Expanding Test Menus: A Compliance Roadmap for FDA-Regulated Labs
Two OIG advisory opinions guide laboratories that want to work with pharma or medical device companies on expanded testing
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Heed AKS and EKRA to Properly Market Clinical Lab Services
Read this overview of legislation and regulations governing laboratory marketing practices and learn tips to ensure these activities remain compliant
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Labs in Court: Alleged Stark Law Violations Lead to $10m Settlement with DOJ
Other recent legal actions include a self-disclosure settlement and punishment for alleged improper diagnostic test add-ons
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Recent Decision in FCA Case Has Key Implications for Labs
The decision deepens a split among circuit courts regarding how to determine liability for false claims
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Labs in Court: A Full Circle
Cases filed or resolved by the U.S. Department of Justice in the fourth quarter reveal the same compliance issues from early in 2024
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