Winston Churchill once said, “[t]hings are not always right because they are hard, but if they are right one must not mind if they are also hard.”
How does one define “right” and “hard” during the current pandemic and the care allocation decisions which must be made?
Winston Churchill once said, “[t]hings are not always right because they are hard, but if they are right one must not mind if they are also hard.”
Worldwide there are more than 1 million confirmed cases related to the Coronavirus COVID-19 disease,1 which was declared a pandemic by the World Health Organization on March 11, 2020.2 Just as HIV is the virus which leads to the end disease AIDS, the SARS-CoV-2 virus leads to the infectious disease coronavirus disease COVID-19.3 “In humans, several coronaviruses are known to cause respiratory infections ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). The most recently discovered coronavirus causes coronavirus disease COVID-19.”4
The COVID-19 pandemic is certainly not the first in recent memory. For instance, the cholera pandemic of 1817 had spread worldwide.5 Additionally, according to the Centers for Disease Control and Prevention (CDC), there were four pandemics between 1918 and 2018: 1918 influenza (H1N1);6 1957-1958 influenza A (H2N2) (aka Asian Flu);7 1968 influenza A (H3NN2);8 and 2009 novel influenza A (H1N1).9 However, a significant difference between most of the prior pandemics and COVID-19 is the changes in triage protocols as a result of advancements in medical care and technology, as well as the emergence of Do Not Resuscitate (DNR) orders in the 1970s.
COVID-19 is raising issues around the globe regarding the application of battlefield medicine, the allocation of resources (i.e., ventilators and equipment) and the invocation of universal DNR orders. Interestingly, there is an intersection among mass casualty response, allocation of resources and DNR orders. This article will address battlefield triage medicine, allocation of resources (specifically ventilators) and DNR orders in relation to the COVID-19 pandemic.
“Pandemic disease is arguably one of the greatest threats to global stability and security.”10 Italy was forced to make extraordinary decisions regarding COVID-19 weeks before the United States and implement battlefield triage as the number of cases reached over 10,000 on March 11, 2020.11 “Effective mass casualty response is founded on the principle of triage, the system of sorting and prioritizing casualties based on the tactical situation, mission, and available resources.”12 Triage can be further explained as follows:
A mass casualty scenario is a place where entropy could reign supreme; however, triage provides stability and order. During a mass casualty, the allocation of resources, as well as the assessment time of the injuries, is vital to mitigating loss of life. Not everyone needs to be resuscitated. Those victims should be diverted into the appropriate medical treatment or surgical area.
There are four general categories of triage: immediate, delayed, minimal and expectant. These categories are based on the severity of injury and the timeframe for significant treatment in order to avoid death or major disability.
- Immediate (threatened loss of limb; multiple extremity amputations; uncontrolled hemorrhage; etc.): these individuals are the most critical, with the greatest chance of survival, unlike those who are expectant.
- Delayed (blunt or penetrating torso injuries without signs of shock; fracture; survivable burns; etc.): this group needs surgery but they can wait to undergo the treatment without a significant threat to loss of life or limb. Typically, sustaining treatment in the form of antibiotics, fracture stabilization, pain relief and gastric decompression is required.
- Minimal (abrasions; low degree burns; small bone fractures; etc.): nursing staff can handle these individuals and they should be detoured away from the main medical treatment facility.
- Expectant (no vital signs; transcranial gunshot wounds; etc.): although these types of casualties should not be abandoned, there should be a separate area where they can be monitored and assessed, while the greater resource allocation should go to those whose injuries have a greater chance of recovery.13
Appreciating that triage is used in military medicine, as well as every day in emergency rooms and during mass casualties such as the Mandalay Bay shooting,14 how can battlefield triage be utilized in the COVID-19 pandemic? In relation to the medical decision-making process, physicians are always expected to consider the following when rendering care, especially when resources are limited. In determining whether particular procedures or treatments should be included in the adequate level of healthcare, the following ethical principles should be considered:
- degree of benefit (the difference in outcome between treatment and no treatment),
- likelihood of benefit,
- duration of benefit,
- cost, and
- number of people who will benefit (referring to the fact that a treatment may benefit the patient and others who come into contact with the patient, as with a vaccination or antimicrobial drug).15
These elements are in keeping with the concept of evidence-based medicine. Evidence-based medicine:
[i]s the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. By individual clinical expertise we mean the proficiency and judgment that individual clinicians acquire through clinical experience and clinical practice. Increased expertise is reflected ... in more effective and efficient diagnosis and in the more thoughtful identification and compassionate use of individual patients’ predicaments, rights, and preferences in making clinical decisions about their care.16
Appreciating that while no situation where battlefield triage is being deployed on a mass scale is ideal, having a framework in place can enable more individuals to live because resources are deployed to those with the greatest likelihood of survival.
Allocation of Resources
COVID-19 has stressed resources in the United States and throughout the world. Hospitals in the United States and manufacturers are continuing to report equipment shortages (i.e., ventilators17 and personal protective equipment (PPE).18 “Adequate production and distribution of both types of equipment are crucial to caring for patients during the pandemic.”19 Therefore, a decision-making process needs to be made on both macro and micro levels in relation to resource allocation.
Resource allocation has been described as “the distribution of resources – usually financial – among competing groups of people or programs.”20 In healthcare, three distinct levels of decision-making are associated with decision-making in the context of resource allocation:
- Level 1: allocating resources to healthcare versus other social needs;
- Level 2: allocating resources within the healthcare sector; and
- Level 3: allocating resources among individual patients.21
At Level 1, which addresses macro-level considerations, the issue of resource allocation is fundamentally a brutal trade-off – “inducing massive economic suffering in order to save human lives.”22 The trade-offs between social needs and healthcare require tough decisions. Once those decisions have been made by leaders on a federal, state and local level, with the input of participants from a variety of industries and public health officials, then the step of allocating resources within the healthcare sector can begin.
Level 2, which addresses resource allocation between different providers, is a contentious matter that is discussed multiple times a day in the media. “What am I going to do with 400 ventilators when I need 30,000?” New York’s Governor posited at a March 24, 2020 press conference.23 Additionally, there are tensions between the federal government and a variety of state governments regarding PPE.24
Level 3 requires medical professionals to allocate the available resources among individual patients. This is where battlefield medicine and triage are used to assess who has the best chance of survival, based on a variety of factors. The American Medical Association’s (AMA) Council on Ethical and Judicial Affairs published Opinion 2.03 – Allocation of Limited Medical Resources.25 Opinion 2.03 sets forth three major obligations in relation to physicians who are practicing in a situation where resources are limited or rationed. First, a physician must act in the best interest of the patient in light of the circumstances.26 Second, “[d]ecisions regarding the allocation of limited medical resources among patients should consider only ethically appropriate criteria relating to medical need.”27 Third, to the extent possible, a physician must remain a patient advocate.28 In relation to the third obligation, one must bear in mind that patients have “the right to be informed of the reasoning” behind the allocation decision.29
The second obligation is particularly germane to the COVID-19 pandemic in relation to having a battlefield triage framework in place, which enables the greatest number of people to survive. Kidney dialysis, which is used during the treatment of end-stage renal disease (ESRD), may be illustrative as it was once a rationed resource.30 Prior to 1972, dialysis was viewed as experimental, and there were many more ESRD patients needing treatment than dialysis machines or available funds.31 “There was a public outcry based on the inherent injustice of dialysis allocation, and the federal government responded with Public Law (P. L.) 92-603 in 1972. P. L. 92-603 established the U.S. ESRD program, mandating Medicare coverage for dialysis patients, regardless of age or ability to pay.”32 Note that dialysis supplies and other medical and surgical supplies were not always single-use, disposable items. With appropriate sterilization and cleaning, some items can be reused.
Throughout the evolution of utilizing dialysis for ESRD, four bioethical principles have been applied differently based upon changing considerations related to technology, resource limitations and societal values.33 These four bioethical principles -- beneficence, nonmaleficence, autonomy and justice -- should be considered when setting the framework for battlefield triage and allocating resources during the COVID-19 pandemic. The framework needs to be established beforehand, so that a universal application can occur. As a potential result, scarce resources can be deployed and utilized more effectively.
Do Not Resuscitate (DNR) Orders
“A do not resuscitate order is an advance directive that is to be followed when a person’s heart or breathing stops and they are unable to communicate their wishes to refuse treatment that could allow them to die.”34 In other words, a DNR order requires that the patient not be resuscitated under certain circumstances.
These laws vary on a state-by-state basis, so it is crucial to check the laws of that particular state when drafting a DNR order. For example, in Texas, the law for in-hospital DNR orders tightened considerably. Prior to April 2018, it was possible for a physician to enter a DNR order without the consent of either the patient or the surrogate decision maker.35 Now, physicians need to make certain that patients meet the criteria. Otherwise, a risk of criminal liability is present.
What about the notion of unilateral DNR orders? The seminal case addressing right-to-die decisions is Cruzan v. Director, Missouri Department of Health.36 The Court held that the United States Constitution does not forbid Missouri to require clear and convincing evidence of an incompetent’s wishes to withdraw life-sustaining treatment.37 The Court also opined that “[m]ost state courts have based a right to refuse treatment on the common law right to informed consent, see, e.g., In re Storar, 52 N.Y.2d 363, 438 N.Y.S.2d 266, 420 N.E.2d 64, or on both that right and a constitutional privacy right, see, e.g., Superintendent of Belchertown State School v. Saikewicz, 373 Mass. 728, 370 N.E.2d 417. In addition to relying on state constitutions and the common law, state courts have also turned to state statutes for guidance, see, e.g., Conservatorship of Drabick, 200 Cal. App. 3d 185, 245 Cal. Rptr. 840. However, these sources are not available to this Court, where the question is simply whether the Federal Constitution prohibits Missouri from choosing the rule of law which it did.”
But perhaps the Court’s statement that has the most relevance to DNR orders and the COVID-19 pandemic is that:
“[t]he State may also properly decline to make judgments about the "quality" of a particular individual's life, and simply assert an unqualified interest in the preservation of human life to be weighed against the constitutionally protected interests of the individual. It is self-evident that these interests are more substantial, both on an individual and societal level, than those involved in a common civil dispute.38
Arguably, the notion of “these interests are most substantial, both on an individual and societal level, than those involved in a common civil dispute” is a cornerstone of resource allocation, battlefield triage and the rights of an individual during a pandemic.39 On March 25, 2020, The Washington Post published an article, Hospitals consider universal do-not-resuscitate orders for coronavirus patients, which stated that the basis of these conversations are based on risk management and resource allocation.40 “Northwestern Memorial Hospital in Chicago has been discussing a do-not-resuscitate policy for infected patients, regardless of the wishes of the patient or their family members – a wrenching decision to prioritize the lives of the many over the one.”41 If an appropriate battlefield triage framework, specific to COVID-19 is implemented, is such a drastic measure -- universal DNR orders -- necessary and is it in violation of the United States Constitution, as well as individual state constitutions?
On March 28, 2020, The Atlantic published an article, The Curve is Not Flat Enough, which acknowledged that hospitals are “poised to face the kind of life-and-death decisions that industrialized countries typically encounter only in times of war and natural disaster:”42
Under usual circumstances, a person with a dangerous, infectious respiratory disease such as COVID-19 requires special precautions in a hospital. Everyone who enters the patient’s room—even to ask how they’re doing or to pick up a lunch tray—is required to don a fresh gown, gloves, and a mask. If the worker must get in close contact with the patient, the mask has to be an N95 respirator, and a face shield is required to guard the eyes. Without exception, every piece of this gear must be discarded in a biohazard dispenser upon leaving the room. An errant mask or glove or gown, coated in virus, can become lethal.43
Usual circumstances are not the reality for many providers, especially those in the “hot spots” (i.e., New York, New Orleans, Miami, Chicago), with the United States leading the world in COVID-19 diagnoses and deaths.44 “But without more widespread testing and basic protective equipment, the problem will be less the number of ventilators, and more the number of health-care workers available to operate them. The United States has entered its coronavirus rationing era, and the kind of medical care many people are used to isn’t going to be available all the time.”45
This is why it may be helpful to utilize battlefield triage to minimize the misuse of precious and scarce resources without resorting to universal DNR orders.
While battlefield triage does not eliminate the fact that many lives will be lost, at least it is possible to minimize the loss in a realistic and respectful manner. “Advance directives guide healthcare providers to listen to and respect patients' wishes regarding their right to die in circumstances when cardiopulmonary resuscitation is required, and hospitals accredited by The Joint Commission are required to have a do-not-resuscitate (DNR) policy in place.”46 The Joint Commission has specifications on National Quality Measures related to advanced directives and advance care planning, which require notation in a patient’s medical record.47 DNR orders are a part of everyday life in clinical medicine and hospital operations. But universal DNR orders were proposed to apply to anyone who has the virus regardless of the associated symptoms.48
There is no perfect solution to the issue of having a greater number of patients who have the same need while a limited number of providers and equipment exist. Applying battlefield triage, along with evidence-based decision making, these proposed principles should be considered in relation to COVID-19, in the following order:
- Assess the situation on a country-wide, local and provider-to-patient basis and accept that people will die;
- With the guidance of physicians from a variety of specialties, as well as public health officials and professionals, set universal criteria for treatment (immediate, delayed, minimal, expectant) in relation to the symptoms and stage of COVID-19 with which each individual presents; and
- Flag patients who have a DNR directive, which was executed by a patient ahead of time. Although the Joint Commission requires that hospitals have policies and procedures in place to address this, it appears as though these directives would be disregarded if a universal DNR order is implemented for anyone with COVID-19, regardless of their symptoms, stage of the disease and other factors.
Note that as the Department of Health and Human Services’ Office for Civil Rights (OCR) has signaled, age cannot be the basis of withholding care, as OCR indicated that not providing access to ventilators by the elderly constitutes a civil rights violation.49 Using a battlefield triage model based on evidence-based medicine, providers have to take into account the totality of the person’s medical factors and the likelihood of survival. For instance, an 80-year old who plays golf and only has Type 2 diabetes would be considered healthier and have a better chance of survival than a 30-year old heroin addict.
The reality is that the number of patients infected with COVID-19 far outnumber the medical personnel and supplies that are available to treat them, which triggers the application of pre-determined mass casualty/battlefield triage and treatment protocols specific to COVID-19. This unfortunately requires gut-wrenching decisions related to both the allocation of resources and the application of DNR orders. It’s important that individual rights are considered during this process as well as Constitutional considerations, and the realization that with equipment being utilized instead of mouth-to-mouth resuscitation, a universal DNR order may be an extreme measure. Everyone with COVID-19 would not be resuscitated – is that realistic, ethical and/or legal? That is what a universal DNR order may do.
This article opened with a thought-provoking quotation from Winston Churchill: “Things are not always right because they are hard, but if they are right one must not mind if they are also hard.” How does one define “right” and “hard” during the current pandemic and the care allocation decisions which must be made? Reasonable people would agree that the aforementioned decisions that have to be made are hard. The right course of action is to save as many individuals as possible with the resource constraints that are “in play” at any given time. This means facing the stark reality that not everyone is going to be saved.
- Johns Hopkins, Coronavirus COVID-19, https://coronavirus.jhu.edu/map.html (last visited Apr. 2, 2020).
- World Health Organization, WHO Director-General’s opening remarks at the media briefing on COVID-19 (Mar. 11, 2020), https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020.
- Centers for Disease Control and Prevention, Situation Summary, https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/summary.html (last visited Apr. 1, 2020).
- World Health Organization, Q&A on coronavirus (COVID-19) (Mar. 9, 2020), https://www.who.int/news-room/q-a-detail/q-a-coronaviruses.
- World Health Organization, Global epidemics and impact of cholera, https://www.who.int/topics/cholera/impact/en/ (last visited Mar. 30, 2020). “Throughout history, populations all over the world have sporadically been affected by devastating outbreaks of cholera. Records from Hippocrates (460-377 BC) and Galen (129-216 AD) already described an illness that might well have been cholera, and numerous hints indicate that a cholera-like malady was also known in the plains of the Ganges River since antiquity.”
- Centers for Disease Control and Prevention, 1918 Pandemic (H1N1 virus), https://www.cdc.gov/flu/pandemic-resources/1918-pandemic-h1n1.html (last visited Mar. 30, 2020).
- Centers for Disease Control and Prevention, 1957-1958 Pandemic (H2NN2 virus), https://www.cdc.gov/flu/pandemic-resources/1957-1958-pandemic.html (last visited Mar. 30, 2020).
- Centers of Disease Control and Prevention, 1968 Pandemic (H3N2); https://www.cdc.gov/flu/pandemic-resources/1968-pandemic.html (last visited Mar. 30, 2020).
- Centers for Disease Control and Prevention, 2009 H1N1 Pandemic (H1N1pdm09 virus), https://www.cdc.gov/flu/pandemic-resources/2009-h1n1-pandemic.html (last visited Mar. 30, 2020).
- Monaco, L., & Gupta, V., The Next Pandemic Will Be Arriving Shortly (Sept. 28, 2018), https://foreignpolicy.com/2018/09/28/the-next-pandemic-will-be-arriving-shortly-global-health-infectious-avian-flu-ebola-zoonotic-diseases-trump/.
- Mounk, Y., The Extraordinary Decisions Facing Italian Doctors, The Atlantic (Mar. 11, 2020), https://www.theatlantic.com/ideas/archive/2020/03/who-gets-hospital-bed/607807/.
- Rose, R., V., Lessons from the Battlefield: Effective Implementation of Mass Casualty Response, Nevada State Board of Medical Examiners Newsletter, Vol. 65 (Dec. 2017), http://medboard.nv.gov/uploadedFiles/medboardnvgov/content/Resources/Newsletters/Volume%2065%20-%20December%202017.pdf. See also Cubano, M. L & Lenhart, M. K., Emergency War Surgery, Mass Casualty and Triage, Chap. 3, p.29, http://www.cs.amedd.army.mil/FileDownloadpublic.aspx?docid=68aca9a0-9cd7-4d8f- a17f-a4c01264daef; Woodson, J., MD, Military Medicine Benefits Civilians (Apr. 2014), http://www.usmedicine.com/agencies/department-of-defense-dod/military-medicine-also-benefits-civilians/ (last visited Apr. 7, 2020).
- Tim Craig, ‘Something we would see in a war zone’: Military surgeons on the wounds they treated in Las Vegas, The Washington Post (Oct. 5, 2017), https://www.washingtonpost.com/news/post-nation/wp/2017/10/05/something-we-would-see-in-a-war-zone-military-surgeons-on-the-wounds-they-treated-in-las- vegas/?utm_term=.9fa52afe757d.
- American Medical Association, Opinion 2.03, https://journalofethics.ama-assn.org/article/ama-code-medical-ethics-opinions-allocating-medical-resources/2011-04 (last visited Mar. 30, 2020).
- See Sackett, D.L., Rosenberg, W. M., Gray, J. A., Haynes, R.B., Richardson, W.S., Evidence based medicine: What it is and what it isn’t, BMJ (Jan. 13, 1996); 312 (7023):71–2. doi: 10.1136/bmj.312.7023.71.
- U.S. Food and Drug Administration, 42 C.F.R. § 868.5895, Continuous ventilator, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=868.5895 (defining this Class II device as “[a] continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing of gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.”). Importantly, a continuous ventilator is distinguishable from a multi-function one, which was approved in 2018 by the U.S. Food and Drug Administration through the 510(k) process for durable medical equipment (DME). Known as VOCSN, it’s a device that combines five respiratory therapies: ventilation, oxygen, cough, suction and nebulization. See 83 Fed. Reg. 34304 (Sept. 10, 2018). On April 3, 2020, CMS announced that “Medicare’s multi-function ventilator policy applies to beneficiaries who are prescribed and meet the medical necessity coverage criteria for a ventilator and at least one of the four additional functions (namely, oxygen concentrator, cough stimulator, suction pump, and nebulizer). HCPCS code E0467 is used to describe multi-function ventilators. This article informs DME suppliers that effective immediately, you may provide and bill for multi-function ventilators described by code E0467 as an upgrade in situations where beneficiaries only meet the coverage criteria for a ventilator.” [emphasis in the original]. See https://www.cms.gov/files/document/se20012.pdf.
- Ranney, M., et al., Critical Supply Shortages – The Need for Ventilators and Personal Protective Equipment during the Covid-19 Pandemic, NEJM (Mar. 25, 2020), https://www.nejm.org/doi/full/10.1056/NEJMp2006141.
- See https://www.ahc.umn.edu/img/assets/25857/resource_allocation.pdf (last visited Apr. 2, 2020).
- Northwestern University, Kellogg School of Management, Containing COVID-19 Will Devastate the Economy. Here’s the Economic Case for Why It’s Still Our Best Option (Mar. 26, 2020), https://insight.kellogg.northwestern.edu/article/economic-cost-coronavirus-recession-covid-deaths.
- Nilsen, E., New York is in dire need of ventilators. China just donated 1,000 (Apr. 4, 2020), https://www.vox.com/2020/4/4/21208109/china-donates-1000-ventilators-new-york.
- See https://journalofethics.ama-assn.org/article/ama-code-medical-ethics-opinions-allocating-medical-resources/2011-04 (last visited Apr. 2, 2020).
- See https://www.kidney.org/sites/default/files/v36b_a4.pdf (last visited Apr. 2, 2020).
- Butler, C., The Evolving Ethics of Dialysis in the United States: A Principlist Bioethics Approach, Clin J Am Soc Nephrol (Apr. 7, 2016), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4822659/.
- US Legal, Do Not Resuscitate Order Law and Legal Definition, https://definitions.uslegal.com/d/do-not-resuscitate-order/ (last visited Apr. 1, 2020).
- See https://capitol.texas.gov/tlodocs/851/billtext/pdf/SB00011F.pdf#navpanes=0 (last visited Apr. 1, 2020). Notably, S.B. 11 does not apply to an out-of-hospital DNR order.
- Cruzan v. Director, Missouri Department of Health, 497 U.S. 261 (1990).
- Rose, R.V., Individual rights and communicable diseases in light of the Coronavirus, Physicians Practice (Mar. 26, 2020), https://www.physicianspractice.com/health-law-policy/individual-rights-and-communicable-diseases-light-coronavirus.
- See https://www.washingtonpost.com/health/2020/03/25/coronavirus-patients-do-not-resucitate/.
- See https://www.theatlantic.com/health/archive/2020/03/coronavirus-forcing-american-hospitals-ration-care/609004/.
- Sumrall, W. D. et al., Do Not Resuscitate, Anesthesia, and Perioperative Care: A Not So Clear Order, Ochsner J., pp. 176-179 (Summer 2016), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4896664/.
- Joint Commission, Specifications Manual for Joint Commission National Quality Measures (v2018A), https://manual.jointcommission.org/releases/TJC2018A/DataElem0613.html (last visited Apr. 6, 2020).
- See supra n. 41.
- OCR Reaches Early Case Resolution With Alabama After It Removes Discriminatory Ventilator Triaging Guidelines, Apr. 8, 2020, https://www.hhs.gov/about/news/2020/04/08/ocr-reaches-early-case-resolution-alabama-after-it-removes-discriminatory-ventilator-triaging.html.
About the Authors
Rachel V. Rose advises clients on healthcare, cybersecurity and qui tam matters. Ms. Rose also teaches bioethics at Baylor College of Medicine. She has been consecutively named by Houstonia Magazine as a Top Lawyer (Healthcare), the National Women Trial Lawyer’s Top 25 and the National Trial Lawyers Top 100.
Lance H. Rose, MHA, MS, LFACHE, is a retired hospital chief executive officer, who began his healthcare career serving in the United States Navy during Vietnam, where, first-hand, he experienced the application of battlefield medicine. Mr. Rose has served on numerous boards, including the American Hospital Association’s Regional Policy Board. He also taught as an adjunct professor at The Pennsylvania State University.
The authors can be reached at email@example.com.