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Myoelectric Prosthetic and Orthotic Components for the Upper Limb

Policy Number: MP-124

Latest Review Date: August 2024                             

Category: Durable Medical Equipment (DME)

DRAFT

NOTE: Coverage may be subject to legislative mandates, including but not limited to the following, which applies prior to the policy statements:

  • Minnesota Statute §62Q.665 Coverage for Orthotic and Prosthetic Devices.
  • Minnesota Statute §62Q.6651 Medical Necessity and Nondiscrimination Standards for Coverage of Prosthetics or Orthotics.

POLICY:

Effective for dates of service January 6, 2025, and after:

I. Myoelectric Upper Limb Prosthetic

Myoelectric upper limb prosthetic devices and/or components may be considered medically necessary when ALL of the following conditions are met:

  • The individual has an amputation or missing limb at the wrist or above (e.g., forearm, elbow, shoulder); AND
  • Standard body-powered prosthetic devices cannot be used or are insufficient to meet the functional needs of the individual (e.g., gripping, releasing, holding, and coordinating movement of the prosthesis); AND
  • The remaining musculature of the arm(s) contains the minimum microvolt threshold to allow operation of a myoelectric prosthetic device; AND
  • Meets requirements of the device specified by the manufacturer; AND
  • The individual has demonstrated sufficient neurological and cognitive function to operate the prosthesis effectively; AND
  • The individual is free of comorbidities that could interfere with function of the prosthesis (e.g., neuromuscular disease); AND
  • Functional evaluation indicates that with training, use of a myoelectric prosthesis is likely to meet the maximum functional mobility and/or physical activity needs of the individual (e.g., ADLs, running, biking, swimming). This evaluation should consider the individual’s needs for control, durability (maintenance), function (speed, work capability), and usability.

II.  Repair or Replacement

Repair of a myoelectric upper limb device and/or component may be considered medically necessary when ALL of the following are met:

  • Individual meets medical necessity criteria for the current device; AND
  • Repair required to make the prosthesis serviceable; AND
  • Expenses for repairs do not exceed the estimated expense of purchasing another prosthesis; AND
  • The component is not covered under warranty.

Replacement of a myoelectric upper limb device and/or component may be considered medically necessary when ALL of the following are met:*

  • Individual meets medical necessity criteria for the current device; AND
  • At least one of the following is met:
    • Change in the physiologic condition or functional level of the individual which necessitates replacement of the requested component(s); OR
    • There is an irreparable change in the condition of the component(s) that is not a result of misuse or neglect; AND
  • The condition of the component(s) requires repairs which would exceed the estimated expense of purchasing a new prosthesis; AND
  • The component is not covered under warranty.

III. Not Medically Necessary

Use of a myoelectric prosthesis of the upper limb is considered not medically necessary for any of the following:

  • Individual does not meet medical necessity criteria in Section I of the policy;
  • Duplication (e.g., back-up prosthetic device) or upgrade of a functional prosthesis;
  • Repair or replacement of parts for a duplicate myoelectric upper limb prosthesis;
  • Repair or replacement of a myoelectric upper limb prosthesis for any of the following:
    • Appearance or convenience;
    • Malicious damage or neglect;
    • Use in environments that limit functional life of the device (e.g., excessive moisture, dust or other conditions not recommended by manufacturer).

IV. Experimental/Investigative

The following are considered investigational due to the lack of clinical evidence demonstrating an impact on improved health outcomes:

  • A prosthesis with individually powered digits, including but not limited to a myoelectric partial hand prosthesis (e.g., ProDigits, iDigits);
  • Upper-limb prosthetic components with both sensor and myoelectric control (e.g., Luke™ Arm);
  • Myoelectric controlled upper-limb orthotic for home use (e.g., MyoPro®, MyoPro2® Motion).

Documentation Submission

Documentation supporting the medical necessity criteria described in the policy must be included in the prior authorization, when prior authorization is required. In addition, the following documentation must be submitted by the treating physician, or a prosthetist experienced in fitting myoelectric upper-limb prostheses, including the following:

1.         Clinical notes confirming:

  • The individual meets the requirements of the device specified by the manufacturer;
  • Sufficient neurological and cognitive function to operate the prosthesis;
  • Standard body-powered prosthetic devices cannot be used or are insufficient to meet the maximum functional mobility and/or physical activity needs of the individual;
  • Evidence of functional evaluation demonstrating the individual’s ability to adequately control and use the prosthetic device;

2.         If requesting repair or replacement, documentation of reason for repair and/or replacement.

Effective for dates of service prior to January 6, 2025:

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

  • The individual has an amputation or missing limb at the wrist or above (e.g., 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 arms(s) contains the minimum microvolt threshold to allow operation of a myoelectric prosthetic device; AND
  • The individual has demonstrated sufficient neurological and cognitive function to operate the prosthesis effectively; AND
  • The individual is free of comorbidities that could interfere with function of the prosthesis (e.g., 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 coordination movement of the prosthesis) when performing activities of daily living. This evaluation should consider the individuals needs for control, durability (maintenance), function (speed, work capability), and usability. 
  • Children aged 2 years or older who have shown at least 6 months successful use of a passive prosthetic device and have a minimum EMG signal of 6μV threshold.

One myoelectric prosthesis per limb per five years is covered when medically indicated.

Coverage will not be provided if the prosthesis is functioning properly and in good general condition.

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

High-definition silicone used to make a prosthesis resemble an individual’s skin is considered investigational and cosmetic.

Myoelectric prostheses are contraindicated, and therefore considered investigational for individuals with upper limb amputations:

  • Whose ADLs require frequent lifting of heavy objects (16lbs or greater);
  • Whose environments involve frequent contact with dirt, dust, grease, water, and solvent;
  • Whose neuromas and/or phantom limb pain are exacerbated with the use of the prosthesis.

Myoelectric controlled upper-limb orthoses are considered investigational.

Advanced upper-limb prosthetic components with both sensor and myoelectric controls (e.g., LUKE/DEKA arm) are considered investigational. 

Additions or upgrades to the prosthetic for convenience, sports or recreational activities are considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Upper limb prostheses are used for amputations at any level from the hand to the shoulder. The need for prosthesis can occur for a number of reasons including trauma, surgery, or congenital anomalies. The primary goals of the upper limb prosthesis are to restore natural appearance and function. 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 as the level of amputation (digits, hand, wrist, elbow, and shoulder), and thus the complexity of joint movement, increases.

Upper limb prostheses are classified into three categories depending on the means of generating movement at the joints: passive, body-powered, and electrically powered movement. All three types of prostheses have been in use for over 30 years; each possesses unique advantages and disadvantages. Myoelectric prostheses of the upper limb use muscle activity from the remaining limb for the control of joint movements. Electromyographic signals from the remaining limb stump are detected by surface electrodes, amplified, and then processed by a controller to drive battery-powered motors to move the hand, wrist, or elbow.

Myoelectric hand attachments are similar in form to those offered with body-powered prostheses but are battery operated. These may include grasping mechanisms and individually powered digits. Partial hand myoelectric prostheses are designed to replace the function of digits in individuals missing one or more of their fingers as a result of partial-hand amputation.

Hybrid systems incorporate body-powered and myoelectric components to allow control of two joints at once. These systems may be used for amputations at or above the elbow. One hybrid system is the LUKE™ Arm (formerly the DEKA Arm) which includes a combination of mechanisms including switches, movement sensors, vibration pressure and grip sensors.

Individuals with upper limb amputations 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.

APPROVED BY GOVERNING BODIES:

Manufacturers must register prostheses with the restorative 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. The LUKE™ Arm was cleared for marketing by FDA through the de novo 513(f)(2) classification process for novel low- to moderate-risk medical devices that are first-of-a-kind.

Available myoelectric devices include the ProDigits™,  i-limb™, SensorHand™ Speed, Michelangelo® Hand LTI Boston Digital Arm™, MyoHand™ and the Utah Arm Systems (Motion Control).

A powered upper-extremity orthotic, the MyoPro®, is a myoelectric device with manual wrist articulation, and myoelectric initiated bi-directional elbow movement. The MyoPro® detects weak muscle activity from the affected muscle groups. A therapist can adjust the gain (amount of assistance), signal boost, thresholds, and range of motion. Potential users include individuals 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. It is registered with FDA as a class 1 limb orthosis.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP: Special benefit consideration may apply. Refer to member’s benefit plan. 

CURRENT CODING: 

HCPCS Codes:

L6026

Transcarpal/metacarpal or partial hand disarticulation prosthesis, external power, self-suspended, inner socket with removable forearm section, electrodes and cables, two batteries, charger, myoelectric control of terminal device, excludes terminal device(s)

L6715

Terminal device, multiple articulating digit, includes motor(s), initial issue or replacement.

L6880

Electric hand, switch or myoelectric controlled, independently articulating digits, any grasp pattern or combination of grasp patterns, includes motor(s).

L6925

Wrist disarticulation, external power, self-suspended inner socket, removable forearm shell, otto bock or equal electrodes, cables, two batteries and one charger, myoelectronic control of terminal device

L6935

Below elbow, external power, self-suspended inner socket, removable forearm shell, otto bock or equal electrodes, cables, two batteries and one charger, myoelectronic control of terminal device

L6945

Elbow disarticulation, external power, molded inner socket, removable humeral shell, outside locking hinges, forearm, otto bock or equal electrodes, cables, two batteries and one charger, myoelectronic control of terminal device

L6955

Above elbow, external power, molded inner socket, removable humeral shell, internal locking elbow, forearm, otto bock or equal electrodes, cables two batteries and one charger, myoelectronic control of terminal device

L6965

Shoulder disarticulation, external power, molded inner socket, removable shoulder shell, shoulder bulkhead, humeral section, mechanical elbow, forearm, otto bock or equal electrodes, cables, two batteries and one charger, myoelectronic control of terminal device

L6975

Interscapular-thoracic, external power, molded inner socket, removable shoulder shell, shoulder bulkhead, humeral section, mechanical elbow, forearm, otto bock or equal electrodes, cables, two batteries and one charger, myoelectronic control of terminal device

L7007

Electric hand, switch or myoelectric controlled, adult

L7008

Electric hand, switch or myoelectric, controlled, pediatric

L7009

Electric hook, switch or myoelectric controlled, adult

L7045

Electric hook, switch or myoelectric controlled, pediatric

L7190

Electronic elbow, adolescent, Variety Village or equal, myoelectronically controlled

L7191

Electronic elbow, child, Variety Village or equal, myoelectronically controlled

L8701

Elbow, wrist, hand device, powered, with single or double upright(s), any type joint(s), includes microprocessor, sensors, all components and accessories

L8702

Elbow, wrist, hand, finger device, powered, with single or double upright(s), includes microprocessor, sensors, all components and accessories

POLICY HISTORY:

October 2021: Annual review completed. Updates to Key Points. Policy statement updated to remove “not medically necessary,” no change to policy intent.

September 2021:Added clarification statement to include non-coverage for convenience items.

January 2022: Updates to Current Coding (added L6621, L6881-L6882, L7181).

March 2022: Annual review completed. Updates to Description, Key Points, Governing Bodies and References.

November 2022: Updates to Key Words.

April 2023: Annual review completed. Updates to Key Points.

January 2024: Added L6638/L6693 to Current Coding.

March 2024: Annual review completed. Updates to Key Points.

September 2024: Updates to Current Coding (+L6920,L6930,L6940, L6960, L6970).

November 2024. Annual review completed. Updates to Policy statement, Description, Key Points, Governing Bodies, Practice Guidelines, Current Coding and References.

On Draft 11/18/24-1/5/25.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member's contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage. 

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

  1. The technology must have final approval from the appropriate government regulatory bodies;
  2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
  3. The technology must improve the net health outcome;
  4. The technology must be as beneficial as any established alternatives;
  5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

  1. In accordance with generally accepted standards of medical practice; and
  2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
  3. Not primarily for the convenience of the patient, physician or other health care provider; and
  4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.