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Law360 (April 27, 2020, 6:10 PM EDT )
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| Elizabeth Hein |
For hospitals in Pennsylvania, the Interim Pennsylvania Crisis Standards of Care for Pandemic Guidelines created jointly by the Pennsylvania Department of Health and Hospital & Healthsystem Association of Pennsylvania[2] provide welcome guidance and potential legal protection for facilities preparing to implement scarce resource allocation policies.
Crisis Guidelines
The crisis guidelines create a process that aims to maximize the benefits of scarce resources (i.e., ventilators and ICU beds) after all other strategies for boosting the surge capacity of hospitals have been implemented. Specifically, the allocation framework aims to (1) save lives and (2) save life years.
In service of this goal, the crisis guidelines acknowledge that under crisis standards of care, "[t]he focus of medical care shifts from focusing on individuals to promoting the thoughtful use of limited resources for the best possible health outcome of the population as a whole."[3]
The process relies on a patient evaluation tool, which is used to triage and prioritize patients based on a multifactor assessment that evaluates patients based on their likelihood of survival to hospital discharge and presence of advanced medical conditions that severely limit their near term prognosis.
The patient evaluation tool assigns points to patients based on the Sequential Organ Failure Assessment, or SOFA, which assesses the presence and extent of organ failure. The SOFA score addresses a patient's likelihood of survival to discharge. The patient evaluation tool assigns additional points based on the presence of medical conditions that are likely to lead to death within five years (2 points added) and medical conditions that are likely to lead to death within one year (4 points added).
No specific morbidity automatically leads to assignment of additional points; clinicians are required to conduct an individualized analysis of each patient's prognosis.
The crisis guidelines suggest additional scoring considerations, including giving a two-point reduction for pregnant patients at or beyond the usual standard for fetal viability, and a one-point reduction for critical health care workers and other key personnel (e.g., maintenance staff that disinfects hospital rooms).[4]
Once patients are scored as indicated, they would be divided into color-coded priority groups, with patients scoring the lowest in the highest priority group. Patients in the highest priority group would be deemed to have the best chance to benefit from critical care interventions. The availability of critical care resources would determine how many eligible patients will receive care.
In the event that there are ties within priority groups and not enough resources for the full group to receive critical care, the crisis guidelines recommend using life-cycle considerations as a tiebreaker, with priority going to patients in younger life-cycle categories. The following categories are recommended: age 12-40, age 41-60, age 61-75 and older than age 75.
The crisis guidelines emphasize that use of this principle does not rely on "considerations of one's intrinsic worth or social utility. Rather, younger individuals receive priority because they have had the least opportunity to live through life's stages."[5] A lottery system is recommended as a last-resort tiebreaker.
The last step in the process is to conduct regular reassessments on patients already receiving critical care to determine whether it should continue. The crisis guidelines recommend that all patients receiving critical care should receive a baseline trial period to determine how well they are responding to treatment.
After the trial period, patients who are showing substantial deterioration, as indicated by SOFA scores and the exercise of clinical judgment, should not receive ongoing critical care/ventilation. The crisis guidelines expressly state that patients who are already using personal (supplied by the patient, not the hospital where they are present for care) ventilators for preexisting conditions will not have those withdrawn.
Hospitals may be justifiably concerned about the potential for bias in scarce resource decision-making. Various groups have suggested that these types of guidelines discriminate against racial minorities and disabled persons.[6] In fact, the original crisis guidelines prompted Disability Rights Pennsylvania to file an administrative complaint with the U.S. Department of Health and Human Services Office of Civil Rights.
In response, the Pennsylvania Department of Health worked with the OCR to modify the crisis guidelines to alleviate some of these concerns. The current version of the crisis guidelines removed features such as consideration of specific diagnoses associated with shorter life expectancy and consideration of comorbidities that impact life-expectancy beyond five years in the patient evaluation tool.[7]
Implementation Considerations
While coming to agreement about fair rules for triaging patients is an important step, creating a process that can fairly implement those rules is also critical. Poor implementation can make an already difficult process even more challenging. Researchers have found that badly run scarce resource allocation teams can be indecisive, dominated by a handful of loud voices, and can systematically ignore important perspectives.[8]
The crisis guidelines recommend identifying a crisis triage officer team consisting of physicians not directly involved in the care of specific affected patients to implement the scarce resource allocation policy. The crisis triage officer team (or crisis triage officer, in smaller facilities) reviews all patients for whom those patients' individual providers have recommended a scarce resource (e.g., ICU admission, ventilator support) to determine which patients should receive the highest priority.
Hospitals should carefully consider who is to be on the crisis triage officer team. While the Pennsylvania crisis guidelines recommend that the CTOT consist of physicians not directly involved in the patient's care, others have recommended including nonphysician staff, such as critical care nurses, respiratory therapists and nonclinical staff with relevant experience.
The crisis guidelines recommend providing bias training to members of the CTOT, if feasible, although in light of crisis conditions, hospitals may not have the time or resources to do so.
Hospitals should also create clear guidelines regarding the scope of decision-making of the crisis triage officer team (i.e., whether it is serving in an advisory capacity, and which scarce resources fall within its purview), the process for referring cases to the team, the timeframe for decision-making, procedures regarding documentation of such decision-making, and whether any appeals process will be made available to patients.[9]
Legal Risks for Health Care Providers in Providing Care with Scarce Resources
Clearly, implementing and executing a scarce resource allocation policy comes with liability risks for individual providers and hospitals. When a health care provider makes a decision to withdraw or withhold care based on some reason other than the patient's wishes, the decision raises a risk of civil and even criminal liability for the provider.
Some states, such as New Jersey, have passed legislation providing statutory immunity for health care providers against being held liable for civil damages for injury or death caused by an act or omission of that person in the course of providing medical services in support of the state's response to the coronavirus during the public health emergency.[10]
The immunity does not extend to acts or omissions constituting a crime, actual fraud, actual malice, gross negligence, recklessness or willful misconduct.[11] Pennsylvania has not yet passed any form of immunity for health care provider specific to COVID-19, although the Pennsylvania Medical Society has requested that Gov. Tom Wolf issue an executive order creating such immunity.[12]
In the absence of immunity, the crisis guidelines provide the next best thing: compelling evidence of a crisis standard of care that has explicitly been endorsed by the state agency responsible for regulating hospitals.
Nevertheless, health care facilities should keep in mind that there is no guarantee that a court will defer to the crisis guidelines, and that they will not protect a provider or facility for misconduct or gross deviations from the crisis standards of care set forth in the guidelines.
Conclusion
No health care provider wants to be in the position of deciding which patients do and do not receive potentially life-saving treatment. But preparing for the worst case scenario puts facilities in the best position to ensure that their decision-making in a crisis is consistent, fair and that it does not rely on the intuitions of physicians at the bedside.
Furthermore, to the extent that hospitals can model their scarce resource allocation policies on the crisis guidelines, they can position themselves to limit liability to the extent possible.
Hospitals that have not done so would be well advised to start developing an approach to allocating scarce resources in earnest to be prepared should the necessity arise.
Elizabeth M. Hein is an associate at Post & Schell PC.
The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.
[1] Ezekiel Emanuel, et al., "Fair Allocation of Scarce Medical Resources in the Time of COVID-19," NEJM (March 23, 2020), available at https://www.nejm.org/doi/full/10.1056/NEJMsb2005114 (last visited April 17, 2020).
[2] See PA DOH & HAP, "Interim Pennsylvania Crisis Standards of Care for Pandemic Guidelines" (April 10, 2020) (version 2), available at https://www.health.pa.gov/topics/Documents/Diseases%20and%20Conditions/COVID-19%20Interim%20Crisis%20Standards%20of%20Care.pdf.
[3] Crisis Guidelines, at p. 11.
[4] Importantly, the crisis guidelines do not recommend prioritizing physicians over other front-line personnel, or prioritizing health care workers not involved in pandemic care provision. The justification for prioritizing front-line personnel are that they help save other lives and that doing so signals that certain protections are in place for those risks such workers take during a public health emergency.
[5] Crisis Guidelines, at p. 33.
[6] See.e.g., Dr. Harold Schmidt, "The Way We Ration Ventilators is Biased," The New York Times (April 15, 2020), available at https://www.nytimes.com/2020/04/15/opinion/covid-ventilator-rationing-blacks.html. Dr. Schmidt points out that baseline health and life expectancy is reduced for particular ethnic and racial groups for structural and historical reasons. He advocates adjusting scoring of patients to account for structural disadvantages by using "weights" based on demographics, insurance status, and/or zip code.
[7] See DRP Press Release, "Civil Rights Complaint Filed by Disability Rights Pennsylvania Resulted in Progress on Pennsylvania's Medical Rationing Guidelines" (April 16, 2020), available at https://www.disabilityrightspa.org/newsroom/civil-rights-complaint-filed-by-disability-rights-pennsylvania-resulted-in-progress-on-pennsylvanias-medical-rationing-guidelines/ (last visited April 17, 2020).
[8] See generally Julia Lynch et al., "A Practical Approach to Running a Scarce Resource Allocation Team (SRAT)," available at https://litfl.com/a-practical-approach-to-running-a-scarce-resource-allocation-team-srat/.
[9] Id. While the Crisis Guidelines do not specifically recommend making an appeals process available, the University of Pittsburgh model upon which the Crisis Guidelines were largely based did. See University of Pittsburgh, Department of Critical Care, "A Model Hospital Policy for Allocating Critical Care Resources," (April 3, 2020), available at https://www.ccm.pitt.edu/sites/default/files/UnivPittsburgh_ModelHospitalResourcePolicy.pdf (last visited April 17, 2020).
[10] SB 2333, 219th Leg., (N.J. 2020), available at https://www.njleg.state.nj.us/2020/Bills/S2500/2333_I1.PDF.
[11] Id.
[12] As of April 14, 2020, the Pennsylvania Medical Society requested an executive order providing similar immunity as New Jersey. See Miles Bryan, "Frontline Healthcare Workers Seek Immunity from Malpractice During COVID-19," WSKG (April 15, 2020), available at https://wskg.org/news/frontline-health-care-workers-seek-immunity-from-malpractice-during-covid-19/.
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