Posts tagged CLIA Certification.
Blogs
3 minute read
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
- Important Negotiating Points in Commercial Real Estate Purchase and Sale Contracts Negotiating the Letter of Intent
- 2025 Picks Up Steam with Increased Scrutiny of Health Care Transactions and Corporate Structures
- HHS Reverses Its Longstanding Policy and Limits Public Participation in Rulemaking
- Sitting Atop a Telehealth Cliff?
- A Regulatory Haze of Uncertainty Continues as the Clock Ticks Toward Phase One of FDA’s LDT Final Rule