Getting Started with the FDA’s New LDT Rule
Experts explain what the phase-in process will look like—and how labs can get ahead of the game.
Experts explain what the phase-in process will look like—and how labs can get ahead of the game.
Federal enforcement actions at the end of October and first two weeks of November featured some unusual characters.
Most of the recent settlements and enforcement actions involving labs related to medically unnecessary UDTs and genetic tests.
A recent $3.5 million settlement illustrates the kinds of pitfalls that can result in liability for hospital and freestanding sleep labs.
Recent case shows that fraud and kickback schemes involving CGx testing continue to be on the federal enforcement radar.
Most healthcare-related enforcement actions from July and August involved urine drug tests and genetic testing.
The OIG’s new Fraud Alert can help labs and other providers steer clear of potentially suspect arrangements with telemedicine companies.
The DOJ recently charged 21 defendants across the US for allegedly carrying out COVID-19 scams worth just under $150 million.