Regulatory Impact on Target Marketing
Payor reimbursement is critical to the business model of a medical device company. The gold standard for reimbursement is a CPT code that assigns a fixed number of Relative Value Units (RVUs) to a device, which then must be adhered to by all payors (i.e., negotiation occurs once). An HCPCS code is much easier to get, but reimbursement must be negotiated with each insurance company individually. Ultimately, the question at hand is: what is the best path forward for Otolith Labs post-FDA approval?
“Which type of code should we lobby for, and when does the lobbying effort begin?”