CMS Proposes Medicare Coverage Criteria for Topical Oxygen Therapy in Nonhealing Diabetic Foot Ulcers
Medicare has released a proposed Local Coverage Determination (LCD) that would establish coverage criteria for topical oxygen therapy (TOT) as an adjunctive treatment for certain nonhealing diabetic foot ulcers (DFUs). The proposal is currently open for public comment and does not represent final Medicare policy.
3 Key Takeaways
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Coverage would be limited to select patients with nonhealing DFUs. The proposed LCD would allow Medicare coverage for topical oxygen therapy only for beneficiaries with non-gestational diabetes whose DFUs have failed to achieve at least a 50% reduction in ulcer area after 4 consecutive weeks of optimized wound care and who meet additional clinical criteria.
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Ongoing documentation would be required. Continued monthly coverage would require in-person practitioner visits and documentation demonstrating clinical improvement.
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The proposal excludes other wound types. Under the draft policy, topical oxygen therapy would not be covered for indications other than nonhealing diabetic foot ulcers and would be denied in the presence of specified exclusions.
The Centers for Medicare & Medicaid Services (CMS), through the Durable Medical Equipment Medicare Administrative Contractors (DME MACs), has issued a proposed Local Coverage Determination (LCD) outlining when topical oxygen therapy would be considered reasonable and necessary for Medicare beneficiaries with nonhealing DFUs. The proposal is currently in the public comment period and has not yet been finalized.1
Under the proposal, initial coverage would be available only when topical oxygen therapy is used as an adjunct to optimized DFU care. Eligible beneficiaries would need to have non-gestational diabetes, demonstrate less than a 50% reduction in ulcer area after at least 4 weeks of optimized care, have a hemoglobin A1c below 12% within the previous 3 months, show adequate arterial perfusion based on specified vascular assessments, and continue adhering to optimized wound care throughout treatment.1
The proposed LCD would provide initial coverage for 1 month. To continue coverage beyond the first month, treating practitioners would need to conduct monthly in-person evaluations and document that the ulcer is responding to therapy. Acceptable measures of improvement would include at least a 20% reduction in ulcer area compared with the prior measurement period or improvement on a clinically validated wound classification scale. Continued adherence to optimized DFU care would also be required.1
The draft policy also specifies circumstances in which topical oxygen therapy would not be covered. These include use for wound types other than nonhealing DFUs and cases involving ulcer-related abscess, osteomyelitis, joint sepsis, gangrene, or recent ipsilateral deep vein thrombosis or malignancy.1
CMS notes that proposed LCDs are works in progress and are made available for public review and comment before a final coverage determination is issued. In this particular case, CMS lists the comment period as extending to September 5, 2026.
Reference
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Centers for Medicare & Medicaid Services. Proposed Local Coverage Determination (DL40403): Topical Oxygen Therapy. Medicare Coverage Database. Accessed July 24, 2026. https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=40403&ver=11&contractorName=all&contractorNumber=all&proposedStatus=all&sortBy=commentStart&bc=10
