This article examines the five forms of payment for healthcare that are common in the United States: out-of-pocket, charity, direct public provision, public health insurance, and private health insurance (including employer-sponsored insurance). After discussing the history of each of the five approaches, the article considers their advantages and disadvantages as well as their current status. It examines next the 2010 Affordable Care Act. Although the Affordable Care Act focuses primarily on expanding public health insurance and public financing for private health insurance, it incorporates all five approaches to financing care. Finally this chapter considers why the United States retains this patchwork of different forms of coverage rather than adopting a single coherent system of health care finance and discusses the likely future of the American approach.
Eleanor D. Kinney and Priscilla Keith
This chapter examines the issue of access to healthcare, with particular emphasis on the five dimensions of the model proposed by Roy Penchansky and J. William Thomas: availability, accessibility, accommodation, affordability, and acceptability. It also discusses the constitutional powers of states and the federal government with respect to health, along with relevant health law. It outlines the three categories of law governing access to physicians and hospitals: direct obligations of physicians and hospitals to provide free care to the indigent; federal programs to provide health insurance or health services to vulnerable populations; and laws that affect the delivery of care based on the patient’s physical characteristics and immigration status. The chapter concludes by considering the United States’s failure to realize the human rights aspect of health in international treaties and suggesting that the country’s efforts when it comes to access to physicians and hospitals leave much to be desired.
Marshall B. Kapp
This chapter examines issues arising from an aging population, particularly those affecting the population, community, family, and individuals. It considers the legal and policy challenges relating to an aging population, along with the implications of responses to such challenges for the regulation of clinical care at the individual level and the structure and financing of healthcare delivery for older persons as a group. The chapter provides a demographic background on the elderly, with emphasis on the changing epidemiology of aging and its disability consequences as well as long-term services and supports for the aged. It looks at adverse cognitive changes associated with aging and relevant law relating to older persons’ impaired medical decision-making. It also describes best practices in clinical geriatrics before concluding with an explanation of how physician perceptions of legal standards of care undermine efforts to provide more rational care to the elderly through best practices initiatives.
Lawrence O. Gostin, Daniel Hougendobler, and Anna E. Roberts
This chapter explores U.S. public health law and illustrates how it works in the control and prevention of two salient epidemics: infectious diseases and noncommunicable diseases. It first presents a theory and a definition of public health law, with particular emphasis on the law’s five essential characteristics: government, populations, relationships, services, and power. It then considers the doctrinal boundaries of public health law, and why population health should be a salient public value. It also describes seven models for legal intervention designed to prevent injury and disease, encourage healthful behaviors, and promote public health more generally. Finally, it looks at the use of public health law in infectious disease surveillance and response, as well as the law’s diverse roles in noncommunicable disease prevention and control before concluding with a discussion of the major reasons for social and political opposition to noncommunicable disease interventions.
William M. Sage
This chapter examines the role of antitrust law in the governance of healthcare competition in the United States as the Patient Protection and Affordable Care Act of 2010 (ACA) takes full effect. It provides an overview of U.S. antitrust law before turning to recent and ongoing controversies involving antitrust law and healthcare, including those relating to hospital mergers, consolidation in the health insurance industry, accountable care organizations, and generic drugs. It then steps back to consider deeper questions of competition policy in the post-ACA era that may determine the economic sustainability and quality of the U.S. healthcare system.
This article focuses on debates, both historic and contemporary, surrounding assisted reproductive technologies (ART) and abortion. After providing a historical background on ART and abortion and their integration into modern reproductive life, the article discusses the current usage of both techniques in America. It then compares the populations who avail of ART and abortion before turning to an analysis of the regulatory landscape surrounding the two procedures, along with reproduction as a fundamental right. It also examines the issue of whether the existing jurisprudence concerning the right to avoid procreation can be applied equally to the right to access parenthood through assisted conception. The article concludes with an assessment of three areas in which ART and abortion have overlapped: selective reduction of multiple pregnancy, the personhood movement, and perinatal genetic diagnosis.
This article explores the relationship between respect for individual autonomy and the law governing end-of-life treatment in the United States. It begins with a review of the law governing treatment decision-making for competent adults, incompetent adults, and children. It then turns to the issue of determining death. After that, the article discusses the limitations of the autonomy-based approach in addressing three areas of end-of-life law: “futile” treatment disputes, treatment decisions for incompetent patients, and access to physician-assisted death. It concludes that courts and other legal decision-makers will face pressure to consider the proper role of quality of life, cost, medical judgment, and patient vulnerability in determining end-of-life law.
Mark Barnes and David Peloquin
This article examines federal and state laws on biomedical research in the United States. It also considers the tension among various regulatory regimes and highlights conflicting regulations that could be better harmonized. The article first describes regulatory regimes that govern protections for human subjects, with particular reference to the federal Common Rule and the Food and Drug Administration’s regulations on the protection of human subjects. The discussion then turns to state laws on informed consent; privacy laws; laws on clinical trials registration and data transparency; financial disclosure requirements; research misconduct such as fabrication, falsification, and plagiarism; and animal research requirements. The article concludes by presenting additional considerations related to federal funding of research.
This chapter focuses on key characteristics of U.S. communicable disease control law. It describes federal and state powers, reviews the relative roles of voluntary and coercive public health programs, and describes the scope and limitations of the police power. Next, it examines specific legal provisions particularly relevant to communicable disease control and explores two emerging issues: how to successfully craft legal and policy measures to reduce the negative impact of antibiotic resistance and expanded use of public health surveillance data. The chapter concludes with three ongoing dilemmas that require both technical solutions and thoughtful debate, how to: 1) balance individual rights and effective disease control when using isolation and quarantine; 2) develop legal and policy tools that will incentivize development of novel antibiotics; and 3) assess the benefits and risks of utilizing the explosion of personal data that advances in medicine, public health, and technology have made available.
This chapter examines financial incentives that might result in conflicts of interest (COIs) in treatment and research relationships, along with the regulation of those COIs. It considers financial incentives for healthcare providers to reduce spending on clinical care and incentives for researchers and their institutions to pursue commercially viable biomedical discoveries. The chapter discusses the goals that the law should attempt to achieve through the regulation of potential COIs in treatment and research relationships, such as promoting self-protection among those at risk of harm. The chapter describes the purposes of legal mandates to disclose financial interests in clinical medicine and in biomedical research and assesses the existing law with respect to COI disclosure and advocacy protections. It shows that current law does little to enable patients, insurance beneficiaries, and human subjects to protect themselves. Finally, it proposes changes to the law to prevent COIs in both clinical and research settings.
Nadia N. Sawicki
This article focuses on professional and regulatory bodies to which patients can lodge complaints and other concerns over the quality of care provided by medical practitioners and healthcare institutions. It first considers state regulation of professional licensing boards, together with the procedures employed by medical boards for patient complaints, as well as the challenges and criticisms faced by such boards with respect to their approach to complaint investigation and disciplinary enforcement. It then turns to federal regulation of providers and institutions that participate in Medicare and Medicaid, with particular reference to the Centers for Medicare and Medicaid Services. It also examines private organizations, such as the Joint Commission (formerly the Joint Commission for the Accreditation of Health Organizations) and specialty medical associations. Finally, the article looks at online consumer reviews and healthcare ratings websites as alternative mechanisms for patient reporting and complaints.
This article examines conflicts of conscience that arise between patients, healthcare providers, and institutions in the field of medicine, especially with regard to reproductive health and end-of-life care. More specifically, it considers “conscientious refusal”—a provider’s exercise of his or her conscience in refusing to perform or participate in a procedure that is deemed ethically and legally permissible. The discussion begins with an overview of the history and development of legislative and court protections for conscientious refusals of healthcare. It then turns to theoretical justifications for protecting conscience in medicine, along with proposals to strike a balance between patient access and provider conscience. It also analyzes current legislation governing refusal vis-à-vis true exercise of conscience and argues that institutional conscience poses practical and theoretical challenges to the protection of conscience. The article concludes with an assessment of future directions for research.
Leslie Francis, Anita Silvers, and Michael Stein
This chapter examines the impact of disability law on certain areas of health law and the implications for people with disabilities. It first considers a number of issues in the provider-patient relationship with respect to disability rights, including informed consent and decision-making both at the beginning of life and at the end of life. In particular, it discusses questions concerning prenatal testing and reproductive liberty, as well as the so-called “Baby Doe” regulations. It then explores the impact of the Patient Protection and Affordable Care Act on access to healthcare, along with statutory definitions of disability. Statutes employing functional definitions of disability are compared with statutes employing condition-based definitions of disability. The chapter concludes by focusing on Medicare and the obligations of providers and programs under the Americans with Disabilities Act.
Peter Grossi and Keri Arnold
This article examines the law of drug product liability in the United States. It first considers the liability for adverse effects of prescription drugs under the older regulatory deference model before turning to a discussion of the current debate over liability for the risks even properly prepared drugs. It then looks at drug withdrawals and the growing distrust of the Food and Drug Administration’s approval and surveillance process for prescription drugs. It also reviews the arguments and a number of court decisions about the FDA’s approval of drug labels, with particular focus on the arguments for the preemption of tort claims preemption of tort claims that such labels failed to warn of the drug’s adverse effects, as well as the direct challenge to FDA approval presented by “design-defect” claims. The article concludes with an analysis of recent challenges to the traditional protection afforded by the learned intermediary doctrine and tort challenges to “off-label” uses which the FDA tacitly permits.
Drugs, Biologics, and Devices: FDA Regulation, Intellectual Property, and Medical Products in the American Healthcare System
This article examines the basic framework of the U.S. Food and Drug Administration (FDA)’s approval process for drugs, biologics, and medical devices within the broader context of the country’s healthcare system. The article also discusses intellectual property protections and statutory exclusivity periods for medical products and their effect on the market entry of follow-on therapies. It then considers a number of current developments shaping FDA regulation of pharmaceuticals and medical devices, including the rise of personalized medicine, the strengthening of First Amendment commercial speech protections, and the agency’s expanding involvement in the practice of medicine. Finally, the article examines how the FDA must increasingly share its gatekeeping role with third-party payers and considers the agency’s future in light of this phenomenon.
Michael Frakes, Matthew B. Frank, and Kyle Rozema
This chapter examines the economics of healthcare rationing. The chapter begins with an overview of the various dimensions across which healthcare rationing operates, or at least has the potential to operate, in the first place. The chapter then describes the types of economic analyses used in healthcare rationing decision-making, with particular reference to cost-benefit analysis and cost-effectiveness analysis. The chapter also considers healthcare rationing in practice, such as how economic analyses inform decisions regarding which services to cover, and concludes by discussing various practical and conceptual challenges that may arise with economic analyses and that span both economics and ethics.
This article examines the complexities of employer-sponsored health insurance in the United States, along with its history and future prospects. It begins with an overview of the economic and legal factors that account for employers’ dominant position in the private health insurance market. It then considers a number of public policy problems that arise when insurance premiums are sheltered from income tax, such as the bias toward “first-dollar” coverage, which in turn causes higher medical spending. Finally, the article discusses future prospects for employment-based coverage, with emphasis on the provisions of the Patient Protection and Affordable Care Act (ACA) and its mandated benefits, but also considering insurance exchanges and defined contributions, health reimbursement and savings accounts, preemption and self-insurance under the Employee Retirement Income Security Act (ERISA), and managed care liability.
This chapter examines the ethics of healthcare rationing based on the definition of “rationing” as a policy or practice of consciously limiting access to medical interventions of known benefit. It first considers the different types of healthcare rationing and the factors that influence how the various policies and practices that involve rationing are sorted out. It then places the wide range of rationing policies and practices in a three-dimensional topographic space before turning to a discussion of the principal strategies for making such policies “ethical.” Four principles are explored—beneficence, nonmaleficence, respect for persons, and justice—along with the competition between the concepts of utilitarian distribution versus allocation. This chapter argues that rationing involves not a single but multiple realities and that we need to determine whether the benefits of rationing inherent in policies developed for other reasons justify the costs of that rationing.
Maxwell J. Mehlman
This chapter explores the legal implications of the entire human genome, or “genomics.” It begins with an overview of scientific aspects of human genomics and a discussion of the history of the legal, ethical, and policy challenges raised by the science of genomics. It looks at the eugenics movement in the early twentieth century and state sickle-cell screening programs targeting African Americans in the 1970s. It then considers the basic rules governing genomic research and the legal issues raised by genomic research on human subjects, so-called incidental findings, ownership of DNA samples, government oversight, and genomic research aimed at altering the human germ line. The chapter examines whether discoveries arising from genomic research are entitled to intellectual property protection, or whether they can be patented; genomic screening and testing; liability in genomic testing; genomic therapy and enhancement; forensics; and genomic discrimination. Finally, it outlines future prospects for genomic research.
This chapter examines the impact of globalization on healthcare. It considers six important parts of the health industry being influenced by globalization: hospitals, health insurance, patient care, drugs and medical devices, telemedicine, and medical personnel. This chapter uses two common themes to understand how globalization might represent “the great rebalancing” in healthcare: first, “market-driven convergence” is pushing standards and practices in the health industry to become more alike across jurisdictions; second, the lack of international law and the limits of domestic law create a transnational legal void in which globalization advances almost unfettered. The chapter considers the limits of domestic law and the feasibility of international cooperation before concluding with an assessment of various “soft law” levers and their ability to correct market failures as well as inequities in global healthcare markets.