RegulatoryJul 2, 2026, 04:03 PM
Orthofix: CMS Reverses Reimbursement Changes for Bone Growth Stimulators
AI Summary
Orthofix Medical Inc. announced that the Centers for Medicare & Medicaid Services (CMS) has withdrawn its previously modified billing requirements for non-invasive bone growth stimulators. This reversal follows the U.S. Food and Drug Administration's (FDA) reclassification of these devices from Class III to Class II. As a result, Orthofix expects average Medicare reimbursement for these devices to return to the rates that were in effect prior to May 18, 2026.
Key Highlights
- FDA reclassified non-invasive bone growth stimulators from Class III to Class II on April 16, 2026.
- CMS modified billing requirements and Medicare fee schedule for these devices effective May 18, 2026.
- CMS issued revised guidance on July 1, 2026, withdrawing previous changes.
- Devices furnished on or after May 18, 2026, will be processed consistent with prior treatment.
- Orthofix expects average Medicare reimbursement to return to pre-May 18, 2026 rates.
Price Impact
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