Red Flags in Clinical Lab Operations Rise from Recent Court Cases
Guilty plea points to patient data collection, while settlement implicates an undisclosed relationship
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Lessons in Laboratory Compliance from a $30 Million Settlement
‘Lean lab’ setup appears to have caught the eyes of investigators
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2026 Predictions for Clinical Labs: AI, Audits, and Increased Enforcement
How clinical laboratories should prepare for the next wave of oversight in the new year
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Criminal Charges May Spell the End for Theranos
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ACA: DOJ Won’t Defend Individual Mandate in Court—But 16+ States Will
From – National Intelligence Report
One of the DOJ’s principal roles is to defend the federal laws in court cases challenging their constitutionality. But the agency has made it known that…
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Case of the Month: $33.2 Million Alere Settlement Sends Warning Shot Across Bow of LDT & DX Device Makers
From – National Intelligence Report
One of the reasons Abbott Laboratories got cold feet about consummating the $5.3 billion Alere acquisition was concern over the legal proceedings against the…
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New Laws: Very Quietly, Congress Doubles Penalties for Medicare Fraud & Abuse
From – National Intelligence Report
Sneaky may be too strong a word. But what is fair to say is that the new hikes in federal health care fraud violation penalties have flown totally under the radar despite…
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DOJ to Prosecutors: Show Tough Love to Whistleblowers with Weak Cases
From – National Intelligence Report
A newly leaked internal Justice Department memo signals a new prosecution policy that may make it harder for whistleblowers to bring qui tam whistleblower lawsuits under the…
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New Fraud Takedown Shows that Coordinated Enforcement Remains Alive & Well under Trump
From – National Intelligence Report
Last year at this time, the Justice Department announced the results of a nationwide takedown involving “the most defendants charged and largest alleged loss amount in…
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Medical Necessity Requirement Bites Anatomic Pathologists
By Robert Mazer bio
The DOJ has announced two separate settlements involving claims for allegedly unnecessary special stains…
OIG and DOJ Provide Tips for Determining Effectiveness of Compliance Programs
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Health Care Fraud and Abuse Program Faces Declining ROI
From – National Intelligence Report
The federal government’s return on investment (ROI) in the fight against health care fraud continues a steady decline according to the latest numbers reported for the Health Care Fraud and…
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