Understanding New Jersey’s Ventilator Allocation Guidelines
By Carl H. Coleman
Professor of Law and Academic Director of Division of Online Learning
Earlier this month, the New Jersey Department of Health released guidance for the allocation of ventilators and other critical care resources during a public health emergency. Adapted from a model policy developed by the University of Pittsburgh, the guidance applies if a regional authority has declared a public health emergency, the hospital is operating under “crisis standards of care,” and “critical care capacity is, or will shortly be, overwhelmed despite taking all appropriate steps to increase the surge capacity to care for critically ill patients.” It includes both substantive standards and procedures for how these difficult decisions should be made.
Once the guidelines are triggered, on what basis will patients be prioritized for access to critical care resources?
Under the guidelines, all adult patients who meet usual medical indications for intensive care unit (ICU)/critical care beds and services will be given a priority score of 1 (highest priority) to 8 (lowest priority). Priority scores will be based on two components:
1-4 points will be given based on the patient’s prognosis for short-term survival (i.e., survival to hospital discharge), as determined by an objective, validated measure such as the Sequential Organ Failure Assessment (SOFA) score. Consideration of a patient’s prospects for short-term survival is based on the goal of saving the most lives.
An additional 0, 2, or 4 points will be given based on the patient’s prognosis for longer-term survival, with 2 points added for patients with a life expectancy of less than 5 years, 4 points added for patients with a life expectancy of less than 1 year, and 0 points added for all other patients. Consideration of a patient’s prospects for longer-term survival is based on the goal of saving the most “life years.”
Hospitals will determine on a daily basis what priority scores will result in access to critical care services, based on the scarcity of existing resources and information about the predicted volume of new cases over the next several days. When resources are severely limited, they will be provided only to patients with the highest priority scores; when more resources become available, access will be expanded to patients with progressively lower priority. Hospitals may choose to prioritize patients either according to their raw priority score (i.e., on a scale of 1 to 8) or by grouping patients into three priority categories (i.e., highest priority (scores 1-3), intermediate priority (scores 4-5), and lowest priority (scores 6-8)).
In the event there are ties in priority scores or categories and insufficient resources for all patients with the lowest scores, the guidelines provide that two “tie-breakers” should be considered:
First, priority should be given to younger patients over older patients, grouping patients into age categories of 0-17, 18-40, 41-60, 61-75, and over 75. The justification for relying on age as a tie-breaker is that younger persons “have had the least opportunity to live through life’s stages.” (In the ethics literature, this rationale is known as the “fair innings argument,” based on the idea that everyone should have an opportunity to experience all of the “innings” of life.)
Second, priority should be given to “individuals who are vital to the acute care response,” a category that “should be broadly construed to include those individuals who play a critical role in the chain of treating patients and maintaining societal order.” The guidelines state that it would not be appropriate to prioritize front-line physicians without also prioritizing other front-line clinicians and “other key personnel (e.g., maintenance staff that disinfects hospital rooms).”
If ties remain after the application of these two criteria, those ties should be broken by using a lottery.
Because of the absence of evidence-based data on the triage of children for ventilator allocation, the guidelines provide that decisions for children should be based on “best clinical judgment” as opposed to a calculation of specific priority scores. They emphasize the “basic principle” that “the more severe a patient’s health condition is based on these clinical factors, the less likely s/he survives even with ventilator therapy, and triage decisions should be made accordingly.”
Once a patient receives critical care resources, can they later be taken away?
Yes. All patients who receive critical care resources will be given a therapeutic trial “of a duration to be determined by the clinical characteristics of the disease” and “other non-pandemic diseases and patient contexts.” Patients will be reassessed periodically, and if they are show improvement they will continue with critical care until the next reassessment. Patients who show “substantial clinical deterioration” will have critical care withdrawn after disclosure of the decision to the patient and/or family. The guidelines provide that patients should “generally” be given the full duration of their initial therapeutic trial, but that in some cases it may be appropriate to withdraw clinical care before the completion of the trial if the patient experiences “a precipitous decline” or a “highly morbid complication” that “portends a very poor prognosis.”
Who has the authority to make prioritization decisions under the guidelines?
The guidelines emphasize that decisions about a patient’s priority for scarce critical care resources should never be made by the patient’s treating physician. This “separation of the triage role from the clinical role” is necessary to “enhance objectivity, avoid conflicts of commitments, and minimize moral distress.” To achieve this separation, the guidelines call for the creation of “triage teams” at each hospital, which will be responsible for giving patients initial priority scores as well as conducting periodic reassessments. Triage teams must consist of at least one physician, one nurse, and one hospital administrator, and should function in shifts lasting no longer than 13 hours.
Can the decisions of triage teams be challenged?
Citing the importance of “procedural fairness,” the guidelines provide that patients, families, and clinicians who object to decisions by the triage team should have access to mechanisms for resolving disputes. For initial prioritization decisions, where time is of the essence, the review will be limited to claims that the triage team made an error in the calculation of the priority score or the use or non-use of a tie-breaking factor. If such a claim is made, the triage team must recalculate the priority score and explain the calculation of the patient or family on request. In contrast, objections to decisions about withdrawing critical care resources from patients already receiving them may be brought to a “triage review committee” that is independent of both the triage team and the patient’s care team. Decisions of the triage review committee will be final and unappealable.
How will the allocation principles affect access to critical care for people with disabilities?
Several states’ guidelines for access to critical care resources have come under attack for devaluating the lives of people with disabilities. For example, Alabama’s 2010 guidance for ventilator triage, which has since been revised, provided that “persons with severe mental retardation, advanced dementia or severe traumatic brain injury may be poor candidates for ventilator support.” In response to multiple complaints about potentially discriminatory policies, the Department of Health and Human Services issued a bulletin in late March emphasizing that "persons with disabilities should not be denied medical care on the basis of stereotypes, assessments of quality of life, or judgments about a person’s relative ‘worth’ based on the presence or absence of disabilities or age,” and that decisions about access to medical resource “should be based on an individualized assessment of the patient based on the best available objective medical evidence.”
The New Jersey guidelines are consistent with the Department of Health’s bulletin. Emphasizing the importance of individualized determinations, the guidelines reject the use of any “categorical exclusion criteria” in making prioritization decisions. The guidelines also emphasize that no one should be “denied care based on stereotypes, assessments of quality of life, or judgments about a person’s ‘worth’ based on the presence or absence of disabilities or other factors.” Other aspects of the guidelines further demonstrate the state’s efforts to ensure fair treatment of patients with disabilities. For example, the guidelines recognize that a patient’s pre-existing disabilities may justify a longer therapeutic trial of critical care resources to determine whether the patient is experiencing a benefit. In addition, while the guidelines give lower priority to patients with conditions associated with a limited prognosis for longer-term survival, they explicitly decline to offer examples of such conditions, on the theory that “such lists run the risk of being applied as blanket judgments” about particular groups.
Nonetheless, some disability rights advocates have argued that any consideration of patients’ prospect of long-term survival is inherently discriminatory, as such considerations “tend to disproportionately affect people with disabilities” and “facilitate ‘ableist’ presumptions about survival chances or quality life after ICU treatment seeping into clinical evaluations.” They maintain that “survival estimates should be restricted to survival of the event for which the specific critical care intervention, such as a ventilator, is required,” without consideration of the patient’s prognosis once leaving the hospital. Those who take this position might therefore object to the New Jersey guidelines to the extent they disfavor patients with life expectancies of less than five years.
What is the legal status of the guidelines?
The New Jersey Commissioner of Health has issued an Executive Directive, pursuant to the New Jersey Emergency Health Powers Act, providing that health care facilities that adopt the guidelines’ model policy, as well as their workers, will be immune from “any damages arising from an injury to a patient caused by any act or omission pursuant to, and consistent with, such policy.” In addition, Attorney General Gurbir Grewal has directed prosecutors not to bring criminal charges against health care facilities or their workers “arising from an injury to a patient caused by any act or omission pursuant to, and consistent with, such policy.”
How likely is it that New Jersey hospitals will need to ration access to ventilators?
As of April 20, 51.2% of the ventilators available in New Jersey were in use. With the number of patients hospitalized for COVID declining in recent days, it appears that there will be no immediate need to ration access to ventilators. However, state officials emphasize the need to be prepared for a second wave of infections, especially if restrictions on social distancing are loosened.
Carl H. Coleman is a Professor of Law at Seton Hall University School of Law and specializes in the legal, ethical, and public policy implications of medical treatment, research, and public health. He also currently serves as Academic Director of the Law School's Division of Online Learning. Professor Coleman's biography and publications are available online.