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clinical lab testing
Expense of Phlebotomy Leases Raise Cost of Care in Australia
By Joseph Burns | From the Volume XXIII, No. 17 – December 19, 2016 Issue
CEO SUMMARY: In the United States, medical labs have long recognized that paying over-market rates to lease phlebotomy space in physicians’ officers is an inducement and a violation of federal anti-kickback laws. In Australia, a law in 2010 that removed the cap on what labs could pay to…
Much Disruption for Labs In 2016’s Top 10 Stories
By Robert Michel | From the Volume XXIII, No. 17 – December 19, 2016 Issue
CEO SUMMARY: Within THE DARK REPORT’S list of the Top 10 Lab Industry Stories for 2016 is one story of disruption that might have been one story of disruption about to happen. The disintegration of Theranos during 2016 is the big story about a self-proclaimed disruptor of the lab indust…
Medicare Part B Lab Test Prices Versus Budgeted Payment
By R. Lewis Dark | From the Volume XXIII No. 15 – November 7, 2016 Issue
THERE IS AN IMPORTANT QUESTION THAT lab industry magazines and news sources have failed to address: How many years are left before Medicare officials drop fee-for-service payment for clinical lab testing? On January 26, 2015, the Department of Health and Human Services (HHS) issued a press rele…
How Reference Pricing Encourages Patients to Help Cut Cost of Care
By Joseph Burns | From the Volume XXIII No. 14 – October 17, 2016 Issue
USE OF REFERENCE PRICING by Safeway to lower the cost of clinical laboratory tests was the subject of a study published by JAMA Internal Medicine in July. In a special issue, THE DARK REPORT analyzed the study, which showed that reference-based pricing …
What will the future hold for Theranos?
By R. Lewis Dark | From the Volume XXIII No. 10 – July 25, 2016 Issue
This is an excerpt from a 1,900-word article in the July 25 issue of THE DARK REPORT. The complete article is available to paid members of the Dark Intelligence Group. …
Theranos Now Scrambling To Save What It Can
By Joseph Burns | From the Volume XXIII No. 10 – July 25, 2016 Issue
CEO SUMMARY: On July 7, CMS imposed severe sanctions on Theranos for CLIA violations. Included is a two-year ban on owning and operating a clinical laboratory for Theranos, CEO Elizabeth Holmes, the former COO, and the former medical director. Theranos appears to be pivoting away from a c…
Quest Makes Second Deal For Inpatient Lab Volume
By Joseph Burns | From the Volume XXIII No. 8 – June 13, 2016 Issue
NEWS OF A HOSPITAL INPATIENT LAB MANAGEMENT AGREEMENT between HealthONE of Denver and Quest Diagnostics Incorporated marks the second time in six months that the public lab company has earned an inpatient lab management pact with a multi-hospital health system. Ther…
Quest to Manage Six Labs at HCA HealthONE Hospitals
By Joseph Burns | From the Volume XXIII No. 8 – June 13, 2016 Issue
CEO SUMMARY: For decades, hospitals were reluctant to allow any outside lab company to run their inpatient lab operations because they preferred to maintain control over quality results and turnaround times. That attitude may be changing as health systems face increasing margin compressio…
Is Theranos Kowtowing To CMS over Pending CLIA Sanctions?
By Robert Michel | From the Volume XXIII No. 7 – May 23, 2016 Issue
CEO SUMMARY: Having ignored the profession of laboratory medicine for nearly all of its 13-year corporate life, Theranos suddenly began engaging with expert laboratorians last month. The timing of this new outreach coincides with public disclosure that CMS proposed the severest sanctions …
Do Regulators Really Protect Patients, Consumers?
By R. Lewis Dark | From the Volume XXIII No. 7 – May 23, 2016 Issue
IMAGINE, FOR A MOMENT, THAT ONE OF YOUR LOVED ONES had gone to Theranos during the past two years to get lab tests. Assume that your loved one was being tested for significant biomarkers that directly affected the care provided to your family member for significant health issues and that your loved o…
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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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