Orthofix Medical expects average Medicare reimbursement for non‑invasive bone growth stimulators to return to pre‑May 18, 2026 rates.
Key Highlights:
- FDA reclassified non‑invasive bone growth stimulators from Class III to Class II on April 16, 2026, prompting CMS billing and fee schedule changes for HCPCS E0747, E0748 and E0760.
- On July 1, 2026, CMS withdrew those changes and directed that devices furnished on/after May 18, 2026 be processed and paid consistent with treatment prior to the reclassification.
- Orthofix currently expects average Medicare reimbursement for the three HCPCS codes to revert to rates in effect before May 18, 2026.
- Company cautions these are forward‑looking expectations subject to implementation, claim volumes, payer behavior and other risks that could affect actual results.
Original SEC Filing:
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