On December 4, 2020, the United States Department of Health and Human Services (the “HHS”) amended the Public Readiness and Emergency Preparedness Act (the “PREP Act”) to institute further countermeasures against COVID-19 and prepare for the administration of the COVID-19 vaccine. We are pleased to provide the five key takeaways from this latest amendment:
- TELEHEALTH EXPANSION. Healthcare personnel can now utilize telehealth services to serve patients and implement certain medical countermeasures (“Covered Countermeasures”) in a state other than the state where the healthcare personnel is permitted to practice, even if state law forbids this practice.[1]
- EXPANDED IMMUNITY FOR DISTRIBUTION. Healthcare personnel now have expanded protection from liability when distributing and administering on-labeled Covered Countermeasures to combat the COVID-19 public health emergency, even if the Covered Countermeasure is not administered pursuant to a federal agreement.[2] However, this new immunity does not apply to claims involving willful misconduct.
- EXPANDED IMMUNITY FOR RESPIRATORY PROTECTIVE DEVICES. Healthcare personnel now have protection from liability when providing a respiratory protective device approved by the National Institute for Occupational Safety and Health (“NIOSH”) to prevent, mitigate, and limit the harm from COVID-19.[3]
- VACCINES. In preparation for the administration of the COVID-19 vaccine, the PREP Act now requires certain training for any licensed pharmacist administering the COVID-19 vaccine.[4]
- EXPANDED COVERAGE. The Amendment expanded the definition of a covered person (“Covered Person”) under the PREP Act to include, in part, (a) any state-licensed pharmacist who orders and administers vaccines; and (b) any pharmacy interns who administers vaccines.[5]
SLG has leveraged its extensive knowledge in the technology arena to support our clients serving the U.S. healthcare industry. For more information, please contact SLG at [email protected].
[1] For further information on what treatments qualify as a Covered Countermeasure, see 42 U.S.C. 247d-6d(i); see also 85 FR 79190; see also https://www.federalregister.gov/d/2020-26977/p-56.
[2] See 85 FR 79190; see also https://www.federalregister.gov/d/2020-26977/p-5. In order to qualify for this immunity, a covered person must “manufacture, test, develop, distribute, administer, or use the Covered Countermeasure pursuant to the FDA licensure, approval, clearance, or authorization (or pursuant to an Investigational New Drug Application or Investigational Device Exemption), or the NIOSH approval.” See https://www.federalregister.gov/d/2020-26977/p-70.
[3] See https://www.federalregister.gov/d/2020-26977/p-68.
[4] See https://www.federalregister.gov/d/2020-26977/p-91. A licensed pharmacist must have completed the immunization training that the licensing State requires in order for the pharmacists to administer the COVID-19 vaccine. If the state does not have immunization training, the licensed pharmacist must complete a training program of at least 20 hours authorized by either the American Nurses Credentialing Center, the Accreditation Council for Pharmacy Education, or the Accreditation Council for Continuing Medical Education. See https://www.federalregister.gov/d/2020-26977/p-60.
[5] See 42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B); see also https://www.federalregister.gov/d/2020-26977/p-83.
