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lab risk & compliance

Comment Period Closing on Federal Surprise Billing Rule

PATHOLOGY GROUPS AND CLINICAL LABS HAD UNTIL SEPTEMBER 7 to comment on an interim final rule that provides federal protections against surprise billing and limits out-of-network (OON) cost sharing under many of the circumstances in which surprise bills arise most frequently….

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Insurers Get Aggressive with Years-Old Audits

CEO SUMMARY: Not only are health insurers looking back to find overpayments and funds paid erroneously, but payers also are requiring documentation for overpayments. If clinical labs and anatomic pathology groups do not appeal such claims quickly, they may be liable for any amount i…

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CLIA Accreditation Market: More Competitive Now?

CEO SUMMARY: It’s been three decades since compliance with the Clinical Laboratory Improvement Amendments (CLIA) became mandatory. During that time, there has been little competition among the major organizations with deeming status by the Medicare Program to accredit labs to CLIA…

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CMS Shuts Missouri Lab Due to ‘Immediate Jeopardy’

CEO SUMMARY: CMS ordered Gamma Healthcare to close its two labs, revoked the owners’ CLIA licenses, prohibited them from operating a lab for two years, and ordered payment of more than $55,000 in civil penalties. The two lab facilities had been running COVID-19 and other tests for…

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Whistleblower Lab Manager Files Response to PerkinElmer Lawsuit

IN A DAVID-VERSUS-GOLIATH-LIKE BATTLE, perhaps the most unusual lawsuit in decades involving clinical laboratory operations and compliance is unfolding in a federal courthouse in California. In this case, a multi-billion-dollar in vitro diagnostics (IVD) company is suing a laboratory manager w…

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Ransomware Attackers Target Health Providers

CEO SUMMARY: Both malware and ransomware have been around for a number of years. But the attacks launched today against healthcare providers are more sophisticated and better at achieving the total shutdown of targeted hospitals, doctor groups, and clinical laboratories. For this re…

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Federal Judges: Paying Commissions Violates AKS

CEO SUMMARY: Health Diagnostic Laboratory and its marketing partner, BlueWave Consultants, were back in the news recently after a three-judge panel of a federal appeals court denied a challenge from the former principals of those companies to an earlier court ruli…

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Restitution and Guilty Plea in Two Lab Fraud Cases

CEO SUMMARY: In one case, owners and a sales rep agreed to pay restitution totaling almost $10 million. In the second case, three defendants pled guilty to federal charges involving payment or receipt of kickbacks and illegal inducements. A fourth defendent in this second case, a ph…

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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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