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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National Lab Reporter
Keeps You Up-to-Date on Federal & State Laws, Regulations, New Legislation, and Court Cases that Affect Your Diagnostic Lab or Pathology Practice
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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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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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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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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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Why Revenue Cycle Management Systems Fall Behind—and How to Modernize Them
Clinical lab billing teams face an overwhelming number of challenges if revenue cycle strategies fall short
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Lawyers Give Their Tips to Spot Clinical Lab Fraud
Medical laboratories should monitor fraud cases across the country and also stay vigilant of suspicious patterns of behavior
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