Myoelectric Prosthetic and Orthotic Components for the Upper Limb

POLICY NUMBER

A.1.04.04

DESCRIPTION

Myoelectric prostheses are powered by electric motors with an external power source. The joint movement of an upper-limb prosthesis or orthosis (e.g., hand, wrist, and/or elbow) is driven by microchip-processed electrical activity in the muscles of the remaining limb or limb stump.

Upper-Limb Amputation

The need for a prosthesis can occur for a number of reasons, including trauma, surgery, or congenital anomalies.

Treatment

The primary goals of the upper-limb prostheses are to restore function and natural appearance. Achieving these goals also requires sufficient comfort and ease of use for continued acceptance by the wearer. The difficulty of achieving these diverse goals with an upper-limb prosthesis increases with the level of amputation (digits, hand, wrist, elbow, shoulder), and thus the complexity of joint movement increases.

Upper-limb prostheses are classified into 3 categories depending on the means of generating movement at the joints: passive, body-powered, and electrically powered movement. All 3 types of prostheses have been in use for more than 30 years; each possesses unique advantages and disadvantages.

Passive Prostheses

• The passive prostheses rely on manual repositioning, typically using the opposite arm and cannot restore function. This unit is the lightest of the three prosthetic types and is thus generally the most comfortable.

Body-Powered Prostheses

• The body-powered prostheses use a body harness and cable system to provide functional manipulation of the elbow and hand. Voluntary movement of the shoulder and/or limb stump extends the cable and transmits the force to the terminal device. Prosthetic hand attachments, which may be claw-like devices that allow good grip strength and visual control of objects or latex-gloved devices that provide a more natural appearance at the expense of control, can be opened and closed by the cable system. Patient complaints with body-powered prostheses include harness discomfort, particularly the wear temperature, wire failure, and the unattractive appearance.

Myoelectric Prostheses

• Myoelectric prostheses use muscle activity from the remaining limb for control of joint movement. Electromyographic signals from the limb stump are detected by surface electrodes, amplified, and then processed by a controller to drive battery-powered motors that move the hand, wrist, or elbow. Although upper arm movement may be slow and limited to one joint at a time, myoelectric control of movement may be considered the most physiologically natural.

• Myoelectric hand attachments are similar in form to those offered with the body-powered prosthesis, but are battery-powered.

• A hybrid system, a combination of body-powered and myoelectric components, may be used for high-level amputations (at or above the elbow). Hybrid systems allowfor control of two joints at once (i.e., one body-powered and one myoelectric) and are generally lighter and less expensive than a prosthesis composed entirely of myoelectric components.

Technology in this area is rapidly changing, driven by advances in biomedical engineering and by the U.S. Department of Defense Advanced Research Projects Agency, which is funding a public and private collaborative effort on prosthetic research and development. Areas of development include the use of skin-like silicone elastomer gloves, “artificial muscles,” and sensory feedback. Smaller motors, microcontrollers, implantable myoelectric sensors, and reinnervation of remaining muscle fibers are being developed to allow fine movement control. Lighter batteries and newer materials are being incorporated into myoelectric prostheses to improve comfort.

The LUKE Arm (previously known as the DEKA Arm System) was developed in a joint effort between DEKA Research & Development and the U.S. Department of Defense Advanced Research Projects Agency program. It is the first commercially available myoelectric upper-limb that can perform complex tasks with multiple simultaneous powered movements (eg, movement of the elbow, wrist, and hand at the same time). In addition to the electromyographic electrodes, the LUKE Arm contains a combination of mechanisms, including switches, movement sensors, and force sensors. The primary control resides with inertial measurement sensors on top of the feet. The prosthesis includes vibration pressure and grip sensors.

Myoelectric Orthoses

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.

Manufacturers must register prostheses with the Restorative and Repair Devices Branch of the U.S. Food and Drug Administration (FDA) and keep a record of any complaints, but do not have to undergo a full FDA review.

Available myoelectric devices include, but are not limited to, i-Digits® and i-limb™ (Touch Bionics [now part of Össur]), the SensorHand™ Speed and Michelangelo® Hand (Otto Bock), the LTI Boston Digital Arm™ System (Liberating Technologies), the Utah Arm Series 3 (Fillauer Motion Control), and bebionic (Ottobock).

In 2014, the DEKA Arm System (DEKA Integrated Solutions, now DEKA Research & Development), now called the LUKE™ Arm (Mobius Bionics), was cleared for marketing by the FDA through the de novo 513(f)(2) classification process for novel low- to moderate-risk medical devices that are first-of-a-kind.

The MyoPro® (Myomo) is registered with the FDA as a class 1 limb orthosis.

Also, see the related medical policies,  Microprocessor-Controlled Prostheses for the Lower Limb  and  Functional Neuromuscular Electrical Stimulation .

POLICY

Myoelectric upper-limb prosthetic components may be considered medically necessary when the following conditions are met:

• The individual has an amputation or missing limb at the wrist or above (eg, forearm, elbow); AND

• Standard body-powered prosthetic devices cannot be used or are insufficient to meet the functional needs of the individual in performing activities of daily living; AND

• The remaining musculature of the arm(s) contains the minimum microvolt threshold to allow operation of a myoelectric prosthetic device; AND

• The individual has demonstrated sufficient neurologic and cognitive function to operate the prosthesis effectively; AND

• The individual is free of comorbidities that could interfere with function of the prosthesis (eg, neuromuscular disease); AND

• Functional evaluation indicates that with training, use of a myoelectric prosthesis is likely to meet the functional needs of the individual (e.g., gripping, releasing, holding, and coordinating movement of the prosthesis) when performing activities of daily living. This evaluation should consider the individual needs for control, durability (maintenance), function (speed, work capability), and usability.

Advanced upper-limb prosthetic components with both sensor and myoelectric control (e.g., LUKE Arm) are considered investigational.

A prosthesis with individually powered digits, including but not limited to a partial hand prosthesis, is considered investigational.

Myoelectric controlled upper-limb orthoses are considered investigational.

Myoelectric upper-limb prosthetic components are considered investigational under all other conditions.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member’s specific benefit plan language.

Amputees should be evaluated by an independent qualified professional to determine the most appropriate prosthetic components and control mechanism (e.g., body-powered, myoelectric, or combination of body-powered and myoelectric). A trial period may be indicated to evaluate the tolerability and efficacy of the prosthesis in a real-life setting.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

2/4/2009: Policy added.

04/23/2010: Policy description updated regarding device availability; added links to related medical policies. Policy statement expanded to include conditions that must be met for myoelectric upper limb prosthetic components to be considered medically necessary, such as remaining musculature, neurological function, and absence of comorbidities that could interfere with the function of the prosthesis. Statement regarding trial period added to the policy guidelines. FEP verbiage added to the Policy Exceptions section.

04/19/2012: Policy title changed from "Myoelectric Prosthesis for the Upper Limb" to "Myoelectric Prosthetic Components for the Upper Limb." Policy statement unchanged. 

07/19/2012: Policy title changed back to "Myoelectric Prosthesis for the Upper Limb." Added the following policy statement: A prosthesis with individually powered digits, including but not limited to a partial hand prosthesis, is considered investigational.

09/03/2013: Policy title changed from "Myoelectric Prosthesis for the Upper Limb" to "Myoelectric Prosthetic Components for the Upper Limb." Policy statement unchanged. Added HCPCS codes L6880, L7190, and L7191 to the Code Reference section.

08/14/2014: Policy reviewed; description updated regarding devices. Policy statement unchanged.

12/31/2014: Added the following new 2015 HCPCS code to the Code Reference section: L6026.

08/26/2015: Medical policy revised to add ICD-10 codes.

10/20/2015: Policy description updated regarding devices. Policy statements unchanged. Policy guidelines updated to add medically necessary and investigative definitions.

05/31/2016: Policy number A.1.04.04 added. Removed deleted HCPCS code L6025 from the Code Reference section.

12/21/2016: Policy description updated regarding devices. Policy statements unchanged.

10/11/2017: Policy description updated. Policy statements unchanged.

04/03/2018: Policy title changed from "Myoelectric Prosthetic Components for the Upper Limb" to "Myoelectric Prosthetic and Orthotic Components for the Upper Limb." Policy description updated regarding myoelectric orthoses. Added the following policy statements: 1) Upper-limb prosthetic components with both sensor and myoelectric controlled are considered investigational. 2) Myoelectric controlled upper-limb orthoses are considered investigational.

12/20/2018: Code Reference section updated to add new HCPCS codes L8701 and L8702 as investigational, effective 01/01/2019.

04/04/2019: Policy reviewed; no changes.

04/14/2020: Policy reviewed; no changes.

09/23/2020: Code Reference section updated to revise the code descriptions for HCPCS codes L8701 and L8702, effective 10/01/2020.

05/24/2021: Policy description updated. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

06/23/2022: Policy description updated. Second policy statement updated to change "Upper-limb prosthetic components" to "Advanced upper-limb prosthetic components" and added "(e.g., LUKE Arm)." Policy statement updated to change "not medically necessary" to "investigational."

04/13/2023: Policy description updated regarding devices. Policy statements unchanged.

04/10/2024: Policy description updated. Policy statements updated to change "patient" to "individual."

04/01/2025: Code Reference section updated to add new HCPCS code L6700, effective 04/01/2025.

04/16/2025: Policy description updated regarding devices. Policy statements unchanged.

SOURCE(S)

Blue Cross Blue Shield Association policy # 1.04.04 

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

Investigational Codes

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