Rebecca E. Wolitz, A Corporate Duty to Rescue: Biopharmaceutical Companies and Access to Medications
, 94 Indiana L.J.
__ (forthcoming 2019), available at SSRN
For far too many Americans, prices of pharmaceutical medications pose a major threat to access and, ultimately, wellness. Indeed, drug costs in the United States pose a problem fraught with challenges, one that has led scholars to focus on achieving a lasting regulatory solution. None has been forthcoming. Given the intractability of the problem, creative solutions that go beyond attempting to devise the perfect recipe of governmental intervention are welcome additions to the legal scholarship. In this vein, a particularly creative new article seeks to investigate whether biopharmaceutical companies owe an ethical duty to provide their medications to those who cannot afford them.
In A Corporate Duty to Rescue: Biopharmaceutical Companies and Access to Medications, Rebecca Wolitz grapples with this question. In her piece, Professor Wolitz presents a complete and critical analysis of the structure, enforceability, and workability of a “corporate duty to rescue” (CDTR). Defining a CDTR as the “application of a moral duty to rescue to for-profit companies” regarding access to their products, Wolitz’s analysis is significant, kicking off a conversation that should precede any “self-regulatory changes [corporations] justifiably could be urged to implement.” Indeed, as she notes, “a CDTR is particularly interesting as it offers a moral foundation for corporate self-regulation.”
After situating her work among other scholarship from authors who have proposed the adoption of a CDTR, Professor Wolitz begins her analysis by examining whether a CDTR would be legally enforceable by tort law. After concluding that a CDTR “as a form of external regulation under current tort law appears unpromising,” she instead argues that CDTR should be considered as a corporate governance tool. In support of this formulation, she convincingly argues that both the corporation’s profit motive and its shareholder primacy structure would not, by themselves, prevent the corporation from discharging a CDTR. To drive home the point, she also argues that discharging a CDTR would likely be protected by the business judgment rule (BJR) because of its operational, as opposed to structural, character.
Professor Wolitz next analyzes current corporate efforts to secure patient access to needed medications. These efforts include forbearance of patent rights, voluntary licenses, donations, price reductions, and patient assistance programs. Although they are framed as potential “means for discharging obligations of corporate rescue,” Professor Wolitz argues that because they are not undertaken due to a “moral obligation to rescue, so much as good business sense or even optional charity,” they may not discharge a moral duty. Part of this is because of the opacity problem that continues to obfuscate what the duty actually requires of corporations.
Additionally, as Professor Wolitz argues, general challenges—“thorny moral issues”—to the CDTR’s application continue to exist. In this part, she takes apart the five features of a duty to rescue—a rescuee, a capable rescuer, an emergency situation, a rescue receipt of significant benefit, and minimal cost to the rescuer. Going element by element, Professor Wolitz highlights the tensions involved in seeking to apply a CDTR, concluding that their complexities make the applicability of the rescue doctrine in the context of access to medicines uncertain, and at least non-obvious, in need of more study. She uses this analysis not to deride those arguing for an explicit duty, but as a call for additional work in the area.
Professor Wolitz finishes her analysis by focusing on two specific normative issues that are implicated by the CDTR. The first is whether a corporation’s efforts to discharge a CDTR would conflict with its obligations to shareholders, a position that Professor Wolitz generally dismisses. The second concern focuses on whether or not biopharmaceutical companies bear any responsibility for the fact that patients face high prices in the first place. This, of course, would have major impacts on the applicability of the rescue doctrine generally, largely because a rescuer that is responsible for causing peril to the rescuee faces different and additional moral duties.
In examining whether biopharmaceutical companies are responsible for any “wrongful causal contribution to harm via pricing,” Wolitz notes that there are “practices pervasive in the biopharmaceutical industry” that “at least raise this possibility.” These include anticompetitive efforts undertaken by biopharmaceutical companies and their influence over political debate and legal regulation—where she powerfully focuses on their lobbying prowess. Ongoing challenges raise the possibility that, at least where biopharmaceutical companies are engaged in harmful conduct that may cause or contribute to the pricing crisis in the first place, surface-level focuses on a CDTR—without an appropriate accounting for this other corporate conduct—may seem incomplete.
In all, Professor Wolitz’s article is a compelling and forceful analysis of the CDTR in the context of drug pricing. Her arguments are thoughtfully presented and well-articulated. And her suggestions—looking for solutions to the drug-pricing crisis that come from outside government regulation—reset the conversation in a powerful and meaningful way. In an era in which creative, well-reasoned scholarship is needed in the area of drug pricing, Professor Wolitz’s article is a much-welcomed contribution.
Over the past decade, the emergence of CRISPR-Cas-9 as a means to “edit” the human genome has brought human genetic modification out of the realm of science fiction and into the real world. This revolutionary technology enables users to “make specific and efficient modifications to a genome” through a process that is “simple, inexpensive, and remarkable effective.” A variety of efforts are now underway to harness this technology to treat inherited diseases and cancers. Most scientists and bioethicists, however, have collectively shuddered at the possibility of using CRISPR-Cas-9 to make germline genetic modifications—i.e., changes in sperm, eggs, or early embryos that would passed on to future generations. Groups ranging from UNESCO to the National Academies of Sciences, Engineering and Medicine have called for extreme caution in proceeding with research on human germline editing, and for a complete moratorium on clinical applications of the technology pending further public deliberation.
In a provocative analysis, Beyond Nature? Genomic Modification and the Future of Humanity, Julia Mahoney and Gil Siegal challenge this “go-slow” approach on both theoretical and practical grounds. They argue that the chief arguments for extreme caution—the interests of future generations, safety considerations, equality concerns, the “evils of eugenics,” and the importance of public trust in science—not only fail to withstand rigorous analysis, but in fact “militate instead for advancing with all deliberate speed.” (P. 196.) In addition, they warn that efforts to limit human germline modification are unlikely to be effective; instead, they will simply “drive cutting edge work into the shadows,” (P. 197) thereby “decreasing public transparency and accountability by moving activity out of sight of democratically responsive entities” (P. 213).
Mahoney and Siegal offer thoughtful responses to the common justifications offered in favor of a moratorium on germline genetic modification. First, while they acknowledge that germline modification will have uncertain impacts on future generations, they point out that the same is true for many other practices and technologies currently in use. For example, antibiotics and other medical treatments allow individuals with disease-causing mutations to survive to reproductive age, thereby altering the frequency of these mutations in the human gene pool. In addition, pre-implantation genetic diagnosis and prenatal genetic testing allow parents to screen out embryos, or terminate pregnancies, based on genetic characteristics they deem undesirable. Reasoning that “human behavior already has a significant impact on the genotypes of members of future generations,” (P. 205) they conclude that germline genetic modification’s impact on future generations is not fundamentally unique.
Second, Mahoney and Siegel challenge the claim that germline modification necessarily raises greater safety concerns compared to other technological developments. Noting that “[a]ll new medical technologies entail risks,” they question whether “the ‘heritable’ component of genomic editing is such a reliable proxy for danger that it makes sense to continue to put a heavy thumb on the scale for developing somatic genome editing applications while stalling heritable ones.” (Pp. 206-207.) As an example, they cite the case of Jesse Gelsinger, who died in a trial of an experiment involving somatic cell gene transfer. Mahoney and Siegel do not deny the possibility that particular applications of germline genetic modification might be excessively dangerous; rather, their point is that “[i]nsisting on a bright line between somatic and heritable genome editing…is not a reliable means of ensuring safety.” (P. 207.)
Third, contrary to critics who fear that allowing germline genetic modifications “will worsen social inequalities and lead to a world of genetic haves and have-nots,” Mahoney and Siegel argue that the possibility of eradicating devastating heritable conditions “will result in greater, not lesser, equality” because more people will be able to enjoy life free of serious disease. (Id.) In addition, they point out that complex traits like intelligence and athletic ability are unlikely to be susceptible to genetic manipulation. Moreover, to the extent they are, a ban on germline genetic modification would not prevent wealthy people from using somatic gene editing to enhance these characteristics in themselves.
Fourth, Mahoney and Siegel reject the claim that allowing germline genetic modification would “usher in a new era of ‘eugenics.’” The evil of eugenics, they argue, was the belief that certain individuals should not reproduce “for the benefit of society.” (Pp. 208-209.) Germline genetic modification is “the opposite” of eugenics, as its goal is “to expand the options available to individuals while leaving sensitive decisions about family life up to them.” (P. 209.)
Finally, Mahoney and Siegel dispute the assumption that a moratorium on germline genetic modification is necessary to preserve public support for science. Pointing to public opinion polls showing substantial support for both somatic and germline gene therapies, they suggest that arguments based on public trust “amount to little more than overwrought speculation.”
Mahoney and Siegel also offer a more practical reason for rejecting a go-slow approach to genetic modification—it simply won’t work. The simplicity and low cost of gene editing techniques have already led some scientists to engage in what Mahoney and Siegel call “genomic moonshining”—i.e., clandestine experimentation by “entities not beholden to the policies and value judgments of the establishment organs that produce ethical and legal guidelines.” (P. 202.) These secretive practices, they argue, pose far greater dangers than publicly funded, transparent, and accountable research. Their analogy to moonshining is apt here: “What makes moonshine hazardous, after all, is not that it is an alcoholic beverage. It is that making alcohol on the sly often entails methods and materials that pose grave risks—both short and long-term—to end users.” (P. 203.)
Personally, I must admit to some lingering hesitation about the prospect of germline genetic modification. While other practices and technologies may also involve unknown risks to future generations, germline genetic modification seems to heighten those risks to an unprecedented degree. Yet Mahoney and Siegel have convinced me that many of the objections to germline modification are not logically defensible, and that in any event the idea of calling a time-out on technological development is probably naïve. Policy-makers concerned about the ethics and regulation of new technologies would be well advised to consider Mahoney and Siegel’s arguments before concluding that a moratorium on germline modification is the best way to ensure that technologies like CRISPR-Cas-9 are used in an ethically responsible way.
William M. Sage, Explaining America’s Spendthrift Health Care System: The Enduring Effects of Public Regulation on Private Competition
, Healthcare Finance
(forthcoming 2019), available at SSRN
Do you ever wonder why our healthcare system costs double that of many other industrialized nations, yet the health of Americans is faltering? Why has our healthcare not progressed in terms of safety, efficiency, affordability, or equity in the last 20 years? In his forthcoming chapter in Healthcare Finance, Bill Sage argues that rather than the failings of partisan politics or corporate greed, our nation’s healthcare system struggles to provide quality care for a reasonable price in large part due to an inefficient legal infrastructure that hinders competition and distorts the collective investment in population health. Specifically, Sage critiques “the accumulation of laws, regulations, self-regulatory practices, and financial subsidies which locks US health care into inefficient, unfair patterns and practices.”
What follows in this impressively short, yet comprehensive, chapter is a description of how shifts in our understanding of the cost drivers in healthcare and the resultant healthcare reform efforts have created an inextricable web of laws and regulations that make healthcare so complicated and expensive. Beginning with the Affordable Care Act (ACA), Sage details the key provisions that sought to address the challenges facing health and healthcare in the US in 2010. He then points out that the ACA’s approach to national reform reflected a major shift in expert understanding of the US healthcare system in the past 20 years, and that the “dramatic implications of this new knowledge are not explicitly acknowledged in public policy debates.” The ACA’s policies transitioned the dominant health reform paradigm from one of a “three-legged stool” of tradeoffs between cost quality and access to the Triple Aim which sought policies that improved population health, improved the patient experience, and reduced costs simultaneously. This new paradigm captured the attention and focus of policymakers, telling them that eliminating “waste, fraud, and abuse” could improve healthcare quality and reduce costs. Under this paradigm, the fix could come from curbing overutilization, promoting efficiency, and expanding preventive care.
The crux of Sage’s argument is that we must go further—to really fix the ills of the US healthcare system, we must also look closely at and challenge the laws and regulations that constrain it. Sage discusses how a litany of laws, regulations and legal standards contribute to the dysfunction of our healthcare system, including scope of practice laws, physician privileges, corporate practice of medicine laws, certificate of need, tax-exempt and non-profit status for hospitals, tax benefits of employer sponsored insurance, physician-hospital employment arrangements, defining the standard of care as “customary practice,” unfettered consolidation, and physician, clinic and hospital licensing requirements. (All the things we health law professors teach about every day.) Sage discusses how many of these laws and other common occurrences in medical practice greatly hinder competition and market efficiency. While it will take great political will and fortitude to overturn these laws and practices, we must give each of them a hard look to see how they contribute to the problem, and whether they are hurting more than helping.
Finally, Sage identifies three key lessons for future policy and practice reform efforts: 1) National health reform models should align around the task of “facilitating decentralized, incremental improvement rather than asserting a national political consensus on setting limits”; 2) DOJ and FTC should pursue long term strategies to reverse the market distortions that currently burden competition; and 3) America needs to stop over-medicalizing social and economic problems like poverty, lack of education, and substandard or lack of housing, and instead invest dollars spent on healthcare to alleviate these conditions more appropriately in non-medical social services.
Perhaps these are the places to start. While there is plenty of blame to go around when we look at the problems facing the US healthcare system, I, for one, agree with Bill Sage that we should start looking at “the deep legal architecture of US health care” to help us find some of our answers.
Ordinarily, jots feature forthcoming or just published works of scholarship that we find useful or notable. These are no longer ordinary times. As events depart increasingly from our usual frames of reference, I find myself seeking scholarship with a longer historical horizon. In doing so, I have encountered two remarkable books: Giorgio Agamben’s Homo Sacer: Sovereign Power and Bare Life and The Use of Bodies. These two represent the first and last installments of Agamben’s nine-volume Homo Sacer series, and speak most directly to our work as students of health law as it intersects with the political darkening we are living through today.
After 9/11, Agamben’s State of Exception (2003, translated 2005) was discussed amid the rise of emergency powers. But his work on “bare life” is rarely mentioned by American legal scholars (with some exceptions) even as bodies and bare lives have become ever more politicized and manifestly tied to the problem of sovereign power in the age of Trump. I believe that our work as health law scholars cannot avoid orienting itself in some way to Agamben.
Homo Sacer itself is an obscure term from Roman law indicating someone who can be killed without punishment, yet, having no more political stature in the community, cannot be sacrificed to the gods. Homo Sacer is humanity doomed to “bare life.” For Agamben, this excluded figure lies at the foundation of Western political sovereignty. Without a sovereign act of line-drawing, to exclude some persons from those otherwise within the polis, no political community exists. This fundamental fracture is, in his analysis, related to characteristic divisions throughout in our intellectual history, starting from Aristotle’s distinction of simple life, or zoe, from bios, the life of men qualified for politics. This separation of bare life, to which women and slaves were relegated, from politically qualified form of life also reflects the ontological divisions between physis and nomos, body and mind, substance and accident from which Western thought has descended. Homo Sacer is also lurking in the Hobbesian sovereign origin myth. In a state of nature, everyone is bare life for everyone else. But the sovereign retains this power over bare life that everyone else has instead renounced. State power, if not based on social contract, is in Agamben’s view founded on the investiture of the sovereign with power to demarcate life that may be harmed without punishment or acknowledgment.
And this is evident in the founding norms of the Western nation-state. Though the modern nations invoked ringing assertions of the “rights of man,” states afford rights only to qualified citizens, not to humans qua humans. Protection and acknowledgement apply only to those within the polis by virtue of birth or other sovereign inclusion. Though we pay lip service to rights that obtain solely based on the human life of the bearer, never do we see this norm fulfilled, as the worldwide migrant crisis illustrates.
That state sovereignty is only imperfectly grounded in liberal humanist ideologies means that sovereignty must ground its power instead by demonstrating the ability to undertake the original act of demarcating vulnerable bare life from “qualified” life. This imperative contributes to the ongoing pattern of crises of legitimacy followed by the urgent marshaling of loyalties around national security, trade wars, and other emergency threats. Agamben says, “State sovereignty can only affirm itself by separating bare life from its form in every sphere.” (Bodies, P. 213.) At the same time, “because power today has no form of legitimation other than emergency, [it] everywhere and continually refers to it, and, at the same time, secretly works to produce it.” (Bodies, P. 209.)
So far so familiar. Trump’s rhetoric is saturated with references to bare life, reducing women to sexualized parts, mocking the disabled, attacking Hillary Clinton’s stamina, lying about his own weight and health. Trump’s claims to power also center pointedly on abandoning bare life. The border crises, with the exclusion of asylum seekers, is only the most obvious example as has been noted in the press. In the immigration context, his use of language like “infestation” similarly depends on the framework of exclusion from the body politic. This Agambian theme of bare life also characterizes his abandonment of Puerto Ricans to devastation and mortality.
Given Trump’s need to demonstrate power over bare life, it is no surprise that control of health system and its institutions are what our political system in crisis has sought to achieve. Thus Trump is abandoning people with preexisting conditions to the depredations of insurance market discrimination. He has effectively relegated the victims of gun violence to the status of homines sacri, unprotected and unacknowledged. Meanwhile, the upcoming Supreme Court nomination fight centers on whether to declare the fetus as politically qualified life. Trump has pushed to inscribe a boundary of exclusion between the working and non-working body, leading to the conditioning of Medicaid on work in ways contrary to the purpose of providing medical assistance, as at least one court has ruled.
Agamben thus helps us understand our times, but does he offer a way out? This question is one I believe we as scholars could take up. Agamben does admonish us “to learn to recognize this structure of the ban [of Homo Sacer] in the political relations and public spaces in which we still live….In our age all citizens can be said…to appear virtually as homines sacri.” (Bodies, P. 211.) Indeed, our political and economic structures immiserate us all, abandoning us to the consequences of “winner-take-all, blame-the-victim” market competition.
By extension, we should, as I have written elsewhere, attend to risks and probabilities of harm that we have been told to simply accept out of acquiescence to the smooth economism of cost-benefit analysis shorn of attention to lives and health. One category of Homo Sacer in our world is thus the “statistical person.” As Heinzerling says, “she is no one’s sister, or daughter, or mother,” and her absorption of social costs is written off in quality-adjusted life years.
We should recognize the separation of bare life from the type of life that qualifies us for political participation, derived from the exhausted paradigm of substance and attribute. This separation lets Facebook and pollsters reduce us to our demographic attributes, and “disqualify” voters from political participation. This same broken subject-attribute schism is evident in the fracture of Medicaid eligibility into a dizzying array of categories while leaving us the paperwork burden of piecing ourselves back together.
Health institutions can be part of the solution or part of the problem. Health care is the rare remaining social institution that in aspiration, if not in practice, meets us where we are, rather than presuming qualifying conditions of autonomy and full information. Who understands better than those of us in the health sector that the mind and the body are not divided when it comes to human flourishing? Agamben warns, “we will have to abandon decidedly, without reservation, the fundamental concepts through which we have so far represented the subjects of the political….and build our political philosophy anew.”
Today our politics is in crisis. Agamben tries to heal that rift, recover a different strand of our intellectual and political inheritance, and central to that is recognition of the figure of the body in use. Can we build a politics upon that, a politics that recognizes humans in their embodied selves? Health law could be ground zero for that task.
As more and more states legalize physician aid in dying, it appears that the acceptability of aid in dying turns on three critical requirements—that the patients be competent to make medical decisions, that they be terminally ill, and that they self-administer the lethal dose of medication. From Oregon to Hawaii, every state that has legalized aid in dying has included these three criteria for eligibility. But a report from Canada on that country’s experience with aid in dying suggests that only two of the three requirements may be needed.
The three basic requirements help ensure that patients really are suffering from a serious illness that is incurable and irreversible. They also help ensure that the desire for aid in dying reflects a genuine expression of self-determination rather than the irrational choice of someone suffering from mental illness. Controversial cases of aid in dying have involved patients who were no longer able to express their wishes or who appeared to need psychiatric care.
Like Oregon and other states, Canada restricts aid in dying to adults who possess decision-making capacity and who are terminally ill, though Canada has a different definition of terminal illness (the patient’s death must be “reasonably foreseeable” rather than expected within six months). But Canada allows physicians and nurse practitioners to administer the lethal dose rather than requiring self-administration. And in the government’s most recent report on the country’s experience with aid in dying, health practitioners administered the medication in virtually all cases. Self-administration occurred in only 5 out of the 1,382 cases that were included in the report. (The Netherlands reports similar data—in 2015, physician-administration outnumbered self-administration by 829 to 22.)
We don’t know exactly why so few cases involve self-administration, but the Canadian report suggests a number of factors—many physicians and nurses “are less comfortable with self-administration due to concerns around the ability of the patient to effectively self-administer the series of medications, and the complications that may ensue.” As a result, aid in dying protocols at some health institutions do not encourage self-administration. And in Quebec, the end-of-life legislation only permits provider-administered assisted dying. Also, in some communities, it can be difficult for patients to obtain the drugs needed for self-administration.
A family report from California elaborates on the concern about the ability of patients to self-administer the series of aid in dying medications. A niece described the challenges associated with emptying the contents of 100 capsules of secobarbital into her aunt’s final cup.
Physician or nurse-administration also addresses another important concern with a requirement of self-administration—some mentally competent, terminally ill patients may not be physically able to self-administer their lethal dose, as in the case of patients who suffer from ALS. If the purpose of aid in dying is to provide relief from the suffering at the end of life, why should access to aid in dying turn on the ability to self-administer?
I’ve observed before that the requirement of a terminal illness provides a critical protection against misuse of aid in dying. When one considers the controversies over particular aid in dying cases in the Netherlands and Belgium, as well as over particular illicit aid in dying cases in the United States, they typically involve patients who were not terminally ill. Illustrative examples include Jack Kevorkian and the woman with chronic pelvic pain or the Belgian woman featured in a New Yorker article who suffered from chronic depression.
The requirement of mental capacity also is an important safeguard. It makes it much less likely that aid in dying will reflect the wishes of family members or physicians rather than of the patients themselves.
Does the requirement of self-administration add another important layer of protection against abuse? For example, by resting full control in the hands of the patients, does self-administration better ensure that the choice of aid in dying is truly the patient’s choice? The patient with some ambivalence may be more likely to hesitate with self-administration than to stop the physician who is assigned to administer. It would be useful to know if there are cases in the United States or other countries where the patient had scheduled a self-administration and then called it off and how often that happens compared to cases in which the patient scheduled a physician or nurse-administration and then called it off.
In the past, proposals for physician-administration have not fared well in the United States. Ballot initiatives that included both self-administration and physician-administration failed in Washington in 1991 and California in 1992 before Oregon’s successful ballot initiative for self-administration in 1994. It will be helpful to see how aid in dying plays out in Canada over the coming years and whether the Canadian experience suggests that states in the United States can feel comfortable with the administration of lethal medication by physicians or nurses.
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.