Diagnosis: Venous stasis ulcer

Treatment: Durable medical equipment: topical oxygen wound therapy (TOWT) a total of 16 units

The insurer denied coverage for durable medical equipment: TOWT a total of 16 units.

The denial is upheld.

Topical hyperbaric oxygen (HBO) is not a proven treatment for the patient's condition and thus not medically necessary. The Undersea and Hyperbaric Medical Society has issued a Position Statement regarding Topical HBO. The following is quoted from their Position Statement:

Therefore, the policy of the Undersea and Hyperbaric Medical Society in regard to topical oxygen is stated as follows:

1) Topical oxygen should not be termed hyperbaric oxygen since doing so either intentionally or unintentionally suggests that topical oxygen treatment is equivalent or even identical to hyperbaric oxygen. Published documents reporting experience with topical oxygen should clearly state that topical oxygen not hyperbaric oxygen is being employed. 2) Mechanisms of action or clinical study results for hyperbaric oxygen cannot and should not be co-opted to support topical oxygen since hyperbaric oxygen therapy and topical oxygen have different routes and probably efficiencies of entry into the wound and their physiology and biochemistry are necessarily different. 3) The application of topical oxygen cannot be recommended outside of a clinical trial at this time based on the volume and quality of scientific supporting evidence available, nor does the Society recommend third party payor reimbursement. 4) Before topical oxygen can be recommended as therapy for non-healing wounds, its application should be subjected to the same intense scientific scrutiny to which systemic hyperbaric oxygen has been held.

In 2021, Hayes (1) rates topical oxygen therapy for chronic wound healing as D2. A D rating indicates that the technology is experimental and investigational and is not supported by the majority of the medical community.

Overall, current evidence supporting topical HBO for any condition is limited and consists of small, low-quality studies that support the categorization of topical oxygen therapy as experimental and investigational. A search using Pubmed with the terms "venous stasis ulcer" AND "topical oxygen" returned one pilot study for patients with pressure ulcer involving 18 patients.

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably, with sound medical judgment, and in the best interest of the patient. The medical necessity for durable medical equipment: topical oxygen wound therapy (TOWT) a total of 16 units is not substantiated.