Clinical Lab Management
News related to managing clinical laboratories.
South Carolina Doctor Pays $585,000, Agrees to Cooperate With DOJ to Resolve Lab Fraud Allegations
Moustafa Moustafa and his medical practice allegedly received kickbacks in violation of the Anti-Kickback Statute in exchange for referring patients for lab testing.
The proposed rule, which is likely to face industry challenges, calls for a four-year phase-in of LDT regulation while also suggesting possible carve-outs.
FDA Releases Proposed Rule for Oversight of Laboratory-Developed Tests
The rule, which would make explicit FDA's authority to regulate LDTs, is certain to face pushback from many in the laboratory and diagnostics industries.
US Wins $370M Judgment in Lab Fraud Case
A US district court awarded the judgment against a Kentucky lab owner accused of billing Medicare for molecular testing not ordered by a healthcare provider.
Biora Therapeutics Settles Claims of Misleading Genetic Testing Advertisements
The company, formerly known as Progenity, was accused of violating consumer protection laws by making misleading claims about the costs of its genetic testing services.