Since 1995, Reliable Business Intelligence for Clinical Laboratories, Pathology Groups and Laboratory Diagnostics

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molecular lab

Detroit Hospital Develops 10 Ways To Add More Value

CEO SUMMARY: Clinical labs are beginning to make the transition from a volume-based financial model to a model based on value-based payments. To survive this transition, labs must find ways to create value. The lab at Henry Ford Health System has  identified 10 ways that it c…

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FDA Notifies Congress that It Will Regulate LDTs

CEO SUMMARY: Since 2006, the FDA has said it has the authority to regulate lab-developed tests, but it has held off on doing so. Now the agency says it’s time, defining LDTs as being, “designed, manufactured, and used within a single laboratory. LDTs include some genetic tests and tes…

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Excluding Lab Competitors Helps Big Labs Grab Greater Market Share

CEO SUMMARY: Changes in healthcare are motivating health insurers and the nation’s largest lab testing companies to enter into contracts in which the large lab company lowers its lab test prices to the payer in return for having the payer exclude that lab company’s toughest competitor…

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April 28, 2014 Intelligence: Late Breaking Lab News”

In recent years, a series of decisions involving molecular diagnostics tests made by Medicare officials and the Medicare Administrative Contractors (MACs) have caused much disruption in the clinical laboratory industry. In response to these developments, on April 16, the California Clinical L…

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Whole Genome Sequencing Is Poised for Clinical Use

CEO SUMMARY: Pathologists and clinical lab managers interested in following the advances in use of whole human genome sequencing for clinical purposes should follow the money. Within weeks of obtaining FDA clearance for its MiSeqDx system and reagents, Illumina had inked major agreements …

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Better Data Needed to Support Pathologists as Consultants

MULTIPLE TRENDS ARE UNFOLDING that mutually reinforce the need for pathologists and PhDs to be experts and consultants in how physicians order and follow up on molecular diagnostics assays and genetic tests. “Healthcare in the United States is approaching a tipping point that can greatly favor pat…

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Claritas Is Example of New Lab Business Model

CEO SUMMARY: One by one, new business models for clinical laboratory testing are popping up. Each is a response to healthcare’s rapid evolution, the ongoing decline in lab test reimbursement, and the growing role for molecular diagnostics and genetic testing. In Cambridge, Massachusetts…

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Frederick Sanger Dies at Age 95, Hailed as Father of Genomics

EVERY DAY, ACROSS THE GLOBE, labs perform testing using Sanger sequencing and other fundamental techniques of proteomics and genomics pioneered and developed by Frederick Sanger, who died last month at the age of 95. Sanger is considered one of the giants in biochemistry. He was one of only three pe…

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Labs Have New Hurdles as Some Payments Start

CEO SUMMARY: Some payments are beginning to flow for claims submitted under the new molecular test CPT codes. But there is a new issue. Medicare contractors, Medicaid programs, and private health insurers are deeming certain molecular tests to be medically unnecessary. Th…

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Much Uncertainty About Pay for Molecular Codes

CEO SUMMARY: Having gone unpaid since January 1 for the 114 new molecular CPT codes, many clinical labs and pathology groups have stopped running these tests or laid off staff. Some are considering closing their doors. Evidence indicates that certain Medicare contractors are deciding that…

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