Medical Policy Non-covered Home Electrical Stimulation Devices

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1 Effective Date: September 2008; Revised [9/10; 9/12; 9/14; 9/16] Subject: Non-covered Home Electrical Stimulation Devices Medical Policy Non-covered Home Electrical Stimulation Devices Overview: Electrical stimulation devices are used in a variety of ways to rehabilitate and treat injured and healing tissues. Many are used as part of a supervised rehabilitation plan in an effort to restore muscle functionality. Some devices can also be prescribed for home use as part of a treatment plan. Policy and Coverage Criteria: Harvard Pilgrim does NOT cover functional electrical stimulation devices for home use as they are considered not medically necessary based on insufficient proof of long-term efficacy in current literature. Examples of these devices include (but not limited to): NESS H200; NESS L300; NESS L300 Plus Bionicare Knee System WalkAide Odstock Dropped Foot Stimulator (ODFS) Pace Exclusions: N/A Supporting Information: 1. Technology Assessment: Functional electric stimulation (FES) devices and neuromuscular electric stimulation (NMES) devices are used in a variety of ways to help rehabilitate and restore muscle function. FES has been designed to help replace stimuli from destroyed nerve pathways and assist patients with neurological damage with functional movement and suppress spasticity. NMES is intended to promote muscle restoration and prevent or diminish muscle atrophy and spasms. Both are primarily used in comprehensive rehabilitation programs. 2. Literature Review: Studies evaluating the safety and efficacy of FES and NMES devices are varied. Most studies report on findings from clinician supervised treatment programs. However, some devices have also been designed for use at home by the patient. There is less information on the safety and efficacy of these devices when used unsupervised in the home-setting. Studies showing long-term benefits of home use and sustained improvements in functional outcomes are lacking. NESS H200; NESS L300: Upper limb: There is limited amount of published literature regarding functional electrical stimulation (FES) of the upper limb following stroke. Ring and Rosenthal (2005) evaluated the effects of daily neuroprosthetic (NESS Handmaster) FES in sub-acute stroke. 22 patients were classified into a group with no active finger movement or a group with partial active finger movements. Patients were then randomized to control and neuroprosthesis groups. Observer blinded evaluations were performed at baseline and completion of the 6-week study. The neuroprosthesis group used the device at home. The neuroprosthesis group had significantly greater improvements in spasticity, active ROM and scores on the functional hand tests (those with partial active motion). Based on the study results, the authors concluded the addition daily home neuroprosthetic activation improves upper limb outcomes when combined with traditional rehabilitation.

2 Studies by Meilink et al. (2008), Meijer et al. (2009), (Hesse et al. 2008) also looked at upper limb stimulation following stroke. Short-term results were promising, but further studies are needed to support long-term, home use. Lower limb: Danino et al. (2013) discussed results of 5 hemiplegic patients treated with FES NESS L300 to improve gait. Results found all scores improved when walking with stimulation. However, no significant improvements were noted. At the 1-year follow-up, all patients expressed high satisfaction. A small study by Hausdorff and Ring reported improved gait and dynamic stability in study of 24 patients experiencing foot drop with chronic hemiparesis. Patients were treated on an outpatient basis with the NESS L300. A small study by van Swigchem et al. (2010) evaluated whether community-dwelling chronic stroke patients wearing an ankle-foot orthosis would benefit from changing to FES for the peroneal nerve. 26 patients began wearing the NESS L300. A baseline walking speed was recorded with the original ankle-foot orthosis. Walking speed was also measured at 2 and 8 weeks with both the orthosis and FES. Patients satisfaction was assessed with a questionnaire at baseline and at week 8. Results showed patients were more satisfied after the addition of FES. However, measurements of walking speed and physical activity could not objectify the reported benefits of FES. The authors noted additional outcome measures are needed to quantify the FES benefits in this population. The NESS L300 Plus is an expanded FES system for foot drop that includes a thigh cuff to assist in the bending and straightening of the knee. Bionicare Knee System: The BioniCare Knee System (formerly the BioniCare Bio-1000 System) is a noninvasive, low-amplitude, pulsed electrical stimulation (PES) device designed to reduce pain and improve function in patients with osteoarthritis of the knee. The device, which is used by outpatients, consists of a signal generator, signal applicator and contact elements encased in a soft wrap with a Velcro closure. PES is intended for patients with knee pain due to osteoarthritis who do not respond well to nonsteroidal anti-inflammatory drug treatment or who are candidates for total knee arthroplasty. There are few peer-reviewed studies evaluating the effects of the BioniCare Knee System for knee osteoarthritis. A manufacturer-sponsored study conducted by Zizic et al., 78 patients were randomly allocated to active or sham treatment using an identical-appearing device for 6 hours per day for 4 weeks and were followed for 6 months. Primary outcomes included patient pain, patient function, and physician global evaluation of patient condition. Patients treated with the active device demonstrated significantly greater improvement compared with baseline values than the placebo group for all primary outcomes. There was 50% improvement in all three primary outcomes in 24% of the active device group versus 6% of the placebo group (P<0.05). Patients treated with the active device experienced 120% improvement in pain and associated osteoarthritis symptoms compared with the placebo group. A 2006 study by Farr et al. showed that after 750 hours of cumulative use of a pulsed electrical stimulation device there was an improved dose-response. Less than 250 hours of therapy provided symptom relief. The clinical trial evaluated 288 patients who had previously failed non-operative therapy for knee osteoarthritis. Mont et al. (2006) reported on results of a controlled trial that evaluated the BioniCare device in 157 patients with knee OA. Patients were instructed to use the device daily and were allowed to use it up to 4 years. Outcomes were compared to a historical control group of 101 OA patients mached for age, gender and weight who had undergone total knee replacement. At the end of 4 years, 40% of the study patients had elected to undergo knee replacement. The study found patients who used the BioniCare device were more likely to defer knee replacement. However, the study contained large flaws and is not able to effectively compare the two groups. WalkAide: The WalkAide device is designed to improve gait and ambulation for patients with foot drop due to neuromuscular damage. It has been evaluated in patients with foot drop from central nervous system conditions like stroke and multiple sclerosis. A trial published in 2016 (El-Shamy and Abdelaal) investigated the effects of WalkAide FES on gait pattern and energy expenditure in children with hemiplegic cerebral palsy. The trial included 17 children who received FES and 17 children who participated in a conventional physical therapy exercise program for 3 successive months. Assessments were made at baseline and posttreatment using the GAITRite system to evaluate gait parameters and using an open-circuit indirect calorimeter to evaluate energy expenditure. The results showed that children in the study group showed a significant improvement compared to the control group. The authors concluded that

3 the WalkAide functional electrical stimulation may be a useful tool for improving gait pattern and energy expenditure in children with hemiplegic cerebral palsy. A 2014 trial (van der Linden et al.) investigated the medium term effects of FES to treat foot-drop over a period of 12 weeks on gait and patient reported outcomes for patients with MS. Results found FES to treat foot-drop appears to offer the potential for a medium term training effect on ankle kinematics and walking speed, yet this did not correspond with the patient reported outcomes. The authors observed this discrepancy warrants further investigation. Everaert et al. (2013) reported results of a study comparing the effect of the Walkaide to a traditional ankle-foot orthosis in patients experiencing foot drop following a stroke. Individuals with stroke within the previous 12 months and residual foot drop were enrolled in a multicenter, randomized controlled, crossover trial. Primary outcomes were walking speed and Physiological Cost Index for the Figure-of-8 walking test. Secondary measures included 10-m walking speed and perceived safety during this test, general mobility, and device preference for arms 1 and 2 for continued use. Walking tests were performed with (On) and without a device (Off) at 0, 3, 6, 9, and 12 weeks. Results found both devices had significant orthotic and therapeutic effect on walking speed. Combined effects on speed after 6 weeks did not differ between the devices. The authors noted more patients preferred the Walkaide, but both devices produced equivalent functional gains. study by Stein et al. (2010) reported on the results of a multicenter, nonrandomized prospective trial evaluating WalkAide for treating foot drop in two different groups of patients. The orthotic and therapeutic effects of the WalkAide on straight line and figure-8 walking performance on patients with chronic nonprogressive disorders (i.e., stroke, spinal cord injury, head injury, cerebral palsy) and chronic progressive disorders (secondary progressive multiple sclerosis, familial spastic paraparesis) resulting in foot drop were evaluated. 41 nonprogressive disorder patients and 32 progressive disorder patients participated. Patients were tested with the devices on and off to evaluate the orthotic effect and also both before and after use for the therapeutic effect. Follow up ranged from 3 to 11 months. At the 3 month follow up, both groups had similar significant orthotic and therapeutic effects on figure-8 walking speed. At 11 months, only the therapeutic effect was significant both groups. The non-progressive group continued to increase speed with and without the device compared to the progressive group who reached a plateau of gait speed with a tendency to decline in speed. While some improvements were seen, the study is limited by its small patient population, lack of randomization and control group, and a short-term follow up. Everaert et al. (2010) published a study looking at long-term use of the WalkAide. 10 patients with nonprogressive disorders and 26 with progressive disorders used the device for 3 to 12 months while walking. Walking performance and electrophysiological variables were measured before and after FES use. Measurements included motor-evoked potential from transcranial magnetic stimulation over the motor cortex, maximum voluntary contraction, and maximum motor wave from stimulating the common peroneal nerve. Compared with baseline, the mean increase in walking speed after use of the FES device in patients with progressive disorders was 7% and in patients with non-progressive disorders, the mean increase was 24%. The results suggest increased walking speed was not due to increased effort by the patient, but that patients may have been walking with less effort after FES use. There is not enough robust information showing functional electric stimulation for foot drop is effective in treating and improving foot drop. Available studies have small patient populations with short follow up periods. Odstock Dropped Foot Stimulator (ODFS) Pace: The ODFS Pace uses FES to elicit timed stimulation via a pressure-sensitive foot switch placed under the heel. Stimulation occurs after the heel is lifted from the ground and continues until after weight returns to the heel. This aims to lower the foot to the ground in a controlled manner. It is designed for people whose walking is affected due to nerve damage/disease in the spine or brain. A 2014 study by Miller et al. compared the orthotic effect of the Odstock device with the Walkaide in MS patients. 20 patients already using the Odstock device walked using the Odstock, the Walkaide and then without stimulation. Results of the small study found a significant increase in walking speed for the Odstock device and near significant increase with the Walkaide. The authors noted further research with larger study populations is needed to support the clinical impact of the devices. Paul et al. (2008) published the results of a RCT comparing the outcomes of 12 MS patients who received FES with the ODFS Pace with outcomes of matched controls not treated with FES. The aim was to investigate the effects of FES in terms of speed and physiological cost of gait. Results showed MS patients walked faster with FES

4 than without. The authors noted FES offers an orthotic benefit to MS patients and should be considered as a possible treatment option. A 2009 study by Barrett et al. randomly assigned 20 secondary progressive multiple sclerosis patients to FES and 24 patients to home exercise program in order to determine the effects of FES on walking performance. Patients had a dropped foot that was impairing mobility. Follow up was at 6, 12, and 18 weeks. Significant improvements in the 10 meter walking speed and distance walked in three minutes were seen in the exercise group. No significant improvement was seen in the FES group. Within the FES group, there was a significant increase in mean values for 10m walking speed and distance in three minutes with stimulation compared to no stimulation. Limitations of this study include the small patient population, no baseline walking analysis, and the drop out rate. Barrett and Taylor (2010) reported on perceived quality of life (QOL) changes in patients with stroke or MS using the ODFS. 21 patients completed the Psychosocial Impact of Assistive Devices Scale (PIADS) questionnaire after 18 weeks of using the ODFS. Both stroke and MS patients recorded positive median scores for Cometence, adaptability, and self-esteem. There was no significant correlation between changes in PIADS and changes in walking speed. The authors concluded FES for foot drop as a beneficial effect on perceived QOL, but it is not correlated with an objective measure of gait. A 2010 study by Esnouf et al. described results of an RCT comparing MS patients with food drop treated either with ODFS or with exercises. 32 patients underwent FES and 32 underwent physiotherapy. Outcome measures were the Canadian Occupational Performance Measure (COPM) and a falls diary. The FES group used the ODFS daily for mobility and the exercise group was instructed to perform exercise for about 30 minutes 1 to 2 times daily. Results showed improvements in performance and satisfaction scores were greater in the ODFS group than the exercise group. The FES patients also perceived a reduction in tripping and increased walking distance. 4. Professional/Governmental Organizations: FDA: NMES and FES devices are classified by the FDA as Class II and require a prescription. Codes: E0770 Fucntional electrical stimulatory, transcutaneous stimulation of nerve and/or muscle groups, any type, complete system, not otherwise specified E1399 Durable medical equipment, miscellaneous References: 1. Hayes, Inc. Search and Summary, Functional Electrical Stimulation (FES) for Upper Limb Rehabilitation Post- Stroke. Landsdale, PA: Hayes, Inc. September 5, Hayes, Inc. Health Technology Brief. Functional Electrical Stimulation (FES) for Treatment of Foot Drop in Multiple Sclerosis Patients. Lansdale, PA: Hayes, Inc. July 16, Ring, H., Rosenthal, N. Controlled study of neuroprosthetic functional electrical stimulation in sub-acute poststroke rehabilitation. J Rehabil Med Jan; 37(1): Hara Y., Ogawa S., Tsujiuchi K., Muraoka Y. A home-based rehabilitation program for the hemiplegic upper extremity by power-assisted functional electrical stimulation. Disabil Rehabil, 2008; 20(4): Berner YN, Lif Kimchi O, Spokoinv V, Finkeltov B. The effect of electric stimulation treatment on the finctional rehabilitation of acute geriatric patients with stroke a preliminary study. Arch Gerontol Geriatr, 39(2):125-32, Sept-Oct 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 Jan;87(1): Van Swigchem, R., Vloothuis, J., den Boer, J., et al. Is transcutaneous peroneal stimulation beneficial to patients with chronic stroke using an ankle-foot arthosis? A within-subjects study of patients satisfaction, walking speed and physical activity level. J Rehabil Med. 2010; 42(2): Hayes, Inc. Health Technology Brief: BioniCare Knee System (VQ OrthoCare) for Treatment of Osteoarthritis of the Knee. Lansdale, PA: Hayes, Inc. October 17, Zizic TM, Hoffman KC, Holt PA, et al. The treatment of osteoarthritis of the knee with pulsed electrical stimulation. J Rheumatol. 1995; 22(9): Mont, MA., Hungerford, DS., Caldwell, JR., et al. Pulsed electrical stimulation to defer TKA in patients with knee osteoarthritis. Orthopedics. 2006; 29(10):

5 11. Farr J, Mont MA, Farland D, Caldwell JR, Zizic TM. Pulsed electrical stimulation in patients with osteoarthritis of the knee: follow up in 288 patients who had failed non-operative therapy. Surg Technol Int. 2006; 15: Stein, RB., Everaert, DG., Thompson, AK., Chong, SL., Wittaker, et al. Long-term therapeutic and orthotic effects of a foot drop stimulator on walking performance in progressive and nonprogressive neurological disorders. Neurorehabil Neural Repai. 2010; 24(2): Barrett, CL., Mann, GE., Taylor, PN., Strike, P. 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): Paul, L., Rafferty, D., Young, S., Miller L., et al. The effect of functional electrical stimulation on the physiological cost of gait in people with multiple sclerosis. Mult Scler. 2008; 14(7): Barrett, C., Taylor, P. The effects of the odstock drop foot stimulator on perceived quality of life for people with stroke and multiple sclerosis. Neuromodulation. 201; 13(1): Esnouf, JE., taylor, PN., Mann, GE., Barrett, CL. 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. 201; 16(9): Van der Linden, ML., Hooper, JE., Cowan, P., et al. Habitual Functional Electrical Stimulation Therapy improves Gait Kinematics and Walking Performance, but not Patient-Reported Functional Outcomes, of People with Multiple Sclerosis who Present with Food-Drop. PLoS One. 2014; 9(8): e Miller, L., Rafferty, D., Paul, L., Mattison, P. A comparison of the orthotic effect of the Odstock Dropped Foot Stimulator and the Walkaide functional electrical stimulation systems on energy cost and speed of walking in Multiple Sclerosis. Disabil Rehabil Assist Technol Mar 17 [epub ahead of print]. 19. Meilink A, Hemmen B, Seelen HA, Kwakkel G. Impact of EMG-triggered neuromuscular stimulation of the wrist and finger extensors of the paretic hand after stroke: A systematic review of the literature. Clin Rehabil. 2008;22(4): Hesse, S., Werner, C., Pohl, M., et al. Mechanical arm trainer for the treatment of the severely affected arm after a stroke: a single-blinded randomized trial in two centers. Am J Phys Med Rehabil. 2008; 87(10): Meijer, JW., Voerman, GE., Santegoets, KM., Geurts, AC. Short-term effects and long-term use of a hybrid orthosis for neuromuscular electrical stimulation of the upper extremity in patients after chronic stroke. J Rehabil Med. 2009; 41(3): Danino, B., Khamis, S., Hemo, Y., et al. The efficacy of neuroprosthesis in young hemiplegic patients, measured by three different gait indicies: early results. J Child ORthop. 2013; 7(6): El-Shamy, SM., Abdelaal, AA. WalkAide efficacy on gait and energy expenditure in children with hemiplegic cerebral palsy: A randomized controlled trial. Am J Phys Med Rehabil. 2016; 95(9):