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
OIG Advisory Opinion Says GPO That Includes Labs Has “Acceptably Low” Anti-Kickback Risk
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Risk of FCA Liability Increases as Supreme Court Recognizes Implied False Certification Theory
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Do What the OIG Does: Use Analytics to Address Compliance Efforts and Resources
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News at a Glance – June 2016
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CMS Reports Medicare Fraud Prevention System Saves $1.5 Billion
From - National Intelligence Report
While Big Data can mean new opportunities for increasing efficiencies and revenues for the laboratory industry, the Centers for Medicare & Medicaid Services (CMS) claims Big Data has yielded big savings for…
Biden Launches Genomic Data Commons to Aid Sharing in Oncology
From - Diagnostic Testing & Emerging Technologies
Genomic Data Commons (GDC) launched this week as a core component of the National Cancer Moonshot and the President's Precision Medicine Initiative to promote data sharing between cancer researchers and accelerate the pace of…
OIG Updates 2016 Work Plan Adding New Lab Agenda Item
From - G2 Compliance Advisor
The U.S. Health and Human Services Office of Inspector General released its mid-year update to the Annual Work Plan, adding and revising items relevant to…
LabCorp Receives Emergency FDA Approval for Molecular Zika Test
From - Laboratory Industry Report
LabCorp has received emergency approval from the U.S. Food and Drug Administration for a molecular-based rapid detection test for…
OIG Mid-Year Work Plan Update Adds PAMA-Focused Lab Item
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Genomic Data Commons Promotes Personalized Cancer Care
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