BlueCross and BlueShield of Montana Medical Policy/Codes
Functional Neuromuscular Electrical Stimulation (FNMES)
Chapter: Therapies
Current Effective Date: June 01, 2013
Original Effective Date: June 16, 2011
Publish Date: June 01, 2013
Revised Dates: April 6, 2012; April 3, 2013
Description

Functional neuromuscular electrical stimulation (FNMES) is a method being developed to restore function to patients with damaged or destroyed nerve pathways through use of an orthotic device with microprocessor-controlled electrical neuromuscular stimulation.

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.  FNMESs 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 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 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 reeducation, 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 FNMES 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.  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’ radio-frequency 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 FNMES is to provide spinal cord injured patients with the ability to stand and walk.  Generally, only spinal cord injury patients with lesions from T4-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. 

To date, the Parastep® Ambulation System is the only noninvasive functional walking neuromuscular stimulation device to receive premarket approval 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.”  Other devices include a reciprocating gait orthosis (RGO) 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.

Policy

Investigational

Blue Cross Blue Shield of Montana (BCBSMT) considers functional neuromuscular electrical stimulation (FNMES) as a technique to restore function following nerve damage or nerve injury experimental, investigational and unproven.  This includes, but is not limited to, its use in the following situations:

  • As a technique to provide ambulation in patients with spinal cord injury; or
  • 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 foot drop caused by nerve damage (e.g., post-stroke or in those with multiple sclerosis).

Federal Mandate

Federal mandate prohibits denial of any drug, device, or biological product fully approved by the FDA as investigational for the Federal Employee Program (FEP). In these instances coverage of these FDA-approved technologies are reviewed on the basis of medical necessity alone. Call the BCBSMT FEP Customer Service Department at 1-800-634-3569 for benefit information.

Rationale for Benefit Administration

This medical policy was developed through consideration of peer reviewed medical literature, FDA approval status, accepted standards of medical practice in Montana, Technology Evaluation Center evaluations, and the concept of medical necessity. BCBSMT reserves the right to make exceptions to policy that benefit the member when advances in technology or new medical information become available.

The purpose of medical policy is to guide coverage decisions and is not intended to influence treatment decisions. Providers are expected to make treatment decisions based on their medical judgment. Blue Cross and Blue Shield of Montana recognizes the rapidly changing nature of technological development and welcomes provider feedback on all medical policies.

When using this policy to determine whether a service, supply or device will be covered please note that member contract language will take precedence over medical policy when there is a conflict.

Rationale

Ambulation in Patients with Spinal Cord Injury

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, or positively affect 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 (Chaplin, 1996).  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 five studies from the same group of investigators, which focused on different outcomes in the same group of 13–15 patients (Klose et al., 1997; Jacobs et al., 1997; Needham-Shropshire et al., 1997; Guest et al., 1997; Nash et al., 1997).  In a 1997 study, Guest and colleagues reported on the ambulation performance of 13 men and three women with thoracic motor complete spinal injury (Giest et al., 1997).  All patients underwent 32 training sessions prior to measuring ambulation.  The group’s 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 patients to get out of the wheelchair at will, stretch, and take a few steps every day (Graupe, Kohn, 1998). 

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 (Chaplin, 1996; Brissot et al., 2000; Davis et al., 2001; Sykes et al., 1996).  There are no data regarding whether patients remain compliant and committed with long-term use.

Brissot and colleagues reported independent ambulation was achieved in 13 of 15 patients, with two patients withdrawing from the study.  In the home setting, five of the 13 patients continued using the device for physical fitness, but none used it for ambulation.  Sykes and colleagues found low use of an RGO 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.

In summary, as stated by various authors, the Parastep system 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.

Functional Neuromuscular Electrical Stimulation of the Upper Extremity

Spinal Cord Injury

Most of the early published evidence for upper extremity devices to restore function in patients with spinal cord injuries report experience with the Freehand System, an implantable device that is no longer marketed in the U.S. (Mulcahey et al., 2004; Mulcahey et al., 1997; Taylor et al., 2002).  The device is controlled through a joystick on the shoulder or wrist.  A disadvantage of this system is that additional surgery is required to repair hardware failures.  The published studies, all case series with fewer than 10 subjects, suggest that the device may give patients the ability to grasp and release objects, and independence or greater independence in such activities of daily living 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 are not provided.  In a review of the role of electrical stimulation for rehabilitation and regeneration after spinal cord injury, Hamid and Hayek report that the company that marketed the Freehand System in the United States no longer manufactures new devices. 

Use of the Handmaster NMS I was reported in a series of 10 patients with cervical spinal cord injuries Snoek et al., 2000).  After two months of training, performance on a defined set of tasks and one or more tasks chosen by the patient was evaluated.  In six 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 using the Handmaster, while they were not able to do so without the Handmaster.  Eventually, one patient continued using the Handmaster during activities of daily living (ADLs) at home.  In another study using the Handmaster device, seven subjects with C5 or C6 spinal cord injury practiced using the device daily on one of their paralyzed hands to regain the ability to grasp, hold, and release objects (Alon et al., 2003).  They were observed 2-3 times weekly for three weeks and their ability to pick up a telephone, eat food with a fork, and perform an individually selected activity of daily living task plus two grasp-, hold-, and release- tasks was evaluated.  At the end of the study, all seven subjects were successful at using the device in the studied ADLs, and grasp-, hold-, and release-tasks.  Improvements occurred in secondary measures of grip strength, finger linear motion, and Fugl-Meyer (developed to assess sensory-motor recovery after stroke) scores.

Hamid notes that, with either device, there is a time delay of 1-2 seconds between command generation and execution of grasp function, which interferes with the speed with which the patient can grasp and release objects.

Stroke

Alon and colleagues (2003) investigated whether the Handmaster system could improve selected hand function in persons with chronic upper extremity paresis following stroke, reporting on a case series of 29 patients.  The main outcome measures were three ADL tasks: lifting a two-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 spherical grasp, and perceived pain scale.  At the end of the three-week study period, the percent of successful trials compared to baseline were: lifting pot, 93% versus 0%, lifting 600 gram weight, 100% versus 14%, and lifting bag, 93% versus 17%.  All subjects performed their selected ADL successfully and improved their Fugl-Meyer scores using the neuroprosthesis.

Interpretation of the evidence for upper extremity neuroprostheses for patients with spinal cord injuries or post-stroke is limited by the small number of subjects and lack of data demonstrating its utility outside the study setting.  The available evidence is insufficient to conclude that FNMES improves outcomes by providing some upper extremity function.

Functional Neuromuscular Electrical Stimulation for Foot Drop

Stroke and Spinal Cord Injury

In 1999, Taylor et al. reported a retrospective study on the clinical use of the Odstock Dropped Foot Stimulator in 151 patients with chronic foot drop resulting from an upper motor lesion Taylor et al., 1999).  This retrospective study included 27 age-matched able-bodied controls and 140 patients (93%) who used the device for at least 4.5 months (111 patients with chronic foot drop due to stroke, 21 patients with multiple sclerosis [MS, described below], and eight patients with incomplete spinal cord injury).  The average time since stroke was 5.4 years.  Walking speed was assessed on a 10-meter course.  The physiologic cost index (PCI), which is an indication of the amount of effort in walking, was assessed by the difference between resting heart rate and heart rate during walking, divided by the average walking speed over the 4-minute walking period and reported as beats per meter.  In stroke patients, the immediate (orthotic) effect of the stimulation was an increase in walking speed of 12% and a decrease in PCI of 18%.  An improvement over time was also observed, with an increase in walking speed of 14% and a reduction of PCI of 19%, suggesting a therapeutic, as well as orthotic effect for this group.  Over 50% of patients with stroke or spinal cord injury achieved a therapeutic effect of greater than 10% increase in walking speed or 10% decrease in PCI.

Three reports from Israel describe the effects of the NESS L300 for post-stroke foot drop.  Hausdorff and Ring report on gait symmetry and rhythmicity in 24 patients with chronic hemiparesis whose walking was impaired by foot drop.  Subjects increased time wearing the prosthesis from one hour per day to all day over a four-week period, then wore it all day for four weeks.  In response to a yes/no question, all 24 patients reported that they increased their physical activities (not quantified) and had greater confidence in walking on inclines and/or uneven ground while wearing the prosthesis.  Fourteen subjects recalled one or more falls occurring in the two months before the study, and no subject reported falling while wearing the prosthesis.  Laufer et al. report a repeated measures follow-up of 16 patients with chronic hemiparesis who used the prosthesis for one year and were available for follow-up.  Outcome measures included the Short Version and the Participation domain of the Stroke Impact Scale.  Gains of 18% in physical functioning and 25% in participation in community life were attained two months after application of the device and maintained at one year.  In a study by Ring et al., 15 patients with chronic hemiparesis from stroke or traumatic brain injury who regularly used an ankle-foot orthosis which was adapted to the neuroprosthesis increased their daily use while using their ankle-foot orthosis the remainder of the day.  Outcomes related to activities of daily living, safety, or quality of life were not reported.

Van Swigchem et al. published a within-subject comparison of an FNMES device (NESS L300) and an ankle-foot orthosis (AFO) in 26 patients with chronic (> six months) post-stroke foot drop in 2010.  Baseline walking speed on a 10-meter walkway was assessed with the patient’s custom made AFO physical activity at home was measured with a pedometer and averaged over seven days, and satisfaction with the device was assessed with a “purpose-designed” 5-point questionnaire.  After a 2-week period of adaptation to the NESS L300, walking speed was assessed with both the AFO and the NMES devices.  For the next six weeks, patients increased use of the NMES device to the whole day, using the AFO one hour a day in order to maintain familiarity of walking with this device.  At the end of the study, walking speed was assessed with both the AFO and the NMES devices, while activity at home and satisfaction were assessed for the NMES device.  Two patients dropped out of the study due to discomfort from the electrical stimulation (n=1) and skin reaction to the electrodes (n=1).  The remaining 24 patients provided an average satisfaction rating of 3.0 (neutral) for the AFO and 4.0 (satisfied) for the NMES device regarding comfort to wear, appearance, quality of gait, walking distance, effort of walking, and stability during gait.  The objective measures of walking speed (1.02 for the AFO and 1.03 for NMES) and steps per day (5,541 for the AFO and 5,733 for NMES) were not significantly different for the two devices.

In 2010, Stein et al. reported improvements in both the orthotic and therapeutic effects of NMES in 41 patients with chronic nonprogressive foot drop (26 stroke, nine spinal cord injury, three surgical complication, two head injury, and one cerebral palsy) and 32 patients with progressive foot drop (described in more detail following) after 1, 2, 3, 6, 9, and 11 months of use.  The orthotic effect of the device was considered to be the immediate effect of NMES measured at any of the time points with the stimulator on compared to off.  The therapeutic effect was the improvement over time (improvement in neuromuscular function) measured under the same conditions (i.e., stimulator on vs. on or stimulator off vs. off) at different time points.  With the stimulator on compared to off (orthotic effect), walking speed improved by 5% for a figure-8 (0.59 vs. 0.56 m/s) and 6% for a 10-meter test (0.80 vs. 0.76 m/s).  With the stimulator off, walking speed at three months had improved by 17% for a figure 8 (0.56 vs. 0.48 m/s) and 12% for a 10-meter test (0.76 vs. 0.68 m/s – all respectively) compared to baseline.  The combined (orthotic and therapeutic) improvement in walking speed over the three months was 23% for the figure-8 (0.59 vs. 0.48 m/s) and 18% for the 10-meter test (0.80 vs. 0.68 m/s –both respectively).  Only 14 subjects (35%) returned for testing after 11 months due to external factors (e.g., cost of the device, distance from the test site).  Analysis indicated no differences between subjects who were in the study for three months and those who returned at 11 months.  Continued use resulted in total improvement of 39% on the figure-8 (0.74 vs. 0.54 m/s) and 32% on the 10-meter test (1.02 vs. 0.77 m/s – both respectively).  The PCI improved by -18% (0.70 vs. 0.86 beats/m, respectively) at 11 months.  Subjects with nonprogressive foot drop used the device for an average 73% of days, 7.3 hours per day, and walked nearly 2 km/day.

Multiple Sclerosis

The 1999 study by Taylor et al. described earlier included 21 patients with MS.  This group showed a 7% decrease in walking speed and a 16% increase in PCI over the course of the study when not using the Odstock Dropped Foot Stimulator (absence of a therapeutic effect), while use of the stimulator (orthotic effect) resulted in an increase in walking speed of 16% and a decrease in PCI of 24%.

In 2009, a randomized controlled trial of FNMES to improve walking performance in patients with MS was published by Barrett and colleagues.  Fifty-three patients with secondary progressive MS and unilateral dropped foot were randomized to an 18-week program of either FNMES of the common peroneal nerve using a single channel Odstock Dropped Foot Stimulator or a home exercise program, and assessed at 6, 12, and 18 weeks.  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 two 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.  The primary outcome measure was walking speed over a 10-meter distance.  Two secondary outcome measures were energy efficiency based on increase in heart rate during walking and walking distance in three minutes.  Six subjects in the FNMES group and three in the exercise dropped out very early in the study leaving 20 in the FNMES group and 24 in the exercise group.  In the FNMES group, mean changes between baseline and 18-week measures were non-significant for all three outcome measures, both with and without stimulation.  However, within the FNMES group, when mean values for walking speed and distance walked were compared with and without stimulation, outcomes were significantly better with stimulation.  In the exercise group, increases in walking speed over 10 meters and distance walked in three minutes were highly significant, P=0.001 and P=0.005 respectively.  At 18 weeks, the exercise group walked significantly faster than the FNMES group (P=0.028).  The authors note 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 (issues with blinding), and the validity and reliability of the three-minute walk test have not been confirmed (fatigue prevented use of the validated six-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 impacted adherence to the exercise regimen as well as retention in the trial.  The authors concluded that “while a simple program of home exercise therapy appears to significantly increase walking speed and endurance over an 18 week intervention period, single channel common peroneal stimulation does not.  However, it does appear to have a significant orthotic benefit, resulting in significantly increased walking speed and endurance when performance without stimulation is compared to performance with stimulation.”

A 2010 publication by the same group of investigators reported the impact of 18 weeks of physiotherapy exercises or the Odstock Dropped Foot Stimulator on activities of daily living (ADL) (Esnouf et al., 2010).  Results of 53 patients from the trial described above were reported, using the Canadian Occupational Performance Measure (COPM).  The COPM is a validated semi-structured interview that was originally designed to assist the design of 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 problems had an increased score of 2 or more) than the exercise group (17% of problems had an increased score of 2 or more).  The median satisfaction rating improved from 2.2 to 4.0 in the NMES group and remained stable (from 2.6 to 2.4) in the exercise group.  The median number of falls recorded per patient over the 18-week study period was five in the NMES group and 18 in the exercise group.  About 70% of the falls occurred while not using the NMES device or an ankle-foot orthotic device.

In a preliminary study, Sheffler et al. compared functional ambulation tasks under conditions of no device or peroneal nerve stimulator.  Eleven subjects with MS, dorsiflexion weakness, and prior usage of an ankle-foot orthosis were evaluated on the timed 25-foot walk component of the MS Functional Composite and the Floor, Carpet, Up and Go, Obstacle, and Stair components of the Modified Emory Function Ambulation Profile.  Performance on Stair and Obstacles components was enhanced in the stimulator condition versus no device (P=.05 and P=.09 respectively), and there were no significant differences between no device and stimulator conditions on other measures.  The authors concluded that “the neuroprosthetic effect of the peroneal nerve stimulator is modest relative to no device in the performance of specific functional tasks of ambulation in MS gait.  A longitudinal, controlled trial is needed to show effectiveness.”

The study by Stein et al. described above also assessed the orthotic and therapeutic effects of NMES in 32 patients with progressive foot drop (31 MS and one familial spastic paresis).  With the stimulator on compared to off (orthotic effect), walking speed improved by 2% for a figure-8 test and 4% for a 10-meter test.  With the stimulator off (therapeutic effect), walking speed at three months had improved by 9% for a figure-8 test and 5% for a 10-meter test when compared to baseline.  The combined improvement in walking speed over the three months was 13% for the figure-8 (0.61 vs. 0.53 m/s) and 13% for the 10-meter test (0.88 vs. 0.78 m/s – both respectively).  The 20 subjects (63%) who returned for testing at 11 months did not show continued improvement when compared to three-month test results, with a combined (orthotic and therapeutic) improvement of 13% on the figure-8 (0.62 vs. 0.55 m/s) and 10% on the 10-meter test (0.86 vs. 0.78 m/s – both respectively) compared to baseline.  The PCI was not significantly improved (0.73 vs. 0.78 b/m, respectively).  Subjects with nonprogressive foot drop used the device for an average 85% of days, 9.2 hours per day, and walked about 2 km/day.

A search of www.ClinicalTrials.gov (available online) in March 2012 identified a number of studies on FNMES for treatment of patients with acute and chronic stroke conditions.

In January 2009, the National Institute for Health and Clinical Excellence (NICE) published guidance stating that the current evidence on functional electrical stimulation (FES) for drop foot of neurologic origin appears adequate to support its use, provided that normal arrangements are in place for clinical governance, consent, and audit.  They noted that patient selection should involve a multidisciplinary team.  NICE advises that further publication on efficacy of FES would be useful, specifically including patient-reported outcomes, such as quality of life and activities of daily living, and these outcomes should be examined in different ethnic and socioeconomic groups.

Summary

FNMES is a method being developed to restore function to patients with damaged or destroyed nerve pathways (e.g., stroke, spinal cord injury, multiple sclerosis) through use of an orthotic device with microprocessor-controlled electrical stimulation.  Evidence for neuromuscular stimulation to provide functional movement is limited by the small number of subjects studied to date.  A cross-over study of NMES and AFO in patients with chronic post-stroke foot drop showed improved satisfaction with NMES but no change in walking speed.  A small randomized trial examining neuromuscular stimulation for foot drop in patients with MS showed a reduction in falls and improvement in satisfaction when compared to a program of exercise, but did not demonstrate a clinically significant benefit in walking speed.  Additional study in a larger number of subjects is needed to permit conclusions regarding the effect of this technology on health outcomes.  Therefore, FNMES remains experimental, investigational and unproven.

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. 

Rationale for Benefit Administration
 
ICD-9 Codes

340, 342.0-342.92, 343.0, 334.1, 344.00-344.9, 433.01, 433.11, 433.21, 433.31, 433.81, 433.91, 736.79, 780.72, 806.0-806.9

ICD-10 Codes
G35, G81.00-G.8194, G82.20-G82.54, G83.0-G83.9, I63.00- I63.9, I69.30-I69.398, M21.371-M21.379
Procedural Codes: 97116, 97530, 97760, E0764, E0770, A4595
References
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  2. Chaplin E. Functional neuromuscular stimulation for mobility in people with spinal cord injuries.  The Parastep I System.  J Spinal Cord Med 1996; 19(2):99-105.
  3. 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 1997; 78(8):789-93.
  4. 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 physiologic responses to peak arm ergometry.  Arch Phys Med Rehabil 1997; 78(8):794-8.
  5. 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.  Arch Phys Med Rehabil 1997; 78(8):799-803.
  6. 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.  Arch Phys Med Rehabil 1997; 78(8):808-14.
  7. Guest RS, Klose J, Needham-Shropshire BM et al.  Evaluation of a training program for persons with SCI paraplegia using the Parastep®1 Ambulation System: part 4.  Arch Phys Med Rehabil 1997; 78(8):804-7.
  8. 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 1997; 78(6):597-607.
  9. Graupe D, Kohn KH.  Functional neuromuscular stimulator for short-distance ambulation by certain thoracic-level spinal-cord-injured paraplegics.  Surg Neurol 1998; 50(3):202-7.
  10. Taylor PN, Burridge JH, Dunkerley AL et al.  Clinical use of the Odstock dropped foot stimulator: its effect on the speed and effort of walking.  Arch Phys Med Rehabil 1999; 80(12):1577-83.
  11. Snoek GJ, MJ IJ, in't Groen FA et al.  Use of the NESS handmaster to restore handfunction in tetraplegia: clinical experiences in ten patients.  Spinal Cord 2000; 38(4):244-9.
  12. Brissot R, Gallien P, Le Bot MP et al.  Clinical experience with functional electrical stimulation-assisted gait with Parastep in spinal cord-injured patients.  Spine 2000; 25(4):501-8.
  13. 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 2001; 38(6):609-17.
  14. Taylor P, Esnouf J, Hobby J.  The functional impact of the Freehand System on tetraplegic hand function.  Clinical Results.  Spinal Cord 2002; 40(11):560-6.
  15. Alon G, McBride K, Ring H.  Improving selected hand functions using a noninvasive neuroprosthesis in persons with chronic stroke.  J Stroke Cerebrovasc Dis 2002; 11(2):99-106.
  16. Alon G, McBride K. Persons with C5 or C6 tetraplegia achieve selected functional gains using a neuroprosthesis.  Arch Phys Med Rehabil 2003; 84(1):119-24.
  17. Mulcahey MJ, Betz RR, Kozin SH et al.  Implantation of the Freehand System during initial rehabilitation using minimally invasive techniques.  Spinal Cord 2004; 42(3):146-55.
  18. Hamid S, Hayek R.  Role of electrical stimulation for rehabilitation and regeneration after spinal cord injury: an overview.  Eur Spine J 2008; 17(9):1256-69.
  19. Hausdorff JM, Ring H.  Effects of a new radio frequency-controlled neuroprosthesis on gait symmetry and rhythmicity in patients with chronic hemiparesis.  Am J Phys Med Rehabil 2008; 87(1):4-13.
  20. Laufer Y, Hausdorff JM, Ring H.  Effects of a foot drop neuroprosthesis on functional abilities, social participation, and gait velocity.  Am J Phys Med Rehabil 2009; 88(1):14-20.
  21. Ring H, Treger I, Gruendlinger L et al.  Neuroprosthesis for footdrop compared with ankle-foot orthosis: effects on postural control during walking.  J Stroke Cerebrovasc Dis 2009; 18(1):41-7.
  22. 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 2009; 15(4):493-504.
  23. Sheffler LR, Hennessey MT, Knutson JS et al.  Neuroprosthetic effect of peroneal nerve stimulation in multiple sclerosis: a preliminary study.  Arch Phys Med Rehabil 2009; 90(2):362-5.
  24. National Institute for Health and Clinical Excellence.  Functional electrical stimulation for drop foot of central neurological origin 2009.  Available at: www.nice.org (accessed 2012 January).
  25. van Swigchem R, Vloothuis J, den Boer J et al.  Is transcutaneous peroneal stimulation beneficial to patients with chronic stroke using an ankle-foot orthosis?  A within-subjects study of patients' satisfaction, walking speed and physical activity level.  J Rehabil Med 2010; 42(2):117-21.
  26. 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 2010; 24(2):152-67.
  27. 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 2010; 16(9):1141-7.
  28. Functional Neuromuscular Electrical Stimulation.  Chicago, Illinois:  Blue Cross Blue Shield Association Medical Policy Reference Manual (2012 February).  Therapy 8.03.01.
History
June 2011 Neuromuscular stimulation policy retired, This policy created with statement of investigational; changed from not medically necessary when functional neuromuscular elecrical stimulation was included in the general neuromuscular stimulation policy. CRSP updated.
April 2012 Policy updated with literature review through December 2011; reference 25 added; policy statement unchanged
April 2013 Title changed from "Functional Neuromuscular Electrical Stimulation" to "Functional Neuromuscular Electrical Stimulation (FNMES)".  Policy language and formatting revised.  Policy statement unchanged.  Added HCPCs code A4595.
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Functional Neuromuscular Electrical Stimulation (FNMES)