U.S. Reimbursement Strategy Development and Implementation

In the U.S., regulatory approval alone is not enough, without reimbursement (coding, coverage, and payment), even breakthrough technologies struggle to reach patients. JGS helps European companies develop a tailored Reimbursement Intelligence Assessment, mapping the path to secure payer acceptance. We analyse coding options (CPT, HCPCS, PLA codes), payer coverage policies (Medicare, Medicaid, and private insurers), and competitor benchmarks. We also review clinical evidence to ensure it meets payer requirements, and advise on protocol design to close evidence gaps. Our team can support payer engagement, appeals and claims processes, and even patient assistance programmes. The result is a strategy that ensures your technology is not only approved by FDA, but also adopted and paid for in the U.S. system. FDA strategy development, representation with the FDA for submissions, FDA submissions and approval, FDA US Agent representation. Reimbursement analysis report which would include a strategy, a path to payment for the technology from insurance companies and Medicare. Clinical trial protocol development for FDA and for payers and industry. Identify and introduction to distribution partners for sales on the US market