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Medicaid

Federal Cases against Labs Result in Convictions

CEO SUMMARY: Over the past 24 months, federal prosecutors have announced a steady parade of criminal convictions, guilty pleas, and settlement agreements involving fraud and clinical laboratory testing. Not only are these cases numerous, but some resolve legal actions initiated by the fed…

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Physicians Tempted by Lure of In-Office Labs, Payers Balk

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Federal Prosecution of Lab Test Fraud & Abuse

SOMETHING NEW AND DIFFERENT IS HAPPENING WITH THE ENFORCEMENT OF FRAUD AND ABUSE LAWS by the federal Department of Justice (DOJ). The number of cases being filed has increased over recent years. In turn, that means an increase in press releases announcing criminal convictions, guilty…

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Several Times, Feds Tried to ‘Redirect’ Lab Activities

CEO SUMMARY: Regulation of laboratory developed tests (LDTs) by the Food and Drug Administration (FDA) may turn out to be one of the most impactful federal laws or regulations ever promulgated, so far as it pertains to clinical laboratories.cThe Dark Report provides this historical look b…

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April 29, 2024, Intelligence: Late-Breaking Lab News

It may be that the genetic data cat is out of the bag already. Nonetheless, lawmakers in Delaware are considering a bill that—among other things—would prevent life insurance companies from buying or using genetic testing data if it was obtained from ancestry companies and not from medical records…

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Feds Bar Elizabeth Holmes from Government Health Programs

ONCE AGAIN, ELIZABETH HOLMES, THE DISGRACED FORMER CEO OF THERANOS, is in the news. This time it is because the federal Department of Health and Human Services (HHS) Office of the Inspector General (OIG) announced in January that Elizabeth Holmes is …

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Layoffs at Major Health Plans Slow Processing of Lab Claims

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OPKO’s BioReference, Sonic Each Release Earnings Reports

BELOW IS A SUMMARY OF RECENT FINANCIAL EARNING REPORTS for OPKO’s BioReference Laboratories and Sonic Healthcare Ltd’s lab operations in the U.S. This finishes our coverage of Q3-23 financial reporting by the larger public laboratory corporations. …

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Violating EKRA Earns Lab Owner an Eight-Year Prison Sentence

THIS MAY BE THE MOST HIGH-PROFILE CASE involving a clinical laboratory and the Eliminating Kickbacks in Recovery Act of 2018 (EKRA). Former Arrayit Corporation president Mark Schena was sentenced in October 2023 to eight years in federal prison and ordered to pay $24 million in resti…

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Whole Genome Sequencing for Newborns Gains Favor

CEO SUMMARY: Evidence is swiftly accumulating that use of rapid Whole Genome Sequencing (rWGS) for certain children in NICUs can enable diagnostic insights that guide effective interventions. Further, these pilot rWGS programs in childrens’ hospitals are showing a solid return on invest…

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