Reimbursement Strategies, LLC has many years of experience: Policy Knowledge combined with Business Intelligence and market surveillance

Medical device and diagnostic manufacturers complete the FDA Regulatory process, win FDA-approval, and then find out that the more grueling insurance coverage and reimbursement process of approval has just begun. At the onset of product introduction, it difficult to ascertain what the result will be.

Medical device technologies face different challenges than do pharmaceutical products post approval. Once the device is FDA-approved, the manufacturer must seek individual approval from most payers; government, commercial, and managed care.

The chances of coverage and reimbursement success increase significantly, if during the Regulatory Phase more defined clinical and economic endpoints are included in the clinical trial design.

Reimbursement Implications are at times unseen or remain unknown until market launch…and sometimes well after.  We provide innovative reimbursement strategies, business development, and policy and market assessments in your product sphere. RS has deep expertise and understanding of this environment with professional experience spanning diverse payers, physician and trade association, device manufacturers and across all types of providers.