An Ethical Framework for the Responsible Leadership of Accountable Care Organizations

Ethics and Medical Ethics

Ethics is the disciplined study of morality. Ethical reasoning aims to provide reliable, practical frameworks that guide and assess the two components of morality: behavior and character. Ethics clarifies relevant ethical concepts and then uses those concepts to make arguments. Rigorous ethical reasoning—in the form of arguments that meet standards of clarity, consistency, coherence, and applicability—creates practical tools to guide and critically appraise behavior and character.^7,8 Ethical reasoning aims to improve morality by improving behavior and character.

Medical ethics is the disciplined study of morality in medicine that centers on 2 questions: How should physicians act in the care of patients (and research subjects)? What character should physicians develop so that they become and sustain themselves as professionals in patient care (and clinical research)? Medical ethics has constituted an essential component of medical practice since ancient times in all global cultures. ⁹

The Ethical Concept of Medicine as a Profession: The Physician as Fiduciary of the Patient

Many physicians believe that the ethical concept of medicine as a profession originated in the Hippocratic Oath and other ethical texts attributed to Hippocrates and has come down to us from the world of ancient Greece. The Oath, however, reads more as a guild oath than it does as a statement of professionalism. Moreover, no continuous tradition of physicians taking the Hippocratic Oath exists. Taking the Oath is a practice of very recent vintage—much too recent, from an historical perspective, to consider this practice a tradition. ¹⁰

The credit for introducing the ethical concept of medicine as a profession into the history of medical ethics goes to two 18th-century British physicians, John Gregory (1724-1773) of Scotland and Thomas Percival (1740-1804) of England. ¹¹ Gregory taught Edinburgh medical students the first modern, philosophically rigorous medical ethics, resulting in the first modern English-language book on medical ethics.^12,13 Benjamin Rush (1746-1813) studied medical ethics with Gregory and brought Gregory’s ideas to the then British colony of Pennsylvania.^13,14 Gregory’s book influenced European medical ethics through French, German, Italian, and Spanish translations. ¹³ Percival’s Medical Ethics was the first book thus titled in any language in the global history of medical ethics. ¹⁵ Percival’s Medical Ethics, as well as Gregory’s medical ethics, strongly influenced the 1847 Code of Medical Ethics of the then newly formed American Medical Association. ¹³

These transformative figures in the history of medical ethics responded to major ethical challenges of their time. The sick who sought out physicians, surgeons, apothecaries, midwives, and other practitioners did so uncertain about whether any of these practitioners knew what they were doing, creating a crisis of intellectual distrust. The sick also worried whether practitioners were more interested in lining their pockets with the money of the sick than in helping them to recover from disease and injury, creating a crisis of moral distrust. ¹⁶ Gregory responded to this crisis of loss of intellectual and moral trust in physicians.

Gregory also focused on the power of physicians over the sick in the Royal Infirmary of Edinburgh. Infirmaries—the forerunner and model of our not-for-profit, voluntary hospitals—had been created by landed aristocrats and the increasingly powerful owners of emerging industries. These employers created a hospital in which their employees could receive reliable medical and surgical care and quickly return to work. These employers made annual contributions to support the work of infirmaries. Concerned about misuse of resources, the trustees, as they were known, deliberately underfunded infirmaries. Concerned that physicians would admit the sick for unnecessary intervention, the trustees set up a screening system. The trustees put lay managers in charge of this process with the goal of denying admission to those who were gravely ill. The trustees understood that an infirmary with a reputation for high mortality rates, like a physician or surgeon with such a reputation, would not survive and would make them look bad socially and politically. ¹⁷

The trustees put apothecaries—the rivals of physicians and surgeons in the oversupplied and unforgiving private marketplace for medical services—in charge of the formulary, a major cost center. Physicians became accountable for the utilization and cost of therapeutics to nonphysicians. The trustees did not know about the concepts of poor quality as unmanaged variation in the processes of patient care and of poor quality as the principal driver of uncontrolled costs, but they appear—in the hindsight of historical study—to have attained an intuitive grasp of these concepts and their implications for the fiscal strength of health care organizations. Gregory recognized that there existed no ethical framework to guide physicians in their newly acquired (though limited) organizational power over patients. Gregory also was concerned that no ethical framework existed to guide organizational leaders in their wielding of newly acquired, and growing, power to control organizational resources. ¹³

Percival focused on organizational leadership and resource management. He added to Gregory’s agenda the lack of cooperation among physicians, surgeons, and apothecaries at the Manchester Infirmary. Given their fierce competition in the limited market of private practice, cooperation among practitioners encountered serious obstacles. Epidemics exacerbated the problem, because the Infirmary needed its entire staff to care for the many who required admission. Percival was concerned that there existed no common ethical framework for physicians and surgeons, who were then still bitter rivals, to weld disparate practitioners into a unified effort. ¹⁸

Between them, Gregory and Percival invented the ethical concept of medicine as a profession, and of the physician as fiduciary of the patient. ¹¹ Gregory drew on the ethical concepts of David Hume (1711-1776), the foremost philosopher of the Scottish Enlightenment. ¹⁹ Percival drew on the ethical concepts of Richard Price (1723-1791), the foremost philosopher of the English Enlightenment. ²⁰ Physicians called themselves “professional” at the time, but they used this word to mean that they had attended the university or possessed a medical degree. “Professional” physicians attempted to discredit competitors—scurrilous surgeons, incompetent midwives, and greedy apothecaries. ¹³

Gregory and Percival gave “professional” an ethical content by arguing for three commitments that make physicians professionals worthy of the name.^11,13 First, the physician should commit to becoming and remaining scientifically and clinically competent. This required submitting to the discipline of scientific method as set out by Francis Bacon (1561-1626), the great English philosopher of science and medicine. Bacon called for science, and therefore medicine, to be based on “experience.” By this he meant that clinical practice should be based on the careful observation and analysis of natural experiments (eg, observing the course of disease or injury and how it responded to clinical management) and of controlled experiments (eg, separating a compound drug into its constituent agents and testing each separately for its effects on the course of disease or injury with the aim of avoiding unnecessary, and clinically more risky, compound drugs).^13,21 Experience-based medicine proved to be a nascent form of what we now call evidence-based reasoning. The updated version of the first component of the ethical concept of medicine as a profession becomes the commitment to become and remain clinically and scientifically competent by submitting clinical judgment, decision making, and practice to the discipline of evidence-based reasoning. ²² Making this first commitment secures the intellectual integrity of medicine as a profession.

Second, physicians should commit to using their scientific and clinical competence primarily for the clinical benefit of patients and keep self-interest systematically secondary. This commitment aims to minimize bias originating in economic and other forms of self-interest. Physicians should systematically blunt—and be prepared to sacrifice—self-interest into order to become individually morally trustworthy. Third, physicians should maintain, strengthen, and pass medicine on to future physicians and patients as a public trust. This commitment acts as a bulwark against the bias introduced by the guild interests of physicians in economic, social, and political power. This grounds the moral trustworthiness of the profession of medicine. Making the second and third commitments of the ethical concept of medicine as a profession secures the moral integrity of medicine as a profession.

Physicians and Health Care Organizations as Co-Fiduciaries of a Population of Patients

Based on Gregory and Percival’s ethical concept of medicine as a profession and of the physician as fiduciary of the patient, the ethical concept of co-fiduciary responsibility^23,24 can be introduced as the core component of the ethical framework for the responsible leadership of ACOs. All philosophical ethical theories agree that individuals or organizations bear responsibility—and therefore accountability—for the consequences of actions that they freely undertake. Any individual or organization that influences the processes of patient care therefore becomes responsible and accountable for the consequences of the processes and outcomes of patient care. Consequences affecting patients come under the ethical concept of fiduciary responsibility to and for patient care. It follows that any individual or organization that influences the processes of patient care incurs co-fiduciary responsibility for the population of patients served by that organization.

Co-fiduciary responsibility obviously applies to physicians and to the leadership of health care organizations that deliver medical care to patients. Payers—private and public alike—who use their power to influence the processes of patient care incur co-fiduciary responsibility for the consequences of doing so. Co-fiduciary responsibility also applies to patients and the family members of patients who act as surrogate decision makers. Their decisions influence the processes of patient care for which they are responsible. Their decisions also drive consumption of resources that are needed for the care of other patients. Patients and surrogate decision makers may not be aware of these consequences for other patients, but physicians and organizational leaders surely are. Sometimes the decisions of physicians and organizational leaders, and especially of patients and patient’s surrogates, result in harmful consequences for other patients. This occurs when implementing a decision results in unacceptable opportunity costs: The use of health care resources for a patient when that use is reliably judged (ie, is supported in evidence-based reasoning) not to be clinically beneficial and when that use blocks access to health care resources that could be used to provide expected clinical benefit to another patient. Physicians, organizational leaders, patients, and patients’ surrogates have an equal co-fiduciary obligation not to create unacceptable opportunity costs. Their autonomy should be constrained to prevent such harmful consequences. The concept of the co-fiduciary obligations of patients and surrogates has the important implication that patients and surrogates are not simply consumers of medical care; they are also stewards of organizational resources and should be held to account along with physicians and organizational leaders for the quality of the processes of patient care.

Preventive Ethics

To assert responsible leadership of ACOs, physician and lay leaders of health care organizations should use a preventive ethics approach ²⁵ to apply the ethical concept of co-fiduciary responsibility to the ethical challenges of ACOs. Poorly managed ethical conflicts can take an unwelcome biopsychosocial toll on health care professionals, patients, and their families and can warp organizational culture based on co-fiduciary responsibility. Preventive ethics creates ethically informed organizational policies and practices designed to anticipate and prevent ethical conflicts, thus minimizing their occurrence. Preventive ethics fashions rapid responses to ethical conflicts and their rapid resolution. Preventive ethics emphasizes critical appraisal of organizational culture to ensure that core values, mission, policies, and practices express and promote co-fiduciary responsibility. Of special importance is the tolerance of what leaders should not tolerate: the erosion of an organizational culture of co-fiduciary responsibility originating in the ethically unjustified decisions of physicians, patients, and patients’ surrogates.

Improving Quality as an Ethical Imperative

The improvement of quality—defined as the evidence-based, progressive reduction of variation in the processes of patient care—should result in healthier patients. The first and second components of the ethical concept of fiduciary responsibility obviously support improved quality in the processes and outcomes of patient care. Health care organizations have a co-fiduciary obligation to commit the resources necessary to achieve this goal. To create morally responsible ACOs, organizational leaders should seek to continuously improve the quality of the processes of patient care for which physicians and other health care professionals bear responsibility. Candor, the core intellectual virtue of Gregory’s medical ethics, applies here and means routinely subjecting one’s clinical judgment, decision making, and behavior to evidence-based correction.^12,13 Percival called for monthly meetings of the Manchester Infirmary’s physicians and surgeons to review all cases and seek ways to improve the processes and outcomes of patient care. ¹⁵ The ethical concept of co-fiduciary responsibility requires the creation of an organizational culture of Gregorian candor and Percivalian accountability—and the commitment of organizational resources to make these professional virtues definitive of an organizational culture of co-fiduciary responsibility. The creation and maintenance of evidence-based protocols, guidelines, and checklists becomes essential to achieving the preventive ethics goal of rapid and effective evidence-based improvement of the processes of patient care for which physicians and other health care professionals are responsible.

The result should be the healthiest possible patients. “Healthiest possible” will sometimes mean cure but more often will mean sustainable health status in the context of chronic illness. For both meanings, the healthiest possible patients become less expensive to care for than patients for whom the processes of patient care display unmanaged, wide variation, and, therefore, uncontrolled cost. Candor-based organizational cultures of accountability will result in health care costs that should rise less steeply than is the case when the processes of patient care display unmanaged variation. The responsible pursuit of quality in the processes of patient care becomes the means to achieve economic savings. Incentivizing physicians and health care organizations to achieve increased economic value by increasing quality is fully consistent with the ethical concept of co-fiduciary responsibility. Aligning economic incentives to pursue quality—responsible reduction of variation in the processes of patient care—becomes a powerful preventive ethics policy in the responsible leadership of ACOs.

Reasserting the Physician’s Professional Role in the Informed Consent Process

Patients’ and surrogates’ decisions can drive unmanaged variation in the processes of patient care, especially when those preferences lack an evidence base of expected clinical benefit. The preventive ethics approach to the challenge of scientifically and clinically undisciplined patients’ or surrogates’ preferences is to constrain the autonomy of patients and surrogates via the informed consent process. Health law and medical ethics agree that the informed consent process begins with the physician identifying the medically reasonable alternatives for the clinical management of the patient’s condition, disease, or injury. ²⁶ Using evidence-based reasoning, the physician should critically appraise technically possible alternatives and identify those that are reliably expected to result in net clinical benefit for the patient. The physician should then offer these to the patient or the patient’s surrogate. If evidence-based critical appraisal supports only one medically reasonable alternative or one of several as clinically superior, the physician should recommend that alternative. The physician should respond to a patient’s or surrogate’s request for an alternative that is not medically reasonable with a respectful, clear, evidence-based explanation for this clinical judgment. The physician should explore the patient’s or surrogate’s reasons for the request and point out how the health of the patient will be better served by considering the medically reasonable alternatives. The physician should not implement requests for clinical management that fail the test of medical reasonableness because the physician has a fiduciary obligation to the patient to protect the patient from poor-quality medical care—unmanaged variation in the processes of patient care. Unmanaged variation results in mistreatment, undertreatment, or overtreatment, which harm the patient’s health-related interests. Therefore, organizational leaders have a co-fiduciary responsibility to all of the organization’s patients to support physicians in holding the line against requests for medically unreasonable clinical management—especially requests to “do everything” at the end of life. Organizational leaders also have a co-fiduciary responsibility to prevent unacceptable opportunity costs that will arise when medically unreasonable requests are fulfilled. Failure to fulfill these co-fiduciary obligations will result in an organizational culture that tolerates violation of the intellectual and moral integrity of evidence-based clinical judgment and practice. Organizational leaders should not regard themselves to be ethically free to tolerate what should not be tolerated. Preservation and support for the core legal and ethical obligations of physicians in the informed consent process become another essential component of responsible leadership of ACOs.

Constraining Patients’ and Surrogates’ Autonomy

Patients have a co-fiduciary obligation to the other patients served by a health care organization to accept ethically justified constraints on their autonomy. This is because their decisions can affect the processes of care for other patients. Specifically, patients and surrogates have a co-fiduciary obligation to other patients to prevent unacceptable opportunity costs. The model of the patient as consumer should be replaced with the model of the patient (and surrogate) as responsible comanager of organizational resources, so that evidence-based processes of care are routinely provided to all of an organization’s patients. The model of the patient as consumer obscures the patient’s social responsibilities in health care, further calling into question the clinical and ethical adequacy of the consumer model as a basis for clinical practice, organizational culture, and health policy.

Patients and surrogates also should act prudently. The virtue of prudence calls for the identification of self-interests, especially our legitimate self-interests, and their protection. Patients’ and surrogates’ decisions that will result in unmanaged variation in the processes of patient care will result in mistreatment, undertreatment, and overtreatment. These, in turn, put the patient’s health-related interests systematically at risk. Gregorian candor, applied to patients, leads to the recognition that patients have a right to effective health care. Physicians and health care organizations have a co-fiduciary obligation to provide effective health care. Payers have a co-fiduciary obligation to pay for such care. Patients and their surrogates have a co-fiduciary obligation to authorize and accept effective medical care. Incentivizing patients by sharing the savings of effective health care with them is consistent with and supported by the ethical concept of co-fiduciary responsibility and the virtue of prudence. Therefore, responsible leadership of ACOs includes development and implementation of policies that school patients and surrogates in the discipline of evidence-based reasoning and its prudential value, and incentivize patients and surrogates to accept and implement effective health care. Organizational leaders should support physicians in justifiably constraining patient autonomy when patients prefer ineffective or harmful medical care—especially when implementing such preferences will result in unacceptable opportunity costs for other patients. Responsible ACOs are ethically justified in establishing limits on medical care based on sound medical judgment and clinical evidence. Patients and surrogates are ethically obligated to accept such limits. Organizational leaders should be unflinching in their support of physician colleagues who uphold such limits.