On September 23, 2021, a panel of experts from the CDC, the Advisory Committee on Immunization Practice (“ACIP”), recommended that three categories of people should receive a COVID-19 booster shot: (1) those aged 65 and older; (2) those in long-term
September 2021
COVID-19 update: Availability of the Pfizer vaccine
On September 17, 2021, the US Food and Drug Administration’s (“FDA”) Vaccines and Related Biological Products Advisory Committee rejected Pfizer’s application for the booster shot of its COVID-19 vaccine for all individuals. The advisory committee was tasked with discussing Pfizer’s…
CMS issues proposed rule repealing Medicare pending new “reasonable and necessary” definition and HHS issues proposed rule implementing provisions of the No Surprises Act
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On Wednesday, September 15, 2021, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule that would, among other things, repeal the pending new definition for items and services that are considered “reasonable and necessary” under Medicare Parts…
COVID-19 update: FDA warns against COVID-19 vaccine for children younger than twelve
On September 10, 2021, the Acting Commissioner of Food and Drugs, Janet Woodcock, M.D., and Director of the Center for Biologics Evaluation and Research, Peter Marks, M.D., PhD., issued a statement on behalf of the FDA regarding the…
COVID-19 Update: Biden Administration requires COVID-19 vaccine or proof of negative COVID-19 test for employees at large companies
On September 9, 2021, President Biden announced a new, upcoming mandate that requires all employers with 100 or more employees “to ensure their workforce is fully vaccinated or require any workers who remain unvaccinated to produce a negative test result…