CMS Seeking Comment on CLIA Rule Allowing Remote Access to Digital Laboratory Data
The Centers for Medicare & Medicaid Services is seeking comment on a proposed rule to amend regulations from the Clinical Laboratory Improvement...
The U.S. Food and Drug Administration (FDA) formally rescinded its final rule regulating laboratory-developed tests as medical devices, and regulatory review is now pending.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
Bill to Reform No Surprises Act Arbitration Process Introduced in House
Rep. Frank Pallone (D-N.J.), ranking member of the House Energy & Commerce Committee, introduced legislation to fix the No Surprises Act arbitration...
UHC Drops Lp(a) from Its Non-Coverage List
UnitedHealthcare has released an updated version of its Cardiovascular Disease Risk Tests medical policy for Commercial and Individual Exchange...