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Attorneys Assess Impact of FDA’s Final LDT Rule

CEO SUMMARY: Publication of the Food and Drug Administration’s final rule on laboratory developed tests (LDTs) is already causing some labs to consider withdrawing their existing LDTs because of compliance costs. Two experienced lab industry attorneys discuss aspects of the LDT rule and…

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OIG’s Issues New Opinion on Use of Gift Cards for Lab Specimens

CEO SUMMARY: This new Advisory Opinion from the Office of Inspector General (OIG) outlines a narrow situation in which it may be allowable for clinical laboratories to use gift cards to encourage pa…

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New Percentage-Based Commissions Ruling

CEO SUMMARY: In denying a motion to dismiss certain charges against a clinical laboratory owner, a federal court in California has declared that the Eliminating Kickbacks in Recovery Act (EKRA) of 2018 applies to payments for marketing to physicians and other referral sources. This …

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