Special Report: The 2024 Lab Enforcement Landscape
Lab leaders should be wary of telemedicine arrangements, certain marketing firms, and unnecessary PGx and CGx testing
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Articles and Reports
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.
LDTs Around the World
Curious about how laboratory-developed tests are regulated in other countries? We compare in-house test guidance across six regions
CGx Testing and Kickbacks Remain Key Enforcement Targets
In our latest roundup, schemes involving cancer genetic testing and kickbacks remain the most common, but there were some surprises.
December 2022 Enforcement Scorecard: Unusual Suspects
Federal enforcement actions at the end of October and first two weeks of November featured some unusual characters.
November 2022 Enforcement Scorecard: UDTs and Genetic Tests
Most of the recent settlements and enforcement actions involving labs related to medically unnecessary UDTs and genetic tests.
Feds Lower the Boom on Home Sleep Test False Billing and Kickbacks
A recent $3.5 million settlement illustrates the kinds of pitfalls that can result in liability for hospital and freestanding sleep labs.
Feds Not Backing Away from Punishing CGx Testing Scams
Recent case shows that fraud and kickback schemes involving CGx testing continue to be on the federal enforcement radar.
Unnecessary Drug and Genetic Tests the Theme in Recent Enforcement Actions
Most healthcare-related enforcement actions from July and August involved urine drug tests and genetic testing.
How to Guard Your Lab from Telehealth Liability Risk
The OIG’s new Fraud Alert can help labs and other providers steer clear of potentially suspect arrangements with telemedicine companies.
Lowering the Boom on COVID-19 Relief Scammers
The DOJ recently charged 21 defendants across the US for allegedly carrying out COVID-19 scams worth just under $150 million.
CMS Set to Crack Down on Hospitals Over Price Transparency
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OCR Continues HIPAA Right of Access Crackdown, but at a Much Slower Pace
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