Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Burn.
Treatment: Topical oxygen therapy.
The insurer denied the topical oxygen therapy. The health plan's determination is upheld. 

This male presented to the hospital with 5% total body surface area near circumferential partial and full thickness oil burns to the left upper extremity. He was treated with wound debridement and skin grafts. He developed cellulitis on postoperative day #3 and was treated with Ancef. Graft take is 90%. Topical oxygen therapy is being recommended and is the subject of this review.

Based on peer literature and the Undersea and Hyperbaric Medical Society guidelines, topical oxygen therapy is not medically necessary for this patient. Mechanisms of action whereby topical oxygen might be effective have not been defined or substantiated to date. Conversely, cellular toxicities due to extended courses of topical oxygen have been reported, although again, these data are not conclusive, and no mechanism for toxicity has been examined scientifically. Generally, collagen production and fibroblast proliferation are considered evidence of improved healing, and these are both enhanced by hyperbaric oxygen therapy. Paradoxically, claims of decreased collagen production and fibroblast inhibition in wounds subjected to topical oxygen have been reported in studies of topical oxygen as a benefit of topical oxygen therapy. Literature on topical oxygen is mostly small case series or small controlled but not randomized trials. Moreover, the studies generally are not aimed at specific ulcer types, but rather at "chronic wounds." This non-specific approach is recognized as a major design flaw in any study of therapies designed to improve impaired wound healing. I am unable to identify any literature, which establishes, in a prospective, randomized trial, that topical HBO (Hyperbaric oxygen) is an effective treatment for burn wounds or skin graft healing. To the contrary, a randomized, controlled study by Leslie et al came to the following conclusion: "A trend toward slower healing was observed in the THO group. Healing of diabetic foot ulcers was not accelerated by THBO (Topical Hyperbaric Oxygenation) in this study." Heng, in an experimental study, found that TBO was toxic for endothelial cells. In the absence of any randomized, controlled studies supporting the use of this therapy for burn wounds and skin grafts, the treatment is appropriately considered experimental. In fact, the studies by Leslie et al and Heng et al suggest that topical hyperbaric oxygen may actually delay the healing of foot ulcers. The Undersea and Hyperbaric Medical Society issued a Position Statement regarding THBO. The following is quoted from their Position Statement (6): 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.