Durable Medical Equipment Section - Electrostimulation and Electromagnetic Therapy for the Treatment of Chronic Wounds in the Home Setting

IMPORTANT REMINDER

This Medical Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status.

Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control.

The purpose of medical policy is to provide a guide to coverage. Medical Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care.

Description

The normal wound healing process involves inflammatory, proliferative and remodeling phases. When the healing process fails to progress properly and the wound persists for longer than one month, it may be described as a chronic wound. The types of chronic wounds most frequently addressed in studies of electrical stimulation for wound healing are:

1. Pressure ulcers
2. Venous ulcers
3. Arterial ulcers
4. Diabetic ulcers

Conventional or standard therapy for chronic wounds involves local wound care as well as systemic measures including debridement of necrotic tissues, wound cleansing and dressing that promote a moist wound environment, antibiotics to control infection and optimizing nutritional supplementation. Non-weight bearing is another important component of wound management. Since the 1950s, investigators have used electrical stimulation as a technique to promote wound healing, based on the theory that electrical stimulation may:

• Increase ATP concentration in the skin
• Increase DNA synthesis
• Attract epithelial cells and fibroblasts to wound sites
• Accelerate the recovery of damaged neural tissue
• Reduce edema
• Increase blood flow
• Inhibit pathogenesis

Electrical stimulation refers to the application of electrical current through electrodes placed directly on the skin in close proximity to the wound. The types of electrical stimulation and devices can be categorized into 4 groups based on the type of current:

1. Low intensity direct current (LIDC)
2. High voltage pulsed current (HVPC)
3. Alternating current (AC)
4. Transcutaneous electrical nerve stimulation (TENS)

Electromagnetic therapy is a related but distinct form of treatment that involves the application of electromagnetic fields rather than direct electrical current.

At the present time there are no electrical stimulation devices that have received FDA approval specifically for the treatment of wound healing. A number of devices have been cleared for marketing for other indications. Use of these devices for wound healing is an off-label indication.

Stage III and IV skin ulcers are defined as follows:

Stage III:
Full thickness skin loss involving damage to, or necrosis of, subcutaneous tissue that may extend down to, but not through, underlying fascia. The ulcer presents clinically as a deep crater with or without undermining of adjacent tissue.

Stage IV:
Full thickness skin loss with extensive destruction, tissue necrosis or damage to muscle, bone, or other supporting structures (e.g., tendon, joint capsule). Undermining and sinus tracts also may be associated with Stage IV pressure ulcers.

Policy/Criteria

Electrical stimulation and electromagnetic therapy for the treatment of wounds performed by the patient in the home setting is considered investigational.  All electrical stimulation devices are included in the category, including but not limited to, low intensity direct current, high voltage pulsed current (HVPC), alternating current (AC) and transcutaneous electrical nerve stimulation (TENS)*.

*Note:  Electrical stimulation as a treatment of pain and other musculoskeletal conditions are considered separately in Regence Medical Policies DME 11, 56, 57, 65, 66, and Surgery 44.

Position Summary

It is unknown whether electrical stimulation or electromagnetic therapy in the home setting without supervision by a healthcare provider improves wound healing compared with conventional wound care techniques.

The current body of evidence in the published literature only addresses the use of electrical stimulation therapy applied and supervised by health care professionals.

References

1. BlueCross and BlueShield Association Medical Policy Reference Manual, Policy No. 2.01.57

Cross References

Electrical Stimulation Devices for Home Use; Regence Medical Policy Manual, DME, Policy No. 11

Non-Contact Ultrasound Treatments for Wounds, Regence Medical Policy Manual, Medicine, Pol.icy No. 131

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