The NEW ENGLA ND JOURNAL of MEDICINE Perspective July 28, 2022 Fundamental s of He alth L aw The History of Health Law in the United States Erin C. Fuse Brown, J.D., M.P.H., and Aaron S. Kesselheim, M.D., J.D., M.P.H. The History of Health Law in the United States W hat is health law? The field can be described in broad terms as the laws and public policies that apply to the health care system or affect health care delivery.1 Not surprisingly, it is sprawling, fragmented, and complex. Health law covers the web of relationships among patients, clinicians, payers, health institutions, product manufacturers, and governments. The types and sources of relevant laws vary, from state to federal and from judge-made common law to legislative statutes and agency-made regulations. And the history of health law in the United States is woven into the history of health care in the United States. Health law is slow-moving and accretive, but it also shapes the landscape of health care delivery in powerful ways. Since implementation of the law requires democratic deliberation, admin- istrative oversight, and judicial enforcement, health law is often a lagging indicator of the norms of health care practice. But law can correct for problems that professional norms alone cannot address, such as inequitable access to care, inadequate quality or cost controls, and collectiveaction challenges to ensuring the provision of “common goods,” such as basic scientific research. For example, important health laws passed during the Covid-19 pandemic helped provide the essential investments necessary to develop highly effective vaccines and ensure that they were widely available. As U.S. society has evolved, so has health law. The history n engl j med 387;4 nejm.org of health law can be broken into four eras, each with its own prevailing ethos: the professionalautonomy paradigm, the patients’rights paradigm, the law-andeconomics paradigm, and a nascent paradigm focused on health justice and equity. As in the Triassic, Jurassic, and Cretaceous periods of the Mesozoic era, each period’s dominant features have built on those of the previous period, which has resulted in a sedimentary mountain of health laws reflecting the paradigms of the past (see timeline). In the late 19th century and much of the early 20th century, health law emphasized the professional autonomy of physicians, with courts and legislatures largely taking a hands-off approach in deference to professional judgment and self-governance.2 The concept of professional autonomy was embodied in the regulation of physicians by means of July 28, 2022 The New England Journal of Medicine Downloaded from nejm.org at CHANG GUNG UNIVERSITY on September 5, 2023. For personal use only. No other uses without permission. Copyright © 2022 Massachusetts Medical Society. All rights reserved. 289 The History of Health Law in the United States P ERS P E CT IV E LAW AND ECONOMICS (1980s–present) PROFESSIONAL AUTONOMY (1870s–1950s) State medical licensing boards, which govern entry into the profession, manage professional discipline, and prohibit the unlicensed practice of medicine, are established. Customary standards of care guiding medical-malpractice litigation are established as part of state common law. HEALTH JUSTICE AND EQUITY (2010s–present) PATIENTS’ RIGHTS (1960s–1980s) Informed-consent doctrine, which requires physicians to obtain the informed consent of patients for medical treatments and decisions, is established as part of state common law. 2010 1965 The Pure Food and Drug Act of 1906 makes it illegal to misbrand or adulterate drugs. 1870 1880 1890 1900 1910 1986 Statutes establishing Medicare and Medicaid are passed, providing coverage to people ≥65 yr of age and to certain categories of low-income Americans. 1906 1960 1970 The Emergency Medical Treatment and Labor Act is passed, requiring Medicare-participating hospitals to provide stabilizing treatment to persons presenting with emergency conditions or in active labor. 1980 1990 2000 The Affordable Care Act bolsters health insurance marketplaces for people shopping for private health insurance, provides protection for patients with preexisting conditions, and expands Medicaid to lowincome, nonelderly adults in participating states. 2010 2020 1964 1982 2003 Title VI of the Civil Rights Act prohibits discrimination on the basis of “race, color, or national origin,” by hospitals and other recipients of federal funds. The Tax Equity and Fiscal Responsibility Act of 1982 creates Medicare Part C, allowing private managed-care plans to be offered to Medicare beneficiaries. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 creates tax-advantaged health savings accounts and high-deductible health plans. Dominant Health Law Paradigms and Related Legislation in the United States. state medical licensing boards made up of peers and was extended to practices related to specialty certification, the granting of hospital privileges, and the establishment of customary standards of care guiding medicalmalpractice litigation. It also manifested in physicians’ resistance to salaried employment. Even notable regulatory advances during this era — such as the 1906 Pure Food and Drug Act, which included measures that made it illegal to mislabel or adulterate the contents of drugs sold to patients — were defined primarily by their hands-off approach. The ethos of professional autonomy was also a strong factor in institutional resistance to competition and social change, 290 such as the enactment of national health coverage, during this era.3 By the mid-20th century, health law took a major turn, as deference to professional autonomy gave way to a patients’-rights approach.4 Spurred by the growing civil rights movement, health law moved away from the paternalism that had characterized the physician–patient relationship under the professional-autonomy paradigm. At the patient level, this new focus took the form of the establishment of the legal doctrine of informed consent.4 Although the legal requirement to obtain patients’ consent for medical procedures had been recognized for decades, courts began to understand that the right to consent was meaningless unless n engl j med 387;4 nejm.org patients were fully informed about the risks and benefits of their medical options. Obtaining informed consent involved conveying the information necessary for patients to make a free choice.5 The doctrine of informed consent generally set as the default standard the information that a reasonable patient would want for making a medical decision — not the information that a reasonable physician would ordinarily divulge — which marked a shift from a physician-centric to a patient-centric ethic of care. At the societal level, the erosion of professional sovereignty took the form of broadening concepts of health as a human and civil right during a time of postwar economic expansion. The July 28, 2022 The New England Journal of Medicine Downloaded from nejm.org at CHANG GUNG UNIVERSITY on September 5, 2023. For personal use only. No other uses without permission. Copyright © 2022 Massachusetts Medical Society. All rights reserved. The History of Health Law in the United States PE R S PE CT IV E 1960s ushered in the Great Society health programs — Medicare and Medicaid — and the passage of Title VI of the Civil Rights Act, which desegregated hospitals and other entities receiving federal funding. Medicare and Medicaid responded to the pressing social problem that health care was increasingly inaccessible to people who were left out of the World War II era’s employment-based health insurance system: the elderly, people with disabilities, and poor mothers and children. Yet Medicare and Medicaid were not just the triumph of advocates for expanding access to health care. These new public programs drew political support from an increasingly powerful hospital industry, which had growing capacity and clout as a result of hundreds of millions of dollars in federal Hill–Burton Act investments into hospital construction in the postwar period.3 In addition to establishing coverage for 19 million new beneficiaries, the creation of Medicare spawned a vast administrative apparatus in the Health Care Financing Administration (now the Centers for Medicare and Medicaid Services) and furthered the shift in the locus of health law from state-based common law to federal statutes and administrative regulations. As Medicare became the lifeblood of much of the health care system, it also transformed health law, furnishing the legal hook for the requirement that hospital emergency departments provide certain kinds of care under the Emergency Medical Treatment and Labor Act, for federal fraud and abuse laws, and for payment and delivery-system reforms. In the 1980s, in tandem with the rise of managed care, lawand-economics theory — which framed the health care industry as a market and patients as consumers — gained force.2,4 The primary policy problem that this school of health law sought to address was spiraling health care costs. Policymakers and other proponents of this theory thought that deregulation, market competition, and economic incentives could control costs, increase efficiency, and improve quality of care. The law-and-economics approach transmuted the patients’rights model into a consumerdirected health care approach. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003, for example, created tax-subsidized health savings accounts that allowed patient–consumers to exert market pressure with their health care shopping decisions. Stalwart public programs such as Medicare and Medicaid were modified to incorporate private managed-care plans. The Affordable Care Act (ACA) represented a culmination of the market-centric approach, embracing “managed competition” among private health plans on the marketplaces — although it also included protection against preexisting-condition exclusions and other insurance underwriting practices that restricted people’s access to coverage on the basis of health status, perhaps heralding the next paradigm. Today, another shift is slowly occurring, toward a health-justice approach that emphasizes distributive justice, equity, and social solidarity as organizing principles of health law and policy.2,4 Advocates for moving health law into this era seek to deemphasize actuarial fairness — a model in n engl j med 387;4 nejm.org which the amount that people pay for insurance depends on their risk levels — in favor of a universal right to health care coverage, regardless of one’s health status or ability to pay.4 But they are often hamstrung by the fact that this emerging era is built on the foundation of health laws of prior eras, particularly those that established the Great Society programs of the 1960s and the ACA. It’s too soon to tell whether the global coronavirus pandemic that painfully demonstrated the limits of an overly medicalized, individualistic, and fragmented approach to health care will help catalyze further change in this direction. Each U.S. health law paradigm has had blind spots to which subsequent approaches reacted. The shortcomings of the professional-autonomy paradigm were its suppression of competition and lack of attention to both patient-centered care and efforts to make health care more egalitarian.3 The weaknesses of both the patients’-rights and law-andeconomics approaches were their focus on individual patients instead of populations and fragmentation of risk pools under an actuarial fairness model, in which the societal value of health care was ignored. Although progress has been made during each era, none of the major approaches to health law has been able to control rising health care costs, prevent industry consolidation, or ensure equitable, universal access to health care. Whereas health law of the past focused on the individual physician–patient relationship, we believe the next era should expand its view to embrace society’s collective interest in an equitable, affordable, July 28, 2022 The New England Journal of Medicine Downloaded from nejm.org at CHANG GUNG UNIVERSITY on September 5, 2023. For personal use only. No other uses without permission. Copyright © 2022 Massachusetts Medical Society. All rights reserved. 291 The History of Health Law in the United States P ERS P E CT IV E An audio interview with Prof. Fuse Brown is available at NEJM.org The Primary History Careof and Health Financial Law in Risk the United States and well-functioning health care system for the benefit of patients. coepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital — both in Boston (A.S.K.). Disclosure forms provided by the authors are available at NEJM.org. The series editors are Erin C. Fuse Brown, J.D., M.P.H., Aaron S. Kesselheim, M.D., J.D., M.P.H., Debra Malina, Ph.D., Genevra Pittman, M.P.H., and Stephen Morrissey, Ph.D. From the Center for Law, Health, and Society, Georgia State University College of Law, Atlanta (E.C.F.B.); and Harvard Medical School and the Program on Regulation, Therapeutics, and Law, Division of Pharma- 1. Hall MA. The history and future of health care law: an essentialist view. Wake Forest Law Rev 2006;41:347-63. 2. Rosenblatt RE. The four ages of health law. Health Matrix Clevel 2004;14:155-96. 3. Starr P. The social transformation of American medicine: the rise of a sovereign profession and the making of a vast industry. New York: Basic Books, 1982. 4. Wiley LF. From patient rights to health justice: securing the public’s interest in affordable, high-quality health care. Cardozo Law Rev 2016;37:833-89. 5. Capron AM. Informed consent in catastrophic disease research and treatment. Univ PA Law Rev 1974;123:340-438. DOI: 10.1056/NEJMp2207360 Copyright © 2022 Massachusetts Medical Society. Primary Care and Financial Risk — Navigating the Crossroads Zirui Song, M.D., Ph.D., Dave A. Chokshi, M.D., and Matthew J. Press, M.D. U nderresourced practices. Clinician burnout. Fragmentation of care. These long-standing challenges to practicing primary care in the United States have contributed to an increasingly unsustainable reality, marked by a shortage of primary care clinicians, an aging population’s mounting health needs, and pressure from payers and employers to control health care spending. In this environment, primary care practices are increasingly taking on accountability for total health care spending for a defined patient population. Such practices reap financial rewards if total spending is below a prospective benchmark or budget (often called upside risk) but may incur financial losses if spending exceeds the budget (downside risk) — which means they function, to some degree, as an insurer. Practices continue to receive fee-for-service payments or could accept capitated monthly payments for primary care services, along with facing performance incentives related to quality of care. At year’s end, savings or losses relative to the budget are typically shared with the insurer, the practice’s accountable 292 care organization (ACO), or a company that helped the practice bear risk. Such arrangements could have important implications for clinicians and patients. Primary care practices enter risk-bearing arrangements in various ways. Companies such as Oak Street Health and ChenMed have built brick-and-mortar practices throughout the United States geared toward serving Medicare Advantage beneficiaries, for whom they can receive rather generous risk-adjusted prospective payments from the federal government.1 Other companies, such as Aledade and Agilon Health, have created virtual groups of independent primary care practices (or ACOs) and assumed financial risk from insurers, while offering incentives to member practices. National and regional insurers have pursued similar arrangements, either by working with these types of companies or by adding provisions to their contracts with primary care practices that make the practices accountable for total spending. Bearing risk for total spending presents clinical and economic opportunities for practices. Clinically, it allows them to n engl j med 387;4 nejm.org move away from incentives under a purely fee-for-service model that mainly reward providing higher volumes of services and to potentially move toward practice styles that focus more on promoting population health. The opportunity to earn shared savings and the flexibility associated with having a budget could reorient practices toward providing higher-value care that produces health — rather than producing reimbursable services. Moving in this direction could involve supporting non–visit-based disease management, reducing unnecessary referrals and utilization, and pursuing activities that aren’t on traditional fee schedules, including those addressing social determinants of health (e.g., housing and food insecurity). Indeed, some companies emphasize a philosophy centered primarily on offering a better care experience for patients and clinicians. Bearing risk also presents financial opportunities. Given that primary care accounts for only 2 to 7% of U.S. health care spending, taking on risk for total health care spending has the potential — even if spending July 28, 2022 The New England Journal of Medicine Downloaded from nejm.org at CHANG GUNG UNIVERSITY on September 5, 2023. For personal use only. No other uses without permission. Copyright © 2022 Massachusetts Medical Society. All rights reserved.