Coverage Policy Manual - Arkansas Blue Cross and Blue Shield

Coverage Policy Manual
Policy #:	2019007
Category:	Medicine
Initiated:	September 2019
Last Review:	July 2023

Electrical Stimulation, Advanced Transcutaneous Electrical Stimulation (Interferential Current Stimulation, Electrical Stimulation Treatment, Combined Electrical Stimulation Treatment, H-Wave Electrical Stimulation )

Description:

Interferential stimulation (IFS) is a type of electrical stimulation. It is believed that IFS permeates the tissues more effectively and thus is more comfortable than transcutaneous electrical nerve stimulation (TENS). Interferential stimulation has been investigated as a technique to reduce pain, but has also been proposed to increase function of patients with osteoarthritis and to treat other conditions such as dyspepsia, irritable bowel syndrome, and constipation.

Interferential stimulation (IFS) is a type of electrical stimulation that uses paired electrodes of 2 independent circuits carrying high-frequency (4,000 Hz) and medium-frequency (150 Hz) alternating currents. The superficial electrodes are aligned on the skin around the affected area. It is believed that IFS permeates the tissues more effectively and, with less unwanted stimulation of cutaneous nerves, is more comfortable than transcutaneous electrical stimulation (TENS). Interferential stimulation has been investigated as a technique to reduce pain, improve range of motion, treat a variety of gastrointestinal disorders. There are no standardized protocols for the use of interferential therapy; the therapy may vary according to the frequency of stimulation, the pulse duration, treatment time, and electrode-placement technique.

Electronic signal treatment (EST) is an advanced electrical stimulation treatment that delivers electronic signal energy waves produced by an ultra-high digital frequency generator (UHdfg) called the Sanexas.

Combined electrochemical therapy (CET) is a combination of a nerve block injection (with lidocaine & vitamins) with electronic signal treatment used to treat pain and neuropathy.

H-wave stimulation is a form of advanced transcutaneous electrical stimulation that uses a H-waves.

Regulatory Status

A number of IFS devices have been cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process, including the Medstar™ 100 (MedNet Services) and the RS-4i® (RS Medical). IFS may be included in multimodal electrotherapy devices such as transcutaneous electrical nerve stimulation and functional electrostimulation.

Coding

There are specific CPT/HCPCS codes for electrical and interferential current stimulation. There are no specific CPT/HCPCS codes for advanced electrical stimulation or combined electrochemical therapy. The following CPT codes may be used:

S8130 Interferential current stimulator, 2 channel

S8131 Interferential current stimulator, 4 channel

97039 Unlisted modality (specify type and time if constant attendance)

97139 Unlisted therapeutic procedure (specify)

99199 Unlisted special service, procedure or report

64999 Unlisted procedure, nervous system

Policy/
Coverage:

EFFECTIVE JANUARY 01, 2021

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Interferential current stimulation does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.

For members with contracts without primary coverage criteria, interferential current stimulation is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Electronic signal treatment (EST) as a monotherapy or in combination with nerve block injections does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.

For members with contracts without primary coverage criteria, electronic signal treatment (EST) as a monotherapy or in combination with nerve block injections is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

H-Wave electrical stimulation does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for all indications including but not limited to pain management, wound healing, or improvement of circulation and musculoskeletal function.

For members with contracts without primary coverage criteria, H-Wave electrical stimulation is considered investigational for all indications including but not limited to pain management, wound healing, or improvement of circulation and musculoskeletal function.

Effective Prior to JANUARY 01, 2021

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Interferential current stimulation does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.

Rationale:

Musculoskeletal Conditions

A network meta-analysis by Zeng et al identified 27 RCTs on 5 types of electrical stimulation therapies used to treat pain in patients with knee osteoarthritis (OA) (Zeng, 2015). Reviewers found that IFS was significantly more effective than control interventions for pain relief (standardized mean difference, 2.06; 95% credible interval, 1.10 to 3.19) and pain intensity (standard mean difference, -0.92; 95% credible interval, -1.72 to -0.05). The validity of these conclusions is uncertain due to the limitations of the network meta-analysis, which used indirect comparisons to make conclusions. A further limitation is that the findings of placebo-controlled studies were not reported separately; rather, they were pooled in the analysis of usual care comparators.

Fuentes et al published a systematic review and meta-analysis of RCTs evaluating the effectiveness of IFS for treating musculoskeletal pain (Fuentes, 2010).Twenty RCTs met the following inclusion criteria: adults diagnosed with a painful musculoskeletal condition (eg, knee, back, joint, shoulder, or OA pain); compared IFS alone or as a co-intervention with placebo, no treatment, or an alternative intervention; and assessed pain using a numeric rating scale. Fourteen of the trials reported data that could be pooled. IFS as a stand-alone intervention was not found to be more effective than placebo or an alternative intervention at reducing pain. For example, a pooled analysis of 2 studies comparing IFS alone with placebo did not find a statistically significant difference in pain intensity at discharge; the pooled mean difference (MD) was 1.17 (95% confidence interval [CI], -1.70 to 4.05). Also, a pooled analysis of 2 studies comparing IFS alone with an alternative intervention (eg, traction or massage) did not find a significant difference in pain intensity at discharge; the pooled MD was -0.16 (95% CI, -0.62 to 0.31). Moreover, in a pooled analysis of 5 studies comparing IFS as a co-intervention with a placebo, there was a nonsignificant finding in pain intensity at discharge (MD=1.60; 95% CI, -0.13 to 3.34; p=0.07). The meta-analysis found IFS plus another intervention to be superior to a control group (eg, no treatment) for pain intensity at day 1 and 4 weeks; a pooled analysis of 3 studies found an MD of 2.45 (95% CI, 1.69 to 3.22; p<0.001). However, that analysis did not distinguish the specific effects of IFS from the co-intervention nor did it control for potential placebo effects.

Two placebo-controlled randomized trials were included in the Fuentes et al (2010) meta-analysis, one of which was also included in the Zeng et al meta-analysis. The Defrin et al trial included 62 patients with OA knee pain (Defrin, 2005). Patients were randomized to one of six groups (four active treatment groups and two control groups, sham and non-treated). Acute pre- vs posttreatment reductions in pain were found for all active groups but neither control group. Stimulation resulted in a modest pretreatment elevation of pain threshold over this four-week trial. Taylor et al randomized 40 patients with a temporomandibular joint syndrome or myofascial pain syndrome to active or placebo IFS (Taylor, 1987). Principal outcomes were pain assessed by a questionnaire and range of motion. There were no statistically significant differences in the outcomes between groups.

Two other RCTs, both published in 2012, were included in the Zeng et al meta-analysis. One found significantly better outcomes with IFS vs placebo while the other did not find significant differences between active and sham interventions. Atamaz et al compared IFS, transcutaneous electrical nerve stimulation, shortwave diathermy, and sham interventions for treating knee OA (Atamaz, 2012). A total of 203 patients were randomized to 1 of 6 groups, 3 with active treatment and 3 with sham treatment. The primary outcome was knee pain as assessed on a visual analog scale (VAS; range, 0-100). Other outcomes included range of motion, time to walk 15 meters, paracetamol intake, the Nottingham Health Profile score, and the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) score. At the 1-, 3-, and 6-month follow-ups, there were no statistically significant differences across the six groups in VAS pain scores, Nottingham Health Profile pain scores, or WOMAC pain scores. Moreover, WOMAC function scores, time to walk 15 meters, and Nottingham Health Profile physical mobility scores did not differ significantly among groups at any follow-up assessments. At the one-month follow-up, paracetamol intake was significantly lower in the IFS group than in the transcutaneous electrical nerve stimulation group.

Gundog et al randomized 60 patients with knee OA to 1 of 4 groups: 3 IFS groups at frequencies of 40 Hz, 100 Hz, and 180 Hz, and sham IFS (Gundog, 2012). The primary outcome was pain intensity assessed by the WOMAC. Mean WOMAC scores 1 month after treatment were 7.2 in the 40-Hz group, 6.7 in the 100-Hz group, 7.8 in the 180-Hz group, and 16.1 in the sham IFS group (p<0.05 vs active treatment groups). Secondary outcomes (eg, VAS score) also showed significantly higher benefit in the active treatment groups compared with the sham IFS group. The number of patients assigned to each group and patient follow-up rates was not reported.

In addition to the placebo-controlled trials, several RCTs have compared IFS with another active intervention or with usual care. However, studies with active comparators, as well as those with usual care control groups, may be subject to the placebo effect. Receiving an older or known, rather than a novel, intervention, may elicit a placebo response.

Placebo-controlled randomized trials of IFS for treating musculoskeletal pain and impaired function have mostly found that IFS does not significantly improve outcomes. A meta-analysis limited to placebo-controlled trials also did not find a significant benefit of IFS for treating pain and function. RCTs with usual care or active treatment comparisons may be subject to the placebo effect.

Gastrointestinal Disorders

Constipation

Several RCTs evaluating IFS for treating children with constipation and/or other lower gastrointestinal symptoms were identified. The RCTs had small sample sizes and did not consistently find a benefit of IFS. For example, Kajbafzadeh et al in Iran randomized 30 children with intractable constipation to IFS or sham stimulation (Kajbafzadeh, 2012). Children ranged in age from 3 to 12 years old and had failed 6 months of conventional therapy (eg, dietary changes, laxatives). Patients received 15, IFS sessions (20 minutes long), 3 times a week for 5 weeks. Over six months, the mean frequency of defecation increased from 2.5 times a week to 4.7 times a week in the treatment group and from 2.8 times a week to 2.9 times a week in the control group. The mean pain during defecation score decreased from 0.35 to 0.20 in the treatment group and from 0.29 to 0.22 in the control group. The authors reported a statistically significant between-group difference in constipation symptoms.

Another RCT, published by Clarke et al, was conducted in Australia (Clarke, 2009). Thirty-three children with slow transit time constipation (mean age, 12 years) were randomized to IFS or sham treatment. They received 12, 20-minute sessions over 4 weeks; the primary outcome was health-related QOL, and the main assessment instrument used was the Pediatric Quality of Life Inventory. The authors only reported within-group changes; they did not compare the treatment and control groups. There was no statistically significant change in QOL, as perceived by the parent group. The mean parent-reported QOL scores changed from 70.3 to 70.1 in the active treatment group and from 69.8 to 70.2 in the control group. There was also no significant difference in QOL, as perceived by the child after sham treatment. The Pediatric Quality of Life Inventory score, as perceived by the child, did increase significantly in the active treatment group (mean, 72.9 pretreatment vs 81.1 posttreatment, p=0.005).

Irritable Bowel Disease

An RCT by Coban et al randomized 67 adults with irritable bowel syndrome to active or placebo IFS (Coban, 2012). Patients with functional dyspepsia were excluded. Patients received 4, 15-minute IFS sessions over 4 weeks. Fifty-eight (87%) of 67 patients completed the trial. One month after treatment, primary outcome measures did not differ significantly between treatment and control groups. For example, for abdominal discomfort, the response rate (ie, >50% improvement) was 68% in the treatment group and 44% in the control group. For bloating and discomfort, the response rate was 48% in the treatment group and 46% in the placebo group. Using a VAS, 72% of the treatment group and 69% of the control group reported improvement in abdominal discomfort.

Dyspepsia

One RCT, by Koklu et al in Turkey, has evaluated IFS for treating dyspepsia (Koklu, 2010). The trial randomized adults to active IFS (n=25) or sham treatment (n=25); patients were unaware of their treatment allocation. Patients received 12 treatment sessions over 4 weeks; each session lasted 15 minutes. Forty-four (88%) of 50 randomized patients completed the therapy session and follow-up questionnaires at 2 and 4 weeks. The trialists did not specify primary outcome variables; rather, they measured the frequency of ten gastrointestinal symptoms. In an intention-to-treat analysis at four weeks, IFS was superior to placebo for the symptoms of early satiation and heartburn, but not for the other eight symptoms. For example, before treatment, 16 (64%) of 25 patients in each group reported experiencing heartburn. At 4 weeks, 9 (36%) patients in the treatment group and 13 (52%) patients in the sham group reported heartburn (p=0.02). Among symptoms that did not differ between groups at follow-up, 24 (96%) of 25 patients in each group reported epigastric discomfort before treatment. In the intention-to-treat analysis, 5 (20%) of 25 patients in the treatment group and 6 (24%) of 25 patients in the placebo group reported epigastric discomfort.

IFS has been tested as a treatment option for a variety of gastrointestinal conditions, with a small number of trials completed for each condition. Trial results were mixed, with some reporting benefit and others not. This body of evidence is inconclusive on whether IFS is an efficacious treatment for gastrointestinal conditions.

Poststroke Spasticity

In 2014, Suh et al published a single-blind RCT evaluating IFS as a treatment of chronic stroke (Suh, 2014). Forty-two inpatient stroke patients with plantar-flexor spasticity were randomized to a single 60-minute session with IFS or placebo IFS treatment following 30 minutes of standard rehabilitation. In the placebo treatment, electrodes were attached; however, the current was not applied. Outcomes were measured immediately before and one hour after the intervention. The primary outcomes were gastrocnemius spasticity (measured on a 0 to 5 Modified Ashworth Scale) and two balance-related measures: the Functional Reach Test and the Berg Balance Scale. Also, gait speed was measured using a 10-meter walk test, and gait function was assessed with the Timed Up & Go Test. The IFS group performed significantly better than the placebo group on all outcomes (p<0.05 for each comparison). For example, the mean (standard deviation) difference in Modified Ashworth Scale score was 1.55 (0.76) in the IFS group and 0.40 (0.50) in the placebo group. A major limitation of the trial was that outcomes were only measured one hour after the intervention and no data were available on longer-term impacts of the intervention.

Data from a small RCT with very short follow-up provides insufficient evidence on the impact of IFS on health outcomes in patients with post-stroke spasticity.

For individuals who have musculoskeletal conditions who receive IFS, the evidence includes RCTs and meta-analyses. The relevant outcomes are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. Placebo-controlled randomized trial(s) have found that IFS when used to treat musculoskeletal pain and impaired function(s), does not significantly improve outcomes; additionally, a meta-analysis of placebo-controlled trials did not find a significant benefit of IFS for decreasing pain or improving function. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have gastrointestinal disorders who receive IFS, the evidence includes RCTs. The relevant outcomes are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. IFS has been tested for a variety of gastrointestinal conditions, with a small number of trials completed for each condition. The results of the trials are mixed, with some reporting benefit and others not. This body of evidence is inconclusive on whether IFS is an efficacious treatment for gastrointestinal conditions. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have poststroke spasticity who receive IFS, the evidence includes an RCT. The relevant outcomes are symptoms, functional outcomes, QOL, and treatment-related morbidity. The RCT had a small sample size and very short follow-up (immediately posttreatment). The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

American College of Physicians and the American Pain Society

Clinical practice guidelines from the American College of Physicians and the American Pain Society (2009) concluded that there was insufficient evidence to recommend interferential current stimulation (IFS) for the treatment of low back pain (Chou, 2009),

American College of Occupational and Environmental Medicine

The American College of Occupational and Environmental Medicine published several relevant guidelines. For shoulder disorders, guidelines found the evidence on IFS to be insufficient and, depending on the specific disorder, either did not recommend IFS or were neutral on whether to recommend it (ACCEM, 2011). For low back disorders, guidelines found the evidence on IFS to be insufficient and did not recommend it. The sole exception was that IFS could be considered as an option on a limited basis for acute low back pain with or without radicular pain (ACCEM, 2016). For knee disorders, guidelines recommended IFS for postoperative anterior cruciate ligament reconstruction, meniscectomy, and knee chondroplasty immediately postoperatively in the elderly (ACCEM, 2011). This was a level C recommendation.

2020 Update

Annual policy review completed with a literature search using the MEDLINE database through August 2020. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.

A more recent systematic review and meta-analysis by Ferreira et al evaluated non-surgical and non-pharmacological interventions for knee osteoarthritis (Ferreira, 2019). However, as it only evaluated 1 RCT on IFS, it did not add new information to the network meta-analysis by Zeng et al (2015) discussed previously in the rationale.

The National Institute of Health and Care Excellence (NICE) published an evidence review on non-invasive treatments for low back pain (NICE, 2016). This review included 4 non-US RCTs published between 1999 and 2014 that compared IFC to sham (n=117), usual care (n=60), or manual therapies (n=387). NICE reported that compared to sham or traction, IFC did not demonstrate a clinically important improvement in pain. No studies evaluated impact on quality of life, nor did any studies include people with sciatica. NICE concluded that evidence does not support IFC for low back pain.

To evaluate IFS after arthroscopic knee surgery, Kadi et al conducted a double blind, placebo controlled RCT in 98 individuals (Kadi, 2019). IFS or sham treatment (pads applied with no current) was delivered for 30 minutes, twice a day for 5 days postoperatively. Although IFS significantly reduced the amount of paracetamol used by day 5, no significant difference was found between the groups with respect to pain, range of motion, or edema at days 0 through 30.

A systematic review of neuromodulation approaches for constipation and fecal incontinence in children by Iacona et al included 2 of the RCTs, as well as 1 prospective study, and 2 pilot studies (N=126) (Iacona, 2019). Study follow-up times ranged from 1 to 6 months. Systematic review authors reported that all of the studies reported an improvement in symptoms reported including defecation frequency, soiling episodes, and abdominal pain. This systematic review included the RCT by Kajbafzadeh et al discussed previously in the rationale. Overall, the systematic review authors concluded additional evidence including longer length of follow-up is needed to consider neuromodulation as an established therapy for the management of constipation and fecal incontinence.

In adults, 1 small, single-blind, sham-controlled RCT conducted in Australia was identified (Moore, 2020). Thirty-three women (mean age, 45 years) with functional constipation were randomized to IFS (N=17) or sham treatment (N=16). The IFS was self-delivered by the participants in their homes for 1 hour per day for 6 weeks. The participants were trained by an unblinded study coordinator in the placement of the 4 electrodes as either crossed for active IFS or uncrossed for sham IFS. The primary outcome was the number of patients with ≥3 spontaneous bowel movements per week. Although active IFS significantly increase the primary outcome (53% versus 12%; P=.02), there were no between-group differences on numerous other secondary outcomes, such as quality of life and the more clinically meaningful and guideline-recommended outcome of spontaneous complete bowel movement.

Additionally, an RCT comparing IFS (n=20) to electrical acupuncture (EAC) (n=20) in individuals with hemiplegic shoulder pain after stroke was published by Eslamian et al (Eslamian, 2020). The interventions were added to standard care and delivered twice a week for a total of 10 sessions. The primary outcome was reduction in pain intensity at 5-weeks compared to baseline as measured using a 10 cm Visual Analogue Scale (VASs). Results were mixed across outcomes. For example, rates of clinically significant improvement of at least 13 on the Shoulder Pain and Disability Index (SPADI) questionnaire were similar between groups (75% versus 65%). However, rate of clinically significant improvement in pain intensity (defined as 1.4 points on the VAS at 5-weeks) was lower in the IFS group (35.0% versus 70.0%). Additionally, this study has several limitations, including lack of sham control group, very small sample size, short follow-up interval.

An update of the clinical practice guidelines by the American College of Physicians confirmed the 2009 findings that there was insufficient evidence to determine the effectiveness of interferential current stimulation (IFS) for the treatment of low back pain (Qaseem, 2017).

In 2016, the National Institute for Health and Care Excellence had a guideline (NG59) on assessment and management of low back pain and sciatica in people aged 16 and over (Nice, 2016). The guideline states “Do not offer interferential therapy for managing low back pain with or without sciatica”.

2021 Update

Annual policy review completed with a literature search using the MEDLINE database through August 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.

Alqualo Costa et al conducted a placebo-controlled RCT of ICS and photobiomodulation in 168 adults with knee osteoarthritis (Alqualo-Costa, 2021). Participants were randomized to one of 4 groups: active IFS plus placebo phobiomodulation, placebo IFS plus active photobiomodulation, active IFS plus active photobiomodulation, and placebo IFS plus placebo photobiomodulation. Patients received treatments 3 times a week for 4 weeks, totaling 12 sessions. Both patients and outcome assessors were blinded to treatment allocation. The combination of active IFS plus active photobiomodulation significantly reduced pain intensity at rest and during movement compared to the IFS alone and placebo groups. Similar improvements were not shown in the group that received IFS alone. This study was limited by its small sample size and multiple statistical comparisons.

In addition to placebo-controlled trials, several RCTs have compared IFS with another active intervention or with usual care (Dissanayaka, 2016; Koca, 2014; Lara-Palomo, 2013; Facci, 2011; Albornoz-Cabello, 2017; Albornoz-Cabello, 2019; Albornoz-Cabello, 2021). However, studies with active comparators, as well as those with usual care control groups, may be subject to the placebo effect. Receiving an older or known, rather than a novel, intervention, may elicit a placebo response.

The American College of Occupational and Environmental Medicine published several relevant guidelines. For low back disorders, guidelines found the evidence on IFS to be insufficient and did not recommend it (Hegmann, 2020).

2022 Update

Annual policy review completed with a literature search using the MEDLINE database through June 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.

Hussein et al included 19 trials in a meta-analysis of patients (N=1167) with musculoskeletal pain (Hussein, 2021). Two trials compared IFS with placebo and the pooled mean difference in pain was significantly reduced with IFS versus placebo (-0.98; 95% confidence interval [CI], -1.42 to -0.54; p<.0001), but not in the 6 trials comparing IFS to other interventions (-0.04; 95% CI, -0.20 to 0.12; p<.65). When used as an adjunct to other pain interventions, IFS did not significantly improve pain compared with placebo in 4 studies (-0.06; 95% CI, -0.6 to 0.48; p=.82) or compared with active treatment in 8 studies (0.02; 95% CI, -0.88 to 0.92; p=not reported). The authors concluded that IFS reduced musculoskeletal pain when used as a single agent compared with placebo, but this is limited by the small number of trials (n=2) and patients enrolled (n=91) in these trials.

2023 Update

Annual policy review completed with a literature search using the MEDLINE database through June 2023. No new literature was identified that would prompt a change in the coverage statement.

CPT/HCPCS:

References:

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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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