Latest Review Date: March 2024

Category: Durable Medical Equipment (DME)                                                                    

POLICY:

Neuromuscular stimulation as a technique to restore function following nerve damage or nerve injury is considered investigational in the following situations:

• As a technique to provide ambulation in individuals with spinal cord injury; or
• To provide upper extremity function in individuals with nerve damage (e.g., spinal cord injury or post-stroke); or
• To improve ambulation in individuals with foot drop caused by congenital disorders (e.g., cerebral palsy) or nerve damage (e.g., post-stroke or in those with multiple sclerosis).

Functional electrical stimulation devices for exercise in individuals with spinal cord injury are considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

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

Functional Neuromuscular Electrical Stimulation

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

FES 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 benefit the most from this technology.

Applications include upper-extremity grasping function after spinal cord injury and stroke, lifting the front of the foot during ambulation in individuals with foot drop, ambulation and exercise for patients with spinal cord injury. Some devices are used primarily for rehabilitation rather than home use. This evidence review focuses on devices intended for home use.

KEY POINTS:

This evidence review was created and updated regularly with searches of the PubMed database. The most recent literature update was performed through January 22, 2024.

Summary of Evidence

For individuals who have loss of hand and upper-extremity function due to SCI or stroke who receive FES, the evidence includes case series and a randomized controlled trial (RCT). The relevant outcomes are functional outcomes and QOL. Evidence on FES for the upper limb in patients with SCI or stroke includes a few small case series. The low number of patients studied and lack of data demonstrating the utility of FES outside the investigational setting limit interpretation of the evidence. It is uncertain whether FES can restore some upper-extremity function or improve the QOL. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have chronic foot drop who receive FES, the evidence includes randomized controlled trials (RCTs), meta-analyses, and a longitudinal cohort study. Relevant outcomes are functional outcomes and quality of life. For chronic poststroke foot drop, two RCTs comparing FES with a standard ankle-foot orthosis (AFO) showed improved patient satisfaction with FES but no significant differences between groups in objective measures such as walking. Another RCT found no significant differences between use versus no use of FES on walking outcomes. Similarly, one meta-analysis found no difference between AFO and FES in walking speed, and another meta-analysis found no difference between FES and conventional treatments. The cohort study assessed patients’ ability to avoid obstacles while walking on a treadmill using FES versus AFO. Although the FES group averaged a 4.7% higher rate of avoidance, the individual results between devices ranged widely. One RCT with 53 subjects examining neuromuscular stimulation for foot drop in patients with multiple sclerosis showed a reduction in falls and improved patient satisfaction compared with an exercise program but did not demonstrate a clinically significant benefit in walking speed. Another RCT showed that at 12 months, both FES and AFO had improved walking speed, but the difference in improvement between the two devices was not significant. Another study found FES (combined with postural correction) and neuroproprioceptive facilitation and inhibition physiotherapy did not differ in in walking speed or balance immediately or 2 months after program end. A reduction in falls is an important health outcome. However, it was not a primary study outcome and should be corroborated. The literature on FES in children with cerebral palsy includes 3 systematic reviews of small studies with within-subject designs. All included studies only measure short-term results; it is unclear what the long-term effects of FES may be in this population. Further study is needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

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

For individuals who have SCI who receive FES exercise equipment, the evidence includes prospective comparisons. The relevant outcomes are symptoms, functional outcomes, and QOL. The evidence on FES exercise equipment consists primarily of within subject, pre- to post-treatment comparisons. Evidence was identified on two commercially available FES cycle ergometer models for the home, the RT300 series and the REGYS/ERGYS series. There is a limited amount of evidence on the RT300 series. None of the studies showed an improvement in health benefits and one analysis of use for 314 individuals over 20000 activity sessions with a Restorative Therapeutics device showed that a majority of users used the device for 34 minutes per week. Two percent of individuals with SCI used the device for an average of six days per week, but caloric expenditure remained low. Compliance was shown in one study to be affected by the age of participants and level of activity prior to the study. Studies on the REGYS/ERGYS series have more uniformly shown an improvement in physiologic measures of health and in sensory and motor function. A limitation of these studies is that they all appear to have been conducted in supervised in research centers. No studies were identified on long-term home use of ERGYS cycle ergometers. The feasibility and long-term health benefits of using this device in the home is uncertain. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

National Institute for Health and Care Excellence

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

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Functional Neuromuscular Stimulation, Stimulation, Electrical, Functional Neuromuscular, Parastep, WalkAide, Handmaster, Bioness NESS L300, Odstock Foot Drop Stimulator, ReGrasp (Rehabtronics), NeuroControl Freehand®, MyGait® Stimulation System, Functional electrical stimulation, Freehand®, NESS H200®, MyndMove System, ReGrasp, WalkAide® System, ODFS® (Odstock Dropped Foot Stimulator), ODFS® Pace XL, L300 Go, L100 Go, Foot Drop System, MyGait® Stimulation System, ERGYS, RT300, Myocycle Home, StimMaster Orion, cycle ergometer, Nerve And Muscle Stimulator, MStim Drop Model LGT-233, Cionic Neural Sleeve NS-100, EvoWalk 1.0

APPROVED BY GOVERNING BODIES:

A variety of FES devices have been cleared by the U.S. Food and Drug Administration (FDA) and are available for home use. Table 1 provides examples of devices designed to improve hand and foot function as well as cycle ergometers for home exercise. The date of the FDA clearance is for the first 510(k) clearance identified for a marketed device. Many devices have additional FDA clearances as the technology evolved, each in turn listing the most recent device as the predicate.

Table 1. Functional Electrical Stimulation Devices Cleared by the FDA

FDA: Food and Drug Administration.

To date, the Parastep® Ambulation System (Sigmedics) 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 to T12) to stand and attain limited ambulation and/or take steps, with assistance if required, following a prescribed period of physical therapy training in conjunction with rehabilitation management of spinal cord injury.”  FDA product code: MKD.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP:  Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING: 

CPT Codes:

There are no specific CPT codes for these devices and associated services.

HCPCS:

REFERENCES:

1. Anderson KD, Korupolu R, Musselman KE, et al. Multi-center, single-blind randomized controlled trial comparing functional electricalstimulation therapy to conventional therapy in incomplete tetraplegia. Front Rehabil Sci. 2022; 3: 995244.
2. Berenpas F, Geurts AC, den Boer J, et al. Surplus value of implanted peroneal functional electrical stimulation over ankle-foot orthosis for gait adaptability in people with foot drop after stroke. Gait Posture. Jun 2019; 71: 157-162.
3. Bethoux F, Rogers HL, Nolan KJ, et al. The effects of peroneal nerve functional electrical stimulation versus ankle-foot orthosis in patients with chronic stroke: a randomized controlled trial. Neurorehabil Neural Repair. Sep 2014; 28(7):688-697.
4. Cauraugh JH, Naik SK, Hsu WH et al. Children with cerebral palsy: a systematic review and meta-analysis on gait and electrical stimulation. Clin Rehabil 2010; 24(11):963-78.
5. Chen YH, Wang HY, Liao CD, et al. Effectiveness of neuromuscular electrical stimulation in improving mobility in children with cerebralpalsy: A systematic review and meta-analysis of randomized controlled trials. Clin Rehabil. Jan 2023; 37(1): 3-16.
6. Dolbow DR, Credeur DP, Lemacks JL, et al. Electrically induced cycling and nutritional counseling for counteracting obesity after spinal cord injury: A pilot study. J Spinal Cord Med. Jul 2021; 44(4): 533-540.
7. Dolbow, DD, Gorgey, AA, Ketchum, JJ, Moore, JJ, Hackett, LL, Gater, DD. Exercise adherence during home-based functional electrical stimulation cycling by individuals with spinal cord injury. Am J Phys Med Rehabil, 2012 Oct 23; 91(11).
8. Dolbow, DD, Gorgey, AA, Ketchum, JJ, Gater, DD. Home-based functional electrical stimulation cycling enhances quality of life in individuals with spinal cord injury. Top Spinal Cord Inj Rehabil, 2013 Nov 19; 19(4).
9. 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.
10. Everaert DG, Stein RB, Abrams GM et al. 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.
11. Farkas GJ, Gorgey AS, Dolbow DR, et al. Energy Expenditure, Cardiorespiratory Fitness, and Body Composition Following Arm Cycling or Functional Electrical Stimulation Exercises in Spinal Cord Injury: A 16-Week Randomized Controlled Trial. Top Spinal Cord Inj Rehabil. 2021; 27(1): 121-134.
12. Hachisuka K, Ochi M, Kikuchi T, et al. Clinical effectiveness of peroneal nerve functional electrical stimulation in chronic stroke patients with hemiplegia (PLEASURE): A multicentre, prospective, randomised controlled trial. Clin Rehabil. Oct 26 2020: 269215520966702.
13. Hunt, KK, Fang, JJ, Saengsuwan, JJ, Grob, MM, Laubacher, MM. On the efficiency of FES cycling: a framework and systematic review. Technol Health Care, 2012 Oct 20; 20(5). 
14. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
15. Jaqueline da Cunha M, Rech KD, Salazar AP, et al. Functional electrical stimulation of the peroneal nerve improves post-stroke gait speed when combined with physiotherapy. A systematic review and meta-analysis. Ann Phys Rehabil Med. May 24 2020: 101388.
16. Kluding PM, Dunning K, O'Dell MW et al. Foot drop stimulation versus ankle foot orthosis after stroke: 30-week outcomes. Stroke 2013; 44(6):1660-9.
17. Kressler, JJ, Ghersin, HH, Nash, MM. Use of functional electrical stimulation cycle ergometers by individuals with spinal cord injury. Top Spinal Cord Inj Rehabil, 2014 Dec 6; 20(2). 
18. Meilahn JR. Tolerability and effectiveness of a neuroprosthesis for the treatment of foot drop in pediatric patients with hemiparetic cerebral palsy. PM R. 2013 Jun; 5(6):503-9.
19. Mulcahey MJ, Betz RR, et al. Implantation of the Freehand System during initial rehabilitation using minimally invasive techniques. Spinal Cord, March 2004; 42(3): 146-155.
20. Nascimento LR, da Silva LA, Araujo Barcellos JVM, et al. Ankle-foot orthoses and continuous functional electrical stimulation improve walking speed after stroke: a systematic review and meta-analyses of randomized controlled trials. Physiotherapy. Dec 2020; 109: 43-53.
21. O'Dell MW, Dunning K, Kluding P, et al. 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.
22. Prokopiusova T, Pavlikova M, Markova M, et al. Randomized comparison of functional electric stimulation in posturally corrected position and motor program activating therapy: treating foot drop in people with multiple sclerosis. Eur J Phys Rehabil Med. Aug 2020; 56(4): 394-402.
23. Prosser LA, Curatalo LA, Alter KE et al. Acceptability and potential effectiveness of a foot drop stimulator in children and adolescents with cerebral palsy. Dev Med Child Neurol 2012; 54(11):1044-9.
24. Renfrew LM, Paul L, McFadyen A, et al. The clinical- and cost-effectiveness of functional electrical stimulation and ankle-foot orthoses for foot drop in Multiple Sclerosis: a multicentre randomized trial. Clin Rehabil. Jul 2019; 33(7): 1150-1162.
25. Rohde LM, Bonder BR, Triolo RJ. Exploratory study of perceived quality of life with implanted standing neuroprostheses. J Rehabil Res Dev 2012; 49(2):265-78.
26. Sadowsky, CC, Hammond, EE, Strohl, AA, Commean, PP, Eby, SS, Damiano, DD, Wingert, JJ, Bae, KK, McDonald, JJ. Lower extremity functional electrical stimulation cycling promotes physical and functional recovery in chronic spinal cord injury. J Spinal Cord Med, 2013 Oct 8; 36(6). 
27. 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.
28. Triolo RJ, Bailey SN, Miller ME et al. Longitudinal performance of a surgically implanted neuroprosthesis for lower-extremity exercise, standing, and transfers after spinal cord injury. Arch Phys Med Rehabil 2012; 93(5):896-904.
29. U.S. Department of Health and Human Services Office of Disease Prevention and Health Promotion. Physical activity guidelines, second edition. https://health.gov/paguidelines/second-edition/
30. 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.
31. Venugopalan L, Taylor PN, Cobb JE, et al. Upper limb functional electrical stimulation devices and their man-machine interfaces. J Med Eng Technol. 2015; 39(8):471-479.
32. Zhu Q, Gao G, Wang K, et al. Effect of Functional Electrical Stimulation on Gait Parameters in Children with Cerebral Palsy: A Meta-Analysis. Comput Math Methods Med. 2022; 2022: 3972958.

POLICY HISTORY:

Medical Policy Group, June 2009 (3)

Medical Policy Administration Committee, July 2009

Available for comment July 1-August 14, 2009

Medical Policy Group, November 2009 (1)

Medical Policy Administration Committee, November 2009

Available for comment November 6-December 21, 2009

Medical Policy Group, March 2010 (3)

Medical Policy Administration Committee, April 2010

Available for comment April 15-May 29, 2010

Medical Policy Group, March 2011

Medical Policy Group, February 2012 (2): 2012 Update-Key Points, References and Key Words; no change in policy statement

Medical Policy Group, December 2012 (3): 2013 Coding Updates: Verbiage change to Code 97530 – removed “by the provider”.

Medical Policy Panel, February 2013

Medical Policy Group, February 2013 (3): 2013 Updates: Policy statement updated to include congenital disorders; Description, Key points and References also updated.

Medical Policy Committee February 2013

Available for comment February 21 through April 7, 2013

Medical Policy Group, November 2013 (2): New literature search. No change in policy statement. Title updated.

Medical Policy Panel February 2014

Medical Policy Group February 2014 (4): Updated Description, Key Points, Approved Governing Bodies, References.  No change to policy statement at this time.

Medical Policy Panel, February 2015

Medical Policy Group, February 2015 (6):  Updates to Key Points and References; no change to policy statement.

Medical Policy Panel, August 2016

Medical Policy Group August 2016 (6): Updates to Description, Key Points, Key Words, Summary and References. No change to policy statement.

Medical Policy Group, February 2017 (6): For information regarding Functional Electrical Stimulation cycle devices refer to medical policy #132, Rehabilitative/Habilitative Medical Criteria for Physical/Occupational Therapy added to Description.

Medical Policy Panel, August 2017

Medical Policy Group, September 2017 (6): Updates to Description and Key Points. No change to policy statement.

Medical Policy Group, December 2017. Annual Coding Update 2018. Updated verbiage for revised CPT code 97760.

Medical Policy Panel, March 2018

Medical Policy Group, March 2018 (6): Updates to Description, Key Points, Key Words and Coding.

Medical Policy Panel, May 2019

Medical Policy Group, June 2019 (6): Updates to Description, Key Points, Key Words (Functional electrical stimulation, Freehand®, NESS H200®, MyndMove System, ReGrasp, WalkAide® System, ODFS® (Odstock Dropped Foot Stimulator), ODFS® Pace XL, L300 Go, Foot Drop System, MyGait® Stimulation System, ERGYS, RT300, Myocycle Home, StimMaster Orion) , Governing Bodies and References. FES cycle ergometer transferred from MP#132 Rehabilitative/Habilitative Medical Criteria for Physical/Occupational Therapy. Functional electrical stimulation devices for exercise in patients with spinal cord injury are considered investigational.

Medical Policy Panel, May 2020

Medical Policy Group, July 2020 (3): 2020 Updates to Key Points, Approved By Governing Bodies, and References. No changes to policy statement or intent.

Medical Policy Panel, March 2021

Medical Policy Group, April 2021(3): 2021 Updates to Key Points and References. Policy section updated to remove not medically necessary from statement. No change in intent.

Medical Policy Panel, March 2022

Medical Policy Group, March 2022 (6): 2022 Updates to Key Points, Key Words (L100 Go, Nerve And Muscle Stimulator, MStim Drop Model LGT-233), Approved By Governing Bodies, and References. No changes to policy statement or intent.

Medical Policy Panel, March 2023

Medical Policy Group, March 2023 (6): Updates to Key Points, Practice Guidelines, Key Words (Cionic Neural Sleeve NS-100) Benefit Application and References.

Medical Policy Panel, March 2024

Medical Policy Group, March 2024 (6): Updates to Key Points, Key Words and Governing Bodies.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.