Orthofix Medical Inc. 8-K

What Happened

• On July 2, 2026 Orthofix Medical Inc. filed an 8-K (Item 7.01, Regulation FD Disclosure) reporting that CMS has withdrawn prior changes to Medicare billing and payment for non-invasive bone growth stimulators.
• Background: the FDA issued a final order reclassifying these devices from Class III to Class II on April 16, 2026. CMS had initially modified billing and fee-schedule treatment for HCPCS codes E0747, E0748 and E0760 for dates of service on or after May 18, 2026, but on July 1, 2026 CMS issued guidance reversing those modifications and directing payers to process claims consistent with pre-May 18 treatment.
• Orthofix currently expects average Medicare reimbursement for those HCPCS codes to return to the rates that were in effect prior to May 18, 2026.

Key Details

• Filing date: July 2, 2026 (8-K, Item 7.01 – Regulation FD Disclosure).
• FDA reclassification date: April 16, 2026 (Class III → Class II for non-invasive bone growth stimulators).
• CMS reversal date: July 1, 2026; initial CMS changes applied to services on/after May 18, 2026.
• Affected HCPCS codes: E0747, E0748, E0760; Orthofix expects average Medicare reimbursement for these codes to revert to pre-May 18, 2026 levels.

Why It Matters

• For investors, reimbursement rates for the listed HCPCS codes directly affect revenue from Medicare-covered sales of Orthofix’s non-invasive bone growth stimulators. A return to prior Medicare rates would tend to stabilize expected Medicare revenue for those products versus the temporary May 18 changes.
• The company’s statement is forward-looking and subject to risks (implementation, claim volumes, payer behavior). Orthofix notes these statements are not guarantees and refers investors to risk disclosures in its 2025 Form 10-K and 2026 Form 10-Q.