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”
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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
A roundup of recent cases and enforcement actions involving the diagnostics industry
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Genomic Testing Utilization Is Low & Geographically Inconsistent but Not Just Due to Payor Coverage
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Using Waivers to Avoid Getting Sued for COVID-19 Infections
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Labs Lost Less & Will Recover More than Other Healthcare Sectors, Says New Report
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Lab’s Duty to Protect Returning Employees from COVID-19 Discrimination and Harassment
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Agency to Provide Emergency Clearance for Multi-Analyte Respiratory Panels
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New Guidelines Advise Against Using Polygenetic Risk Scores for Routine Patient Management
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COVID-19 Retesting Should Be Pushed Back to 4 Weeks to Give Virus Ample Time to Shed
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Back to the Foundational Facts of Lab Safety
By Dan Scungio...
Here’s new guidance on COVID-19 and FLSA
By Mike O’Brien...