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Machine Learning Is Ready to Give Clinical Labs New Capabilities
November 13th, 2023
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)â€...
Clinisys CEO Discusses Strategic Changes That Labs Need to Make
October 27th, 2023
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 ...
FDA Releases Proposed Rule to Further Regulate LDTs
October 2nd, 2023
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....
IVD Consolidation Reduces Choices for Labs
September 11th, 2023
Since the launch of The Dark Report in 1995, consolidation of hospitals, physician groups, clinical labs, p...
Actions Pathologists Can Take to Protect Their Income
August 21st, 2023
Given that pathology reimbursements are always on the chopping block and labor costs are at all-time highs, it’s understandable tha...
OIG Says Billing Code 81408 Is at Risk of ‘Improper’ Payment
August 3rd, 2023
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...
UHC Z-code Deadline Looms, Raising Concerns About Technical Assessment Timelines
July 14th, 2023
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...
Experts Discuss Genetic Test Claim Review
June 23rd, 2023
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...
UHC’s Z-Code Requirement for Molecular Test Claims Starts Aug. 1
May 30th, 2023
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. ...
Kaiser Acquires Geisinger Health in Blockbuster, Value-Based Deal
May 8th, 2023
The Dark Report examines how the acquisition of Geisinger Health by Kaiser Permanente not only sets the stage for more blockbuster hospital deals, but offers a platform for new value-based reimbursement models. Kaiser is forming a new value-based organization to include Geis...
Don’t Be at the Mercy of the Tumultuous Healthcare Revolution
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CURRENT ISSUE

Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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