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stark law

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…

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Federal Healthcare Fraud Enforcement Turns to Emerging Areas

CEO SUMMARY: Healthcare compliance attorneys say the Department of Justice (DOJ) is turning its focus to fraudulent activity related to COVID-19 testing. But that’s not the only area attracting greater scrutiny by the DOJ. Fraud stemming from opioid treatment has snared clinical l…

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Seven Doctors Settle Lab Test Fraud Case

CEO SUMMARY: In January, a U.S. Attorney from East Texas announced that seven physicians and a hospital CEO had agreed to settle allegations of fraud involving the payment of bribes in exchange for lab test orders. This is a positive development for the clinical laboratory profession because it…

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Revised Stark Law, Anti-Kickback Statute Rules Are Good News for Labs

This is an excerpt of a 1,385-word article in the March 22, 2021 issue of  THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: The Dark Report explains how changes to the Stark Law and Anti-Kickback Statute will benefit labs,…

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Revised Stark and AKS Rules Are Good News for Labs

CEO SUMMARY: It must be rewarding for federal rulemakers at the Centers for Medicare and Medicaid Services and the Office of the Inspector General to hear that attorneys representing clinical labs and pathology groups consider the new final rules for the Stark Law and the Anti-Kickb…

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Understanding Key Parts of New AKS, Stark Law Rules

CEO SUMMARY: Both the federal Stark Law and Anti-Kickback Statute have been revised and the final rules became effective on Jan. 19. The good news for clinical laboratories and anatomic pathology groups is that federal regulators from the Centers for Medicare and Medicaid Services a…

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Labs May Be Excluded from Revised Stark, AKS Rules

CEO SUMMARY: When CMS and the OIG issued proposed rules last fall to make it easier for providers to participate in value-based and coordinated care arrangements, they considered excluding clinical labs, pharma companies, and DME firms because of concerns that the proposed rules could pro…

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Labs May Be Excluded from Revised Stark Law, AKS Rules

This is an excerpt of a 1,460-word article in the Jan. 6, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Here are early insights about a federal compliance reform that has not gotten much attention among clinical la…

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Pathology Firm Pays $63M to Settle Qui Tam Case

CEO SUMMARY: Inform Diagnostics, formerly Miraca Life Sciences, settled the federal qui tam case while denying wrongdoing. The $63.5 million settlement will by paid by the former owner, Miraca Holdings, a Japanese company. The federal Department of Justice alleged that the company—then …

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Defunct, Oft-Troubled Calloway Labs Hit with $1.4M Federal Judgement

HOW OFTEN IS A DEFUNCT LAB COMPANY IN THE NEWS? That was the odd development last week when it was announced that a U.S. District Court had entered a $1.4 million civil judgement against Calloway Laboratories, Inc., a toxicology lab company formerly based in Woburn, Mass., for busine…

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