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clinical laboratories
Top 10 2020 Lab Stories Are about More than Just COVID-19
By Robert Michel | From the Volume XXVII, No. 18 – December 28, 2020 Issue
This is an excerpt of a 3,689-word article in the December 28, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: There are several surprises in The Dark R…
2020’s Top 10 Lab Stories Are Without Precedent!
By Robert Michel | From the Volume XXVII, No. 18 – December 28, 2020 Issue
CEO SUMMARY: There are several surprises in The Dark Report’s list of the Top 10 Lab Stories for 2020. Despite the SARS-CoV-2 pandemic dominating every aspect of clinical care, social…
OIG Says Medicare Spending On Testing Increased in 2019
By Robert Michel | From the Volume XXVII, No. 18 – December 28, 2020 Issue
CEO SUMMARY: Newly-released data indicates that Medicare officials are falling far short of their goal to decrease the total amount of money spent annually on Part B clinical laboratory tests. That is one finding by the federal Office of the Inspector General in its report of Medica…
THE DARK REPORT’s Ranking of 2019’s Top 10 IVD Companies
By Robert Michel | From the Volume XXVII, No. 18 – December 28, 2020 Issue
One trend continues to reshape the in vitro diagnostics (IVD) industry year after year: acquisitions. Since the 1990s, the biggest IVD companies have frequently used acquisitions to boost their revenue and keep shareholders happy. But acquisition…
Congress Passes Bill to Ban Surprise Medical Bills
By Robert Michel | From the Volume XXVII, No. 18 – December 28, 2020 Issue
Starting Jan. 1, 2022, out-of-network clinical laboratories may no longer be allowed to bill patients for lab tests performed in certain settings under a law both houses of Congress passed on Dec. 21. The COVID relief bill includes a ban on unexpected m…
NorDx Lab Started COVID Preparation in 2019
By Robert Michel | From the Volume XXVII, No. 17 – December 7, 2020 Issue
This is an excerpt of a 2,995-word article in the December 7, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: In a remarkable example of prescience, informed by decades-long experience in clinical lab testin…
Why Labs Operate in a ‘Duality’ during Pandemic
By R. Lewis Dark | From the Volume XXVII, No. 17 – December 7, 2020 Issue
HAS IT OCCURRED TO MANY OF YOU THAT YOUR CLINICAL LABORATORIES today must operate in what I will describe as an operational “duality”? On one side, your lab must deal with COVID-19 testing. This is true whether your lab performs molecular SARS-CoV-2…
One Genetic Test CPT Code Earns ‘Fraudomatic’ Title
By Robert Michel | From the Volume XXVII, No. 17 – December 7, 2020 Issue
CEO SUMMARY: Several genetic testing companies have noticed that some of the nation’s Medicare Administrative Contractors (MAC) pay about $2,000 for test claims billed with CPT code 81408. From 2018 through and 2019, the number of 81408 claims rose dramatically at just two of thes…
NorDx Lab Started to Prepare for COVID-19 Testing in 2019
By Joseph Burns | From the Volume XXVII, No. 17 – December 7, 2020 Issue
CEO SUMMARY: In a remarkable example of prescience, informed by decades-long experience in clinical lab testing and past epidemics, the president of NorDx Laboratories in Maine saw the December news accounts of a widespread outbreak of a new respiratory disease in China. He warned h…
CMS Sends Cease/Desist Letters to Labs Lacking CLIA Certificates
By Robert Michel | From the Volume XXVII, No. 17 – December 7, 2020 Issue
CLINICAL LABORATORIES DOING COVID-19 TESTING and lacking the proper CLIA certificates to do so are receiving cease-and-desist letters from the federal Centers for Medicare and Medicaid Services (CMS). The first letters were sent on Aug. 12 and le…
CURRENT ISSUE

Volume XXVII, No. 18 – December 28, 2020
There are several surprises in The Dark Report’s annual list of the Top 10 Lab Stories for 2020. Despite the SARS-CoV-2 pandemic dominating every aspect of clinical care, social life, and economic activities since March, at least one major health insurer pushed ahead with two major policies governing how labs can submit claims. In another big story, for the first time in decades, the federal Anti-Kickback Statute and the Stark Law were revised with new final rules. Also, Medicare lab test spending increased in 2019 despite PAMA cuts.
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