LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
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Labs in Court: Alleged Stark Law Violations Lead to $10m Settlement with DOJ
Other recent legal actions include a self-disclosure settlement and punishment for alleged improper diagnostic test add-ons
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SCOTUS Ruling May Save Labs from Baseless Qui Tam Lawsuits
The recent 8-1 decision expands the DOJ’s power to request such cases be thrown out.
Fraud Trial of Theranos CEO Is Back on Track
After several delays, the trial of former Theranos CEO Ramesh “Sunny” Balwani on charges of fraud and wire fraud resumes today. The prosecution evidence includes records showing that Theranos voided lab test results to cure CLIA deficiencies cited in...
Website Ad Doesn’t Bar Qui Tam Suit for Rewards Program Fraud
A new case from the US Court of Appeals for the Ninth Circuit tests how far the public disclosure bar goes.
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