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When Does Healthcare Ethics Consultation Constitute the Practice of Law?

Anya E. R. Prince & Arlene M. Davis, Navigating Professional Norms in an Interprofessional Environment: The 'Practice' of Healthcare Ethics Committees, 15 Conn. Pub. Int. L.J. 115 (2016), available at SSRN.

Following the New Jersey Supreme Court’s endorsement of healthcare ethics committees (HCECs) in its 1976 decision, In the Matter of Karen Quinlan, HCECs have become ubiquitous features of health care institutions throughout the United States. In addition to developing policies and providing education about ethical issues in medicine, HCECs play a central role in resolving ethical conflicts related to the care of particular patients. While most HCECs do not purport to issue binding determinations, the manner in which they frame ethical issues and present options for consideration can have significant impacts on how disputes are resolved.

In a thoughtful and comprehensive article published in the Connecticut Public Interest Law Journal, Anya Prince and Arlene Davis consider “whether participation in ethics consultations could be considered the practice of law.” The consequences of characterizing ethics consultations as a type of legal practice are potentially significant. Non-attorney HCEC members, or attorney members who are not licensed in the HCEC’s jurisdiction, could be subject to civil or criminal penalties for the unauthorized practice of law. Even attorneys who are licensed in the HCEC’s jurisdiction might run into problems when serving as HCEC members, as they might find it difficult to comply with professional legal obligations “that may be at odds with the expectations and professional rules of the ethics committee itself.”

As Prince and Davis explain, many of the most common issues that HCECs address have clear legal dimensions. For example, HCECs may be involved in disputes over whether a patient has decision-making capacity, or, for patients determined to lack capacity, the identification of an appropriate surrogate decision-maker. They also may be called upon when patients or surrogates insist on treatment that a health care provider considers ineffective or “futile.” The appropriate resolution of these questions requires not only on ethical analysis but also familiarity with the legal parameters established by applicable caselaw and legislation.

Prince and Davis identify five tests that have been used to determine when an activity constitutes the “practice of law.” The first, which they describe as the “most expansive” of the five, asks whether an activity “affects legal rights.” They argue that many aspects of HCECs’ work could be considered the practice of law under this definition, “especially given that one of the initial motivations of HCECs was to avoid litigation of complicated medical-ethical issues.” The second test is whether the activity in question is “commonly understood in the community to be the domain of attorneys.” Here, too, they suggest that HCECs could “cross the line into the practice of law” if they “engage in problem-solving” with respect to “complex issues that are commonly associated with law.”

The third test involves a distinction between providing legal information — which does not constitute the practice of law — and “applying law to specific facts,” which could be considered to “jump[] into the realm of [legal] opinion and advice.” Prince and Davis note that the distinction between providing information and giving legal advice has arisen in debates over the scope of activities that may be performed by non-attorney mediators. For example, guidance in Virginia prohibits non-attorney mediators from offering “legal advice,” which is defined under state law as “the application of legal principles to facts ‘in a manner that (1) in effect predicts a specific resolution of a legal issue or (2) directs, counsels, urges, or recommends a course of action by a disputant or disputants as means of resolving a legal issue.’” They argue that HCEC members could potentially cross this line “through detailed analysis of how case law may apply to a specific consult or what the outcome of potential litigation may be.”

The final two tests that Prince and Davis discuss are whether an individual believes she is receiving legal services (the “client reliance” test), and whether the activity results in the creation of “a relationship that looks like the attorney-client relationship.” Both tests could potentially pose problems for HCEC members, particularly those who are also attorneys. In this regard, Prince and Davis cite a survey of physicians in Maryland in which two-thirds of respondents thought that “providing legal advice” was an appropriate HEC function. They argue that these results “suggest[] that physicians may expect a certain amount of legal analysis and opinion from ethics consultations.” Even if these expectations are mistaken, in some circumstances they could be sufficient to form “an implicit attorney-client relationship.”

Having concluded that “HCE consultants may be held as engaging in the practice of law under several of the five common legal tests,” Prince and Davis make several practical recommendations for HCEC members. For example, they counsel HCE members to “limit[] in-depth analysis and application of the facts of the consultation to case law and potential litigation outcomes,” and to “make explicitly clear when interacting with individuals as part of the consult that they are not providing legal services and that the parties may want to seek outside legal advice.” They also call on professional associations, including the American Bar Association, to issue guidance on the distinction between engaging in ethics consultations and practicing law, similar to guidance the association has already issued in the area of mediation.

Price and Davis recognize that, unlike many other professional turf battles — such as the conflict between dentists and non-professional teeth whitening services at issue in the Supreme Court’s 2015 decision in North Carolina State Board of Dental Examiners v. FTC, or disputes between lawyers and online legal document services like LegalZoom — there is little economic incentive for the legal profession to bring actions against HCEC members for the unauthorized practice of law. It is not as if there is a lucrative market for hospital-based ethics consultations, which private attorneys are eager to exploit. Nonetheless, they argue that HCEC members should still be careful about overstepping their bounds because “[i]ndividuals who are providing legal services should be competent to do so or the public may be harmed.”

Prince and Davis’ article makes an important contribution to the literature on the practice of healthcare ethics consultation. It is highly recommended for both members of HCECs and policy-makers charged with defining the concept of the unauthorized practice of law.

Cite as: Carl Coleman, When Does Healthcare Ethics Consultation Constitute the Practice of Law?, JOTWELL (December 12, 2017) (reviewing Anya E. R. Prince & Arlene M. Davis, Navigating Professional Norms in an Interprofessional Environment: The 'Practice' of Healthcare Ethics Committees, 15 Conn. Pub. Int. L.J. 115 (2016), available at SSRN), https://health.jotwell.com/healthcare-ethics-consultation-constitute-practice-law/.

Rethinking Medicaid’s Core Mission

John V. Jacobi, Medicaid, Managed Care, and the Mission for the Poor, 9 St. Louis Univ. J. of Health L. & Pol’y 187 (2016).

Republican efforts to “repeal and replace” the Affordable Care Act have generated heated debate over the Medicaid program. Underlying this debate is a fundamental question: How should we define Medicaid’s core mission? In his article Medicaid, Managed Care, and the Mission for the Poor, Professor John Jacobi provides a possible answer to this question: raising the health status of the poor and vulnerable by improving their access to both medical care and the social goods and services whose absence impede health. His vision of Medicaid deserves serious attention by policymakers.

As Professor Jacobi explains, the health-related needs of the poorest Americans differ significantly from the non-poor. An enormous body of research documents the impact that social, environmental, and economic conditions have on individuals’ health. Indeed, poor quality housing, food insecurity, the stress of social inequalities, and other non-medical factors likely exert a greater influence on health than access to health coverage and medical care. Because these determinants of health disproportionately affect the poor and vulnerable populations served by Medicaid, their health care needs are far more fragile and complex than those of other populations. Many experts therefore have concluded that medical care should no longer be provided in isolation from social services, but instead should be part of a delivery system that coordinates clinical and non-clinical services and interventions. As Jacobi explains, “[t]his coordination requires not only the purposeful interaction of previously separate public services, but also coordination of the funding that flows to and through the providers of those services.”

State Medicaid programs, however, have done little to promote this broader vision of the health care system (with a few notable exceptions). Jacobi explains that this unfortunate state of affairs stems from Medicaid’s traditional mission of simply providing its beneficiaries with medical coverage. This narrow focus has culminated in states relying on commercial managed care plans. Because commercial insurers operate their Medicaid plans largely in the same manner that they do their commercial plans – connecting enrollees to medical care through the formation of provider networks and claims payment functions – they are ill-equipped to address the non-medical barriers to improving Medicaid beneficiaries’ health.

Jacobi somewhat overstates his case, however, as some states do contract with niche Medicaid managed care plans that focus exclusively on poor and vulnerable populations and the social determinants that impact their health. Nor does Jacobi distinguish among different Medicaid subpopulations, some of whom may closely resemble the non-Medicaid population. For example, the health care needs of low-income adult students and temporarily unemployed individuals typically are less complex than those of the homeless or disabled. Medicaid managed care plans may be sufficient to meet the health care needs of the former groups even if inadequate for the latter. Nevertheless, many Medicaid beneficiaries with complex health needs remain enrolled in commercial or managed care plans that primarily focus on narrow payment functions, and Jacobi rightly questions whether we should continue to mainstream care for these individuals.

Consistent with his broader vision of a Medicaid program that promotes coordination of medical and social interventions, Jacobi advocates for new forms of health care delivery and finance. His article highlights two such models – Medicaid accountable care organizations (ACOs) and Health in All Policies (HiAP) networks. He also cautions against federal regulatory policies that limit states’ ability to experiment with innovative health delivery and financing models to address Medicaid beneficiaries’ clinical and non-clinical health needs.

Although Jacobi’s article was published prior to Congress’s repeal and replace efforts, his concerns nevertheless remain instructive for federal policymakers seeking to reform Medicaid. In particular, proposals to both roll back Medicaid coverage of low-income adults and reduce Medicaid funding would constrain the program’s ability to raise the health status of the poor. With reduced funding to support transformation of the health delivery system, states would abandon any movement toward a Medicaid program consistent with Jacobi’s vision and would continue their narrow focus on providing coverage of medical care, albeit with a narrower scope of benefits.

Cite as: Jessica Lind Mantel, Rethinking Medicaid’s Core Mission, JOTWELL (November 2, 2017) (reviewing John V. Jacobi, Medicaid, Managed Care, and the Mission for the Poor, 9 St. Louis Univ. J. of Health L. & Pol’y 187 (2016)), https://health.jotwell.com/rethinking-medicaids-core-mission/.

Mapping the Axis of Disability onto the Axis of Race: Can We Reclaim the Possibilities?

Kimani Paul-Emile, Blackness as Disability, 106 Geo. L. J (forthcoming, 2017).

This is how a myth becomes reality: how contingent social choices and practices can create the disabled subject.1

What counts as healthy and what counts as disability are not necessarily biologically determined, but rather can be socially constructed. Kimani Paul-Emile’s forthcoming paper, Blackness as Disability, calls our attention to this truth, and does so in a way that shows how our chosen constructions could not have higher stakes for any given individual, or for the fate of our collective life.

Any definition of health, even the most biomedical, depends on a conception of “normal” functioning, as I have written of before. Wendy Parmet puts it thus: “[T]he questions of whether the capacity to stay focused in a classroom or to see well at night are [part of normal functioning depend] . . . on what is expected in a given society of people and their interactions with their environment.”

The ADA’s definition of disability is similarly littered with socially contingent parameters, such as whether the individual has a “physical or mental impairment,” which is defined to include any “physiological condition,” that “substantially limits” one’s ability to perform any “major life activity.” Of course, what our way of life prioritizes as a “major life activity” or “normal” functioning is variable, not necessary or given. Indeed our current economic structure may well shape the designation of sleeping patterns as functional or disordered.

As the social model of disability teaches us, the physiological conditions themselves do not produce disability, until they meet social structures, institutions, and norms that “substantially limit” a person in what we have rendered “a major life activity.” One could view some mobility impediments as stemming not from individual physical characteristics, but from the architectural choice of steps over ramps. If the so-called “actual” disability prong of the ADA definition already harbors these many layers of social construction, then surely the “regarded as” prong of the definition even more explicitly extends ADA protection to those whom society has stigmatized as less able, due to certain physiological and other markers, despite those markers’ irrelevance to functional abilities.

So how have we as a society made “blackness” disabling to those with the physical, cultural, and linguistic characteristics that Americans have constructed into that racial label? What, as Paul-Emile phrases it, are the “social structures, institutions and norms” that “substantially limit” a black person in such dimensions as 1) in basic mobility through public space, 2) overall health prospects, 3) choice of housing, 4) ability to work and 5) ability to pursue schooling? We know the litany, but not in this particular frame. Police stops and other racially disparate law enforcement practices limit the basic ability to navigate territory, much as door jambs and stairs might limit someone in a wheelchair. Disparate housing opportunities, resulting from government-sponsored discrimination in part, disproportionately expose Black Americans to substandard living conditions and environmental hazards, contributing to increased health risk factors and disadvantages in accessing care. These circumstances lead to physical health outcomes that may themselves be disabling conditions. Unequal access to jobs and education limit a person’s ability to work, no less then the failure to accommodate an employee in taking their epilepsy medication, or refusal to adjust for hearing loss, would pose barriers.

Paul-Emile’s article is plainly a pragmatist, not an essentialist, project. She is hardly saying that the nature of race is like the nature of disability, because she does not believe we get very far viewing either of these things as having “natures” at all. We are the ones who have chosen to dub them one or another through the manner by which our social institutions and norms respond to certain clusters of circumstance. I believe this point could be foregrounded even more. The piece could have been entitled “How We Render Blackness Disabling,” because the polemical title, “Blackness as Disability” does not cue the reader to what we can never be reminded of enough: that “blackness” and to a great extent, “disability,” are as real or as unreal–as salient or not to a person’s life opportunities–as we decide in any historical moment.

Given the malleability of each of these constructed categories, why have we chosen to treat them distinctly, and might it be fruitful to trouble the boundary between the two?

Paul-Emile usefully recounts the differing conceptions of equality reflected by our race-related and disability-focused civil rights regimes. The disability regime envisions affirmative obligations such as reasonable modification/accommodation, it focuses on disparate impact rather than intent in recognition of structural causes of discrimination, and it prohibits reverse discrimination claims. The cramped principles and doctrines that have arisen around race law lack these equality-enhancing features. Why? The juxtaposition Paul-Emile proposes helps to, as she says, “center[] our attention on the aspects of Blackness that really matter, revealing its purpose as being to disable ….” Paul-Emile uses her article to pose the question of whether the civil rights paradigm could be harnessed to address the disadvantage imposed upon Black Americans.

Another fruitful result of her re-mapping is to expose the radical potential at the core of disability law, in particular its conception of remedy. If particular physiological conditions themselves do not necessarily bear any inherent valence, and our social institutions, practices, and norms are what often render any characteristic “disabling,” disability law’s virtue is that it forthrightly calls for a change of that social structure, in other words, a “reasonable modification.” Disability law envisions not mere deterrence of individual wrongdoing, or compensation for rogue behavior. It assumes that social institutions and norms can and should be changed. Paul-Emile reminds us that Samuel Bagenstos has characterized disability law thus: the “greater part of disadvantage is best addressed through attempts to change the environment.”

The paper asks big questions and therefore prompted me to mull over all sorts inquiries related and tangential (such as thinking over what if any significance attaches to Wesley Hohfeld’s designation of “power” and “disability’ as jural opposites). However, what captivates me most about this paper, about the disability law regime, and indeed about the possibilities of collective action afforded by law in any context, is this point: here is the world we have made, un-made, and can re-make again. Will we?

  1. Kimani Paul-Emile, Blackness as Disability, 106 Geo. L. J (forthcoming, 2017). []
Cite as: Christina Ho, Mapping the Axis of Disability onto the Axis of Race: Can We Reclaim the Possibilities?, JOTWELL (October 3, 2017) (reviewing Kimani Paul-Emile, Blackness as Disability, 106 Geo. L. J (forthcoming, 2017)), https://health.jotwell.com/mapping-the-axis-of-disability-onto-the-axis-of-race-can-we-reclaim-the-possibilities/.

A Must-Read on Health Care Nudges

Nudging Health: Health Law and Behavioral Economics (I. Glenn Cohen, Holly Fernandez Lynch & Christopher T. Robertson eds., 2016).

Nudging Health: Health Law and Behavioral Economics is essential reading for anyone interesting in moving the health reform ball forward. The insights are especially important amid United States lawmakers’ persistent emphasis on individual responsibility and market-based solutions for health care. In their edited volume, esteemed authors I. Glenn Cohen, Holly Fernandez Lynch, and Christopher T. Robertson draw together canonical threads of legal theory, applying them to timely, essential health law and policy topics. The forty-five essays included in Nudging Health explore various ways that behavioral science may be applied to nudge health law and policy in the direction of better health and better health care spending. The book builds on a deep and provocative foundation of earlier scholars, including Kenneth Arrow, Cass Sunstein, and Richard Thaler.

Anyone who has spent even a little time around health law and policy is well aware that neoclassical economic models fail to accurately depict modern health care. Viewed through that lens, health care is a highly imperfect market, as Kenneth Arrow’s timeless 1963 essay, Uncertainty and the Welfare Economics of Medical Care, describes. Arrow accurately depicts a market characterized by, among other features: the uncertain nature of demand for health care; imperfect information and information asymmetries between buyers (patients) and sellers (health care providers); distorted trust, or fiduciary, relationships between health care providers and patients; barriers to entry and other supply limits on medical care; and third-party payment (insurance) leading to moral hazard and pooling of unequal risks.

More recently, legal theorists have questioned the accuracy of the neoclassical economic model in law and policy generally, observing that, even in less flawed markets, individuals often fail to act as rational “homo economicus.” Applying cognitive psychology and behavioral economics, those theorists observe various ways in which individuals make choices based on reasons other than maximizing their own welfare, rely on various shortcuts and heuristics in decision-making, and operate under limited willpower and self-control. Cass Sunstein’s 1998 edited volume, Behavioral Law and Economics, provides an authoritative survey of those insights, noting various implications for legal analysis and policymaking across contexts, including taxation, labor and employment law, voting, corporate governance, personal injury law, and constitutional law.

Building on that volume and decades of research on behavioral law and economics, Sunstein in 2009 joined with University of Chicago colleague Richard Thaler to publish Nudge: Improving Decisions About Health, Wealth, and HappinessNudge became a best-seller in both academic and trade presses, introducing the concepts of “libertarian paternalism” and “choice architecture” to the public through numerous detailed, salient examples. The book takes issue with the rational actor model, which generally presumes that individuals will make decisions that promote their own best interests. Under this model, paternalistic policies, such as mandatory seatbelt laws, are disfavored, on the theory that individuals should be permitted to make their own decisions as long as those choices do not directly harm others. Behavioral law and economics points out the problems with relying on the expectations underlying the rational actor model, revealing the various ways in which individuals may act other than for their own best interests. Thus enters Sunstein & Thaler’s notion of “libertarian paternalism,” which accepts the various predictable ways in which individuals err in their judgment and allows for greater government involvement in shaping individual choice.

The approach advocated by Sunstein and Thaler is called choice architecture, referring to the way that choices are packaged and presented to consumers, thus influencing decisionmaking. For example, simply placing “green” healthy labels, and “red” unhealthy labels, on food in the cafeteria line may influence diners’ choices, without limiting their autonomy. Likewise, some email programs, such as Gmail, send users a pop-up reminder if the text mentions an attachment but none has actually been attached. Changing default rules also operates as choice architecture. For example, workers might be automatically enrolled in, and required to take steps to opt out of, employer-sponsored health insurance, instead of being required to take steps to sign up for those benefits. Or we might address the shortage of donor organs by adopting a presumed consent rule, instead of requiring individuals to affirmatively opt-in to becoming a donor.

Those and additional suggestions are explored in-depth in Nudging Health. The book opens with an introduction by Sunstein himself, laying out the essential theoretical framework. What follows is a masterful collection of in-depth discussions and specific examples, including the use of penalty nudges via the Affordable Care Act’s individual mandate and employer shared responsibility payments; reward nudges via financial incentives for individuals’ adopting healthy behaviors, or physicians’ prescribing lower-cost generic or follow-on drugs; default rules around end-of-life care and surrogate decision-makers, as well as the aforementioned automatic insurance enrollment; choice architecture to guide consumers’ decisions among health insurance plans, and physicians’ recommendations around treatment alternatives; and strategies to address other cognitive biases, including patients’ unchecked deference to physicians’ recommendations.

The book does not, however, does not operate as an untempered valentine to the behavioral law and economics school of thought. Rather, a number of the contributors offer critical, skeptical, or cautionary notes about the theory’s ability to operate effectively in health care. Criticisms include the possibility that choice architecture may be overly coercive, obscure individuals’ true preferences, backfire with unintended results, serve social aims at the expense of individual rights, or be the result of law- and policymakers’ own biases and judgment errors. Including those voices gives the overall volume greater credibility and balance than if the book had neglected them. In sum, Nudging Health deserves its own place in the cannon of health law and policy, and health economics, literature. I anticipate that the conversations and suggestions that it sparks will find their way into many important academic and lawmaking circles.

Cite as: Elizabeth Weeks Leonard, A Must-Read on Health Care Nudges, JOTWELL (September 5, 2017) (reviewing Nudging Health: Health Law and Behavioral Economics (I. Glenn Cohen, Holly Fernandez Lynch & Christopher T. Robertson eds., 2016)), https://health.jotwell.com/a-must-read-on-health-care-nudges/.

Healthism in the Current Political Climate

Jessica L. Roberts & Elizabeth Weeks Leonard, What Is (and Isn't) Healthism, 50 Ga. L. Rev. 833 (2016), available at SSRN.

As we are all aware, the current political time is one of great upheaval and unsureness in numerous areas, with health care and the health care system repeatedly taking center stage. The change in the presidential administration coupled with the Republican majority in both houses of Congress have led to many new approaches to the health care system being proposed, debated, hurriedly being voted on, amended, withdrawn, and subjected to a hot and passionate debate. As this is going on, recent polling has made it clear that a significant percentage of the voting population in this country had no or minimal understanding about how health care laws affect them and their loved ones, leading to a pattern of voting in the 2016 elections that often appeared to be against voters’ self-interest.

As we grapple with analyzing and communicating the ramifications of proposed changes, the analytic approach to assessing the effect of health care policy delineated in Roberts’ and Weeks Leonard’s article, What is (and isn’t) Healthism, has much to offer in a climate wildly different than the one in which it was written. Healthism, as this article and a forthcoming book define it, is a form of discrimination based on a person’s health status. As the article states in the introduction, the passage of the Affordable Care Act in 2010 created significant protections for persons with health problems. For example, that law prevents discrimination in the health insurance market against those with preexisting conditions. Taking the question of disparate treatment further, the authors consider the possibility that a person’s health status could be the basis for disparate treatment in a number of other areas, such as employment and the provision of services, privileges, or opportunities. In light of the possibility of multiple arenas for this type of discrimination, the article asks when, if at all, the law should intervene to protect persons from these wrongs, and then presents a framework for answering that question.

The article is excellent, and gives an engaging analysis of this issue. Of particular interest to me in the current environment is the authors’ analytic framework for determining if healthism has occurred. There are seven different elements to guide the analysis, and health status distinctions that meet one or more of these elements are healthist and deserving of legal or policy intervention. The elements are as follows: If a distinction is 1. Driven by animus, 2. Stigmatizes individuals unfairly, 3. Punishes people for their private conduct, 4. Impedes access to health care, 5. Cuts off resources or otherwise limits the ability to adopt healthy life choices, 6. Produces worse health outcomes, or 7. Maintains or increases existing disparities, it is likely healthist.

One can add an examination of intersectionality as it relates to these elements, and to healthism, generally. Numerous groups of people are already at risk of baseless disparate treatment due to ethnicity, religion, gender, sexual or gender identity, disabilities, and numerous other criteria. Healthism can become much more harmful when it is combined with these unjust burdens.

Utilizing this framework to identify healthism and to pinpoint the occurrence of intersectionality that compounds injustice gives a crisp and comprehensible framing for the analysis of proposed changes to the health care system, and does so in a way that I think helps people outside of health policy understand more clearly what the proposed changes mean to them.

For example, the changes to Medicaid proposed in current Congressional legislative proposals include changes that are extremely damaging to people who are vulnerable to healthism. The proposed changes cut off access to health care by gradually eliminating Medicaid benefits. The changes impede people’s capacity to pursue a healthy lifestyle by imposing rigid work requirements as a prerequisite to receiving care. Analyzing the law through a lens of intersectionality, it becomes clear that it would have a disparate impact on the elderly who live in nursing homes, on women who rely on Medicaid for access to family planning and to maternity care, and on those who have disabilities, who often receive the bulk of their therapy, home care and health care through this program. Data already consistently show that minorities have poorer health outcomes and lesser access to care in the current system, and the changes would exacerbate those problems.

I highly recommend this article, and this method for analyzing future proposed systemic changes in an effort to educate and give voice to those who will suffer the most.

Cite as: Jacqueline Fox, Healthism in the Current Political Climate, JOTWELL (July 27, 2017) (reviewing Jessica L. Roberts & Elizabeth Weeks Leonard, What Is (and Isn't) Healthism, 50 Ga. L. Rev. 833 (2016), available at SSRN), https://health.jotwell.com/healthism-in-the-current-political-climate/.

Federal Funding with State Flexibility: A Timely Look at Federalism and Health Care Reform

Nicholas Bagley, Federalism and the End of Obamacare, 127 Yale L.J. F. 1 (2017).

In our era of increasingly divisive politics and fiery rhetoric, particularly around Obamacare and efforts to repeal it, Nicholas Bagley’s article, Federalism and the End of Obamacare, is a rare treat. It is a thoughtful, balanced look at the arguments for the respective roles of federal and state governments should play in the financing and regulation of health care.

Professor Bagley’s article makes three key points that are highly relevant to the current debate about the future of Obamacare: First, only the federal government has the fiscal capacity to fund health care; second, states should be granted significant flexibility in regulating their health care markets, even if that means that they’ll sometimes get it wrong; and third, current reform proposals do not empower states, but rather take power away from the states by deregulating (and defunding) health care.

Professor Bagley makes a strong case for the necessity of federal funding of health care. Providing health care to low-income individuals tends to be countercyclical; the need for such care is greatest when the economy is not doing well. For state governments, which must balance their budgets, this creates significant difficulty in funding health care for the low income because costs are likely to be highest when state revenues are depressed. The federal government is not constrained by balanced budget requirements and therefore can deficit spend in times of need.

Recognizing that the structural fiscal argument may not satisfy those who strongly favor state authority, Professor Bagley considers whether states that want to provide health care to their citizens could simply tax residents in order to pay for such care, even if such needs may be countercyclical. He argues, however, that taxing individuals to pay for such health care is problematic because some of the individuals taxed already receive lower take-home pay because they are offered employer-provided health care coverage. Essentially, a worker who has employer-provided coverage would pay twice: once to cover her own health care costs, and once to cover the costs of fellow state residents who do not receive employer-provided coverage and therefore enjoy higher wages as a result. The obvious answer to this inequity is to either require employers to offer employees coverage, or at least to tax those that do not. States, however, are largely powerless to do so, because the federal Employee Retirement Income Security Act of 1974 (ERISA) broadly preempts state laws that “relate to” employee benefit plans. As a result, only the federal government is able to level the playing field by requiring employers to either offer coverage or pay a tax.

The second significant contribution this article makes is to push back against the notion that states cannot be left to determine the terms of their health care markets because they will make suboptimal choices. For example, Professor Bagley discusses the ACA’s strict rules regarding the premiums that health insurers may charge, noting that the ACA provides that older people may be charged no more than three times what younger people pay for coverage. Without this rating restriction, young people would pay less for coverage, while old people would pay more. It is in this type of normative judgment that he argues states should have more flexibility and input. He acknowledges in this discussion that states might get it wrong. They might make decisions that are harmful to some groups. But, he argues, this is the price we pay for federalism (which we should tolerate unless states’ bad ideas turn on views about the inferiority of minority groups). As he succinctly puts it, “Sometimes federalism means letting the states wave their crazy flags.” Professor Bagley does not, however, argue that the states should simply be given federal funding without limitation. He argues that the federal government can (and should) set broad conditions on the use of the federal funding but, particularly where there are so many unknowns about how best to achieve universal coverage within our existing system, and so many disagreements about what burdens should be born and by whom, there is merit in letting fifty flowers bloom.

After making this case for increased state authority, Professor Bagley turns to examine current proposals to “repeal and replace” the ACA. And it is here that Professor Bagley makes one of his most important contributions because he explains that, while reformers rely heavily on states’ rights rhetoric, current proposals actually strip authority from states. In particular, reform efforts that seek to authorize interstate sale of health insurance prevent a state from regulating the health insurance market for its own residents, because those residents can simply opt out of that regulation by purchasing in another state. The home state no longer controls health insurance markets for its own citizens. Professor Bagley argues that this is an even greater infringement on state authority than federal regulation. It is, he argues, a clear attempt to deregulate health insurance, rather than shift regulatory control back to the states. He makes similar arguments regarding Medicaid block grants, which, under current proposals, would entail shrinking Medicaid to a degree that would prevent states from exerting much meaningful control of the program.

Professor Bagley’s article deserves attention and praise for many reasons. First of all, it is legal scholarship that is directly relevant to one of the major policy debates currently underway in our country, and it is written in a format, length, and style that can actually be read and digested by all stakeholders. But I also think it is powerful precisely because it is legal in orientation and not political. Professor Bagley’s arguments are likely to cause both sides of the political spectrum to bristle. The article may cause Democrats to rethink their assumptions that tight federal regulation of all aspects of health care markets is the only way to accomplish health care reform. And it may cause Republicans to rethink their arguments that the ACA must be dismantled in order to return power to the states.

Cite as: Amy Monahan, Federal Funding with State Flexibility: A Timely Look at Federalism and Health Care Reform, JOTWELL (June 23, 2017) (reviewing Nicholas Bagley, Federalism and the End of Obamacare, 127 Yale L.J. F. 1 (2017)), https://health.jotwell.com/federal-funding-with-state-flexibility-a-timely-look-at-federalism-and-health-care-reform/.

Unpacking the Shortcomings of the Vaccine Injury Compensation Program

Nora Freeman Engstrom, A Dose of Reality for Specialized Courts: Lessons from the VICP, 163 U. Penn. L. Rev. 1631 (2015).

The National Childhood Vaccine Injury Act of 1986 established the Vaccine Injury Compensation Program (“VICP”) as a replacement regime for vaccine-related injuries. The VICP is funded by a seventy-five cent tax on each vaccine dose. Individuals alleging vaccine-related injuries file a petition, which is adjudicated by a special master of the U.S. Court of Federal Claims. Petitioners may seek damages for, inter alia, health care and rehabilitation costs (past and anticipated), though damages for pain and suffering or death are capped at $250,000. The law provides broad legal immunities for vaccine manufacturers, including preemption of tort claims for design or warning defects. In 2011, the U.S. Supreme Court interpreted the preemption provision to include design defects where the vaccine manufacturer failed to incorporate a safer alternative design.

The VICP maintains a Vaccine Injury Table that lists compensable injuries—these are deemed “on-table” injuries, and causation is presumed. All other injuries are deemed “off-table” injuries, and petitioners have the burden of proving causation. This distinction is significant; between 1999 and 2014, six vaccines were added to the table, and none had an on-table injury. During that same time period, the percent of petitions alleging off-table injuries increased from 25% to 98%. Importantly, the statute does not mandate that the data needed to meet the causation bar be collected by manufacturers or disclosed to the public; moreover, FDA regulations have not filled this legal gap. To the contrary, as officials from the FDA and CDC explain, “no active effort is made to search for, identify and collect information [on vaccine adverse events], but rather information is passively received from those who choose to voluntarily report.” Given the challenges in demonstrating causation and the lack of data to analyze causation, the net result is a large decrease in awarded claims and a large increase in uncompensated harms.

There can be no question that vaccines are a public health triumph. At the same time, however, with statistical certainty a small number of vaccinees will suffer catastrophic injuries or death. As health policy expert Michelle Mello has argued, vaccinations involve a high stakes gamble where the overwhelming majority will benefit but no one knows (or can predict with reliable certainty) who will suffer harm. Over the past three decades the VICP has adjudicated over 14,000 petitions, and thus there is ample data from which to evaluate the VICP. Herein steps Nora Freeman Engstrom. Her article, A Dose of Reality for Specialized Courts: Lessons from the VICP, is an elegant and comprehensive investigation of the VICP, and her findings highlight several troubling trends.

As Engstrom details, “[t]he picture is bleak. The VICP has simply failed to offer compensation as consistently, as quickly, as easily, or as simply as it proponents had predicted.” (P. 1675.) For example, the average vaccine-injury petition takes longer to adjudicate that the average tort claim alleging medical malpractice. The Government Accountability Office has underscored the fact that the expectations of the VICP “have often not been met,” while patient advocacy groups have lambasted the VICP as “a betrayal of the promise that was made to parents about how the compensation program would be implemented.” (Pp. 1675-76.) Even the VICP’s Chief Special Master, who served in that role for over two decades, publicly stated that “litigating causation cases has proven the antithesis of Congress’s desire for the Program.” (P. 1676.) Moreover, due to the structure of the law (particularly, the preemption provisions), in cases where an injury resulted because a vaccine manufacturer failed to use a safer alternative design, the manufacturer “is not in any way affected if a decision is made to compensate the petitioner.” (P. 1671.) Compensation awards are derived entirely from the Vaccine Injury Trust Fund (not from the vaccine manufacturer), and special masters do not have the legal authority to require a new vaccine design.

The adversarial nature of the petitions is particularly troubling, and not just for questions of causation. This is despite the fact that Congress directed that the VICP “provide for a less-adversarial, expeditious, and informal proceeding.” (P. 1711, n.376.) As Engstrom details, government attorneys dig into the minutia of claims; in one case the government argued that $150 was too much to spend per year on wheelchair maintenance, while in another the government argued that a 14-year old girl with vaccine-related “profound mental retardation and severe spastic quadriplegia” was not entitled to $40 high-top tennis shoes. (P. 1692.) In a case where a child was crippled by the Hepatitis B vaccine, the government haggled over whether a competent nurse could be obtained for $50 or $60 per hour, and tried to limit the hours that the child could be assisted by a nurse to five hours per day (the family indicated they needed the nurse for eight hours). Meanwhile, the vaccine injury trust fund has a “bulging surplus” of over $3.6 billion, and in many years the interest on the trust fund is sufficient to pay out all awarded claims.

Replacement regimes like the VICP, Engstrom explains, “are the go-to weapon in serious tort reformers’ collective arsenals.” (Pp. 1640-41.) Such regimes—which jettison tort law in favor of some version of a “no-fault” compensation mechanism—have been proposed for dozens of scenarios, including injuries resulting from medical malpractice, motor vehicles, firearms, lead paint, and nuclear accidents. By closely examining the VICP, Engstrom sounds the alarm bells for specialized courts, particularly specialized health courts. As she highlights, “before the traditional tort system is abandoned . . . there must be substantial grounds to ensure confidence in an alternative institutional mechanism that would serve as its replacement.” (P. 1717.) Engstrom’s arguments are compelling, and must be taken seriously.

Cite as: Efthimios Parasidis, Unpacking the Shortcomings of the Vaccine Injury Compensation Program, JOTWELL (May 25, 2017) (reviewing Nora Freeman Engstrom, A Dose of Reality for Specialized Courts: Lessons from the VICP, 163 U. Penn. L. Rev. 1631 (2015)), https://health.jotwell.com/unpacking-the-shortcomings-of-the-vaccine-injury-compensation-program/.

Cost Containment—Global Budget Caps

Nelson Sabatini, Joseph Antos, Howard Haft & Donna Kinzer, Maryland’s All-Payer Model—Achievements, Challenges, And Next Steps, Health Affairs Blog (Jan. 31, 2017).

While the Affordable Care Act has done much to improve access to care—20 million more Americans carry health care insurance as a result of ACA—the Act’s ability to contain health care spending is less clear. Accordingly, efforts to identify effective policies for limiting health care costs are critical.

Unfortunately, the experience with many cost-containment strategies has been disappointing. What seems promising in theory may not pan out in practice. That makes a recent review by Nelson Sabatini and colleagues especially worth reading. They highlight a model in Maryland that has shown very encouraging results so far.

As observers have long noted, fee-for-service reimbursement leads physicians and hospitals to provide excessive care. When insurers base pay on the amount of care provided, lots of care will be provided, and much of it will be unnecessary. Public and private insurers have implemented quality-based measures, bundled payments, and other strategies to counter the incentives from fee-for-service reimbursement. As Sabatini et al. discuss, Maryland draws on an important approach common in other countries—global budget caps.

Three years ago, Maryland modified its already innovative policy for payment of hospital bills. For a long time, Maryland had set hospital reimbursement rates that were the same for all payers. Private insurers, Medicare, and Medicaid paid for services at the same rates. While much good came from this approach, hospitals still pushed spending higher by increasing the quantity of services provided. In response, Maryland instituted more quality-based measures for payment. More importantly, Maryland is in the midst of a five-year trial of caps on the total reimbursement each year for the state’s hospitals. With a global budget cap, hospitals are forced to become more efficient. If they run up the tab, they’ll hit or exceed their budget cap, and will have to eat any losses.

As Sabatini et al. report, hospitals have responded to their new limits in desirable ways. For example, they have worked to prevent the need for hospitalization by expanding their chronic care management programs for diabetes, heart disease, lung disease, and other conditions. They also have provided more support for patients after discharge to smooth the transition to less acute health care facilities or to home and reduce the need to return to the hospital for additional care. Though readmission rates still are higher in Maryland than the national average, the gap has narrowed considerably, to less than half of its previous size.

With the improvements in quality of care have come reductions in costs of care. Maryland’s global budget policy caps the growth in hospital revenues to no more than the long-term growth rate of the state’s economy, which is 3.58 % per year. Hospitals have come in comfortably below their target each of the three years during which the global budget caps have been in effect, with revenue growing only 0.35 % in 2016, 2.31 % in 2015, and 1.47 % in 2014. (The data for 2016 are partial-year to date, through September 2016.) Thus, while Maryland hoped to save $330 million in Medicare hospital costs over five years, it has already saved Medicare $429 million in spending for inpatient care.

Of course, reducing inpatient spending need not lead to a reduction in overall spending. Care that used to be provided in a hospital might shift to an outpatient setting. Hence, as Sabatini et al. observe, Maryland monitors overall health care spending to make sure its budget caps are truly effective. To some extent, savings in hospital-based care have been offset by increased spending on home health care, the chronic care management that the hospitals provide, and care at rehabilitation facilities. This increased spending for Medicare patients has totaled $110 million, for a net reduction in Medicare hospital spending of $319 million. To fully judge the effectiveness of Maryland’s budget caps, we would need to see data for spending on patients insured privately or by Medicaid.

Global budget caps have much to offer. They bring more predictability to budget planning, they make it harder for providers to evade efforts to contain spending, and they give providers the freedom to decide how they will lower their costs.

There also is good reason to think that budget caps can be implemented without compromising care. Not only is that the experience in Maryland to date, it also is the experience in the European countries that employ budget caps and are able to deliver good quality care at much lower cost than in the United States. It seems that physicians, hospitals and other providers can adjust their manner of practice to their fiscal environment and preserve quality of care even as they reduce the quantity of care delivered.

Since policies that promise much in theory need not pan out in practice, it is critical for policymakers to test their ideas on a trial basis and move forward only after they have been able to demonstrate effectiveness. As Sabatini et al. indicate in their important analysis, the evidence from Maryland’s use of hospital budget caps supports more trials with global budget caps in the U.S. health care system. Indeed, Maryland is planning to expand global budgeting beyond the hospital setting.

Cite as: David Orentlicher, Cost Containment—Global Budget Caps, JOTWELL (April 27, 2017) (reviewing Nelson Sabatini, Joseph Antos, Howard Haft & Donna Kinzer, Maryland’s All-Payer Model—Achievements, Challenges, And Next Steps, Health Affairs Blog (Jan. 31, 2017)), https://health.jotwell.com/cost-containment-global-budget-caps/.

An Opportunity for Demand Side Innovation

Rebecca S. Eisenberg & W. Nicholson Price II, Promoting Healthcare Innovation on the Demand Side, Oxford Academic J.L. & Biosciences (2017).

The intersection of healthcare information goods, resulting products, and the legal system is frequently reduced to unhelpful binary generalizations such as “regulation (particularly drug safety and data laws) impedes innovation.” Eisenberg and Price helpfully consign such caricatures to the past, substituting far more nuanced (and a lot more interesting) reflections on healthcare and innovation.

Their primary contribution is to describe a different idea of innovation; one based on the demand side rather than the supply side. This is to be contrasted with the “Innovation Law Beyond Intellectual Property (IP)” literature which has examined non-IP mechanisms such as grants, prizes, or insurance to incentivize innovation without utilizing exclusionary patent rights. Those approaches, while they may have been shaped on the demand side, are executed on the supply side (such as a government subsidy paid to a drug company to encourage production of an unprofitable drug). In contrast, Eisenberg and Price are interested in true demand-side innovation based on the data accessible to payers; providers or insurers and, optimally, vertically integrated stakeholders such as large HMOs. These payers, the authors argue, could leverage the enormous clinical and prescribing data sets they can access “to develop new information about drug toxicity, comparative effectiveness, precision medicine, and to perform other forms of innovation.” If successful, “[t]he incentives of payers to cut costs… could be a corrective counterweight to the incentives of product sellers to maximize their own patent-protected profits.”

This counterbalancing idea is a smart one given the poorly functioning marketplace that is healthcare’s fate. Currently, supply-side pharmaceutical companies can transfer their information goods into IP-protected profit centers. Thereafter, even major payers such as private insurance companies have difficulty negotiating down drug prices while federal law embarrassingly prohibits price negotiation for Medicare Part D drugs. Essentially, Eisenberg and Price are encouraging payers to undertake roles such as “new technology assessment” (NTA) that in other healthcare systems are undertaken by regulatory or independent agencies. For example, the UK’s National Institute for Health and Care Excellence and the German Institute for Quality and Efficiency in Health Care evaluate new drugs on the basis of their comparative or cost effectiveness. Their findings determine whether such drugs are included in the national formulary (UK) or subject to reference pricing (Germany). There are few regulatory analogs in the U.S. and the closest one, the Patient-Centered Outcomes Research Institute (PCORI), is expressly prohibited from using the classic NTA outcome measure, the quality-adjusted life year.

The authors recognize that the opportunity for demand-side innovation faces practical barriers. The data required is often hopelessly fragmented; payers may have the opportunity to innovate but, the vertically integrated aside, few will have the incentive; and (because no paper on innovation is complete without a criticism of dear HIPAA) they argue that data laws may hinder access to or use of clinical data. Equally, the examples the authors give of government programs that could help demand-side innovation (Meaningful Use, the FDA Sentinel System, and PCORI) are hardly shining examples of regulatory home runs. However, maybe some of the provisions of the recently enacted 21st Century Cures Act will turn those around. That legislation also raises the interesting question whether those on the supply side increasingly will be interested in demand-side data given the increasing role of patient experience and clinical data in the drug approval process.

The decline in the number of breakthrough drugs suggests supply-side innovation is slowing, and the authors also note the pharmaceutical industry’s ambivalence to a successful precision medicine initiative. Equally, we may not yet have reached the inflection point for data-driven analysis on the demand side, and we are a long way from realizing the benefits of patient access to useful information built on such data. However, although the balance of innovation power remains on the supply side, Eisenberg and Price provocatively suggest that should change. If the authors’ predictions play out it will be interesting to see whether the result will be demand-led safer and cheaper products, or whether the supply side will demand increased IP and other rewards to reassert the supply-side imbalance.

Cite as: Nicolas Terry, An Opportunity for Demand Side Innovation, JOTWELL (March 28, 2017) (reviewing Rebecca S. Eisenberg & W. Nicholson Price II, Promoting Healthcare Innovation on the Demand Side, Oxford Academic J.L. & Biosciences (2017)), https://health.jotwell.com/an-opportunity-for-demand-side-innovation/.

Targeted, Concise Treatments for the American Health Care System

  • David Orentlicher, Controlling Health Care Spending: More Patient “Skin in the Game?", 13 Indiana Health L. Rev. 348 (2016), available at SSRN.
  • Barbara A. Noah, The (Ir)rationality of (Un)informed Consent, 34 Quinnipiac L. Rev. 691 (2016), available at SSRN.

From a health law and policy perspective, the recent presidential election results have undoubtedly ushered in a new period of tremendous uncertainty. With President-elect Trump ascending to the office this year, it is likely that the health care delivery and financing system—to say nothing of the numerous health law syllabi in health care law courses across the country—will look radically different in the years to come. As I write, policymakers and prognosticators are debating which—and how many—pieces of the Affordable Care Act will survive. Nevertheless, no matter the makeup of American health care system in the future, many challenges the system currently faces will endure—and likely intensify. Chief among those concerns revolves around the strangling cost of American health care.

Examining the issue in two separate manifestations and focusing on patient decision-making in two separate contexts, David Orentlicher and Barbara Noah provide practical and succinct suggestions in well-written, recently-published essays, Controlling Health Care Spending: More Patient “Skin in the Game?” and The (Ir)rationality of (Un)informed Consent, respectively. Both tackle problems that contribute to the nagging challenge of cost—Orentlicher largely with an eye on influencing patient decision-making through coverage incentives and penalties, and Noah with an eye on improving patient clinical decision-making at the end-of-life. As overutilization and cost are a focus of much of my scholarship, I was delighted to discover both pieces and to engage with their insights as we overlook a new period of yawning uncertainty in health law and policy.

First, in his insightful essay, Professor David Orentlicher paints a dark picture of American health care cost and quality before diving into a few suggested policy changes. Orentlicher focuses on two main solutions: (1) recalibrating patient cost-sharing, and (2) using employer wellness programs to address inefficiencies and incentives. On improving patient cost-sharing, Orentlicher rightly observes the main challenge: if the insurance’s cost-sharing amount is too high, patients are deterred from seeking care (especially those of lower economic means), and if the cost-sharing is too low, patients will seek too much health care and waste resources.

After identifying this challenge, Professor Orentlicher presents targeted solutions. First, he notes that aggressive cost-sharing must be reserved for lower-value care; this way, patients are appropriately steered to the doctor when it is most efficient for them to visit. Second, Orentlicher notes the importance of reference pricing to standardize the cost of a given procedure or product, pushing patients to lower-cost providers. And third, he highlights “scaled” cost-sharing, in which he suggests that deductibles and other cost-sharing mechanisms be scaled to one’s familial income, and not a raw dollar amount. This would address the problem of those without disposable income avoiding the doctor too much, and those with more disposable income visiting the doctor too often.

Finally, Professor Orentlicher highlights the upside of employer wellness programs in cutting the cost of health care. Within this section, after describing some of the limitations and threats facing wellness programs, he encourages program designers to think about three main features for incentives: first, programs should reward short-term progress; second, programs should structure incentives indefinitely; and finally, programs must carefully consider the benefits and downsides of a system with either built-in rewards or penalties (Professor Orentlicher seems to suggest that rewards may work better).

Second, in her artfully titled essay, Professor Barbara Noah tackles the inadequacies of informed consent. She starts by highlighting the size and scope of the problems raised by dying in America—most notably that we overutilize certain care and that we underutilize other types of care—and forecasts that it is likely to worsen due to shifts in population. Referencing everyone’s different conception of, and approaches to, end-of-life decision-making, Professor Noah notes that a substantial amount of end-of-life care provides no measurable benefit. She laments the “default model” that pushes doctors to continue to provide care unless the patient undertakes a burdensome effort to opt out of often needless treatment.

Professor Noah does a masterful job of describing the difficulty facing patients at the end-of-life. After highlighting a number of other complicating factors, including cultural challenges (both of physicians’ concerns about liability and of society’s conception of death) and payment incentives, Noah attacks as impossible the idea of a “perfect” decision at the end-of-life in the face of a number of unconquerable obstacles. To explain this complication, Professor Noah effectively relies on recent work by philosophers to observe that clinical decision-making at the end-of-life is characterized by “necessary fallibility,” and is defined by unknowable and unpredictable variables. Sneakily, “unknown unknowns” may impact the real likelihood of survival, but cannot be fully understood during the clinical decision-making process. As a result, Noah argues, there is no “best” approach or treatment for a patient who may be facing the end of his or her life. This uncertainty swamps the abilities of both the provider and patient to come to a rational “best” clinical decision.

Noah finishes by pointing out a number of pressures that impact the decision-making process—from optimism bias, to a false belief that patients can achieve a perfect and rational end-of-life decision, to an inability to convey the hard edges of what can be known. She notes that we must continue to strive for informed consent, but must recognize that the doctrine is limited and imperfect. In the end, it comes down to patients being able to face the situation with as much knowledge as possible while understanding this imperfection of the decision-making process, and, above all perhaps, the fragility of life.

Both Orentlicher and Noah provide clear and focused works geared toward improving the delivery of American health care with an eye toward building a more just and efficient system. Their pieces remind all Americans—during this time of remarkable uncertainty—that some of the same old challenges will remain in need of adequate legal and policy-based solutions.

David Orentlicher, Controlling Health Care Spending: More Patient “Skin in the Game?", 13 Indiana Health L. Rev. 348 (2016); Barbara A. Noah, The (Ir)rationality of (Un)informed Consent, 34 Quinnipiac L. Rev. 691 (2016).