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Keeps you up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
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 Issues Proposed Rule Implementing MACRA
From - National Intelligence Report
In January, the Centers for Medicare & Medicaid Services (CMS) Acting Administrator Andy Slavitt indicated the "Meaningful Use program as it has existed, will now…
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…