Archive
COVID
DOJ Releases 2024 COVID-19 Fraud Enforcement Task Force Report
Summary of article from Morrison Foerster, by Adam Braverman, Kate Driscoll, Kamran Jamil, Brian Kidd, Nathaniel Mendell: The U.S. Department of Justice (DOJ) has released a…
Pandemic Fraud Suits Have Yielded Over $100 Million, Report Says
From Bloomberg Law, by Daniel Seiden: The Covid-19 Fraud Enforcement Task Force has reported that over $100 million has been reclaimed by the US government through…
Improper CBD Product Marketing Lands in FDA’s Crosshairs
The FDA issued warning letters to five companies for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the sale of cannabidiol…
HHS Amends PREP Act Declaration, Including to Expand Access to COVID-19 Countermeasures Via Telehealth
On December 3, the U.S. Department of Health and Human Services (HHS) issued a fourth amendment to the Declaration under the Public Readiness and Emergency Preparedness…
CMS Encourages Faster COVID-19 Diagnostic Testing
CMS is changing its payment methodology to encourage higher throughput of COVID-19 diagnostic testing. Previously, CMS would reimburse $100 per test Starting January 1, 2021, Medicare…
CMS Issues Cease and Desist Orders to Uncertified Labs Performing COVID-19 Testing
Since August 12, 2020, CMS issued 171 cease and desist letters to entities across the U.S. that were testing for COVID-19 without the appropriate certifications under…
HHS Renews Public Health Emergency Declaration through January 20, 2021
On Friday, October 2, the U.S. Department of Health & Human Services (HHS) announced that the Public Health Emergency (PHE) declaration for COVID‑19 will be renewed…
FDA Will No Longer Review EUA Requests for COVID-19 Laboratory Developed Tests
The Food and Drug Administration (FDA) will no longer require premarket review of laboratory developed tests (LDTs), including COVID-19 tests, decline to review emergency use authorization…
Unapproved and Misbranded COVID Treatments Get FDA Attention
There is no FDA-approved treatment for COVID-19, but that hasn’t stopped one compounding pharmacy from making bold claims. Marketing products as “COVID PACK” and “COVID ‘POSITIVE’…