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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
Quest Receives Emergency FDA Clearance for Zika Test
From - Laboratory Industry Report
Quest Diagnostics has received emergency clearance from the U.S. Food and Drug Administration to distribute its molecular assay for…
Molecular Profiling of Lung Cancer Tumors Feasible on National Scale
From - Diagnostic Testing & Emerging Technologies
Routine, nationwide molecular profiling of patients with advanced non-small cell lung cancer (NSCLC) is feasible and the screening detects actionable alterations that…
Top 10 Patient Safety Concerns Include Lab Related Issues
From - National Intelligence Report
Labs will find most relevant the safety issue appearing at number five on ECRI's list: Inadequate Test-Result Reporting and…
OMB Reviewing Final Rule on Medicare Lab Test Payment System
From - National Intelligence Report
Despite ongoing efforts to delay the changes to the Clinical Laboratory Fee Schedule (CLFS) directed by the Protecting Access to Medicare Act of 2014 (PAMA), the Centers for Medicare & Medicaid Services's final rule implementing the…
Viewpoints Debate Merits of Universal Tumor Sequencing
From - Diagnostic Testing & Emerging Technologies
There is universal recognition that genomic information has forever changed oncology care and is increasingly driving treatment decisions. For patients who have exhausted standard therapy or with…
Convictions, Sentences and a Costly Settlement in Recent Lab Test Enforcement Cases
From - G2 Compliance Advisor
In just this month, lab anti-kickback and false claims enforcement cases have led to the conviction of two lab professionals, prison sentences for a physician and for…
Aurora Diagnostics Acquires Another Pathology Practice
From - Laboratory Industry Report
Florida-based Aurora Diagnostics has acquired another pathology practice, this one located in the central part of the Sunshine State. Aurora announced…
Invitae Greatly Expands Testing Panels, Introduces Pricing for Uninsured
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Quest Sells Much of Focus Affiliate to Italian Laboratory
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Aurora Breaks Into Pacific Northwest Market With Pathology Practice Acquisition
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