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When Corporate Integrity Agreements Multiply, Firms Know What To Expect

This article was originally published in The Gray Sheet

Executive Summary

Orthopedic companies will likely be among the next device firms subject to corporate integrity agreements with the HHS Office of Inspector General, and stakeholders say there are clues as to what they should expect

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Ortho Industry Reaches $311 Mil. Settlement With DoJ On Kickback Charges

Four major hip and knee implant manufacturers will pay the government a total of $311 million to settle anti-kickback claims resulting from a two-year Department of Justice and HHS investigation into the companies' financial relationships with surgeons, the New Jersey U.S. Attorney's office announced Sept. 27

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Orthopedic firm and U.S. Attorney's office in New Jersey begin discussions of a potential resolution to a Department of Justice investigation into Biomet's relationships with surgeons, the firm discloses in a July 9 SEC filing. Justice has been looking into Biomet's consulting and professional service agreements, as well as research agreements and other grants, with potential orthopedic surgeon customers for the company's hip and knee implants from 1998 to the present (1"The Gray Sheet" June 25, 2007, p. 13). "The results of any resolution remain uncertain at this time, but could, among other things, require monetary payments, cause the company to significantly change some of its existing business practices, and include the potential for additional governmental oversight," Biomet says...

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