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April 17, 2020
Health Law Weekly

Ventilator Allocation: Considerations During the COVID-19 Pandemic

  • April 17, 2020
  • Raj Shah , Institute at MagMutual
  • Susannah Gleason , MagMutual Insurance Company

The COVID-19 pandemic exposed the scarcity of ventilators throughout the United States. Both health care providers and the American public acknowledge that the nation’s health care system does not have sufficient ventilator capacity and challenging decisions regarding ventilator allocation and usage must be made. This concern is coupled with a lack of federal regulatory guidance on how hospitals should allocate the existing ventilators that are available when a hospital’s demand for additional ventilators exceeds its ventilator supply. While some states enacted guidance regarding ventilator allocation, the majority of hospitals are located within states that have not provided sufficient regulatory guidance outlining the optimum allocation of existing ventilators. This article explores the current state of hospital decision making regarding ventilator allocation and the existing ventilator allocation models available during the COVID-19 pandemic.

Most hospitals are not used to making decisions regarding scarce resources and ventilator allocation. Because of this inexperience, hospitals generally establish a triage committee.[1] A triage committee is composed of individuals, such as physicians and nurses, removed from the care of the patient.[2] The triage committee creates guidance regarding how the hospital will handle its ventilator allocation and then makes decisions based on that guidance.[3] This way, a health care provider treating a patient does not have to compromise their legal duty of care to their patient by making the ventilator allocation decision, but rather, can focus on advocating for their patient within the bounds of the triage committee’s guidance.[4]

The guidance the triage committee develops involves multiple considerations, including existing state guidelines or their health care system’s existing guidelines. A few states have enacted new guidance on how health care providers within that state should allocate resources such as ventilators, while others are following older models.[5] For example, New York issued guidelines in 2015 that essentially boil down to “save the most lives,” which has been recommended for physicians to follow now as well.[6] Alternatively, Minnesota and Pennsylvania use a point system, which prioritizes patients based on who benefits the most.[7] Arizona created a color-coded chart to assess a patient’s need.[8] Colorado is following its influenza plan from 2018, which sets exclusion criteria for allocation.[9] In 2011, the Centers for Disease Control and Prevention (CDC) published guidelines recommending that hospitals follow basic bioethics principles in allocation decision making, which include respect, beneficence, and justice.[10] These principles include informed consent, the best interest of the patient, and allocating with equality.[11] While these principles provide some framework, many of these principles are in conflict during the COVID-19 pandemic, such as balancing the best interest for the patient versus the best interest for public health. To date, the CDC has not issued updated guidelines during the COVID-19 pandemic. The only recent guidance that the CDC issued, involves allocation of ventilators from stockpiles to facilities but not allocation between patients.[12] Accordingly, there are no federal guidelines available during the COVID-19 pandemic and only a patchwork of limited state-specific guidance.

Most recently, the University of Pittsburgh published a model on March 27, 2020 that addresses the concerns of existing models and provides a new framework for allocation decisions (the Pittsburgh Model).[13] First, the Pittsburgh Model cautions against excluding certain patients from access to ventilators.[14] According to the Pittsburgh Model, excluding certain patients violates the basic bioethics principle of justice or equality.[15] Further, excluding certain patients could lead to discrimination claims because it is separating out certain patient types from access to a ventilator. Second, the Pittsburgh Model recommends against a “save the most lives” model because it does not take into account other necessary considerations.[16] For example, experts debate whether to “save the most lives” or to “save the most life-years” is a better model.[17] A “save the most life-years” model gives higher priority to those who are younger and have not had the same opportunities to go through life.[18] The Pittsburgh Model recommends providing priority to health care workers because these workers add value in continuing to fight COVID-19.[19]

With its multi-faceted approach, the Pittsburgh Model is becoming well-recognized.[20] The Pittsburgh Model recommends a prioritization tool like that currently being used by the state of Pennsylvania.[21] Under the Pittsburgh Model, patients are assigned a score based on their likely benefit from critical care.[22] The score considers the likelihood of survival upon discharge, the severity of illness, and chances of long-term survival.[23] These scores are then color-coded into priority groups.[24] Additionally, heightened priority is given to workers performing vital tasks to responding to the pandemic and in tie-breakers, younger patients are given priority.[25] Compared to the “save the most lives” model, the Pittsburgh Model gives care to those most likely to benefit.[26]

In addition to the Pittsburgh Model, some hospitals have adopted The Sequential Organ Failure Assessment (SOFA) as their ventilator allocation prioritization model.[27] A SOFA score is calculated based on the patient’s oxygen levels, blood platelet count, and other factors.[28] Additionally, a New England Journal of Medicine paper recommends four values to consider when making a rationing decision: (1) maximizing the benefits, (2) equality in allocating to both COVID-19 and non-COVID-19 patients, (3) promoting and rewarding instrumental value (i.e. prioritizing health care workers), and (4) giving priority to the worse off.[29] Maximizing benefits, in this case, can be applied by saving the most lives, life-years, or a balance in between, as long as it is applied consistently across the board.[30]

No matter what model a hospital triage committee chooses to adopt, consistency and transparency in allocation are key.[31] Following a policy consistently will help hospitals limit their liability exposure when making these challenging decisions regarding ventilator allocation.

About the Authors

Raj Shah is a Senior Regulatory Attorney, Policyholder Advisor, with MagMutual Insurance Company. Susannah Gleason is a Risk Intern with MagMutual Insurance Company  

 
 

 
[1] Robert D. Truog, M.D. et al, The Toughest Triage—Allocating Ventilators in a Pandemic, New Eng. J. Med., Mar. 23, 2020, https://www.nejm.org/doi/full/10.1056/NEJMp2005689.  
[2] Id.  
[3] Sacha Pfeiffer, U.S. Hospitals Prepare Guidelines for Who Gets Care Amid Coronavirus Surge, NPR, Mar. 21, 2020, https://www.npr.org/2020/03/21/819645036/u-s-hospitals-prepare-guidelines-for-who-gets-care-amid-coronavirus-surge.
[4] Truog, supra note 1.
[5] See generally Kevin McCoy and Dennis Wagner, Which coronavirus patients will get life-saving ventilators? Guidelines show how hospitals in NYC, US will decide, USA Today, Apr. 4, 2020, https://www.usatoday.com/story/news/2020/04/04/coronavirus-ventilator-shortages-may-force-tough-ethical-questions-nyc-hospitals/5108498002/.
[6] New York State Dep’t of Health, Ventilator Allocation Guidelines (2015), https://www.health.ny.gov/regulations/task_force/reports_publications/docs/ventilator_guidelines.pdf.
[7] Douglas B. White, MD, MAS and Bernard Lo, MD, A Framework for Rationing Ventilators and Critical Care Beds During the COVID-19 Pandemic, JAMA Network, Mar. 27, 2020, https://jamanetwork.com/journals/jama/fullarticle/2763953. See generally Minnesota Dep’t of Public Health, Patient Care Strategies For Scarce Resource Situations (2019), https://www.health.state.mn.us/communities/ep/surge/crisis/standards.pdf; Pennsylvania Dep’t of Health, Interim Pennsylvania Standards of Care for Pandemic Guidelines, (Apr. 10, 2020), https://www.health.pa.gov/topics/Documents/Diseases%20and%20Conditions/COVID-19%20Interim%20Crisis%20Standards%20of%20Care.pdf.
[8] Arizona Dep’t of Health Resources, Arizona Crisis Standards of Care Plan, (2020), https://www.azdhs.gov/documents/preparedness/emergency-preparedness/response-plans/azcsc-plan.pdf; see also McCoy, supra note 5.
[9] See generally Colorado Dep’t of Public Health & Environment, CDPHE All Hazards Internal Emergency Response and Recovery Plan, (May 10, 2018), https://cha.com/wp-content/uploads/2018/10/Crisis-Standards-of-Care-05102018-FINAL.pdf.
[10] Ctrs. for Disease Control and Prevention, Ethical Considerations for Decision Making Regarding Allocation of Mechanical Ventilators during a Severe Influenza Pandemic or Other Public Health Emergency, 1, 10 (July 1, 2011), https://www.cdc.gov/od/science/integrity/phethics/docs/Vent_Document_Final_Version.pdf.
[11] Id.
[12] See Ctrs. for Disease Control and Prevention, Strategies to Allocate Ventilators from Stockpiles to Facilities (Mar. 20, 2020), https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/ventilators.html.
[13] White, supra note 7.
[14] Id.
[15] Id.; Ctrs. for Disease Control and Prevention, supra note 10, at 10.
[16] White, supra note 7.
[17] Truog, supra note 1.
[18] Id.; White, supra note 7.
[19] Id.
[20] McCoy, supra note 5; Glenn Cohen, JD, Potential Legal Liability for Withdrawing or Withholding Ventilators During COVID-19, JAMA Network, Apr. 1, 2020, https://jamanetwork.com/journals/jama/fullarticle/2764239?widget=personalizedcontent&previousarticle=2763953.
[21] White, supra note 7.
[22] Id.
[23] Id.; See also Univ. of Pittsburgh Sch. of Med., Allocation of Scarce Critical care Resources During a Public Health Emergency, 1 (Apr. 3, 2020), https://www.ccm.pitt.edu/sites/default/files/UnivPittsburgh_ModelHospitalResourcePolicy.pdf.
[24] Univ. of Pittsburgh Sch. of Med., supra note 23, at 1.
[25] White, supra note 7.
[26] Id.
[27] Maia Anderson, UPMC develops 8-point system to allocate scarce ventilators, Becker’s Hosp. Rev., Apr. 2, 2020, https://www.beckershospitalreview.com/supply-chain/upmc-develops-8-point-system-to-allocate-scarce-ventilators.html.
[28] Id.
[29] Truog, supra note 1.
[30] Id.
[31] Ctrs. for Disease Control and Prevention, supra note 10, at 11.
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