Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
Testing Recommendations Expand as Zika Season Approaches
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Could the AHCA Slow Interest in Genetic Testing?
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CDC Updates Zika Testing Recommendations
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Genomic Testing May Be Currently Overhyped, Oncologists Say
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FDA Approves First-Ever, Pan-Cancer Drug in Milestone for Personalized Medicine
From - Diagnostic Testing & Emerging Technologies
In what is being heralded a major milestone for personalized medicine, in late May the U.S. Food and Drug Administration (FDA) approved the first…
AACC Calls for Lab Professionals to Support Value-Based Care
From - Laboratory Industry Report
Laboratory professionals have a central role to play in supporting the transition to value-based care, according to…
Employment Law Update for HR Managers
By Mike O'Brien bio
This is my periodic update prepared for interested HR professionals trying to deal with the complex American employment laws…
GAO Faults U.S. Handling of Zika Outbreak; IDs Challenges to Test Development
From - National Intelligence Report
The US. Government Accountability Office (GAO) found that the U.S. Department of Health and Human Services was "reactive" in its handling of the…
Medical Necessity Requirement Bites Anatomic Pathologists
By Robert Mazer bio
The DOJ has announced two separate settlements involving claims for allegedly unnecessary special stains…
Signs Point to Expansion of Provider-Initiated Personal Genomic Testing
From - Diagnostic Testing & Emerging Technologies
Since 2013 when the U.S. Food and Drug Administration (FDA) effectively stopped direct-to-consumer personal genomic testing, there has been pent up demand among healthy individuals for…
