Important guidance regarding COVID-19 testing in the workplace was recently issued by the Centers for Medicare & Medicaid Services (“CMS”) in the form of Frequently Asked Questions regarding Over the Counter (“OTC”) Home Testing and CLIA Applicability.
CMS regulates clinical laboratory testing pursuant to the federal Clinical Laboratory Improvement Act (“CLIA”). Generally, a laboratory or clinical setting (such as a physician’s office) must obtain CLIA certification to perform laboratory testing. Some OTC tests, however, are approved by the Food and Drug Administration (“FDA”) for home use and the new FAQs address the use of OTC home tests in the workplace.
As we previously reported, the Centers for Medicare and Medicaid Services’ (CMS) interim final rule (“the Rule”) requiring full COVID-19 vaccination for staff and others at Medicare- and Medicaid-certified providers and suppliers (i.e., the “vaccine mandate”) has been challenged in the U.S. District Courts for the Eastern District of Missouri (“the Missouri Court”) and the Western District of Louisiana, Monroe Division (“the Louisiana Court”). As of the date of this writing, both Courts have granted preliminary injunctions placing the Rule on hold.
On November 29, 2021, the Missouri Court granted a preliminary injunction of the Rule, which applies to the coalition of ten states  that filed the challenge there. The following day, the Louisiana Court entered a similar injunction, which applies to the remaining forty states.
In this episode of the Diagnosing Health Care Podcast: Federal and state cannabis regulation and enforcement appear to be moving in different directions. While the Food and Drug Administration (“FDA”) has broadened its net to target businesses making claims that their products can treat specific conditions, a growing number of states have passed bills that, among other things, legalize adult-use cannabis.
Our colleague Nathaniel M. Glasser and Jennifer Barna of Epstein Becker Green have co-authored an article in Bloomberg Law that will be of interest to our readers: "COVID-19 Vaccines and Workplace Challenges."
The following is an excerpt:
As COVID-19 vaccines become widely available, employers will face a critical set of challenges, ranging from whether they can—or will want to—mandate all or some employees get vaccinated, to what liability may attach to mandating vaccination, and even whether the Occupational Safety and Health Administration (OSHA) could require a ...
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