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molecular testing

November 4, 2019 Intelligence: Late Breaking Lab News

Pharmacogenetic testing is gaining acceptance by a growing number of health insurers. On Oct. 1, UnitedHealthcare (UHC) began coverage of genetic tests that help physicians identify the anti-depressant drugs most likely to benefit their patients. UHC’s policy also extends coverage …

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October 14, 2019 Intelligence: Late Breaking Lab News

Two interesting partners are working on a project to map the human immune system with the goal of creating a knowledge base that can be used to develop diagnostic tests. Microsoft and Adaptive Biotechnologies of Seattle are collaborating on this project. “Google c…

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PGx Testing Labs Concerned by FDA’s Statements, Actions

This is a synopsis of two in-depth articles in the Sept. 3, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: Since April, 2019, the federal Food and Drug Administration (FDA) ha…

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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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Labs Get High Denial Rates Under New NCCI Rules

CEO SUMMARY: Under guidelines the National Correct Coding Initiative issued last year, many clinical laboratories are not getting paid for some tests. The rates of denial for labs running mostly molecular tests could range from 40% to 100% of revenue, one billing expert said. Implemented …

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Nine Lab Groups Say New NCCI Policy Is Inconsistent

CEO SUMMARY: By its name alone, the National Correct Coding Initiative (NCCI) Policy Manual implies that it will be accurate and consistent with other coding initiatives. But nine groups representing various clinical laboratories say NCCI guidelines that the federal Centers for Medicare a…

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Sonic to Pay $540 Million to Buy Aurora Diagnostics

CEO SUMMARY: Sonic Healthcare, Ltd., announced that it would pay $540 million—a multiple of 9.2 times EBITDA—to acquire Aurora Diagnostics, the anatomic pathology company based in Palm Beach Gardens, Fla. Sonic will gain 32 pathology practice sites and add 220 pathologists to its netw…

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Under Audit, Labs Need Statistics on Their Side

CEO SUMMARY: When commercial and government payers use auditors to review a lab’s claims, they often use statistical sampling and extrapolation to limit the time needed to review claims. But proper sampling and extrapolation require following the rigorous scientific methods to produce a…

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Near Real-time Data Helps Lab Save $500K Annually

CEO SUMMARY: After hospital labs and pathology groups implement Lean and process improvement methods to harvest the easiest cost savings and boost quality, they often take the next step of introducing real-time analytics systems. Access to detailed data about workflows, productivity, and …

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Key Lab Trends Described At Executive War College

CEO SUMMARY: Innovative clinical labs and pathology groups are absorbing this year’s Medicare Part B price cuts while continuing to pursue opportunities to add value. A common theme from many speakers at last week’s Executive War College in New Orleans is that the lab must get mastery…

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