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NASDAQ: OFIX Orthofix Medical Inc. 8-K

Orthofix wins Medicare reimbursement restoration for bone growth stimulators

Filed July 2, 2026 · Period ending July 1, 2026 · ~1 min read

2 key changes 2 high relevance 1 section

Key Changes

  • high

    CMS reversed May 18 billing changes for bone growth stimulators, restoring prior Medicare payment rates effective retroactively to May 18, 2026.

  • high

    Company expects average Medicare reimbursement to return to pre-May 18 levels, ending an undisclosed amount six weeks under CMS's modified billing treatment.

Summary

CMS issued revised guidance on July 1, 2026, withdrawing billing changes it had implemented on May 18 for non-invasive bone growth stimulators (HCPCS codes E0747, E0748, E0760). The May changes had followed an FDA reclassification of these devices from Class III to Class II in April, which triggered CMS to modify billing requirements and fee schedules. The reversal restores the prior Medicare payment treatment retroactively to May 18.

For Orthofix, this means Medicare reimbursement rates for its bone growth stimulator products will return to pre-May 18 levels, reversing what were presumably lower rates that had been in effect for about six weeks. The company's bone growth stimulator business now operates under the same Medicare payment structure it had before the brief May-July disruption. The guidance directs that devices furnished on or after May 18 be paid under the prior treatment, so the retroactivity covers the interim period, though the filing does not address how already-processed claims will be handled.

Section-by-Section Diff

Event · Item 7.01 — Regulation FD Disclosure

~500 words

Item 7.01 — Regulation FD Disclosure filed; see Key Changes for terms.

2 Added
Added Medicare reimbursement restoration high

Added in current filing · verify on EDGAR →

On July 1, 2026, CMS issued revised guidance that withdrew those changes and directed that Devices furnished on or after May 18, 2026 be processed and paid consistent with the treatment in effect prior to the FDA reclassification.

CMS reversed its May 18, 2026 billing changes for non-invasive bone growth stimulators (HCPCS codes E0747, E0748, E0760), restoring the prior Medicare payment treatment. This reversal followed an FDA reclassification of these devices from Class III to Class II on April 16, 2026, which had initially triggered CMS to modify billing requirements and fee schedules.

Added Expected reimbursement impact high

Added in current filing · verify on EDGAR →

Based on these developments, Orthofix Medical Inc. (the “Company”) currently expects average Medicare reimbursement for these codes will return to the rates in effect prior to May 18, 2026.

The company expects Medicare reimbursement rates for its bone growth stimulator products to return to pre-May 18, 2026 levels. This is positive for revenue, as it reverses what were presumably lower reimbursement rates that had been in effect for an undisclosed amount six weeks between May 18 and July 1, 2026.

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Figures/quotes linked to EDGAR · Narrative written by AI · Jul 5, 2026 · How we verify