Diagnostic Tests

Courts of Appeals Continue to Limit the Government’s Aggressive False Claims Act Theories

This spring saw two significant victories for health care providers in the federal courts of appeals. In both cases, the courts rejected an aggressive government theory under the False Claims Act (FCA), the first related to...more

FDA Regulation of Laboratory Developed Tests: Benefit or Unnecessary Burden?

The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine clinical care. Interested stakeholders such as the...more