The upper limb myoelectric orthosis (e.g., MyoPro®) has been proposed as an assist device to enable individuals to self-initiate and control movements of a partially paralyzed or weakened arm and to regain the ability to perform activities of daily living. Sensors built into the custom wearable device detect the electrical activity of muscles at rest in the affected arm in four locations - bicep/triceps and the forearm flexor/extensor muscle groups. These signals are amplified when a user initiates movement, driving small motors which allow the individual to extend/flex their elbow and open/close their thumb and fingers. The intent of the upper limb myoelectric orthosis device is to increase functional capacity and retain range of motion.
The use of myoelectric upper limb orthosis for all indications, including but not limited to, stroke, trauma, or neurological disorders is considered investigational.
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, the express terms of the health plan will govern.
The evidence base for this technology consists of a few small studies with inconsistent outcomes. Additional studies with larger numbers of participants are needed that show consistent improvements in relevant outcome measures to determine the technology’s effect.
BlueCross BlueShield Association. Evidence Positioning System. (4:2020). Myoelectric prosthetic and orthotic components for the upper limb (1.04.04). Retrieved January 27, 2021 from https://www.evidencepositioningsystem.com/. (13 articles and/or guidelines reviewed)
ECRI Institute. Clinical Evidence Assessment. (2020, December). MyoPro (Myomo, Inc) for patients with upper-arm neuromuscular impairment. Retrieved January 27, 2021 from ECRI Institute. (7 articles and/or guidelines reviewed)
McCabe, J.P., Henniger, D., Perkins, J., Skelly, M., Tatsuoka, C., & Pundik, S. (2019). Feasibility and clinical experience of implementing a myoelectric upper limb orthosis in the rehabilitation of chronic stroke patients: A clinical case series report. PLoS One, 14 (4), e0215311. (Level 4 evidence)
National Institute for Health and Care Excellence. (2013). Stroke rehabilitation in adults. Retrieved January 27, 2021 from www.nice.org.uk/guidance/cg162.
Page, S., Hill, V., & White, S. (2013). Portable upper extremity robotics is as efficacious as upper extremity rehabilitative therapy: a randomized controlled pilot trial. Clinical Rehabilitation, 27 (6), 494-503. (Level 2 evidence)
Peters, H., Page, S., & Persch, A. (2017). Giving them a hand: wearing a myoelectric elbow-wrist-hand orthosis reduces upper extremity impairment in chronic stroke. Archives of Physical Medicine and Rehabilitation, 98 (9), 1821-1827. Abstract retrieved May 17, 2017 from PubMed database.
U.S. Food and Drug Administration. (2007, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K062631. Retrieved May 18, 2017 from https://www.accessdata.fda.gov.
Willigenburg, N., McNally, P., Hewett, T., & Page, S. (2017). Portable myoelectric brace use increases upper extremity recovery and participation but does not impact kinematics in chronic, poststroke hemiparesis. Journal of Motor Behavior, 49 (1), 46-54. Abstract retrieved May 18, 2017 from PubMed database.
ORIGINAL EFFECTIVE DATE: 11/14/2015
MOST RECENT REVIEW DATE: 3/11/2021
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.
This document has been classified as public information.