Decision Memo for Hyperbaric Oxygen Therapy for Hypoxic Wounds and Diabetic Wounds of the Lower Extremities (CAG-00060N)
Diabetic Wounds of the Lower Extremities: The evidence is adequate to conclude that HBO therapy is clinically effective and, thus, reasonable and necessary in the treatment of certain patients with limb-threatening diabetic wounds of the lower extremity. Accordingly, Medicare has decided to announce its intention to issue a national coverage determination for HBO therapy in the treatment of diabetic wounds of the lower extremities in patients who meet each of the following three criteria:
- patient has type I or type II diabetes and has a lower extremity wound that is due to diabetes;
- patient has a wound classified as Wagner grade III or higher; and
- patient has failed an adequate course of standard wound therapy (defined below).
The use of HBO therapy will be covered as adjunctive therapy only after there are no measurable signs of healing for at least 30-days of treatment with standard wound therapy and must be used in addition to standard wound care…