TAG:
DOJ
Attorney Advises Labs to Track Genetic Test LCDs
CEO SUMMARY: Skyrocketing numbers of genetic test referrals and telehealth claims since 2016 are getting the full attention of both federal prosecutors and auditors from Medicare and private health insurers. The DOJ has filed criminal cases against a growing number of telehealth pro…
Feds Target Genetic Test and Telemedicine Fraud
MEDICARE FRAUD TOTALING $562 MILLION in genetic and cardiovascular tests is at the heart of recent federal criminal cases involving telemedicine that names clinical laboratory owners, physicians, and healthcare marketers as defendants. A host of indictm…
September 19, 2022 Intelligence: Late-Breaking Lab News
Déjà vu? Lawmakers in Congress question whether public health officials have done enough to stay ahead of monkeypox, including the availability of diagnostic tests. Concerns about such testing came up during a Sept. 14 hearing before the Senate’s Health, Education, Labor, and Pensions Committee. …
Balwani Guilty! Sentencing Is Next for Theranos Execs
CEO SUMMARY: The trial of former Theranos President and Chief Operating Officer Ramesh “Sunny” Balwani ended with convictions by a jury on 12 counts of wire fraud and conspiracy. Now all eyes are looking ahead to the sentencing of Balwani and Elizabeth Holmes, the founder and fo…
New Percentage-Based Commissions Ruling
CEO SUMMARY: In denying a motion to dismiss certain charges against a clinical laboratory owner, a federal court in California has declared that the Eliminating Kickbacks in Recovery Act (EKRA) of 2018 applies to payments for marketing to physicians and other referral sources. This …
Halfway Through 2022, More Changes Come at Labs
APPROACHING THE MIDWAY MARK OF 2022, some clinical laboratory directors and pathologists might feel like they’ve already experienced enough changes to last the whole year. For example, since the start of 2022, we’ve seen SARS-CoV-2 testing surges co…
DOJ Charges Execs over Alleged Lab Kickbacks to Obtain Restitution
CEO SUMMARY: Multiple executives and sales representatives at True Health Diagnostics and Boston Heart Diagnostics have been named as defendants in a civil suit filed by the U.S. Department of Justice. The complaint centers on alleged kickbacks in return for clinical laboratory test…
Labs Can Expect COVID-19 Lab Testing Audits and Federal Investigations
This is an excerpt of a 2,081-word article in the May 16, 2022 issue of THE DARK REPORT. The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Billions of federal dollars were paid out for needed SARS-CoV-2 testing during the pandemic. Now, even th…
Labs Can Expect COVID-19 Test Audits, Investigations
CEO SUMMARY: Billions of federal …
DOJ: EKRA Governs Lab Sales and Marketing Commissions
BY FILING A MOTION IN A U.S. DISTRICT COURT RECENTLY, officials from the federal Department of Justice (DOJ) took steps to oppose an earlier ruling by a federal judge in Hawaii dealing with the way the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) governs how percentage-based commission…
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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