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...

Stay ahead of the curve

In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.


  • Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
  • Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
  • Create custom alerts for specific article and case topics and so much more!

TRY LAW360 FREE FOR SEVEN DAYS

Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Beta
Ask a question!