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Network for Public Health Law
Guidance Crisis Standards of Care

Guidance for Health Care Systems & Providers: Making Decisions When There Are Limited Resources for COVID-19 Patients

March 18, 2020

by Donna Levin

Overview

As we look at the trajectory of the COVID-19 pandemic, we will be, and even now are facing to some extent, the inability of health care personnel, equipment and resources to keep pace with the need for live-saving treatment, acute hospital care and intervention.

What do hospitals and providers do when there are insufficient resources to provide care for all? Where a pandemic results in a high number of patients suffering from life-threatening respiratory failure, who will receive one of a limited supply of respirators? What is fair? Who decides? What is legally permissible? Crisis Standards of Care (CSC) planning and guidance can help providers address these and other critical issues that arise when health care systems are in crisis operations.

Crisis Standards of Care: 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.

During the 2009 influenza A (H1N1) pandemic, the Assistant Secretary for Preparedness and Response at the Department of Health and Human Services (DHHS), along with other federal agencies, asked the Institute of Medicine (IOM, now National Academies) to develop guidance for local and state health officials and health care providers.  The Committee convened by the IOM issued a Letter Report, Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations and, in 2012, the Committee reconvened and prepared more comprehensive guidance addressing crisis standards of care, which is on-line and available to all:  Crisis Standards of Care: A Systems Framework for Catastrophic Disaster Response.

The Report is organized with a functional format and design to provide a series of stand-alone resources for ease of use aimed at key stakeholder groups, including state and local governments, emergency medical services, hospitals and acute care facilities and out-of- hospital and alternate care systems. 

The Report emphasizes that the bedrock for how we provide care in all these settings rests on two key issues: Ethical Considerations and Legal Authority/Legal Environment.

The two cornerstones for the foundation of this framework are the ethical considerations that govern planning and implementation and the legal authority and legal environment within which plans are developed.

Ethical decision making is of paramount importance in the planning for and response to disasters. Without it, the system fails to meet the needs of the community and ceases to be fair, just, and equitable. As a result, trust—in professionals, institutions, government, and leadership—is quickly lost.

Ethical values are the starting point and these are the key considerations in the context of overwhelming scarcity that are recognized as fair and equitable by the larger community and patients and families: Fairness, Duty to care; Duty to steward resources; Transparency; Consistency; Proportionality; and Accountability.  The discussion of these considerations will help health care facilities, providers and their advisors frame or amend the crisis standards of care protocol at health care facilities.

The second cornerstone grounding this framework is the legal authority/environment.

Establishing and implementing CSC plans requires careful consideration of the substantial legal challenges involved, including potential liability. Among the legal topics the committee identified as requiring assessment and potential resolution during the course of CSC planning efforts are emergency declarations (local, state, federal), medical versus legal standards of care, mutual-aid agreements, liability risks (including medical malpractice), liability protections (e.g., Public Readiness and Emergency Preparedness [PREP] Act) during emergencies, licensing and credentialing, regulation of EMS and health care facilities, and health care practitioners’ scopes of practice. 

The following Table from the Report sets out some of these legal issues in greater detail.

Practical, Ethical, and Legal Challenges Underlying Crisis Standards of Care

Table 3-1. Select Legal Issues Related to Implementing CSC

SUBJECT

Organization of Personnel

LEGAL ISSUES

  • How are employees, independent contractors, and volunteers legally distinguished for the purpose of coordinating services and benefits?
  • Do existing labor contracts or union requirements affect the ability of the entity and its personnel to respond to an emergency?
  • Have appropriate contractual or other mechanisms been executed to facilitate the delivery of services by employed or volunteer personnel, ensure worker safety, or make available workers’ compensation or other benefits

Access to Treatment

  • Has the entity assessed its strategy for conducting medical triage under legal requirements for treating existing and forthcoming patients?
  • Is the entity prepared to screen and potentially divert excess numbers of patients during an emergency consistent with the Emergency Medical Treatment and Active Labor Act (EMTALA), absent its waiver?
  • Do healthcare personnel who are designated to treat existing and forthcoming patients pose any risks to patients either through (1) exposure to infectious or other conditions or (2) the use of personal protective equipment that may impede the delivery of medical services?

Coordination of Health Services

  • Are healthcare personnel aware of the legal effects of a shift to crisis standards of care and changes relating to scopes of practice during a declared emergency?
  • Are healthcare personnel knowledgeable about conditions related to FDA’s  issuance of emergency use authorizations, including accompanying mandatory emergency use information for patients and providers?
  • Are adequate mechanisms in place to ensure compliance with surveillance, reporting, testing, screening, partner notification, quarantine, isolation, or other public health mandates?
  • Are legal issues concerning the use of volunteer health professionals during an emergency addressed via the entity’s emergency plan?

Patients’ Interests

  • Can patients with physical or mental disabilities be accommodated during the emergency consistent with disability protection laws?
  • Do patients have adequate access to available medical countermeasures to ensure their health and safety?
  • Are there appropriate measures to ascertain patients’ informed consent?
  • Barring waiver are the entity and its personnel prepared to respect patients’ health information privacy rights?
  • Is the entity prepared to evacuate at-risk patients in response to an emergency?

Allocation of Resources

  • Is the process for allocating scarce resources fair, reasonable, nondiscriminatory, and credibly based on protecting the public’s health?
  • Are federal, state, or local policies regarding resource allocation followed?
  • Can government appropriate existing resources (with just compensation) for communal purposes during an emergency?

Liability

  • When may the entity and its personnel be liable for their actions in treating patients via a CSC?
  • What legal protections from liability for entities, their healthcare personnel, independent contractors, or volunteers (including insurance coverage) apply?
  • May entities and their personnel face potential liability for failure to adequately plan or train for emergencies?

Reimbursement

  • Are there established reimbursement protocols for treating patients?
  • Are private health insurers or other payors legally required to reimburse for care delivered to patients in furtherance of the public’s health?
  • Are entities organized to seek federal and state reimbursement through the Centers for Medicare & Medicaid Services, the Federal Emergency Management Agency, or other sources for care delivered in off-site facilities operated by the entity?
  • Have federal/state authorities accelerated, altered, or waived Medicare/Medicaid requirements for reimbursement?

Interjurisdictional
Cooperation

  • Has the entity executed memoranda of understanding (MOUs), mutual-aid agreements (MAAs), or other agreements to facilitate interjurisdictional coordination of emergency health services?
  • Are these agreements consistent with governmental requirements?
  • Is the entity’s all-hazards emergency plan integrated with community-level emergency planning and objectives?
  • Have state or local governments on international borders addressed specific concerns through lawful agreements?

See additional resources on Crisis Standards of Care and Public Health Emergency Ethics.

The Network for Public Health Law provides information and education about laws related to the public’s health. We do not provide legal representation or provide advice on a particular course of action.