The November 2021 Infrastructure Investment and Jobs Act (IIJA) requires manufacturers of separately paid, single use/single dose container Part B drugs and biologics to provide rebates for discarded units above a 10% threshold of separately paid spending for these products. Refunds apply to quarters beginning January 1, 2023. CMS is expected to issue proposed regulations implementing these provisions this summer.
The AACU believes that urologic patients should have access to beneficial therapies without interruption and submitted comments on behalf of our members and patients related to this issue.