Electrical stimulation and electromagnetic therapy have been used or studied for many different applications, one of which is accelerating wound healing. Electrical stimulation for the treatment of wounds involves the application of electrical current through electrodes placed directly on the skin in close proximity to the wound. Electromagnetic therapy uses a pulsed magnetic field to induce current.

Note: For other documents addressing electrical or magnetic stimulation, please see:

• ANC.00006 Biomagnetic Therapy
• BEH.00002 Transcranial Magnetic Stimulation as a Treatment of Depression and Other Neuropsychiatric Disorders
• CG-ANC-03 Acupuncture
• CG-DME-03 Neuromuscular Stimulation in the Treatment of Muscle Atrophy
• CG-DME-04 Electrical Nerve Stimulation, Transcutaneous, Percutaneous
• CG-SURG-08 Sacral Nerve Stimulation as a Treatment of Neurogenic Bladder Secondary to Spinal Cord Injury
• DME.00004 Electrical Bone Growth Stimulation
• DME.00011 Electrical Stimulation as a Treatment for Pain and Related Conditions: Surface and Percutaneous Devices
• DME.00022 Functional Electrical Stimulation (FES); Threshold Electrical Stimulation (TES)
• SURG.00010 Treatment of Urinary Incontinence and Urinary Retention 
• SURG.00026 Deep Brain Stimulation
• SURG.00046 Gastric Electrical Stimulation
• SURG.00060 Implanted Spinal Cord Stimulators (SCS)

Medically Necessary:

Electrical stimulation* or electromagnetic therapy is considered medically necessary as a treatment of arterial ulcers, diabetic ulcers, venous stasis ulcers, and Stage III or Stage IV pressure ulcers, when a 30-day trial of conventional wound management has failed and when the procedure is performed in a medically supervised setting.

* Electrical stimulation can be categorized as follows, based on the type of current: alternating current (AC), high voltage pulsed current (HVPC), and low intensity direct current (LIDC).

Not Medically Necessary:

Continuation of electrical stimulation or electromagnetic therapy for wound healing is considered not medically necessary if no evidence of healing is noted within any 30-day period of treatment.

Note:  Progressive healing is generally demonstrated by decrease in wound surface area or volume, decrease in amount of exudate, or decrease in amount of necrotic tissue. 

Investigational and Not Medically Necessary:

The use of electrical stimulation or electromagnetic therapy is considered investigational and not medically necessary for wound healing other than as described above as medically necessary, including but not limited to electrical stimulation performed by the individual in the home setting.

This document is based on a 2002 technology assessment performed by the Centers for Medicare and Medicaid Services that serves as the basis for the national Medicare policy. This technology assessment was in turn derived in part from a technology assessment conducted by ECRI (Emergency Care Research Institute), which CMS commissioned in 1996, which was then updated by CMS. In its policy development process, CMS grouped all etiologies of chronic wounds together, and also grouped all forms of electrical stimulation devices.

In general, the duration of treatment varied between studies reviewed, often depending on the size of the initial ulcer and rate of healing. In the majority of clinical trials, electrical stimulation was given 3 times per week until the chronic ulcer healed. There was no direct evidence to determine the optimal duration or amount of electrical stimulation. However, it would be clinically rational and appropriate to discontinue treatment with electrical stimulation if the ulcer is not healing.

Consistent with a previous CMS coverage decision and the Agency for Health Care Policy and Research (AHCPR) guidelines on treatment of pressure ulcers, a chronic wound should demonstrate progressive healing within 4 weeks if the treatment being used is effective. Therefore, if progressive healing is not demonstrated after a 30-day period of treatment, electrical stimulation is unlikely to provide benefit. Progressive healing is generally demonstrated by decrease in wound size in surface area or volume, decrease in amount of exudate, and decrease in amount of necrotic tissue.

CMS was asked to reconsider its national noncoverage determination for electromagnetic therapy. After thorough review, CMS determined that the results from the use of electromagnetic therapy for the treatment of wounds were similar to the results from the use of electrical stimulation. Therefore, effective July 1, 2004, Medicare covers electromagnetic therapy for the same settings and conditions for which electrical stimulation is covered.

The available evidence regarding the efficacy of the use of electrical stimulation or electromagnetic therapy for conditions not addressed in the medically necessary section is currently insufficient to allow reasonable conclusions to be made. Further studies are needed to provide this data and to allow thorough evaluation of other uses of these technologies.

Chronic wounds, including venous ulcers, diabetic foot ulcers, and pressure sores, are a major public health problem in the United States; the total prevalence of these wounds has been estimated to range from 3 to 6 million. Difficult-to-heal wounds lead to high rates of morbidity and mortality, and negative effects on quality of life. While leg and foot ulcers have numerous causes, such as venous disease, arterial disease, mixed venous-arterial disease, diabetic neuropathy, trauma, immobility, and vasculitis, over 90% of chronic lesions are related to venous disease, arterial disease, and neuropathy. Chronic wounds require intervention to promote healing and to prevent infection, progression, and recurrence. Regardless of the cause, ulcer treatment usually begins with conservative therapies such as pressure relief, sterile dressings, and topical antibiotics. Debridement to remove necrotic tissue may also be necessary. If conservative treatments fail to promote wound healing, surgical treatments such as skin flap reconstruction or amputation of a digit or foot may be necessary. A less invasive approach to management of chronic wounds involves electrical stimulation.

Electrical stimulation refers to the application of an electrical current through electrodes placed directly onto the skin in close proximity to the wound. Since the 1950s, investigators have used electrical stimulation as a technique to promote wound healing, based on the theory that electrical stimulation may: 1) increase adenosine triphosphate (ATP) concentration in the skin; 2) increase DNA synthesis; 3) accelerate the recovery of damaged neural tissue; 4) reduce edema; 5) increase blood flow; 6) inhibit pathogenesis, or 7) attract epithelial cells and fibroblasts to wound sites.

Electromagnetic therapy (e.g., Diapulse® Wound Treatment System™ (Diapulse Corporation of America, Great Neck, NY), PROVANT® Wound-Closure System (Regenesis Biomedical, Inc., Scottsdale, AZ), also known as pulsed electromagnetic field stimulation, does not involve the use of current, leads, or electrodes as does electrical stimulation. Devices used for electromagnetic therapy utilize generators designed to create radiofrequency signals that are typically delivered through coils that do not directly contact the skin. Such devices are purported to stimulate cell division (proliferation) that aids wound closure.

Although a number of electrical stimulation and electromagnetic therapy devices are FDA approved for various applications, none of these devices is approved specifically for the treatment of chronic wounds.

Risks are uncommon but may occur with unsupervised treatments, including rashes at the site of electrode placement or in rare cases burns on the skin.

Arterial Ulcers: Ulcers caused by insufficient arterial blood supply.

Diabetic Ulcers: Ulcers resulting from diabetic complications, such as blockage of small blood vessels in the legs.

The following definitions of pressure ulcers and stages are from the National Pressure Ulcer Advisory Panel:
Pressure Ulcer (National Pressure Ulcer Advisory Panel, 2007)
A pressure ulcer is localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear and/or friction. A number of contributing or confounding factors are also associated with pressure ulcers; the significance of these factors is yet to be elucidated.

Pressure Ulcer Stages:

Suspected Deep Tissue Injury:  Purple or maroon localized area of discolored intact skin or blood-filled blister due to damage of underlying soft tissue from pressure and/or shear. The area may be preceded by tissue that is painful, firm, mushy, boggy, warmer or cooler as compared to adjacent tissue.
Further description:
Deep tissue injury may be difficult to detect in individuals with dark skin tones. Evolution may include a thin blister over a dark wound bed. The wound may further evolve and become covered by thin eschar. Evolution may be rapid exposing additional layers of tissue even with optimal treatment.

Stage I:  Intact skin with non-blanchable redness of a localized area usually over a bony prominence. Darkly pigmented skin may not have visible blanching; its color may differ from the surrounding area.
Further description:
The area may be painful, firm, soft, warmer or cooler as compared to adjacent tissue. Stage I may be difficult to detect in individuals with dark skin tones. May indicate "at risk" persons (a heralding sign of risk)

Stage II:  Partial thickness loss of dermis presenting as a shallow open ulcer with a red pink wound bed, without slough. May also present as an intact or open/ruptured serum-filled blister.
Further description:
Presents as a shiny or dry shallow ulcer without slough or bruising.* This stage should not be used to describe skin tears, tape burns, perineal dermatitis, maceration or excoriation.
*Bruising indicates suspected deep tissue injury

Stage III:  Full thickness tissue loss. Subcutaneous fat may be visible but bone, tendon or muscle are not exposed. Slough may be present but does not obscure the depth of tissue loss. May include undermining and tunneling.
Further description:
The depth of a stage III pressure ulcer varies by anatomical location. The bridge of the nose, ear, occiput and malleolus do not have subcutaneous tissue and stage III ulcers can be shallow. In contrast, areas of significant adiposity can develop extremely deep stage III pressure ulcers. Bone/tendon is not visible or directly palpable.

Stage IV:  Full thickness tissue loss with exposed bone, tendon or muscle. Slough or eschar may be present on some parts of the wound bed. Often include undermining and tunneling.
Further description:
The depth of a stage IV pressure ulcer varies by anatomical location. The bridge of the nose, ear, occiput and malleolus do not have subcutaneous tissue and these ulcers can be shallow. Stage IV ulcers can extend into muscle and/or supporting structures (e.g., fascia, tendon or joint capsule) making osteomyelitis possible. Exposed bone/tendon is visible or directly palpable.

Unstageable:  Full thickness tissue loss in which the base of the ulcer is covered by slough (yellow, tan, gray, green or brown) and/or eschar (tan, brown or black) in the wound bed.
Further description:
Until enough slough and/or eschar is removed to expose the base of the wound, the true depth, and therefore stage, cannot be determined. Stable (dry, adherent, intact without erythema or fluctuance) eschar on the heels serves as "the body's natural (biological) cover" and should not be removed.

Unattended (Electrical Stimulation):  The individual is positioned and the appropriate type of stimulation is applied to an area over a specific period of time; the procedure is supervised by a health care provider but the provider is not in constant attendance.

Venous stasis Ulcers:  Wounds resulting from blood pooling in the legs due to poor blood flow in the veins leading back to the heart.

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. 

When services are Medically Necessary: 

When services are Investigational and Not Medically Necessary: 

Peer Reviewed Publications:

1. Adunsky A, Ohry A; DDCT Group. Decubitus direct current treatment (DDCT) of pressure ulcers: results of a randomized double-blinded placebo controlled study. Arch Gerontol Geriatr. 2005; 41(3):261-269.
2. Baker LL, Chambers R, DeMuth SK, et al. Effects of electrical stimulation on wound healing in patients with diabetic ulcers. Diabetes Care. 1997; 20(3):405-412.
3. Feedar JA, Kloth LC, Gentzkow GD. Chronic dermal ulcer healing enhanced with monophasic pulsed electrical stimulation. Phys Ther. 1991; 71(9):639-649.
4. Goldman RJ, Brewley BI, Golden MA, et al. Electrotherapy reoxygenates inframalleolar ischemic wounds on diabetic patients. Adv Skin Wound Care. 2002; 15:112-120.
5. Houghton PE, Kincaid CB, Lovell M, et al. Effect of electrical stimulation on chronic leg ulcer size and appearance. Phys Ther. 2003; 83(1):17-28.
6. Kenkre JE, Hobbs FD, Carter YH, et al. A randomized controlled trial of electromagnetic therapy in the primary care management of venous leg ulcerations. Fam Pract. 1996; 13(3):236-241.
7. Kloth LC, Feedar JA. Acceleration of wound healing with high voltage, monophasic, pulsed current. Phys Ther. 1988; 68:503-508.
8. Lundberg T, Kjartansson J, Samuelsson U. Effect of electrical nerve stimulation on healing of ischaemic ulcers. The Lancet. 1988; 2:712-714.
9. Salzberg CA, Cooper-Vastola SA, Perez F, et al. The effects of non-thermal pulsed electromagnetic energy on wound healing of pressure ulcers in spinal cord-injured patients: a randomized, double-blind study. Ostomy Wound Manage. 1995; 41(3):42-51.
10. Sheffet A, Cytryn AS, Louria DB. Applying electrical and electromagnetic energy as adjuvant treatment for pressure ulcers: a critical review. Ostomy Wound Manage. 2000; 46(2):28-33,36-40,42-44.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Blue Cross Blue Shield Association. Electrostimulation and Electromagnetic Therapy for the Treatment of Chronic Wound. TEC Assessment, 2005; 20(2).
2. Centers for Medicare and Medicaid Services. National Coverage Determination for Electrical Stimulation (ES) and Electromagnetic Therapy for the Treatment of Wounds. NCD #270.1. Effective July 1, 2004. Available at: http://www.cms.gov/medicare-coverage-database/indexes/national-and-local-indexes.aspx. Accessed on March 04, 2011.
3. National Pressure Ulcer Advisory Panel. Pressure ulcer staging system. Revised February 2007. Available at: http://www.npuap.org/. Accessed on March 04, 2011.

Chronic Wounds
Diapulse® Wound Treatment System™
DynaWave® 12 Pulse Generator
Electromagnetic Therapy for Chronic Wounds
Electrostimulation Treatment of Chronic Wounds
PROVANT® Wound-Closure System
SofPulse™
Tenzcare® Stimulator 

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.