Treatment for Diabetic and Other Non-healing Wounds is medically approved and insurance will normally cover this when HBOT is delivered in a hospital setting.
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;
- 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. CMS has used 30 days as the cut-off for determining whether or not a particular wound treatment, such as standard wound therapy, has produced measurable signs of healing in an individual patient in previous national coverage determinations (e.g., Coverage Issues Manual 60-19 Air-Fluidized Beds decision).
Measurable signs of improved healing include a decrease in wound size either in surface area or volume, decrease in amount of exudates and decrease in amount of necrotic tissue. Standard wound care in patients with diabetic wounds includes: assessment of a patient’s vascular status and correction of any vascular problems in the affected limb if possible, optimization of nutritional status, optimization of glucose control, debridement by any means to remove devitalized tissue, maintenance of a clean, moist bed of granulation tissue with appropriate moist dressings, appropriate off-loading, and necessary treatment to resolve any infection that might be present, such as systemic antibiotics and surgical debridement. Failure to respond to standard wound care occurs when there are no measurable signs of healing for at least 30 consecutive days. Wounds must be evaluated at least every 30 days during administration of HBO therapy. Continued treatment with HBO therapy is not covered if measurable signs of healing have not been demonstrated within any 30-day period of treatment.
Medicare intends to retain its non-coverage of HBO therapy in the treatment of diabetic wounds of the lower extremities in all other subgroups. Medicare will also retain its non-coverage policy for use of HBO therapy as an initial treatment for diabetic ulcers of the lower extremities.