Red Flags in Clinical Lab Operations Rise from Recent Court Cases
Guilty plea points to patient data collection, while settlement implicates an undisclosed relationship
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Articles and Reports
FDA Watch: OraSure’s Collection Device for Cobas STI Testing Receives Approval
At-home sample collections can be mailed to a clinical laboratory
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Dx Deals: Danaher Acquires StatLab in Deal Valued at More than $1 Billion
The company will fold into Leica Biosystems after the transaction closes at the end of this year
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Loper Bright Renews Interest in the VALID Act
The US Supreme Court decision that recently overturned the Chevron doctrine is influencing potential enactment of new legislation
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September 2024 Labs in Court
Recent DOJ settlements continue to focus on issues involving medical necessity and marketer compensation
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What Labs Need to Know About MolDX
How the MolDX® program works, what it covers, and how it can support better test access, use, and reimbursement in the clinical lab
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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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Key Developments and Challenges in Laboratory Networks
The current landscape of medical laboratory networks and challenges that will need to be addressed to improve data sharing and efficiency.
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Dx Deals: Outreach Deals by Quest, Labcorp Are Still Ramping Up
Though the two national players have closed dozens of such deals over the past decade, much runway for new transactions apparently remains
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Electronic Device Use in the Laboratory: The Keys to Safety
Three main risks to consider when it comes to personal electronic devices, and how to safely incorporate their use in the laboratory
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Considering the Impact of Digital Pathology on Recruitment Efforts
How might a modestly sized lab or pathology group harness technology to address their recruitment needs?
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August 2024 Labs in Court
COVID-19-related schemes dominated recent enforcement efforts, which include a national healthcare fraud enforcement action
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FDA Watch: How Could the End of Chevron Impact the FDA and LDTs?
A lawsuit by a group of herring fishermen upended 40 years of legal precedent regarding how federal agencies interpret statutes
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