Achieving reimbursement for regenerative medicine products in the USA.

Achieving reimbursement for regenerative medicine products is potentially a greater challenge than gaining US FDA approval, making it a decisive factor in the success or failure of small businesses. However, the mechanisms by which reimbursement is achieved are still seen as something of a 'black box', especially to those outside of the USA. This report aims to provide insights into the mechanisms of reimbursement and variety of payers in the USA, and to act as a starting point for a successful US reimbursement strategy. Fundamental concepts such as coverage, payment and coding are explained and linked with the factors that potentially determine the successful reimbursement of regenerative medicine products, including cost of goods and clinical study design. Finally, important considerations for the design of clinical studies that satisfy both the payers and the FDA are discussed and the key elements of a successful company strategy identified.