Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Final Rules Offer Real Stark and Kickback Relief but Largely Exclude Labs
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Texas Court Nixes Toxicology Labs’ ERISA Beneficiary Unpaid Claims Lawsuit against United Healthcare
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“COVID captains” promote safety precautions
By Dan Scungio bio The year 2020 is roaring to a close, and COVID-19 is unfortunately still around. We have made changes to our lives at home, in public, and at work. Lab workers and other healthcare workers, in particular, made several changes early on with PPE...
New Artificial Intelligence-Based Risk Score May Help Avoid Unnecessary COVID-19 Hospitalizations
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Qiagen Launches Portable COVID-19 Antigen Digital Testing Hub
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Research Supports Viability of Using Health Data from Consumer Wearables to Diagnose COVID-19
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CDC Knowingly Sent Flawed COVID-19 Test Kits to Public Laboratories in Early Days of Crisis
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HHS Orders FDA to Resume EUA Review of Laboratory Developed Tests for COVID-19
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EKRA Prosecution: What Does this Mean for the Laboratory Industry?
By Charles Dunham, IV, Shareholder at Greenberg Traurig, LLP & Benjamin Nipper, Associate at Greenberg Traurig, LLP In January 2020, the U.S. Department of Justice (DOJ) made its first public announcement of a prosecution under the Eliminating Kickbacks...
Surging COVID-19 Cases Are Pushing Laboratories to the Breaking Point
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