Medicare Contractors Hear Support for Topical Oxygen Coverage Proposal for Foot Ulcers

Speakers at a Medicare contractor meeting on Wednesday backed a proposal to begin covering topical oxygen therapy for chronic diabetic foot ulcers, while several asked the contractors to loosen the draft's blood-flow and healing-progress requirements before it is finalized.

The four Durable Medical Equipment Medicare Administrative Contractors (DME MACs) held the virtual open meeting on August 26 to take comments on a proposed revision to the Oxygen and Oxygen Equipment local coverage determination (LCD), DL33797. The DME MACs released the proposal on July 23, describing it as reasonable and necessary coverage criteria for topical oxygen therapy for Medicare beneficiaries with diabetic foot ulcers that have failed to heal with four consecutive weeks of optimized diabetic foot ulcer care. Written comments are due September 5, 2026.

What the draft would cover

Opening the meeting, Dr. Smitha Ballyamanda of Noridian Healthcare Solutions, the Jurisdiction A contractor, said the draft would create a new coverage category, Group 5, for topical oxygen as an adjunctive treatment, according to the meeting transcript posted by Noridian. She said coverage would be restricted to a carefully selected population, would require objective evidence of healing for continued payment, and would exclude all other wound types.

"The proposed oxygen LCD shifts topical oxygen therapy from non-coverage to coverage for carefully selected Medicare beneficiaries with refractory diabetic foot ulcers using entry criteria, monthly evidence of benefit requirements, and exclusion of all non-diabetic foot ulcer indications," she said. She reminded participants that the contractors respond only to written comments and take no action until the policy is final.

Requests from speakers

Speakers included representatives of manufacturers, wound care clinicians and the Alliance of Wound Care Stakeholders. John Fritz of Mölnlycke Healthcare said the company strongly supports a clear coverage pathway and asked that the final policy stay flexible enough to support innovation and patient access.

Karen Ravitz, health policy advisor for the Alliance, said the group sees six areas needing clarification or revision. Among them, she asked that all topical oxygen provisions be gathered under one heading in an LCD built mainly around respiratory oxygen, and pointed to inconsistencies between the LCD and its billing and coding article, including whether the arterial perfusion threshold is an ankle-brachial index (ABI) greater than 0.7 or greater than or equal to 0.7. She also asked the contractors to accept point-of-care imaging such as near-infrared spectroscopy as a way to establish adequate perfusion.

Other recurring requests in the transcript included:

• Lowering the ABI threshold, with one proposal to accept an ABI of 0.5 or higher, or other perfusion measures.
• Replacing the requirement of more than 20 percent wound area reduction each month with a broader clinical assessment of healing.
• Narrowing exclusions for infection to cases that are active and untreated.
• Extending coverage to other chronic wounds such as venous leg ulcers and pressure ulcers.
• Recognizing intermittent and continuous topical oxygen as distinct modalities with their own coding.

Company reaction and next steps

AOTI, an AIM-listed wound care technology company that sells an intermittent topical oxygen device called TWO2, said every speaker at the session backed the measure, as reported by Proactive, read via The Market Reporter, where the Proactive link leads. Chief executive Mike Griffiths said the company was delighted with the views expressed and looked forward to working with CMS as the determination is finalized, according to the report. One speaker at the meeting disclosed past consulting work for AOTI.

The report noted that the contractors have up to 365 days from publication of the draft to finalize the determination. The DME MACs said in July that the content of a proposed LCD may be revised based on the written comments received.