Information has power – to inspire, to transform, and to harm. Recent technological advancements have enabled the creation of products that offer consumers direct access to a level of personal health information unprecedented in history. But how are we to balance the promise of health and wellness information with its risks?

Two agencies are tasked with protecting consumers from false claims of health products: the FDA and the FTC. This Article investigates if they are up to the task. In part a study of agency policymaking choices, and in part a prescription for more thoughtful and focused regulation, this Article compares both intra-agency and inter-agency regulation of informational health and wellness products. Certain procedural and substantive characteristics of FDA regulation are unsuited to informational health and wellness products, rendering comprehensive regulation by the FDA unrealistic. This gap creates an opportunity for the FTC to use its distinct and well-tailored enforcement tools to police harmful product claims that escape the FDA’s purview. I posit that by tailoring the FDA’s responsibility and sustaining the FTC’s engagement with health claims, the agencies can dovetail into a cohesive and comprehensive regulatory regime.

The Physician Payments Sunshine Act (“Sunshine Act”), enacted to address financial conflicts in health care, is the first comprehensive federal legislation mandating public reporting of payments between drug companies, device manufacturers, and medicine. This article analyzes the Sunshine Act's uneven record, exploring how the law serves as an intriguing example of the uncertain case for transparency regulation in health care. The Sunshine Act's bumpy rollout demonstrates that commanding transparency through legislation can be arduous because of considerable implementation challenges. Capturing all the relevant information about financial relationships and reporting it with sufficient contextual and comparative data has proven disappointingly difficult. In addition, the law suffers from uncertainty and poor design as to the intended audience. Indeed, there is strong reason to believe that it will not significantly impact decision-making of primary recipients like patients.

Yet the Sunshine Act nonetheless retains important and perhaps underappreciated value. From the almost four years of information generated, we have learned that industry-medicine financial ties vary significantly by physician specialty, and somewhat by physician gender. In many medical fields the distribution of top dollar payments tends to be heavily skewed to a few recipients, all of which have important implications for optimal management of financial conflicts and for health policy more generally. Accordingly, the Sunshine Act's greatest potential is not guiding decisions of individual patients or physicians, but its downstream effects. This Article traces how secondary audiences, such as regulators, watchdogs, and counsel are already starting to make productive use of Sunshine Act information. Public reporting has, for example, made more feasible linking industry payment information with Medicare reimbursement data. As a result, policymakers can more closely examine correlations between industry spending directed at individual physicians and their prescribing and referral decisions. Moreover, savvy counsel are recognizing that Sunshine Act information provides explosive evidence in private civil litigation and this Article explores the first wave of cases.

The United States' health care system is mired in uncertainty. Public opinion on the Patient Protection and Affordable Care Act (“ACA”) is undeniably mixed and politicized. The individual mandate, tax subsidies, and Medicaid expansion dominate the discussion. This Article argues that the ACA and reform discourse have given short shrift to a more static problem: the law of emergency care. The Emergency Medical Treatment and Active Labor Act of 1986 (“EMTALA”) requires most hospitals to screen patients for emergency medical conditions and provide stabilizing treatment regardless of patients' insurance status or ability to pay. Remarkably, this law strengthened the health safety net in a country that has no universal health care. But it is an unfunded mandate that responded to the problem of emergency care in a flawed fashion and contributed to the supposed “free rider” problem that the ACA attempted to cure.

But the ACA has also not been effective at addressing the issue of emergency care. The ACA's architects reduced funding for hospitals that serve a disproportionate percentage of the medically indigent but did not anticipate the Supreme Court's ruling in NFIB v. Sebelius, which made Medicaid expansion optional. Public and non-profit hospitals now face a scenario of less funding and potentially higher emergency room utilization due to continued uninsurance or underinsurance. Alternatives to the ACA have been insufficiently attentive to the importance of emergency care in our health system. This Article contends that any proposal that does not seriously consider EMTALA is incomplete and bound to produce some of the same problems that have dogged the American health care system for the past few decades. Moreover, the Article shows how notions of race, citizenship, and deservingness have filtered into this health care trajectory, and in the context of reform, have the potential to exacerbate existing health inequality. The paper concludes with normative suggestions on how to the mitigate EMTALA's problems in ways that might improve population health.

Pregnant women with a prior cesarean delivery face challenges in accessing a vaginal birth due to both hospital and provider preferences and practices. Although the doctrine of informed consent secures women's reproductive rights, it is not a viable legal remedy. Instead, women should champion increased maternity-related education and transparency as well as medical malpractice reform to increase the desired access.

Statistical adjustment is a ubiquitous practice in all quantitative fields that is meant to correct for improprieties or limitations in observed data, to remove the influence of nuisance variables or to turn observed correlations into causal inferences. These adjustments proceed by reporting not what was observed in the real world, but instead modeling what would have been observed in an imaginary world in which specific nuisances and improprieties are absent. These techniques are powerful and useful inferential tools, but their application can be hazardous or deleterious if consumers of the adjusted results mistake the imaginary world of models for the real world of data. Adjustments require decisions about which factors are of primary interest and which are imagined away, and yet many adjusted results are presented without any explanation or justification for these decisions. Adjustments can be harmful if poorly motivated, and are frequently misinterpreted in the media’s reporting of scientific studies. Adjustment procedures have become so routinized that many scientists and readers lose the habit of relating the reported findings back to the real world in which we live.

Despite the U.S. substantially outspending peer high income nations with almost 18% of GDP dedicated to health care, on any number of statistical measurements from life expectancy to birth rates to chronic disease,1 the U.S. achieves inferior health outcomes. In short, Americans receive a very disappointing return on investment on their health care dollars, causing economic and social strain.2 Accordingly, the debates rage on: what is the top driver of health care spending? Among the culprits: poor communication and coordination among disparate providers, paperwork required by payors and regulations, well-intentioned physicians overprescribing treatments, drugs and devices, outright fraud and abuse, and medical malpractice litigation.

Fundamentally, what is the best way to reduce U.S. health care spending, while improving the patient experience of care in terms of quality and satisfaction, and driving better patient health outcomes? Mergers, partnerships, and consolidation in the health care industry, new care delivery models like Accountable Care Organizations and integrated care systems, bundled payments, information technology, innovation through new drugs and new medical devices, or some combination of the foregoing? More importantly, recent ambitious reform efforts fall short of a cohesive approach, leaving fundamental internal inconsistencies across divergent arms of the federal government, raising the issue of whether the U.S. health care system can drive sufficient efficiencies within the current health care and antitrust regulatory environments.

While debate rages on Capitol Hill over “repeal and replace,” only limited attention has been directed toward reforming the current “fee-for-service” model pursuant to which providers are paid for volume of care rather than quality or outcomes. Indeed, both the Patient Protection and Affordable Care Act (“ACA”)3 and proposals for its replacement focus primarily on the reach and cost of providing coverage for health care, rather than specifics for the delivery of health care.4 With the U.S. expenditures on health care producing inferior results, experts see consolidation and alternatives to fee-for-service as fundamental to reducing costs.5 Integrating care coordination and delivery and increasing scale to drive efficiencies allows organizations to benefit from shared savings and relationships with payors and vendors.6 Deloitte forecasts that, by 2024, the current health system landscape—which includes roughly 80 national health systems, 275 regional systems, 130 academic medical centers, and 1,300 small community systems—will morph into just over 900 multi-hospital systems.7

Even though health care market and payment reforms encourage organizations to consolidate and integrate, innovators must proceed with extreme caution. Health care organizations attempting to drive efficiencies and bring down costs through mergers may run afoul of numerous federal and state laws and regulations.8 Calls for updates or leniency in these laws are growing, including the possible recognition of an “Obamacare defense” to antitrust restrictions9 and speculation that laws restricting physicians from having financial relationships will be repealed, ostensibly to allow sharing of the rewards reaped from coordinated care.10 In the meantime, however, absent specific waivers or exemptions, all the usual rules and regulations apply, including antitrust constraints,11 physician self-referral12 and anti-kickback laws and regulations,13 state fraud and abuse restrictions,14 and more. In short, a maelstrom of conflicting political prescriptions, health care regulations, and antitrust restrictions undermine the ability of innovators to achieve efficiencies through joint ventures, transactions, innovative models, and other structures.

This article first considers the conflicting positions taken by the United States government with respect to achieving efficiencies in health care under the ACA and alternative delivery models, on the one hand, and health care regulatory enforcement and antitrust enforcement, on the other. At almost a fifth of the U.S. economy,15 health care arguably has grown ungovernable, exceeding the ability of any one law or branch of government to create or implement coherent reform. Indeed, the article posits that although the ACA reformed and expanded access to health care, it failed to transform the way health care is delivered beyond limited “demonstration projects”, leaving fee-for-service intact. Nonetheless, even with limited rather than revolutionary goals, the ACA still lacks sufficient authority across disparate branches of government to achieve its stated goals. The article then examines the conflicting positions of the various United States regulatory schemes and enforcement agencies governing health care, and whether they can be reconciled with the stated goal of the government, often referred to as the “Triple Aim”:16 improving quality of care, improving population health, and lowering health care costs. It examines fundamental, systemic challenges to achieving the “Triple Aim”: longstanding health care regulatory laws that impede adoption of innovative delivery systems beyond their current “demonstration project” status, and antitrust enforcement that promotes waste and duplication in densely populated areas, while preventing necessary consolidation to more efficiently reach rural areas. The article concludes with recommendations for promoting efficiency through modest reconciliation of the conflicting goals and regulations in health care.

“The price of culture is a Lie.”

This Article advances a critical race approach to the health sciences by examining “culture talk” as a discursive repertoire that attributes distinct beliefs, behaviors, and dispositions to ethno-racialized groups. Culture talk entails a twofold process of obfuscation – concealing the social reality of the people it describes and hiding the positionality of those who employ cultural generalizations. After tracing how culture talk circulates and reproduces racist narratives in and beyond the health sciences, I examine how cultural competency training in medical schools and diversity initiatives in stem cell research use the idiom of culture to manage and manufacture group differences. From culturing cells in the lab to enculturing people in the clinic, I apply the concept of coproduction to argue that culture talk is a precondition and product of scientific knowledge construction.

The current political economic crisis in the United States places in sharp relief the tensions and contradictions of racial capitalism as it manifests materially in health care and in knowledge-producing practices. Despite nearly two decades of investment in research on racial inequality in disease, inequality persists. While the reasons for persistence of inequality are manifold, little attention has been directed to the role of medical education. Importantly, medical education has failed to foster critical theorizing on race and racism to illuminate the often-invisible ways in which race and racism shape biomedical knowledge and clinical practice. Medical students across the nation are advocating for more critical anti-racist education that centers the perspectives and knowledge of marginalized communities. This Article examines the contemporary resurgence in explicit forms of white supremacy in light of growing student activism and research that privileges notions of innate differences between races. It calls for a theoretical framework that draws on Critical Race Theory and the Black Radical Tradition to interrogate epistemological practices and advocacy initiatives in medical education.