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.
Recent Updates
- What CMS's 2027 Fee Schedule Changes Mean for Shared Savings Program ACOs
- CMS Wants to End Certain COVID Requirements, Natural Light in Patient Care Areas: Proposed Rule Would Update CoPs for Hospitals, LTC Facilities, and Other Providers
- The Structural Pressures Behind Senior Living and Long-Term Care Distress
- CMS Proposed Rule to Implement Section 6224 of the Consolidated Appropriations Act
- FDA Finalizes Key Parts of Its NDIN Guidance Related to Identity and Safety Information: What Dietary Supplement Companies Should Know