Subject:
Electrostimulation and Electromagnetic Therapy for Treating Wounds
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Electrostimulation (electrical stimulation) refers to the application of electrical current through electrodes placed directly on the skin. Electromagnetic therapy involves the application of electromagnetic fields, rather than direct electrical current. Both are proposed as treatments for wounds, generally chronic wounds.
| Populations | Interventions | Comparators | Outcomes |
Individuals:
- With any wound type (acute or nonhealing)
| Interventions of interest are:
| Comparators of interest are:
| Relevant outcomes include:
- Symptoms
- Change in disease status
- Morbid events
- Quality of life
- Treatment-related morbidity
|
Individuals:
- With any wound type (acute or nonhealing)
| Interventions of interest are:
| Comparators of interest are:
| Relevant outcomes include:
- Symptoms
- Change in disease status
- Morbid events
- Quality of life
- Treatment-related morbidity
|
BACKGROUND
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 more 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, and (4) diabetic ulcers.
Treatment
Conventional or standard therapy for chronic wounds involves local wound care, as well as systemic measures including débridement of necrotic tissues, wound cleansing, and dressing that promotes a moist wound environment, antibiotics to control infection, and optimizing nutritional supplementation. Avoidance of weight bearing is another important component of wound management.
Electrostimulation
Since the 1950s, investigators have used electrostimulation to promote wound healing, based on the theory that electrostimulation may:
· Increase adenosine 5¢-triphosphate 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.
Electrostimulation refers to the application of electrical current through electrodes placed directly on the skin near the wound. The types of electrostimulation and devices can be categorized into groups based on the type of current. This includes low-intensity direct current, high-voltage pulsed current, alternating current, and transcutaneous electrical nerve stimulation.
Electromagnetic Therapy
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 electrostimulation or electromagnetic therapy devices have received approval from the U.S. Food and Drug Administration 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 off-label.
Related Policies
- Electrotherapies in Pain Management (Policy #025 in the Treatment Section)
- Negative-Pressure Wound Therapy (Policy #013 in the Treatment Section)
- Non-Contact Ultrasound Treatment for Wounds (Policy #122 in the Treatment Section)
Policy:
(NOTE: For further information on the use of transcutaneous electrical nerve stimulation (TENS) and electromagnetic therapy (e.g., Diapulse) in pain management please refer to a separate policy on Electrotherapies in Pain Management (Policy #025) in the Treatment Section.
NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
1. Electrical stimulation for the treatment of wounds, including but not limited to low-intensity direct current, high-voltage pulsed current, alternating current, and transcutaneous electrical nerve stimulation, is considered investigational.
2. Electrical stimulation performed by the member in the home setting for the treatment of wounds is considered investigational.
3. Electromagnetic therapy for the treatment of wounds is considered investigational.
Medicare Coverage:
Per NCD 270.1 Electrical Stimulation (ES) and Electromagnetic Therapy for the Treatment of Wounds, one covered electrical stimulation therapy or one covered electromagnetic therapy is covered for the treatment of chronic stage III or stage IV pressure ulcers, arterial ulcers, diabetic ulcers, and venous stasis ulcer when performed by a physician, physical therapist, or incident to a physician service.
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.
For additional information and eligibility, refer to: National Coverage Determination (NCD) for Electrical Stimulation (ES) and Electromagnetic Therapy for the Treatment of Wounds (270.1). Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=131&ncdver=3&bc=AAAAQAAAAAAAAA%3d%3d&
Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE-SNP Coverage:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
[RATIONALE: This policy was created in 2003 and has been updated regularly with searches of the MEDLINE database. The most recent literature update was performedthrough November 16, 2018.
Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function¾including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.
To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, two domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.
A 2005 TEC Assessment concluded that there was insufficient evidence from high-quality RCTs that electrostimulation and/or electromagnetic therapy are effective as standard adjunctive treatments for wound healing.1,At the time, few RCTs were available, and they tended to have small sample sizes and poor methodologic quality. The following is a summary of the key literature.
ElectroStimulation
Clinical Context and Test Purpose
The purpose of electrostimulation is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with any wound type (acute or nonhealing).
The question addressed in this policy is: does electrostimulation improve the net health outcome in individuals with acute or nonhealing wounds?
The following PICOTS were used to select literature to inform this review.
Patients
The relevant population of interest are individuals with any wound type (acute or nonhealing).
Interventions
The therapy being considered is electrostimulation.
Comparators
Comparators of interest include standard wound care.
Outcomes
The general outcomes of interest are symptoms, change in disease status, morbid events, quality of life, and treatment-related morbidity.
Timing
Follow-up over months is of interest for electrostimulation to monitor relevant outcomes.
Setting
Patients with any wound type (acute or nonhealing) are actively managed by primary care providers and wound specialists in an outpatient clinical setting.
Study Selection Criteria
Methodologically credible studies were selected using the following principles:
a. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
b. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
c. To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
· Studies with duplicative or overlapping populations were excluded.
After the TEC Assessment, several RCTs and systematic reviews on electrostimulation for treating wounds have been published.2,3,4,5,6,7,8, Two of the systematic reviews pooled study findings.
Systematic Reviews
The systematic review by Barnes et al (2014) included RCTs evaluating the comparative effectiveness of electrostimulation for chronic ulcers of any etiology and standard treatment and/or sham stimulation.2, Twenty-one trials were selected; 14 used pulsed currents, 5 used alternating currents, and 2 used direct currents. Pressure ulcers were evaluated 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 reported outcomes related to the decrease in wound size. Meta-analyses were performed on several of these secondary outcomes. A pooled analysis of 6 studies (n=201 patients) found that electrostimulation 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 (n=266 patients) found that electrostimulation 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 [CI], 1.66 to 3.17 cm2; p<0.001) and there was significant heterogeneity. Reviewers conducted sensitivity analyses, and the significant benefit of electrostimulation on ulcer size remained when studies of pulsed current and direct current were analyzed separately. Limitations of the evidence base identified in the systematic review included few high-quality studies, variability in study designs, and lack of data on complete healing.
A systematic review by Lala et al (2016) addressed electrostimulation for treating pressure ulcers in individuals with spinal cord injury.6, Fifteen studies met inclusion criteria; six were RCTs, six were prospective controlled trials, two were retrospective controlled trials, and four were case series. Several studies, published by the same research group and using the same populations, might have overlapped. Reviewers used a 10-point methodologic quality score and judged the overall quality of the controlled studies to be low (mean quality score, 5.3). A pooled analysis was conductedof data from four RCTs that reported healing rate. Sample sizes were small; 2 of the 4 RCTs included fewer than 20 patients. In the pooled analysis, pressure ulcer healing was significantly higher with electrostimulation than sham stimulation or usual care (relative risk, 1.55; 95% CI, 1.12 to 2.15). Several other pooled analyses assessed outcomes related to wound size (of less clinical interest) and data from nonrandomized studies.
A meta-analysis by Khouri et al (2017) included 29 randomized trials (total n=1510 patients; total n=1753 ulcers) of individuals treated with electrostimulation, sham stimulation, or standardized wound care.9, The primary finding was a highly heterogeneous overall standardized mean difference of 0.72 (95% CI, 0.48 to 1; I2=78%). Modalities varied: in 18 studies, active electrostimulation was placed near the wound, and in 17 studies, electrostimulation was placed over the wound; additionally, types of waveform varied between studies (types included direct-, high-, or low-voltage current, and alternating current). Electrostimulation had the greatestefficacy when the active electrode was placed over the wound, and high-voltage pulsed current (HVPC) was used (standardized mean difference, 0.8; 95% CI, 0.38 to 1.21; I2=79%). Other factors that may have affected the efficacy of electrostimulation were ulcer type, size, and duration (small, quick-healing pressure ulcers were favorable), although the association was not statistically significant (p=0.28). In subgroup analyses, reviewers found a greater sensitivity for wound size area than for other outcomes. Potential sources of heterogeneity were electrode polarity, ulcer etiology, and type of outcome. Reviewers noted that 52% of the studies had a high-risk of bias but concluded that the overall safety and efficacy of electrostimulation seem confirmed, given the current evidence.
Randomized Controlled Trials
Representative RCTs on electrostimulation for treating chronic wounds are described next (this includes the most recently published trials identified in systematic reviews).
Houghton et al (2010) in Canada published a single-blind trial evaluating the effect of adding treatment with HVPC to a community-based standard wound care program.4, The trial included 34 adults with spinal cord injuries and stage II to IV pressure ulcers of at least 3 months in duration. The trial 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 eight hours per day (eg, overnight). A compliance analysis found that HVPC treatment was actually used for a mean of three hours per day. All randomized patients completed the three-month follow-up. Two wounds, both in the standard care only group, were unstageable. The primary efficacy outcome (the percentage decrease in wound care surface) was significantly greater in the group receiving HVPC (n=16) than in the standard care only group (n=18) (mean decrease, 70% vs 36%, respectively; p=0.048). By three months, all stage II wounds had healed (one in the HVPC group, four 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 (80%) of 15 in the HVPC group and 5 (36%) of 14 in the standard care only group; this difference was statistically significant (p=0.02). There was no statistically significant difference in the number of wounds completely healed at three months¾six in the HVPC group and five in the standard care only group.
Franek et al (2012) in Poland evaluated high-voltage electrical stimulation for treating lower-extremity pressure ulcers in an unblinded RCT.3, Fifty-seven patients with stage II or III pressure ulcers were randomized to electrostimulation plus standard wound care or standard care only. The electrical stimulation intervention involved 5, 50-minute procedures per week until the wound was healed or until a maximum of 6 weeks. Fifty (88%) of 57 patients completed treatment. After six weeks, there were statistically, significantly greater changes in the treatment group than in the control group on several outcomes. They included a 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), respectively. The rate of complete healing was not reported because trialists were unable to follow patients long enough for healing to occur.
Polak et al (2017) conducted a prospective RCT in which 63 patients were randomized to cathodal or cathodal plus anodal electrostimulation by high-voltage monophasic pulsed current or sham stimulation.10 All patients had pressure ulcers of 0.5 cm2 or greater on the pelvic girdle, and most patients (n=49 [77.78%]) were immobile; also, regardless of the regimen administered, standard wound care was given to all patients. Of patients who received high-voltage monophasic pulsed current, 23 were given daily 50-minute treatments of cathodal electrostimulation 5 times per week for 6 weeks; a comparator group (n=20) was given cathodal stimulation for 1 week, then anodal stimulation for 5 weeks. No statistically significant differences in wound-related outcomes were observed between cathodal and cathodal-anodal groups, although outcomes in both groups were significantly superior to those for the group receiving sham stimulation. Decreases in wound size area of 82.34% and 70.77% for the cathodal and cathodal-anodal groups, respectively, were significantly larger than the decrease observed in the placebo group (40.53%). Similarly, the high-voltage monophasic pulsed current groups achieved a 50% decrease in wound size area faster (1.92 weeks and 2.60 weeks) than the sham group (10.60 weeks). During the 6 weeks of treatment, 47.83% of wounds treated with cathodal stimulation closed, as did 45% of those treated with cathodal-anodal stimulation. For the sham group, none of the patients achieved full wound closure at six weeks. These results would suggest that the active stimulation protocols were comparable in efficacy and superior to standard wound care. Limitations of the trial were that the authors did not confirm blinding rates or follow patients to complete wound closure, so the optimal treatment time was not determined.
Section Summary: Electrostimulation
The evidence on the use of electrostimulation to treat wounds includes systematic reviews, a meta-analysis, and RCTs. Many studies reported short-term outcomes such as wound healing rate or decrease in wound size; several of the trials found improvements for these outcomes. However, few studies evaluated complete healing or time to complete healing, two more clinically important outcomes. Systematic reviews were limited by the inclusion of studies with poor methodological quality and high heterogeneity.
Electromagnetic Therapy
Clinical Context and Test Purpose
The purpose of electromagnetic therapy is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with any wound type (acute or nonhealing).
The question addressed in this policy is: does electromagnetic therapy improve the net health outcome in individuals with acute or nonhealing wounds?
The following PICOTS were used to select literature to inform this review.
Patients
The relevant population of interest are individuals with any wound type (acute or nonhealing).
Interventions
The therapy being considered is electromagnetic therapy.
Comparators
Comparators of interest include standard wound care.
Outcomes
The general outcomes of interest are symptoms, change in disease status, morbid events, quality of life, and treatment-related morbidity.
Timing
Follow-up over months is of interest for electromagnetic therapy to monitor relevant outcomes.
Setting
Patients with any wound type (acute or nonhealing) are actively managed by primary care providers and wound care specialists in an outpatient clinical setting.
Study Selection Criteria
Methodologically credible studies were selected using the following principles:
a. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
b. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
c. To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
· Studies with duplicative or overlapping populations were excluded.
Two Cochrane reviews have evaluated electromagnetic therapy for treating wounds: one addressed the treatment of pressure ulcers (last updated in 2012) and the other addressed leg ulcers (last updated in 2015).11,12, Each review identified a few RCTs (two and three studies, respectively) with small sample sizes. Consequently, these reviewers were unable to conduct robust pooled analyses of study findings. Both concluded that there is insufficient evidence that electromagnetic therapy is effective for treating chronic wounds.
Khooshidehet al (2017) reported on an RCT of 72 women treated with pulsed electromagnetic field (PEMF) therapy or sham PEMF following Cesarean section.13, The primary outcome was a reduction of pain during recovery, which was assessed using a visual analog scale (VAS) at regular intervals for seven days following surgery. At each assessment, women treated with PEMF (n=36) reported significantly lower levels of pain than did their counterparts treated with sham (n=36). For example, 2 hours after surgery, PEMF patients had a mean VAS score of 53 compared with that of sham patients (VAS score, 63; p=0.01). Comparisons were similar between groups through the seventh day of follow-up, when the PEMF group reported a mean VAS score of 0.8 and the sham group reported a mean VAS score of 3 (p=0.01). The percentage of patients who reported severe pain (defined as VAS score, ≥75) 24 hours or less after surgery was lower in the PEMF group (36%) than in the sham group (72%; p=0.002). Secondary outcomes were wound healing and use of the pain medication available to each patient at discharge (diclofenac suppository 100 mg as needed); unlike other outcomes, wound healing was assessed 10 days after surgery, rather than 7. None of the patients in the PEMF group showed signs of wound exudate or edema, compared with 13% and 11% of sham patients who had exudate or edema, respectively (p=0.04). Patients in the PEMF group consistently used fewer suppositories to treat postoperative pain (mean, 1.7) than those treated with sham (mean, 3.7; p<0.001). Patients in both groups took an average of 3 to 4 days before they were able to resume normal activities, with no significant difference between groups (p=0.58) but listed no limitations to their study other than a change from 10 days of follow-up to 7.
Section Summary: Electromagnetic Therapy
The evidence on the use of electromagnetic therapy includes two systematic reviews of RCTs (one on pressure ulcers and the other on leg ulcers) and an RCT of electromagnetic treatment following Cesarean section. The reviews were limited by the inclusion of small studies and a lack of robust pooled analyses. The RCT was focused primarily on postoperative pain, with wound healing being a secondary outcome that was assessedaccording to a previous protocol. The evidence on the use of electromagnetic therapy to treat wounds is inadequate to support drawing a conclusion about efficacy.
Summary of Evidence
For individuals who have any wound type (acute or nonhealing) who receive electrostimulation, the evidence includes systematic reviews, a meta-analysis, and RCTs. The relevant outcomes are symptoms, change in health status, morbid events, quality of life, and treatment-related morbidity. Systematic reviews of RCTs on electrical stimulation have reported improvements in some outcomes, mainly intermediate outcomes such as a decrease in wound size and/or the velocity of wound healing. There are few analyses of the more important clinical outcomes of complete healing and the time to complete healing, and many of the trials are of relatively low quality. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals who have any wound type (acute or nonhealing) who receive electrostimulation, the evidence includes systematic reviews, a meta-analysis, and randomized controlled trials (RCTs). The relevant outcomes are symptoms, change in health status, morbid events, quality of life, and treatment-related morbidity. Systematic reviews of RCTs on electrical stimulation have reported improvements in some outcomes, mainly intermediate outcomes such as a decrease in wound size and/or the velocity of wound healing. There are few analyses of the more important clinical outcomes of complete healing and the time to complete healing, and many of the trials are relatively low quality. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals who have any wound type (acute or nonhealing) who receive electromagnetic therapy, the evidence includes two systematic reviews of RCTs (one on pressure ulcers and the other on leg ulcers) and an RCT of electromagnetic treatment following Cesarean section. The relevant outcomes are symptoms, change in health status, morbid events, quality of life, and treatment-related morbidity. The systematic reviews identified a few RCTs with small sample sizes that do not permit drawing definitive conclusions. The evidence is insufficient to determine the effects of the technology on health outcomes.
SUPPLEMENTAL INFORMATION
Practice Guidelines and Position Statements
American College of Physicians
The American College of Physicians (2015) published guidelines on the treatment of pressure ulcers.14, The guidelines recommended the electrostimulation be used as adjunctive treatment in patients with pressure ulcers. This was considered by the College to be a weak recommendation, based on moderate-quality evidence.
Association for the Advancement of Wound Care
The Association for the Advancement of Wound Care (2014) published guidelines on the care of venous ulcers and pressure ulcers.15, Guidelines for venous ulcer care included electrostimulation and electromagnetic stimulation as treatment modalities. Guidelines for pressure ulcer care include electrostimulation as adjunctive interventions when pressure ulcers do not respond to the first-line of treatment.
Previously, the Association (2010) published guidelines on the care of pressure ulcers.16, Electrostimulation was included as a potential second-line intervention if first-line treatments did not result in wound healing.
Wound, Ostomy and Continence Nurses Society
The Wound, Ostomy and Continence Nurses Society (2016) published guidelines on the prevention and management of pressure ulcers.17, The guidelines stated that electrostimulation can be considered as adjunctive treatment and rated the evidence as level A.
U.S. Preventive Services Task Force Recommendations
Not applicable.
Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov in December 2018 did not identify any ongoing or unpublished trials that would likely influence this review.]
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Electrostimulation and Electromagnetic Therapy for Treating Wounds
Electrostimulation and Electromagnetic Therapy for the Treatment of Chronic Wounds
Diapulse
Electrical Stimulation for Wound Healing
Electromagnetic Stimulation for Wound Healing
Ulcer Healing, Electrical Stimulation
Wound Healing, Electrical Stimulation
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. 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
3. 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
4. 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. May 2010;91(5):669-678. PMID 20434602
5. 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
6. Lala D, Spaulding SJ, Burke SM, et al. Electrical stimulation therapy for the treatment of pressure ulcers in individuals with spinal cord injury: a systematic review and meta-analysis. Int Wound J. Dec 2016;13(6):1214-1226. PMID 25869151
7. 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. Nov 2014;37(6):703-718. PMID 24969965
8. Thakral G, La Fontaine J, Kim P, et al. Treatment options for venous leg ulcers: effectiveness of vascular surgery, bioengineered tissue, and electrical stimulation. Adv Skin Wound Care. Apr 2015;28(4):164-172. PMID 25775200
9. Khouri C, Kotzki S, Roustit M, et al. Hierarchical evaluation of electrical stimulation protocols for chronic wound healing: An effect size meta-analysis. Wound Repair Regen. Oct 20 2017. PMID 29052946
10. Polak A, Kloth LC, Blaszczak E, et al. The Efficacy of Pressure Ulcer Treatment With Cathodal and Cathodal-Anodal High-Voltage Monophasic Pulsed Current: A Prospective, Randomized, Controlled Clinical Trial. Phys Ther. Aug 1 2017;97(8):777-789. PMID 28789467
11. Aziz Z, Flemming K. Electromagnetic therapy for treating pressure ulcers. Cochrane Database Syst Rev. Dec 12 2012;12:CD002930. PMID 23235593
12. Aziz Z, Cullum N. Electromagnetic therapy for treating venous leg ulcers. Cochrane Database Syst Rev. Jul 2 2015;7:CD002933. PMID 26134172
13. Khooshideh M, Latifi Rostami SS, Sheikh M, et al. Pulsed electromagnetic fields for postsurgical pain management in women undergoing cesarean section: a randomized, double-blind, placebo-controlled trial. Clin J Pain. Feb 2017;33(2):142-147. PMID 28060214
14. Qaseem A, Humphrey LL, Forciea MA, et al. Treatment of pressure ulcers: a clinical practice guideline from the American College of Physicians. Ann Intern Med. Mar 3 2015;162(5):370-379. PMID 25732279
15. Bolton LL, Girolami S, Corbett L, et al. The Association for the Advancement of Wound Care (AAWC) venous and pressure ulcer guidelines. Ostomy Wound Manage. Nov 2014;60(11):24-66. PMID 25380098
16. Association for the Advancement of Wound Care (AAWC). Association for the Advancement of Wound Care guideline of pressure ulcer guidelines. Malvern, PA: AAWC; 2010.
17. Wound Ostomy and Continence Nurses Society (WOCN). Guideline for prevention and management of pressure ulcers (injuries). 2016; https://www.guideline.gov/summaries/summary/50473. Accessed January 3, 2018.
18. Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Electrical Stimulation (ES) and Electromagnetic Therapy for the Treatment of Wounds (270.1). 2004; https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?ncdid=131&ver=3. Accessed January 3, 2018.
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
E0761
E0769
G0281
G0282
G0295
G0329
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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