*** This policy was implemented in the absence of National Coverage Determinations (NCD) or Local Coverage Determinations (LCD) coverage criteria. This policy applies to all Blue Medicare HMO, Blue Medicare PPO, Blue Medicare Rx members, and members of any third-party Medicare plans supported by Blue Cross NC through administrative or operational services. ***

Description of Procedure

Upper extremity powered exoskeleton devices are used for chronic upper limb weakness; these custom fabricated orthotic (braces) devices are used to support, stabilize, position, and assist movement, thereby promoting functional activities of daily living. They can also use sensors on the muscles to help self-initiate movement. These devices are intended for stroke patients undergoing rehabilitation and would be included as part of
prescribed physical therapy to enable stroke patients to exercise independently otherwise they would be unable to do so.

The MyoPro (Myomo) is a myoelectric powered upper-extremity orthotic. This orthotic device weighs about 1.8 kilograms (4 pounds), has manual wrist articulation, and myoelectric initiated bi-directional elbow movement. The MyoPro detects weak muscle activity from the affected muscle groups. A therapist or prosthetist/orthoptist can adjust the gain (amount of assistance), signal boost, thresholds, and range of motion. Potential users include patients with traumatic brain injury, spinal cord injury, brachial plexus injury, amyotrophic lateral sclerosis, and multiple sclerosis. Use of robotic devices for therapy has been reported. The MyoPro is the first myoelectric orthotic available for home use.

IpsiHand is a brain-computer interface (BCI) device designed to help stroke survivors regain upper extremity function. It uses brain signals to control a hand-worn device, enabling patients to perform movements they might otherwise be unable to do. 

Policy Statement

Myoelectric controlled upper-limb orthoses (e.g., MyoPro) are considered
experimental/investigational.

Benefit Application

Please refer to the member’s individual Evidence of Coverage (EOC) for benefit determination.  Coverage will be approved according to the EOC limitations if the criteria are met. 

Coverage decisions will be made in accordance with:

• The Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD);
• General coverage guidelines included in Original Medicare manuals unless superseded by operational policy letters or regulations; and
• Written coverage decisions of local Medicare (LCD, LCA) carriers and intermediaries with jurisdiction for claims in the geographic area in which services are covered.

Benefit payments are subject to contractual obligations of the Plan.  If there is a conflict between the general policy guidelines contained in the Medical Coverage Policy Manual and the terms of the member’s particular Evidence of Coverage (EOC), the EOC always governs the determination of benefits.

Indications for Coverage

Myoelectric upper extremity orthotic devices (e.g., MyoPro) is considered experimental, investigational, and unproven for all indications, including but not limited to use by individuals with stroke, trauma, brachial plexus injury, cerebral palsy, or any other neurological or neuromuscular disease or injury.

IpsiHand is a brain-computer interface (BCI) device is considered experimental, investigational and unproven for all indications including but not limited to use by individuals whom have had a stroke.  

There is insufficient literature in the peer-reviewed publications to assess safety, efficacy, long-term outcomes, or patient management associated with the use of the myoelectric upper extremity orthotic devices (e.g., MyoPro Orthosis, IpsiHand) for upper extremity paralysis or paresis.

Billing/ Coding/physician Documentation Information

This policy may apply to the following codes.  Inclusion of a code in the section does not guarantee reimbursement. 

Applicable codes: L8701, L8702, E0738, E0739

• Note: Per CMS miscellaneous/unspecified codes cannot be used for billing of these devices.

References:

1. National Coverage Determination Durable Medical Equipment Reference List 280.1 accessed on 02/06/2025 via NCD - Durable Medical Equipment Reference List (280.1)
2. BCBSNC Corporate Medical Policy “Myoelectric Prosthetic Components for the Upper Limb” effective 8/2020; accessed via Myoelectric Prosthetic Components for the Upper Limb | Providers | Blue Cross NC on 2/6/2025
3. Improved Disabilities Of The Arm, Shoulder And Hand Scores After Myoelectric Arm Orthosis Use At Home In Chronic Stroke: A Retrospective Study; Pub. March 21, 2024
4. Myoelectric Arm Orthosis Assists Functional Activities: A 3 Month Home Use Outcome Report; Pub. September 2023
5. Giving Them a Hand: Wearing a Myoelectric Elbow-Wrist-Hand Orthosis Reduces Upper Extremity Impairment in Chronic Stroke; Pub. January 25, 2017
6. Prosthetics & Orthotics, Prosthetics Devices, & Therapeutic Shoes (CMS.gov) accessed on 02/06/25 via Prosthetics & Orthotics, Prosthetic Devices, & Therapeutic Shoes | CMS
7. Medicare Claims Processing Manual, Chapter 20 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Effective date 03/28/2024 via Medicare Claims Processing Manual, accessed on 02/06/2025

Policy Implementation/Update Information:

Revision Dates:

2/6/2025 New policy implemented. Power Enhanced Upper Extremity Rehabilitative Devices (MyoPro/IpsiHand)

Approval Dates:

Medical Coverage Policy Committee: April 17, 2025      

Physician Group Advisory/UM Committee:

Policy Owner:  Amy Russo, LPN

Medical Policy Coordinator