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\fTllr NEW ENGLAND JOURNAL nfMEDlClNE Table 1. Potential us. Health and Health Care E'ects of Pandemic Covid-IB as Compared with Influenza? Category Inuenza Covid-lg'i' Moderate Severe Moderate Severe Percentage of population infected 20 20 5 20 (U.S. population, 320 million) No. ofill persons 64,000,000 64,000,000 16,000,000 64,000,000 No. ofoutpatients 32,000,000 32,000,000 3,200,000 12,300,000 No. ofhospitalized patients 800,000 3,800,000 1,280,000 5,120,000 No. of patients admitted to the ICU 160,000 1,200,000 960,000 3,840,000 No. ofdeaths 48,000 510,000 80,000 1,920,000 * Inuenza numbers are based on the HHS Pandemic Inuenza Plan. Moderate and severe cases differ with respect to case severity, not prevalence. Covid~19 infections and hospitalization estimates are based on references from China and Italy.\" ICU usage numbers are based on the Imperial College Covid-19 Response team predictions.a 'l' The Covid-19 scenarios are much more conservative than the Imperial College Covid-19 Response team predictions that 81% ofthe population will be infected over the course ofthe epidemic without any action. The moderate and severe COVIDA19 scenarios assume that public health measures such as social distancing reduce infection rates by roughly 95% and 75%, respectively. The moderate Covid-19 scenario is based on the following assumptions: 80% of infected patients are asymptomatic or have mild symptoms not requiring health care services; ofthe 20% requiring health care services, 40% (8% overall) need hospitalization; 6% ofall infected patients 7 30% ofthose needing health care need intensive care; and there is a death rate of 0.5%. The severe Covid-19 scenario is based on the following assumptions: 80% ofinfected patients are asymptomatic or have mild symptoms not requiring health care services; ofthe 20% requiring health care services, 40% (8% overall) need hospitalization; 6% of all infected patients 7 30% of those needing health care 7 need intensive care, and there is a death rate of 3.0%. and other interventions. However, the estimate given above that 5% of the population is infected 7 is low; new data are only likely to increase estimates of sickness and demand for health care infrastructure. HEALTH SYSTEM CAPACITY Even a conservative estimate shows that the health needs created by the coronavirus pan- demic go well beyond the capacity of US. hospi tals.9 According to the American Hospital Asso ciation, there were 5198 community hospitals and 209 federal hospitals in the United States in 2018. In the community hospitals, there were 792,417 beds, with 3532 emergency departments and 96,500 ICU beds, of which 23,000 were neo- natal and 5100 pediatric, leaving just under 68,400 ICU beds of all types for the adult popu lation.12 Other estimates of ICU bed capacity, which try to account for purported undercounting in the American Hospital Association data, show a total of 85,000 adult ICU beds of all types.13 There are approximately 62,000 fullfeatured ventilators (the type needed to adequately treat the most severe complications of Covid-19) avail able in the United States.\" Approximately 10,000 to 20,000 more are estimated to be on call in our N ENGLJ MED Strategic National Stockpile,15 and 98,000 venti lators that are not full-featured but can provide basic function in an emergency during crisis stan dards of care also exist.\" Supply limitations con- strain the rapid production of more ventilators; manufacturers are unsure of how many they can make in the next year.16 However, in the Covid19 pandemic, the limiting factor for ventilator use will most likely not be ventilators but healthy re- spiratory therapists and trained critical care staff to operate them safely over three shifts every day. In 2018, community hospitals employed about 76,000 full-time respiratory therapists,12 and there are about 512,000 critical care nurses of which ICU nurses are a subset.17 California law requires one respiratory therapist for every four ventilated patients; thus, this number of respira- tory therapists could care for a maximum of 100,000 patients daily (25,000 respiratory thera pists per shift). Given these numbers 7 and unless the epi- demic curve of infected individuals is flattened over a very long period of time 7 the Covid-19 pandemic is likely to cause a shortage of hospital beds, ICU beds, and ventilators. It is also likely to affect the availability of the medical workforce, since doctors and nurses are already becoming ill or quarantined.lg Even in a moderate pandemic, NE} MORE. The New England Journal ofMedicine Downloaded from nejm.org on April 1, 2020. For personal use only. No other uses without permission. Copyright 2020 Massachusetts Medical Society. All rights reserved. SOUNDING BOARD hospital beds and ventilators are likely to be scarce in geographic areas with large outbreaks, such as Seattle, or in rural and smaller hospitals that have much less space, staff, and supplies than large academic medical centers. Diagnostic, therapeutic, and preventive inter- ventions will also be scarce. Pharmaceuticals like chloroquine, remdesivir, and favipiravir are cur- rently undergoing clinical trials, and other experi- mental treatments are at earlier stages of study.\"21 Even if one of them proves effective, scaling up supply will take time.22 The use of convalescent serum, blood products from persons whose im- mune system has defeated Covid-19, is being contemplated as a possible treatment and pre- ventive intervention.\" Likewise, if an effective vac- cine is developed, it will take time to produce, distribute, and administer. Other critical medical supplies and equipment, such as personal protec- tive equipment [PPE), are already scarce, present- ing the danger that medical staff time will itself become scarce as physicians and nurses become infected.2 Technical and governmental failures in the United States have led to a persistent scar- city of tests.23 As more countries have been af- fected by Covid-19, worldwide demand for tests has begun to outstrip production, creating the need to prioritize patients. Public health measures known to reduce viral spread, such as social distancing, cough etiquette, and hand hygiene, finally seem to be a U.S. na- tional priority and may make resource shortages less severe by narrowing the gap between medi- cal need and the available supply of treatments. But public health mitigation efforts do not obviate the need to adequately prepare for the allocation of scarce resources before it becomes necessary. The choice to set limits on access to treatment is not a discretionary decision, but a necessary re- sponse to the overwhelming effects of a pandemic. The question is not whether to set priorities, but how to do so ethically and consistently, rather than basing decisions on individual institutions' approaches or a clinician's intuition in the heat of the moment. ETHICAL VALUES FOR RATIONING HEALTH RESOURCES IN A PANDEMIC Previous proposals for allocation of resources in pandemics and other settings of absolute scarcity, including our own prior research and analysis, N ENGLJ MED converge on four fundamental values: maximizing the benets produced by scarce resources, treating people equally, promoting and rewarding instru- mental value, and giving priority to the worst off?\"9 Consensus exists that an individual per- son's wealth should not determine who lives or dies\"? Although medical treatment in the United States outside pandemic contexts is often restricted to those able to pay, no proposal endorses abili- ty-to'pay allocation in a pandemic.2MB Each of these four values can be operational- ized in various ways [Table 2). Maximization of benets can be understood as saving the most individual lives or as saving the most life-years by giving priority to patients likely to survive longest after treatment.2\"'2\"'23'29 Treating people equally could be attempted by random selection, such as a lottery, or by a firstcome, first-served alloca- tion.\"28 Instrumental value could be promoted by giving priority to those who can save others, or rewarded by giving priority to those who have saved others in the past.2\"" And priority to the worst off could be understood as giving priority either to the sickest or to younger people who will have lived the shortest lives if they die untreat- eat-24,2840 The proposals for allocation discussed above also recognize that all these ethical values and ways to operationalize them are compelling. No single value is sufficient alone to determine which patients should receive scarce resources.\"33 Hence, fair allocation requires a multivalue ethical frame- work that can be adapted, depending on the re- source and context in question?\" WHO GETS HEALTH RESOURCES IN A COVlD-19 PANDEMIC? These ethical values 7 maximizing benefits, treat- ing equally, promoting and rewarding instrumen- tal value, and giving priority to the worst offi yield six specific recommendations for allocating medical resources in the Covid-19 pandemic: maximize benets; prioritize health workers; do not allocate on a first-come, firstserved basis; be responsive to evidence; recognize research par- ticipation; and apply the same principles to all Covid-19 and nonHCovid-19 patients. Recommendation 1: In the context of a pan- demic, the value of maximizing benefits is most important.\"613193133 This value reflects the im- portance of responsible stewardship of resources: NEJM.ORG The New England Journal of Medicine Downloaded from nejmbrg on April 1, 2020. For personal use only. No other uses without permission. Copyright 2020 Massachusetts Medical Society. All rights reserved. The NEW ENGLAND JOURNAL ufMEDJClNE Table 2. Ethical Values to Guide Rationing of Absolutely Scarce Health Care Resources in a Covid-IB Pandemic. Ethical Values and Guiding Principles Maximize benets Save the most lives Save the most life-years i maximize prognosis Treat people equally FirstAcome, rst-served Random selection Promote and reward instrumental value (benet to others) Retrospective priority to those who have made relevant contributions Prospective 7 priority to those who are likely to make relevant contributions Give priority to the worst of'f Sickest rst Youngest rst Application to COVlD-19 Pandemic Receives the highest priority Receives the highest priority Should not be used Used for selecting among patients with similar prognosis Gives priority to research participants and health care workers when other factors such as maximizing benets are equal Gives priority to health care workers Used when it aligns with maximizing benets Used when it aligns with maximizing benets such as preventing spread ofthe virus it is difcult to justify asking health care work- ers and the public to take risks and make sacri- ces if the promise that their efforts will save and lengthen lives is illusory.\" Priority for lim ited resources should aim both at saving the most lives and at maximizing improvements in individuals' post-treatment length of life. Saving more lives and more years oflife is a consensus value across expert reportsvl'u" It is consistent both with utilitarian ethical perspectives that emphasize population outcomes and with non- utilitarian views that emphasize the paramount value of each human life.\" There are many rea sonable ways of balancing saving more lives against saving more years of life\"; whatever bal- ance between lives and life-years is chosen must be applied consistently. Limited time and information in a Covid-19 pandemic make it justiable to give priority to maximizing the number of patients that survive treatment with a reasonable life expectancy and to regard maximizing improvements in length of life as a subordinate aim. The latter becomes relevant only in comparing patients whose like- lihood of survival is similar. Limited time and information during an emergency also counsel against incorporating patients' future quality of life, and qualityadjusted life-years, into benet maximization. Doing so would require time- N ENGLJ MED The New England Journal consuming collection of information and would present ethical and legal problems?\" However, encouraging all patients, especially those facing the prospect of intensive care, to document in an advance care directive what future quality of life they would regard as acceptable and when they would refuse ventilators or other life-sustaining interventions can be appropriate. Operationalizing the value of maximizing ben- efits means that people Who are sick but could recover if treated are given priority over those who are unlikely to recover even if treated and those who are likely to recover without treatment. Because young, severely ill patients will often comprise many of those who are sick but could recover with treatment, this operationalization also has the effect of giving priority to those who are worst off in the sense of being at risk of dy- ing young and not having a full lifezs'mo Because maximizing benefits is paramount in a pandemic, we believe that removing a patient from a ventilator or an ICU bed to provide it to others in need is also justiable and that pa- tients should be made aware of this possibility at admission.\"23'29'm' Undoubtedly, withdrawing ventilators or ICU support from patients who arrived earlier to save those with better progno- sis Will be extremely psychologically traumatic for clinicians 7 and some clinicians might re- NEJM.ORG of Medicine Downloaded from nejmorg on April 1, 2020. For personal use only. No other uses without permission. Copyright 2020 Massachusetts Medical Society. All rights reserved. SOUNDING BOARD fuse to do so. However, many guidelines agree that the decision to withdraw a scarce resource to save others is not an act of killing and does not require the patient's consent.26~23-2"'33"' We agree with these guidelines that it is the ethical thing to do.26 Initially allocating beds and venti- lators according to the value of maximizing ben- ets could help reduce the need for withdrawal. Recommendation 2: Critical Covid-19 inter- ventions testing, PPE, ICU beds, ventilators, therapeutics, and vaccines 7 should go rst to front-line health care workers and others who care for ill patients and who keep critical infra- structure operating, particularly workers who face a high risk ofinfection and whose training makes them difficult to replace.27 These workers should be given priority not because they are somehow more worthy, but because of their in- strumental value: they are essential to pandemic response.2723 If physicians and nurses are inca- pacitated, all patients 7 not just those with Covid-19 7 will suffer greater mortality and years of life lost. Whether health workers who need ventilators will be able to return to work is uncertain, but giving them priority for ventila- tors recognizes their assumption of the highrisk work of saving others, and it may also discourage absenteeisma'36 Priority for critical workers must not be abused by prioritizing wealthy or famous persons or the politically powerful above first responders and medical staff 7 as has already happened for testing.37 Such abuses will under- mine trust in the allocation framework. Recommendation 3: For patients with similar prognoses, equality should be invoked and op- erationalized through random allocation, such as a lottery, rather than a rstcome, firstserved allocation process. First-come, first-served is used for such resources as transplantable kidneys, where scarcity is long-standing and patients can survive without the scarce resource. Conversely, treatments for coronavirus address urgent need, meaning that a rst'come, first-served approach would unfairly benefit patients living nearer to health facilities. And rst-come, first-served med- ication or vaccine distribution would encourage crowding and even violence during a period when social distancing is paramount. Finally, first-come, first-served approaches mean that people who happen to get sick later on, perhaps because of their strict adherence to recommended public health measures, are excluded from treatment, N ENGLJ MED worsening outcomes without improving fairness.\" In the face of time pressure and limited informa- tion, random selection is also preferable to trying to make nergrained prognostic judgments with- in a group of roughly similar patients. Recommendation 4: Prioritization guidelines should differ by intervention and should respond to changing scientific evidence. For instance, younger patients should not be prioritized for Covid19 vaccines, which prevent disease rather than cure it, or for experimental post or pre- exposure prophylaxis. Covid-19 outcomes have been signicantly worse in older persons and those with chronic conditions.E Invoking the value of maximizing saving lives justifies giving older persons priority for vaccines immediately after health care workers and first responders. If the vaccine supply is insufcient for patients in the highest risk categories 7 those over 60 years of age or with coexisting conditions then equal- ity supports using random selection, such as a lottery, for vaccine allocation.\"28 Invoking in- strumental value justifies prioritizing younger patients for vaccines only if epidemiologic mod- eling shows that this would be the best way to reduce viral spread and the risk to others. Epidemiologic modeling is even more relevant in setting priorities for coronavirus testing. Fed- eral guidance currently gives priority to health care workers and older patients,38 but reserving some tests for public health surveillance (as some states are doing) could improve knowledge about Co- vid-19 transmission and help researchers target other treatments to maximize benets.\" Conversely, ICU beds and ventilators are cura- tive rather than preventive. Patients who need them face life-threatening conditions. Maximizing ben- ets requires consideration of prognosis 7 how long the patient is likely to live if treated 7 which may mean giving priority to younger patients and those with fewer coexisting conditions. This is consistent with the Italian guidelines that poten- tially assign a higher priority for intensive care access to younger patients with severe illness than to elderly patients.\"4 Determining the ben- etzmaximizing allocation of antivirals and oth- er experimental treatments, which are likely to be most effective in patients who are seriously but not critically ill, will depend on scientific evi- dence. These treatments may produce the most benefit if preferentially allocated to patients who would fare badly on ventilation. NEJM.ORG The New England Journal of Medicine Downloaded from nejm org on April 1, 2020. For personal use only No other uses without permission. Copyright 2020 Massachusetts Medical Society. All rights reserved. The NEW ENGLAND JOURNAL of MEDICINE Recommendation 5: People who participate in side direct patient care, or committees of expe research to prove the safety and effectiveness of rienced physicians and ethicists, to help apply vaccines and therapeutics should receive some guidelines, to assist with rationing decisions, or priority for Covid-19 interventions. Their assump- to make and implement choices outright - re- tion of risk during their participation in research lieving the individual front-line clinicians of that helps future patients, and they should be re- burden.2 Institutions may also include appeals warded for that contribution. These rewards will processes, but appeals should be limited to con- also encourage other patients to participate in cerns about procedural mistakes, given time and clinical trials. Research participation, however, resource constraints. should serve only as a tiebreaker among patients with similar prognoses. CONCLUSIONS Recommendation 6: There should be no dif- ference in allocating scarce resources between Governments and policy makers must do all they patients with Covid-19 and those with other medi- can to prevent the scarcity of medical resources. cal conditions. If the Covid-19 pandemic leads to However, if resources do become scarce, we be- absolute scarcity, that scarcity will affect all pa- lieve the six recommendations we delineate should tients, including those with heart failure, cancer, be used to develop guidelines that can be applied and other serious and life-threatening conditions fairly and consistently across cases. Such guide- requiring prompt medical attention. Fair alloca- lines can ensure that individual doctors are never tion of resources that prioritizes the value of tasked with deciding unaided which patients re- maximizing benefits applies across all patients ceive life-saving care and which do not. Instead, who need resources. For example, a doctor with we believe guidelines should be provided at a an allergy who goes into anaphylactic shock and higher level of authority, both to alleviate physi- needs life-saving intubation and ventilator sup- cian burden and to ensure equal treatment. The port should receive priority over Covid-19 patients described recommendations could shape the de- who are not frontline health care workers. velopment of these guidelines. Disclosure forms provided by the authors are available with IMPLEMENTING RATIONING POLICIES the full text of this article at NEJM.org. The need to balance multiple ethical values for From the Department of Medical Ethics and Health Policy, Perel- man School of Medicine, University of Pennsylvania, Philadel- various interventions and in different circumstance phia (E.J.E., A.G., C.Z., C.B.); the University of Denver Sturm Col- es is likely to lead to differing judgments about lege of Law, Denver (G.P.); the Division of Clinical Public Health, how much weight to give each value in particular Dalla Lana School of Public Health, University of Toronto, To- ronto (R.U.), and the School of Health Studies, Western Univer- cases. This highlights the need for fair and con- sity, London, ON (M.S.) - both in Canada; the Preventive Medi- sistent allocation procedures that include the af- cine Department, Federal University of Sao Paulo, Sao Paulo fected parties: clinicians, patients, public officials, (B.T.); the Wellcome Centre of Ethics and Humanities, the Ethox Centre, University of Oxford, Oxford, United Kingdom (M.P.); and others. These procedures must be transparent and the Department of Emergency Medicine, George Washing- to ensure public trust in their fairness. ton University Hospital, Washington, DC (J.P.P.). The outcome of these fair allocation proce- This article was published on March 23, 2020, at NEJM.org. dures, informed by the ethical values and recom- mendations delineated here, should be the devel- 1. Pandemic influenza plan: 2017 update. Washington, DC: opment of prioritization guidelines that ensure Department of Health and Human Services, 2017 (https://www .cdc.gov/flu/pandemic-resources/pdf/pan-flu-report-2017v2.pdf). that individual physicians are not faced with the 2. Strategies for optimizing the supply of N95 respirators. At terrible task of improvising decisions about lanta: Centers for Disease Control and Prevention, 2020 (https:/ whom to treat or making these decisions in iso- www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/ index.html). lation. Placing such burdens on individual physi- 3. Vergano M, Bertolini G, Giannini A, et al. Clinical Ethics cians could exact an acute and life-long emotional Recommendations for the Allocation of Intensive Care Treat- toll. However, even well-designed guidelines can ments, in Exceptional, Resource-Limited Circumstances. Italian Society of Anesthesia, Analgesia, Resuscitation, and Intensive present challenging problems in real-time deci- Care (SIAARTI). March 16, 2020 (http:/www.siaarti.it/ sion making and implementation. To help clini- SiteAssets/News/COVID19%20-%20documenti%20SIAARTI/ cians navigate these challenges, institutions may SIAARTI%20-%20Covid-19%20-%20Clinical%20Ethics%20 Reccomendations.pdf). employ triage officers, physicians in roles out- 4. Mounk Y. The extraordinary decisions facing Italian doctors. N ENGL J MED NEJM.ORG The New England Journal of Medicine Downloaded from nejm.org on April 1, 2020. For personal use only. No other uses without permission. Copyright 2020 Massachusetts Medical Society. All rights reserved