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IVD Companies Launch New Assays, Analyzers, Automation

Steep declines in SARS-CoV-2 test revenue were reported by the top in vitro diagnostics (IVD) companies in Q2 2023 earnings compared to a year earli…

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August 21, 2023, Intelligence: Late-Breaking Lab News

New research about ownership of physician practices will be of interest to anatomic pathologists who operate their own businesses. According to an analysis by the American Medical Association (AMA),…

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CMS: TJC Made ‘Business Decision’ to Not Recognize COLA

Following up on a prior briefing, The Dark Report has learned that the Centers for Medicare and Medicaid Services (CMS) does not appear to hav…

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Proposed Electronic Signature Rule Has Compliance Risks

CEO SUMMARY: Proposed HHS rule aims to define and standardize physician electronic signatures. For clinical laboratories, this is important because lab test claims require a signed requisition form. Given …

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Draft Rule Standardizes Electronic Signatures

CEO SUMMARY: Every year, payers refuse laboratory test claims on grounds that the ordering provider’s signature is missing or illegible—a situation that costs clinical labs million of dollars in…

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Pharmacogenetic Tests Deliver for Avera Health Lab

CEO SUMMARY: When Avera Institute for Human Genetics wanted to expand its genomics program, it used its past learning with pharmacogenetics to guide the effort. Two key insights? Ask physicians abo…

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IVD Firms Prepare for OTC, Home Test Market Expansion

CEO SUMMARY: With public interest in home testing growing, some IVD manufacturers are preparing to serve a fast-expanding market for over-the-counter and at-home tests. IVD firms are banking on the…

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Six Important Themes to Help Labs Succeed

CEO SUMMARY: Clinical laboratories face business challenges with day-to-day operations, genetic testing, and evolving care delivery models. The 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management returns on April 25-26 in New Orleans. Participant…

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Building Collaborations to Deliver More Value

Innovative clinical laboratory leaders closely monitoring the financial health of their labs or hospitals will find plenty to chew on in this issue of The Dark Report.  The laboratory team at Atrium Health in Charlotte, N…

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Joint Commission Will Not Accept COLA Accreditation

CEO SUMMARY: This may be a first in the 40-year history of CLIA accreditation of clinical laboratories. The Joint Commission (TJC) announced it will no longer recognize COLA’s laboratory accreditation program within “TJC-accredited facilities,” effective Jan 1, 2023. COLA-accredited labs …

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