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
- Health Care Without the Hospital: ChatGPT Health and Claude Go Direct to Consumers
- The HTI-5 Proposed Rules: ASTP/ONC’s Cleanup and the Hard Work that Lies Ahead
- Just Released: Telemental Health Laws – Download Our Complimentary Survey and App
- OIG Limits Sign-On Bonuses to In-Home Family Caregivers
- Governing Health AI Development and Adoption: Insights from HHS’s Recently Announced Strategy to Promote AI in Healthcare