OIG: Warranty Safe Harbor Protects Device Manufacturer’s Plan to Offer Compensation to Users for Needle Stick Injuries
- July 11, 2025
A proposed arrangement whereby a device manufacturer would offer up to $2,500 to reimburse purchasers for actual costs incurred associated with a needle stick injury from requestor’s device would not generate prohibited remuneration under the Anti-Kickback Statute (AKS) because it is protected by the safe harbor for warranties, the Department of Health and Human Services Office of Inspector General (OIG) said in an advisory opinion posted June 30.
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