Mark A. Lemley, Lisa Larrimore Ouellette, and Rachel Sachs, The Medicare Innovation Subsidy
, N.Y.U. L. Rev. (forthcoming 2020), available at SSRN
Over the past few decades, policymakers have used Medicare reimbursement policy to achieve wide-ranging changes in the health care system. Recent efforts have focused on using the levers of Medicare payments to encourage innovation in providers’ organizational structures and health care delivery. In their forthcoming article The Medicare Innovation Subsidy, Lemley, Ouellette, and Sachs consider another type of innovation influenced by Medicare reimbursement – innovation in the pharmaceutical market.
Both the Trump Administration and members of Congress have put forth various proposals to address high prescription drug costs in the Medicare program. In addition, some Democrats have advanced health reform proposals that would broaden insurance coverage for prescription drugs and lower patients’ out-of-pocket drug spending. While debates over these proposals have largely focused on the policy goals of lowering prescription drug costs and increasing access, Lemley et al. argue that attention also should be given to how these proposals impact incentives for developing new drugs. Specifically, the authors argue that health insurance coverage changes market demand for prescription drugs, thereby impacting drug manufacturers’ profits and their financial incentives to innovate.
The U.S. has a long history of encouraging drug innovation through the patent system. Patent owners enjoy various legal rights that allow them to charge higher prices than they otherwise would garner in a competitive market with generic competitors. Accordingly, conventional wisdom predicts that drug policies lowering reimbursement rates below the supracompetitive prices patent holders could otherwise charge would reduce the returns for developing new drugs, thereby negatively impacting innovation. Indeed, one frequently hears this argument from the pharmaceutical industry. The authors, however, argue that this story is incomplete, as it overlooks how public subsidies funneled through the Medicare program increase incentives to innovate by expanding pharmaceutical companies’ profits.
After providing an overview of drug coverage under Medicare and other government programs in Part I of the article, Part II explains how Medicare increases innovation incentives for the pharmaceutical industry. As compared to a market without insurance, insurance coverage for prescription drugs shifts the demand curve for drugs by lowering consumers’ out-of-pocket costs. For example, a consumer with a 20 percent coinsurance obligation who is willing to pay $100 out-of-pocket for a drug can buy a $500 drug, as their insurer will cover the $400 difference. This increased demand not only leads to a larger volume of drugs sold, but also permits the monopolist-patent holder to charge a higher price to the insured consumers who can now pay more for their drugs. Consequently, adding a prescription drug benefit to Medicare (known as Part D) increased pharmaceutical companies’ profits through both higher volume and higher prices, with the additional profits creating incentives for further drug development. A number of empirical studies cited by the authors support this story, finding increases in private-sector investment in research and development (R&D) following implementation of Medicare Part D, especially for those drugs with higher Medicare market share. The authors refer to this as the Medicare innovation subsidy.
In Parts II.C and III, the authors discuss how recognition of the Medicare innovation subsidy changes the policy discussion about prescription drugs. For example, to the extent Medicare expansion would give more Americans access to generous drug benefits, policymakers wishing to keep overall innovation incentives unchanged can offset the increased Medicare innovation subsidy with reduced drug prices. Alternatively, policymakers can cut other innovation incentives, such as making patent laws less favorable to patent holders or lowering R&D tax incentives. Policymakers also should be mindful of the innovation asymmetries caused by Medicare and Medicaid reimbursement policies that make certain types of drugs more profitable than others. For example, Medicare rules that require Part D plans to cover all FDA-approved drugs within six protected drug classes has resulted in higher prices, and thus higher profits, for these drugs. The higher profits in turn have spurred a larger increase in new R&D for drugs in the protected classes relative to other drugs. Similarly, Medicaid cost-containment policies that lower Medicaid drug prices relative to Medicare drug prices can bias new R&D in favor of drugs that primarily benefit the elderly.
More broadly, in highlighting the interplay between patent law and Medicare policy, the article reminds us that Medicare policy does not exist in a vacuum; rather, policymakers should be mindful of Medicare’s far-reaching impact and its potential to change incentives throughout the health care system.
Nicole Huberfeld, Rural Health, Universality, and Legislative Targeting, 13 Harv. L. & Pol’y. Rev. 242 (2018).
Numerous challenges plague health care in America’s rural areas. These challenges, which manifest as health disparities and limitations on access, are worsening as rural hospitals continue to close across the country. As this is a problem particularly located in the American south (including in my home state), I was interested to read Rural Health, Universality, and Legislative Targeting by Nicole Huberfeld, one of the truly eminent scholars within health law, and an expert in rural health care, Medicaid, and the Affordable Care Act (ACA).
In the piece written for the Harvard Law & Policy Review, Huberfeld starts by documenting the health disparities that citizens living in rural America face—from lower rates of insurance coverage; to limited access to primary care; to higher rates of chronic diseases and poverty. After providing useful discussion about the definition of what it means to be “rural” and how spatial characteristics and population trends complicate and exacerbate rural health disparities, Huberfeld then skillfully weaves these data and trends into other data that reflect higher rates of deaths of despair, mental and public health challenges, and ultimately, differences amongst financial structures that negatively impact access to health care in rural areas. Coupled with lower employment and income, rural Americans exhibit higher uninsurance rates and lower rates of access to care. A detrimental feedback pattern develops, as these factors further negatively impact population health in these areas, which heightens the need for access to rural health care. In this section of the paper she provides a particularly salient example of the impact of access challenges on maternal health in rural America.
In the second part of her paper, Huberfeld contemplates the appropriate legal solution to the challenges facing rural health care. She observes that nearly ten years ago, the ACA stepped into the space, seeking to bring universal access to health care and health insurance for all Americans—including rural Americans. But, the Supreme Court’s decision in NFIB v. Sebelius allowed states to opt out of Medicaid expansion, a decision that has had a particular impact on health care access and delivery in rural states. Here she makes the argument that the resulting non-expansion states have been most resistant to the ACA’s universal approach and, instead, have sought to apply targeted legislative solutions to what ails their health care delivery systems, segmenting off pieces of health care access crises in their states in an attempt to deal with discrete, narrow solutions. She provides a number of examples of what she calls “targeted legislation to offset ACA resistance.”
Here Huberfeld skillfully places these attempts—to establish targeted solutions to the rural health care crisis while blocking the universal solution presented by the ACA—in broader political science literature, and particularly Professor Theda Skocpol’s work that argues that anti-poverty legislative interventions are most successful when “packaged so that they do not look like special care for the needy.” In essence, the argument goes, universal application of an anti-poverty regime adds to its durability, insulating it from legislative retrenchment. Examples include the Social Security Act and universal government benefits. Huberfeld cites to the vastly different durabilities and histories of Medicare and Medicaid to help make her point.
Relying on Skocpol’s work, Huberfeld then makes the central contribution of her paper, arguing that targeted interventions meant to improve rural health care and access may “have the effect of buffering rural disparities, but targeting without universalism holds limited promise both in theory and in practice.” Focusing on targeted approaches is unlikely to solve the problem of rural health disparities, she argues.
This piece was well-written and well-researched. It is a treasure of data for those who are seeking good information on rural health disparities. And it contributes a key insight. Indeed, Professor Huberfeld is the authority on Medicaid and rural health care within the United States, and her astute observation regarding the appropriate legislative solution should be heeded by state policymakers. In a time in which the rural health care crisis is worsening and rural hospitals continue to close, Huberfeld’s well-reasoned and well-articulated suggestions should be amplified from the academy to the statehouse.
Nir Eyal, Paul L. Romain, & Christopher Robertson, Can Rationing through Inconvenience Be Ethical?
48 Hastings Ctr. Rep.
10 (2018), available at SSRN
An unfortunate reality of all healthcare systems is that, left unchecked, demand for medical services will inevitably outpace available supply. On the one hand, there will almost always be one more intervention that might, at least in theory, improve a patient’s condition or avert a future harm. On the other hand, in a society with multiple urgent priorities—education, poverty reduction, and national defense to name just a few—devoting all available resources to health care is neither possible nor desirable. Moreover, some healthcare resources are finite in an absolute sense; for example, there are simply not enough transplantable organs for everyone in need.
In light of this conundrum, no matter how much the public tends to bristle at the concept of “rationing,” setting limits on access to health care is ultimately unavoidable. In a few situations, limit-setting mechanisms are explicit and transparent; examples include the national system for allocating transplantable organs, or insurers’ use of formularies to limit the cost of prescription drug coverage. Often, however, healthcare rationing occurs implicitly, with limited public scrutiny. Examples of implicit rationing include governmental decisions about which healthcare services to fund, or a healthcare professional’s judgment about whether to prescribe a particular drug or refer a patient to a hospital.
In a provocative and thoughtful article, Can Rationing through Inconvenience Be Ethical, Nir Eyal, Paul Romain, and Christopher Robertson consider a critical, but often overlooked, form of implicit rationing—the use of “burdensome arrangements” such as “application processes, forms, waiting periods, and the like,” that make accessing health care inconvenient. To the extent “rationing through inconvenience” has received attention, they note, it has typically been to condemn it. At best, it is considered a waste of time and energy; at worst, it is attacked as a harmful barrier to care. However, they argue that, “under certain conditions, rationing through inconvenience may turn out to serve as a legitimate and even a preferable tool for rationing,” as compared to other available alternatives. (P. 11.)
For purposes of their analysis, Eyal et al. define “rationing through inconvenience” as “a nonfinancial burden (the inconvenience) that is either intended to cause or has the effect of causing patients or clinicians to choose an option for health-related consumption that is preferred by the health system for its fairness, efficiency, or other distributive desiderata beyond assisting the immediate patient.” (Id.) In other words, their focus is on barriers that have the effect of nudging patients to make socially desirable choices, as opposed to barriers that are imposed for other reasons, such as to increase profits for third-party payors. They identify six considerations relevant to assessing the advantages and drawbacks of these measures.
First, they note that, like other forms of indirect rationing, rationing through inconvenience preserves patient choice. No one is denied care entirely, but a patient seeking a rationed service can access it only if she (and/or her provider) is willing to jump through various hoops. One advantage of this approach is that, “[p]atients who perceive the greatest benefits from a treatment” are more likely to be willing to undergo the burdens associated with obtaining it. “By separating individuals who are willing to accept inconvenience to procure a good or service from ones who are not,” they argue, “rationing through inconvenience gathers that information and applies it to personalize rationing policy.” (P. 14.)
Second, they argue that rationing through inconvenience may be less regressive than relying on financial incentives, such as cost-sharing mechanisms, because all people, regardless of income level, “have twenty-four hours in a day, a limited attention span, and a body that can be in only one place at a time.” (P. 15.) They recognize, however, that rationing through inconvenience can sometimes impose disproportionate burdens on disadvantaged populations, as a result of factors like limited paid medical leave, inadequate transportation, or lack of access to nearby care facilities. In light of this potential, they call for “[f]ormal, periodic assessments” to evaluate the impact of particular strategies on different populations, as well as the use of “ameliorative measures” to reduce any disparities found. (P. 16.) For example, they suggest that, in some cases, adverse impacts on disadvantaged populations might be ameliorated by “maintain[ing] a plurality of optional inconveniences—stand in a long line or fill out a long form, for example.” (Id.)
The third consideration they address is largely a negative one—the fact that inconvenience, perhaps by definition, involves wasted time and effort. This waste is incurred not only by the patient but also, in some cases, by health care professionals, who may need to divert attention away from other patients to satisfy procedural requirements (for example, completing prior authorization requests). The impact of inconveniences on health care providers also can give rise to a conflict of interest, as physicians may recommend against treatments that involve significant burdens for them.
Fourth, the authors suggest that rationing through inconvenience often has the advantage of being highly salient to patients. Unlike costs, which “are often opaque to the patient,” inconveniences such as waiting in line and filling out forms are painfully obvious to those who experience them. They point out, however, that inconveniences are not always apparent in advance; moreover, the salience of inconvenience “is a double-edged sword” because it can lead to the underuse of necessary services and “it can also make rational priority setting less acceptable to the public.” (P. 18.)
Fifth, they suggest that rationing through inconvenience is arguably preferable to rationing through cost because it avoids “put[ting] a price on people’s bodies, or health, or on professional integrity.” (Id.) On the other hand, they note that rationing through inconvenience raises other concerns about respect for persons: “Mobilizing our aversions to standing in line, to listening to annoying muzak on the phone, and jumping out of bed earlier exploit our bodily vulnerability to inconvenience—or our psychological and physical need for comfort.” (Id.) The significance of these concerns, however, depends on the extent of the inconveniences involved.
Finally, they argue that, because “the deliberate imposition of inconvenience may be outrageous to the public,” efforts to ration through inconvenience may often be adopted on a less-than-transparent basis. For example, a public hospital may simply “fail to invest in added resources that would have alleviated long waits for a certain service,” without any opportunity for public scrutiny. (P. 19.) On the one hand, they suggest that this lack of transparency is arguably a significant ethical problem. On the other hand, “some obliqueness in resource allocation” may be necessary in a society where rationing, although inevitable, “remains hopelessly unpopular.” (Id.)
In conclusion, the authors suggest several areas for future research on the effects of rationing through inconvenience. For example, what types of rationing through inconvenience is already in use? When do these mechanisms actually lead patients and clinicians to make more socially desirable choices about health care? How can the disutility associated with these mechanisms be measured? What are the effects of these mechanisms on individual and population health?
By bringing attention to the common, but under-explored mechanism of rationing through inconvenience, this article is an important addition to the literature on health care prioritization. The authors’ careful analysis persuasively demonstrates that inconvenience can be a useful mechanism for allocating limited resources, and that in some cases it may be superior to other methods currently in use. However, it also shows that, like co-payments and other financial disincentives, imposing costs in the form of time and effort can also have a downside. Ideally, once armed with the research data Eyal et al. have called for, policy makers will be better equipped to strategically use inconvenience to achieve socially desirable goals.
Erin C. Fuse Brown & Elizabeth Y. McCuskey, Federalism, ERISA, and State Single-Payer Health Care
, 168 U. Pa. L. Rev.
____ (forthcoming 2020), available at SSRN
My first job out of law school was for then-Congressman John F. Tierney, who represented the North Shore of Massachusetts. John Tierney believed in single-payer health care. He also believed in states as laboratories of democracy, and wanted to make sure Massachusetts had the latitude to undertake health reform and establish a model of universal health care for the nation. I was hired to write a bill that could accomplish that vision. Perhaps realizing that I was going to be overmatched, Tierney asked me—as my very first duty, even before I was officially on payroll—to meet with Rashi Fein, the “father of Medicare.” The one detail I remember from that meeting was that Rashi warned I would need to write an ERISA waiver. I was terrified. I had just finished taking my last law school exam, commencement was still a few days away, and quite frankly, I had muddled my way through ERISA preemption in school without ever really understanding it. Consequently, my handiwork, H.R. 4412 for the 107th Congress, was a bit, shall we say, rough.
I feel a special appreciation now, two decades later, when I read Erin Fuse Brown and Elizabeth McCuskey’s article, Federalism, ERISA, and State Single-Payer Health Care, giving the issue of ERISA preemption the masterful treatment it deserves. In the interim, the political gyre has turned one complete revolution, through Massachusetts’ success in modeling health reform and the nation’s subsequent adoption of that model, to unrelenting Republican efforts to tear down the Affordable Care Act (ACA), leading us once again to serious consideration of state-based single-payer health care in otherwise dark times. Rep. Ro Khanna has even introduced a next-generation version of the Tierney bill.
The Fuse Brown-McCuskey article manages to accomplish so many important things in one neat package. First, it surveys all of the single-payer bills that have been introduced across the 50 states and identifies three characteristic mechanisms featured by these proposals. These three mechanisms are identified as Type A payroll taxes, Type B provider restrictions, and Type C subrogation/secondary payer mechanisms. Already, this article is a gift for health law scholars. Second, it calls out and analyzes the fundamental legal vulnerability that shapes the fate of these proposals: ERISA preemption. I’m sure I’m not the only one who feels enormous gratitude that someone out there performed this task so that I don’t have to hurt my brain beating it against the painful body of ERISA jurisprudence. As if it were the Energizer Bunny of all law review articles, it’s still not done—after that, the article cleanly and elegantly draws out specific proposals (including an ERISA waiver!) that would clear a path forward. Along the way, Fuse Brown and McCuskey include granular historical detail about these proposals and specific legislative language that they are already promoting with the National Council of Insurance Legislators.
This article is ostensibly about state single-payer health care and ERISA, and that is more than enough to furnish a rich, rewarding read. But the articles that we return to repeatedly are the ones with implications that keep radiating outward, beyond their topical focus, recontextualizing a whole range of other issues. The authors elaborate the implications of their findings for the broader federalism conversation, but this doesn’t do justice to the many nuggets of insight they embed throughout the piece on the history of U.S. health reform, statutory interpretation, interagency collaboration, the politics of pay-or-play, the history of Hawaii’s ERISA exception, the relation between cost of capital and employer decisions to self-fund, and so much more.
Moreover, the article has implications for the health reform debate taking place at the national level during this Presidential election season. One aspect of the early Democratic primary debate has been the frustrating specter of single-payer purists attacking the public option proponents as neoliberal shills, while in return, the ACA 2.0 crowd demonizes the Medicare-for-All proposal as tax-and-spend socialism. It is distressing to watch when we all know that the real enemy is the right-wing project of shredding the ACA and all its hard-won health gains.
The state-based conversation revealed by Fuse Brown and McCuskey demonstrates just how the division among primary candidates is overdrawn, as I’ve also argued elsewhere. The state bills that their article examines are recognizably single-payer proposals, but if judged by the rigid skirmish lines of the presidential campaign discourse, many of them might not qualify as such. First of all, the authors concede that many of the state plans seem to expect and even plan for the persistence of private employer-based plans. State single-payer bills thereby straddle the line between Medicare-for-All and Medicare-for-America, the plan that anchors public option proposals such as the ones Kamala Harris and Beto O’Rourke have championed on the campaign trail. Yet the Medicare-for-America public option plan, like these state single-payer bills, employs the single-payer hallmarks of Type A income and payroll taxes, as well as stringent nonduplication and Type B provider restrictions. To illustrate, the Type B provider restrictions in Medicare-for-America stipulate that no participating providers can direct-bill individuals eligible for the public plan for any coverable services, nor may they bill any more than the prescribed rates. If providers elect not to participate in the public plan, they are then barred from re-joining for two years afterward. Some public option plans, then, are demonstrably intended to put us on the glide path to single payer.
Fuse Brown and McCuskey prompt an important discussion and I am eager to hear more. For instance, I’d love to hear the back-room history of who pushed the Type C subrogation/assignment feature, and how it propagated among state actors. For the uninitiated, these features are designed to help funnel money into the “single” payer, even when employer-sponsored coverage and other private plans persist. They do so by giving the single-payer the right to pay first for the service, and then recoup the money for that service collaterally from the private plans that would have covered that benefit otherwise. I’m not convinced that it is much likelier to survive preemption than pay-or-play, nor would it necessarily capture that much employer funding, especially as compared to a payroll tax, since under subrogation, employers could just drop coverage or revert to a wraparound plan, only covering items that the single-payer plan does not. Moreover, employers could easily side-step their collateral payment obligations by including an anti-subrogation term in their plans (whose prohibition among the self-funded plans would certainly be preempted).
Instead, I kept expecting that payment reform would figure more prominently in these state single-payer bills, especially since payment reform constitutes a big part of why we would want single-payer in the first place. Perhaps the bills do discuss global budgets and the article, which is already chock-full of fascinating detail, simply could not fit it in. Certainly, we get a whiff of all-payer rate setting around the margins of the discussion here. Perhaps what states need is a broadened policy discussion that fosters further evolution of these interesting state proposals. Fuse Brown and McCuskey have laid down a strong marker for this kind of polyglot conversation, one that spans state AND federal domains, that involves practitioners AND academics, that draws from the economics AND politico-legal discourses. Here’s hoping that this article proves as fruitful in generating further scholarship as it is excellent in its own right.
Cite as: Christina Ho, State Single-Payer
(December 3, 2019) (reviewing Erin C. Fuse Brown & Elizabeth Y. McCuskey, Federalism, ERISA, and State Single-Payer Health Care
, 168 U. Pa. L. Rev.
____ (forthcoming 2020), available at SSRN), https://health.jotwell.com/state-single-payer/
Angela P. Harris & Aysha Pamukcu, The New Civil Rights of Health: A New Approach to Challenging Structural Inequality
, 66 UCLA L. Rev.
__ (forthcoming 2019), available at SSRN
As of 2018, health disparities cost the U.S. $93 billion in excess medical costs and $42 billion in lost productivity per year. Since 1985, the federal government has recognized that there are health disparities, yet research and programs addressing these problems have focused on individual choice, ignoring the significance of structural inequality. Even when the government announced that health disparities were caused by the social determinants of health (SDOH), which are outside an individual’s control, it focused on solutions concerning individual choice. In The New Civil Rights of Health, Professor Angela Harris and Aysha Pamukcu argue that in order to address health disparities, we must understand that individual choice is limited by structural inequalities caused by subordination, “a set of policies, practices, traditions, norms, definitions, cultural stories, and explanations that function to systematically hold down one social group to the benefit of another social group.”
Subordination, particularly racial subordination, limits individual choice and control over access to health-promoting opportunities and resources. To address subordination and end health disparities, the authors suggest a partnership between public health advocates trying to address the SDOH and civil rights advocates trying to address structural inequality. Building on the work of other public health and critical race scholars, Harris and Pamukcu discuss the limitations of public health and civil rights laws to address subordination and propose a new “civil rights of health” that builds on the “health justice framework” to address subordination, which leads to health disparities. By adopting this new “civil rights of health,” advocates can help educate policymakers and the public about the health effects of subordination, create new legal tools for challenging subordination, and ultimately reduce or eliminate unjust health disparities.
The article is significant because it not only emphasizes how subordination impacts population health, but also how subordination influences assumptions, methods, and research priorities in public health. The authors note that although public health advocates understand that social context (e.g., unequal access to housing, education, and employment) limits individuals’ health-promoting opportunities and resources, most advocates ignore the impact of subordination on individual choice. For example, although the overall prevalence of cigarette smoking in the U.S. has declined significantly, use has not declined by racial minorities and the poor. This is in part because of subordination. Due to governmental policies and practices, tobacco retailers are disproportionately placed in low-income and racial minority communities, tobacco companies systematically target people of color in marketing campaigns, and the government collects increased taxes from these communities for cigarette purchases. This allows the government and tobacco retailers and companies to make money, while systematically holding down the poor and racial minorities. Obscuring the impact of these subordination policies and practices, most public health research studying on continued disparities in smoking often focuses only on individual choice in the research question, design, and conclusions.
After making the case that public health has limitations, the authors highlight the limits of current civil rights law to address subordination. Recently, Hahn, Truman, and Williams have shown that when the government enforces civil rights laws to address racial discrimination in healthcare, employment, and housing, racial health disparities decrease. Yet, there are several limitations in using civil rights laws to address all of the subordination that causes health disparities. First, civil rights laws do not protect all groups against discrimination, e.g., the poor. Second, the laws only provide “negative rights’ (the right to be left alone by government), not “positive rights” (governmental obligations for its citizens). Third, courts have limited civil rights protections to individual inequalities, not structural inequalities. Finally, courts have also required showings of intent or evidence of disparate impact that cannot be explained by racially neutral reasons.
Thus, the authors suggest that public health and civil rights advocates work together to create a new “civil rights of health” that encompasses the health justice framework, which combines knowledge of the SDOH with a commitment to legal principles of equal justice. Building on the discourse of prior justice movements (including the environmental justice, climate justice, and food justice movements), the authors propose going beyond law to include “empowerment” and prioritizing the right of racial minorities, the poor, and others to participate in decision-making and policymaking, in concert with political action.
By incorporating the health justice framework into the discussion, the authors place subordination at the forefront of the conversation about eradicating SDOH, explicitly stressing that current efforts to address SDOH have failed because the “universalist-individualist approaches to disparities in access to resources and exposure to harm are inevitably limited and inadequate.” Their new “civil rights of health” proposal expands current civil rights laws to address structural inequalities that result without intent. They also recommend the use of impact assessments to evaluate the impact of current policies, which can then be used to advocate policy change or create a record of intentional discrimination. Finally, the authors champion state and local efforts to address subordination through innovative health-related protections, such as minimum wage increases, paid leave, and safe and affordable housing in all neighborhoods.
The authors offer readers a new framework for addressing health disparities that is not limited by an outdated notion of the supremacy of individual choice. Most valuably, the article incorporates lessons from civil rights law and prior justice movements to propose a new opportunity to end health disparities caused by subordination so that the entire population of the United States can achieve health and well-being.
Recent reporting has drawn public attention to a crisis in U.S. maternity care. Concerns include the extensive use of C-sections and other medical interventions in hospital births, high rates of maternal mortality and morbidity, racial disparities in maternal and fetal outcomes, and the increase in planned home births. While many factors contribute to these problems, one rarely acknowledged factor that Professor Elizabeth Kukura highlights in her 2018 article of the same name is the phenomenon of obstetric violence. Examples of obstetric violence include performing interventions (such as C-sections, episiotomies, and artificial rupture of membranes) on birthing patients against their express refusal; coercing patients to accept such interventions by threatening them with withdrawal of care or legal action; physically restraining birthing patients with no medical justification; verbally disrespecting patients in labor; and questioning competent patients’ medical decisions.
The phenomenon of obstetric violence raises a host of questions about law, policy, and medical ethics–but to date, it has received limited attention from U.S legal scholars. Kukura’s Obstetric Violence is the type of foundational article that clearly and effectively lays the groundwork for continued scholarship in this area. Anyone interested in health law, tort law, reproductive privacy, feminist jurisprudence, or the intersection of law and medical ethics would be well-advised to read this piece and cite it extensively.
Those who have experienced obstetric violence during childbirth have long pushed for increased public awareness, publishing books and reporting their experiences in online forums. Unfortunately–as with many issues relating to reproductive health care–those with no first-hand experience of obstetric conflict are generally less inclined to view it as a pressing problem that needs immediate attention.
In the past decade, however, several legal scholars–among them, Jamie Abrams, Farah Diaz-Tello, Linda Fentiman, Michele Goodwin, Margo Kaplan, and Sylvia Law–have focused on legal issues that directly or indirectly relate to obstetric violence. Their scholarship addresses the trope of maternal-fetal conflict, state interests in fetal protection, the criminalization of mothers and pregnant women, women’s rights to informed choice, and the challenges in securing tort recovery when a patient’s autonomous medical decisions have been overriden.
Kukura’s Obstetric Violence is a natural and necessary continuation of this line of scholarship. Although there is a substantial body of international scholarship about obstetric violence (a term that was originally coined in Latin America), Kukura is one of the first to recognize its prevalence in the U.S., and to explicitly use the term as a foundation for legal scholarship.
For those unfamiliar with the various forms of obstetric violence many experience during childbirth Part I of her article examines them in (sometimes shocking) detail. Kukura offers real-world examples like that of Kimberly Turbin, a laboring woman who vocally and repeatedly refused an episiotomy. In response to her refusals, her physician verbally berated her, and made twelve incisions in her perineum while she shouted “No! No! No!”
Although there are many anecdotal examples of experiences like Ms. Turbin’s, empirical data quantifying the prevalence of obstetric mistreatment in the U.S. have (until recently) been scarce. However, Kukura astutely recognizes that this research gap “does not mean the problem is nonexistent or can simply be attributed to isolated rogue health care providers”–rather, “it reflects the extent to which it has been obscured from public awareness.” (P. 768.)
In this article, Kukura makes two extremely important contributions to the literature on reproductive autonomy and legal mechanisms for protecting it. First, she enumerates the various structural problems within the U.S. medical system that contribute to mistreatment during childbirth. Second, she offers a thorough analysis of why traditional legal approaches–in particular, tort claims for malpractice or lack of informed consent–are powerless to prevent or remedy these harms.
Kukura enumerates numerous challenges that victims face in bringing tort suits, including the fact that the harms they suffer are often intangible and/or difficult to monetize, making it almost impossible to find attorneys willing to take their cases; the difficulty of satisfying each of the elements of an informed consent claim, even if a victim alleges that her consent was coerced; and the bias exhibited by many legal decisionmakers who conclude that the birth of a healthy child outweighs any dignitary harm a mother may suffer, effectively concluding that those who have experienced obstetric violence have no legally cognizable injury.
Kukura identifies various other sources of law, beyond tort, that might be helpful in preventing or remedying these harms, but she concludes that they too are likely to be inadequate. Her conclusion is that active public advocacy is the best way to address both law and medicine’s inability thus far to address the phenomenon of obstetric violence.
In presenting the “lay of the land” of obstetric violence, Kukura has set up future scholars brilliantly for further inquiries into this problem. Social scientists will certainly be prompted to quantify the prevalence of obstetric violence and report on its real-world impact on women (such as the recently published Giving Voice to Mothers study). Tort and regulatory scholars may be drawn to explore other legal solutions that Kukura might not have considered fully, including the question of whether birth plans might be treated as advance directives (a question that is already under exploration). Questions about coerced consent might be guided by criminal law scholarship about the meaning of coercion in sexual assault cases. I very much look forward to reading the work that is inspired by Kukura’s foundational article on this important issue.
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/