May 15, 2020

Best Practices for Immunizing Healthcare Professionals from COVID-19's Legal Side Effects

By Lorinda Holloway, Esq. and Samuel Rajaratnam, Esq., Husch Blackwell, Austin, TX

The Coronavirus Aid, Relief and Economic Security Act (the CARES Act) provides for $100 billion in relief funding to healthcare providers. These funds will help alleviate the unprecedented physical and financial burden COVID-19 has placed on the healthcare industry across the country. But during a time when healthcare facilities and professionals should be able to focus on beating the outbreak, there are other constant sources of anxiety at play:  the risks which come with spending the relief funds1 and the threat of COVID-19-related lawsuits.

The CARES Act protects only volunteer healthcare professionals, and most state immunity laws are limited in scope. While section 3215 of the CARES Act establishes a specific limitation on professional liability for volunteer healthcare professionals during the COVID-19 emergency response, it is silent as to non-volunteer healthcare professionals, thus providing no wide-spread federal protection to employed or contracted professionals treating patients during the pandemic.2 And it certainly does not provide protection for general negligence or premises liability claims. Rather, the federal government is making it clear it is up to the states to address basic provider COVID-19-related liability issues. The federal government is encouraging state governors to take some action, but even the encouragement is focused on limiting liability where regulations have been relaxed for purposes of addressing the pandemic. Secretary of Health and Human Services Alex Azar recently sent a letter to all state governors, encouraging them to develop a list of liability protections for in-state and out-of-state physicians, telehealth services, and services consistent with expanded scopes of practice in order “to carry out a whole-America response to the COVID-19 pandemic.”3 Presumably, some states will issue corresponding protections, but a number have already taken action to protect those on the front line from liability. The protections vary greatly, though, and few are as broad as the immunity provided in Louisiana:

  • Governor Edwards of Louisiana, through Proclamation No. 25 JBE 2020,4 declared a public health emergency, which means under Louisiana State Legislature RS 29:771(B)(2)(c) that “[d]uring [the] state of public health emergency, any health care providers shall not be civilly liable for causing the death of, or, injury to, any person or damage to any property except in the event of gross negligence or willful misconduct.” This immunity is not limited to COVID-19-related care but rather it appears to operate as a blanket immunity for as long as there is a state of public health emergency.
  • Governor Cuomo of New York, through Executive Order No. 202.10, granted more tailored immunity—immunity from civil and criminal liability to healthcare facilities and professionals for “any injury or death alleged to have been sustained directly as a result of an act or omission by such medical professional in the course of providing medical services in support of the State’s response to the COVID-19 outbreak,” unless the act or omission was caused by gross negligence or willful misconduct.5 Governor Pritzker of Illinois took similar action through Executive Order No. 17, which granted healthcare facilities and professionals immunity from civil liability for any injury or death which occurs while the provider rendered healthcare services in response to COVID-19.6  Like New York, the immunity does not extend to injuries caused by gross negligence or willful misconduct.  
  • Governor Evers of Wisconsin recently signed into law the 2019 Wisconsin Act 185 with bipartisan support, enacting substantially similar protections as New York and Illinois, though referring to health services provided (or not provided) in good faith, or which are “substantially consistent” with public health emergency guidance (instead of referring specifically to COVID-19), absent reckless or wanton conduct or intentional misconduct.7 This immunity is arguably broader than New York’s or Illinois’ immunity provisions because it is not expressly limited to acts or omissions “in the course of providing medical services.” In other words, perhaps it is broad enough to protect a provider sued for delaying an elective surgery, when that provider would have no protection otherwise in light of Wisconsin not issuing an order requiring the delay of elective surgeries. 
  • Governor Kelly of Kansas tied immunity more directly to COVID-19 care,8 specifically providing immunity for “making clinical and triage decisions and rendering assistance, testing, care or advice in the care of patients reasonably suspected or confirmed to be infected with COVID-19” through Executive Order 20-26.9 The order does not provide liability protection for healthcare providers delaying or deferring non-urgent care to non-COVID-19 patients during the declared emergency.
  • Still other states like Alabama (through Governor Ivey) have chosen to allow healthcare facilities which have invoked emergency operation plans in response to the pandemic to implement “alternative standards of care” plans, and those alternative standards of care are declared to be the state-approved standard of care in healthcare facilities to be executed by healthcare professionals and allied professions and occupations providing services in response to the outbreak.10

Healthcare facilities and professionals must consider the specific executive orders and temporary licensing agency rules passed in their respective states that may have created new areas of liability (for example by relaxing certain requirements for telehealth or licensing requirements for out-of-state providers) but may have not provided for related immunity. Even with an overall trend toward state legislation which protects providers at least to some degree, there will undoubtedly be situations which will expose healthcare providers to liability based on their healthcare acts or omissions during the COVID-19 crisis.

The provider should document his or her rationale with reference to the applicable executive order.
Whether the provider is in a state with broad COVID-19-related immunity, discrete immunity, or no immunity at all, the best defense (assuming reasonable medical judgment) is the provider’s documentation. If the provider is in a state providing relatively broad immunity like New York, the provider should be clear in his/her documentation that the care was provided in support of the state’s response to the COVID-19 outbreak, when that’s the case. This seems obvious today, but it may not be obvious two years from now when someone is scrutinizing the medical record. If the provider is in a state like Wisconsin, the provider should document the circumstances that show why or how the services were provided (or omitted) “in good faith.” The same approach is true with regard to delaying non-emergent care under an executive order.

Documentation is especially important when it comes to delaying non-emergent elective procedures.
Encouraged by the Centers for Disease Control and Prevention (CDC), the Centers for Medicare & Medicaid Services (CMS), and provider associations, many state governors issued orders requiring the postponement of elective procedures in order to ease the strain on hospitals and conserve personal protective equipment (PPE). In Texas, for example, there have been two such executive orders. On March 22, 2020, Governor Abbott issued Executive Order No. GA-09, a month-long order directing all licensed healthcare professionals and facilities to postpone all surgeries and procedures which were not an immediate medical necessity to improve a serious medical condition or to preserve the life of a patient who, without immediate performance of the surgery or procedure, would be at risk for serious adverse medical consequences or death, as determined by the patient’s physician (if it would deplete hospital capacity or the need for PPE).11 On April 17, 2020, he issued Executive Order No. GA-15, which then loosened restrictions on elective surgeries at hospitals under certain circumstances but maintained the same restrictions as outlined in Executive Order GA-09 for elective procedures typically conducted in a non-hospital setting such as physician offices and ambulatory surgery centers (ASCs).12 Per a third order, Executive Order No. GA-19, these restrictions expired on May 1, 2020, though healthcare professionals must now comply with emergency rules promulgated by their respective licensing agencies dictating minimum standards for safe practice during the COVID-19 disaster, and hospitals must reserve at least 15 percent of capacity for COVID-19 patients.13 None of these executive orders provided healthcare providers immunity from liability.

Therefore, under these first two orders, a cardiologist could conduct a telemedicine visit with a patient but be unable to administer a routine test, like a cardiogram, which could only be done during a face-to-face encounter. Or oncologists could ask their cancer patients to delay treatment to avoid coming to the hospital and potentially getting infected—a decision the provider may have thought was best. But what if those patients suffer negative consequences due to the provider’s failure to provide a face-to-face test or the delay of “non-urgent” case? How should healthcare professionals protect themselves absent broad immunities?

The key is for providers to document their medical judgment to delay (or not delay) the elective procedure and why such judgment satisfies the “test” of the executive order. For example, the cardiologist should document why there would likely be no serious adverse medical consequences due to delaying a test or screening. i.e. the physician’s medical judgment, and such test or screening falls under a procedure which must be delayed under an executive order. Similarly, for oncologists in Texas advising their cancer patients to delay treatment to avoid coming to a treatment center or hospital thus, potentially getting infected, the oncologist should reference the executive order and document why a delay in treatment would likely not risk serious adverse medical consequences or death. Such documentation should also include information on the patient’s medical history, prescriptions, lab results, imaging, guiding medical literature, or other relevant factors the provider used to make the care decision.

Steps to take as executive orders are lifted.
As executive orders and stay-at-home orders begin lifting and practices start resuming elective procedures, it will be important to implement a safe and smooth process. Below are steps which should be taken and considered in order to navigate the related liability risks. Keep in mind documentation remains important throughout this process.

  • Implement and perform solid infection control and prevention measures, including patient triage strategies to mitigate the spread of COVID-19 throughout the practice or facility;
  • Check the CDC, local public health, and licensing board websites daily for updates and adjust operations as necessary;
  • Implement return to work best practices for employers,14 and consult applicable professional associations and insurance carriers for guides to returning to practice, including tips on educating and training employees, scheduling visits, and additional telehealth and documentation strategies involved in safely returning to work; 
  • Check with the malpractice insurance carrier to determine whether expanded coverage is necessary given the changes during COVID-19 (like expanded use of telehealth or bringing back retired practitioners) and whether the carrier is requiring reference to COVID-19 risks in informed consent forms;
  • Consult professional associations to see what guidelines they are promoting particular to the practice type; and
  • Document the steps taken in order to reduce the risk of COVID-19 exposure to patients and staff so when looking back the reasonableness of the actions taken is clear. In other words, do not assume a reviewer months or years from now will give providers the benefit of the doubt because a pandemic has occurred. Taking the time now to document the actions taken could spare providers from having to re-create history later and will help demonstrate the reasonableness of the provider’s actions.

Conclusion

The questions of whether providers are immune from liability for their acts or omissions during the COVID-19 pandemic and how far any immunity extends must be answered by looking primarily at state law. Regardless of the state the provider is in, documenting his or her rationale for medical recommendations with reference to the applicable executive order or licensing agency rule is a best practice to implement, particularly when it comes to delaying non-emergent elective procedures. As executive orders and stay-at-home orders begin lifting and practices start resuming elective procedures, providers should consider a number of steps to address the risk of exposure to their staff and patients and the legal risks to their own practice.  

  1. https://www.huschblackwell.com/newsandinsights/risks-of-spending-public-health-and-social-services-emergency-fund-payments.
  2. https://www.congress.gov/bill/116th-congress/house-bill/748/text?loclr=bloglaw#toc-H16DA8E9326B14CE8B59468B2CC20C7FF.
  3. https://www.ncsbn.org/HHS_Secretary_Letter_to_States_Licensing_Waivers.pdf. There is a federal statute providing some immunity for certain conduct in a discrete context, but it is limited. On March 10, 2020, the Secretary of Health and Human Services issued a Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) for certain medical products to be used against COVID-19. The PREP Act provides immunity to “covered persons” in certain discrete circumstances. Therefore, while it is certainly possible that a provider could have immunity under the PREP Act depending on the exact circumstances, its scope is decidedly narrow to start, and there has been such confusion around the scope and application of the PREP Act that HHS has issued an Advisory Opinion about it. https://www.hhs.gov/sites/default/files/prep-act-advisory-opinion-april-14-2020.pdf.
  4. https://gov.louisiana.gov/assets/ExecutiveOrders/25-JBE-2020-Public-Health-Emergency-COVID-19.pdf.
  5. https://www.governor.ny.gov/news/no-20210-continuing-temporary-suspension-and-modification-laws-relating-disaster-emergency.
  6. https://www2.illinois.gov/Pages/Executive-Orders/ExecutiveOrder2020-19.aspx.
  7. https://www.huschblackwell.com/newsandinsights/wisconsin-act-removes-barriers-to-providing-care-during-covid-19.
  8. https://www.healthcarelawinsights.com/2020/04/kansas-governor-issues-protections-for-health-practitioners-and-expands-health-workforce/.
  9. https://governor.kansas.gov/wp-content/uploads/2020/04/EO-20-26-Executed.pdf.
  10. https://governor.alabama.gov/assets/2020/03/2020-03-13-Initial-COVID-19-SOE.pdf.
  11. https://gov.texas.gov/uploads/files/press/EO-GA_09_COVID-19_hospital_capacity_IMAGE_03-22-2020.pdf.
  12. https://gov.texas.gov/uploads/files/press/EO-GA-15_hospital_capacity_COVID-19_TRANS_04-17-2020.pdf.
  13. https://gov.texas.gov/uploads/files/press/EO-GA-19_hospital_capacity_COVID-19.pdf.
  14. https://www.huschblackwell.com/newsandinsights/ten-initial-considerations-for-businesses-returning-to-work.

About the Authors

Lorinda G. Holloway, Office Managing Partner, is an experienced healthcare and education focused attorney who guides clients successfully through the stress of litigation. She began working in the healthcare field early in her career, cutting her teeth on medical malpractice defense. Her practice expanded from there to work with medical boards, the False Claims Act, the Texas Medicaid Fraud Prevention Act, healthcare business disputes and litigation against providers. She may be reached at Lorinda.Holloway@huschblackwell.com.

Samuel P. Rajaratnam, Associate, is a commercial litigator who focuses on solving contentious business disputes so clients can get back to work. Providing the due diligence and drafting that are integral to innovative case strategy, Sammy helps clients with complex matters of breach of contract, commercial bankruptcy, discrimination claims, negligence claims and government investigations. He may be reached at Sammy.rajaratnam@huschblackwell.com