MDMA Cites Gainsharing Concerns in Comments on OIG Proposal
MDMA filed comments today to the Department of Health and Human Services (HHS) Office of Inspector General (OIG) expressing strong concerns over creating a new safe harbor to permit gainsharing in a recent OIG proposal. MDMA’s comments centered upon erecting another barrier to entry that could, potentially, be insurmountable for many small medical device manufacturers.
The OIG proposed rule would amend the Anti-Kickback Statute’s regulatory safe harbors (AKS Safe Harbors) and expand permitted gainsharing arrangements under the Civil Monetary Penalty law (CMP). In addition to potentially limiting market access to entrepreneurial companies, MDMA’s comments also expressed concern over OIG’s proposal that could limit patient access to innovative medical technologies as well.
To view MDMA’s comments in their entirety, please click here.