In an advisory opinion released June 30th, the U.S. Department of Health and Human Services Office of Inspector General (OIG) confirmed that it would not seek to impose monetary sanctions on a medical device manufacturer for its efforts to reimburse purchasers of its device for accidental needle stick injuries caused by a failure of the device’s safety mechanism.
According to the OIG, the manufacturer’s plan fits under the federal Anti-Kickback Statute’s regulatory safe harbor for warranties and does not generate prohibited remuneration under that statute, despite the offer to pay purchasers for failure of the device which might induce purchasers to choose the manufacturer’s product.Continue Reading OIG Advisory Opinion Supports Plan to Reimburse for Needle Stick Injuries