Company A needed to determine whether they could receive a favorable reimbursement decision from the Centers for Medicare and Medicaid Services (CMS) based upon its 510(k) clearance and the results of a pivotal clinical trial. At the time, no favorable CMS reimbursement precedent for Client’s product existed. Although ICD-9-CM inpatient procedure codes had been assigned for similar devices, they lacked association with a billing rate and were not reimbursed.
Clinical Trial Reimbursement Advisement
BMS proposed a multi-staged approach to assist company: 1) objectively access the clinical data to determine whether a sufficient case can be argued that the device results in a substantial clinical improvement; 2) prepare for a case presentation to CMS; and 3) prepare and deliver reimbursement applications to CMS.
Based on analysis, BMS concluded the clinical data provided strong support with respect to key issues affecting CMS decision making for both inpatient and outpatient procedures. BMS developed a compelling argument to present to CMS, and submitted applications for an ICD-9-CM code and new technology add-on payment.