Reliable Business Intelligence News About Clinical Laboratories, Pathology Groups, & Laboratory
Diagnostics Since 1995

Labs and Path Groups Should Prepare for Arrival of ‘Perfect Storm’

In the near future, clinical labs and pathology groups will need to address three major developments. One involves the FDA proposed LDT rule. A second is the adoption by payers of guidelines that require genetic test claims to have Z-Codes. The third centers around coming reforms and updates to the 1...

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Machine Learning Is Ready to Give Clinical Labs New Capabilities

In the second part of an exclusive Q&A with The Dark Report, Clinisys CEO Michael Simpson explains how new developments in digital technologies will expand the value and role of lab test data. He predicts that labs will use artificial Intelligence (AI)...

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Clinisys CEO Discusses Strategic Changes That Labs Need to Make

In an exclusive Q&A with The Dark Report, Clinisys CEO Michael Simpson describes the main forces transforming healthcare here in the United States and abroad. He connects these trends with advances in cloud-based technology, artificial intelligence, and ...

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FDA Releases Proposed Rule to Further Regulate LDTs

The U.S. Food and Drug Administration (FDA) has taken the first step to regulate laboratory developed tests (LDTs). Many in the clinical laboratory oppose the FDA on this point....

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IVD Consolidation Reduces Choices for Labs

Since the launch of The Dark Report in 1995, consolidation of hospitals, physician groups, clinical labs, p...

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Actions Pathologists Can Take to Protect Their Income

Given that pathology reimbursements are always on the chopping block and labor costs are at all-time highs, it’s understandable tha...

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OIG Says Billing Code 81408 Is at Risk of ‘Improper’ Payment

Clinical laboratories may have heard billing code 81408 referred to as "fraudomatic," and now the Office of Inspector General (OIG) has attached a remarkable number to t...

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UHC Z-code Deadline Looms, Raising Concerns About Technical Assessment Timelines

By now, many of you are aware that UnitedHealthcare is scheduled to begin requiring Z-codes for genetic test claims under its private health plans. That Aug. 1 deadline raises questions about whether labs that need to complete a technical assessment as part of their Z-code requests w...

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Experts Discuss Genetic Test Claim Review

GENETIC TESTING LABORATORIES CAN EXPECT PRIVATE HEALTH INSURERS to require better data about the accuracy and clinical relevance of the genetic test claims being s...

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UHC’s Z-Code Requirement for Molecular Test Claims Starts Aug. 1

In what may be an alarming development for certain clinical laboratories, as of Aug. 1, UnitedHealthcare will require Z-codes for molecular test claims filed under its commercial health plans. ...

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