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CLIA: CMS Proposes 20% Fee Increase—and Further Increases Could Follow
From - National Intelligence Report
As if Year 2 of PAMA lab fees wasn't enough, CMS dished out another dose of agita to the lab industry: CLIA fees will…
CLIA: After 36 Years, CMS Gives Lab Accreditation a Good Hard Look
From - National Intelligence Report
If you've been in the clinical labs business for a while, you probably appreciate the wisdom behind this ancient Chinese curse. 2018 is shaping up to be a very…
FDA Watch: Agency to Allow DTC Marketing of Genetic Tests without Premarket Approval
From - National Intelligence Report
The FDA's longstanding policy of restricting direct-to-consumer (DTC) marketing of products without formal premarket approval is well known. But while it always applied to…
FDA Watch: Agency Moves to Boost CLIA Waiver Transparency
From - National Intelligence Report
The CLIA standards that a lab must meet are based on the complexity of the in vitro diagnostic tests it…
Theranos Settles with CMS and Arizona Attorney General
From - National Intelligence Report
After facing federal and state government scrutiny for more than a year, Theranos has reached agreements with the Centers for Medicare & Medicaid Services (CMS) and the Arizona Attorney General to…
