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AACC reveals details of its invitation to Theranos CEO

TDR Insider / By Mary Van Doren

This is an excerpt from a 925-word article in the May 23 issue of THE DARK REPORT. The complete article is available to paid members of the Dark Intelligence Group. CEO SUMMARY: In its latest lab industry scoop, THE DARK REPORT has reached out to American Association of Clinical Chemistry (AACC) leaders to find out how …

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Theranos Saga Just Keeps Getting More Intriguing

TDR Insider / By Mary Van Doren

IT’S BEEN AN EVENTFUL COUPLE OF MONTHS for Theranos, the lab testing company that says its goal is to disrupt the clinical laboratory industry. Novelists cannot write fiction as compelling as the unfolding real story about this controversial company.

During March and April, The Wall Street Journal published a series of articles that revealed the extent of the problems Theranos had with CLIA inspections of its clinical laboratory in Newark, California. The Journal published its analysis of the CLIA inspection report and the serious deficiencies identified during lab inspections that happened last fall and earlier this year.

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CMS Update Plans for Medicare Clinical Lab Fee Schedule Could Be in Trouble

TDR Insider / By Mary Van Doren

This is an excerpt from a 1,400-word article in the April 11 issue of THE DARK REPORT. Full details of the California program are included in the original article, available to paid members. CEO SUMMARY: Evidence from California shows that national lab test price reporting, required for CMS to set rates for the Medicare Clinical Lab Fee …

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UnitedHealthcare Warns Labs: Don’t Waive Patient Fees

TDR Insider / By Joseph Burns

This article is an excerpt from a 1,500-word article in the March 21 issue of THE DARK REPORT. Full details of UHC’s battle against out-of-network labs, as well as its plans to begin requiring pre-authorization for genetic testing, are included in the original article, available to paid members. IN ITS LATEST NETWORK BULLETIN, UnitedHealthcare warned out-of-net- …

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At FDA, Laboratory-Developed Tests Are in the Crosshairs

TDR Insider / By Mary Van Doren

This article is an excerpt from a 600-word article in the March 21 issue of THE DARK REPORT. Full details of FDA’s laboratory-developed test guidance and recent actions against labs that are marketing LDTs are included in the original article, available to paid members. The Food and Drug Administration claims that clinical laboratories are marketing their (LDTs) laboratory-developed tests – which make …

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Payers Using Two Approaches To Price Molecular and Genetic Tests

TDR Insider / By Joseph Burns

EXECUTIVE SUMMARY: This analysis, unique to THE DARK REPORT, contrasts the decision of Palmetto GBA to distinguish between “hotspot” tumor panels (meaning those targeting 5 to 50 genes and 51 or more genes) versus “sequencing” tumor panels in coding and pricing NGS test panels, with simpler approaches used by other health insurers. Understanding these differences …

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Henry Ford Health System Labs Show How Lean Methodology in Healthcare Increases Revenues

TDR Insider / By Mary Van Doren

EXECUTIVE SUMMARY: Here’s a major accomplishment by the lab division of a nationally-recognized health system that has gone unreported until this DARK REPORT intelligence briefing. This article explains how using the quality management system of ISO 15189 and the Lean methodology in healthcare allow it to absorb shrinking lab budgets while improving quality, and, at the …

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Doctors’ resistance to BeaconLBS comes to Florida legislature

TDR Insider / By Mary Van Doren

CEO SUMMARY: THE DARK REPORT IS THE ONLY LAB INDUSTRY NEWS SOURCE to report on this important development. A hearing took place recently on a healthcare bill in the Florida senate. Physicians in Florida are working to get language inserted into a state law that would restrict the ability of health insurers to use a clinical decision support …

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Direct Access Testing Wars Are Heating Up

TDR Insider / By Mary Van Doren

CEO SUMMARY: In Phoenix, where Theranos already operates patient service centers in about 40 Walgreens pharmacies, Sonora Quest Diagnostics has an agreement with Safeway to provide clinical laboratory testing services in two grocery stories in the Phoenix metro as part of a pilot arrangement. Find out what’s unfolding in this highly-competitive market for direct access testing customers. IT’S …

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Official Makes Case in Favor of FDA LDT Guidance

TDR Insider / By Mary Van Doren

IN THIS EXCLUSIVE NEWS COVERAGE of a public appearance by a key FDA official, THE DARK REPORT provides lab executives and pathologists with a more nuanced understanding about the thinking behind the proposed FDA LDT guidance. Among the interesting insights are that FDA officials will not be surprised if some labs file a lawsuit challenging …

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