BlueCross and BlueShield of Montana Medical Policy/Codes
Electrostimulation and Electromagnetic Therapy for the Treatment of Wounds
Chapter: Therapies
Current Effective Date: December 05, 2012
Original Effective Date: November 01, 2010
Publish Date: December 05, 2012
Revised Dates: December 5, 2012
Description

Electrical stimulation refers to the application of electrical current through electrodes placed directly on the skin in close proximity to the wound. Electromagnetic therapy involves the application of electromagnetic fields rather than direct electrical current. Both are proposed as treatments for chronic wounds.

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 1 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, and 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 promotes 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 adenosine 5’-triphosphate (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), and 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.

Regulatory Status

No electrical stimulation or electromagnetic therapy devices have received approval from the U.S. Food and Drug Administration (FDA), 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.

Policy

Investigational

Blue Cross and Blue Shield of Montana (BCBSMT) considers the following investigational, including but not limited to:

  • Electrical stimulation using low-intensity direct current (LIDC), high-voltage pulsed current (HVPC), alternating current (AC), and transcutaneous electrical nerve stimulation (TENS) for the treatment of wounds.
  • Electrical stimulation performed by the patient in the home setting for the treatment of wounds.
  • Electromagnetic therapy for the treatment of wounds.

Federal Mandate

Federal mandate prohibits denial of any drug, device or biological product fully approved by the FDA as investigational for the Federal Employee Program (FEP).  In these instances coverage of these FDA-approved technologies are reviewed on the basis of medical necessity alone.

Policy Guidelines

The following HCPCS codes are available for this treatment:

  • G0281
  • G0282
  • G0295
  • G0329
  • E0761
  • E0769

The HCPCS code G0281 (unattended electrical stimulation) was specifically developed to make a distinction between attended and unattended electrical stimulation. Attended electrical stimulation is identified by CPT code 97032. Although the description of this CPT code is non-specific and could describe any type of electrical stimulation, electrical stimulation for wound healing would not require constant attendance, and thus the CPT code would not be applicable.

The Medicare policy notes that coverage for electrical stimulation is limited to supervised settings. Although the terminology is confusing, for the purposes of Medicare policy, supervised is interpreted to mean that while a physician or other health professional is supervising the treatment, this person does not have to be in constant attendance. Therefore, for the purposes of implementing the Medicare policy, "supervised" essentially means "unattended" as described in the G code.

Rationale for Benefit Administration

This medical policy was developed through consideration of peer reviewed medical literature, FDA approval status, accepted standards of medical practice in Montana, Technology Evaluation Center evaluations, and the concept of medical necessity. BCBSMT reserves the right to make exceptions to policy that benefit the member when advances in technology or new medical information become available.

The purpose of medical policy is to guide coverage decisions and is not intended to influence treatment decisions. Providers are expected to make treatment decisions based on their medical judgment. BCBSMT recognizes the rapidly changing nature of technological development and welcomes provider feedback on all medical policies.

When using this policy to determine whether a service, supply or device will be covered, please note that member contract language will take precedence over medical policy when there is a conflict.

Rationale

This policy was originally created in 2010 and has been with searches of the MEDLINE database. The most recent literature search was performed for the period July 2011 through August 2012. Following is a summary of the key literature:

In February 2005, a TEC Assessment on electrostimulation and electromagnetic therapy for the treatment of chronic wounds was conducted. (1) The following summarizes the conclusions of the TEC Assessment:

  • The most clinically important outcome in evaluating treatments for wound healing is the percent of patients that heal completely following a course of treatment. Time to complete healing is another important, objective outcome measure. Secondary outcomes that have some clinical relevance are decrease in the size of a wound, pain associated with a wound, and facilitation of surgical closure. Adverse outcomes with electrical stimulation and electromagnetic therapy are expected to be minimal but may include discomfort and infection associated with the device.
  • The evidence is not sufficient to permit conclusions on the efficacy of electrical stimulation and electromagnetic therapy as adjunctive treatments for wound healing. For studies of wound healing, high-quality randomized, controlled trials (RCTs) are essential to determining the efficacy of an intervention independent of the many confounding factors and the variable natural history of the disorder. The body of evidence for electrical stimulation and electromagnetic therapy consisted of numerous small, relatively poor-quality RCTs (N=10 for electrical stimulation; N=5 for electromagnetic therapy) that compare active treatment with a placebo sham device.
  • Although results suggest that electrical stimulation and electromagnetic therapy may promote wound healing or some aspect of wound healing, considerable uncertainty remains as to whether these modalities lead to clinically significant health outcome benefits, given the relatively poor quality of the available evidence. Larger RCTs are needed that focus on one type of wound, that demonstrate baseline comparability on important confounders, and that report the outcome of complete healing.

Based on the conclusions of the February 2005 TEC Assessment, the policy statement regarding electrostimulation of wounds was changed from may be considered medically necessary to investigational. Previously, consistent with conclusions of a 2002 technology review performed by the Centers for Medicare and Medicaid Services (CMS), the policy had stated that electrostimulation may be considered medically necessary for the treatment of chronic ulcers. (2) The policy on electromagnetic therapy of wounds has remained investigational.

Subsequent to the TEC Assessment, several systematic reviews on treatments for wounds have been published that address electrostimulation and/or electromagnetic stimulation. In 2012, Game and colleagues reviewed studies on interventions to enhance healing of diabetic foot ulcers and stated that they did not find sufficient evidence that electrical stimulation was clinically effective for treating foot ulcers. (3) Moreover, two Cochrane reviews have evaluated electromagnetic stimulation for treating wounds; one addressed treatment of pressure ulcers and the other addressed leg ulcers. (4, 5) Each review identified few RCTs (2 and 3 studies, respectively) with small sample sizes. Consequently, the investigators were not able to conduct robust pooled analyses of study findings. Both reviews concluded that there is insufficient evidence that electromagnetic therapy is effective for treating chronic wounds.

Representative RCTs on electrostimulation or electromagnetic stimulation for treating chronic wounds are described below:

In 2005, Adunsky and colleagues published a randomized, double-blind, placebo-controlled trial to determine the benefits of adding direct current electrostimulation to conservative wound care for stage III degree pressure sores of 30 days’ to 24 months’ duration. (6) This multicenter trial of 63 patients found no significant differences in complete wound closure or time to complete wound closure between the treatment groups after 8 consecutive weeks of electrostimulation. Nor were there any significant differences between groups after an additional follow-up of 12 weeks. While the authors reported an increase in absolute wound area reduction and speed of wound healing up until the 45th day of treatment in the electrostimulation group, this was not statistically significant and did not result in a greater rate of complete wound closure.

In 2010, Houghton and colleagues in Canada published a single-blind trial evaluating the effect of adding treatment with high-voltage pulsed current (HVPC) to a community-based standard wound care program. (7) The trial included 34 adults with spinal cord injuries and stage II to IV pressure ulcers of at least 3 months’ duration. The study excluded potential participants who were likely to have limited healing potential e.g., those with anemia or uncontrolled diabetes. Patients in the HVPC group or their caregivers were trained to administer the treatment and instructed to apply it for 8 hours per day e.g., overnight. (An analysis of compliance found that HVPC treatment was actually used for a mean of 3 hours per day.) All randomized patients completed the 3-month follow-up. Two wounds, both in the standard care only group, were unstageable. The primary efficacy outcome, percentage decrease in wound care surface, was significantly greater in the group receiving HVPC (n=16) than the standard care only group (n=18), mean decrease of 70% versus36%, respectively (p=0.048).By 3 months, all of the stage II wounds had healed (1 in the HVPC group and 4 in the standard care only group). The number of the remaining wounds (stage III, IV, or unstageable) that were at least 50% smaller at 3 months was 12 of 15 (80%) in the HVPC group and 5 of 14 (36%) in the standard care only group; this difference was statistically significant (p=0.02). There was not a statistically significant difference in the number of wounds that were completely healed at 3 months, 6 in the HVPC group and 5 in the standard care only group.

In 2012, Franek and colleagues in Poland evaluated high-voltage electrical stimulation for treating lower extremity pressure ulcers in an unblinded RCT. (8) Fifty-seven patients with stage II or III pressure ulcers were randomized to receive electrical stimulation in addition to standard wound care or standard care only. The electrical stimulation intervention involved five 50-minute procedures per week until the wound was healed or until reaching a maximum of 6 weeks. A total of 50 of 57 patients (88%) completed treatment. After 6 weeks, there were statistically significantly greater changes in the treatment group compared to the control group on several outcomes. These included change in wound surface area (88.9% vs. 44.4%, p<0.0001) and change in the longest length of the wound (74.0% vs. 36.1%, p<0.0001). The rate of complete healing was not reported; the authors noted that they were unable to follow patients long enough for healing to occur.

One small RCT on electromagnetic therapy, published in 2009, was identified. (9) The study was conducted in India and included only 12 patients. Patients were in-patients with neurologic disorders and stage 3 or 4 pressure ulcers. Six patients were assigned to active treatment, and the other 6 were assigned to a sham intervention. After 6 months of follow-up, there was no significant difference between groups in the degree of wound healing. The sample size was too small to allow a meaningful comparison of the proportion of patients whose wounds had healed completely.

Summary

There is insufficient evidence from well-designed randomized controlled trials (RCTs) that electrostimulation or electromagnetic stimulation improves health outcomes for wound care patients beyond that provided by standard treatment. Some small RCTs on electrostimulation have reported improvements in some intermediate outcomes, such as decrease in wound size and/or the velocity of wound healing. However, these studies have not demonstrated consistent improvements on the more important clinical outcomes of complete healing and the time to complete healing. For electromagnetic therapy, there is a lack of high-quality RCTs. Therefore, these treatments are considered investigational for the treatment of wounds.

Practice Guidelines and Position Statements

In 2010, the Association for the Advancement of Wound Care (AAWC) published a guideline on care of pressure ulcers. (10) Electrical stimulation was included as a potential second-line intervention if first-line treatments did not result in wound healing. The guideline did not mention electromagnetic therapy.

Medicare National Coverage

National Medicare Coverage of electrical stimulation and electromagnetic stimulation is limited to chronic stage III or stage IV pressure ulcers, arterial ulcers, diabetic ulcers, and venous stasis ulcers. (11)

Effective July, 2004, Medicare’s national coverage decision is as follows:

  1. Electrical stimulation and electromagnetic therapy will not be covered as an initial treatment modality;
  2. Continued treatment with electrical stimulation and electromagnetic therapy is not covered if measurable signs of healing have not been demonstrated within any 30-day period of treatment;
  3. Unsupervised use of electrical stimulation or electromagnetic therapy is not covered;
  4. All other uses of electrical stimulation and electromagnetic therapy for the treatment of wounds remain at the discretion of local contractors.
ICD-9 Codes
707.00-707.9
ICD-10 Codes
E08.621, E08.622, E09.621, E09.622, E10.621, E10.622, E11.621, E11.622, E13.621, E13.622, I83.001-I83.029; I83.201-I83.229, L00-L08.9, L89.00-L89.95, L97.10-L97.929, L98.41-L98.499, L99  
Procedural Codes: G0281, G0282, G0295, G0329, E0761, E0769
References
  1. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Electrical stimulation or electromagnetic therapy as adjunctive treatments for chronic skin wounds. TEC Assessments 2005; Volume 20, Tab 2.
  2. Medicare Technology Assessments for Electrostimulation for Wounds (CAG-00068N). Available online at: http://www.cms.hhs.gov/mcd/viewtechassess.asp?id=27 . Last accessed July, 2011.
  3. Game FL, Hinchliffe RJ, Apelqvist J et al. A systematic review of interventions to enhance the healing of chronic ulcers of the foot in diabetes. Diabetes Metab Res Rev 2012; 28 Suppl 1:119-41.
  4. Aziz Z, Cullum NA, Flemming K. Electromagnetic therapy for treating venous leg ulcers. Cochrane Database Syst Rev 2011; (3):CD002933.
  5. Aziz Z, Flemming K, Cullum NA et al. Electromagnetic therapy for treating pressure ulcers. Cochrane Database Syst Rev 2010; (11):CD002930.
  6. Adunsky A, Ohry A, Ddct G. Decubitus direct current treatment (DDCT) of pressure ulcers: results of a randomized double-blinded placebo controlled study. Arch Gerontol Geriatr 2005; 41(3):261-9.
  7. Houghton PE, Campbell KE, Fraser CH et al. Electrical stimulation therapy increases rate of healing of pressure ulcers in community-dwelling people with spinal cord injury. Arch Phys Med Rehabil 2010; 91(5):669-78.
  8. Franek A, Kostur R, Polak A et al. Using high-voltage electrical stimulation in the treatment of recalcitrant pressure ulcers: results of a randomized, controlled clinical study. Ostomy Wound Manage 2012; 58(3):30-44.
  9. Gupta A, Taly AB, Srivastava A et al. Efficacy of pulsed electromagnetic field therapy in healing of pressure ulcers: a randomized control trial. Neurol India 2009; 57(5):622-26.
  10. Association for the Advancement of Wound Care (AAWC). Association for the Advancement of Wound Care guideline of pressure ulcer guidelines. Available online at: www.guideline.gov . Last accessed September, 2011.
  11. CMS Manual System. Pub. 100-43 Medicare National Coverage Determinations. 2004. Available online at: www.cms.hhs.gov . Last accessed September, 2011.
History
December 2012  Policy updated with literature review; policy statements unchanged. References 3 and 8 added; other references renumbered or removed. 
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Electrostimulation and Electromagnetic Therapy for the Treatment of Wounds