CMS, CDC, and HHS Seek Public Input on Potential CLIA Updates
Centers for Medicare & Medicaid Services (CMS), Centers for Disease Control and Prevention (CDC), and the Department of Health and Human Services...
The U.S. Food and Drug Administration (FDA) formally rescinded its final rule regulating laboratory-developed tests as medical devices, and regulatory review is now pending. Because the FDA did not move to appeal this decision, the rescission is essentially a formality.
The recission comes following the decision filed March 31 in the U.S. District Court in the Eastern District of Texas, which ruled the FDA exceeded its authority and subsequently vacated the final rule. The FDA did not appeal this decision.
Once the Office of Information and Regulatory Affairs completes the regulatory review, a formal notice will be posted to the Federal Register within 60 days.
Sources:
https://www.reginfo.gov/public/do/eoDetails?rrid=1044563
https://documents.cap.org/documents/ldt-courtruling-03-31-2025.pdf
https://www.cap.org/advocacy/latest-news-and-practice-data/august-12-2025#story3
White Paper: The in-house vs. outsourced billing questions answered
Most labs answer them as one, and that is what makes the decision expensive. Separating them is what makes it reversible. BY TELCOR WITH KWAMI...
CMS Releases October Quarterly Update to CLFS and CLIA HCPCS Codes
The Centers for Medicare & Medicaid Services (CMS) posted the October 2026 Quarterly Update to the Clinical Laboratory Fee Schedule (CLFS) and...