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.
Blog Editors
Recent Updates
- Medicaid Behavioral Health Investigations and Payment Suspensions in D.C. Are Increasing – How Providers Can Limit Risk
- ‘Emilie’ Is Not a Psychiatrist: Pennsylvania Board of Medicine Alleges Unlawful Practice of Medicine by an AI Chatbot
- DOJ’s West Coast Strike Force to Target Health Care Fraud in Arizona, Nevada, and Northern California
- DOJ FOCUS Initiative Prioritizes “High Quality” Data Miner Actions by FCA Whistleblowers
- FDA Proposal Would Leave Semaglutide, Tirzepatide, and Liraglutide Off 503B Bulks List