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FDA Watch: New Policy Would Allow DTC Marketing of Genetic Tests without Premarket Approval
From - Laboratory Industry Report
For years, the lab industry has been pressing the FDA to relinquish its rigorous oversight of direct-to-consumer (DTC) genetic health tests…
Medicare Exclusions: One Week, Two Different Labs Get the Boot
From - G2 Compliance Advisor
Exclusion of a clinical lab from participating in Medicare or other government health programs is a relatively rare penalty…
Malpractice Lawsuit Calls Out Lack of Genetic Counseling
From - Diagnostic Testing & Emerging Technologies
A 36-year-old Oregon woman filed a $1.8 million medical malpractice lawsuit against her doctors and a southwest Oregon medical center for…
CMS Ignores Flawed Processes, Finalizes 2018 PAMA Pricing; Labs Need to Take Immediate Action to Offset Impending Lean Times
By Kyle Fetter bio
The final 2018 clinical laboratory fee schedule (CLFS) is out, and it is evident that the argument that the Centers for Medicare & Medicaid Services (CMS) PAMA process was…