July 2, 2013

Office of the Inspector General Issues Advisory Opinion 13-07

Arnold & Porter Advisory

A recent Advisory Opinion issued by the Office of the Inspector General (OIG) provides helpful guidance on the application of the discount safe harbor for pharmaceutical and device companies. In Advisory Opinion 13-07, published on July 1, 2013, the OIG provided additional clarity on the definition of a "bundle" under the discount safe harbor, and clarified a seller's obligations as well, while determining that the Requestor's proposed Global Rebate Program would not generate prohibited remuneration under the anti-kickback statute.

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