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Criminal Penalties Department of Health and Human Services (HHS) 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

Miles & Stockbridge P.C.

HHS Publishes Proposed Stark and AKS Updates

Miles & Stockbridge P.C. on

On October 9, 2019, the Department of Health and Human Services' Centers for Medicare and Medicaid ("CMS") and Office of Inspector General ("OIG"), respectively, published proposed rules updating the long-standing physician...more

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