Clinical UM Guideline
|Subject:||Neuromuscular Stimulation in the Treatment of Muscle Atrophy|
|Guideline #:||CG-DME-03||Current Effective Date:||10/06/2015|
|Status:||Revised||Last Review Date:||08/06/2015|
This document addresses the use of neuromuscular stimulation (also known as neuromuscular electrical stimulation or NMES), which is the application of electrical stimulation for the treatment of muscular atrophy when the nerve supply to the muscle is intact. This document does not address functional electrical stimulation (FES) or transcutaneous or percutaneous electrical nerve stimulation (TENS, PENS). NMES differs from TENS, PENS and FES, in that NMES stimulation is directed to the motor nerves, TENS/PENS is directed to the sensory nerves and FES is for use in neurologically impaired individuals.
Note: Please see the following related document(s) for additional information:
FDA approved neuromuscular stimulator devices are considered medically necessary when prescribed for any of the following indications when muscular atrophy is present in the setting of an intact nerve supply to the muscle, including brain, spinal cord and peripheral nerves:
Not Medically Necessary:
Neuromuscular stimulation is considered not medically necessary when the above criteria are not met and for all other indications, including but not limited to:
The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
|E0731||Form-fitting conductive garment for delivery of TENS or NMES (with conductive fibers separated from the patient's skin by layers of fabric) [when specified as NMES garment]|
|E0745||Neuromuscular stimulator, electronic shock unit|
|ICD-10 Diagnosis||[For dates of service on or after 10/01/2015]|
|ICD-9 Diagnosis||[For dates of service prior to 10/01/2015]|
When subjected to insufficient use or exercise, muscles atrophy, resulting in a loss of strength and mass. Muscle atrophy may also occur when the limbs are immobilized after injury or surgery. NMES stimulates the motor nerves with electrical currents, which generate muscle contractions to reverse muscle atrophy. When nerve innervation is intact, NMES promotes re-innervation and slows the development of disuse atrophy, relaxes muscle spasms, and increases voluntary muscle control. The intensity and frequency of stimulation can vary based on the level of muscular function and treatment response.
Monaghan and colleagues (2010) conducted a review of the available literature to assess the effectiveness of NMES as a means of improving quadriceps strength before and after total knee replacement. Two studies comparing NMES and exercise, and exercise alone pre- and post-op, were identified and included in the review. These two studies reported no significant differences between the NMES and control groups for maximum voluntary isometric torque or endurance. In one study, there was significantly better quadriceps activation in the exercise and neuromuscular stimulation group compared with the exercise group alone. This difference was statistically significant at 6 weeks of follow-up, but not at 12 weeks. Raw data scores were not reported by study authors and hence, further analysis of both studies was not possible. Both studies were characterized by several weaknesses, which conferred a high degree of bias. The authors concluded that the available studies for this review preclude any conclusions for the clinical efficacy and safety of NMES for quadriceps strengthening pre- and post-op total knee replacement.
Stevens-Lapsley and colleagues (2012) published results from a small clinical trial studying initiation of quadriceps NMES, as an adjunct to standard rehabilitation, with outcomes assessed 48 hours after total knee replacement. A total of 66 subjects were randomly assigned to the control group (standard rehabilitation) or the treatment group (standard rehabilitation plus quadriceps NMES). Muscle strength, functional performance, and self-report measures were collected pre- and post-surgery and at 3.5, 6.5, 13, 26 and 52 weeks after total knee replacement. Significant improvements in the NMES group were seen post-op at 3.5 weeks for quadriceps and hamstring muscle strength, functional performance, knee extension, and active range of motion. At 52 weeks, the statistically significant differences between groups for most outcome measures were no longer observed, but improvements with NMES were still significant for quadriceps and hamstring muscle strength, functional performance, and some self-report measures. The authors concluded that early administration of NMES effectively reduced the loss of quadriceps strength and improved functional performance following total knee replacement. The effects were most pronounced and clinically meaningful within the first month after surgery, but persisted through 1 year after surgery. The authors acknowledged a few study limitations; treatment volume was not matched for both study arms and NMES was added to the standard of care treatment, which does not allow the evaluation of the efficacy of NMES alone. Also, testers were not blinded during testing. The authors also stated that further research evaluating early intervention after total knee replacement is warranted.
Broderick and colleagues (2010) studied the impact of bedrest on decreased circulation. They proposed that lack of activation of the calf muscle pump during this resting period leads to venous stasis, which may result in deep vein thrombosis (DVT). A pilot study was conducted to investigate the effects of 4 hours of bed rest on lower limb hemodynamics of healthy subjects. Researchers also investigated the effects of electrically elicited contractions of the calf muscles on bed rest. Outcome measurements included popliteal vein blood flow and heart rate in two groups; one without stimulation and one with stimulation. The resting group without stimulation experienced a significant decline in popliteal venous blood flow of approximately 47% and an approximate13% decrease in heart rate. The stimulated group maintained a significantly higher venous blood flow and heart rate. The authors proposed that electrically elicited calf muscle contractions significantly improve lower limb blood flow and can alleviate some debilitating effects of bed rest. Further randomized studies are needed to substantiate this pilot study.
A systematic review investigated the effect of NMES on muscle wasting in critically ill individuals that had limited physical activity (Williams, 2014). A total of 8 studies were chosen for inclusion. The methodologic heterogeneity was too great for quantitative analysis so alternatively, a qualitative narrative was presented. Although no adverse effects of NMES were identified and some potential benefits were seen, such as preservation of muscle strength and shorter intensive care unit (ICU) lengths of stay, authors concluded that, "Evidence of the clinical benefits of NMES in the ICU is inconclusive and provides minimal guidance for use in clinical practice. There is a need for further research in this area."
In 2014, McAlindon and colleagues published guidelines by the Osteoarthritis Research Society International (OARSI) on the non-surgical management of knee osteoarthritis. The guideline recommendations were based on meta-analyses, systematic reviews and randomized controlled trials published through 2013. Interventions were ranked according to the RAND/UCLA Appropriateness Method. Based on evidence-based consensus, recommendations were provided for categorizing 29 interventions into one of four categories; (1) appropriate, (2) appropriate for specific subpopulations; (3) uncertain appropriateness, or (4) not appropriate. NMES was considered by expert consensus to be an inappropriate treatment modality for osteoarthritis of the knee.
Lin and colleagues (2011) investigated the long-term efficacy of NMES to enable motor recovery in the upper extremities of post-stroke individuals. A total of 46 subjects were randomized into a NMES treatment group or a control group. All subjects participated in a standard rehabilitation program. Those in the NMES group received NMES for 30 minutes, 5 days a week, for 3 weeks. Measurements were recorded before treatment, at the second and third week of treatment, and 1, 3 and 6 months after treatment ended. The Modified Ashworth Scale (MAS) for spasticity, the upper extremity section of the Fugl-Meyer motor assessment, and the Modified Barthel Index (MBI) were used to assess the results. Significant improvements were found in both groups and persisted 1 month after treatment had been discontinued. At 3 and 6 months after treatment was discontinued, the average scores in the NMES group were significantly better than those in the control group. The authors acknowledged several limitations of the study, including its small size and lack of a blinded sham group. They concluded that additional studies, using similar stimulation protocols with a larger sample, are needed to assess the value of NMES to restore functionality after stroke.
Malhotra and colleagues (2013) conducted a single-blind, randomized controlled trial (RCT) to assess the treatment effects of surface NMES on wrist pain, spasticity, and contractures in individuals with no functional use of their arms following stroke. A total of 90 subjects were randomized to either the treatment group (30 minutes of surface NMES to the wrist and finger extensors and 45 minutes of physiotherapy) or the control group (45 minutes of physiotherapy alone). Treatment duration was 6 weeks. Although the treatment appeared to prevent pain and deterioration of contractures, there were no statistically significant improvements in stiffness and spasticity. Statistical analyses of the differences between the treatment and control groups suggest that the prevention of pain and contractures may not have been clinically meaningful. Other limitations include lack of patient-relevant outcome measures to assess the degree of change in functional use of participant's arms and lack of follow-up.
Maddocks and colleagues (2013) reported on 11 studies involving a total of 218 participants with chronic obstructive pulmonary disease (COPD), chronic heart failure, and thoracic cancer. The primary outcome measure was evaluating the effectiveness of NMES for improving muscle strength, and secondary measures included the safety of NMES, muscle mass, exercise capacity, breathlessness, and health-related quality of life (HR-QOL). The authors concluded that NMES appears to improve leg muscle strength, and the ability to exercise; however, these results need to be confirmed in larger clinical trials. A meta-analysis conducted by Pan and colleagues (2014) analyzed results of 8 randomized clinical trials including 156 individuals with COPD who underwent NMES to improve quadriceps strength. Study investigators found that NMES was not associated with an improvement in muscle strength, walking distance, or muscle fiber characteristics. Authors conclude that evidence to support the use of NMES as an intervention to improve muscle strength in individuals is currently inadequate.
Ongoing clinical trials for NMES identified in the ClinicalTrials.gov database are currently in progress for other indications including muscle strengthening for cerebral palsy, muscular sclerosis, rheumatoid arthritis, and post-op total hip replacement.
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
|Revised||08/06/2015||Medical Policy & Technology Assessment Committee (MPTAC) review. Clarified criteria, updated Description, Discussion/General Information and Reference sections.|
|Reviewed||08/14/2014||MPTAC review. Updated Description, Discussion/General Information, and Reference sections.|
|Reviewed||08/08/2013||MPTAC review. Updated Discussion/General Information and References.|
|Reviewed||08/09/2012||MPTAC review. Discussion/General Information and References updated.|
|Reviewed||08/18/2011||MPTAC review. Coding, Discussion/General Information and References updated.|
|Reviewed||08/19/2010||MPTAC review. Place of Service deleted. Background and References updated.|
|Reviewed||08/27/2009||MPTAC review. References updated.|
|Reviewed||08/28/2008||MPTAC review. References updated.|
|Reviewed||08/23/2007||MPTAC review. References updated.|
|Revised||09/14/2006||MPTAC review. Revision addressed use of neuromuscular stimulation garment. References updated.|
|Reviewed||06/08/2006||MPTAC review. References and coding updated.|
|11/22/2005||Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).|
|Revised||07/14/2005||MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.|
|Pre-Merger Organizations||Last Review Date||Document Number||Title|
|WellPoint Health Networks, Inc.||06/24/2004||None||Neuromuscular Stimulation in the Treatment of Muscle Atrophy|