A Clear Guidance From OIG For Device Manufacturers

Law360, New York (July 16, 2013, 12:36 PM EDT) -- A recent advisory opinion issued by the U.S. Department of Health and Human Services' 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 requester's proposed global rebate program would not generate prohibited remuneration under the anti-kickback statute.

According to the advisory opinion, the requester manufactures and sells items reimbursed either directly or...

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