On March 12, 2021, the US Department of Health and Human Services (“HHS”) amended, its Declaration under the Public Readiness and Emergency Preparedness Act (“PREP Act”) for the seventh time. The Seventh Amendment expands the...more
On January 28, 2021, the U.S. Department of Health and Human Services (“HHS”) issued a Fifth Amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (“PREP Act”), which expands the categories of...more
The US Department of Health and Human Services (“HHS”) issued an Advisory Opinion (“21-01”) Friday, reinforcing how the Public Readiness and Emergency Preparedness Act (“PREP Act” or the “Act”) (1) provides complete...more
On December 3, 2020, the U.S. Department of Health and Human Services (HHS) issued another groundbreaking amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act). ...more
12/8/2020
/ Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
Health Care Providers ,
Immunity ,
Infectious Diseases ,
Liability ,
Medical Supplies ,
Personal Protective Equipment ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Telehealth
As mentioned in our earlier report, on November 20, 2020, The Department of Health and Human Services (HHS) Office of Inspector General (OIG) and Centers for Medicare & Medicaid Services (CMS) published two long-awaited final...more
Earlier last Friday, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) of U.S. Department of Health and Human Services (HHS) announced their new, long-awaited rule changes to the...more
The U.S. Department of Health and Human Services (HHS) recently issued two new advisory opinions dramatically illuminating the wide scope of the PREP Act and its immunities for organizations using covered countermeasures in...more
To assist in the response of the nation’s health care providers to the COVID-19 pandemic, on August 24, 2020, the Secretary for the U.S. Department of Health and Human Services (HHS) issued a Third Amendment to his March 10,...more
On June 4, 2020, the Secretary for the US Department of Health and Human Services (HHS) issued a Notice of Amendment (Amendment) to his March 10, 2020 Declaration that had applied the federal immunities of the Public...more
On May 19, 2020, the US Department of Health and Human Services (HHS) Office of General Counsel (OGC) issued an advisory opinion (Advisory Opinion) finding that the Public Readiness and Emergency Preparedness Act1(PREP Act)...more
To enhance regulatory flexibility necessary to adequately respond to the COVID-19 pandemic, the US Department of Health and Human Services (HHS) Office of the Inspector General (OIG) recently announced that it is accepting...more
With crisis comes uncertainty, and even the best-intentioned regulations can leave those combating the current COVID-19 public-health emergency out in the cold. Many have asked whether the recent Declaration under the...more
4/15/2020
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Eligibility ,
Emergency Response ,
Enrollment ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Hospitals ,
Medicaid ,
Medicaid Expansion ,
Medicare ,
OIG ,
Public Health ,
Regulatory Agencies ,
State and Local Government
A critical aspect of the response to the COVID-19 public-health crisis in the United States is the rapid expansion of testing capabilities across the country. Given that almost all Americans live in close proximity to retail...more