Reflections on New Evidence on Crisis Standards of Care in the COVID-19 Pandemic.

Crisis standards of care have been widely developed by healthcare systems and states in the United States during the COVID-19 pandemic, and in some rare cases have actually been used to allocate medical resources. All publicly available U.S. crisis standards of care with a mechanism for allocating scarce resources make use of the Sequential Organ Failure Assessment (SOFA) score in hopes of assigning scarce resources to those patients who are more likely to survive. We reflect on the growing body of evidence suggesting that the SOFA score has limited accuracy in predicting mortality among patients hospitalized with COVID-19 and that the SOFA score systematically disfavors Black patients. Use of the SOFA score for allocating scarce resources may therefore result in Black patients with equal likelihood of survival being deprived of life-saving medical resources. There is also a risk of injustice for patients with non-COVID-19 diagnoses, for whom the SOFA score may be a more accurate prognostic score, but who might nevertheless be unfairly (de)prioritized when assessed alongside COVID-19 patients using the same scoring system. For these reasons we recommend that the SOFA score not be used for triage purposes during the COVID pandemic, and that a national effort be made to develop and empirically test crisis standards of care in advance of the next public health emergency.

Racial disparities in the SOFA score among patients hospitalized with COVID-19.

BACKGROUND: Sequential Organ Failure Assessment (SOFA) score predicts probability of in-hospital mortality. Many crisis standards of care suggest the use of SOFA scores to allocate medical resources during the COVID-19 pandemic. RESEARCH QUESTION: Are SOFA scores elevated among Non-Hispanic Black and Hispanic patients hospitalized with COVID-19, compared to Non-Hispanic White patients? STUDY DESIGN AND METHODS: Retrospective cohort study conducted in Yale New Haven Health System, including 5 hospitals with total of 2681 beds. Study population drawn from consecutive patients aged ≥18 admitted with COVID-19 from March 29th to August 1st, 2020. Patients excluded from the analysis if not their first admission with COVID-19, if they did not have SOFA score recorded within 24 hours of admission, if race and ethnicity data were not Non-Hispanic Black, Non-Hispanic White, or Hispanic, or if they had other missing data. The primary outcome was SOFA score, with peak score within 24 hours of admission dichotomized as <6 or ≥6. RESULTS: Of 2982 patients admitted with COVID-19, 2320 met inclusion criteria and were analyzed, of whom 1058 (45.6%) were Non-Hispanic White, 645 (27.8%) were Hispanic, and 617 (26.6%) were Non-Hispanic Black. Median age was 65.0 and 1226 (52.8%) were female. In univariate logistic screen and in full multivariate model, Non-Hispanic Black patients but not Hispanic patients had greater odds of an elevated SOFA score ≥6 when compared to Non-Hispanic White patients (OR 1.49, 95%CI 1.11-1.99). INTERPRETATION: Given current unequal patterns in social determinants of health, US crisis standards of care utilizing the SOFA score to allocate medical resources would be more likely to deny these resources to Non-Hispanic Black patients.

The potential impact of triage protocols on racial disparities in clinical outcomes among COVID-positive patients in a large academic healthcare system.

BACKGROUND: The COVID-19 pandemic has had a devastating impact in the United States, particularly for Black populations, and has heavily burdened the healthcare system. Hospitals have created protocols to allocate limited resources, but there is concern that these protocols will exacerbate disparities. The sequential organ failure assessment (SOFA) score is a tool often used in triage protocols. In these protocols, patients with higher SOFA scores are denied resources based on the assumption that they have worse clinical outcomes. The purpose of this study was to assess whether using SOFA score as a triage tool among COVID-positive patients would exacerbate racial disparities in clinical outcomes. METHODS: We analyzed data from a retrospective cohort of hospitalized COVID-positive patients in the Yale-New Haven Health System. We examined associations between race/ethnicity and peak overall/24-hour SOFA score, in-hospital mortality, and ICU admission. Other predictors of interest were age, sex, primary language, and insurance status. We used one-way ANOVA and chi-square tests to assess differences in SOFA score across racial/ethnic groups and linear and logistic regression to assess differences in clinical outcomes by sociodemographic characteristics. RESULTS: Our final sample included 2,554 patients. Black patients had higher SOFA scores compared to patients of other races. However, Black patients did not have significantly greater in-hospital mortality or ICU admission compared to patients of other races. CONCLUSION: While Black patients in this sample of hospitalized COVID-positive patients had higher SOFA scores compared to patients of other races, this did not translate to higher in-hospital mortality or ICU admission. Results demonstrate that if SOFA score had been used to allocate care, Black COVID patients would have been denied care despite having similar clinical outcomes to white patients. Therefore, using SOFA score to allocate resources has the potential to exacerbate racial inequities by disproportionately denying care to Black patients and should not be used to determine access to care. Healthcare systems must develop and use COVID-19 triage protocols that prioritize equity.

A Small-Town Heart.

Melanie presented at twenty weeks of gestation to an obstetrics clinic in a critical access hospital in rural Vermont. She was excited to undergo routine fetal ultrasonography, but her obstetrician gave her grave news: the ultrasound revealed hypoplastic left heart syndrome, a devastating congenital heart defect. Initially, Melanie agreed in general to pursue surgical care for her fetus-a three-stage process that has somewhat uncertain results and could only be done in tertiary care facilities far from her home in Vermont. A week later, while the maternal fetal medicine and pediatric cardiology units made arrangements with colleagues in Boston, Melanie began having second thoughts. An ethics meeting was called to discuss conflicting clinician reactions to Melanie's dilemma. Most of the clinicians were stunned that the patient would change her mind. What advice should the ethics consultant offer the team about caring for Melanie?

Hospital Taxes, Medicaid Supplemental Payments, and State Budgets.

The federal Medicaid statute provides states an incentive to tax hospitals (even otherwise tax-exempt ones) as a means of raising revenue and then leverage federal matching funds by returning at least some of the tax back to the hospitals in the form of Medicaid supplemental payments. The potential for supplemental payments is attractive to hospitals, especially those struggling to recoup the costs of treating Medicaid and uninsured patients, and has resulted in political support from hospitals for states to create hospital "taxes" in name only-hospitals and states both end up with more money than they did when they started because of the federal match. When state officials begin to perceive, however, that nonprofit hospitals may be serving private rather than public interests, they are able to use these hospital taxes as a way to incrementally chip away at the historic governmental support provided through tax exemption by redirecting the revenue raised from the hospital tax to general fund purposes rather than Medicaid supplemental payments. This article looks at how states have been using hospital taxes and supplemental payments to balance state budgets and whether this practice is consistent with the Medicaid program objectives that make the taxes politically feasible.

Developing a Triage Protocol for the COVID-19 Pandemic: Allocating Scarce Medical Resources in a Public Health Emergency.

The coronavirus disease-2019 (COVID-19) has caused shortages of life-sustaining medical resources, and future waves of the virus may cause further scarcity. The Yale New Haven Health System developed a triage protocol to allocate scarce medical resources during the COVID-19 pandemic, with the primary goal of saving the most lives possible, and a secondary goal of making triage assessments and decisions consistent, transparent, and fair. We outline the process of developing the triage protocol, summarize the protocol itself, and discuss the major ethical challenges encountered, along with our answers to these challenges. These challenges include (1) the role of age and chronic comorbidities; (2) evaluating children and pregnant patients; (3) racial, ethnic, and socioeconomic disparities in health; (4) prioritization of healthcare workers; and (5) balancing clinical judgment versus protocolized assessments. We conclude with a review of the limitations of our protocol and the lessons learned. We hope that a robust public discussion of such protocols and the ethical challenges that they raise will result in the fairest possible processes, less need for triage, and more lives saved during future waves of the COVID-19 pandemic and similar public health emergencies.

The ethics of caring for hospital-dependent patients.

BACKGROUND: Hospital-dependent patients are individuals who are repeatedly readmitted to the hospital because their acute medical needs cannot be met elsewhere. Unlike the chronically critically ill, these patients do not have a continuous need for life-sustaining equipment and can experience periods of relative stability where they have a good quality of life. However, some end up spending months or even years in the hospital receiving resource-intensive care because they are unable to be safely discharged, despite an initial optimistic prognosis. It is hard to reliably identify these patients on admission and more research is needed to better understand the unique medical needs of this population. But the inability to safely discharge these patients to their home or to a skilled nursing facility without rapid readmissions also creates ethical implications for the physicians who care for them. The aim of this paper is to clarify some of the ethical considerations involved in caring for hospital-dependent patients. MAIN BODY: Among physicians, the care of hospital-dependent patients is likely to disproportionately affect hospitalists and intensivists, whose care is often evaluated in terms of reducing patient length of stay and readmissions. Because hospital-dependent patients' medical needs thwart the traditional goal of safe discharge, both clinical ethics and physicians' professional obligations are implicated by their care. The inability to reliably identify these patients early can complicate discussions about treatment goals and informed consent. Similarly, the tremendous dedication of limited resources to these patients without safe discharge back to the community may raise concerns about the just allocation of healthcare resources. CONCLUSION: Our current acute care hospitals are not designed to provide long-term care for hospital-dependent patients. Unfortunately, safe discharge options remain elusive for these patients. Further research and support of this population is needed to more reliably identify hospital-dependent patients on admission, better inform the discussions of short- and long-term treatment goals, and more wisely allocate resources both within our acute care hospitals and larger healthcare system.

Permanent Patients: Hospital Discharge Planning Meets Housing Insecurity.

Not all hospital inpatients need the level of care (including staffing, testing, monitoring, and treatment) uniquely available in the acute-care setting. In the United States, these longer-term, nonacute inpatients tend to be some combination of chronically ill, poor, homeless, undocumented, uninsured, and disabled-all groups who have struggled for health equity, political recognition, and voice. Even so, these "permanent patients" continue to receive care in one of the most expensive settings. This phenomenon is the result of federal legislation that creates an affirmative duty to care for all able to access our emergency departments without also making safe housing available to all. A handful of federal laws and policies as well as a potpourri of state laws and policies are involved.

How Medicare Part D, Medicaid, electronic prescribing, and ICD-10 could improve public health (but only if CMS lets them).

A simple change to the Medicare and Medicaid outpatient prescription drug billing systems could improve patient safety and the systems' long-term fiscal stability. Including diagnosis codes on prescription drug claims (codes already in use for other billing purposes) would transform the Medicare Part D and Medicaid prescription drug claims databases into powerful public health research tools--ones that could provide much-needed (and, to date, elusive) information on how prescription drugs work in vulnerable patient populations underrepresented in clinical research. Achieving the full potential of this proposal, though, depends upon the federal agency responsible for Medicare and Medicaid, the Centers for Medicare and Medicaid Services (CMS), maintaining its current reimbursement policy, which is perhaps best characterized as one of benign neglect of the statutory standard for coverage. If, instead of continuing coverage for the vast majority of prescription drugs, CMS decided to deny payment for the millions of prescriptions falling short of the statutory standard (and thus avoid spending billions of federal health care dollars), prescribers would find themselves in an ethical dilemma between truth-telling and effectively treating their patients. Due to the systemic incentives for prescribers and pharmacists to miscode diagnoses in order to get CMS to pay for the prescription drugs needed by patients, the decision to treat patients effectively in the short-term under a strict coverage enforcement policy would undermine the potential to more effectively treat vulnerable patients, reduce prescription errors, and properly allocate federal health care dollars in the future. Even in the midst of a financial crisis, or perhaps especially because of our current financial crisis, we cannot afford to sacrifice improved patient safety and better informed long-term management of federal health care dollars for a short-term reduction in federal spending on prescription drugs.