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Medicaid
OPKO Settles Allegations of Fraudulent Billing
By Robert Michel | From the Volume XXXII, No. 6 – April 21, 2025 Issue
DEMONSTRATING THAT EVEN ROUTINE TESTS CAN CAUSE LEGAL HEADACHES for clinical laboratories, the U.S….
Managing Denials and Appeals of Clinical Lab, Path Claims
By Robert Michel | From the Volume XXXI No. 15 – November 4, 2024 Issue
CEO SUMMARY: Based on a study of denials and appeals involving about 20 million lab test claims, the team at XiFin Inc. presents here their findings. They also provide recommendations on steps labs can take to reduce denials and win a greater proportion of appeals. IN RECENT…
Federal Cases against Labs Result in Convictions
By Robert Michel | From the Volume XXXI, No. 14 – October 14, 2024 Issue
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…
Physicians Tempted by Lure of In-Office Labs, Payers Balk
By Virchow | From the Volume XXXI, No. 14 – October 14, 2024 Issue
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Federal Prosecution of Lab Test Fraud & Abuse
By R. Lewis Dark | From the Volume XXXI, No. 14 – October 14, 2024 Issue
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…
Several Times, Feds Tried to ‘Redirect’ Lab Activities
By Robert Michel | From the Volume XXXI, No. 8 – June 10, 2024 Issue
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…
April 29, 2024, Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXXI, No. 6 – April 29, 2024 Issue
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…
Feds Bar Elizabeth Holmes from Government Health Programs
By Robert Michel | From the Volume XXXI, No. 2 – February 5, 2024 Issue
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 …
Layoffs at Major Health Plans Slow Processing of Lab Claims
By Virchow | From the Volume XXXI, Number 1 – January 16, 2024 Issue
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OPKO’s BioReference, Sonic Each Release Earnings Reports
By Robert Michel | From the Volume XXX, Number 18 – December 26, 2023 Issue
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. …
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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