Does not apply to Medicare Advantage, please refer to the Medicare policy addressing this topic.
DESCRIPTION
Functional neuromuscular electrical stimulation (NMES) involves the use of an orthotic device with microprocessor-controlled electrical muscular stimulation. These devices are proposed to restore function to individuals with damaged or destroyed nerve pathways (e.g., spinal cord injury, stroke, multiple sclerosis, cerebral palsy). This approach to rehabilitation focuses on the restoration of useful movements such as standing, stepping, pedaling for exercise, reaching, or grasping. Proposed applications of functional neuromuscular electrical stimulation include the following: to restore upper-extremity functions such as grasp-release, forearm pronation, and elbow extension in individuals with stroke, or C5 and C6 tetraplegia; treatment of foot drop (weakness of foot and ankle that causes reduced dorsiflexion and difficulty with ambulation); provide individuals with spinal cord injury the ability to stand and walk.
Functional neuromuscular stimulators are closed–loop systems that provide feedback information on muscle force and joint position, thus allowing constant modification of stimulation parameters, which are required for complex activities (e.g., walking). Examples of FDA-cleared devices include the HandMaster™ (now named NESS H200®) cleared for maintaining or improving range of motion, reducing muscle spasm, preventing or retarding muscle atrophy, providing muscle re-education, improving circulation, and provision of hand active range of motion and function for individuals with C5 tetraplegia. Systems intended for individuals with foot drop to assist with ankle dorsiflexion during the swing phase of gait include the WalkAide® System, the ODFS® (Odstock® Dropped Foot Stimulator), NESS L300®, and MyGait® Stimulation System. The Parastep® Ambulation System is FDA approved to enable appropriately selected skeletally mature spinal cord injured individuals (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.
Note: BCBST considers functional electrical stimulation (FES) cycle ergometers that are used for legs and/or arms to be exercise equipment. These devices may also be called FES cycles or FES bikes. There are essentially two types: one type allows an individual to remain in a wheelchair and the other is a recumbent bike that requires individuals transfer into the seat of the cycle. Examples of such devices include, but are not limited to, the MyoCycle Home, ERGYS 3 and the RT300 FES Cycle Ergometer.
POLICY
Functional neuromuscular electrical stimulation for the treatment of all conditions/diseases, including, but not limited to, the following is considered investigational:
As a technique to provide ambulation in individuals with spinal cord injury
To provide upper extremity function in individuals with nerve damage (e.g., spinal cord injury or stroke)
To improve ambulation in individuals with foot drop caused by nerve damage (e.g., post stroke, multiple sclerosis, congenital disorders such as cerebral palsy)
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
Does not apply to Medicare Advantage, please refer to the Medicare policy addressing this topic.
ADDITIONAL INFORMATION
There remains a lack of randomized controlled trials providing evidence of the efficacy of functional neuromuscular electrical stimulation (NMES).
SOURCES
Bethoux, F., Rogers, H.L., Nolan, K.J., Abrams, G.M., Annaswamy, T.M., Brandstater, M., et al. (2014). The effects of peroneal nerve functional electrical stimulation versus ankle-foot orthosis in patients with chronic stroke: a randomized controlled trial. Neurorehabilitation and Neural Repair, 28 (7), 688-697. (Level 2 evidence)
BlueCross BlueShield Association. Evidence Positioning System. (4:2023). Functional neuromuscular electrical stimulation (8.03.01). Retrieved February 6, 2024 from https://www.evidencepositioningsystem.com/. (45 articles and/or guidelines reviewed)
Centers for Medicare & Medicaid Services. CMS.gov. National Coverage Determination (NCD) for neuromuscular electrical stimulation (NMES) (160.12). Retrieved October 19, 2015 from http://www.cms.gov.
Hachisuka, K., Ochi, M., Kikuchi, T., & Saeki, S. (2021). Clinical effectiveness of peroneal nerve functional electrical stimulation in chronic stroke patients with hemiplegia (PLEASURE): A multicentre, prospective, randomised controlled trial. Clinical Rehabilitation, 35 (3), 367–377, doi: 10.1177/0269215520966702. Abstract retrieved January 12, 2023 from PubMed database.
Kluding, P.M., Dunning, K., O’Dell, M.W., Wu, S.S., Ginosian, J., Feld, J., & McBride, K. (2013). Foot drop stimulation versus ankle foot orthosis after stroke: 30-week outcomes. Stroke, 44 (6), 1660-1669. Abstract retrieved August 15, 2018 from PubMed database.
Lee, J-H., Baker, L.L., Johnson, R.E., & Tilson, J.K. (2017). Effectiveness of neuromuscular electrical stimulation for management of shoulder subluxation post-stroke: A systematic review with meta-analysis. Clinical Rehabilitation, 31 (11), 1431-1434. Abstract retrieved May 21, 2020 from PubMed database.
National Institute for Health and Care Excellence (2009, January). Interventional procedure guidance 278: Functional electrical stimulation for drop foot of central neurological origin. Retrieved September 20, 2016 from www.nice.org.uk.
O’Dell, M.W., Dunning, K., Kluding, P., Wu, S.S., Feld, J., Ginosian, J., & McBride, K. (2014). Response and prediction of improvement in gait speed from functional electrical stimulation in persons with poststroke drop foot. PM & R, 6 (7), 587-601. Abstract retrieved August 15, 2018 from PubMed database.
Renfrew, L. M., Paul, L., McFadyen, A., Rafferty, D., Moseley, O., Lord, A. C., et al. (2019). The clinical- and cost-effectiveness of functional electrical stimulation and ankle-foot orthoses for foot drop in Multiple Sclerosis: a multicentre randomized trial. Clinical Rehabilitation, 33 (7), 1150-1162, doi: 10.1177/0269215519842254. Abstract retrieved January 12, 2023.
U. S. Food and Drug Administration. (1993, October). Center for Devices and Radiological Health. 510(k) Pre-market Notification Database. K933176. Retrieved February 7, 2011 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2008, January). Center for Devices and Radiological Health. 510(k) Pre-market Notification Database. K080219. Retrieved February 7, 2011 from http://www.accessdata.fda.gov.
Winifred S. Hayes, Inc. Comparative Effectiveness Review. (2019, May; last update search April 2022). Functional electrical stimulation for upper extremity rehabilitation post stroke. Retrieved January 12, 2023 from www.Hayesinc.com/subscribers. (58 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Comparative Effectiveness Review. (2021, November; last update search November 2023). Functional electrical stimulation (FES) for treatment of foot drop in multiple sclerosis patients. Retrieved February 6, 2024 from www.Hayesinc.com/subscribers. (35 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Comparative Effectiveness Review. (2022, June; last update search June 2023). Functional electrical stimulation for foot drop in acute or subacute phases of stroke recovery. Retrieved February 6, 2024 from www.Hayesinc.com/subscribers. (51 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Comparative Effectiveness Review. (2022, June; last update search June 2023). Functional electrical stimulation for foot drop in chronic phase of stroke recovery. Retrieved February 6, 2024 from www.Hayesinc.com/subscribers. (52 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2017, November; last update search January 2022). Functional electrical stimulation for rehabilitation following spinal cord injury. Retrieved January 12, 2023 from www.Hayesinc.com/subscribers. (56 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 3/1980
MOST RECENT REVIEW DATE: 3/14/2024
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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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