HHS Amends PREP Act Declaration, Including to Expand Access to COVID-19 Countermeasures Via Telehealth
HHS issued a fourth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to increase access to critical countermeasures against COVID-19. The fourth amendment makes two important changes. First, any licensed healthcare provider who is permitted to order and administer a Covered Countermeasure in any one state may now order and administer that Covered Countermeasure in any other state via telehealth, even if the provider is not licensed in the other state (subject to compliance with any rules established by the practitioner’s state of licensure). Second, the fourth amendment broadens the scope of protection afforded to all “covered persons” who manufacture, test, develop, distribute, administer, or use Covered Countermeasures (including those who provide telehealth services). Prior to the fourth amendment, PREP Act protection was limited to activities with a qualifying nexus to a government contract, grant, directive, or similar authorization. However, this broader protection applies only to on-label uses of a Covered Countermeasure; off-label uses, though common in the practice of medicine, would not qualify for the PREP Act’s liability shield absent a qualifying governmental nexus. HHS indicated that CMS will provide additional information on the implications of this Amendment for Medicaid and CHIP.