Medical Policies - Medicine


Functional Neuromuscular Electrical Stimulation (FNMES)

Number:MED201.033

Effective Date:07-15-2018

Coverage:

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Functional neuromuscular electrical stimulation (FNMES) is considered experimental, investigational and/or unproven as a technique to restore function following nerve damage or nerve injury. This includes, but is not limited to, its use in the following situations:

To provide upper extremity function in patients with nerve damage (e.g., spinal cord injury or post-stroke); or

To improve ambulation in patients with footdrop caused by congenital disorders (e.g., cerebral palsy) or nerve damage (e.g., poststroke, or in those with multiple sclerosis); or

As a technique to provide ambulation in patients with spinal cord injury.

Description:

Functional neuromuscular electrical stimulation (FNMES) involves the use of an orthotic device with microprocessor-controlled electrical muscular stimulation. These devices are being developed to restore function to patients with damaged or destroyed nerve pathways (e.g., spinal cord injury [SCI], stroke, multiple sclerosis, cerebral palsy).

Background

Functional neuromuscular electrical stimulation (NMES) is an approach to rehabilitation that applies low-level electrical current to stimulate functional movements in muscles affected by nerve damage. It focuses on the restoration of useful movements, like standing, stepping, pedaling for exercise, reaching, or grasping.

Functional NMES devices consist of an orthotic and a microprocessor-based electronic stimulator with one or more channels for delivery of individual pulses through surface or implanted electrodes connected to the neuromuscular system. Microprocessor programs activate the channels sequentially or in unison to stimulate peripheral nerves and trigger muscle contractions to produce functionally useful movements that allow patients to sit, stand, walk, and grasp. Functional neuromuscular stimulators are closed-loop systems that provide feedback information on muscle force and joint position, thus allowing constant modification of stimulation parameters, which are required for complex activities (e.g., walking). These systems are contrasted with open-loop systems, which are used for simple tasks (e.g., muscle strengthening alone); healthy individuals with intact neural control benefit the most from this technology.

Applications

Upper-Extremity Function After Spinal Cord Injury and Stroke

One application of FNMES is to restore upper extremity functions such as grasp-release, forearm pronation, and elbow extension in patients with stroke, or C5 and C6 tetraplegia (quadriplegia). The NeuroControl Corp. developed the Freehand® system, an implantable upper extremity neuroprosthesis to improve a patient's ability to grasp, hold, and release objects for patients with tetraplegia due to C5 or C6 spinal cord injury (SCI). NeuroControl is no longer in business, but FNMES centers in the United States and the United Kingdom provide maintenance for implanted devices. The NESS H200® (previously known as the Handmaster NMS I system) is an upper extremity device that uses a forearm splint and surface electrodes. The device, controlled by a user-activated button, is intended to provide hand function (fine finger grasping, larger palmar grasping) for patients with C5 tetraplegia or stroke.

Footdrop

Other FNMES devices have been developed to provide FNMES in patients with footdrop. Footdrop is weakness of the foot and ankle that causes reduced dorsiflexion and difficulty with ambulation. It can have various causes such as cerebral palsy, stroke or multiple sclerosis (MS). Functional electrical stimulation of the peroneal nerve has been suggested for these patients as an aid in raising the toes during the swing phase of ambulation. With these devices, a pressure sensor detects heel off and initial contact during walking. A signal is then sent to the stimulation cuff, initiating or pausing the stimulation of the peroneal nerve, which activates the foot dorsiflexors. Examples of such devices used for treatment of footdrop are the Innovative Neurotronics’ WalkAide®, Bioness’ radiofrequency controlled NESS L300™, Otto Bock’s MyGait and the OFDS®. An implantable peroneal nerve stimulator system (ActiGait®) is being developed in Europe.

Ambulation After SCI

Another application of functional electrical stimulation is to provide patients with SCI the ability to stand and walk. Generally, only SCI patients with lesions from T4 to T12 are considered candidates for ambulation systems. Lesions at T1 to T3 are associated with poor trunk stability, while lumbar lesions imply lower-extremity nerve damage. Using percutaneous stimulation, the device delivers trains of electrical pulses to trigger action potentials at selected nerves at the quadriceps (for knee extension), the common peroneal nerve (for hip flexion), and the paraspinals and gluteals (for trunk stability). Patients use a walker or elbow-support crutches for further support. The electrical impulses are controlled by a computer microchip attached to the patient’s belt that synchronizes and distributes the signals. In addition, there is a finger-controlled switch that permits patient activation of the stepping.

Other devices include a reciprocating gait orthosis with electrical stimulation. The orthosis used is a cumbersome hip-knee-ankle-foot device linked together with a cable at the hip joint. The use of this device may be limited by the difficulties in donning and doffing the device.

Other Applications

Other devices, such as the ReGrasp (Rehabtronics), are used for rehabilitation rather than home use. Neuromuscular stimulation is also proposed for motor restoration in hemiplegia and treatment of secondary dysfunction (e.g., muscle atrophy and alterations in cardiovascular function and bone density) associated with damage to motor nerve pathways. These applications are not addressed in this policy.

Regulatory Status

In 1997, the Freehand® System was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval (PMA) process. The implantable Freehand® System is no longer marketed in the United States. The Handmaster NMS I system (now named NESS H200) was originally cleared for marketing by the FDA through the 510(k) process for maintaining or improving range of motion, reducing muscle spasm, preventing or retarding muscle atrophy, providing muscle re-education, and improving circulation (K022776); in 2001, its 510(k) marketing clearance was expanded to include provision of hand active range of motion and function for patients with C5 tetraplegia. FDA product code: GZC.

The WalkAide® System (Innovative Neurotronics, Gainesville, FL; formerly NeuroMotion) was first cleared for marketing by the FDA through the 510(k) process in the 1990s (K052329); the current version of the WalkAide® device received 510(k) marketing clearance in 2005. The OFDS® (Odstock Dropped Foot Stimlator; Odstock Medical, Salisbury, U.K.) received 510(k) marketing clearance in 2005 (K050991). The NESS L300® (Bioness, Valencia, CA) was cleared for marketing by the FDA through the 510(k) process in 2006. In 2015, the MyGait® Stimulation System (Otto Bock HealthCare, Duderstadt, Germany) received 510(k) marketing clearance (K141812). FDA summaries of the devices state that they are intended for patients with footdrop and assist with ankle dorsiflexion during the swing phase of gait. FDA product code: GZI.

To date, the Parastep® Ambulation System (Sigmedics, Northfield, IL) is the only noninvasive functional walking neuromuscular stimulation device to receive PMA from the FDA. The Parastep® device is approved to “enable appropriately selected skeletally mature spinal cord injured patients (level C6-T12) to stand and attain limited ambulation and/or take steps, with assistance if required, following a prescribed period of physical therapy training in conjunction with rehabilitation management of spinal cord injury.” FDA product code: MKD.

Rationale:

This policy was created in 2010 and has been updated periodically using the MEDLINE database. The most recent literature update was performed through January 8, 2018.

Medical policies assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function--including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to 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 a technology, 2 domains are examined: the relevance and the 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. The following is a summary of the key literature to date.

Functional Neuromuscular Electrical Stimulation of the Upper Limb

Spinal Cord Injury

Much of the early published evidence assessing upper-extremity devices to restore function in patients with spinal cord injuries (SCIs) reported on experience with the Freehand System, an implantable device no longer marketed in the United States. (1-4) The published studies have suggested that the device might give patients the ability to grasp and release objects and independence or greater independence in such activities of daily living (ADLs) as using a fork or the telephone in the study setting. User satisfaction was generally high, and most subjects reported continued use of the device at home, although details of specific activities or frequency of use at home were not provided.

Use of the Handmaster NMS I (NESS L200), another upper-extremity device, was reported in a 2000 series of 10 patients with cervical SCIs. (5) After 2 months of training, performance on a defined set of tasks and one or more tasks chosen by the patient was evaluated. In 6 patients, a stimulated grasp and release with either one or both grasp modes (key and palmar pinch) of the Handmaster was possible. Four patients could perform the set of tasks with but not without the Handmaster. Eventually one patient continued using the Handmaster during ADLs at home. In another study (2003) using the Handmaster device, 7 subjects with C5 or C6 SCI practiced using the device daily in an effort to regain the ability to grasp, hold, and release objects. (6) All patients were observed 2 to 3 times during the week for 3 weeks, and they were evaluated on their ability to perform the following tasks: pick up a telephone, eat food with a fork, perform an individually selected ADL task, and perform 2 tasks relating to grasping, holding, and releasing certain items. At the end of the study, all 7 subjects successfully used the device for each required task. Improvements occurred in secondary measures of grip strength, finger linear motion, and Fugl-Meyer Assessment scores (the instrument assesses sensorimotor recovery after stroke).

Stroke

Alon et al. (2002), reporting on a case series of 29 patients, investigated whether the Handmaster system (NESS L200) could improve select hand function in persons with chronic upper-extremity paresis following stroke. (7) The main outcome measures were 3 ADL tasks: lifting a 2-handled pot, holding a bag while standing with a cane, and another ADL chosen by the patient. Secondary measures included lifting a 600-gram weight, grip strength, electrically induced finger motion, Fugl-Meyer Assessment spherical grasp, and perceived pain scale. At the end of the 3-week study period, the percentage of successful trials compared with baseline were: lifting pot, 93% vs 0%, lifting 600-gram weight, 100% vs 14%; and lifting bag, 93% vs 17% -- all respectively. All subjects performed their selected ADLs successfully and improved their Fugl- Meyer Assessment scores using the neuroprosthesis.

Section Summary: Functional Neuromuscular Electrical Stimulation of the Upper Limb

The evidence on FNMES for the upper limb in patients with SCI or stroke includes a limited number of small case series. Interpretation of the evidence for upper-extremity neuroprostheses for these populations is limited by the small number of patients studied and lack of data demonstrating its utility outside the investigational (study) setting.

FNMES for Chronic Footdrop

Stroke

Functional NMES with a footdrop stimulator (WalkAide) was compared with an ankle-foot orthosis (AFO) in a 2014 industry-sponsored multicenter RCT (NCT01087957) that included 495 Medicare-eligible individuals who were at least 6 months poststroke. (8) A total of 399 individuals completed the 6-month study. Primary outcome measures were the 10-Meter Walk Test (10MWT), a composite measure of daily function, and device-related serious adverse events. Seven secondary outcome measures assessed function and quality of life. The intention-to-treat analysis found that both groups improved walking performance over the 6 months, and the NMES device was found noninferior to the AFO for the primary outcome measures. Only the WalkAide group showed significant improvements from baseline to 6 months on several secondary outcome measures, but there were no statistically significant between- group differences for any outcome.

FASTEST (NCT01138995) was a 2013 industry-sponsored, single-blinded, multicenter trial that randomized 197 stroke patients to 30 weeks of a footdrop stimulator (NESS L300) or a conventional AFO. (9) The AFO group received transcutaneous electrical nerve stimulation at each physical therapy visit during the first 2 weeks to provide a sensory control for stimulation of the peroneal nerve received by the NESS L300 group. Evaluation by physical therapists blinded to group assignment found that both groups improved gait speed and other secondary outcome measures over time, with a similar improvement in the 2 groups. There were no between-group differences in the number of steps per day at home, which was measured by an activity monitor over a week. User satisfaction was higher with the footdrop stimulator.

Secondary analysis of data from this study was reported by O’Dell et al. (2014). (10) Comfortable gait speed was assessed in the 99 individuals from the NESS L300 group at 6, 12, 30, 36, and 42 weeks, with and without the use of the footdrop stimulator. A responder was defined as one achieving a minimal clinically important difference of 0.1 m/s on the 10MWT or advancing by at least 1 Perry Ambulation Category (which measures functional walking ability in the home or community). Noncompleters were classified as nonresponders. Seventy percent of participants completed the assessments at 42 weeks, and 67% of participants were classified as responders. Of the 32 participants classified as nonresponders, 2 were nonresponders, and 30 were noncompleters. The percentage of patients in the conventional AFO group classified as responders at 30 weeks was not reported. There were 160 adverse events, of which 92% were classified as mild. Fifty percent of the adverse events were related to reversible skin issues, and 27% were falls.

Multiple Sclerosis (MS)

An RCT by Barrett et al. (2009) assessed FNMES to improve walking performance in patients with MS. (11) Fifty-three patients with secondary progressive multiple sclerosis and unilateral dropped foot were randomized to an 18-week program of an Odstock Dropped Foot Stimulator device or a home exercise program. Patients in the stimulator group were encouraged to wear the device most of the day, switching it on initially for short walks and increasing daily for 2 weeks, after which they could use the device without restriction. Subjects in the control group were taught a series of exercises tailored to the individual to be done twice daily. Six patients in the NMES group and 3 in the exercise group dropped out, leaving 20 in the NMES group and 24 in the exercise group. The primary outcome measure was walking speed over a 10-meter distance. At 18 weeks, the exercise group walked significantly faster than the NMES group (p=0.028). The authors noted a number of limitations of their study: power calculations were based on the 10-meter walking speed measure only and indicated that 25 subjects would be required in each group, patients were highly selected, clinical assessors also provided treatment (compromising blinding), and the validity and reliability of the 3-minute walk test have not been confirmed (fatigue prevented use of the validated 6-minute test). In addition, subjects in the exercise group were told they would receive a stimulator at the end of the trial, which may have biased exercise adherence and retention in the trial.

A 2010 publication by the same investigators reported on the impact of 18 weeks of physical therapy exercises or ODFS use on ADLs. (12) Results of 53 patients from the trial previously described were reported, using the Canadian Occupational Performance Measure. The Canadian Occupational Performance Measure is a validated semi-structured interview (higher scores indicate improvement) originally designed to assist occupational therapy interventions. The interviews at baseline identified 265 problems of which 260 activities were related to walking and mobility. Subjective evaluation at 18 weeks showed greater improvements in performance and satisfaction scores in the NMES group (35% of the identified problems increased by a score of >2) than in the exercise group (17% of problems increased by a score of >2). The median satisfaction rating improved from 2.2 to 4.0 in the NMES group and remained stable (2.6 to 2.4) in the exercise group. The median number of falls recorded per patient over the 18- week study was 5 in the NMES group and 18 in the exercise group. About 70% of the falls occurred while not using the NMES device or an AFO.

A study by Stein et al. (2010) assessed the orthotic and therapeutic effects of NMES in 32 patients with progressive footdrop (31 multiple sclerosis, 1 familial spastic paresis). (13) With the stimulator on (orthotic effect), walking speed improved by 2% for the figure-8 test and by 4% for the 10MWT. With the stimulator off (therapeutic effect), walking speed at 3 months had improved by 9% for the figure-8 test and by 5% for the 10MWT compared with baseline. The combined improvement in walking speed over the 3 months was 13% for the figure 8 (0.61 m/s vs 0.53 m/s) and 13% for the 10MWT (0.88 m/s vs 0.78 m/s, both respectively). The 20 (63%) subjects who returned for testing at 11 months did not show continued improvement compared with 3-month test results, with a combined (orthotic and therapeutic) improvement of 13% on the figure 8 (0.62 m/s vs 0.55 m/s) and 10% on the 10MWT (0.86 m/s vs 0.78 m/s, both respectively) compared with baseline. The Physiological Cost Index did not improve significantly (0.73 beats/min vs 0.78 beats/min, respectively). Subjects with nonprogressive footdrop used the device for an average 85% of days, 9.2 hours per day, and walked about 2 km per day.

Cerebral Palsy

Cauraugh et al. (2010) conducted a systematic review and meta-analysis of 17 studies on NMES and gait in children with cerebral palsy. (14) Fourteen studies used a pretest-posttest that included a within-subjects design. A total of 238 participants had NMES. Included were studies on acute NMES, functional NMES, and therapeutic NMES (continuous subthreshold stimulation). Five studies examined functional NMES, and one of these studies examined percutaneous NMES. There were 3 outcome measures for impairment: range of motion, torque/movement, and strength/force. There were 6 outcome measures for activity limitations: gross motor functions, gait parameters, hopping on 1 foot, 6-minute walk, Leg Ability Index, and Gillette Gait Index. Moderate effect sizes were found for impairment (0.616) and activity limitations (0.635). Studies selected for the review lacked blinding and were heterogeneous for outcome measures. Reviewers did not report whether any study used a commercially available device.

A 2012 report examined the acceptability and effectiveness of a commercially available footdrop stimulator in 21 children with mild cerebral palsy, gait impairments, and unilateral footdrop. (15) Three children who did not improve walking did not complete the study. Gait analysis in the remaining 18 showed improved dorsiflexion compared with baseline. There was no significant change in other gait parameters, including walking speed. Average daily device use was 5.6 hours (range, 1.5-9.4 hours) over the 3-month study, although participants had been instructed to use the device for at least 6 hours per day. Eighteen (86%) children kept using the device after the 3-month trial. Data from this period were collected but not reported.

Meilahn (2013) assessed the tolerability and efficacy of a commercially available device in 10 children (age, 7-12 years) with hemiparetic cerebral palsy who typically wore an AFO for correction of footdrop. (16) All children tolerated the fitting and wore the device for the first 6 weeks. The mean wear times were 8.4 hours per day for the first 3 weeks and 5.8 hours per day for the next 3 weeks. Seven (70%) children wore the device for the 3-month study period, with average device use of 2.3 hours daily (range, 1.0-6.3 h/d). Six (60%) children continued to use the neuroprosthesis after study completion. Gait analysis was performed, but quantitative results were not reported. Although half of the subjects improved their gait velocity, the mean velocity was relatively unchanged with the neuroprosthesis.

Section Summary: Functional NMES for Chronic Footdrop

For chronic poststroke footdrop, 2 large RCTs comparing NMES with a standard AFO showed improved patient satisfaction with NMES but no significant differences between groups in objective measures like walking. An RCT with 53 subjects examining neuromuscular stimulation for footdrop in patients with multiple sclerosis showed a reduction in falls and improved patient satisfaction compared with an exercise program but did not demonstrate a clinically significant benefit in walking speed. A reduction in falls is an important health outcome. However, it was not a primary study outcome and should be confirmed in a larger number of patients. The literature on NMES in children with cerebral palsy includes a systematic review of small studies with within-subject designs. Two within-subject studies evaluated tolerability and efficacy of a commercially available device in this population. Both studies, which should be considered preliminary investigations, showed no improvement in walking speed with the device. Further study in a larger number of subjects over a longer duration is needed to permit conclusions on the effect of the technology on health outcomes.

Ambulation in Patients with SCI

The clinical impact of the Parastep device rests on the identification of clinically important outcomes. The primary purpose of this device is to provide a degree of ambulation that improves patient ability to complete the ADLs or positively affect the patient’s quality of life. Physiologic outcomes (i.e., conditioning, oxygen uptake) have also been reported, but they are intermediate, short-term outcomes.

The largest study (Chaplin, 1996) reported on ambulation outcomes using the Parastep 1 and included 91 patients. (17) Of these 91 patients, 84 (92%) were able to take steps, and 31 (34%) were able eventually to ambulate without assistance from another person. Duration of use was not reported. Other studies on the Parastep device include a series from the same group of investigators, which focused on different outcomes in the same group of 13 to 16 patients. (18-22) Guest et al. (1997) reported on the ambulation performance of 13 men and 3 women with thoracic motor complete spinal injury. (21) The group’s mean peak distance walked was 334 meters, but individual studies varied widely. The mean peak duration of walking was 56 minutes, again with wide variability. Anthropomorphic measurements were taken at various anatomic locations. Increases in thigh and calf girth, thigh cross-sectional area, and calculated lean tissue were all statistically significant. The authors emphasized that the device was not intended as an alternative to a wheelchair, and thus other factors such as improved physical and mental well-being should be considered when deciding whether to use the system. The same point was noted in a review article by Graupe and Kohn (1998). (23)

Brissot et al. (2000) found that 13 of 15 patients evaluated in a case series achieved independent ambulation. (24) Five of the 13 patients continued using the device for physical fitness at home, but none used it for ambulation. Sykes et al. (1996) found low use of a reciprocating gait orthosis device with or without stimulation over an 18-month period, (25) and Davis et al. (2001) found mixed usability/preference scale results for ambulation, standing, and transfers with a surgically implanted neuroprosthesis in 12 patients followed for 12 months. (26) The effects of a surgically implanted neuroprosthesis on exercise, standing, transfers, and quality of life were also reported in 2012. (27, 28) The device used in both studies was not commercially available at that time.

Several publications reported on physiologic responses to use of the Parastep device. Jacobs et al. (1997) found a 25% increase in time to fatigue and a 15% increase in peak oxygen uptake, consistent with an exercise training effect. (19) Needham-Shropshire et al. (1997) reported no relation between use of the Parastep device and bone mineral density, although the interval between measurements (12 weeks) and the precision of the testing device might have limited the ability to detect a difference. (20) Nash et al. (1997) reported that use of the Parastep device was associated with an increase in arterial inflow volume to the common femoral artery, perhaps related to the overall conditioning response to the Parastep. (22)

Section Summary: Ambulation in Patients With SCI

The evidence on FNMES for standing and walking in patients with SCI consists of case series. Case series are considered adequate for this condition because there is no chance for ambulation in patients with SCI between segments T4 to T12. As stated by various authors, these systems are not designed as alternatives to a wheelchair and offer, at best, limited, short-term ambulation. Some studies have reported improvements in intermediate outcomes, but improvement in health outcomes (e.g., ability to perform ADLs) have not been demonstrated. Finally, evaluations of these devices were performed immediately after initial training or during limited study period durations. There are no data in which patients remained compliant and committed with long-term use.

Summary of Evidence

For individuals who have loss of hand and upper-extremity function due to spinal cord injury (SCI) or stroke who receive functional neuromuscular electrical stimulation (FNMES), the evidence includes case series. Relevant outcomes are functional outcomes and quality of life. Evidence on FNMES for the upper limb in patients with SCI or stroke includes a few small case series. Interpretation of the evidence is limited by the low number of patients studied and lack of data demonstrating the utility of NMES outside the investigational setting. It is uncertain whether NMES can restore some upper-extremity function or improve the quality of life. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have chronic footdrop who receive functional NMES, the evidence includes randomized controlled trials and a systematic review. Relevant outcomes are functional outcomes and quality of life. For chronic poststroke footdrop, 2 large randomized trials have shown improved patient satisfaction with NMES; however, in objective measures (e.g., walking), no significant difference has been observed between NMES and a standard ankle-foot orthosis. A small randomized trial examining neuromuscular stimulation for footdrop in patients with multiple sclerosis revealed a clinically significant reduction in falls; the trial also revealed an improvement in patient satisfaction with the neuromuscular stimulation (as opposed to an exercise program). However, in the area of walking speed, the trial failed to demonstrate a clinically significant benefit to the neuromuscular stimulation over an exercise class.

Studies in a larger number of patients are needed to provide greater certainty about the generalizability of this health outcome. The literature on NMES for footdrop in children with cerebral palsy includes a systematic review of small studies that feature within-subject designs; additional study in a larger number of subjects is needed. Overall, there is insufficient evidence for some indications, and a lack of improvement in objective measures for others. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have SCI at segments T4 to T12 who receive functional NMES, the evidence includes case series. Relevant outcomes are functional outcomes and quality of life. No controlled trials were identified on functional NMES for standing and walking in patients with SCI. However, case series are considered adequate for this condition, because there is no chance for unaided ambulation in this population with SCI at this level. Some studies have reported improvements in intermediate outcomes, but improvements in health outcomes (e.g., ability to perform activities of daily living, quality of life) have not been demonstrated. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

In 2009, the National Institute for Health and Care Excellence published guidance stating that the evidence on functional electrical stimulation for footdrop of neurologic origin appeared adequate to support its use. (29) The Institute noted that patient selection should involve a multidisciplinary team. The Institute advised that further publication on the efficacy of functional electrical stimulation would be useful, specifically including patient-reported outcomes (e.g., quality of life, activities of daily living) and these outcomes should be examined in different ethnic and socioeconomic groups.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 1.

Table 1. Summary of Key Trials

NCT No.

Trial Name

Planned Enrollment

Completion Date

Ongoing

NCT03385005

Evaluating Neuromuscular Stimulation for Restoring Hand Movements

15

Mar 2018

NCT00583804

Implanted Myoelectric Control for Restoration of Hand Function in Spinal Cord Injury

50

Jan 2019

NCT02602639

Functional Electrical Stimulation with Rowing as Exercise after Spinal Cord Injury (FES)

6

Sep 2019

NCT02821884

Combine Transcranial Direct Current Stimulation and Neuromuscular Electrical Stimulation on Stroke Patients

90

Dec 2019

NCT03379532

Brain Computer Interface-Controlled NMES in Subacute Stroke

32

Dec 2020

Unpublished

NCT00890916

Hand Function for Tetraplegia Using a Wireless Neuroprosthesis

11

Dec 2017

NCT: national clinical trial.

a Denotes industry-sponsored or cosponsored trial.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

There are no specific CPT codes for functional neuromuscular electrical stimulation devices and associated services. The associated training required for use of a device would probably be coded as physical therapy visits, i.e., 97760, 97760 and/or 97530.

HCPCS code E0764 is specific to a functional neuromuscular stimulator, such as the Parastep, to be used in spinal cord injury patients as an aid in ambulation.

HCPCS code E0770 can be used for other types of functional neuromuscular stimulators such as the stimulators used in patients with footdrop.

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

97116, 97530, 97760, 97763

HCPCS Codes

A4595, E0764, E0770

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position.

A national coverage position for Medicare may have been changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Mulcahey MJ, Betz RR, Kozin SH, et al. Implantation of the Freehand System during initial rehabilitation using minimally invasive techniques. Spinal Cord. Mar 2004; 42(3):146-155. PMID 15001979

2. Mulcahey MJ, Betz RR, Smith BT, et al. Implanted functional electrical stimulation hand system in adolescents with spinal injuries: an evaluation. Arch Phys Med Rehabil. Jun 1997; 78(6):597-607. PMID 9196467

3. Taylor P, Esnouf J, Hobby J. The functional impact of the Freehand System on tetraplegic hand function. Clinical Results. Spinal Cord. Nov 2002; 40(11):560-566. PMID 12411963

4. Venugopalan L, Taylor PN, Cobb JE, et al. Upper limb functional electrical stimulation devices and their man- machine interfaces. J Med Eng Technol. Oct 2015; 39(8):471-479. PMID 26508077

5. Snoek GJ, IJzerman MJ, in’t Groen FA, et al. Use of the NESS handmaster to restore handfunction in tetraplegia: clinical experiences in ten patients. Spinal Cord. Apr 2000; 38(4):244-249. PMID 10822395

6. Alon G, McBride K. Persons with C5 or C6 tetraplegia achieve selected functional gains using a neuroprosthesis. Arch Phys Med Rehabil. Jan 2003; 84(1):119-124. PMID 12589632

7. Alon G, McBride K, Ring H. Improving selected hand functions using a noninvasive neuroprosthesis in persons with chronic stroke. J Stroke Cerebrovasc Dis. Mar-Apr 2002; 11(2):99-106. PMID 17903863.

8. Bethoux F, Rogers HL, Nolan KJ, et al. The effects of peroneal nerve functional electrical stimulation versus ankle-foot orthosis in patients with chronic stroke: a randomized controlled trial. Neurorehabil Neural Repair. Sep 2014; 28(7):688-697. PMID 24526708

9. Kluding PM, Dunning K, O'Dell MW, et al. Foot drop stimulation versus ankle foot orthosis after stroke: 30-week outcomes. Stroke. Jun 2013; 44(6):1660-1669. PMID 23640829

10. O'Dell MW, Dunning K, Kluding P, et al. Response and prediction of improvement in gait speed from functional electrical stimulation in persons with post stroke drop foot. PM R. Jul 2014; 6(7):587-601; quiz 601. PMID 24412265

11. Barrett CL, Mann GE, Taylor PN, et al. A randomized trial to investigate the effects of functional electrical stimulation and therapeutic exercise on walking performance for people with multiple sclerosis. Mult Scler. Apr 2009; 15(4):493-504. PMID 19282417

12. Esnouf JE, Taylor PN, Mann GE, et al. Impact on activities of daily living using a functional electrical stimulation device to improve dropped foot in people with multiple sclerosis, measured by the Canadian Occupational Performance Measure. Mult Scler. Sep 2010; 16(9):1141-1147. PMID 20601398

13. Stein RB, Everaert DG, Thompson AK, et al. Long-term therapeutic and orthotic effects of a foot drop stimulator on walking performance in progressive and nonprogressive neurological disorders. Neurorehabil Neural Repair. Feb 2010; 24(2):152-167. PMID 19846759

14. Cauraugh JH, Naik SK, Hsu WH, et al. Children with cerebral palsy: a systematic review and meta-analysis on gait and electrical stimulation. Clin Rehabil. Nov 2010; 24(11):963-978. PMID 20685722

15. Prosser LA, Curatalo LA, Alter KE, et al. Acceptability and potential effectiveness of a foot drop stimulator in children and adolescents with cerebral palsy. Dev Med Child Neurol. Nov 2012; 54(11):1044-1049. PMID 22924431

16. Meilahn JR. Tolerability and Effectiveness of a Neuroprosthesis for the Treatment of Footdrop in Pediatric Patients with Hemiparetic Cerebral Palsy. PM R. Jan 9 2013. PMID 23313040

17. Chaplin E. Functional neuromuscular stimulation for mobility in people with spinal cord injuries. The Parastep I System. J Spinal Cord Med. Apr 1996; 19(2):99-105. PMID 8732878

18. Klose KJ, Jacobs PL, Broton JG, et al. Evaluation of a training program for persons with SCI paraplegia using the Parastep 1 ambulation system: part 1. Ambulation performance and anthropometric measures. Arch Phys Med Rehabil. Aug 1997; 78(8):789-793. PMID 9344294

19. Jacobs PL, Nash MS, Klose KJ, et al. Evaluation of a training program for persons with SCI paraplegia using the Parastep 1 ambulation system: part 2. Effects on physiological responses to peak arm ergometry. Arch Phys Med Rehabil. Aug 1997; 78(8):794-798. PMID 9344295

20. Needham-Shropshire BM, Broton JG, Klose KJ, et al. Evaluation of a training program for persons with SCI paraplegia using the Parastep 1 ambulation system: part 3. Lack of effect on bone mineral density. Arch Phys Med Rehabil. Aug 1997; 78(8):799-803. PMID 9344296

21. Guest RS, Klose KJ, Needham-Shropshire BM, et al. Evaluation of a training program for persons with SCI paraplegia using the Parastep 1 ambulation system: part 4. Effect on physical self-concept and depression. Arch Phys Med Rehabil. Aug 1997; 78(8):804-807. PMID 9344297

22. Nash MS, Jacobs PL, Montalvo BM, et al. Evaluation of a training program for persons with SCI paraplegia using the Parastep 1 ambulation system: part 5. Lower extremity blood flow and hyperemic responses to occlusion are augmented by ambulation training. Arch Phys Med Rehabil. Aug 1997; 78(8):808-814. PMID 9344298

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25. Sykes L, Ross ER, Powell ES, et al. Objective measurement of use of the reciprocating gait orthosis (RGO) and the electrically augmented RGO in adult patients with spinal cord lesions. Prosthet Orthot Int. Dec 1996; 20(3):182-190. PMID 8985998

26. Davis JA, Jr., Triolo RJ, Uhlir J, et al. Preliminary performance of a surgically implanted neuroprosthesis for standing and transfers--where do we stand? J Rehabil Res Dev. Nov-Dec 2001; 38(6):609-617. PMID 11767968

27. Rohde LM, Bonder BR, Triolo RJ. Exploratory study of perceived quality of life with implanted standing neuroprostheses. J Rehabil Res Dev. 2012; 49(2):265-278. PMID 22773528

28. Triolo RJ, Bailey SN, Miller ME, et al. Longitudinal performance of a surgically implanted neuroprosthesis for lower-extremity exercise, standing, and transfers after spinal cord injury. Arch Phys Med Rehabil. May 2012; 93(5):896-904. PMID 22541312

29. National Institute for Health and Clinical Excellence. Functional electrical stimulation for drop foot of central neurological origin (IPG278) 2009. Available at <http://www.nice.org> (accessed January 22, 2018).

30. Functional Neuromuscular Electrical Stimulation. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2018 March). Therapy 8.03.01.

Policy History:

Date Reason
7/15/2018 Document updated with literature review. Coverage statement modified to include “ following nerve damage or nerve injury”. Reference 4 added.
10/15/2017 Reviewed. No changes.
4/15/2016 Document updated with literature review. The following was added to the experimental, investigational and/or unproven indications: “To improve ambulation in patients with foot drop caused by congenital disorders (e g., cerebral palsy)”. Otherwise coverage unchanged.
6/1/2015 Reviewed. No changes.
6/1/2014 Document updated with literature review. Coverage unchanged.
5/1/2012 Document updated with literature review. Coverage unchanged. Rationale completely revised.
2/15/2010 New Medical Policy document. Functional neuromuscular electrical stimulation is considered experimental, investigational and unproven. (Coverage is unchanged; topic was previously addressed on MED201.026 Surface Electrical Stimulation.)

Archived Document(s):

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