Coverage Policy Manual
Policy #: 1997080
Category: Rehabilitation
Initiated: August 2017
Last Review: August 2018
  Neuromuscular Stimulation, Functional

Description:
This policy addresses functional neuromuscular electrical stimulation and treatment of disuse atrophy as described.
 
Neuromuscular electrical stimulation (NMES) involves the use of a device that transmits an electrical impulse to a group of muscles via electrodes. There are two basic categories of NMES: 1) the application of electrical stimuli to stimulate muscles when the patient is in a resting state to treat muscle atrophy; and 2) the application of electrical stimuli to enhance functional activity (e.g., walking or grasping) of neurologically impaired patients. The latter is commonly referred to as Functional Neuromuscular Electrical Stimulation or Functional Electrical Stimulation (FES).
 
Neural prosthetic 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, which provide feedback information on muscle force and joint position, thus allowing constant modification of stimulation parameters which are required for complex activities such as walking. These are contrasted with open loop systems, which are used for simple tasks such as muscle strengthening alone, and typically in healthy individuals with intact neural control.
 
One application of functional neuromuscular electrical stimulation (NMES) is to restore upper extremity functions such as grasp-release, forearm pronation, and elbow extension in patients with stroke, or C5 and C6 tetraplegia (quadraplegia). The Neurocontrol Freehand system received approval from the U.S. Food and Drug Administration (FDA) in 1997 through the pre-market approval (PMA) process. The system is an implantable upper extremity neuroprosthesis intended to improve a patient's ability to grasp, hold, and release objects and is indicated for use in patients who are tetraplegic due to C5 or C6 spinal cord injury. The implantable Freehand System is no longer marketed in the U.S., though the company provides maintenance for devices already implanted. The Handmaster NMS I [neuromuscular stimulator] is another device that uses surface electrodes and is purported to provide hand active range of motion and function for patients with stroke or C5 tetraplegia. The Handmaster NMS I system was originally cleared for use in maintaining or improving range of motion, reducing muscle spasm, preventing or retarding muscle atrophy, providing muscle re-education, and improving circulation; 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.
 
Other neural prosthetic devices have been developed for functional NMES in patients with foot drop. Foot drop is weakness of the foot and ankle that causes reduced dorsiflexion and difficulty with ambulation. It can have various causes such as 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. Examples of such devices used for treatment of foot drop are the Innovative Neurotronics’ (formerly NeuroMotion, Inc.) WalkAide®, Bioness’ radiofrequency controlled NESS L300™, and the Odstock Foot Drop Stimulator. The WalkAide device first received 510(k) marketing clearance from the FDA in the 1990s; the current version of the WalkAide device received 510(k) marketing clearance in September 2005. The Odstock Foot Drop Stimulator received 510(k) marketing clearance in 2005. The Bioness NESS L300 received 510(k) marketing clearance in July 2006. The FDA summaries for the devices state that they are intended to be used in patients with drop foot by assisting with ankle dorsiflexion during the swing phase of gait.
 
Another application of functional electrical stimulation is to provide spinal cord-injured patients with the ability to stand and walk. Generally, only spinal cord injury patients with lesions from T4 to T12 are considered candidates for ambulation systems. Lesions at T1–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 putting the device on and taking it off.
 
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 (see Benefit Application section).
 
Regulatory Status
The Neurocontrol Freehand system received approval from the U.S. Food and Drug Administration (FDA) in 1997 through the premarket approval (PMA) process. The Handmaster NMS I system was originally cleared for use in maintaining or improving range of motion, reducing muscle spasm, preventing or retarding muscle atrophy, providing muscle re-education, and improving circulation; 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.
 
The WalkAide device first received 510(k) marketing clearance from FDA in the 1990s; the current version of the WalkAide device received 510(k) marketing clearance in September 2005. The Odstock Foot Drop Stimulator received 510(k) marketing clearance in 2005. The Bioness NESS L300 received 510(k) marketing clearance in July 2006. FDA summaries for the devices state that they are intended to be used in patients with drop foot by assisting with ankle dorsiflexion during the swing phase of gait.
 
To date, the Parastep® Ambulation System is the only noninvasive functional walking neuromuscular stimulation device to receive PMA from 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.”
 
The RT300 is FDA approved for use in spinal cord injury and consists of an electrically powered motor and multichannel FES controlled by a microprocessor and custom software. Several different models are available including the RT300-SLSA, a cycle for arms or legs and core muscles, the RT300-SL for legs and core muscles, the RT300-SA cycle for arms and core muscles and the RT300 Supine allowing an individual to cycle from bed with or without FES.

Policy/
Coverage:
Effective April 2012
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Neuromuscular electrical stimulation (NMES) meets primary coverage criteria for effectiveness and is covered for treatment of disuse atrophy where nerve supply to the muscle is intact, including but not limited to atrophy secondary to prolonged splinting or casting of the affected extremity, contracture due to scarring of soft tissue as in burn lesions, and hip replacement surgery (until orthotic training begins).
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Neuromuscular electrical stimulation (NMES) for conditions other than disuse atrophy does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.  For members with contracts without primary coverage criteria, neuromuscular electrical stimulation (NMES) is considered not medically necessary. Services that are considered not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
 
Functional neuromuscular electrical stimulation used to enhance functional activity of neurologically impaired patients does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, functional neuromuscular electrical stimulation used to enhance functional activity of neurologically impaired patients is considered investigational.  Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
NMES devices are contraindicated for:
        • Patients with cardiac demand pacemakers;
        • Patients with cancer.   
 
Use for these conditions does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. For members with contracts without primary coverage criteria, use for these conditions would be considered not medically necessary. Services that are considered not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
 
Effective prior to April 2012
 
 
Functional Neuromuscular Stimulation is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, Functional Neuromuscular Stimulation is considered investigational.  Investigational services are an exclusion in the member certificate of coverage.
 
Neuromuscular electrical stimulation (NEMS) meets primary coverage criteria for effectiveness and is covered for treatment of disuse atrophy secondary to prolonged splinting or casting of the affected extremity.  Neuromuscular electrical stimulation (NEMS) for other conditions is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, Neuromuscular electrical stimulation (NEMS) is considered not medically necessary. Medically unnecessary services are an exclusion in the member certificate of coverage.
 
EMS devices are contraindicated for:
    • Patients with cardiac demand pacemakers;
    • Patients with cancer.  
Use for these conditions is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, EMS devices are contraindicated for:
    • Patients with cardiac demand pacemakers;
    • Patients with cancer.  
Use for these conditions would be considered not medically necessary.  Medically unnecessary services are an exclusion in the member certificate of coverage.

Rationale:
The clinical impact of the Parastep device rests on identification of clinically important outcomes. The primary outcome of the Parastep device and the main purpose of its design is to provide a degree of ambulation that improves the patient’s ability to complete the activities of daily living, seek employment, or positively benefit the patient’s quality of life. Physiologic outcomes (i.e., conditioning, oxygen uptake, etc.) have also been reported, but these are intermediate short term outcomes, and it is not known whether similar or improved results could be attained with other training methods. In addition, the results are reported for mean peak values, which may or may not be a consistent result over time. The effect of the Parastep on physical self-concept and depression are secondary outcomes and similar to the physiologic outcomes; interpretation is limited due to lack of comparison with other forms of training.
 
The largest study was conducted by Chaplin et. al. who reported on the ambulation outcomes using the Parastep I in 91 patients.  Of these 91 patients, 84 (92%) were able to take steps and 31 (34%) were able to eventually ambulate without assistance from another person. Duration of use was not reported. Other studies on the Parastep device include a series of 5 studies from the same group of investigators, which focused on different outcomes in the same group of 13–15 patients.  In a 1997 study, Guest and colleagues reported on the ambulation performance of 13 men and 3 women with thoracic motor complete spinal injury.   All patients underwent 32 training sessions prior to measuring ambulation. The group mean peak distance walked was 334 meters, but there was wide variability, as evidenced by a standard deviation of 402 meters. The mean peak duration of walking was 56 minutes, again with wide variability, evidenced by a standard deviation of 46 minutes. It should be noted that peak measures reflect the best outcome over the period evaluated; peak measures may be an inconsistent one-time occurrence for the individual patient. The participants also underwent anthropomorphic measurements of various anatomic locations. Increases in thigh and calf girth, thigh cross-sectional area, and calculated lean tissue were all statistically significant. The authors emphasize that the device is not intended to be an alternative to a wheelchair, and thus other factors such as improved physical and mental well being should be considered when deciding whether or not to use the system. The same limitations were noted in a review article by Graupe and Kohn, who state that the goal for ambulation is for the patients to get out of the wheelchair at will, stretch, and take a few steps every day.
 
Jacobs and colleagues reported on physiologic responses related to use of the Parastep device.  There was a 25% increase in time to fatigue and a 15% increase in peak values of oxygen uptake, consistent with an exercise training effect. There were no significant effects on arm strength. Needham-Shropshire and colleagues reported no relationship between use of the Parastep device and bone mineral density, although the time interval between measurements (12 weeks), and the precision of the testing device, may have limited the ability to detect a difference.  Nash and colleagues 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.  Also, Guest and colleagues reported significant improvements in physical self-concept and decreases in depression scores.   Finally, it should be noted that evaluations of the Parastep device were performed immediately following initial training or during limited study period durations.  There are no data regarding whether patients remain compliant and committed with long-term use.
 
Summary
As stated by various authors the Parastep system it is not designed to be an alternative to a wheelchair and offers, at best, limited, short-term ambulation. Final health outcomes, such as ability to perform activities of daily living or quality of life have not been reported.
 
2002 Update
A search of the literature was performed on the MEDLINE database for the period of 2000 to October 2002. No published data were identified that would alter the above conclusion; therefore the policy statement is unchanged. Brissot and colleagues reported independent ambulation was achieved in 13 of 15 patients, with 2 patients withdrawing from the study.  In the home setting, 5 of the 13 patients continued using the device for physical fitness, but none used it for ambulation. Sykes and colleagues found low use of a reciprocating gait orthosis device (RGOs) with or without stimulation over an 18-month period.   In addition, the more recent Davis study of a surgically implanted neuroprosthesis for standing and transfers after spinal cord injury showed mixed usability/preference scale results for ambulation with device assistance versus conventional transfers in 12 patients followed up for a 12-month period post-discharge.  Therefore, the advantage of using device assistance could not be evaluated.
 
2005 Update
Updated searches of the literature were performed in the MEDLINE database for the period of 2000 to April 2005. No published data were identified that would alter the above conclusion; therefore, the policy statement is unchanged. Brissot and colleagues reported independent ambulation was achieved in 13 of 15 patients, with 2 patients withdrawing from the study.  In the home setting, 5 of the 13 patients continued using the device for physical fitness, but none used it for ambulation. Sykes and colleagues found low use of a reciprocating gait orthosis device (RGOs) with or without stimulation over an 18-month period.  In addition, the more recent Davis study of a surgically implanted neuroprosthesis for standing and transfers after spinal cord injury showed mixed usability/preference scale results for ambulation with device assistance versus conventional transfers in 12 patients followed up for a 12-month period post-discharge.  Therefore, the advantage of using device assistance could not be evaluated.
 
2006 Update
An updated search of the literature was performed on the MEDLINE database for the period of April 2005 through May 2006. No published data were identified that would alter the above conclusions; therefore, the policy statement is unchanged. Daly and colleagues compared gait component execution in 32 post-stroke patients randomized to gait training with or without FNS.  The authors found gait training with FNS with intramuscular electrodes significantly improved gait component execution (as measured by the Tinetti gait measure, a 12-point scale to assess gait component coordination) and knee flexion coordination over gait training without FNS. However, improvements in balance, overall limb coordination, and the 6-minute walking test were not statistically significant. In addition, final health outcomes, such as the ability to perform activities of daily living or quality of life were not evaluated in this study.
 
2007 Update
A search of the MEDLINE database was conducted for the period of June 2006 through September 2007. The limited published literature suggests that this procedure is at an early experimental stage in patients with spinal cord injury. For example, Forrest and colleagues reported oxygen consumption for a single subject implanted with the Case Western Reserve/Veterans Administration (CWRU/VA) standing neuroprosthesis.  The 12-month post-implantation assessment is part of an ongoing standardized experimental protocol funded by the New York State Department of Health Spinal Cord Injury Research Board, the U.S. Food and Drug Administration Office of Orphan Product Development, a Department of Veterans Affairs Rehabilitation and Development Merit Review, and the National Institute of Health.  The subject was able to stand for up to 2 hours and ambulate 8 to 15 feet in 1 minute using parallel bars. Oxygen consumption while standing was 4.7 mL/kg/min, about twice the expected energy use of a nondisabled person. At a reported ambulation speed of 2.4 to 4.5 meters per minute, the neuroprosthesis was considered to be practical only for standing, transfers, and ambulation for very short distances. Another study, which was funded by the National Center for Medical Rehabilitation Research of the National Institute for Child Health and Development, examined strategies for improving balance during functional tasks (such as reaching and manipulating objects at a counter) in 2 spinal cord injury patients using neuromuscular stimulation devices (1 with the CWRU/VA and 1 with Octostim surface electrodes).  It was reported that 1 of the 2 subjects attained the goal of placing at least 90% of his/her body weight on the lower extremities during standing, potentially allowing safe release of a hand for functional use. A number of publicly listed clinical trials are assessing the effectiveness of functional neuromuscular stimulation following stroke.  The literature indicates that functional neuromuscular neurostimulation is investigational; the policy statement remains unchanged.
 
2012 Update
A literature review using the MEDLINE database was conducted through January 2012.  There was no new information identified that would prompt a change in the coverage statement.
 
2012 Update
This policy is updated with a literature search using the MEDLINE database through January 2013. The update focuses on the new literature on the use of neuromuscular stimulation for the treatment of children with cerebral palsy.
 
Cerebral Palsy
Cauraugh et al. conducted a 2010 meta-analysis of 17 studies on NMES and gait in children with cerebral palsy (Cauraugh, 2010). Fourteen of the studies used a pretest-post-test, 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 of the studies examined functional NMES, and 1 of these studies examined percutaneous NMES. There were 3 outcome measures for impairment; range of motion, torque/moment, and strength/force. There were 6 different outcome measures for activity limitations; gross motor functions, gait parameters, hopping on one 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). The systematic review is limited by a lack of blinding in the included studies and the heterogeneity of outcome measures. The review did not describe if any of the included studies used a commercially available device.
 
A 2012 report examined the acceptability and effectiveness of a commercially available foot drop stimulator in 21 children who had mild gait impairments and unilateral foot drop (Prosser, 2012). Three children did not experience an improvement in walking and did not complete the study. Gait analysis in the remaining 18 showed improved dorsiflexion when compared to baseline. There was no significant change in other gait parameters, including walking speed. The average daily use was 5.6 hours (range, 1.5 to 9.4) over the 3 months of the study, although the participants had been instructed to use the device for at least 6 hours per day. Eighteen children (86%) chose to keep using the device after the 3-month trial period. Data from this period were collected but not reported.
 
In 2013, Meilahn assessed the tolerability and efficacy of a commercially available neuroprosthesis in 10 children (age, 7-12 years) with hemiparetic cerebral palsy who typically wore an ankle foot orthosis for correction of foot drop (Meilahn, 2013).  All of the children tolerated the fitting and wore the device for the first 6 weeks. The mean wear time was 8.4 hours per day in the first 3 weeks and 5.8 hours per day in the next 3 weeks. Seven children (70%) wore the device for the 3-month study period, with average use of 2.3 hours daily (range, 1.0 to 6.3 hours/day). Six children (60%) continued to use the neuroprosthesis after study completion. Gait analysis was performed, but quantitative results were not included in the report. Although it was reported that half of the subjects improved gait velocity, mean velocity was relatively unchanged with the neuroprosthesis.
 
In summary, two recent within-subject studies have evaluated tolerability and efficacy of a commercially available neuroprosthesis in children with cerebral palsy. Both of the studies, which should be considered preliminary, show no improvement in walking speed with the device. In addition, daily use decreased over the course of one trial. Study in a larger number of subjects over a longer duration is needed to permit conclusions concerning the effect of the technology on health outcomes.
 
2014 Update
A literature search was conducted using the MEDLINE database through February 2014. There was no new literature identified that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
 
FASTEST (NCT01138995) is an industry-sponsored single-blinded multicenter trial that randomized 197 patients to 30 weeks of a footdrop stimulator (NESS L300) or a conventional ankle-foot orthosis (AFO) (Kluding, 2013). 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 in the NESS L300 group. Evaluation by physical therapists who were blinded to group assignment found that both groups improved gait speed and other secondary outcome measures over time, with similar improvement in the 2 groups. There were no between-group differences in the number of steps per day at home, which were measured by an activity monitor over a week. User satisfaction was higher with the footdrop stimulator.
 
A multicenter within-subject crossover trial of the WalkAid footdrop stimulator versus conventional AFO was published in 2013 (Everaert, 2013). Patients who had a stroke within the previous12 months and residual footdrop but no prior experience with an orthotic device were randomly assigned to WalkAid followed by AFO (6 weeks each, n=38), AFO followed by WalkAid (n=31), or AFO for 12 weeks (n=24). Walking tests were performed both with and without a device at 0, 3, 6, 9, and 12 weeks. The orthotic effect of the device is considered to be the immediate effect of NMES measured at any of the time points with the stimulator on compared with off. The therapeutic effect is the improvement over time (improvement in neuromuscular function) measured under the same conditions (ie, stimulator on versus on or stimulator off versus off) at different time points. The Physiological Cost Index (PCI), which is an indication of the amount of effort in walking, is assessed by the difference between resting heart rate and heart rate during walking, divided by the average walking speed. Both devices had significant orthotic (on-off difference) and therapeutic (changes over time when off) effects. The AFO had a greater orthotic effect on walking speed (figure 8 and 10-meter), while the WalkAid tended to have a greater therapeutic effect. The orthotic effect on PCI was significantly higher with an AFO than the WalkAid. Users felt equally safe with the 2 devices. Seventy percent preferred to keep the WalkAid after the 12-week study.
 
Ongoing Clinical Trials
A search of online site www.ClinicalTrials.gov in March 2014 identified the following studies with a neuroprosthesis:
 
  • NCT00890916 is a phase I/II study from the Department of Veteran Affairs of the FIRSTHAND System in patients with spinal cord injury. There is an estimated enrollment of 7 patients with anticipated completion in December 2013.
  • NCT00583804 will evaluate the efficacy of an implanted stimulator and sensor on hand and arm function in 50 patients with spinal cord injury. Estimated study completion date is January 2014.
 
Also identified were a number of studies on functional NMES for treatment of patients with acute and chronic stroke conditions. These trials primarily focus on rehabilitation and strengthening.
  
2015 Update
 
A literature search conducted through February 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Randomized Controlled Trials
Functional NMES with a foot-drop stimulator (WalkAide) was compared with an ankle-foot orthosis in an industry-affiliated multicenter randomized controlled trial (NCT01087957) that included 495 Medicare eligible individuals who were at least 6 months post-stroke (Bethoux, 2014).  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 event rates. There were 7 secondary outcome measures that assessed function and quality of life. Intention-to-treat analysis found that both groups improved walking performance over the 6 months of the study and the NMES device was non-inferior to the ankle-foot orthosis on 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 significant between-group differences for any of the outcomes.
 
Secondary analysis of data from this study was reported in 2014 (O’Dell, 2014). 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 use of the footdrop stimulator. A responder was defined as achieving a minimal clinically important difference (MCID) of 0.1 m/sec on the 10-m walk test (10MWT) or advancing by at least 1 Perry Ambulation Category. Non-completers were classified as non-responders. Seventy percent of participants completed the assessments at 42 weeks, and 67% of participants were classified as responders. Out of the 32 participants who were classified as non-responders, 2 were non-responders and 30 were non-completers. The percentage of patients in the conventional AFO group who were classified as responders at 30 weeks was not reported. There were 160 adverse events (AEs), of which 92% were classified as mild. Fifty percent of the AEs were related to reversible skin issues and 27% were falls.
 
Ongoing and Unpublished Clinical Trials
A search of online site www.ClinicalTrials.gov in December 2014 identified the following studies with a neuroprosthesis:
  • NCT00890916 is a phase 1/2 study from the Department of Veteran Affairs of the FIRSTHAND System in patients with spinal cord injury. There is an estimated enrollment of 7 patients with anticipated completion in December 2013. 2014.
  • NCT00583804 will evaluate the efficacy of an implanted stimulator and sensor on hand and arm function in 50 patients with spinal cord injury. Estimated study completion date is January 2014. 2027.
  • NCT01237860 is a manufacturer-sponsored phase 3 study of the NESS L300 Plus System. Enrollment was estimated at 45 patients with completion in January 2011. This study had an enrollment of 45 and is listed as completed. No results have been posted.
 
2017 Update
A literature search conducted through July 2017 did not reveal any new information that would prompt a change in the coverage statement.
 
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2018. No new literature was identified that would prompt a change in the coverage statement.  

CPT/HCPCS:
64565Percutaneous implantation of neurostimulator electrode array; neuromuscular
64580Incision for implantation of neurostimulator electrode array; neuromuscular
E0745Neuromuscular stimulator, electronic shock unit
E0764Functional neuromuscular stimulation, transcutaneous stimulation of sequential muscle groups of ambulation with computer control, used for walking by spinal cord injured, entire system, after completion of training program
E0770Functional electrical stimulator, transcutaneous stimulation of nerve and/or muscle groups, any type, complete system, not otherwise specified
E1399Durable medical equipment, miscellaneous

References: Bethoux F, Rogers HL, Nolan KJ, et al.(2014) 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

Brissot R, Gallien P, Le Bot MP, et al.(2000) Clinical experience with functional electrical stimulation assisted gait with Parastep in spinal cord-injured patients. Spine 2000;25(4):501-8.

Cauraugh JH, Naik SK, Hsu WH et al.(2010) Children with cerebral palsy: a systematic review and meta-analysis on gait and electrical stimulation. Clin Rehabil 2010; 24(11):963-78.

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

Davis JA Jr, Triolo RJ, Uhlir J, et al.(2001) Preliminary performance of a surgically implanted neuroprosthesis for standing and transfers – where do we stand. J Rehabil Res Dev 2001.

Everaert DG, Stein RB, Abrams GM et al.(2013) Effect of a foot-drop stimulator and ankle-foot orthosis on walking performance after stroke: a multicenter randomized controlled trial. Neurorehabil Neural Repair 2013; 27(7):579-91.

Graupe D, Kohn KH.(1998) Functional neuromuscular stimulator for short-distance ambulation by certain thoracic-level spinal-cord-injured paraplegics. Surg Neurol 1998; 50:202-7.

Guest RS, Klose J, Needham-Shropshire, et al.(1997) Evaluation of a training program for persons with SCI paraplegia using the Parastep®1 Ambulation System: Part 4. Arch Phys Med Rehab 1997; 78:904-07.

Jacobs PL, Nash MS, Klose J, et al.(1997) Evaluation of a training program for persons with SCI paraplegia using the Parastep®1 Ambulation System: Part 2. Effects on physiologic responses to peak arm ergonometry. Arch Phys Med Rehab 1997; 78:794-98.

Klose KJ, Jacobs PL, Broton JG, et al.(1997) 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 Rehab 1997; 78:789-93.

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

Meilahn JR.(2013) Tolerability and effectiveness of a neuroprosthesis for the treatment of footdrop in pediatric patients with hemiparetic cerebral palsy. PM R 2013 [Epub ahead of print].

Nash MS, Jacobs PL, Montalvo BM.(1997) Evaluation of a training program for persons with SCI paraplegia using the Parastep®1 Ambulation System: Part 5. Arch Phys Med Rehab 1997; 78:808-14.

Needham-Shropshire BM, Broton JG, Klose J, et al.(1997) Evaluation of a training program for persons with SCI paraplegia using the Parastep®1 Ambulation System: Part 3. Arch Phys Med Rehab 1997; 78:799-803.

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

Prosser LA, Curatalo LA, Alter KE et al.(2012) Acceptability and potential effectiveness of a foot drop stimulator in children and adolescents with cerebral palsy. Dev Med Child Neurol 2012; 54(11):1044-9.

Sykes L, Ross ER, Powell ES, et al.(1996) 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 1996; 20(3):182-90.


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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