DESCRIPTION
A powered exoskeleton (e.g., Rewalk™, Indego®, Ekso™, Ekso GT™, HAL™) consists of an exoskeleton-like framework worn by an individual and a power source that supplies the energy for limb movement. The goal of the powered exoskeleton is to enable people who do not have volitional (i.e., willing) movement of their lower extremities to be able to fully bear weight while standing, to walk and to navigate stairs. The devices reportedly have the potential to restore mobility and, thus, may lead to improvements in functional status, quality of life and health status for individuals with spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis, Guillain-Barre syndrome and spina bifida.
POLICY
Use of a powered exoskeleton for ambulation in individuals with lower-limb disabilities is considered investigational.
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.
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ADDITIONAL INFORMATION
The evidence for the powered exoskeleton in individuals who have lower-limb disabilities is limited to small studies performed in the laboratory setting under close supervision. Further study is required to evaluate the effectiveness and safety of lower limb exoskeletons in the community.
SOURCES
Asselin, P., Knezevic, S., Kornfeld, S., Cirnigliaro, C., Agranova-Breyter, I., Bauman, W., & Spungen,A. (2015). Heart rate and oxygen demand of powered exoskeleton-assisted walking in persons with paraplegia. Journal of Rehabilitation Research & Development, 52 (2), 147-158. (Level 4 evidence)
Bach Baunsgaard, C., Vig Nissen, U., Katrin Brust, A., Frotzler, A., Ribeill, C., Kalke, Y.B., et al. (2018). Gait training after spinal cord injury: safety, feasibility and gait function following 8 weeks of training with the exoskeletons from Ekso Bionics. Spinal Cord, 56 (2),106-116. Abstract retrieved May 13, 2021 from PubMed database.
BlueCross BlueShield Association. Evidence Positioning System. (4:2023). Powered exoskeleton for ambulation in patients with lower-limb disabilities (1.03.04). Retrieved September 5, 2023 from http://www.evidencepositioningsystem.com. (48 articles and/or guidelines reviewed)
Federici, S., Meloni, F., Bracalenti, M., & DeFilippis, M.L. (2015). The effectiveness of powered, active lower limb exoskeletons in neurorehabilitation: a systematic review. NeuroRehabilitation, 37 (3), 321-340. Abstract retrieved January 24, 208 from PubMed database.
Hartigan, C., Kandilakis, C., Dalley,S., Clausen, M., Wilson, E., Morrison, S., et al. (2015). Mobility outcomes following five training sessions with a powered exoskeleton. Topics in Spinal Cord Injury Rehabilitation, 21 (2), 93-99. (Level 4 evidence)
Khan, A.S., Livingstone, D.C., Hurd, C.L., Duchcherer, J., Misiaszek, J.E., Gorassinni, M.A., et al. (2019). Retraining walking over ground in a powered exoskeleton after spinal cord injury: a prospective cohort study to examine functional gains and neuroplasticity. Journal of NeuroEngineering and Rehabilitation, 16, 145. (Level 4 evidence)
Lajeunesse, V., Vincent, C., Routhier, F., Careau, E., & Michaud, F. (2016). Exoskeletons’ design and usefulness evidence according to a systemic review of lower limb exoskeletons used for functional mobility by people with spinal cord injury. Disability Rehabilitation Assistive Technology, 11 (7), 535-547. Abstract retrieved January 24, 2018 from PubMed database.
Miller, L., Zimmermann, A., & Herbert, W. (2016). Clinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injury: systematic review with meta-analysis. Medical Devices: Evidence and Research, 9, 455-466. (Level 2 evidence)
National Institute for Health and Care Excellence. (2017, January). Medtech innovation briefing: Ekso exoskeleton for rehabilitation in people with neurological weakness or paralysis. Retrieved February 2, 2017 from http://nice.org.
Tamburella, F., Lorusso, M., Tramontano, M., Fadlun, S., Masciullo, M., & Scivoletto, G. (2022). Overground robotic training effects on walking and secondary health conditions in individuals with spinal cord injury: systematic review. Journal of Neuroengineering and Rehabilitation, 19 (1), 27. (Level 1 evidence)
U. S. Food and Drug Administration. (2013, June). De Novo Summary (K131798). Evaluation of Automatic Class III Designation (De Novo) for ARGO ReWalk™. Retrieved March 17, 2015 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2016, February). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K152416. Retrieved May 2, 2016 from http://www.accessdata.fda.gov.
van Dijsseldonk, R.B., van Nes, I.J.W., Geurts, A.C.H., & Keijsers, N.L.W.(2020). Exoskeleton home and community use in people with complete spinal cord injury. Scientific Reports, 10 (1), 15600. (Level 3 evidence)
ORIGINAL EFFECTIVE DATE: 8/8/2015
MOST RECENT REVIEW DATE: 10/12/2023
ID_BA
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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