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Federal and State Governments Pass Regulations Providing Immunity to Healthcare Providers Responding to COVID-19 Pandemic

In response to the COVID-19 pandemic, and the overwhelming need for medical care and front-line responders, federal and state governments have responded by implementing regulations affording immunity to licensed healthcare providers. While the immunity may not prevent a healthcare provider from actually being sued for negligence, since public access to courts cannot be limited, it does provide protection for providers to defend against lawsuits. Likewise, the regulations provide immunity from criminal liability in connection with licensure and record-keeping. The goal of the bills is to provide immunity to healthcare providers in order to avoid any impediments to the emergency treatment of COVID-19 patients.

Currently, six states, New York, New Jersey, Connecticut, Illinois, Michigan, and Massachusetts, have enacted COVID-19 related immunity laws.  While each state’s law varies, the immunity general applies to medical professionals, defined to include broad categories of doctors, nurses, technicians and emergency responders, who are providing COVID-19 related care. Not only is there state law that protects providers, but federal law as well.  

The Federal Government has implemented the Public Readiness and Emergency Preparedness (“PREP”) Act to provide broad immunity to “covered persons,” defined generally to include healthcare providers and their employees, with respect to the use of “covered countermeasures.”  Below are some of the most common questions that might arise:

If my practice treats a COVID-19 patient and he/she suffers an injury or death, what are my risks?

Under the laws of the States listed above, so long as your medical treatment was provided in accordance with generally accepted standards of the profession, immunity applies. This immunity even extends to telemedicine. Also, depending on the type of treatment, Federal PREP Act immunity may apply if the treatment was rendered using a covered countermeasure. 

If my practice treated a COVID-19 patient who suffered an injury or death before these laws were passed, what are my risks?

It is difficult to determine exactly how a court will interpret state laws providing immunity during these unprecedented times.  While state laws granting immunity are effective on the dates they have been passed, it is not yet clear whether the courts would apply this immunity retroactively.  Although the plain text of the law provides helpful guidance, a court may consider legislative intent among other factors to broaden the scope of immunity beyond the text of the law.  Under federal law, although the PREP Act was passed in 2006, immunity under the Act for COVID-19 related treatment is effective from February 4, 2020 until the final day of that the Emergency Declaration is in place or October 1, 2024, whichever occurs first.  As a result, the PREP Act would not provide immunity for injury caused by using a covered countermeasure during the treatment of COVID-19 prior to February 4, 2020. 

If I do testing at my office, can I be sued for a false positive or false negative?

To the extent that a State law might apply to malpractice or negligence claims for false diagnoses, it may be preempted by a Federal Law that provides immunity. Under the PREP Act, immunity applies to any claim of injury or loss with respect to a doctor or other licensed health professional who uses a test or diagnostic kit considered to be a “covered countermeasure” in order to diagnose COVID-19.  However, because covered countermeasures are too numerous to list and new countermeasures are frequently added, it is important to stay up-to-date to ensure that the countermeasure you are using is covered by the PREP Act.

Can an employee sue her/his employer if she/he contracts COVID-19 from a patient?

If an employer does not provide PPE to an employee who treats patients, and who subsequently contracts COVID-19, the PREP Act or applicable State law may not provide immunity against such claims.  The Occupational Safety and Health Administration (“OSHA”) obligates employers to provide their employees with PPE to protect against workplace hazards.  Under OSHA guidance, those in direct contact with suspected or confirmed COVID-19 patients are required to be provided with National Institute for Occupational Safety and Health (“NIOSH”)-approved respirators.  If Personal Protective Equipment (“PPE”) was provided, but failed to prevent an employee from contracting COVID-19, the PREP Act provides broad immunity for all claims of loss by employees so long as the PPE is NIOSH-approved and covered under an Emergency Use Authorization made by the FDA.  The Secretary of Health and Human Services encourages all individuals and entities using covered countermeasures, such as PPE, to document the reasonable precautions that have been taken to safely use the covered countermeasures in order to help better assert immunity. 

Are there any circumstances where my organization might be liable under State or Federal Law arising from the treatment of COVID-19 patients?

Under State law, medical professionals are still liable for gross negligence, fraud, and recklessness while treating COVID-19 patients. Under Federal Law, medical professionals and others are still liable for willful misconduct that proximately causes death or serious injury as a result of the use of a covered countermeasure.  Furthermore, the PREP Act does not apply to federal enforcement actions or claims for equitable relief. 

How Frier Levitt Can Help

Despite the immunity, healthcare providers should take all possible measures to comply with pre-COVID laws and regulations, in order to avoid potential lawsuits and regulatory investigations, to the greatest extent possible. Likewise, guidance issued by the Secretary of Health and Human Services encourages “covered persons” to exercise all reasonable precautions, and places the responsibility of those seeking immunity under the PREP Act to determine whether immunity applies to them.  Frier Levitt can provide additional information and guidance on these emergency regulations, as well as discuss your other healthcare practice needs. Contact us today to discuss.