Alerts and Updates

Crisis Standards of Care Guidelines to Address the COVID-19 Pandemic

April 8, 2020

The Institute of Medicine has defined “Crisis Standards of Care” as a substantial change in usual healthcare operations and the level of care it is possible to deliver.

Since March 13, 2020, when President Trump declared a national state of emergency due to the COVID-19 crisis, we have been in a healthcare crisis. The United States’ response to the COVID-19 pandemic has been plagued by increasing shortages of personal protective equipment (PPE), supplies, beds and physicians necessary to care for COVID-19 patients. In addition, drastic patient surges, limited numbers of life-saving ventilators and healthcare providers who have been working tirelessly for weeks in a constant state of emergency all contribute to an extremely strained health system. Not only do more and more patients need care each day, healthcare providers must work quickly to diagnose, triage and treat patients, as well as make difficult decisions on how ventilators are assigned and reassigned. And we have yet to hit the anticipated spikes in COVID-19 cases.

Accordingly, states have either implemented or developed Crisis Standards of Care (CSC). A CSC is triggered when healthcare systems are so overwhelmed by a pervasive or catastrophic public health event, such as COVID-19, that it is impossible for them to provide the normal, or standard, level of care to patients. Instead of meeting the standard of care to avoid liability, providers must now meet the crisis standards of care as set-forth on a statewide basis or adapted by individual facilities. More recently, CSC plans or guidelines have received attention in the COVID-19 pandemic in connection with ventilator triage and the question of which critically ill patients will have access to life-saving technology and which patients will not.

The Institute of Medicine (IOM) has defined “Crisis Standards of Care” as a substantial change in usual healthcare operations and the level of care it is possible to deliver, which is made necessary by a pervasive (e.g., pandemic influenza) or catastrophic (e.g., earthquake, hurricane) disaster. CSC guidelines are the means to mount a response to an incident that far exceeds the usual health and medical capacity and capabilities of a medical community. Medical care shifts from focusing on individuals to promoting the thoughtful use of limited resources for the best possible health outcomes for the population as a whole. Resources are shifted to patients for whom treatment would most likely be lifesaving and whose functional outcome would most likely improve with treatment. Under CSC plans, such patients who, for example, score the lowest on a triage tool are usually given priority over those patients who would likely die even with treatment.

Background of Crisis Standards of Care at the Federal Level

CDC’s PHEP Cooperative Agreement Program with Each State

Crisis Standards of Care, sometimes referred to as triage guidelines, derive from the Center for Disease Control and Prevention’s (CDC) Public Health Emergency Preparedness (PHEP) Cooperative Agreement Program. Today, the PHEP program funds 62 cooperative agreement recipients, including all 50 states, four localities and eight territories or freely associated states. The PHEP program provides a critical source of funding, guidance and technical assistance for states to strengthen their public health preparedness capability and improve their response readiness.

Operational Readiness Review Evaluations for Funding Determinations

To assess operational readiness and related funding, the CDC implements an Operational Readiness Review (ORR), an evidence-based assessment of PHEP program planning and operational functions. The ORR measures a jurisdiction’s ability to execute a large emergency response requiring medical countermeasure (MCM) distribution and dispensing. All PHEP recipients are required to participate in the ORR process. State recipients are not only responsible for ensuring their statewide planning and operation function, but also for reviewing local planning jurisdictions’ submitted forms within their state and monitoring, tracking, and evaluating local activities.

As part of the ORR, states must demonstrate compliance with certain capabilities―including CSC planning―developed by various federal agencies.

In March 2011, the CDC’s Division of State and Local Readiness (DSLR) published the Public Health Preparedness Capabilities: National Standards for State and Local Planning. CDC has required that all PHEP recipients develop and implement capability-based work plans and use their PHEP funding to build and sustain their public health preparedness and response capacity. These 15 capabilities define national standards for public health preparedness capabilities-based planning and are used by state and local PHEP programs to align planning across jurisdictions and response entities.

In November 2016, the U.S. Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response (ASPR) updated the Healthcare Preparedness and Response Capabilities. These capabilities provide unified program evaluation standards for healthcare organizations and response entities (e.g., state/local public health, emergency management, licensing) involved with the ASPR’s Hospital Preparedness Program (HPP). Additionally these healthcare preparedness capabilities correspond directly with eight of the 15 Healthcare Preparedness Capabilities, thereby allowing public health and healthcare system planners to collaborate within a common framework.

An additional set of capabilities central to CSC planning is the Federal Emergency Management Agency’s (FEMA) Core Capabilities. This system of capabilities provides a planning framework for response entities, including emergency management, public safety, public works, schools and others not directly involved in public health or healthcare.

The CDC’s Preparedness and Response Capabilities Incorporate CSC

The CDC’s Public Health Emergency Preparedness and Response Capabilities incorporate the National Health Security Strategy and Crisis Standards of Care for public health activation.

The CDC’s most recent January 2019 guidance for satisfying ORR evaluations requires that all PHEP recipients develop and update risk-based, all-hazards emergency plans by June 30, 2022. Specifically, the CDC requires PHEP recipients to demonstrate an ability to:

  • Use risk assessments to guide preparedness planning for the jurisdiction.
  • Develop and update risk-based, all-hazards emergency plans.
  • Conduct trainings, drills and exercises with jurisdictional partners, including those representing people with disabilities and others with access and functional needs.

Pennsylvania’s Interim Crisis Standards of Care

On March 22, 2020, the Pennsylvania Department of Health, along with the Hospital and Healthsystem Association of Pennsylvania, introduced Interim Pennsylvania Crisis Standards of Care for Pandemic Guidelines. The guidelines are intended to guide the allocation of patient care resources during an overwhelming public health emergency when demand for services dramatically exceeds the supply of resources needed.

Pennsylvania’s CSC guidelines specifically address:

  • Continuum of care, including guidance on determining the available level of care, medical surge strategies and transferring patients to other healthcare facilities.
  • Crisis triage officer teams.
  • Implementation of triage guidelines, including requirements for invasive ventilator support, patient prioritization models, and criteria for prioritization and withdrawal of critical care.
  • Community partners in the CSC guidelines.
  • EMTALA, HIPAA and 1135 waivers and guidance for requesting such waivers.

For instance, Pennsylvania’s guidelines rely on Sequential Organ Failure Assessment (SOFA) scoring to prioritize patient access to care. SOFA measures the function of major body systems, including the heart, lungs, kidneys, liver, blood and neurological system. Physicians assess a variety of a patient’s health conditions, including morbid obesity, impaired growth and intractable seizures. Pennsylvania also considers the likelihood of long-term survival, such as for patients with Alzheimer’s or those with cancer having less than 10 years of expected survival. Pennsylvania also gives greater priority to pregnant women with a healthy fetus, and gives credit to health workers assisting in responding to a crisis.

When two patients end up with the same SOFA score under Pennsylvania’s guidelines, the younger patient gets priority.

The Pennsylvania Interim Guidelines are currently under review by the Pennsylvania Department of Health (PADOH) and comments were accepted by the PADOH until April 7, 2020. It is expected that revised guidelines will be published by April 10, 2020. CSC guidelines are not without controversy. On April 3, 2020, a Pennsylvania advocacy group, Disability Rights Pennsylvania, filed an administrative complaint against the PADOH alleging that the Interim Guidelines violate anti-discrimination laws, including the ADA, the Affordable Care Act and the Rehabilitation Act. Specifically, the administrative complaint alleges that the guidelines engage in unlawful discrimination by using eligibility criteria―such as preexisting conditions and comorbid diagnoses―to screen out individuals with disabilities in its triage scoring process to determine who receives access to care. The administrative complaint is currently pending before HHS’ Office of Civil Rights.

CSC or Triage Guidelines in Other States

Conclusion

Clearly, CSC plans and state policies will be increasingly at the center of healthcare as the COVID-19 crisis spans the nation. More states, hospitals and providers will be faced with difficult questions concerning access to resources and care. If prepared with a sound CSC plan and procedure in place, hospitals and providers will be equipped with one of many tools to address surge situations of COVID-19 patients. Healthcare facilities and providers should make sure they integrate any direction given by state or federal authorities concerning CSC or triage policies and guidelines, and continue to develop their own internal plans moving forward.

About Duane Morris

Duane Morris has created a COVID-19 Strategy Team to help organizations plan, respond to and address this fast-moving situation. Contact your Duane Morris attorney for more information. Prior Alerts on the topic are available on the team’s webpage.

For Further Information

If you have any questions about this Alert, please contact Delphine O'Rourke, Kevin Moran, any member of the COVID-19 Strategy Team or the attorney in the firm with whom you are regularly in contact.

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.