The surge in COVID-19 cases in the past several weeks has had many hospitals scrambling to put in place allocation guidelines for ventilators or other potentially scarce treatment resources. Many forward-thinking state departments of health and individual hospitals had previously developed such guidelines for use during a pandemic or other public health emergency. Although few of these guidelines had been previously been called upon, many hospitals are considering such policies because they fear that, either from this or future waves of COVID-19, they will have to confront difficult allocation decisions.
While such decisions raise profound ethical considerations, they also raise the specter of criminal and/or civil liability in the event of scarcity and concomitant resource allocation. Below are set forth a number of considerations, including the use of well-crafted resource allocation policies, to mitigate liability.
Key Components and Concerns
One potential vulnerability in the current environment is how to make "objective" treatment allocation decisions. Most allocation policies use some form of scoring system, such as the Sequential Organ Failure Assessment (SOFA), to assess patients for likelihood of survival and, in turn, access to life-saving equipment such as ventilators. The SOFA scoring system has been used by hospitals in other contexts for several years and provides a systematic and consistent method of assessing patients. However, under these or other scoring systems, in a shortage situation, some patients could be denied access to treatment – and possibly die as a result. To the extent the death was caused by an alleged "wanton or reckless" deprivation of a ventilator or other product or treatment, that conduct could meet the standard for manslaughter in many states.
To supplement the use of scoring systems, many hospital policies sensibly establish triage committees – comprised of physicians, nurses and sometimes others such as social workers – who are not part of the care team for the patients at issue to make allocation decisions. This allows the treating physician to focus on patient care. It also has the benefit of spreading the decision-making as to allocation among a group of people who are not directly involved in the patient treatment and can therefore apply the allocation policies in a reasoned and consistent manner. Such a process reduces the risk that any one person, or the institution for that matter, could be seen as acting in a "wanton or reckless" (or other) manner that would implicate liability for manslaughter or any other criminal offense.
Another important component of a resource allocation plan involves informing patients. Ensuring that the policy is effectively and consistently communicated to patients is critical.
In response to hospital and physician liability concerns, some states have enacted laws limiting criminal and civil liability of medical professionals and institutions. New York and Maryland are two examples, though in these states and others even the statutory or executive order immunity does not cover criminal conduct or "gross negligence," among other exceptions. In several other states, governors have signed executive orders to establish similar policies. At the federal level, Congress enacted the Public Readiness and Emergency Preparedness (PREP) Act in 2005, which provides immunity related to the manufacture, testing, development, distribution, administration and use of medical countermeasures against pandemics as well as chemical, biological, radiological and nuclear agents of terrorism. These provisions may provide additional liability protection for healthcare workers.
Nonetheless, there are many states without immunity statutes or executive orders, and the PREP Act may not be applicable to hospitals in all circumstances. The primary civil liability exposure is wrongful death based on negligence in denying a patient a ventilator. A specific potential liability paradigm could be that a major donor of the hospital gets the ventilator instead of a Medicaid beneficiary. These risks can be mitigated by an even-handed application of clear and well-communicated policies that apply scoring systems, triage committees and other elements to establish operating procedures for hospitals.
Discrimination Avoidance a Must
While clear policies are important, they do not establish immunity. In fact, fair application of clear policies may not necessarily be a defense to a claim that the policies were clear and faithfully applied but the policies themselves reflected an inherent bias or wrongful discrimination.
The U.S. Department of Health and Human Services Office for Civil Rights (OCR) has already provided guidance and a warning that it will not countenance anyone, including people with disabilities, being left behind in times of emergency. In fact, on April 16, 2020, OCR resolved a complaint it had filed earlier this month against a hospital after the hospital agreed to revise its pandemic policies in a way that did not discriminate against individuals with disabilities. In addition, recently several advocacy groups in the disability community published a guidance document with suggested best practices for hospitals developing resource allocation policies to ensure they "avoid disability discrimination" as potentially life-saving treatments are being allocated. Therefore, it is important to examine allocation policies through the lens of potential OCR enforcement and ensure that policies are applied in the same manner to everyone, including individuals with physical, mental, language and other barriers.
While everyone continues to hope that such allocation policies are never activated, there are steps that can be taken to make sure that if they are, their application minimizes hospitals' risk of liability.