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OIG Advisory Opinion Alert: Yet Another Favorable Decision for Medical Device Manufacturers

Healthcare Law Blog

On Thursday, March 16, the Office of the Inspector General for the Department of Health and Human Services (“OIG”) issued OIG Advisory Opinion (“AO”) No. Like these other AOs, OIG found that while the Proposed Arrangement could generate fraud and abuse risks under both the Federal anti-kickback statute (i.e.,

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The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

Executive Health Resources, Inc. , Executive Health Resources, Inc. , 2023) ( Buckman preemption barred MDL asserting fraud on EPA), cert. United States Department of Health and Human Services , 58 F.4th In 2023, these include United States ex rel. Polansky v. UnitedHealthcare, Inc. , 3d 239 (Cal.

FDA 105