NYSDA Publications

HHS OIG Issues Advisory Opinion Allowing Payment if Needle Does Not Prevent Needlestick Injury

Jul 1, 2025

Per the notice below, the Office of the Inspector General (OIG) of the United States Department of Health and Human Services (HHS) has issued an advisory opinion permitting a needle manufacturer to provide up to $2,500 in benefits to the purchaser if its needle fails to operate properly to prevent a needlestick injury.  HHS OIG found that the payments to the doctor purchasing the needle were protected by the warranty safe harbor under the Federal Anti-kickback Statute.

  • Advisory Opinion 25-05: This favorable opinion regards a proposed arrangement pursuant to which a medical device manufacturer would offer up to $2,500 to reimburse purchasers for actual costs incurred associated with a needle stick injury caused by the failure of a device that it manufactures.  You can read the complete Advisory Opinion here: HHS OIG Advisory Opinion.