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The Future of Laboratory-Developed Tests

The Future of Laboratory-Developed Tests

by Michael Schubert, PhD | Jan 2, 2024 | Essential, FDA-lca, Lab Industry Advisor, LDTs-lir, Legislation-lca

Comments on the FDA’s proposed rule to regulate LDTs as in vitro diagnostic devices reveal mixed reactions.

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October 2023 Labs in Court

October 2023 Labs in Court

by Glenn S. Demby | Sep 25, 2023 | Essential, Lab Compliance Advisor, Laboratory Industry Report, Labs in Court, National Lab Reporter

Recent cases involve charges and judgments related to COVID-19 add-on tests, genetic testing fraud, and kickbacks.

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Lab Institute Virtual Event: Advancing the Profession of Diagnostic Medicine

Lab Institute Virtual Event: Advancing the Profession of Diagnostic Medicine

by G2 Intelligence Staff | Sep 14, 2023 | OLP, Webinars

Our upcoming event will provide lab leaders with analysis of recent legal and regulatory developments, enforcement trends, and more

Enforcement Trends: OIG Calls Out CMS for Not Preventing Medicare Genetic Testing Overpayments

Enforcement Trends: OIG Calls Out CMS for Not Preventing Medicare Genetic Testing Overpayments

by Glenn S. Demby | Aug 24, 2023 | Enforcement-nir, Essential, National Lab Reporter

Inadequate CMS oversight resulted in $888.2 million in improper payments for the highest reimbursing molecular pathology genetic tests, report says.

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Enforcement Trends: The Urine Drug Testing Crackdown and Three Ways to Avoid It

Enforcement Trends: The Urine Drug Testing Crackdown and Three Ways to Avoid It

by Glenn S. Demby | Jul 31, 2023 | Enforcement-nir, Essential, National Lab Reporter

False billing of urine drug tests (UDTs) continues to be a focus for enforcement agencies in 2023, here’s how to avoid compliance issues.

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