"Site License" Reimbursement Model For Limited Use Antibacterials Being Explored By US FDA, CMS

Commissioner Scott Gottlieb notes consideration of the pull incentive shortly after REVAMP Act stalls in the House. 

Antibiotic resistant bacteria closeup biofilm

While US FDA Commissioner Scott Gottlieb touted the 21st Century Cures Act's inclusion of the limited population antibacterial drug (LPAD) pathway as a way to spur antibiotics to market, he stressed the need for pull incentives focusing on the reimbursement of limited use anti-infectives.

The agency is working on one such step with the Centers for Medicare and Medicaid Services (CMS), Gottlieb explained at a July 25 House Energy and Commerce Subcommittee on Health hearing, which involves an attempt "to move toward a different reimbursement paradigm

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