Software as a Medical Service, or SaMS, Takes Spotlight in New CMS Proposal
Clinical labs have until Aug. 31 to submit public comments about the anticipated changes
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Articles and Reports
Six RCM Tips from the ADLM 2026 Meeting
Watch for panel unbundling, Medicare spending shifts, and frequency-based denials
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Lessons in Laboratory Compliance from a $30 Million Settlement
‘Lean lab’ setup appears to have caught the eyes of investigators
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Federal Appellate Decision on EKRA Spells Out How Lab Marketers Can Violate the Law
If clinical lab managers instruct marketing personnel to engage in kickback practices, they also could be held legally accountable
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CMS Clarifies CLIA Personnel Requirements in Rare Memo
Clinical labs gain flexibility in meeting regulatory standards while potentially reducing their costs
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Expert Q&A: AMR Warnings Need to Be Louder, and It Just Can’t Be Up to Labs
John Osiecki of bioMérieux also discusses AI for outbreaks and regulation trends
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Healthcare Fraud Takedown Reveals 4 Lessons for Clinical Labs
The $14.6 billion bust by federal prosecutors shows gaps that every laboratory should monitor
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Could Labs Adopt a CLIA Framework for Regulating Clinical AI?
Learn how CLIA could be used as a blueprint to regulate emerging technologies in an effective and dynamic way
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Dx Deals: QuidelOrtho Acquires LEX Diagnostics, Plans to Switch Out Respiratory Testing Platforms
The $100 million deal will take advantage of LEX VELO technology to detect influenza and SARS-CoV-2
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A Look at How CLIA-Exempt States Operate and Why This Setup Exists
Washington State’s Department of Health details how its medical testing site program meets federal standards
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FDA Will Not Appeal Ruling Against LDT Regulation, Giving a Big Victory to Labs
The legal strategy of the ACLA—and some political luck—prevailed in the lawsuit against LDT oversight
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Expanding Test Menus: A Compliance Roadmap for FDA-Regulated Labs
Two OIG advisory opinions guide laboratories that want to work with pharma or medical device companies on expanded testing
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Dx Deals: Labcorp Continues Dealmaking with Incyte Asset Acquisition in Washington State
The majority of Labcorp’s revenue growth in the first quarter came from clinical lab acquisitions
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