For months, physicians and practice managers have been in crisis mode due to COVID-19 and have faced daunting challenges daily. What the future holds relative to the evolution of COVID-19 remains unknown, but it is certain that litigation for COVID-related claims is on the horizon and will impact physicians in all medical specialties and practice models.

According to attorney John E. Hall Jr., founding partner of Hall Booth Smith in Atlanta, Georgia, which specializes in defense of high-exposure cases involving hospitals and medical malpractice claims, COVID-19 claims are looming in the next one to three years. "The big-dollar plaintiff firms and the plaintiff conglomerates are already starting to advertise for these cases, and they're starting to file them," Hall says. "There are over 800 cases filed already. Many of those are in the long-term care scenario but [they] are developing every day and in a variety of other areas."

Are there existing medical liability protections in place? What types of claims are anticipated? What steps can physicians take now to prepare to defend claims in the future? These important questions were recently addressed by Mr. Hall and other expert healthcare executives and attorneys at The Doctors Company's 2020 Virtual Executive Advisory Board (EAB) meeting.

Are there existing medical liability protections in place?
The Public Readiness and Emergency Preparedness Act (PREP Act) provides a significant safeguard for physicians. Congress originally passed the act in 2005 to provide immunity during the H1N1 epidemic. Secretary of Health and Human Services Alex Azar declared a public health emergency in January 2020 pursuant to the act due to COVID-19. The act provides complete preemption, meaning that "any state law or other federal law that contravenes the PREP Act is replaced by the PREP Act. Except in cases of death or severe injury caused by willful misconduct, the PREP Act provides complete immunity, with no liability under those circumstances" if the claim is COVID-19 related and the case is tried in the federal court system, according to Mr. Hall. In addition to the PREP Act, states have established some level of immunity for medical practices through healthcare immunity orders or executive limited liability orders. These orders vary by state and are meant to provide protection to the medical community for COVID-related claims.

What types of claims are anticipated?
It is expected that COVID-driven claims will take a variety of forms. Some claims may allege:

• Delayed or missed diagnosis caused by failure to follow up on previously ordered tests and consults (while the office was closed or due to lack of a reliable tracking system).
• Failure to triage and assess or testing issues, resulting in missed COVID-19 diagnosis and delayed intervention that contributed to community spread.
• Failure to immunize, resulting in disease, when parents were fearful to bring children into the office.
• Delayed care in office visits, testing, labs, and procedures, including surgical interventions.
• Failure to adhere to infection control protocol and/or lack of PPE, resulting in patient or staff illness.
• Limited resources: Allocation of medications and equipment, meaning access to ventilators/hospital beds, etc.

Most likely the claims that involve loss of life or serious injury will allege failure to diagnose or delayed diagnosis due to practices being closed for business after tests were ordered or referrals made prior to COVID-19. Patients whose information has been lost in the system and are not adequately tracked may miss important medical follow-up appointments, leading to adverse health outcomes. Also, delays in procedures and surgical interventions are of significant concern, and we are already seeing these types of claims reported to The Doctors Company.

What steps can physicians take now to prepare to defend claims in the future?
Mr. Hall suggests that one of the best ways to establish defense of these claims is for practices to begin developing a timeline/diary now describing how COVID-19 events unfolded within their specific practice and community. Because COVID-19 has been a moving target, and mandates and guidelines have been very fluid, keeping records of these changes via a timeline/diary is important for documenting how your practice responded to the crisis. Some considerations may include:

• Was your practice ever unable to obtain PPE?
• What was the infection rate within your community at a given time?
• Did you follow infection control protocols per Centers for Disease Control and Prevention (CDC) guidelines? If so, what were those guidelines at the time?

Documenting these items now ensures information is captured in its most accurate form, rather than trying to re-establish the facts years later. This information will not appear in patient medical records, yet it paints the landscape as to how the practice adapted to a very volatile crisis. It will form the foundation for your defense. As Mr. Hall notes: "Think of this three years from now . . . and a jury is thinking about this case. Juries have a very short mind span, so they do not remember the crisis and the pandemic and how this was going at the time. It's imperative that we take good notes and [develop] outlines now."

Crucially, he adds, "It is important to note that this information should be gathered at the direction of an attorney, peer, or quality committee so as to protect the information from discovery."

Appoint a practice historian who is responsible for developing and keeping the timeline up to date and well documented. This can be a physician, practice manager, or risk manager, but it should be someone familiar with the overall operations of your COVID-19 response who will reliably maintain the timeline from start to finish. To provide guidance on what types of items to document, The Doctors Company provides a sample checklist of important record-keeping elements and recommends keeping this in an administrative diary. You can adapt this checklist to fit your practice; these are merely suggestions of details to include, but it is important to document basic compliance efforts within the environment and timeframe. This checklist should be completed at a defined interval based on your practice, community, and pace of change.

Mr. Hall also recommends that you remind future jurors that the care provided to your patients transpired during the COVID-19 pandemic by including the following in every patient chart:

• Please note that this care is given at a time of national public health emergency due to the pandemic caused by COVID-19 (novel coronavirus). As a result, It is acknowledged and understood that the spread of COVID-19 within our communities places an incomprehensible strain on our providers and hospital systems, including the resources, equipment, beds, treatment options, and services available in support of patient care.
• It is further acknowledged and understood that the provider, during the COVID-19 pandemic, endeavors to remain operational and provide care to all patients commensurable with the resources available and existing at this time. Further, it is acknowledged that the transmission risks, treatment process, and diagnosis are novel, and without well-defined guidelines.
• It is further acknowledged that, due to the novel and emergency nature of this pandemic, treatment is provided utilizing the provider's best judgment and best currently known practices, within the limits of resources.

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