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

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

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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Insights

CMS reversal means Orthofix expects Medicare rates to revert to prior levels.

The filing explains that after the FDA moved non-invasive bone growth stimulators to Class II on April 16, 2026, CMS briefly altered Medicare billing and fee treatment for HCPCS E0747, E0748 and E0760 starting May 18, 2026.

On July 1, 2026, CMS withdrew those changes and instructed that claims from May 18 onward be processed under the prior rules. Orthofix now expects average Medicare reimbursement for these codes to return to pre–May 18 levels, though actual impact will depend on implementation, claim volumes and payer behavior.

Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
FDA reclassification date April 16, 2026 Non-invasive bone growth stimulators moved from Class III to Class II
Initial CMS change effective date May 18, 2026 New billing and Medicare fee schedule treatment began for affected devices
CMS withdrawal guidance date July 1, 2026 CMS withdrew earlier billing changes and reverted to prior treatment
Affected HCPCS codes E0747, E0748, E0760 Non-invasive bone growth stimulators subject to revised guidance
non-invasive bone growth stimulators medical
"reclassifying non-invasive bone growth stimulators from Class III to Class II devices"
Class II devices regulatory
"final order reclassifying non-invasive bone growth stimulators from Class III to Class II devices"
Centers for Medicare & Medicaid Services regulatory
"the Centers for Medicare & Medicaid Services (“CMS”) modified certain billing requirements"
The Centers for Medicare & Medicaid Services (CMS) is the U.S. federal agency that runs major public health insurance programs and sets rules for what treatments and services are paid for and how much providers receive. Think of it as the rulebook and paymaster for a large portion of the health-care system: its coverage decisions, payment rates, and regulations can quickly change revenues, costs, and market access for hospitals, insurers, drugmakers and medical-device companies, so investors track its actions closely.
HCPCS codes financial
"billed under HCPCS codes E0747, E0748 and E0760 (the “Devices”)"
Medicare fee schedule financial
"modified certain billing requirements and Medicare fee schedule treatment"
forward-looking statements regulatory
"This disclosure contains forward-looking statements within the meaning of Section 21E"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.

FAQ

What regulatory change did Orthofix Medical Inc. (OFIX) disclose regarding its bone growth stimulators?
Orthofix disclosed that the FDA reclassified non-invasive bone growth stimulators from Class III to Class II on April 16, 2026. This reclassification initially triggered Medicare billing and reimbursement changes that CMS later withdrew, reverting treatment to the prior rules for affected HCPCS codes.

How did CMS initially change Medicare reimbursement for Orthofix (OFIX) bone growth stimulators?
CMS modified billing requirements and Medicare fee schedule treatment for non-invasive bone growth stimulators under HCPCS E0747, E0748 and E0760 for dates of service on or after May 18, 2026. These changes were tied to the FDA’s device reclassification before being subsequently withdrawn on July 1, 2026.

What did CMS decide on July 1, 2026 that affects Orthofix (OFIX) reimbursement?
On July 1, 2026, CMS issued revised guidance withdrawing earlier billing and fee schedule changes. It directed that devices furnished on or after May 18, 2026 be processed and paid under the same Medicare rules that applied before the FDA reclassification of these non-invasive bone growth stimulators.

What does Orthofix (OFIX) expect for average Medicare reimbursement going forward?
Orthofix currently expects average Medicare reimbursement for HCPCS codes E0747, E0748 and E0760 to return to the rates in effect before May 18, 2026. This expectation reflects CMS’s decision to process and pay these claims consistent with the prior Medicare treatment framework.

Which Orthofix (OFIX) products are affected by the CMS reimbursement guidance?
The guidance affects non-invasive bone growth stimulators billed under HCPCS codes E0747, E0748 and E0760. These devices were impacted first by the FDA’s April 16, 2026 reclassification and then by CMS’s billing and fee schedule changes that were later withdrawn and reverted to prior treatment.

What risks does Orthofix (OFIX) highlight about the reimbursement changes?
Orthofix notes that actual results may differ from expectations due to how revised reimbursement rules are implemented, potential changes in claim volumes, and payer behavior. The company also references broader risks and uncertainties described in its Form 10-K and Form 10-Q risk factor sections.

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0000884624false00008846242026-07-012026-07-01

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 01, 2026

 

 

ORTHOFIX MEDICAL INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

000-19961

98-1340767

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

3451 Plano Parkway

 

Lewisville, Texas

 

75056

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (214) 937-2000

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common stock, $0.10 par value per share

 

OFIX

 

Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Item 7.01 Regulation FD Disclosure.

On April 16, 2026, the U.S. Food and Drug Administration (“FDA”) issued a final order reclassifying non-invasive bone growth stimulators from Class III to Class II devices. Following that order, the Centers for Medicare & Medicaid Services (“CMS”) modified certain billing requirements and Medicare fee schedule treatment applicable to non-invasive bone growth stimulators billed under HCPCS codes E0747, E0748 and E0760 (the “Devices”) for dates of service on or after May 18, 2026.

 

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.

 

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.

Forward-Looking Statements

This disclosure contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, including statements regarding the expected impact of the reimbursement changes on the Company’s business and financial outlook. These statements are based on our current beliefs, assumptions, intentions, plans, expectations, estimates, forecasts and projections. Actual results may differ materially from those indicated in these forward-looking statements as a result of various important factors, including the implementation of the revised reimbursement rules, changes in claim volumes or payer behavior, and other risks and uncertainties affecting the Company’s business. Forward-looking statements are not guarantees of our future performance, are based on our current expectations and assumptions regarding our business, the economy and other future conditions, and are subject to risks, uncertainties and changes in circumstances that are difficult to predict, including the risks described in Part I, Item 1A under the heading Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2025, and in Part II, Item 1A under the heading Risk Factors in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026. Any forward-looking statements speak only as of the date hereof, and the Company undertakes no obligation to update, and expressly disclaims any duty to update, its forward-looking statements, whether as a result of circumstances or events that arise after the date hereof, new information, or otherwise, except as required by law.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

Orthofix Medical Inc.

 

 

 

 

Date:

July 2, 2026

By:

/s/ J. Andrés Cedrón

 

 

 

J. Andrés Cedrón
Chief Legal Officer

 

Source: View Original Filing on SEC EDGAR

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