Health Care Law News and Insights

On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance entitled "Clinical Decision Support Software" (CDS guidance), which updates the framework for FDA's oversight of CDS products, substantially revising the draft guidance that was previously released in 2017, " Clinical and Patient...

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On September 18, 2019, the Department of Justice announced a $21.36 million settlement to resolve a False Claims Act ("FCA") lawsuit alleging a fraudulent kickback scheme through which a pharmaceutical company (Patient Care America, or "PCA") induced doctors to write expensive and unnecessary prescriptions to military veterans. A False Claims...

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The U.S. Department of Justice (DOJ) continues to actively target the healthcare industry for False Claims Act (FCA) and other alleged violations, and it took significant steps to further its reach into the telehealth and genetic testing markets this week. Prosecutors in the Southern District of Florida (SDFL) indicted the...

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