Ethical practice in Telehealth and Telemedicine.

This article summarizes the report of the American Medical Association's (AMA) Council on Ethical and Judicial Affairs (CEJA) on ethical practice in telehealth and telemedicine. Through its reports and recommendations, CEJA is responsible for maintaining and updating the AMA Code of Medical Ethics (Code). CEJA reports are developed through an iterative process of deliberation with input from multiple stakeholders; report recommendations, once adopted by the AMA House of Delegates, become ethics policy of the AMA and are issued as Opinions in the Code. To provide enduring guidance for the medical profession as a whole, CEJA strives to articulate expectations for conduct that are as independent of specific technologies or models of practice as possible. The present report, developed at the request of the House of Delegates, provides broad guidance for ethical conduct relating to key issues in telehealth/telemedicine. The report and recommendations were debated at meetings of the House in June and November 2015; recommendations were adopted in June 2016 and published as Opinion E-1.2.12, Ethical Practice in Telemedicine, in November 2016. A summary of the key points of the recommendations can be found in Appendix A (online), and the full text of the opinion can be found in Appendix B (online).

Professional Ethics for Digital Age Psychiatry: Boundaries, Privacy, and Communication.

PURPOSE OF REVIEW: Internet and social media use continue to expand rapidly. Many patients and psychiatrists are bringing digital technologies into the treatment process, but relatively little attention has been paid to the ethical challenges in doing this. This review presents ethical guidelines for psychiatry in the digital age. RECENT FINDINGS: Surveys demonstrate that patients are eager to make digital technologies part of their treatment. Substantial numbers search for professional and personal information about their therapists. Attitudes among psychiatrists about using digital technologies with patients range from dread to enthusiastic adoption. Digital technologies create four major ethical challenges for psychiatry: managing clinical boundaries; maintaining privacy and confidentiality; establishing realistic expectations regarding digital communications; and upholding professional ideals. Traditional ethical expectations are valid for the evolving digital arena, but guidance must be adapted for actual application in practice.

Using Moral Distress for Organizational Improvement.

Moral distress is a major problem for nurses, other clinicians, and the health system itself. But if properly understood and responded to, it is also a promising guide for healthcare improvement. When individuals experience moral distress or burnout, their reports must be seen as crucial data requiring careful attention to the individuals and to the organization. Distress and burnout will often point to important opportunities for system improvements, which may in turn reduce the experience of distress. For this potential virtuous cycle to happen, individuals must be able to articulate their concerns without fear of retribution, and organizational leaders must be able to listen in an undefensive, improvement-oriented manner.

\How Can Clinical Ethics Committees Take on Organizational Ethics? Some Practical Suggestions.

Although leaders in the field of ethics have for many years pointed to the crucial role that organizations play in shaping healthcare ethics, organizational ethics remains a relatively undeveloped area of ethics activity. Clinical ethics committees are an important source of potential expertise, but new skills will be required. Clinical ethics committees seeking to extend their purview to organizational issues will have to respond to three challenges-how to gain sanction and support for addressing controversial and sensitive issues, how to develop an acceptable process, and how to make a difference on the ground. The article presents practical suggestions for how clinical ethics committees meet these challenges.

A framework of ethics for telepsychiatry practice.

Psychiatrists who provide telepsychiatric services must uphold the standards of ethics and professionalism expected in in-person interactions. Psychiatrists' fundamental ethical responsibilities do not change when they take up a new form of practice. But as in other areas of medicine, the introduction of a new technology - here, Internet use and videoconferencing - raises new ethical challenges, requiring a fresh look at clinical practice and social issues such as equitable access. This review discusses these new challenges under six headings: providing competent, safe care, ensuring informed consent, promoting privacy and confidentiality, managing boundaries, encouraging continuity of care, and addressing health equity. Ethical guidelines for in-person practice have emerged from decades of clinical discussion and carefully observed treatment in the office and hospital setting. New observations, clinical reports, and shared discussion and learning must do the same for telepsychiatry in the years to come.

Consumer awareness and strategies among families with high-deductible health plans.

OBJECTIVE: High-deductible health plans (HDHPs) are a new and controversial approach to increasing the share of health care costs paid by patients. Our study had the following aims: (1) to describe the experiences of families with HDHPs who had incurred high out-of-pocket costs and (2) to identify areas where clinicians could support more effective health care decisions by such families. METHODS: We conducted four focus groups with adults whose families had HDHPs in a New England-based health plan and had experienced high or unexpected out-of-pocket health care costs during the past 12 months. Transcripts of audio recordings were independently coded by three investigators using modified grounded theory techniques. RESULTS: The 21 focus group participants had a good general understanding of how their HDHP worked, but reported confusion about specific processes due to the plans' complexity. They described heightened awareness of health care costs, and identified important barriers to their ability to control costs. These included needing to seek care for urgent problems without having the time to assess potential costs; having mistaken expectations about what services the HDHP covered; and being reluctant to discuss costs with doctors. They attempted to control costs by delaying or avoiding visits to doctors, but felt they had little control over costs once a clinical encounter had begun. CONCLUSIONS: Patients with HDHPs reported heightened sensitivity to health care costs, and described important barriers to their ability to make effective choices. Helping such patients make optimal decisions will likely require systems-level changes that involve clinicians and health insurers.

Cluster randomized trials to study the comparative effectiveness of therapeutics: stakeholders' concerns and recommendations.

PURPOSE: To describe the concerns raised by health plan members, providers and purchasers related to studying the comparative effectiveness of therapeutics using cluster randomized trials (CRTs) within health plans. An additional goal was to develop recommendations for increasing acceptability. METHODS: Eighty-four qualitative in-depth telephone interviews were conducted; 50 with health plan members, 21 with providers, and 13 with purchasers. Interviews focused on stakeholders' concerns about and recommendations for conducting CRTs in health plans. RESULTS: Members expressed concerns that CRTs might compromise their healthcare. Providers and purchasers recognized the value of and the need for comparative effectiveness research. Providers expressed concerns that they would not have sufficient time to discuss a CRT with patients, and that participation in such a study could negatively impact their relationships with patients. Purchasers would want assurances that study participation would not result in members receiving lesser care, and that benefits would remain equitable for all members. CONCLUSIONS: This study provides insight into how health plan members, providers and purchasers might react to a CRT being conducted in their health plan. The recommendations reported here provide guidance for researchers and policy makers considering this methodological approach and suggest that with sufficient preparation and planning CRTs can be an acceptable and efficient methodology for studying the comparative effectiveness of therapeutics in real world settings.

Bystander Ethics and Good Samaritanism: A Paradox for Learning Health Organizations.

In 2012, a U.S. Institute of Medicine report called for a different approach to health care: "Left unchanged, health care will continue to underperform; cause unnecessary harm; and strain national, state, and family budgets." The answer, they suggested, would be a "continuously learning" health system. Ethicists and researchers urged the creation of "learning health organizations" that would integrate knowledge from patient-care data to continuously improve the quality of care. Our experience with an ongoing research study on atrial fibrillation-a trial known as IMPACT-AFib-gave us some insight into one of the challenges that will have to be dealt with in creating these organizations. Although the proposed educational intervention study placed no restrictions on what providers and health plans could do, the oversight team argued that the ethical principle of beneficence did not allow the researchers to be "bystanders" in relation to a control group receiving suboptimal care. In response, the researchers designed a "workaround" that allowed the project to go forward. We believe the experience suggests that what we call "bystander ethics" will create challenges for the kinds of quality improvement research that LHOs are designed to do.

Comparing drug effectiveness at health plans: the ethics of cluster randomized trials.

"Cluster randomized trials," in which groups of patients are randomly assigned to different therapeutic interventions, provide a powerful way of evaluating drugs. CRTs have not been widely used, in good part because of concerns about whether patients must give informed consent to participate in them. A better understanding of how CRTs fit into clinical practice resolves the concerns.

Rationing Care through Collaboration and Shared Values.

Although "rationing" continues to be a dirty word for the public in health policy discourse, Nir Eyal and colleagues handle the concept exactly right in their article in this issue of the Hastings Center Report. They correctly characterize rationing as an ethical requirement, not a moral abomination. They identify the key health policy question as how rationing can best be done, not whether it should be done at all. They make a cogent defense of what they call "rationing through inconvenience" as a justifiable allocational technique. And they wisely call for research on the effectiveness and fairness of this approach and other methods of rationing. I fully agree with their approach to rationing and with their argument that the process they provocatively label "rationing through inconvenience" should not be rejected out of hand. But I believe they have underestimated two ways in which the practical impacts of rationing through inconvenience limit its potential usefulness: the asymmetry of its effect on patients and physicians and the way in which it reduces the capacity of health systems to learn from experience.

Gaps in vaccine financing for underinsured children in the United States.

CONTEXT: The number of new vaccines recommended for children and adolescents has nearly doubled during the past 5 years, and the cost of fully vaccinating a child has increased dramatically in the past decade. Anecdotal reports from state policy makers and clinicians suggest that new gaps have arisen in financial coverage of vaccines for children who are underinsured (ie, have private insurance that does not cover all recommended vaccines). In 2000, approximately 14% of children were underinsured for vaccines in the United States. OBJECTIVES: To describe variation among states in the provision of new vaccines to underinsured children and to identify barriers to state purchase and distribution of new vaccines. DESIGN, SETTING, AND PARTICIPANTS: A 2-phase mixed-methods study of state immunization program managers in the United States. The first phase included 1-hour qualitative telephone interviews conducted from November to December 2005 with 9 program managers chosen to represent different state vaccine financing policies. The second phase incorporated findings from phase 1 to develop a national telephone and paper-based survey of state immunization program managers that was conducted from January to June 2006. MAIN OUTCOME MEASURES: Percentage of states in which underinsured children are unable to receive publicly purchased vaccines in the private or public sectors. RESULTS: Immunization program managers from 48 states (96%) participated in the study. Underinsured children were not eligible to receive publicly purchased meningococcal conjugate or pneumococcal conjugate vaccines in the private sector in 70% and 50% of states, respectively, or in the public sector in 40% and 17% of states, respectively. Due to limited financing for new vaccines, 10 states changed their policies for provision of publicly purchased vaccines between 2004 and early 2006 to restrict access to selected new vaccines for underinsured children. The most commonly cited barriers to implementation in underinsured children were lack of sufficient federal and state funding to purchase vaccines. CONCLUSIONS: The current vaccine financing system has resulted in gaps for underinsured children in the United States, many of whom are now unable to receive publicly purchased vaccines in either the private or public sectors. Additional strategies are needed to ensure financial coverage for all vaccines, particularly new vaccines, among this vulnerable population.

Seeking Legitimacy for DSM-5: The Bereavement Exception as an Example of Failed Process.

In 2013 the American Psychiatric Association (APA) published the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Even before publication, DSM-5 received a torrent of criticism, most prominently over removal of the "bereavement exclusion" for the diagnosis of major depression. We argue that while the APA can claim legitimate authority for deciding scientific questions, it does not have legitimacy for resolving what is ultimately a question of ethics and public policy. We show how the "accountability for reasonableness" framework for seeking legitimacy in health policy could have been used to achieve a better resolution of the conflict than actually occurred.

An ethical template for pharmacy benefits.

We propose an ethical template for pharmacy benefits and a fair process for using it. The template delineates four levels of decisions about pharmacy coverage, connecting ethically acceptable types of rationales for limits with decisions made at each level. It provides a framework for organizing ethically relevant reasons for coverage (or the tiered copayments). The process for using the template assures accountability for the reasonableness of benefit decisions. It requires transparency and relevance of rationales for limit setting and revisability of decisions, including through fair procedures for appeals. The template and the process facilitate broader public learning about fair limit setting.

No place like the hospital.

The gold standard for end-of-life care is home hospice. A case is presented in which a patient dying of irreversible small bowel obstruction from metastatic cancer insisted on remaining in the acute care hospital for care when alternative sites of care, including a skilled nursing facility and residential hospice, were available to her and covered by her health insurance plan. The ethical issues raised by this case are discussed from the perspective of the patient, the clinical team, the hospital, and the insurance company. Over the past decade, hospital-based palliative care consultation and general inpatient hospice care have sought to improve the quality of dying in the hospital. To the extent that such efforts have been successful, they may result in increasing demand for the hospital as the site for terminal care in the future.

Values conflicts in professional-community collaborations.

GAP/I and INP+ represent markedly divergent cultures and therefore highlight the opportunities and strains associated with professional-community collaborations. I believe, however, that the factors that emerge from studying GAP/I-INP+ are not idiosyncratic and are relevant for other professional-community dyads. Every such partnership is likely to require some form of bridging mechanism to serve the same purposes as Mr Varghese's role did. The task of creating a zone of optimal tension may be less familiar than the need to build bridges but it is no less important. Tension between partners with significantly different cultural backgrounds has tremendous potential for generating misunderstanding and distrust. Avoiding tension-laden issues is likely to entail significant cost, whether in the form of resentment, distrust, withdrawal, or settling for a lesser outcome than could be achieved. Finally, creating and sustaining the potential for constructive tension typically requires the humble virtues associated with servant-leadership: patience, persistence and understanding.