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
Enforcement Trends: New Takedown Is Evidence that Genetic Testing Has Become an Enforcement Priority
It’s a pretty good sign that fraudulent billing of genetic lab testing has become a priority for federal fraud enforcers when it gets its very own “takedown.”
Enforcement Trends: New Emphasis on MD Practices Puts Labs at Growing Risk of Antitrust Enforcement
From - Lab Compliance Advisor
In addition to the usual Medicare and Medicaid anti-fraud laws, labs have a new liability risk to contend with…
Kickbacks: Massachusetts Practice Latest Provider Busted for Taking Kickbacks from Millennium
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Ergonomics in the Laboratory Setting
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
Sometimes when I am talking about lab safety and the topic turns to ergonomics, I get an unusual reaction from the audience…
Enforcement Trends: DOJ Changes to Yates Memo Make It Easier for Labs to Get Credit for Cooperating with Investigators
From - Lab Compliance Advisor
For the past five years, the DOJ has followed an enforcement policy designed to hold directors, officers and other top…
Case of the Month: Feds Target Doctors Who Took Kickbacks from HDL
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New OIG Report Confirms that Labs Are Still on the Enforcement Radar
From - Lab Compliance Advisor
After a recent dip, OIG enforcement activity has seemingly rebounded, at least in terms of total recoveries. That's the…
Case of the Month: U.S. Supreme Court Gives Whistleblowers Four More Years to Sue
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Case of the Month: Another MD-Owned Lab Gets Busted for Urine Drug Test Abuses
From - Lab Compliance Advisor
Fraudulent utilization and billing of urine drug screening first became a priority for federal enforcers since the…
Enforcement Trends: CMS Orders Medicare Contractors to Go After Labs that Received Specimen Validity Test Payments
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