On January 28, 2021, the U.S. Department of Health and Human Services (“HHS”) amended the Declaration under the Public Readiness and Emergency Preparedness Act (“PREP Act”). This fifth amendment (the first by the new Biden Administration) adds more categories of persons that are qualified to administer COVID-19 vaccines authorized by the U.S. Food and Drug Administration (“FDA”). The amendment is entitled “Fifth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 and Republication of the Declaration". HHS introduced this amendment to help states and territories “meet the demand for vaccines and protect their communities as quickly as possible”.
Effective as of January 28, 2021, this amendment accomplishes the following:
- authorizes healthcare providers holding an active license in any state to prescribe, dispense and/or administer vaccines in other states or territories, provided that the provider’s license has not been (i) suspended or restricted by any licensing authority, (ii) surrendered while under suspension, discipline or investigation by a licensing authority, and (iii) surrendered following an arrest and such provider is not on the List of Excluded Individuals/Entities maintained by the Office of the Inspector General, subject to the following:
such healthcare providers with an active license and active practice to administer vaccines complete the Centers for Disease Control and Prevention (“CDC”) COVID-19 Vaccine Training, and
such healthcare providers with an active license and inactive practice ensure an on-site observation period by a currently practicing healthcare professional who confirms the competency of the healthcare provider in preparing and administering the particular COVID-19 vaccine(s) to be administered.
- authorize such nurse practitioners, registered nurses, and physicians who held a license that expired within the last five (5) years to prescribe, dispense and/or administer vaccines in other states or territories, provided the license or certification was active and in good standing prior to the date it went inactive and provided that the license has not been (i) suspended or restricted by any licensing authority, (ii) surrendered while under suspension, discipline or investigation by a licensing authority, or (iii) surrendered following an arrest and such provider is not on the List of Excluded Individuals/Entities maintained by the Office of the Inspector General, subject to the following:
such persons complete the CDC COVID-19 Vaccine Training, and
such persons ensure an on-site observation period by a currently practicing healthcare professional who confirms the competency of the healthcare provider in preparing and administering the particular COVID-19 vaccine(s) to be administered.
- pre-empts state laws prohibiting a qualified person from administering vaccines.
Under the PREP Act and its Declaration, a “qualified person” will be considered as a “covered person” for the purposes of being extended liability immunity against any claim of loss, subject to certain limitations and excluding “willful misconduct”. This immunity is extended both under federal and state law and applies to administration of vaccines and use of countermeasures, so long as the conditions set out in the PREP Act are met.
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This Legal Briefing is intended for general informational and educational purposes only and should not be considered legal advice or counsel. The substance of this Legal Briefing is not intended to cover all legal issues or developments regarding the matter. Please consult with an attorney to ascertain how these new developments may relate to you or your business. © 2021 Law Offices of Pullano & Farrow PLLC