|MP 2.01.57||Electrostimulation and Electromagnetic Therapy for Treating Wounds|
|Original Policy Date
|Last Review Status/Date
Reviewed with literature search/9:2014
|Return to Medical Policy Index|
Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract. Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage. Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.
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. Nonweight 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.
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.
Electrical stimulation for the treatment of wounds, including but not limited to low-intensity direct current (LIDC), high-voltage pulsed current (HVPC), alternating current (AC), and transcutaneous electrical nerve stimulation (TENS), is considered investigational.
Electrical stimulation performed by the patient in the home setting for the treatment of wounds is considered investigational.
Electromagnetic therapy for the treatment of wounds is considered investigational.
The following HCPCS codes are available for this treatment:
G0281: Electrical stimulation (unattended), to one or more areas, for chronic stage III and stage IV pressure ulcers, arterial ulcers, diabetic ulcers, and venous stasis ulcers not demonstrating measurable signs of healing after 30 days of conventional care, as part of a therapy plan of care.
G0282: Electrical stimulation (unattended), to one or more areas, for wound care other than described in G0281.
G0295: Electromagnetic therapy, to one or more areas, for wound care other than described in G0329 or for other uses.
G0329: Electromagnetic therapy, to one or more areas, for chronic stage III or stage IV pressure ulcers, arterial ulcers, diabetic ulcers, and venous stasis ulcers not demonstrating measurable signs of healing after 30 days of conventional care as part of a therapy plan of care.
E0761: Non-thermal pulsed high-frequency radiowaves, high peak power electromagnetic energy treatment device.
E0769: Electrical stimulation or electromagnetic wound treatment device, not otherwise classified.
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 nonspecific 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.
BlueCard/National Account Issues
State or federal mandates (e.g., FEP) may dictate that all FDA-approved devices may not be considered investigational, and thus these devices may be assessed only on the basis of their medical necessity.
This policy was originally created in 2003 and was updated regularly with searches of the MEDLINE database. The most recent literature review was performed through August 4, 2014. Following is a summary of the key literature.
The policy was originally based on a 2002 technology review performed by the Centers for Medicare and Medicaid Services.1 The initial policy was that electrostimulation may be considered medically necessary for the treatment of chronic ulcers and electromagnetic stimulation was considered investigational. The statement on electrical stimulation was changed to investigational following publication of a TEC Assessment in 2005.2 The TEC Assessment concluded that there was insufficient evidence from high- quality, randomized controlled trials (RCTs) that electrical stimulation and/or electromagnetic therapy are effective as standard adjunctive treatments for wound healing. At the time, few RCTs were available, and they tended to have small sample sizes and poor methodologic quality.
Literature updates focused on RCTs, especially larger high-quality trials, and systematic reviews of RCTs. Moreover, the review focused on the most clinically important outcome in evaluating treatments for wound healing, percent of patients who 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.
Subsequent to the TEC Assessment, several systematic reviews of the evidence on electrical stimulation for treating wounds have been published. Only 1 of the systematic reviews pooled study findings. This study, published in 2014 by Barnes et al, included RCTs evaluating the effectiveness of electrical stimulation for chronic ulcers of any etiology compared with standard treatment and/or sham stimulation.3 Twenty-one trials were included in the review; 14 used pulsed currents, 5 used alternating currents, and 2 used direct currents. Types of ulcers examined were pressure ulcers in 11 studies, venous ulcers in 3 studies, diabetic ulcers in 2 studies, arterial ulcers in 1 study, and ulcers of mixed etiology in the remaining 4 studies. Only 5 of the 21 trials were rated as ‘good’ quality ie, a score of 4 or 5 on the Jadad scale. Studies generally did not report the clinically important outcomes of percent completely healed or time to complete healing. Instead, they tended to report outcomes related to the decrease in the size of wounds. Meta-analyses were performed on several of these secondary outcomes. A pooled analysis of 6 studies with a total of 201 patients found that electrical simulation increased the mean percentage change in ulcer size by 24 to 62% compared with standard care and/or sham stimulation. The difference between groups was statistically significant (p<0.001), and heterogeneity among trials was not significant. Another
pooled analysis of 6 RCTs with a total of 266 patients found that electrical stimulation resulted in a significantly greater reduction in mean absolute ulcer size compared with standard care and/or sham stimulation. The mean difference in size between groups was 2.42 cm2 (95% confidence interval, 1.66 to 3.17; p<0.001) and there was significant heterogeneity. . The authors conducted sensitivity analyses and the significant benefit of electrical stimulation on ulcer size remained when studies on pulsed current and direct current were analyzed separately. Limitations of the evidence base identified in the systematic review include few high-quality studies, variability in study designs, and lack of data on complete healing.
Other systematic reviews were less comprehensive and did not conduct quantitative meta-analyses. A 2014 systematic review by Kawasaki et al addressed electrical stimulation only for pressure ulcers.4 The authors identified 7 RCTs and 2 observational studies that included at least 15 patients. The authors found the greatest amount of support for high-voltage pulsed current (HVPC, as described in the Houghton et al 2010 and Franek et al 2012 studies next5,6). Another 2014 systematic review, by Liu et al, identified 6 RCTs evaluating electrical stimulation for treating pressure ulcers in people with spinal cord injuries.7 Both reviews concluded that electrical simulation was effective for wound healing. Conclusions
were largely based on secondary outcomes reported in studies such as change in wound size and interface pressure, rather than on complete healing.
Representative RCTs on electrical stimulation for treating chronic wounds are described next. This includes the most recently published trials identified in systematic reviews.
In 2005, Adunsky et al published a randomized, double-blind, placebo-controlled trial to determine the benefits of adding direct current electrical stimulation to conservative wound care for stage III degree pressure sores of 30 days to 24 months in duration.(8) 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 electrical stimulation. 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 electrical stimulation group, this was not statistically significant and did not result in a greater rate of
complete wound closure.
In 2010, Houghton et al in Canada published a single-blind trial evaluating the effect of adding treatment with HVPC to a community-based standard wound care program.(6) The trial included 34 adults with spinal cord injuries and stage II to IV pressure ulcers of at least 3-month duration. The study excluded potential
participants who were likely to have limited healing potential, eg, 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, eg, 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% versus 36%, respectively (p=0.048). By 3 months, all of the stage II wounds had healed (1 in the HVPC group, 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 et al in Poland evaluated high-voltage electrical stimulation for treating lower extremity pressure ulcers in an unblinded RCT.5 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 with the control group on several outcomes. These included change in wound surface area (88.9% vs 44.4%, p<0.001) and change in the longest length of the wound (74.0% vs 36.1%, p<0.001). The rate of complete healing was not reported; the authors noted that they were unable to follow patients long enough for healing to occur.
Two Cochrane reviews have evaluated electromagnetic stimulation for treating wounds; 1 addressed treatment of pressure ulcers (last updated in 2012) and the other addressed leg ulcers (last updated in 2013).9,10 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.
Ongoing and Unpublished Clinical Trials
An online search of ClinicalTrials.gov in August 2014 did not identify any relevant ongoing RCTs.
There is insufficient evidence from well-designed randomized controlled trials (RCTs) that electrical stimulation or electromagnetic stimulation improves health outcomes for wound care patients beyond that provided by standard treatment. Systematic reviews of RCTs on electrical stimulation have reported improvements in some intermediate outcomes, such as decrease in wound size and/or the velocity of wound healing. However, there is insufficient evidence 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 published a guideline on care of pressure ulcers.(11) 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.
In 2010, the Wound, Ostomy, and Continence Nurses Society published a guideline on prevention and management of pressure ulcers.(12) The guideline stated that electrical stimulation can be considered as adjunctive treatment and rates the evidence as level B. Electromagnetic therapy was not mentioned.
U.S. Preventive Services Task Force Recommendations
Use of electrical stimulation and electromagnetic therapy for wound healing is not a preventive service.
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.13
Effective July, 2004, Medicare’s national coverage decision is as follows:
- Electrical stimulation and electromagnetic therapy will not be covered as an initial treatment modality;
- 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;
- Unsupervised use of electrical stimulation or electromagnetic therapy is not covered;
- All other uses of electrical stimulation and electromagnetic therapy for the treatment of wounds remain at the discretion of local contractors.
- Medicare Technology Assessments for Electrostimulation for Wounds (CAG-00068N). http://www.cms.gov/medicare-coverage-database/details/nca-details.aspx?NCAId=27&ver=13&NcaName=Electrostimulation+for+Wounds&DocID=CAG-00068N&from2=viewtechassess.asp&id=27&bc=gAAAAAgAAAAA&&. Accessed July, 2014.
- 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. PMID
- Barnes R, Shahin Y, Gohil R, et al. Electrical stimulation vs. standard care for chronic ulcer healing: a systematic review and meta-analysis of randomised controlled trials. Eur J Clin Invest. Apr 2014;44(4):429-440. PMID 24456185
- Kawasaki L, Mushahwar VK, Ho C, et al. The mechanisms and evidence of efficacy of electrical stimulation for healing of pressure ulcer: a systematic review. Wound Repair Regen. Mar-Apr 2014;22(2):161-173. PMID 24372691
- 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. Mar 2012;58(3):30-44. PMID 22391955
- 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):669-678. PMID
- Liu LQ, Moody J, Traynor M, et al. A systematic review of electrical stimulation for pressure ulcer prevention and treatment in people with spinal cord injuries. J Spinal Cord Med. Jun 26 2014. PMID 24969965
- 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):261-269. PMID
- Aziz Z, Flemming K. Electromagnetic therapy for treating pressure ulcers. Cochrane Database Syst Rev. 2012;12:CD002930. PMID 23235593
- Aziz Z, Cullum N, Flemming K. Electromagnetic therapy for treating venous leg ulcers. Cochrane Database Syst Rev. 2013;2:CD002933. PMID 23450536
- Association for the Advancement of Wound Care (AAWC). Association for the Advancement of Wound Care guideline of pressure ulcer guidelines. www.guideline.gov. Accessed July, 2014.
- Wound, Ostomy and Continence Nurses Society (WOCN). Guideline for prevention and management of pressure ulcers. www.guideline.gov. Accessed August, 2014.
- CMS Manual System. Pub. 100-43 Medicare National Coverage Determinations. 2004; www.cms.hhs.gov. Accessed July, 2014.
|CPT||See Policy Guidelines|
|ICD-9||707.00-707.9||Chronic ulcer of skin, code range|
|HCPCS||See Policy Guidelines|
|ICD-10-CM (effective 10/1/15)||Investigational for all wounds|
|E08.621, E08.622, E09.621, E09.622, E10.621, E10.622, E11.621, E11.622, E13.621, E13.622||Various types of diabetes with skin complications (foot ulcer or other skin ulcer) code list|
|I83.001-I83.029; I83.201-I83.229||Varicose veins with ulcer code range|
|L00 – L08.9||Infections of the skin code range (includes cellulitis – L03)|
|L89.00-L89.95||Pressure ulcer code range|
|L97.10-L97.929||Non-pressure chronic ulcer of skin code range|
|L98.41-L98.499||Non-pressure chronic ulcer of skin not otherwise classified code range|
|L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere|
|ICD-10-PCS (effective 10/1/15)||ICD-10-PCS codes are only used for inpatient services. There is no specific ICD-10-PCS code for the initiation or application of this therapy.|
Alternative Current (AC), Electrical Stimulation, Wounds Electrical Stimulation, Wounds
Electrostimulation and Electromagnetic Therapy
High Voltage Pulsed Current (HVPC)
Low Intensity Direct Current (LIDC), Wounds
Transcutaneous Electrical Nerve Stimulation (TENS), Treatment of Wounds
Ulcers, Electrical Stimulation
Wounds, Electrical Stimulation
|07/17/03||Add policy to Medicine section||New policy|
|04/1/05||Replace policy||Policy updated with February 2005 TEC Assessment; policy statement on electrical stimulation of wounds in now considered investigational. HCPCS code G0329 added to policy guidelines|
|04/25/06||Replace policy||Literature review update for the period of February 2005 through February 2006; reference number 4 added. Policy statement unchanged|
|04/17/07||Replace policy||Policy updated with literature review; policy statement unchanged|
|05/08/08||Replace policy||Policy updated with literature review; references 5-7 added; policy statements unchanged|
|10/06/09||Replace policy||Policy updated with literature review; policy statement unchanged; reference 2 removed and others renumbered; new reference 7 added. Policy guidelines section revised.|
|10/08/10||Replace policy||Policy updated with literature review; no other changes to policy statements; Rationale rewritten; reference numbers 4-6 added.|
|10/11/12||Replace policy||Policy updated with literature review; policy statements unchanged. References 3 and 8 added; other references renumbered or removed.|
|10/10/13||Replace policy||Policy updated with literature review through September 5, 2013; policy statements unchanged. References 4 and 5 added; other references renumbered or removed. The first policy statement was edited to clarify the intent.|
|9/11/14||Replace policy||Policy updated with literature review through August 4, 2014; policy statements unchanged. References 3-4, 7, and 12 added.|