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NJ Lab Sues to Challenge Payers About Its Out-of-Network Status
ONE WAY THAT A CLINICAL LAB can fight back against insurers who refuse to pay lab test claims is to sue them. That’s exactly what Medical Diagnostic Laboratories of Hamilton, N.J. is doing! Not only has MDL filed lawsuits against two major health insurance companies, but in one la…
China Invests $9 Billion In Precision Medicine
CEO SUMMARY: In the 1960s, it was a race to be first in space between the United States and the Soviet Union. This decade, it’s a race to be first in genetic and precision medicine between the U.S. and China. To that end, the Chinese government has budgeted $9 billion as an investment t…
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…
PAMA Economics Drives Merger Of Two Seattle-Area Pathology Groups
CEO SUMMARY: Among the three chief reasons for the merger of CellNetix and Puget Sound Institute of Pathology, the most compelling was the need to address the challenges in the current reimbursement environment and to prepare for reductions in payment to pathologists expected in the comin…
$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…
Theranos implosion was the first Big Story of 2016
This is an excerpt from a 3,200-word article in the December 19 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. …
Expense of Phlebotomy Leases Raise Cost of Care in Australia
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…
Revisiting the ‘Substantially in Excess Rule’
BY NOW, NEARLY EVERY LAB MANAGER knows that Medicare lab test fee cuts will commence in just 13 months, on Jan. 1, 2018. The federal Centers for Medicare & Medicaid Services estimates that the f…
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…
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…
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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