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clinical laboratory industry
Is New Cycle of Laboratory Fraud Plaguing the Industry?
By Mary Van Doren | From the Volume XXII No. 12 – August 24, 2015 Issue
CEO SUMMARY: Taken collectively, the growing number of federal investigations of lab companies and health insurer lawsuits against lab companies alleging fraudulent busine…
Is New Cycle of Fraud Plaguing Lab Industry?
By Robert Michel | From the Volume XXII No. 12 – August 24, 2015 Issue
CEO SUMMARY: Taken collectively, the growing number of federal investigations of clinical lab companies and health insurer lawsuits against lab companies alleging fraudulent business practices signals a disturbing new trend for the lab industry. Although these allegations are lev…
Investment Bank Bullish On Clinical Labs, Pathology
By Joseph Burns | From the Volume XXII No. 11 – August 3, 2015 Issue
CEO SUMMARY: For clinical laboratories and anatomic pathology groups willing to adapt to the evolving needs of the American healthcare system, there are many positive opportunities. That’s the view of a Wall Street investment bank that just published a report on the lab testing…
Beware Ides of March! Lawmakers Are in Session
By Joseph Burns | From the Volume XXII No. 4 – March 9, 2015 Issue
CEO SUMMARY: Few pathologists and lab administrators know that, when the Protecting Access to Medicare Act of 2014 (PAMA) became law last April 1, language in the bill was scored to reduce Part B clinical laboratory test fees by $2.5 billion over 10 years. Congress used those lab…
Healthcare Cost Solutions Will Continue to Pinch Lab Industry Revenues in 2015
By Mary Van Doren | From the Volume XXII No. 1 – January 5, 2015 Issue
CEO SUMMARY: Will 2015 turn out to be a watershed year for the clinical laboratory industry? With healthcare cost solutions continuing to squeeze laboratory profits, two federal agencies are pushing forw…
Lab Industry to Confront Major Issues during 2015
By Robert Michel | From the Volume XXII No. 1 – January 5, 2015 Issue
CEO SUMMARY: Will 2015 turn out to be a watershed year for the clinical laboratory industry? Not only are two federal agencies pushing forward with initiatives that will touch nearly every medical lab in the United States in the next 12 months, but other equally powerful trends c…
Top 10 2014 Biggest News Stories
By Robert Michel | From the Volume XXI No. 17 – December 15, 2014 Issue
Story no.1 SGR Fix by Congress Spawns PAMA; Lab Industry Wary of Law’s Impact ON APRIL 1, PRESIDENT BARACK OBAMA signed into law the Protecting Access to Medicare Act of 2014 (PAMA). As written, it has the potential to be the most impactful federal legislation on the clinical lab industry s…
Public Comment Started on FDA LDT Regulations
By Joseph Burns | From the Volume XXI No. 15 – November 3, 2014 Issue
CEO SUMMARY: On October 3, the FDA published draft guidelines to regulate laboratory-developed tests (LDTs). Pathologists and lab executives now have 120 days to comment on the guidelines. Several prominent national lab associations have expressed concerns about this additional bureaucrat…
FL Docs Say: ‘No Thanks’ to UHC and BeaconLBS
By Joseph Burns | From the Volume XXI No. 14 – October 13, 2014 Issue
CEO SUMMARY: Some Florida physicians are declaring their intent to leave UnitedHealthcare’s network because they find the insurer’s new BeaconLBS laboratory benefit management system to be time consuming and onerous. The defections come as the program goes through a soft launch that b…
Did Labs Rip Off Medicare? Feds Are Investigating
By Robert Michel | From the Volume XXI No. 13 – September 22, 2014 Issue
CEO SUMMARY: One reason why there is not a level playing field in lab industry compliance with laws governing kickbacks and anti-business behavior is that government officials do not act quickly against the lab industry’s worst offenders—if they take any action at all. News of a feder…
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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