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Concerns Raised Over Pharmacogenetic Tests

CEO SUMMARY: Some executives at pharmacogenetic testing companies are criticizing the federal Food and Drug Administration for its recent actions to exercise oversight over PGx testing. But there is more to the story, said one expert who is a past adviser to the FDA on clinical laboratory…

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Few Options for Pathology Groups Facing Anthem’s Payment Cuts

FACED WITH DEEP CUTS in payment for anatomic pathology professional component services from Anthem Inc., pathologist have only a few options in how they can respond, according to consultants who work with AP groups. “These are dire cuts to anatomic pathology reimbursement,” said…

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September 3, 2019 Intelligence: Late Breaking Lab News

Two more clinical laboratory organizations that used American Medical Collection Agency (AMCA) to handle their lab test claims announced in July that their patients’ data was breached. Inform Diagnostics of Irving, Texas, disclosed that the data of 173,716 patient…

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Anthem’s Cuts in AP Fees Could Put Patients at Risk

CEO SUMMARY: Consultants who work with anatomic pathologists have several theories about why Anthem is enacting deep cuts of 50% to 70% for the professional component of many anatomic pathology services. While they have different ideas about what motivates the nation’s second largest he…

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PGx Labs Concerned by FDA’s Statements, Actions

CEO SUMMARY: Since April, the federal Food and Drug Administration has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In response to letters from the FDA, some PGx lab companies have stopped reporting data that predicts a patient’s response to ce…

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After Two-Year Battle with CMS, True Health on Verge of Collapse

CEO SUMMARY: In 2017, an auditor for CMS alleged that True Health filed fraudulent claims and the federal Medicare program cut all payments to the lab company and one month later reduced the cut to 35% of the billed amount. Two months ago, CMS ended all payments again. These facts became …

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Is Pathology Workforce Stable or Shrinking?

CEO SUMMARY: After publishing research in JAMA Network Open showing a coming shortage of pathologists in the United States, the researchers heard from pathologists whose experience in the job market did not match what the researchers found. Anecdotal evidence indicates that the demand for…

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In New Mexico, Three Collaborators Improve Patient Care, Outcomes

IT’S OFFICIAL! A YEAR-LONG COLLABORATION involving a health insurer, a clinical laboratory, and an analytics company showed that insurers and physicians can use clinically-actionable intelligence developed from medical lab test data to improve patient outcomes. This important accomplishment in patie…

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ACLA Gets Procedural Win in Its Appeal of PAMA Case

IN A SIGNIFICANT WIN for the American Clinical Laboratory Association (ACLA) and other groups suing federal Department of Health and Human Services (HHS), the U.S. Court of Appeals for the District of Columbia ruled in the ACLA’s favor on July 30. Ruling on the ap…

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After Two-Year Battle with CMS, True Health Diagnostics on Verge of Collapse

This is a synopsis of three in-depth articles in the Aug. 12, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: In 2017, an auditor for CMS alleged that True Health Diagnostics f…

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