COVID-19 Public Health and Medical Emergency Declarations and Waivers

Emergency Declarations

• January 7, 2021: Renewal of the Determination that a Public Health Emergency Exists Nationwide as the Result of the Continued Consequences of Coronavirus Disease 2019 (COVID-19) Pandemic
• October 2, 2020: Renewal of the Determination that a Public Health Emergency Exists as the Result of the Continued Consequences of Coronavirus Disease 2019 (COVID-19) Pandemic
  
• July 23, 2020: Renewal of the Determination that a Public Health Emergency Exists as the Result of the Continued Consequences of Coronavirus Disease 2019 (COVID-19) Pandemic
• April 21, 2020: Renewal of the Determination that a Public Health Emergency Exists as the Result of the Continued Consequences of Coronavirus Disease 2019 (COVID-19) (formerly called 2019 Novel Coronavirus (2019-nCoV)) Pandemic
• March 13, 2020: Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak
• January 31, 2020: Public Health Emergency Declaration
  

1135 Waiver

• March 13, 2020: Waiver of Modification of Requirements Under Section 1135 of the Social Security Act as a Result of the of the Consequences of the 2019 Novel Coronavirus

PREP Act Declaration

Declaration and Amendments to the PREP Act

• Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 (March 17, 2020)
• First Amendment to Declaration under the PREP Act for Medical Countermeasures against COVID-19 (April 15, 2020)
• Second Amendment to Declaration under the PREP Act for Medical Countermeasures against COVID-19 (June 8, 2020)
• Third Amendment to Declaration under the PREP Act for Medical Countermeasures Against COVID–19 (August 24, 2020)  
  
• Fourth Amendment to Declaration under the PREP Act for Medical Countermeasures Against COVID–19 (December 3, 2020) 
  
• Fifth Amendment to Declaration under the PREP Act for Medical Countermeasures Against COVID–19 (January 28, 2021) 
  

Advisory Opinions of the General Counsel on the PREP Act 

• First Advisory Opinion on the PREP Act Declaration (May 19, 2020)
• Second Advisory Opinion on the PREP Act Declaration (May 19, 2020)
• Third Advisory Opinion on the PREP Act Declaration (October 23, 2020)
• Fourth Advisory Opinion on the PREP Act Declaration (October 23, 2020)
  
• Fifth Advisory Opinion on the PREP Act Declaration (January 8, 2021)
  
• Sixth Advisory Opinion on the PREP Act Declaration (January 12, 2021)
  

HHS Guidance on the PREP Act

• PREP Act Authorization for Pharmacies Distributing and Administering Certain Covered Countermeasures (October 29, 2020)
  
• Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing (October 20, 2020)
  
• Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act (September 3, 2020)
• Guidance for Licensed Pharmacists, COVID-19 Testing, and Immunity under the PREP Act (April 8. 2020)
  
• Guidance for PREP Act Coverage for COVID-19 Screening Tests at Nursing Homes, Assisted-Living Facilities, Long-Term-Care Facilities, and other Congregate Facilities (August 31, 2020)
  

HIPAA

• March 2020: Limited Waiver of HIPAA Sanctions and Penalties During a Nationwide Public Health Emergency
  

Administrative Relief

• March 19, 2020: Administrative Relief for Recipients and Applicants of Federal Financial Assistance Directly impacted by the Novel Coronavirus (COVID-19) due do Loss of Operations