How will Medicare reimbursement for combination products differ from reimbursement for traditional products?
If a combination product receives approval from FDA, the sponsor may next choose to obtain national coverage and reimbursement from the Centers for Medicare and Medicaid Services (CMS). CMS will require evidence that the combination product will provide a clinically more effective therapy than is currently offered. In the case of a novel combination product, the lack of precedence for comparison makes coverage decisions challenging. CMS also wants companies to demonstrate that the combination product will provide a significant health benefit. However, a coverage decision process for combination products has yet to be defined. CMS is not supposed to consider cost when making a national coverage decision, although there are recommendations for it to begin doing so. Because CMS coverage will greatly influence physician adoption of the combination product, companies are advised to begin the reimbursement process as early as possible. This will help to decrease the lag time between FDA appr
