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diagnostic laboratory
January 9, 2017 Intelligence: Late Breaking Lab News
December 27 was the 100th birthday of pathologist Jan Steiner, MD, FRCP (C), FCAP, remembered by many long-serving lab executives and clinical pathologists as one of the co-founders, along with James Root, PhD, of Chi Laboratory Systems in the late 1980s. This was a time when he was…
Pharmacogenomic Testing Draws $26 Million Recoupment from Medicare Audit
This is an excerpt from a 1,340-word article in the January 9 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: Phar…
$26 Million Recoupment from Medicare Audit Hammers Pharmacogenomic Lab
CEO SUMMARY: After Pharmacogenetics Diagnostic Laboratory LLC was audited by a Medicare Zone Program Integrity Contractor (ZPIC), it faced a $26 million repayment demand. The lab company appealed and asked for a redetermination, then filed for Chapter 11 bankruptcy protection. These devel…
Much Disruption for Labs In 2016’s Top 10 Stories
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…
Will Coming Medicare Fee Cuts Reduce Access to Laboratory Tests?
SEVERAL IMPORTANT clinical laboratory associations are concerned that the lab test price reporting under the Patient Access to Medicare Act of 2014 will have a negative effect on diagnostic innovation and on Medicare beneficiaries’ access to lab testing services. The American Clinical Laboratory A…
Why Small Labs and Even Hospitals Are at Risk from PAMA Cuts
CEO SUMMARY: Clinical lab executives and experts who have studied the final rule for PAMA lab test market price reporting are seriously concerned that the design of this rule may put many of the nation’s smallest, but still essential, clinical labs at great risk of financial distress, i…
Labs Have Heavy Burden to Report Lab Price Data
CEO SUMMARY: Clinical labs must assess their responsibilities to report lab test market prices to CMS as part of the Protecting Access to Medicare Act. A panel of three experts took up this topic at a recent webinar hosted by THE DARK REPORT. On June 23, the federal Centers for Medicaid &…
10% PAMA Fee Cut Would Lower Medicare Pay to Laboratories by $400 Million
CEO SUMMARY: Just eight weeks remain before certain clinical laboratories must begin submitting private payer lab test price data to the federal Centers for Medicare & Medicaid Services. A new report …
Health Diagnostics Laboratory lawsuit seeks $600M; will it establish a new precedent?
This is an excerpt from a 1,350-word article in the September 26 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: It’…
HDL Founders, BlueWave, Shareholders Sued for $600 Million by Bankruptcy Trustee
CEO SUMMARY: Unlike federal prosecutors, who to date have shown little interest in seeking to recover money from either the physicians who accepted inducements from Health Diagnostic Laboratory or many of the shareholders, executives, and sales consultants of HDL, the trustee of the HDL b…
CURRENT ISSUE
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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