Monitoring the Pulse of Health Care and Life Sciences
Below is an excerpt of a contributed article co-authored with Robinson+Cole Business Litigation Group lawyer Ben Daniels published in Physicians Practice on September 16, 2022.
On July 25, 2022, the U.S. Court of Appeals for the Second Circuit rejected an appeal brought by Pfizer, Inc. in a case that examines whether a “corrupt” intent is…
The Food and Drug Administration (FDA) has recently undertaken a number of notable actions with respect to vaccines in response to the ongoing COVID-19 pandemic. Below is an overview of these actions and related COVID-19 vaccine information:
Full Approval of the Moderna COVID-19 Vaccine for 18+
On January 31, 2022, the FDA announced its full approval (licensing) of the Moderna COVID-19 Vaccine for individuals 18 and older. The Moderna vaccine had been administered under an Emergency Use Authorization (EUA) from the FDA since December 18, 2020. This is the second COVID-19 vaccine to be approved by the FDA following approval of Pfizer-BioNTech’s COVID-19 vaccine on August 23, 2021. Notably, the approved Moderna COVID-19 vaccine will be marketed and known as the ‘Spikevax.’Continue Reading COVID-19 Vaccine Update – February 2022
On December 2, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a memorandum to state survey agencies indicating that it will not enforce its Interim Final Rule (the “Rule”) regarding health care worker vaccinations while there are court-ordered injunctions against the Rule in place.
Continue Reading CMS Issues Memorandum Stating It Will Not Enforce Its COVID-19 Vaccine Mandate While There are Court-Ordered Injunctions in Place
On November 4, 2021, the Centers for Medicare & Medicaid Services (CMS) issued heavily anticipated emergency regulations requiring COVID-19 vaccination of eligible staff at health care facilities that participate in the Medicare and Medicaid programs. CMS issued an Interim Final Rule (IFR) in response to the COVID-19 “Path out of the Pandemic” Action Plan announced by President Biden on September 9, 2021, that per CMS is intended to protect the health and safety of residents, patients and staff at health care facilities. See our previous analysis of the Plan here.
Below please find key takeaways regarding the new COVID-19 vaccination requirements for health care facilities and staff:
Continue Reading CMS Issues Emergency Regulation Requiring COVID-19 Vaccination for Health Care Facility Workers
