TAG:
anti kickback statute
Top Stories in 2025 Played Out in Courts, Capitol Hill
CEO SUMMARY: The biggest story of the year for clinical laboratories came in a huge court victory, as a federal judge vacated the FDA’s final rule on laboratory developed tests. Labs breathed a sigh of relief after the court decision, as the FDA rule had promised to incr…
December 8, 2025, Intelligence: Late-Breaking Lab News
For the next 46 months, a Georgia fraudster will stay behind bars after pleading guilty to charges he violated the Anti-Kickback Statute by arranging for medically unnecessary genetic tests. A judge sentenced Patrick C. Moore, Jr. on Dec. 2. Moore was also ordered to pay $7.2 million in…
Court: Percentage-Based Comp Is Not Illegal in Itself
OUR MEMBERS LEARNED IN THE PRIOR ISSUE ABOUT AN IMPORTANT COURT RULING that interpreted the Eliminating Kickbacks in Recovery Act of 2018 (EKRA), a law that has long been maligned by clinical laboratories for its murkiness. The Dark Report has since talked in…
For AI Regulation, Look to Data Laws, FDA Action
CEO SUMMARY: AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics. Few court cases exist yet that interpret AI use within clinical settings, but labs must watch how HIPAA and state laws wield influence. Vendor soft…
Federal Court Reverses Conviction in AKS Case
CEO SUMMARY: A federal appeals court has overturned the conviction of an operator of a durable medical equipment company who was accused of violating the Anti-Kickback Statute. A marketing company’s lack of true influence over decision-making related to the case seemed t…
Labs: Why it Pays to Know Your Customers
WOULD IT SURPRISE YOU TO LEARN THAT THERE ARE DOCTORS WHO ARE SERI…
Federal Lawsuit Favors Lab Accused of AKS Violations
CEO SUMMARY: This whistleblower lawsuit initially charged a clinical lab with, among other things, violating the Anti-Kickback Statute and EKRA. After the judge ruled to exclude the AKS and EKRA claims, the whistleblower refiled the case and included claims the lab paid commissions for th…
Multi-year Prison Sentence for Genetic Test Fraud
CEO SUMMARY: In recent years, federal prosecutors are filing ever greater numbers of civil actions and criminal indictments against individuals accused of healthcare fraud and abuse. This includes prosecutions of doctors alleged to have received illegal kickbacks from lab companies in exc…
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…
Physicians Tempted by Lure of In-Office Labs, Payers Balk
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Volume XXXIII, No. 3 – March 2, 2026
The Dark Report highlights the six themes that will carry the 2026 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management,, including finance issues and AI. Also, we show how RCM automation helped one lab conquer billing headaches and increase revenue.
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