On December 3, 2020, HHS issued its fourth amendment to the Declaration for Medical Countermeasures Against COVID-19 under the Public Readiness and Emergency Preparedness Act (PREP Act). The PREP Act authorizes the Secretary of HHS to issue a declaration to provide liability protections to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from, the manufacture, distribution, administration, or use of certain medical countermeasures (Covered Countermeasures). Among other measures, the amendment authorizes qualified healthcare personnel using telehealth to order or administer medical Covered Countermeasures for patients in a state other than the state where the healthcare personnel are already permitted to practice.
Although many states already permit healthcare personnel in other states to provide telehealth services to patients within their borders, not all states have done so. Accordingly, the amendment will expand the ability of qualified healthcare providers to provide services to out-of-state patients via telehealth for Covered Countermeasures, such as authorized COVID-19 diagnostic tests.
The amendment also addresses other non-telehealth issues. For instance, the amendment expands the scope of PREP Act immunity to cover more healthcare providers who could administer COVID-19 and other vaccines by modifying and clarifying what training is required for certain providers to order or administer COVID-19 vaccines or vaccines for children.
In addition, the amendment provides an additional pathway to secure immunity for Covered Persons under the PREP Act if they use on-label Covered Countermeasures licensed, approved, cleared, or authorized by the FDA (or that are permitted to be used under an Investigational New Drug Application or an Investigational Device Exemption) to combat the COVID-19 public health emergency.
The amendment also clarifies additional issues concerning PREP Act immunity and incorporates the HHS Office of the General Counsel’s advisory opinions concerning the PREP Act and Declaration.
The HHS press release is available here, and the fourth amendment to the PREP Act Declaration is available here. Additional information regarding the PREP Act is available here.