Lexology July 1, 2024
The Department of Health and Human Services Office of Inspector General (“OIG”) recently issued a favorable advisory opinion that relates to whether two drug assistance programs would run afoul of the Federal anti-kickback statute (“AKS”).
In good news for the entity that requested the opinion, a United States corporate affiliate of a pharmaceutical manufacturer of the drug at issue (the “Requestor”), the OIG stated that it would not impose administrative sanctions for either program, despite the potential to generate prohibited remuneration under the AKS. Although the advisory opinion is only applicable to the specific programs at issue and can be relied upon only by the Requestor, there are some potential considerations that could be applied more broadly to other arrangements.
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