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How to Cover Genetic Tests Confounds Health Insurers
CEO SUMMARY: Managed care experts say health insurers are being overwhelmed by the number of new genetic tests and that many labs find it tough to get paid for these tests. UnitedHealthcare just announced it will require pre-authorization of molecular and genetic tests during 2016. Me…
Just 66 of 742 Labs Submit Rate Data to California Department of Health Care Services
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Understanding the Future Of Laboratory Medicine
CEO SUMMARY: Healthcare’s transformation is now far enough along that most clinical labs and pathology groups are either feeling the financial pain or are excitedly developing ways to deliver more value from lab testing services. On April 26-27, at the 21st annual …
UPMC-KingMed Digital Pathology Venture Improves Patient Care
CEO SUMMARY: Many experts think that digital pathology will make it possible to create international pathology subspecialty referral networks. Now in its fifth year, a partnership between UPMC’s Pathology Department and KingMed Diagnostics of China uses telepathology to give Chinese pat…
March 21, 2016 Intelligence: Late Breaking Lab News
Tougher times in the clinical lab testing market have claimed another lab company. On February 28, Artherotech, Inc., posted a notice on its website stating that it had closed permanently, as of that date. Along with its several hundred employees, Artherotech’s closure caught many…
FDA Steps Up Test Enforcement, Saying Tests Need Clearance
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Grodman Resigns from BRLI, New President Is Henderson
THERE IS A NEW LEADER at Bio-Reference Laboratories, Inc., now owned by OPKO Health, Inc., of Miami, Florida. Last week, Gregory Henderson, MD, PhD, was named as President of BRLI. Henderson takes over from Marc Grodman, MD, who resigned after serving as Chairman, P…
Payers Using Two Approaches To Price Molecular and Genetic Tests
EXECUTIVE SUMMARY: This analysis, unique to THE DARK REPORT, contrasts the decision of Palmetto GBA to distinguish between “hotspot” tumor panels (meaning those targeting 5 to 50 genes and 51 or more genes) versus “sequencing” tumor panels in coding and pricing NGS test panels, wi…
February 29, 2016 Intelligence: Late Breaking Lab News
Sandy, Utah-based Sure Genomics is the latest genetic testing company to get a letter from the Food and Drug Administration asking why the company is marketing its SureDNA genetic testing kit to consumers without first obtaining clearance from the federal agency. Th…
Henry Ford Health System Laboratory Division Combines Lean with ISO 15189
CEO SUMMARY: As healthcare transitions away from fee-for-service payment and adopts new models of reimbursement, every clinical lab will need to deliver more value with its lab testing services. At Henry Ford Health System in Detroit, the laboratory division has blazed a path of improving…
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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