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Clinical Trial Reimbursement


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 pivotal clinical trial results. At the time, no favorable CMS reimbursement precedent existed for the Client’’s product. Although ICD-9-CM inpatient procedure codes had been assigned for similar devices, they lacked association with a billing rate and were not reimbursed.


BMS proposed a multi-staged approach to assist the 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 the analysis, BMS concluded the clinical data provided strong support regarding key issues affecting CMS decision-making for inpatient and outpatient procedures. BMS developed a compelling argument to present to CMS, and submitted successful applications for a new procedure code and new technology add-on payment.