Coronavirus Regulatory and Legal-Immunity

Coronavirus Regulatory and Legal-Immunity

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LEGAL/REGULATORY—IMMUNITY 
March 22, 2020

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EXECUTIVE SUMMARY 
Do I have legal immunity?

The federal Department of Health & Human Services (HHS) published a Notice of Declaration on March 17, 2020 providing qualified liability immunity to licensed health care professionals and entities against any claim of loss from the manufacturing, distribution, administration or use of medical countermeasures for COVID-19 patients. The immunity does not apply to claims involving willful/wanton misconduct. Medical countermeasures include any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, including those not otherwise approved by the FDA, but designated by the FDA as emergency use authorizations. 

A health care professional should be afforded immunity if he or she acts in accordance with applicable directions, guidelines or recommendations issued by HHS regarding the countermeasure and so long as HHS or the applicable state or local health authority is notified about a resulting serious injury or death within seven days of its discovery.  

COPIC recommends that if you are providing medical services that arguably fall within the scope of any of the government publications that are relaxing laws and regulations to help combat coronavirus that you concisely document in the medical record that you are providing such medical services consistent with the applicable government publication (e.g., adopting a policy to address COVID-19 countermeasures to enhance social distancing).

EXPANDED OVERVIEW
The Scope of the Federal Government Declaration Providing Legal Immunity to Health Care Providers Treating Coronavirus


The federal Department of Health & Human Services published a Notice of Declaration on March 17, 2020 under the federal Public Readiness and Emergency Procedures Act (PREP Act) providing immunity to covered persons providing medical covered countermeasures to COVID-19 effective February 4, 2020. The Declaration provides immunity both under federal and state law to licensed health care providers and entities against any claim of loss caused by, arising out of, relating to or resulting from the manufacturing, distribution, administration or use of medical countermeasures to COVID-19 unless the claim involves willful/wanton misconduct which involves culpable behavior including an intention to obtain a wrongful purpose, knowingly acting without legal or factual justification or disregarding a known and obvious risk that is so great as to make highly probable the risk outweighs the benefit. Willful and wanton misconduct is a much higher culpable mental state than professional negligence. “Covered countermeasures” are defined as any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, including those not otherwise approved by the FDA but designated by the FDA as emergency use authorizations, used to treat, diagnose, cure, prevent or mitigate COVID-19, and includes operative language beyond the use of drugs and vaccines such as “diagnostic” and “device,” i.e., a product or technology intended to enhance the use or effect of such a drug, biologic, or device. Providing such immunity is limited to recommended activities in cooperation with the federal government or any city, county, tribal or state entities having authority for public health and medical resources.

The definitions under the Declaration and the PREP Act would include licensed health care providers and entities. For health care professionals, he or she must be authorized to prescribe, administer or dispense the covered countermeasures under the state of licensure where the countermeasures are provided. While what specifically will be considered a “covered countermeasure” will evolve with greater understanding of COVID-19, a health care professional should be afforded immunity if he or she acts in accordance with applicable directions, guidelines or recommendations issued by HHS regarding the countermeasure and so long as HHS or the applicable state or local health authority is notified about a resulting serious injury or death within seven days of its discovery. 

COPIC recommends that if you are providing medical services that arguably fall within the scope of any of the government publications that are relaxing laws and regulations to help combat coronavirus that you concisely document in the medical record that you are providing such medical services consistent with the applicable government publication (e.g., adopting a policy to address COVID-19 countermeasures to enhance social distancing).

The HHS Declaration and federal statute it is based upon (PREP Act) can be found at:
https://www.federalregister.gov/documents/2020/03/17/2020-05484/declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical-countermeasures 
https://www.govinfo.gov/content/pkg/USCODE-2011-title42/html/USCODE-2011-title42-chap6A-subchapII-partB-sec247d-6d.htm