TAG:
DOJ
In Civil Suit, DOJ Seeks Triple Damages for Lab Test Fraud
CERTAIN CLINICAL LABORATORY EXECUTIVES AND LAB SALES PROFESSIONALS may soon be made to pay where it hurts most—in their wallets. The U.S. Department of Justice (DOJ) announced on April 4 that it had joined a civil complaint against 18 defendant…
Federal Healthcare Fraud Enforcement Turns to Emerging Areas
CEO SUMMARY: Healthcare compliance attorneys say the Department of Justice (DOJ) is turning its focus to fraudulent activity related to COVID-19 testing. But that’s not the only area attracting greater scrutiny by the DOJ. Fraud stemming from opioid treatment has snared clinical l…
Another 10 Doctors Settle Laboratory Kickback Cases, Pay Back $1.68m
FALLOUT CONTINUES FROM A LARGE LABORATORY KICKBACK INVESTIGATION in Texas, as another 10 physicians and one healthcare executive agreed to settle with the government and pay back $1.68 million. Clinical lab sales teams throughout the United States will …
Seven Doctors Settle Lab Test Fraud Case
CEO SUMMARY: In January, a U.S. Attorney from East Texas announced that seven physicians and a hospital CEO had agreed to settle allegations of fraud involving the payment of bribes in exchange for lab test orders. This is a positive development for the clinical laboratory profession because it…
Federal Prosecutors Describe Illegal Lab Bribes to Physicians
PATHOLOGISTS AND CLINICAL LAB MANAGERS SHOULD WELCOME every federal prosecution of a physician who accepts illegal bribes and inducements in exchange for laboratory test referrals. If physicians understood that federal prosecutors would file criminal charges against them for this behavior, fewer doct…
Labs Should Be Cautious about ‘Surprising’ EKRA Ruling
CONFUSION ABOUT WHEN IT IS LEGAL UNDER TWO FEDERAL LAWS to pay commissions to sales reps based on volume and/or revenue has existed since the passage of the federal Eliminating Kickbacks in Recovery Act of 2018 (EKRA). Now, a district court judge in Hawaii has surprisingly ruled that payments of perc…
Florida Laboratory Owner Gets 82-Month Jail Term
CEO SUMMARY: Federal prosecutors are sending a clinical lab owner to federal prison for almost eight years. Hopefully, this is a sign that the Department of Justice (DOJ) is ready to use criminal indictments more frequently against lab owners, lab managers, and lab sales reps who vi…
In Theranos’ Trial, CLIA Laboratory Director Has a Starring Role
CEO SUMMARY: Most clinical lab directors understand the risks that come with running a CLIA-licensed lab. Such risks are at the forefront of the criminal trial of Elizabeth Holmes, founder of now-defunct Theranos. During the trial, federal prosecutors and defense attorneys question…
CLIA Lab Director Testimony Shows Risks to Pathologists
CEO SUMMARY: Elizabeth Holmes’ criminal trial is a case study for clinical lab directors in how not to run a medical lab, according to an attorney with 30 years of advising labs on CLIA-enforcement issues. During the trial, federal prosecutors cited the Clinical Laboratory Improve…
Former Theranos Lab Director Makes News at Elizabeth Holmes Trial
This is an excerpt of a 1,867-word article in the October 18, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: During the trial, a pathologist who was a former Theranos lab director testified about the little…
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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