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molecular tests
Top 10 2014 Biggest News Stories
By Robert Michel | From the Volume XXI No. 17 – December 15, 2014 Issue
Story no.1 SGR Fix by Congress Spawns PAMA; Lab Industry Wary of Law’s Impact ON APRIL 1, PRESIDENT BARACK OBAMA signed into law the Protecting Access to Medicare Act of 2014 (PAMA). As written, it has the potential to be the most impactful federal legislation on the clinical lab industry s…
Pathologist Raises Questions about Theranos’ Business Model
By Robert Michel | From the Volume XXI No. 13 – September 22, 2014 Issue
Dear Editor: I read your two articles on Theranos in the August 11 issue of THE DARK REPORT, and concur in large part with your thoughtful conclusions. For several years, I have closely followed Theranos and have been quoted in trade publications speaking favorably…
Philly Blue Cross Contract: LabCorp In; Quest Out
By Joseph Burns | From the Volume XXI No. 12 – September 2, 2014 Issue
CEO SUMMARY: Independence Blue Cross in Philadelphia decided to select Laboratory Corporation of America for its new eight-year managed care contract that took effect on July 1. However, the real story is the aggressive bidding war between the two national labs. Sources say LabCorp bid an…
At Mid-Year, Labs Struggle to Get Paid for Many Tests
By Joseph Burns | From the Volume XXI No. 10 – July 21, 2014 Issue
CEO SUMMARY: At a recent coding and billing conference, pathology and lab clients of one of the nation’s largest revenue management companies agreed that three trends have caused lower revenues since the start of 2014. One trend seen by labs involves higher deductibles and copayments fr…
Pathology Consolidation Underway in Washington
By R. Lewis Dark | From the Volume XXI No. 7 – May 19, 2014 Issue
CEO SUMMARY: Two regional pathology super-practices have emerged in Washington State. In each case, acquisitions and mergers are fueling the growth of the two large pathology groups. In Western Washington and the Seattle metro, CellNetix is the dominant pathology group, with 53 physicians…
New Pricing Formula for Advanced Diagnostic Tests
By R. Lewis Dark | From the Volume XXI NO. 6 – April 28, 2014 Issue
CEO SUMMARY: One section of the federal H.R. 4302: Protecting Access to Medicare Act of 2014 is getting positive reviews from many lab experts. The law defines advanced diagnostic tests (ADTs) and directs CMS to assign a temporary HCPCS code and use list prices to pay labs for such tests …
UCLA Pathologists to Open Joint Venture Lab in Shanghai
By Robert Michel | From the Volume XXI NO. 6 – April 28, 2014 Issue
PATHOLOGISTS at the University of California Los Angeles Department of Pathology will participate in a unique commercial laboratory company that will be based in Shanghai, China. On April 8, UCLA announced a partnership agreement with Centre Testing International Corp….
April 28, 2014 Intelligence: Late Breaking Lab News”
By Robert Michel | From the Volume XXI NO. 6 – April 28, 2014 Issue
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…
Whole Genome Sequencing Is Poised for Clinical Use
By Robert Michel | From the Volume XXI No. 5 – April 7, 2014 Issue
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 …
Anatomic Pathology Business Faces Uncertain Future
By Robert Michel | From the Volume XXI No. 4 – March 17, 2014 Issue
CEO SUMMARY: There’s a day of reckoning on the way for the traditional business model of the private pathology group practice. At most risk are smaller pathology groups that typically have five or fewer pathologists. Blame it on the reduced prices that Medicare and private insurers are …
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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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