotwell.com/the-myths-and-reality-of-tort-reform/
Although federalism rhetoric has played a central role in debates over the Affordable Care Act (ACA), there has been little research on whether the ACA’s implementation reinforced or stymied federalism values, including state autonomy, cooperation, experimentation, and variation. Professors Abbe Gluck and Nicole Huberfeld fill this void in their article What is Federalism in Healthcare For?. Extrapolating from data on the implementation of ACA’s Medicaid expansion and health insurance exchanges, the authors challenge a longstanding assumption among federalism scholarship—that particular structural arrangements best serve federalism goals and values. They instead argue that federalism goals and values are not dependent on any particular architecture of state-federal separation or entanglement but find expression across a range of governance models.
Traditional theories of federalism view state power as derived from separation from the federal government, with federal authority negating state power. Modern federalism scholars characterize any state activity occurring within federal frameworks as subservient. Gluck and Huberfeld, however, find that the ACA’s implementation supports neither view. Instead, they argue that ACA implementation is a story of states exerting power that checked federal authority from within the statute, not from outside it. Furthermore, this dynamic has resulted in extensive policy variation and experimentation within the ACA’s national framework.
The history of the Medicaid expansion illustrates this point. Although the ACA mandated that all states expand their Medicaid programs to cover low-income adults, the Supreme Court declared this mandate unconstitutional in National Federation of Independent Business v. Sebelius (NFIB), re-interpreting the Medicaid expansion as optional for the states. As detailed in Part IV of the article, the NFIB decision led to dynamic intergovernmental state-federal negotiations. With the U.S. Department of Health and Human Services (HHS) eager for as many states as possible to opt for expanding their Medicaid program, states acquired leverage that they used to obtain concessions from HHS, such as permission to funnel their expansion population into the ACA insurance exchanges. Gluck and Huberfeld further note that these dynamic, pragmatic negotiations produced significant policy and legal diversity across states.
Implementation of the ACA’s insurance exchanges reveals a similar dynamic. Under the ACA, states could establish their own state-run exchanges or default to federal-run exchanges. Traditional federalism would predict that the federalism values of state autonomy, experimentation and variation would flourish in the state-run exchanges and be absent from the federal-run exchanges. Yet actual implementation tells another story. To accommodate red states’ desire to outwardly show resistance to the ACA while retaining some policy control over their exchanges, HHS quietly allowed states to retain authority over key components of the federally-run exchanges. This cooperative federalism “led to significant variation across states,” both among those operating their own exchanges and those with nationally run exchanges. As Gluck and Huberfeld note, “national” exchanges ultimately did not mean “uniform.” (P. 1731.)
While these “hybrid” national and state-level solutions promoted experimentation and variation, Gluck and Huberfeld found that they also jeopardized transparency. For example, states with federal exchanges could “hide the fact they were getting federal help from their constituents,” (P. 1700) displaying public resistance to the ACA while quietly working with the federal government to retain state control over key policies. This obfuscation of state cooperation muddles accountability, particularly at the local level.
Gluck and Huberfeld also call into question recent federalism scholarship that sees partisan politics as playing out within a nationalist narrative based on national party affiliation. Rather than finding state actors presenting a united front consistent with their national party’s stand on ACA, legislators, governors, and insurance commissioners from the same party frequently held divergent views. Gluck and Huberfeld argue that the resulting intrastate negotiations among these players suggest “that state democracy itself—a key federalism attribute—is strengthened by these acts of differentiation from the national party.” (P. 1751.)
Finally, Gluck and Huberfeld raise important questions about what purposes federalism serves in health policy. Should federalism in health care improve health policy goals such as improved access, higher quality care, and lower costs? Or is the goal to advance political or constitutional values independent of policy ends, such as maintaining a balance of power between states and the federal government in the healthcare policy arena? Gluck and Huberfeld caution that this lack of conceptual clarity makes it difficult to evaluate whether federalism in healthcare serves its ostensible purposes and is worth defending. Policymakers and scholars should be mindful of this difficulty when debating the future of the ACA and possible reforms such as a single-payor system.
Rebecca E. Wolitz, A Corporate Duty to Rescue: Biopharmaceutical Companies and Access to Medications
, 94 Indiana L.J.
__ (forthcoming 2019), available at SSRN
For far too many Americans, prices of pharmaceutical medications pose a major threat to access and, ultimately, wellness. Indeed, drug costs in the United States pose a problem fraught with challenges, one that has led scholars to focus on achieving a lasting regulatory solution. None has been forthcoming. Given the intractability of the problem, creative solutions that go beyond attempting to devise the perfect recipe of governmental intervention are welcome additions to the legal scholarship. In this vein, a particularly creative new article seeks to investigate whether biopharmaceutical companies owe an ethical duty to provide their medications to those who cannot afford them.
In A Corporate Duty to Rescue: Biopharmaceutical Companies and Access to Medications, Rebecca Wolitz grapples with this question. In her piece, Professor Wolitz presents a complete and critical analysis of the structure, enforceability, and workability of a “corporate duty to rescue” (CDTR). Defining a CDTR as the “application of a moral duty to rescue to for-profit companies” regarding access to their products, Wolitz’s analysis is significant, kicking off a conversation that should precede any “self-regulatory changes [corporations] justifiably could be urged to implement.” Indeed, as she notes, “a CDTR is particularly interesting as it offers a moral foundation for corporate self-regulation.”
After situating her work among other scholarship from authors who have proposed the adoption of a CDTR, Professor Wolitz begins her analysis by examining whether a CDTR would be legally enforceable by tort law. After concluding that a CDTR “as a form of external regulation under current tort law appears unpromising,” she instead argues that CDTR should be considered as a corporate governance tool. In support of this formulation, she convincingly argues that both the corporation’s profit motive and its shareholder primacy structure would not, by themselves, prevent the corporation from discharging a CDTR. To drive home the point, she also argues that discharging a CDTR would likely be protected by the business judgment rule (BJR) because of its operational, as opposed to structural, character.
Professor Wolitz next analyzes current corporate efforts to secure patient access to needed medications. These efforts include forbearance of patent rights, voluntary licenses, donations, price reductions, and patient assistance programs. Although they are framed as potential “means for discharging obligations of corporate rescue,” Professor Wolitz argues that because they are not undertaken due to a “moral obligation to rescue, so much as good business sense or even optional charity,” they may not discharge a moral duty. Part of this is because of the opacity problem that continues to obfuscate what the duty actually requires of corporations.
Additionally, as Professor Wolitz argues, general challenges—“thorny moral issues”—to the CDTR’s application continue to exist. In this part, she takes apart the five features of a duty to rescue—a rescuee, a capable rescuer, an emergency situation, a rescue receipt of significant benefit, and minimal cost to the rescuer. Going element by element, Professor Wolitz highlights the tensions involved in seeking to apply a CDTR, concluding that their complexities make the applicability of the rescue doctrine in the context of access to medicines uncertain, and at least non-obvious, in need of more study. She uses this analysis not to deride those arguing for an explicit duty, but as a call for additional work in the area.
Professor Wolitz finishes her analysis by focusing on two specific normative issues that are implicated by the CDTR. The first is whether a corporation’s efforts to discharge a CDTR would conflict with its obligations to shareholders, a position that Professor Wolitz generally dismisses. The second concern focuses on whether or not biopharmaceutical companies bear any responsibility for the fact that patients face high prices in the first place. This, of course, would have major impacts on the applicability of the rescue doctrine generally, largely because a rescuer that is responsible for causing peril to the rescuee faces different and additional moral duties.
In examining whether biopharmaceutical companies are responsible for any “wrongful causal contribution to harm via pricing,” Wolitz notes that there are “practices pervasive in the biopharmaceutical industry” that “at least raise this possibility.” These include anticompetitive efforts undertaken by biopharmaceutical companies and their influence over political debate and legal regulation—where she powerfully focuses on their lobbying prowess. Ongoing challenges raise the possibility that, at least where biopharmaceutical companies are engaged in harmful conduct that may cause or contribute to the pricing crisis in the first place, surface-level focuses on a CDTR—without an appropriate accounting for this other corporate conduct—may seem incomplete.
In all, Professor Wolitz’s article is a compelling and forceful analysis of the CDTR in the context of drug pricing. Her arguments are thoughtfully presented and well-articulated. And her suggestions—looking for solutions to the drug-pricing crisis that come from outside government regulation—reset the conversation in a powerful and meaningful way. In an era in which creative, well-reasoned scholarship is needed in the area of drug pricing, Professor Wolitz’s article is a much-welcomed contribution.
Over the past decade, the emergence of CRISPR-Cas-9 as a means to “edit” the human genome has brought human genetic modification out of the realm of science fiction and into the real world. This revolutionary technology enables users to “make specific and efficient modifications to a genome” through a process that is “simple, inexpensive, and remarkable effective.” A variety of efforts are now underway to harness this technology to treat inherited diseases and cancers. Most scientists and bioethicists, however, have collectively shuddered at the possibility of using CRISPR-Cas-9 to make germline genetic modifications—i.e., changes in sperm, eggs, or early embryos that would passed on to future generations. Groups ranging from UNESCO to the National Academies of Sciences, Engineering and Medicine have called for extreme caution in proceeding with research on human germline editing, and for a complete moratorium on clinical applications of the technology pending further public deliberation.
In a provocative analysis, Beyond Nature? Genomic Modification and the Future of Humanity, Julia Mahoney and Gil Siegal challenge this “go-slow” approach on both theoretical and practical grounds. They argue that the chief arguments for extreme caution—the interests of future generations, safety considerations, equality concerns, the “evils of eugenics,” and the importance of public trust in science—not only fail to withstand rigorous analysis, but in fact “militate instead for advancing with all deliberate speed.” (P. 196.) In addition, they warn that efforts to limit human germline modification are unlikely to be effective; instead, they will simply “drive cutting edge work into the shadows,” (P. 197) thereby “decreasing public transparency and accountability by moving activity out of sight of democratically responsive entities” (P. 213).
Mahoney and Siegal offer thoughtful responses to the common justifications offered in favor of a moratorium on germline genetic modification. First, while they acknowledge that germline modification will have uncertain impacts on future generations, they point out that the same is true for many other practices and technologies currently in use. For example, antibiotics and other medical treatments allow individuals with disease-causing mutations to survive to reproductive age, thereby altering the frequency of these mutations in the human gene pool. In addition, pre-implantation genetic diagnosis and prenatal genetic testing allow parents to screen out embryos, or terminate pregnancies, based on genetic characteristics they deem undesirable. Reasoning that “human behavior already has a significant impact on the genotypes of members of future generations,” (P. 205) they conclude that germline genetic modification’s impact on future generations is not fundamentally unique.
Second, Mahoney and Siegel challenge the claim that germline modification necessarily raises greater safety concerns compared to other technological developments. Noting that “[a]ll new medical technologies entail risks,” they question whether “the ‘heritable’ component of genomic editing is such a reliable proxy for danger that it makes sense to continue to put a heavy thumb on the scale for developing somatic genome editing applications while stalling heritable ones.” (Pp. 206-207.) As an example, they cite the case of Jesse Gelsinger, who died in a trial of an experiment involving somatic cell gene transfer. Mahoney and Siegel do not deny the possibility that particular applications of germline genetic modification might be excessively dangerous; rather, their point is that “[i]nsisting on a bright line between somatic and heritable genome editing…is not a reliable means of ensuring safety.” (P. 207.)
Third, contrary to critics who fear that allowing germline genetic modifications “will worsen social inequalities and lead to a world of genetic haves and have-nots,” Mahoney and Siegel argue that the possibility of eradicating devastating heritable conditions “will result in greater, not lesser, equality” because more people will be able to enjoy life free of serious disease. (Id.) In addition, they point out that complex traits like intelligence and athletic ability are unlikely to be susceptible to genetic manipulation. Moreover, to the extent they are, a ban on germline genetic modification would not prevent wealthy people from using somatic gene editing to enhance these characteristics in themselves.
Fourth, Mahoney and Siegel reject the claim that allowing germline genetic modification would “usher in a new era of ‘eugenics.’” The evil of eugenics, they argue, was the belief that certain individuals should not reproduce “for the benefit of society.” (Pp. 208-209.) Germline genetic modification is “the opposite” of eugenics, as its goal is “to expand the options available to individuals while leaving sensitive decisions about family life up to them.” (P. 209.)
Finally, Mahoney and Siegel dispute the assumption that a moratorium on germline genetic modification is necessary to preserve public support for science. Pointing to public opinion polls showing substantial support for both somatic and germline gene therapies, they suggest that arguments based on public trust “amount to little more than overwrought speculation.”
Mahoney and Siegel also offer a more practical reason for rejecting a go-slow approach to genetic modification—it simply won’t work. The simplicity and low cost of gene editing techniques have already led some scientists to engage in what Mahoney and Siegel call “genomic moonshining”—i.e., clandestine experimentation by “entities not beholden to the policies and value judgments of the establishment organs that produce ethical and legal guidelines.” (P. 202.) These secretive practices, they argue, pose far greater dangers than publicly funded, transparent, and accountable research. Their analogy to moonshining is apt here: “What makes moonshine hazardous, after all, is not that it is an alcoholic beverage. It is that making alcohol on the sly often entails methods and materials that pose grave risks—both short and long-term—to end users.” (P. 203.)
Personally, I must admit to some lingering hesitation about the prospect of germline genetic modification. While other practices and technologies may also involve unknown risks to future generations, germline genetic modification seems to heighten those risks to an unprecedented degree. Yet Mahoney and Siegel have convinced me that many of the objections to germline modification are not logically defensible, and that in any event the idea of calling a time-out on technological development is probably naïve. Policy-makers concerned about the ethics and regulation of new technologies would be well advised to consider Mahoney and Siegel’s arguments before concluding that a moratorium on germline modification is the best way to ensure that technologies like CRISPR-Cas-9 are used in an ethically responsible way.
William M. Sage, Explaining America’s Spendthrift Health Care System: The Enduring Effects of Public Regulation on Private Competition
, Healthcare Finance
(forthcoming 2019), available at SSRN
Do you ever wonder why our healthcare system costs double that of many other industrialized nations, yet the health of Americans is faltering? Why has our healthcare not progressed in terms of safety, efficiency, affordability, or equity in the last 20 years? In his forthcoming chapter in Healthcare Finance, Bill Sage argues that rather than the failings of partisan politics or corporate greed, our nation’s healthcare system struggles to provide quality care for a reasonable price in large part due to an inefficient legal infrastructure that hinders competition and distorts the collective investment in population health. Specifically, Sage critiques “the accumulation of laws, regulations, self-regulatory practices, and financial subsidies which locks US health care into inefficient, unfair patterns and practices.”
What follows in this impressively short, yet comprehensive, chapter is a description of how shifts in our understanding of the cost drivers in healthcare and the resultant healthcare reform efforts have created an inextricable web of laws and regulations that make healthcare so complicated and expensive. Beginning with the Affordable Care Act (ACA), Sage details the key provisions that sought to address the challenges facing health and healthcare in the US in 2010. He then points out that the ACA’s approach to national reform reflected a major shift in expert understanding of the US healthcare system in the past 20 years, and that the “dramatic implications of this new knowledge are not explicitly acknowledged in public policy debates.” The ACA’s policies transitioned the dominant health reform paradigm from one of a “three-legged stool” of tradeoffs between cost quality and access to the Triple Aim which sought policies that improved population health, improved the patient experience, and reduced costs simultaneously. This new paradigm captured the attention and focus of policymakers, telling them that eliminating “waste, fraud, and abuse” could improve healthcare quality and reduce costs. Under this paradigm, the fix could come from curbing overutilization, promoting efficiency, and expanding preventive care.
The crux of Sage’s argument is that we must go further—to really fix the ills of the US healthcare system, we must also look closely at and challenge the laws and regulations that constrain it. Sage discusses how a litany of laws, regulations and legal standards contribute to the dysfunction of our healthcare system, including scope of practice laws, physician privileges, corporate practice of medicine laws, certificate of need, tax-exempt and non-profit status for hospitals, tax benefits of employer sponsored insurance, physician-hospital employment arrangements, defining the standard of care as “customary practice,” unfettered consolidation, and physician, clinic and hospital licensing requirements. (All the things we health law professors teach about every day.) Sage discusses how many of these laws and other common occurrences in medical practice greatly hinder competition and market efficiency. While it will take great political will and fortitude to overturn these laws and practices, we must give each of them a hard look to see how they contribute to the problem, and whether they are hurting more than helping.
Finally, Sage identifies three key lessons for future policy and practice reform efforts: 1) National health reform models should align around the task of “facilitating decentralized, incremental improvement rather than asserting a national political consensus on setting limits”; 2) DOJ and FTC should pursue long term strategies to reverse the market distortions that currently burden competition; and 3) America needs to stop over-medicalizing social and economic problems like poverty, lack of education, and substandard or lack of housing, and instead invest dollars spent on healthcare to alleviate these conditions more appropriately in non-medical social services.
Perhaps these are the places to start. While there is plenty of blame to go around when we look at the problems facing the US healthcare system, I, for one, agree with Bill Sage that we should start looking at “the deep legal architecture of US health care” to help us find some of our answers.
Ordinarily, jots feature forthcoming or just published works of scholarship that we find useful or notable. These are no longer ordinary times. As events depart increasingly from our usual frames of reference, I find myself seeking scholarship with a longer historical horizon. In doing so, I have encountered two remarkable books: Giorgio Agamben’s Homo Sacer: Sovereign Power and Bare Life and The Use of Bodies. These two represent the first and last installments of Agamben’s nine-volume Homo Sacer series, and speak most directly to our work as students of health law as it intersects with the political darkening we are living through today.
After 9/11, Agamben’s State of Exception (2003, translated 2005) was discussed amid the rise of emergency powers. But his work on “bare life” is rarely mentioned by American legal scholars (with some exceptions) even as bodies and bare lives have become ever more politicized and manifestly tied to the problem of sovereign power in the age of Trump. I believe that our work as health law scholars cannot avoid orienting itself in some way to Agamben.
Homo Sacer itself is an obscure term from Roman law indicating someone who can be killed without punishment, yet, having no more political stature in the community, cannot be sacrificed to the gods. Homo Sacer is humanity doomed to “bare life.” For Agamben, this excluded figure lies at the foundation of Western political sovereignty. Without a sovereign act of line-drawing, to exclude some persons from those otherwise within the polis, no political community exists. This fundamental fracture is, in his analysis, related to characteristic divisions throughout in our intellectual history, starting from Aristotle’s distinction of simple life, or zoe, from bios, the life of men qualified for politics. This separation of bare life, to which women and slaves were relegated, from politically qualified form of life also reflects the ontological divisions between physis and nomos, body and mind, substance and accident from which Western thought has descended. Homo Sacer is also lurking in the Hobbesian sovereign origin myth. In a state of nature, everyone is bare life for everyone else. But the sovereign retains this power over bare life that everyone else has instead renounced. State power, if not based on social contract, is in Agamben’s view founded on the investiture of the sovereign with power to demarcate life that may be harmed without punishment or acknowledgment.
And this is evident in the founding norms of the Western nation-state. Though the modern nations invoked ringing assertions of the “rights of man,” states afford rights only to qualified citizens, not to humans qua humans. Protection and acknowledgement apply only to those within the polis by virtue of birth or other sovereign inclusion. Though we pay lip service to rights that obtain solely based on the human life of the bearer, never do we see this norm fulfilled, as the worldwide migrant crisis illustrates.
That state sovereignty is only imperfectly grounded in liberal humanist ideologies means that sovereignty must ground its power instead by demonstrating the ability to undertake the original act of demarcating vulnerable bare life from “qualified” life. This imperative contributes to the ongoing pattern of crises of legitimacy followed by the urgent marshaling of loyalties around national security, trade wars, and other emergency threats. Agamben says, “State sovereignty can only affirm itself by separating bare life from its form in every sphere.” (Bodies, P. 213.) At the same time, “because power today has no form of legitimation other than emergency, [it] everywhere and continually refers to it, and, at the same time, secretly works to produce it.” (Bodies, P. 209.)
So far so familiar. Trump’s rhetoric is saturated with references to bare life, reducing women to sexualized parts, mocking the disabled, attacking Hillary Clinton’s stamina, lying about his own weight and health. Trump’s claims to power also center pointedly on abandoning bare life. The border crises, with the exclusion of asylum seekers, is only the most obvious example as has been noted in the press. In the immigration context, his use of language like “infestation” similarly depends on the framework of exclusion from the body politic. This Agambian theme of bare life also characterizes his abandonment of Puerto Ricans to devastation and mortality.
Given Trump’s need to demonstrate power over bare life, it is no surprise that control of health system and its institutions are what our political system in crisis has sought to achieve. Thus Trump is abandoning people with preexisting conditions to the depredations of insurance market discrimination. He has effectively relegated the victims of gun violence to the status of homines sacri, unprotected and unacknowledged. Meanwhile, the upcoming Supreme Court nomination fight centers on whether to declare the fetus as politically qualified life. Trump has pushed to inscribe a boundary of exclusion between the working and non-working body, leading to the conditioning of Medicaid on work in ways contrary to the purpose of providing medical assistance, as at least one court has ruled.
Agamben thus helps us understand our times, but does he offer a way out? This question is one I believe we as scholars could take up. Agamben does admonish us “to learn to recognize this structure of the ban [of Homo Sacer] in the political relations and public spaces in which we still live….In our age all citizens can be said…to appear virtually as homines sacri.” (Bodies, P. 211.) Indeed, our political and economic structures immiserate us all, abandoning us to the consequences of “winner-take-all, blame-the-victim” market competition.
By extension, we should, as I have written elsewhere, attend to risks and probabilities of harm that we have been told to simply accept out of acquiescence to the smooth economism of cost-benefit analysis shorn of attention to lives and health. One category of Homo Sacer in our world is thus the “statistical person.” As Heinzerling says, “she is no one’s sister, or daughter, or mother,” and her absorption of social costs is written off in quality-adjusted life years.
We should recognize the separation of bare life from the type of life that qualifies us for political participation, derived from the exhausted paradigm of substance and attribute. This separation lets Facebook and pollsters reduce us to our demographic attributes, and “disqualify” voters from political participation. This same broken subject-attribute schism is evident in the fracture of Medicaid eligibility into a dizzying array of categories while leaving us the paperwork burden of piecing ourselves back together.
Health institutions can be part of the solution or part of the problem. Health care is the rare remaining social institution that in aspiration, if not in practice, meets us where we are, rather than presuming qualifying conditions of autonomy and full information. Who understands better than those of us in the health sector that the mind and the body are not divided when it comes to human flourishing? Agamben warns, “we will have to abandon decidedly, without reservation, the fundamental concepts through which we have so far represented the subjects of the political….and build our political philosophy anew.”
Today our politics is in crisis. Agamben tries to heal that rift, recover a different strand of our intellectual and political inheritance, and central to that is recognition of the figure of the body in use. Can we build a politics upon that, a politics that recognizes humans in their embodied selves? Health law could be ground zero for that task.
As more and more states legalize physician aid in dying, it appears that the acceptability of aid in dying turns on three critical requirements—that the patients be competent to make medical decisions, that they be terminally ill, and that they self-administer the lethal dose of medication. From Oregon to Hawaii, every state that has legalized aid in dying has included these three criteria for eligibility. But a report from Canada on that country’s experience with aid in dying suggests that only two of the three requirements may be needed.
The three basic requirements help ensure that patients really are suffering from a serious illness that is incurable and irreversible. They also help ensure that the desire for aid in dying reflects a genuine expression of self-determination rather than the irrational choice of someone suffering from mental illness. Controversial cases of aid in dying have involved patients who were no longer able to express their wishes or who appeared to need psychiatric care.
Like Oregon and other states, Canada restricts aid in dying to adults who possess decision-making capacity and who are terminally ill, though Canada has a different definition of terminal illness (the patient’s death must be “reasonably foreseeable” rather than expected within six months). But Canada allows physicians and nurse practitioners to administer the lethal dose rather than requiring self-administration. And in the government’s most recent report on the country’s experience with aid in dying, health practitioners administered the medication in virtually all cases. Self-administration occurred in only 5 out of the 1,382 cases that were included in the report. (The Netherlands reports similar data—in 2015, physician-administration outnumbered self-administration by 829 to 22.)
We don’t know exactly why so few cases involve self-administration, but the Canadian report suggests a number of factors—many physicians and nurses “are less comfortable with self-administration due to concerns around the ability of the patient to effectively self-administer the series of medications, and the complications that may ensue.” As a result, aid in dying protocols at some health institutions do not encourage self-administration. And in Quebec, the end-of-life legislation only permits provider-administered assisted dying. Also, in some communities, it can be difficult for patients to obtain the drugs needed for self-administration.
A family report from California elaborates on the concern about the ability of patients to self-administer the series of aid in dying medications. A niece described the challenges associated with emptying the contents of 100 capsules of secobarbital into her aunt’s final cup.
Physician or nurse-administration also addresses another important concern with a requirement of self-administration—some mentally competent, terminally ill patients may not be physically able to self-administer their lethal dose, as in the case of patients who suffer from ALS. If the purpose of aid in dying is to provide relief from the suffering at the end of life, why should access to aid in dying turn on the ability to self-administer?
I’ve observed before that the requirement of a terminal illness provides a critical protection against misuse of aid in dying. When one considers the controversies over particular aid in dying cases in the Netherlands and Belgium, as well as over particular illicit aid in dying cases in the United States, they typically involve patients who were not terminally ill. Illustrative examples include Jack Kevorkian and the woman with chronic pelvic pain or the Belgian woman featured in a New Yorker article who suffered from chronic depression.
The requirement of mental capacity also is an important safeguard. It makes it much less likely that aid in dying will reflect the wishes of family members or physicians rather than of the patients themselves.
Does the requirement of self-administration add another important layer of protection against abuse? For example, by resting full control in the hands of the patients, does self-administration better ensure that the choice of aid in dying is truly the patient’s choice? The patient with some ambivalence may be more likely to hesitate with self-administration than to stop the physician who is assigned to administer. It would be useful to know if there are cases in the United States or other countries where the patient had scheduled a self-administration and then called it off and how often that happens compared to cases in which the patient scheduled a physician or nurse-administration and then called it off.
In the past, proposals for physician-administration have not fared well in the United States. Ballot initiatives that included both self-administration and physician-administration failed in Washington in 1991 and California in 1992 before Oregon’s successful ballot initiative for self-administration in 1994. It will be helpful to see how aid in dying plays out in Canada over the coming years and whether the Canadian experience suggests that states in the United States can feel comfortable with the administration of lethal medication by physicians or nurses.