Sam Quinones, Dreamland: The True Tale of America’s Opiate Epidemic (2018).
For my Jot this month, I chose a book that is somewhat outside of the typical academic genre, but, for reasons that I will explain, nonetheless worthy of attention by health law scholars. My summer travels this year were cast against the background of reading Sam Quinones’s Dreamland: The True Tale of America’s Opiate Epidemic, which I started mostly out of curiosity and desiring a page-turner, non-fiction story. Quinones is a former newspaper reporter, for various outlets, including the Los Angeles Times, who spent his career covering the crack epidemic, gangs, drug trafficking, immigration, neighborhood news, and local government. For nearly a decade he immersed himself in Mexican culture and politics, learning Spanish and delving into topics ranging from the street gangs, the PRI, Tijuana opera, drag queens, and taco and popsicle vendors. He is the author of myriad news articles and two other nonfiction books of stories. His ground-level experiences and insights come through in Dreamland, which weaves together three primary narratives: (1) heroin dealers from an obscure Mexican state of Nayarit; (2) pharmaceutical marketing practices and the evolution of pain treatment; and (3) economic decline and loss of opportunity in small-town and rural America. The chapters shift among those three narratives, interspersed with poignant anecdotes from individuals and families personally affected by addiction, overdose, and loss.
Working somewhat backwards chronologically, Quinones starts from his comfort zone, the tale of “black-tar” heroin dealers from Nayarit, Mexico, and their novel drug distribution strategy, which he likens to Domino’s pizza franchising. Dealers avoided large cities that were the hotbeds of crack and other earlier illegal drug markets, locating instead in mid-sized cities with enough immigrant populations that the Nayarit dealers could blend in, and with a methadone clinic or two from which the entrepreneurial dealers could establish a customer base. Dealers maintained relatively small inventories and distributed their product via drivers carrying even smaller quantities, packaged in balloons that could be swallowed in the event they were pulled over. Even if caught, the quantities typically were not of much interest to law enforcement and resulted in short jail stays and/or deportation. Drivers who returned to Mexico by choice or by law were quickly replaced by other young, eager recruits, or themselves returned after reveling in the financial spoils (including dark-blue Levi jeans) of their time up North. The distribution method allowed addicts to call their dealer and receive delivery of the product in the comfort of their own cars or homes. Dealers prioritized customer service and loyalty, offering free product (including “welcome home” packages after customers’ rehab or incarceration stays), undercutting the competition, and responding to calls quickly, efficiently, and on-demand.
To make the connection between heroin distribution and the prescription opioid crisis, Quinones has another story, one told with the same investigatory journalistic style as the Nayarit dealers’ story. He describes pharmaceutical product research and development, the rise of pharmaceutical marketing to physicians, evolving medical standards of care for pain management, and the science and treatment of addiction. Knowing that each of those topics are deep and nuanced, and the research foci of serious health law, public health, and medical academics around the world, I was somewhat dubious of Quinones’s ability to accurately address the issues. However, I found his coverage convincing enough, as he connected the dots between overprescribing and heroin addiction. His essential point is that patients prescribed opioids, often, at least initially, for legitimate medical reasons, become addicted, then turn to illegal heroin for greater highs, easier access, and lower cost. The loss of economic opportunity and “diseases of despair” (although he does not use that term, specifically) across America, with the loss of manufacturing and agricultural jobs and the Great Recession, further fuels the addictions.
Again, I remained at times dubious of Quinones’s account, convinced that there was often more to the story. But the parts he told worked well enough to advance a compelling narrative. His account of the role of the zero-to-ten pain scale and the role of Joint Commission standards in incentivizing hospitals and medical providers to aggressively treat post-surgical and other pain was convincing. Also convincing was his assertion that the most widely cited “study” on the non-addictive nature of oxycontin and earlier classes of prescription opioids and narcotics was a back-of-the-envelope tabulation by a Boston University professor, correlating patients prescribed pain medications with patients developing addictions. Dr. Hershel Jick’s “study” was pulled from a single database, never scientifically studied or peer reviewed, and published in a single-paragraph letter to the editor of the New England Journal of Medicine. Quinones is not the only commentator to suggest that Dr. Jick’s letter fueled the opioid crisis, and that one piece of the story is itself a topic of considerable discussion. But my point is that although certain elements of the health care and pharmaceutical industry background may be oversimplified in Dreamland, the book is well-researched, especially through first-person accounts, and does a good-enough job hitting on key points necessary to connect the narrative.
Moreover, the tragic and harrowing stories make for highly engaging reading, regardless of one’s background or interest in the topic. But, to be sure, the topic of opioids is of professional interest and a hot-topic among health law and other scholars. By way of example, I am working on one project examining health care challenges in rural America and another cataloguing local government costs of opioids. A number of colleagues, including Abbe Gluck, Nic Terry, Scott Burris, Kelly Dineen, to name a few, are deeply engaged on various opioid-related topics. Indeed, opioids were front-and-center at my first trip of the summer to the American Society of Law, Medicine & Ethics annual Health Law Professors Conference, which, this year, happened to be in Cleveland, Ohio. The Journal of Law Medicine & Ethics just published a symposium issue dedicated to opioid-related issues. The host school, Case Western, included a keynote address by Judge Dan Polster, U.S. District Court for the Northern District of Ohio, the judge handling the opioid multidistrict litigation (MDL). Sitting a few tables away from the podium, sneaking photos of Judge Polster on my phone, I felt like a teenager at a Bruno Mars concert. Here before me was the man poised to play a central role in the narrative that I was reading and that is still unfolding across the country.
As Judge Polster explained, it is no coincidence that the MDL landed in an Ohio court. Quinones’s book likewise opens by explaining myriad factors that converged to make Ohio Ground Zero for the opioid epidemic: economic downturn and lack of opportunity in small-town America; aggressive marketing and other health policy drivers for overprescribing; lack of access to primary care in rural America; and the unique heroin distribution strategy by dealers from one small region of Mexico targeting mid-sized U.S. cities. The eponymous “Dreamland” reference is to a once-glorious, football-field-sized, public swimming pool in Portsmouth, Ohio, now closed and paved over—a symbol of the decline of the American Heartland.
My second summer trip was a family road trip up and down the East Coast. Viewing the landscape out my car window through the lens of Dreamland was like wearing opioid-colored glasses: Walmarts were filled with addicts shoplifting Levi’s jeans to pay off their dealers; highway billboards advertised McDonalds, alongside Subutox; defunct manufacturing plants and empty Main Streets left scores of unemployed workers, treating their despair with legal and illegal drugs; a hotel in suburban Charlotte, NC, surrounded by upper-class white teenagers with smart phones and drug addictions; highway signs for hospitals prescribing pain meds on one floor while treating overdoses on another; a deflated water balloon in a New York City park; officials in Philadelphia considering supervised injection centers, like the needle exchange programs of the HIV/AIDS crisis.
The true-crime style, sensational accounts, and colorful characters depicted in Dreamland made it a highly readable summer book. As my fellow Jotwell Health Law Section readers know, the pharmaceutical, health care, public health regulatory landscapes are far more complex than even laypersons who have done their homework realize. And I can imagine that other dynamics—law enforcement, criminal investigations, prosecutorial discretion and strategy, immigration policy, medical standards of care, addiction and recovery—are similarly multidimensional topics. But even my skepticism about the straightness of the lines that Quinones draws from opioid prescribing to heroin addiction, from pill mills to government health care programs, from Nayarit, Mexico to Portsmouth, Ohio raised my awareness, anxiety, and desire to know more. Sparking new questions and lines of research seems a hallmark of academic scholarship. The fact that Quinones’s trade publication achieves that purpose, along with crafting a riveting, well-told tale that has drawn public attention to an evolving crisis is surely worthy of praise. In sum, I highly recommend Dreamland to anyone interested in any aspect of the opioid crisis and encourage readers to enjoy the ride while letting their academic formalities take a back seat, at least for the summer.
Barbara J. Evans, The Genetic Information Nondiscrimination Act at Age 10: GINA’s Controversial Assertion that Data Transparency Protects Privacy and Civil Rights
, 60 William & Mary L. Rev.
(forthcoming), available at SSRN
Barbara Evans is one of our preeminent privacy scholars (with a pretty nifty sideline in FDA law). She specializes in intricate and precise analysis, very carefully mixing “big picture” policy arguments with deft doctrinal detail. This article on the Genetic Information Nondiscrimination Act (GINA) is no exception. GINA, of course, was one of the products of The Ethical, Legal and Social Implications (ELSI) Research Program funded by the NIH under the Genome project. The Genetic Information Nondiscrimination Act at Age 10: GINA’s Controversial Assertion that Data Transparency Protects Privacy and Civil Rights is a timely reminder not only of GINA’s tenth anniversary but also, increasingly, the proliferation of genetic information across clinical, research, and consumer domains. As Evans notes, “If GINA failed in its first decade to save us from genetic discrimination, it may have been a harmless error, because the human genome was too poorly understood at the time to lend itself to very many nefarious uses. If GINA failed, then so did the science, and it all somehow worked out. This does not imply, however, that GINA’s civil rights protections are unimportant; they may simply have been premature.” Another reminder inherent in the article is that health care suffers from a poorly synchronized combination of data protection models, including the HIPAA Rules, the Substance Use rule (aka 42 CFR Part 2), GINA, the Americans with Disabilities Act, and the Common Rule.
At the core of the article is a most perceptive observation—that GINA expanded the federal regulatory program for genetic and genomic testing from safety regulation to civil rights regulation, including privacy protections and prohibitions on discrimination. At first sight, the specific legal issue to which Evans turns her attention does not seem particularly earth-shattering—a GINA-authorized amendment to the HIPAA Privacy Rule. HIPAA had already allowed patients to access their healthcare data held by physicians. However, the GINA-initiated regulatory change in 2014 granted them access to “laboratory-held data, including genetic and genomic information as well as assorted other diagnostic test results that laboratories hold in their files.” This change did not sit well with a range of health regulators (or the laboratories). They viewed much of the assembled genetic data as incomplete or of sub-clinical quality, yet here were patients being granted legal access to it!
Expertly, Evans uses this example to illustrate that the underlying problem was a failure to view the access right, not as a safety regulation, but as a “regulation that aims to balance privacy and transparency in a way that allows socially beneficial uses of genomic data while protecting people’s civil rights.” GINA didn’t necessarily care about reliability or clinical significance because “[p]eople can be deprived of civil rights based on unreliable as well as reliable information that is attributed to them.” Safety regulation and civil rights regulation are different and sometimes their intersection will be messy.
Drawing the distinction between safety and civil rights regulation can be enormously helpful. For example, it helps to explain the recent Common Rule revisions that according to Evans, sought to “disentangle safety and civil rights by ceding civil-rights oversight to the HIPAA regulations and focusing the Common Rule on the physical risks of research—that is, on safety issues.” Evans also has an interesting take on HIPAA privacy. It is true that GINA primarily uses a transparency rule to promote privacy (in contrast to GINA’s far more prescriptive approaches to health and employment discrimination) and that GINA adopted HIPAA’s (transparency) access provision. However, it may be an overstatement to assert that the latter “was designed, from its inception, to serve competing values of privacy and data transparency, giving considerable weight to the latter.” The Privacy Rule is imperfect and riddled with exceptions. Yet, at its core, it does provide reasonably robust downstream confidentiality data protection, albeit with rights attaching to HHS’ Office for Civil Rights (OCR) rather than to the data subjects themselves.
Notwithstanding, Evans’ core transparency point is correct—that the “primary purpose of HIPAA’s access right is to force entities that store individually identifiable data to display respect for the individuals’ autonomy.” For example, Evans argues that furthering this autonomy can empower citizen science and improve data quality. However, what Evans amusingly describes as the “Consumer Safety Regulatory Empire” struck back against the autonomy-though-transparency HIPAA-GINA access rule. Soon, laboratories holding genetic data found themselves caught in “crossfire” from different regulatory directives or models from the Department of Health and Human Services, the Food and Drug Administration, the Centers for Medicare and Medicaid Services, the OCR, and even local Institutional Review Boards. Evans pushes back against the Empire, noting “[t]he individual’s civil right of access to genetic information has one of the most unimpeachable statutory pedigrees of any U.S. federal regulation: Congress thrice authorized it.” The last section of the article is dedicated to suggesting routes that can respect or balance that autonomy with the broad consensus of researchers that there should be very limited access to their own genetic data. Evans’ suggestions are cogent and practical.
Professor Evans’ carefully constructed arguments aside, her article also contains some delicious nuggets that are worth digesting on their own. Examples include: “GINA enters its second decade like a misunderstood teenager, struggling to be taken seriously as a civil rights law,” and “GINA, in many respects, was Congress’s response to a mass delusion that genetic information is more informative than, at least to date, it has proved to be.” And, finally, a nugget that also serves as fitting coda to an exemplary piece of legal scholarship: “As GINA enters its second decade, its civil rights protections are more important than they were ten years ago: people’s genomic data are widely used in research, often without their consent; bioinformatics algorithms grow more efficient at re-identifying de-identified data, and progress of genetic science is expanding the range of privacy-invasive inferences that can be drawn when data are wrongly shared or misappropriated.”
The lack of price transparency in health care is well established. Patients are almost never informed of the cost of their care prior to receiving services. Even if a patient makes a concerted effort to determine price prior to receiving care, most are told that price information is simply unavailable. This lack of transparency results in a long list of negative consequences for both patients and the health care system as a whole.
Wendy Netter Epstein’s article, Price Transparency and Incomplete Contracts in Health Care, revisits this well established problem from a novel perspective. The article examines the lack of price transparency between providers and patients through contract theory. After all, when a patient seeks medical care, she signs a contract with an unspecified price term. Most contracts simply require the patient to pay whatever the provider ends up charging. While such incomplete contracts are deemed unenforceable in many other contexts, Professor Epstein explains that courts uniformly allow open-price contracts for medical care, often based on incorrect assumptions about the inability to ever know the cost of care in advance. The article then relies on contract theory to propose a solution: courts should, in appropriate cases, adopt a penalty default rule that provides a price of zero where the price term is unspecified. A default price of zero would essentially force providers to include price in the contract, so that consumers are aware prior to receiving care the financial consequences thereof.
The article is a great read for anyone who wants to know more about what health care pricing looks like from a patient’s perspective, and to understand why price opacity harms both patients and the health care market. But I found two aspects of the article particularly valuable. The first is that Professor Epstein repeatedly challenges the assumption that we simply cannot know the price of medical care in advance. This assumption is everywhere in health care. We can’t know the price because we don’t know what insurance you have, and therefore we don’t know which negotiated rate you are eligible to receive. And, more fundamentally, we can’t know the price because we don’t know what services the doctor is going to provide. Professor Epstein pushes against these assumptions in a thoughtful, nuanced way. First, she explains that while some care is unknown in scope (e.g., a patient presenting at the emergency room following a car accident with unknown injuries, or a patient undergoing exploratory surgery), most medical care is not. For example, there is no reason why a patient coming in for a screening mammogram could not be given at least a cost estimate prior to receiving care. Second, she argues that the claimed inability to know negotiated prices is overblown. Providers, after all, have the relevant insurance information. They just need to query the relevant data. The article does not suggest we can always know price in advance, but it makes a compelling case that, for much of health care, we can disclose price (or at least an estimate thereof) with relatively little burden.
The other particularly valuable contribution of this article is its central thesis—that in examining price from a contractual perspective, we can come up with a solution that strongly encourages the types of contracts we have reason to believe are most efficient. Specifically, Professor Epstein argues that, in certain cases, courts should adopt a penalty default that “fills in” a price of zero in contracts that fail to specify price. While this may sound like an extreme position (if you don’t specify price, you don’t get paid!), the actual proposal is careful and refined. Professor Epstein offers a framework for determining when the penalty default should be applied, and acknowledges that it would not be appropriate in all circumstances. The three factors she would use to determine whether imposing a penalty default is appropriate are (1) the transaction costs associated with providing a price ex ante, (2) the extent of information asymmetry between the parties, and (3) the potential that leaving out a price term will serve to build positive relational capital between the parties. Each of these factors is explored in depth in the article.
It may be an uphill battle to have courts adopt this approach, but this article provides good food for thought for anyone interested in the issue of price transparency in health care. As Professor Epstein points out in a footnote, some states require written price estimates for auto repair services prior to work being performed. Why not for health care?
Most jurisdictions that have legalized some form of Medical Assistance in Dying (MAD), the term now in vogue that includes Physician Assisted Suicide (PAS) and Euthanasia, have done so only for those who are terminally ill or more broadly, close to dying a natural death. In the few jurisdictions that provide broader access, including for mental illness, in particular Belgium and the Netherlands, the growth of the ‘psychiatric euthanasia’ practice in the last five years has faced particular controversy. Yet, some bioethicists and health law scholars argue that other jurisdictions, including in the US and Canada, should follow their example. They tend to build their argument around paradigm cases of patients with “treatment-resistant depression” (TRD), for which, so they argue, there is no hope of recovery. Not providing access to people with TRD, they put forward, is discriminatory and forces people to either suffer indefinitely or to commit suicide in horrible circumstances.
In Four Reasons Why Assisted Dying Should Not Be Offered for Depression, Thomas Blikshavn, Tonje Lossius Husum, and Morten Magelssen provide an exemplary interdisciplinary and sophisticated response. Although their paper focuses on TRD, many of their points are relevant for the broader mental health context. The paper stands out for its thoughtful reflection on the real-life clinical context in which this practice will play out. Inviting us to reflect on how policymaking needs to account for the complex nature of mental illness and the unique mental health care setting, the paper reveals the dangers of basing sweeping policy changes on well-constructed theoretical arguments that are disconnected from the complex clinical and social context in which they will operate.
The authors wisely don’t waste time discussing two common claims, namely that mental-health-related suffering is as serious as physical suffering and that objectors to psychiatric euthanasia ignore the idea that people with mental illness can have capacity to consent to medical treatment. Proponents of broad access laws keep bringing these up as points of contention, even if no one argues the opposite. Moreover, the authors’ discussion of the complexity of mental-health-related suffering also indirectly reflects their appreciation of its seriousness. Instead, they focus on the argument that it is reasonable to allow MAD for depression when there is no “realistic hope of recovery.” They develop four points: one broader policy point about the impact on mental health services of creating a system that relies on determining that particular patients are unlikely ever to get better; and three related to the impact of introducing MAD on clinical practice in the uniquely difficult context of mental illness.
First, they criticize how the concept of ‘treatment resistant depression’ gives a false aura of ‘objectivity’ and scientific rigor to the argument for expansion. TRD is a technical term that indicates a lack of symptom response to some courses of psychopharmalogical treatment. It does not mean that there are no other treatment options. Anyone familiar with the weak evidence undergirding some of the most widely promoted anti-depressants should be extremely concerned about the argument that failure to respond to three (or even more) such treatments should constitute a reliable basis for agreeing to end a patient’s life. The authors point to the irony that, in cognitive behavioral therapy, the belief that nothing will help is treated as a symptom, and modification of this belief a “crucial therapeutic goal.” One has to wonder what kind of therapy will allow us to deal with this belief at a broader societal level.
The second point relates to the fundamental misunderstanding of what psychiatric diagnoses mean. Outside of psychiatry, pathophysiological processes usually explain diseases and allow health care providers to give some reasonable prognosis (even if uncertainty remains). By contrast, psychiatric diagnoses are broad generalizations based on some shared behavioral traits; the explanatory power of diagnoses and the value of diagnostic prediction remain very limited. We statistically know that a percentage of patients with depression fail to recover, but we cannot know in advance who will fall into this category. In addition, the authors powerfully illustrate how interpersonal relations between therapists and patients, as well as patients’ emotional involvement with their therapy, strongly impact treatment outcomes. More so than in other treatment contexts, patients’ expectations and therapists’ attitudes interact with therapeutic interventions and make the success of treatment context-dependent. In other words, while philosophers and lawyers may construct TRD as an objective, measurable ‘access criterion’, the clinical reality reveals that this is illusory. Moreover, offering the choice of MAD itself affects the likely outcome of the health care intervention.
The third related point is the therapeutic significance of hope. Hope is increasingly recognized as an important contributor to all health care outcomes, but this is particularly true in mental health care. It is essential that health care providers transmit hope to patients whose illness has made them lose hope and long for death. When therapists confirm the patients’ (perceived) reasons for hopelessness, the therapeutic alliance, an essential contributor to a good treatment outcome, is shattered. Giving therapists the task to evaluate the ‘stability’ of the desire to die thus creates a self-fulfilling prophecy: when psychiatrists conclude that hope of recovery is futile, the most crucial tool to counter the patient’s loss of hope (i.e. continued support and the therapist’s persistent hope) disappears.
Their final point is about the broader impact of the normalization of MAD on mental health care. The concern is that normalizing the practice of MAD for psychiatric diagnoses might undermine the resilience therapists currently develop against their own despair when confronted with their most desperate patients. Asking therapists to oscillate between transmitting hope and giving up hope in some cases will undermine the therapeutic alliance, which is crucial for good mental health care. In addition, the institutionalization of assisted dying will undermine patients’ ability to develop an ability to cope with and accept some level of suffering, which is increasingly seen as a crucial component of promising behavioral therapy approaches to mental illness.
That their concern about the normalization of the practice is realistic is in my opinion highlighted by the surge in the demand for euthanasia by psychiatric patients in the Netherlands, as reported in the Third Evaluation of the Dutch euthanasia law. Even though the practice itself remains limited (83 out of a total of 6535 reported euthanasia cases in 2017), 1100 psychiatric patients asked for it in 2015, up from 300 in 1995. This huge surge in demand reveals precisely the kind of broader impact on the therapeutic relation the authors aptly describe. The surge in demand also coincides with an increase in its practice, with specialized end-of-life doctors feeling increasingly comfortable providing access to MAD for mental illness. As the authors conclude: “A wish to die does not arise in an ideological vacuum”; “the very availability of assisted dying may lead some depressed patients to give up the hope that is so vital for therapeutic progress.” Policymakers ought to heed this sophisticated warning about the pernicious impact of MAD as a new therapeutic option in the context of mental health care and should take the recent changes in Dutch and Belgian euthanasia practices as a serious warning sign. And scholars should read this piece to reflect on the serious real life implications of some of their theoretical commitments.
Elizabeth Y. McCuskey, Agency Imprimatur & Health Reform Preemption
, 78 Ohio St. L.J.
1099 (2017), available at SSRN
With the future of health law and policy shifting on a nearly daily basis, producing clear and stable health law scholarship has become a daunting task, risking leaving the field adrift during a period of vexing uncertainty. Evocatively handling this challenge, one piece of esteemed scholarship that has boldly filled a gap—and, I would submit, one of the best articles of health law scholarship over the last year—is Agency Imprimatur & Health Reform Preemption by Elizabeth Y. McCuskey. The article was a pleasure to read and review for this Jot.
No matter the future of specific features of the Affordable Care Act (ACA)—as many truly hang in the balance—McCuskey’s piece takes on a core principle and likely enduring feature of health care reform: the federal statute’s waiver mechanism. Her piece places the ACA’s “big” state innovation waiver (housed in Section 1332 of the Act) in the larger context of murky preemption doctrine and highlights its ultimate impact on judicial review, substantive policy expertise, and communicative federalism. McCuskey’s masterful treatment of a complicated topic is valuable not only given the instability in federal health reform, but given the fact that the ACA’s state-empowering waiver process is likely to only increase in importance and focus under the Trump administration. In short, her topic is likely to become only more significant, and her analysis more indispensable.
Starting by painting the picture of preemption doctrine as it relates to health law and policy, Professor McCuskey begins by describing a “particularly complicated” landscape of health law regulation and an “enormously complex preemption picture.” Preemption doctrine—clouded by Congress’s statements (or non-statements)—has undoubtedly been impacted by inconsistent treatment in the courts, and, consequently, a muddled understanding of preemption doctrine has impacted health law and regulation. Citing ERISA as one example, McCuskey captures the complexity in health and policy as it relates to preemption, noting that the “regulatory landscape before the ACA was … littered with various preemptions that established some uniformity, but which also under-enforced important initiatives, undermined experimentation, and stymied coherent health care regulation.” Preemption has obstructed a substantial portion of health law and policy for decades.
Into this fragmented landscape entered the massive ACA, seeking to expand access and improve insurance policies “by making law incrementally in nearly every sphere of health care regulation,” as she notes. Here, Professor McCuskey’s article does a nice of job of providing a quick summary of various types of preemption, and she notes that the ACA contemplates these issues with an express but “muddled” preemption statement. The remainder of the article focuses on the major feature of the ACA in this space, its “State Flexibility to Establish Alternative Programs” under section 1332.
This “big waiver,” also known as the state innovation waiver, allows states to suspend a number of components of the ACA’s most notable reforms that govern the private insurance marketplace—from the individual and employer mandates, to essential health benefits requirements, to the calculation and structure of tax subsidies under the law. The Centers for Medicare and Medicaid Services (CMS) is vested with the power to approve state waivers, and states must show that their proposed programs are similar to the ACA in coverage and affordability.
McCuskey calls the waiver a “giant” waiver because it “has enormous potential to undo the statute’s seminal provisions based on speculative evidence.” Indeed, the waiver operates to allow CMS to suspend the application of major parts of the ACA—not just those provisions based on the Spending Clause, but also those based on Commerce and Taxation powers—and “preapprove” proposed state legislation. Professor McCuskey also briefly discusses recent proposed reforms that would have expanded the waiver mechanism even further.
The most interesting part of Professor McCuskey’s contribution is her analysis of how, exactly, this “big waiver” within the ACA radically changes the operation of health law and policy. Most notably, she argues that due to the ACA’s structure, which is reliant on “preemptive federal health insurance law, coupled with the big-waiver power to officially sanction state-law variations,” it “creates a preemption-diffusion mechanism favoring agency expertise regarding whether state variations serve federal purposes and objectives.” To this end, she presents the agency imprimatur model, which she illustratively notes, “pushes state law out of the regulatory space with preemption, then invites state law into that space if the agency determines state law will serve federal objectives.”
Indeed, CMS retains discretion and supervision over the waiver approval process, which, in theory, eliminates the necessity of employing the judiciary to determine difficult and thorny preemption questions in court. This evinces a major shift from “post hoc judicial application of preemption doctrine to an ex ante federal agency approval of potentially conflicting state law,” as she notes. And, CMS must adhere to the waiver requirements under the ACA, ensuring that “federal regulatory infrastructure and priorities” retain power. McCuskey calls this “pre-preemption.”
The article then evaluates the structure of the ACA’s big waiver, and its shift “from judicial preemption doctrine to agency imprimatur,” addressing the waiver’s delegation and discretion, as well as looking at agency institutional competence as compared to judicial expertise. While noting that empowering the agency makes for a potentially more “fresh” and “nimble” executive body, Professor McCuskey also looks at three relevant metrics—preemption analysis, substantive health law issues, and federalism—to evaluate the shift.
McCuskey leaves the reader with fascinating points on reviewability and review. First, the agency imprimatur model may diffuse and divert preemption litigation in the first place, and, second, where challenged, the agency imprimatur model likely requires courts to defer to CMS’s decision-making authority unless the agency determination was arbitrary and capricious, a major shift from the now utilized de novo review on preemption questions. Third, the agency imprimatur model here theoretically invites additional transparency (given the notice and comment period for wavier applications) and communicative federalism (insofar as the structure of the waiver makes the federalism debate more “engaged” and perhaps, more informed).
In sum, Professor McCuskey’s work is measured and incisive. It addresses a complicated topic with skillful ease. And given the pervasive uncertainty facing health law and policy in this era, it is an appreciated respite of clarity on an increasingly important topic.
The non-stop growth of employee wellness programs presents a rich teaching (and scholarly) opportunity for health law faculty. We can interrogate the employers’ continued embrace of wellness programs, despite the absence of proven cost savings, and consider concerns about the programs’ purported voluntariness and the heavier burdens they place on workers who find meeting program demands difficult or objectionable. We can explore the evolution of laws (HIPAA and the ACA) establishing the legal parameters of wellness programs and how federal agencies have issued regulations seeking to reconcile their incentive structures with the anti-discrimination principles found in the ADA, GINA, and the ACA itself.
A new article by philosophy professor Gordon Hull and law professor Frank Pasquale offers a critical perspective on what wellness programs do accomplish for employers, even if they don’t produce health plan cost savings. The authors’ basic thesis is that wellness programs serve as a vehicle for employers to exercise increasing control over employees’ non-work lives and in the process to “entrench the idea that one belongs to one’s workplace, extending market relations … into the home and other spaces.” By drawing on philosophy (primarily Foucault) and neoliberal economic theory (for example, Gary Becker’s human capital theory), Hull and Pasquale unveil harms associated with employer wellness programs that go beyond concerns about worker privacy and their disparate impact on unhealthy or disabled employees. Integrating aspects of health law, political philosophy, and data analytics, the article offers a fresh, and troubling, view of wellness programs.
After outlining the legal environment of wellness programs, their origins, and the lack of evidence that they generate savings from employees’ improved health, Hull and Pasquale describe how wellness programs exemplify a neoliberal vision of the employer-worker relationship by making individual workers responsible for pursuing “wellness” for their employer’s benefit. An employer implementing a program communicates to a worker that she should invest in her own wellness as part of her human capital, while at the same time “unravel[ing] the risk-pooling aspects of insurance” by shifting the risks of medical costs onto the workers most likely to generate them. In short, wellness programs provide financial incentives and penalties in an effort to convince employees that health risks are something for which the employee is individually accountable, in stark contrast to a risk-spreading conception of insurance.
Hull and Pasquale tease out additional troubling aspects of wellness programs, particularly how they serve to create a “social truth” about what “wellness” even means. Notwithstanding the limitations of current knowledge about what actions truly promote individual health in the long term, programs adopt approaches to “wellness” that rely on employer surveillance and place responsibility squarely on the shoulders of individual workers, while ignoring and even exacerbating factors that lie beyond those workers’ ability to control. A telling example is employment practices that diminish workers’ job security, even though the stresses of job insecurity may contribute to disease. Hull and Pasquale highlight the irony of some employers’ implementing wellness programs that “reward displays of happiness and laughter” while simultaneously and deliberately making employees more insecure.
The article concludes by considering harms associated with wellness programs that go beyond shifting risk to employees for health-related outcomes often beyond their control and reinforcing the idea that workers are obliged – in all aspects of their lives – to invest in themselves in order to benefit their employers. From a public policy perspective, wellness programs also obscure the value of public health measures that could address health-related matters – like clean air, clean water, safe streets, and limits on the availability of dangerous products – that lie beyond individual workers’ control. In contrast to wellness programs’ privatized and individualized vision of health, public health supplies a vision of health as a matter of public concern, subject to empirical validation and democratic policy development.
Hull and Pasquale’s article presents important insights in a manner that is accessible even to readers who may be relatively unschooled in philosophy or political theory. I’ll admit that (after spending the semester telling students to use simple and direct words in their papers) I found off-putting some of the jargon used. (Phrases like “apparatus of neoliberal biopower” and “individual responsibilization” come to mind.) That said, I found the article tremendously valuable in helping to unravel the puzzle of employers’ seemingly illogical ardor for wellness programs and suggesting their broader implications. As Hull and Pasquale conclude: “Those concerned about the substantial burdens imposed by wellness programs on workers must address … politico-economic theory directly, rather than just continuing to point to the dubious outcomes of wellness programs. Because they work to establish the truth of wellness, these programs are difficult to discredit on empirical grounds. For the neoliberal, there is nearly always a rationale for ‘just one more study’ of a private alternative to public service….” I recommend the article highly.
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?
(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/
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.
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.”
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?
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 Happiness. Nudge 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.