CMS has granted its new technology add-on payment to SI-Bone's iFuse Bedrock Granite implant, which received the FDA's breakthrough device designation in November and is designed for sacroiliac fusion and sacropelvic fixation.
The add-on payment "will be based on 65 percent of the per patient anticipated hospital cost achieved ... up to a potential maximum of approximately $9,800," CEO Laura Francis said during SI-Bone's first-quarter earnings call, transcribed by Seeking Alpha.
Once the NTAP proposal is finalized, and if iFuse Bedrock Granite receives FDA clearance, the device will be available for additional Medicare payment in the hospital inpatient setting as part of multisegment spinal fusions, Ms. Francis said.
CMS uses the program to accelerate the adoption of innovative devices meeting certain cost and clinical improvement criteria after FDA approval.
"We believe the benefits of iFuse Granite's differentiated technology, the seamless surgeon workflow integration and potential for incremental reimbursement, puts us in a strong competitive position," Ms. Francis said. "It will allow us to accelerate our growth in an attractive, $250 million adjacent adult deformity market."