Orthofix (OFIX) expects Medicare bone stimulator reimbursement to return to prior levels

Orthofix Medical Inc. reported a regulatory update affecting its non-invasive bone growth stimulators. The FDA reclassified these devices from Class III to Class II on April 16, 2026. After initially changing billing rules from May 18, 2026, CMS later reversed course.

On July 1, 2026, CMS issued revised guidance directing that Medicare claims for devices billed under HCPCS codes E0747, E0748 and E0760 from May 18, 2026 onward be processed and paid as they were before the FDA reclassification. The company currently expects average Medicare reimbursement for these codes to return to pre–May 18, 2026 levels, though it cautions that actual results depend on how the revised rules are implemented and on future claim volumes and payer behavior.

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