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Lab Market Is Fragmenting, Creating New Opportunities
April 8th, 2024 | From the Volume XXXI, No. 5 - April 8, 2024 Issue
Even as consolidation continues in the ownership of hospitals, health systems, office-based physicians, and clinical laboratories, there is a powerful trend of fragmentation quietly transforming the way providers—including clinical labs and pathology groups—serve patients and consumers who want s...
Labs and Path Groups Should Prepare for Arrival of ‘Perfect Storm’
February 29th, 2024 | From the Volume XXXI, No. 3 - February 26, 2024 Issue
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...
Machine Learning Is Ready to Give Clinical Labs New Capabilities
November 13th, 2023 | From the Volume XXX, Number 15 - October 23, 2023 Issue
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)...
Clinisys CEO Discusses Strategic Changes That Labs Need to Make
October 27th, 2023 | From the Volume XXX, Number 15 - October 23, 2023 Issue
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 | From the Volume XXX, No. 14 - October 2, 2023 Issue
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 | From the Volume XXX, No. 13 - September 11, 2023 Issue
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 | From the Volume XXX, No. 12 - August 21, 2023 Issue
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 | From the Volume XXX, No. 11 - July 31, 2023 Issue
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 | From the Volume XXX, No. 10 - July 10, 2023 Issue
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 | From the Volume XXX, No. 9 - June 19, 2023 Issue
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...
Don’t Be at the Mercy of the Tumultuous Healthcare Revolution
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CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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