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CLIA Clinical Laboratories Civil Monetary Penalty

King & Spalding

FDA's LDT Rule Struck Down by Court: FDA Has Lost the Battle, But Is the War Over?

King & Spalding on

A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services. On March 31, 2025, in the consolidated cases American Clinical Laboratory...more

K&L Gates LLP

K&L Gates Triage: CMS Cease and Desist Letters to COVID Labs and Reimbursement Dispute

K&L Gates LLP on

In this episode, Stephen Bittinger discusses the recent announcement that cease and desist letters from the Centers for Medicare & Medicaid Services (CMS) have been sent to 171 facilities testing for COVID-19 without proper...more

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