AdvaMed Comment Letter to OIG – January 27, 2023
In response to an annual solicitation of proposals for new and modified safe harbors and special fraud alerts from the Office of Inspector General, U.S. Department of Health and Human Services, AdvaMed proposed the following:
- Creating a new Anti-Kickback Statute (AKS) Safe Harbor for Value-Based Pricing Arrangements to protect value-based pricing adjustments, where the payment is conditioned or calculated based upon one or more clinical and/or cost outcomes;
- Modifying the existing AKS Safe Harbors for Substantial Downside Financial Risk and Full Financial Risk to enable medtech company participation (excluding physician-owned distributors);
- Creating a new Contingency Management Interventions / Incentives Safe Harbor that also enables medtech company participation; and
- Issuing a Special Fraud Alert concerning Group Purchasing Entities (GPEs, entities like Group Purchasing Organizations (GPOs) that receive fees paid by vendors based upon purchases by entities either wholly owned by the GPE or subsidiaries of a parent corporation that wholly own the GPE) and restoring the integrity of the ownership requirements under the existing GPO safe harbor.