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date: 24 September 2018

(p. xxiii) Introduction

(p. xxiii) Introduction

Perceptions of Health Law as a Field

A decade ago, law professor and legal scholars debated whether health law was a legitimate, coherent field of study.1 Today, health law is indisputably a prominent, well-accepted field that protects a central aspect of our lives, our health, and sets the ground rules for one-sixth of the U.S. economy.

Health law has become the locus for asking and answering some of the most important legal and social policy questions of our time. For better, and in the mind of some health law scholars certainly for worse, it is a frequent topic of discussion for the Supreme Court. In the year this volume will go to print, the Supreme Court will have considered several health law disputes. The topics of these cases range from state licensure requirements for abortion providers, to the preemptive scope of the Employee Retirement and Income Security Act of 1974 over state healthcare regulations, to religious freedom and insurance benefits. These issues are as technically challenging as they are normatively charged. The voices of health law scholars have been instrumental in helping to guide the Court’s deliberations and decisions in these cases and others. The Court’s holdings in these cases will have a tremendous impact on access to abortion and contraception services and the feasibility of state efforts to drive down the cost and improve the quality of healthcare. And as health policy becomes an increasingly charged space for partisan conflict, we have every reason to believe the Supreme Court’s steady diet of health law cases will continue.

The prominence of health law is also evident from its coverage in law schools across the country. Dozens of top law schools have created centers and programs devoted to health law and policy. Hundreds of law scholars and equal numbers in other disciplines—with dozens of new scholars joining the endeavor annually—focus their research on the many aspects of health regulation and policy. Law school graduates step into roles as regulatory and compliance experts, as healthcare litigators, as business and corporate attorneys, and as advocates (p. xxiv) for individuals and for the public’s health, as employment opportunities in the field of health law proliferate.

The influence and importance of this field of law—intellectually and practically—is incontestable. But it is also a field that is rapidly changing. We compiled this volume precisely because the field is at an inflection point in the United States, as we describe below.

Changing Nature of the Field of Health Law

The fifty chapters in this volume confirm that, as the influence of heath law is growing, so is its breadth and sophistication as a field of legal study and scholarship. Health law has transformed from a niche field of law to an all-encompassing one, in which mastery requires proficiency equally with legal, ethical, and empirical analysis. The scholarship in the field is exploding in quantity and is deepening in quality.

Part of this deepening arises from the fact that health law bears greatly on the development of other fields of law, including administrative law, legislation, antitrust, insurance law, and many others. Experts in health law are equally experts in these other fields and have insight into how ideas developed in other contexts are or are not relevant when applied in the context of health. Teaching health law demands an ability to engage in everything from constitutional law and administrative law to family law to corporate law and antitrust.

Furthermore, health law scholarship is increasingly enriched by theoretical and empirical inquiry. Even the questions that have long been topics of health law, since the days when the field was called “Law and Medicine,” such as medical malpractice or informed consent, are now being examined using novel methods and are also benefitting from comparative approaches.

Goal of this Volume

With the 2010 passage of the Patient Protection and Affordable Care Act, the healthcare financing and delivery systems are undergoing substantial change. Not surprisingly, so is the regulation of these systems. While the full ramifications of these changes are yet to be felt, we know enough now to begin chronicling and analyzing the post-ACA picture of health law and also to foreshadow the likely evolution of the field in the decades to come. We think that this critical moment in health law’s evolution offers an ideal time to capture the broad contours of the field.

We envision that this volume will give readers a sense of both the breadth and the depth of health law, through the words and insights of some of the best scholars in the field. As the case is with the field itself, many contributions come from law professors, but several come from scholars who are trained in and teach in other disciplines, including political science, economics, and public health. We also include the wisdom of leading practitioners of health (p. xxv) law, many of whom wrestle with these issues on a daily basis to help clients comply, shape, and, where necessary, challenge the law. Our hope is that the chapters that follow are equally valuable to readers with no background in the field as to those who write, teach, practice, or make policy in health law.

This volume is divided into several parts. Some of these are conventional (for example, devoting a section to public health law), while others reflect our own way of conceptualizing the field, that groups content more thematically than doctrinally.

The first part of the Handbook, “An Overview of the Legal Governance of Healthcare,” explains in broad thematic strokes the major features of American healthcare, its recent and past reforms, its relationship to medical ethics and constitutional doctrines related to federalism, and how it compares to the experience of other countries. This part of the book will orient newcomers to American health law and delight experts with the ways in which the authors understand the terrain.

The first chapter in this part, Relating Health Law to Health Policy: A Frictional Account, by William M. Sage, examines the ways in which American health law does and does not further current goals of American health policy. Sage focuses on legal obstacles to meeting renewed expectations of policy to improve both collective fairness and efficiency, such as health law’s continued focus on professional self-governance and the physician-patient dyad, and the extent to which health law remains decentralized and adjudicatory rather than being grounded in statute and the administrative state.

I. Glenn Cohen’s chapter, The Relationship between Bioethics and U.S. Health Law: Past, Present, and Future, explores bioethics as part of U.S. health law and identifies trends in the way the two fields interact. It begins with an overview of the way in which bioethics content has been integrated in health law textbooks over time and then shifts to examine the question of translation. Drawing on recent cases, Cohen describes the mismatch between rich ethical and formalist legal discourse. He also plots a few trends as to where the translation should be going: increased interest in population-level bioethics and the law, including the increased recognition of intellectual property and drug development as topics for both disciplines, and the rise of libertarian bioethics in litigation.

Allison K. Hoffman discusses health reform, with a focus on the Patient Protection and Affordable Care Act, in a chapter called What Health Reform Reveals about Health Law. It describes the arc of health reform in the United States over the twentieth century and explores the ACA as a window into the idiosyncrasies of U.S. health law and the values that have shaped health law as a field. In particular, this chapter considers themes such as the influence of market-based ideology, federalism, and professionalism on health law. It illustrates how the ACA policies that most strongly push against these values have resulted in conflict and litigation but may also produce a gradual transformation of legal norms.

In A View from a Friend and Neighbor: A Canadian Perspective on U.S. Healthcare and the Affordable Care Act, Colleen Flood and Bryan Thomas compare the path taken in Canada toward universal healthcare and the path taken in the United States with Medicare, Medicaid, and now the ACA. In addition to evaluating the performance of each system, they offer a detailed analysis of the legal and regulatory apparatus governing health systems in both countries, contrasting the five principles of the Canada Health Act with their functional counterparts in the ACA.

Abigail R. Moncrieff and Joseph Lawless’s chapter, Healthcare Federalism, charts the course of the rise and fall of federalism in U.S. healthcare. From the “Articles of Confederation and (p. xxvi) Perpetual Union” to the New Federalism to the Reagan era, the chapter begins with a historical overview of changing legal approaches to federalism in the United States. It then juxtaposes those developments with major health policy initiatives that intersect with federalism: the creation of public health departments and insurance commissions in the mid-1800s, the rise of employer-sponsored insurance during World War II, the introduction of Medicaid and Medicare in the 1960s, and the ACA in the present era. Throughout, the chapter shows how “the federalist structure of the U.S. government has been largely responsible for the piecemeal evolution and perpetual messiness of American healthcare regulation.”

The second part of the Handbook, “Caring and Receiving Care,” explores the legal framework for the patient experience of care from access through treatment to recourse if treatment fails. The chapters in this section focus on individuals with medical needs, whether general or specific, on physicians and other healthcare professionals, on hospitals and health facilities, and on the insurance coverage that makes healthcare possible. Chapters include both core legal material and related ethical considerations. Reflecting the rapid transition in U.S. healthcare to electronic information exchange with its attendant benefits and risks, four chapters are devoted to legal issues involving healthcare information.

The part begins with a section on access to care and financing of care, including hospitals, health professionals, and insurance benefits. The section also addresses discrimination, particularly long-standing racial discrimination, in accessing medical services.

Eleanor D. Kinney’s chapter, Accessing Hospitals and Health Professionals, opens the discussion. Kinney contrasts the U.S. approach to healthcare access based on private charity and limited legal mandate with the human rights approach taken in much of the world, which confers an affirmative constitutional obligation on government. The chapter goes on to categorize and explain the common law and statutory duties of physicians and hospitals to serve patients not of their choosing, including obligations under the Emergency Medical Treatment and Active Labor Act (EMTALA), federal antidiscrimination laws, and public health insurance programs.

In Access to Health Insurance and Health Benefits, Timothy Stoltzfus Jost examines five common forms of payment for healthcare in the United States: out-of-pocket payment, charity, direct public provision, public health insurance, and private health insurance (including employer-sponsored insurance). Jost considers the advantages and disadvantages of each, their current status, and the effect on each of the ACA. The chapter also attempts to explain why the United States retains this patchwork of coverage rather than adopting a single coherent system of healthcare financing.

Dayna Bowen Matthew’s chapter, Legal Battles against Discrimination in Healthcare, discusses racial and ethnic discrimination in U.S. healthcare, beginning with the adverse health effects of American slavery and the Jim Crow eras. Its central focus, however, is persistent racism in healthcare today, examining the legacy for individual and community health of long-standing discrimination in medicine as well as discussing federal laws currently used to redress and prevent discrimination as interpreted by the Supreme Court. The chapter concludes by outlining concrete steps toward achieving nondiscriminatory healthcare delivery, mainly through civil rights legislation.

Many of the most contentious, unsettled, and important issues in contemporary health law involve information. Asymmetric access to information between expert professionals and uneducated, vulnerable patients—as well as the uncertainty associated with illness and attempted treatment—are fundamental attributes of medical care that undergird both (p. xxvii) law and ethics in their traditional forms. The second part of this section explores how these assumptions are finally changing as curable informational deficits in healthcare become apparent and new communication and computational technologies are developed. These improvements, however, come at a price that includes risks to data ownership and control, privacy, and reputation.

Frank Pasquale provides a sophisticated overview called Health Information Law that examines the complexities of subjecting even basic questions in health data ownership and exchange to the sometimes inconsistent requirements of federal and state statutes, regulatory regimes, constitutional decisions, and international treaties. The chapter explains that information shared between physician and patient, a critical focus of policy concern in the 1960s and 1970s, is now only a small part of information flow in the healthcare system. Although a burgeoning field of information economics has helped resolve the problem of information as simultaneously an input and an output of market activity, there remains a strong tension in health information governance between public commitments to open data and corporate interests in limiting sharing to serve proprietary interests.

Robin Fretwell Wilson’s chapter, The Promise of Informed Consent, looks at the relationship between ethical goals of individual autonomy with respect to medical care and the legal embodiment of that autonomy through informed consent law. The chapter traces the historical evolution of physicians’ obligation to secure a patient’s informed consent before focusing on two seminal legal decisions: Culbertson v. Mernitz and Canterbury v. Spence. These cases present competing standards for determining the scope of disclosure: the professional or “reasonable physician” standard and the patient-centered or “reasonable patient” standard. The chapter also explores the application of duties to secure informed consent to medical research, and describes the efforts of state legislatures to standardize disclosure to patients so as to reduce the burden on and legal risk to physicians without compromising the right of patients to receive needed information.

Communicating Loyalty: Advocacy and Disclosure of Conflicts in Treatment and Research Relationships is Robert Gatter’s contribution. The proliferation of agency relationships in healthcare has called many agents’ loyalty into question, especially as payment methods change and new profit opportunities arise. Information disclosure has become the mainstay of managing these “conflicts of interest” in both treatment and research relationships. For example, the federal Sunshine Act requires pharmaceutical companies to make public their payments to physicians. Gatter’s chapter explores the law and ethics of information designed to protect healthcare consumers and patients from disloyalty.

Medical Privacy and Security, contributed by Sharona Hoffman, addresses privacy and security issues arising from the transition from paper charts to electronic health records (EHRs), as well as “big data” uses of computerized health information. The chapter reviews federal and state privacy laws and their limitations, particularly the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. It also considers more general questions about the importance of health privacy in American society.

The next section of this part focuses on the ethics and law of treatments. Chapters in the section relate to specific types of patients or forms of medical care. Experimental treatments for serious conditions, reproductive healthcare, and end-of-life care each merit separate coverage in this part, as do the law and public policy of disability and of healthcare providers with conscientious objections to delivering particular services.

(p. xxviii) In B. Jessie Hill’s chapter, New, Experimental, and Life-Saving Therapies, readers explore issues of equity, distributive justice, and patient autonomy connected with government regulation of access to innovative, potentially life-saving medical care. The chapter begins with the politicized, vague terms that are often used to restrict access to life-saving treatments, such as “experimental,” “investigational,” and “not medically necessary.” It then explores the three frames that legal discourse uses to address problems that arise: constitutional law, public health law, and ethics and human rights. Of these, the chapter suggests that the ethics and human rights framework is the most promising approach in substance but is not politically feasible, at least at present.

Mental Health and Other Behavioral Health Services, by John V. Jacobi, examines the clinical and legal history of exclusion for people with mental illness. Over time, mental illness gained conceptual separation from criminality and deviance, and modern psychiatry is premised on a model of mental illness as susceptible of diagnosis and treatment in the same sense as somatic conditions. However, deep suspicions of the mentally ill linger even among behavioral health professionals. The chapter first addresses healthcare delivery challenges. It then turns to the differential treatment of behavioral healthcare by health insurers, differences that are the subject of antidiscrimination and parity efforts in state and federal law. The chapter ends with the difficult issue of personal decision-making autonomy. Throughout, the focus is on understanding where relevant differences should alter the law of healthcare for people with behavioral health needs, and where equal treatment should be the order of the day.

Judith Daar, in Assisted Reproductive Technologies and Abortion, examines both early and contemporary debates surrounding assisted reproductive technologies (ARTs) and abortion services. After providing historical background on both techniques, describing their integration into modern reproductive life, and comparing the populations who currently access them, the chapter explores the legal and regulatory history of the two procedures and raises the question of whether the law governing the right to avoid procreation also can be applied to the right to access parenthood. The chapter concludes by assessing three areas of overlap between ARTs and abortion: selective reduction of multiple pregnancy, the personhood movement, and perinatal genetic diagnosis.

Elizabeth Sepper’s related chapter, Conscientious Refusals of Care, examines conflicts of conscience that arise among patients, healthcare providers, and institutions, especially with regard to reproductive health and end-of-life care. Sepper focuses on “conscientious refusal”—a provider’s exercise of conscience in refusing to perform or participate in a procedure that is deemed ethically and legally permissible. The chapter begins with the history and development of legislative and court protections for conscientious refusals of care, turns to theoretical justifications for protecting conscience in medicine, discusses recent proposals to strike a balance between patient access and provider conscience (including institutional providers), and concludes with an assessment of future directions for research.

The chapter Disability and Health Law, by Leslie Francis, Anita Silvers, and Michael Ashley Stein, examines the disparate histories of health and disability law in the United States and the more recent need to reconcile and integrate them. An appreciation of two different models of disability is central to understanding both the complementary and the conflicting aspects of health and disability law. The “medical model” conceives of disabilities as mental or physical impairments that it is the task of healthcare to address, supplemented by legally mandated support for people with disabilities in conducting activities of daily life. (p. xxix) This welfarist, paternalistic account of disability law contrasts with the “social model” of disability that views disability law as a form of civil rights law according people with disabilities meaningful access to social life on the terms others enjoy rather than special privileges based on need. Disability law therefore has two major strains; one involving provision of benefits such as health insurance and social security, and the other conferring civil rights protections.

Rebecca Dresser writes about Autonomy and Its Limits in End-of-Life Law. Her chapter explores the relationship between respect for individual autonomy and the law governing end-of-life treatment decisions involving competent adults, incompetent adults, and children. After touching on legal and ethical difficulties in determining death, Dresser discusses the limitations of an autonomy-based approach in three areas: “futile” treatments, treatment decisions for incompetent patients, and access to physician-assisted death. It concludes that courts and other legal decision-makers will face continuing pressure to incorporate quality of life, cost, medical judgment, and patient vulnerability in end-of-life law.

The final part of this section explains the legal recourse patient may have when medical care that they receive proves unsatisfactory or harmful. Separate chapters are dedicated to private litigation alleging medical negligence (i.e., malpractice), product liability suits for dangerous or defective drugs and medical devices, and complaints filed with state licensing boards and other professional and regulatory entities.

Medical Malpractice Liability: Of Modest Expansions and Tightening Standards by Barry R. Furrow examines the recent evolution of medical malpractice litigation procedures, tort doctrines, and judicial responses to medical injuries. Furrow begins with physician liability, emphasizing new evidentiary practices for proving the standard of care such as increased reliance on practice guidelines, including under the ACA. The chapter also discusses informed consent in promoting patient sovereignty; alternative dispute resolution processes; and liability issues involving hospitals, non-hospital systems, and health professionals other than physicians.

Peter Grossi and Keri Arnold contribute a chapter on Drug Product Liability at the Crossroads, which first considers liability for adverse effects of prescription drugs under the established model of regulatory deference before turning to the current debate over liability for the risks of properly prepared drugs and the growing distrust of the FDA’s approval and surveillance process. The chapter also reviews court decisions about FDA-approved drug labels preempting state tort claims for failure to warn and more direct “design-defect” claims, and concludes with a discussion of recent tort challenges to the learned intermediary doctrine.

Nadia N. Sawicki’s chapter, Complaints to Professional and Regulatory Bodies, focuses on patients’ ability to express concerns about the quality of care provided by medical practitioners and healthcare institutions. It first considers the procedures employed by state professional licensing boards for patient complaints, as well as the criticisms faced by such boards with respect to both investigation and disciplinary action. The chapter discusses federal regulation of providers and institutions that participate in Medicare and Medicaid, private organizations that receive complaints such as the Joint Commission, and medical professional associations as oversight bodies. Finally, the chapter looks at online consumer reviews and healthcare ratings websites as alternative mechanisms for patient feedback, including complaints.

The third part of this Handbook, “Organizing and Financing the Healthcare System,” captures the changing nature of healthcare regulation as the healthcare system becomes (p. xxx) increasingly complex. It begins with an examination of the providers in the healthcare system—professionals and facilities—and how they are licensed, organized, and monitored. This part of the book also considers research and innovation and the challenges of defining and encouraging high-value healthcare and avoiding wasteful spending. The part also illuminates the multifaceted system for financing healthcare, including how public and private health insurance overlap and blur following the ACA. Finally, it identifies increasing attention to public (population) health as an integral part of the healthcare system and healthcare law, rather than as an afterthought.

The first section of this part focuses on health professionals and healthcare facilities.

In Structure of Governmental Oversight of Quality in Healthcare, Sandra H. Johnson considers how states have used gatekeeper laws—licensure, registration, and certification—to attempt to set quality standards. Although licensure is often thought of as a state-level responsibility, Johnson shows how federalism concerns arise in areas with concurrent federal regulatory authority. She also looks at how private controls, such as accreditation of hospitals or staff privileges for physicians in hospitals, complement government regulation. Next, she describes the standards used to measure quality of care, as well as informed consent-based alternatives. Finally, the chapter examines how unlicensed practice of medicine and scope of practice laws draw social and economic boundaries, considering specific examples such as the regulation of assistance at childbirth.

John D. Blum, Shawn R. Mathis, and Paul J. Voss examine The Hospital-Physician Relationship and how it has evolved in the context of the Affordable Care Act. This chapter considers the many forces that have shaped this relationship over time, from the rise of health insurance to the changing workforce to the structure of healthcare reimbursement and the introduction of Medicare’s prospective payment system and, recently, bundled payments. It traces the healthcare system’s evolution from regarding physicians and hospitals as distinct entities, bound together only loosely by mutual interests, to seeing them as inextricably intertwined through organizational structures, contractual and employment relationships, and, increasingly, a shared focus on population health.

Jill R. Horwitz’s chapter, Nonprofit Healthcare Organizations and the Law, considers and illustrates the exceptional legal treatment of nonprofit healthcare organizations—when compared both with nonprofits outside of the healthcare industry and with functionally similar for-profits in the healthcare industry. She examines reasons for this special treatment, including a misunderstanding of what is demanded from nonprofits and a false expectation that they must relieve poverty to warrant nonprofit status. Interestingly, such expectations sometimes lead to standards favoring these organizations and other times to more demanding expectations under the law.

David A. Hyman and Charles Silver consider medical malpractice reform in It Was on Fire When I Lay Down on It: Why Medical Malpractice Reform Can’t Fix Healthcare. This chapter reviews an abundance of empirical evidence to make the point that conventional tort reforms (those aimed at reducing litigation involving physicians and hospitals) offer little promise to improve healthcare quality or reduce costs. Instead, the authors advise looking to reform of the healthcare financing and delivery systems to make the market work better, with medical malpractice reform a concordant but not dominant element.

The second section of this part examines competition and innovation.

In The Biomedical Research Enterprise, Mark Barnes and David Peloquin examine the wide variety of state and federal regulations governing biomedical research and offer a succinct (p. xxxi) overview of an especially complex area of healthcare regulation. They survey conflicting regulatory regimes focused on human subjects protections, privacy laws, financial disclosure requirements, and research misconduct, and then offer ways to improve each of these regimes. The chapter ends with considerations that arise specifically when research is federally funded.

William M. Sage, in Antitrust Enforcement and the Future of Healthcare Competition, analyzes the interaction of competition policy with the highly regulated U.S. healthcare system. The chapter reviews the essentials of American antitrust law, and applies it to current controversies involving hospital and health insurance mergers, potentially anticompetitive contracting practices, and specific interactions between competition and other laws governing accountable care organizations, medical licensing, and generic drugs. It also discusses deeper issues involving market failure, regulation, and dislodging the status quo without replacing an overly fragmented system with an excessively consolidated one.

Lewis A. Grossman’s chapter, Drugs, Biologics, and Devices: FDA Regulation, Intellectual Property, and Medical Products in the American Healthcare System, examines the U.S. Food and Drug Administration’s approval process for pharmaceuticals and medical devices. It first sets out the basic framework of FDA approval for drugs, biologics, and medical devices. Then, it considers financial interests created by intellectual property and exclusivity rules, including the Hatch-Waxman Act and the Biosimilars Price Competition and Innovation Act. Finally, it looks at the forces that are reshaping regulation in this area, such as the rise of precision medicine and the FDA’s increasing role in regulating the actual practice of medicine.

In Health Law’s Uneasy Relationship with Delivery System Innovation, Richard S. Saver examines how health law constrains and advances welfare-enhancing delivery system reforms. Saver first defines delivery system innovation and then describes several recent efforts at reform, ranging from more modest efforts, such as comparative effectiveness research, to more fundamental or “disruptive” ones, such as accountable care organizations. The chapter describes how the law both promotes and simultaneously restricts these efforts and considers reasons for the law’s duality with respect to such innovation.

Kristin Madison explores Legal and Policy Issues in Measuring and Improving Quality. The chapter describes tools that policy-makers have relied on to measure and report the quality of healthcare as doing so has become a more prominent regulatory concern. In particular, laws to promote the development of electronic medical records has been foundational to capturing data in ways that can support data aggregation. The chapter reviews ways to refine the accuracy of measurement approaches and explains how patients and providers can remedy faulty quality information. Finally, the chapter suggests an agenda for the next era of policy-making and research on quality reporting.

The third section of this part discusses health insurance and finance.

Mark A. Hall writes the first chapter, Employment-Based Health Coverage, which provides an overview of employers’ dominant position in the private health insurance market in the United States, and considers resulting legal and policy complexities. He first describes the legal and economic factors that spurred and sustained the dominance of employer-based coverage, including tax law and preemption of state laws for many employer-based plans. The chapter then examines how the ACA is likely to shape the future of employer-based coverage, through a mandate that requires most large employers to offer affordable coverage or pay tax penalties and by galvanizing the use of private insurance exchanges to allow (p. xxxii) employees to shop for benefits. Finally, Hall considers the complexities that result from the differential regulation of individual health insurance and employment-based coverage, following the ACA, and previews possible areas of conflict that may arise in the coming years.

In Risk and Regulation in Private Insurance, Robert H. Jerry II examines the regulation of risk in private health insurance and how health insurance is both similar to and different from other forms of insurance. The chapter begins with a discussion of how and why insurance is used as a risk-management technique for uncertain and adverse future events and contextualizes insurance within a larger picture of risk management strategies. It continues with a description of market categories for insurance and legal definitions of what constitutes insurance in order to frame consideration of how health insurance differs from other forms of insurance—both in terms of how it operates and how it is and should be regulated.

Theodore R. Marmor and Jonathan Oberlander’s chapter, Medicare at Fifty, illuminates how Medicare has become the program it is today and what its future might hold. After describing the historical origins of the program, the chapter traces how it has changed over the past fifty years, influenced by both politics and economics. The authors detail successes and challenges in the initial implementation of the program; the evolution of cost containment policies and benefit changes in the 1970s and 1980s; the increasing influence of pro-market approaches, including on outpatient prescription drug coverage under the Medicare Modernization Act; and how Medicare figured into the Affordable Care Act’s universal health insurance agenda. The authors conclude with lessons from the past half-century and reflections on how Medicare might evolve and how it should evolve in the coming decades.

Medicaid at Fifty, by Sara Rosenbaum, reflects on Medicaid as a companion program to Medicare and private insurance—one that provides a safety net and covers people and care that is excluded by these programs, such as long-term services and supports. This chapter begins with a discussion of Medicaid’s aims, parameters, and impact, including reflections on Medicaid’s many purposes. It explains the critical role Medicaid plays in expanding access under the ACA and current challenges the program faces, including operational hurdles and ambiguities about who has access to courts to enforce Medicaid’s rules. The chapter concludes with a reflection on Medicaid’s future.

Amy B. Monahan’s chapter, The Interactions between Public and Private Health Insurance, discusses how private and public health insurance are converging in the United States, as each system incorporates features of the other. The chapter starts with an overview of public and private sources of health insurance and the interactions between the two before the Affordable Act, including ways that private insurance draws on Medicare’s administrative and payment systems and cost-shifting from one payer to the other. It examines how the ACA embraces a public model for health insurance, but still relies in part on private insurance to achieve this goal. The chapter closes with two case examples of innovation at the public/private boundary in Arkansas and Vermont.

The next section of this part examines healthcare costs.

Francis J. Crosson and Laura A. Tollen examine innovative approaches to cost control and managing care, drawing on case studies from Kaiser Permanente, in Managing the Care and Costs of a Defined Insured Population. This chapter surveys different tools for cost control, including the use of benefit design and increased cost-sharing and the creation of relationships with providers that promote lower reimbursement levels. The authors describe Kaiser Permanente and illustrate through two case examples how the company has successfully (p. xxxiii) managed care and spending: hypertension detection and management, and pharmaceutical cost management. Finally, the chapter considers what it would take to replicate Kaiser Permanente’s successes more broadly in the U.S. healthcare system.

In Paying for Healthcare, David M. Frankford expounds on the sociopolitical aspects of and mechanisms of payment for healthcare in the United States. He begins with a historical account of how payment structures developed and resulted in a hybrid system with few cost controls. With a focus on Medicare, he describes the creation of and shortcomings of one attempt at cost control: prospective payment for inpatient care and resource-based payment for physician services. Finally, he pulls the lens back out to see why this example is illustrative of the larger ways in which social and political influences have thwarted and misdirected efforts at payment reforms.

In Integration, Fragmentation, and Human Nature: The Role of Fraud and Abuse Laws in a Changing Healthcare System, Joan H. Krause explains how changes in models of healthcare delivery are posing new challenges for rooting out healthcare fraud. She offers an overview of healthcare fraud, including the strategy behind and results of federal fraud and abuse detection efforts over the past decade, and outlines the key healthcare fraud laws, such as the Anti-Kickback Statute, the Stark Law, and the Civil False Claims Act. Finally, the chapter describes increased integration in healthcare delivery and explains how integration creates new opportunities for providers to exploit the system and demands smarter and more systemic ways to counteract fraud.

Invisible Forces at Work: Health Legislation and Budget Processes, by Timothy Westmoreland, reveals one of the deepest secrets of federal health policy, which is its frequent dependence on fiscal politics and the peculiarities of budgetary accounting as practiced by the Congressional Budget Office. The chapter begins by describing the basics of federal budgeting, and illustrates these admittedly dry facts with gripping accounts of health policy successes and failures driven by budgetary considerations. In particular, the chapter makes a speculative but plausible argument that, but for the ACA’s politically determined budget limits and the arcana of assigning costs to an additional enrollee in a public versus a private insurance program, the Supreme Court would not have declared the law’s Medicaid expansion unconstitutionally coercive.

This section closes with a pair of chapters looking at rationing healthcare from two very different vantage points.

A. M. Capron’s chapter, The Ethics of Rationing Healthcare, examines the policy or practice of consciously limiting access to medical interventions of known benefit, and the legal and ethical analysis thereof. After reviewing the myriad contexts in which healthcare is rationed in the United States, Capron offers a novel topography of forms of rationing and reviews the principles underlying ethical healthcare rationing—focusing on beneficence, nonmaleficence, respect for persons, and justice along with competing concepts of utilitarian distribution versus allocation.

The Economics of Healthcare Rationing, by Michael Frakes, Matthew B. Frank, and Kyle Rozema, begins by drawing some distinctions as to forms of rationing from the economics perspective: the scarcity of healthcare goods or services due to financial versus physical limitations; rationing at the micro versus macro level; and rationing between healthcare and other goods versus rationing within healthcare. They then discuss the use of cost-benefit analysis and cost-effectiveness analysis, challenges with economic methods of rationing, and real-world uses of these techniques by insurers, provider networks, and governments.

(p. xxxiv) The final section of this part focuses on public health law.

American Public Health Law, a chapter by Lawrence O. Gostin, Daniel Hougendobler, and Anna E. Roberts, examines the topic through a wide-angle lens. It focuses on public health law’s five essential characteristics: government, populations, relationships, services, and power. It examines the way these characteristics play out in seven models of legal intervention in public health including taxation and spending, alterations to the built environment, and indirect regulation through tort law.

Zita Lazzarini’s chapter, Communicable Disease Law and Emerging Issues: Antibiotic Resistance, focuses on communicable diseases. Among other things it describes the relevant federal and state power to protect the public from contagion, the relative roles of voluntary and coercive public health programs, and legal limits on the exercise of the police power in this domain. It then shifts to a more in-depth discussion of two cutting-edge issues: the use of public health interventions to reduce antibiotic resistance and public health surveillance data.

In Public Health: Noncommunicable Disease Prevention, Lindsay F. Wiley, Manel Kappagoda, and Anne Pearson write about law and policy interventions to prevent noncommunicable diseases. As they note, the primary drivers of premature deaths in the United States are diseases stemming from problems with diet and tobacco use. The chapter discusses a series of interventions that might be used to target these and other noncommunicable diseases: mandated information disclosures and restrictions on marketing, taxation and pricing strategies, product and retailer regulation, licensing and zoning strategies, spending and procurement strategies, and indirect regulation through tort liability. They also focus on the legal obstacles to these interventions, especially First Amendment objections.

The final chapter in this part, James G. Hodge Jr.’s Public Health Emergency Legal and Ethical Preparedness, examines the law’s response to catastrophic events that threaten the public’s health, particularly in the post-9/11 era. After discussing the complex and shifting landscape of federal, state, and local powers in this area, Hodge flags a number of difficult challenges for implementing these practices in real time: triaging legal and medical resources, dueling declarations of state of emergency, and the liability hospitals, providers, nonprofits, and volunteers face when delivering care in emergency contexts.

The last part of the Handbook, “The Health Law Frontier,” examines issues that we believe will take on an increasing importance not only for healthcare but also for health law—and for which we think new paradigms may be needed.

The first chapter in this part, Who’s In?: Immigrants and Healthcare, by Wendy E. Parmet, looks at the undertheorized overlap between health law and immigration law. She argues that the United States has never treated immigrants as fully equal and deserving users of the healthcare system, but instead has feared them for bringing diseases and for the costs they supposedly place on taxpayers. The chapter examines the pre- and post-ACA treatment of various types of immigrants by American health law and reflects on the future of this body of law.

Marshall B. Kapp’s chapter, Aging Population, examines the issues raised for health by aging as it affects the population, the family, and the individual. Kapp thoroughly reviews the demographics and the epidemiology of aging. He focuses in particular on legal problems of decisional capacity relating to aging, the social support system for aging patients, and the standard of care for physicians treating aging patients.

(p. xxxv) In Globalization, Nathan Cortez examines six forms of globalization of U.S. healthcare: hospitals, health insurance, patient care, drugs and medical devices, telemedicine, and medical personnel. The chapter focuses on two central ideas that knit together these disparate areas. The first is the lack of international law and the limitations faced by domestic law in creating meaningful regulation of healthcare globalization. The second is the way the market is pressing the healthcare industry in various jurisdictions to converge into becoming more alike. Cortez examines the ramifications of each for health law.

The Social Determinants of Health, the Handbook chapter by Rachel Rebouché and Scott Burris, explores the resources and conditions in our social and physical environments that influence exposure and vulnerability as well as immunity to proximate causes of acute or chronic illness, including toxins or pathogens. It examines the impacts of race, low income, inequality, and education status on health outcomes and critically analyzes how successful the ACA will be in wrestling with these issues. It closes by discussing the role for public health strategies and law in fostering a “culture of health.”

Finally, Maxwell J. Mehlman’s chapter, Genomics and the Law, examines the past, present, and future of the intersection between human genomics and health law. Among the topics he covers are regulation of genomic research on human subjects, so-called “incidental findings,” ownership of DNA samples, germ-line gene editing, genomic screening and testing (including liability issues), forensic use of genomic evidence, and genomic discrimination.

Acknowledgments

We thank Amal El Bakhar, Shailin Thomas, Kenneth Kennedy, Mariah Ford, Erynn Embree, Molly Colvard Harding, Kelley McIlhattan, and Preston Moore for their excellent research assistance line editing these chapters. Jennifer Minnich was extremely helpful in coordinating logistics for the project. (p. xxxvi)

Notes:

(1) While the exact borders of “health law” are subject to some imprecision, we use it in this volume to cover a series of interconnected topics: health policy, healthcare law, bioethics, public health law, and the law governing drugs, devices, and biotechnology.