The settlement requires Kyphon to pay $75 million plus accrued interest to the US, to settle allegations relating to reimbursement advice that the company gave to customers regarding kyphoplasty procedures. The settlement agreement reflects the company’s assertion that Kyphon and its employees had not engaged in any wrongdoing or illegal activity.
In addition to the payment, Kyphon will enter into a corporate integrity agreement (CIA) with the Office of Inspector General for the Department of Health and Human Services. The CIA focuses on training about appropriate reimbursement advice to customers, and also requires maintenance and implementation of standard compliance processes.
The settlement amount had been reserved on Kyphon’s books prior to the closing of the acquisition by Medtronic; therefore Medtronic will not be incurring a charge related to this settlement.