Latest Review Date: August 2024                             

Category: Durable Medical Equipment (DME)

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.

KEY POINTS:

Carey et al (2015) published a systematic review conducted to determine differences between myoelectric and body-powered prostheses to inform evidence-based clinical practice regarding prescription of these devices and training of users. A search of 9 databases identified 462 unique publications. Ultimately, 31 of them were included and 11 empirical evidence statements were developed. Conflicting evidence has been found in terms of the relative functional performance of body-powered and myoelectric prostheses. Body-powered prostheses have been shown to have advantages in durability, training time, frequency of adjustment, maintenance, and feedback; however, they could still benefit from improvements of control. Myoelectric prostheses have been shown to improve cosmesis and phantom-limb pain and are more accepted for light-intensity work. Prosthetic selection should be based on a patient's individual needs and include personal preferences, prosthetic experience, and functional needs. The authors conclude that this work demonstrates that there is a lack of empirical evidence regarding functional differences in upper-limb prostheses. Currently, evidence is insufficient to conclude that either system provides a significant general advantage.

Resnik et al (2018) published a study to compare self-reported function, dexterity, activity performance, quality of life and community integration of the DEKA Arm to conventional prostheses; and examine differences in outcomes by conventional prosthesis type, terminal device type and by DEKA Arm configuration level. This was a two-part study; Part A consisted of in-laboratory training. Part B consisted of home use. Study participants were 23 prosthesis users (mean age = 45 ± 16; 87% male) who completed Part A, and 15 (mean age = 45 ± 18; 87% male) who completed Parts A and B. Outcomes including self-report and performance measures, were collected at Baseline using participants' personal prostheses and at the End of Parts A and B. Scores were compared using paired t-tests. Wilcoxon signed-rank tests were used to compare outcomes for the full sample, and for the sample stratified by device and terminal device type. Analysis of outcomes by configuration level was performed graphically. At the End of Part A activity performance using the DEKA Arm and conventional prosthesis was equivalent, but slower with the DEKA Arm. After Part B, performance using the DEKA Arm surpassed conventional prosthesis scores, and speed of activity completion was equivalent. Participants reported using the DEKA Arm to perform more activities, had less perceived disability, and less difficulty in activities at the End of A and B as compared to Baseline. No differences were observed in dexterity, prosthetic skill, spontaneity, pain, community integration or quality of life. Comparisons stratified by device type revealed similar patterns. Graphic comparisons revealed variations by configuration level. The authors concluded that participants using the DEKA Arm had less perceived disability and more engagement of the prosthesis in everyday tasks, although activity performance was slower. After home use experience, activity performance was improved and activity speed equivalent to using conventional prostheses.

Resnik et al (2020) published a survey comparing patient-reported outcomes of disability, activity difficulty, and health-related quality of life (HRQOL) by prosthetic device use and configuration and to identify factors associated with these outcomes. The study participants included population-based sample of veterans (N=755) with unilateral upper limb amputation recruited from a national sample of veterans with upper limb amputation who received care at the Veterans Affairs clinic from 2010-2015. Upper limb-related disability was measured using Disabilities of the Arm, Shoulder, and Hand score (QuickDASH). HRQOL was measured using the Veterans RAND 12-item Health Survey Mental and Physical Component scores. Activity difficulty was assessed for 1-handed and 2-handed tasks and by questions about the need for help with activities of daily living (ADLs). Patients who did not use a prosthesis had more difficulty performing 1-handed tasks using the residual limb as compared with those who used body-powered prostheses. Cosmetic device users had more task difficulty than body-powered or myoelectric users. Linear regression models did not show an association between type of prosthesis used and HRQOL scores but did show that those who did not use a prosthesis (non-users) had worse QuickDASH scores (β=9.4; P=.0004) compared to body-powered users. In logistic regression modeling, the odds of needing help with ADLs were 1.84 times higher (95% confidence interval, 1.16-2.92) for non-users compared with body-powered users. The authors concluded that amputees who did not use a prosthesis or used a cosmetic prosthesis reported more difficulty in activities and greater disability as compared with those who use body-powered and myoelectric devices. Non-users were more likely to need help with ADLs as compared with those who used a body-powered prosthesis. The findings highlight the clinical importance of encouraging prosthesis use. Further research is needed to compare physical performance by prosthesis configuration.

Resnik et al (2022) also published a cross-sectional survey study aimed to modify the Orthotics and Prosthetics User Survey (OPUS) Client Satisfaction with Device (CSD) instrument to incorporate issues of concern to women and (2) evaluate measure's structural and concurrent validity and reliability in persons with upper limb amputation (ULA). In this cross-sectional survey study with retest after 2 weeks, exploratory factor analysis (EFA), confirmatory factor analysis (CFA), and Rasch analyses were used to select items and examine differential item functioning, range of coverage, and person and item reliability. Test-retest reliability was evaluated with intraclass correlation coefficients. Pearson correlations were used to estimate associations with other prosthesis satisfaction measures. Participants included convenience sample of 468 participants in the US (N=468; 19.9% women) with ULA, including a 50-person retest subsample (4% female). The main outcome measure was Modified OPUS CSD. EFA suggested 3 subscales: Comfort, Appearance, and Utility. CFA found acceptable model fit. After dropping items with poor fit and high pairwise correlations in Rasch partial credit models, CFA model fit indices were acceptable (comparative fit index=0.959, Tucker-Lewis Index=0.954, root mean square error of approximation=0.082). Rasch person reliability was 0.62 (Utility), 0.77 (Appearance), and 0.82 (Comfort). Cronbach α was 0.81, 87, and 0.71 for Comfort and Appearance, and Utility subscales, respectively. Correlations between the modified CSD, the original CSD, and the Trinity Amputation and Prosthesis Experience Satisfaction Scale were 0.54-0.94. The authors identified 3 subscales: Comfort (6 items), Appearance (8 items), and Utility (4 items) with 7 new items identified as important to women. The subscales demonstrate evidence of sound concurrent structural and test-retest reliability and concurrent validity. The Appearance and Comfort subscales have good reliability for group-level use in clinical and research applications, whereas the Utility subscale had poor to fair person reliability but excellent item reliability.

Ritchie et al (2011) published a systematic review to establish what is known about adult user's perceptions of upper limb prostheses in terms of both cosmesis and function. A search of the literature between 1990 and 2010 identified over 600 possible citations; these were reduced to 15 citations based on selection criteria. The main themes arising from the review were user satisfaction ratings with current prostheses, priorities for future design and the social implications of wearing a prosthetic limb. While users of cosmetic prostheses were mostly satisfied with their prostheses, satisfaction rates vary considerably across studies, due to variability in demographics of users and an ambiguity over the definitions of cosmesis and function. Design priorities also varied, though overall there is a slight trend toward prioritizing function over cosmesis. The qualitative studies noted the importance users placed on presenting a 'normal' appearance and 'not standing out'. The authors concluded that the reviewed studies mostly examine functionality and cosmesis as separate constructs, and conclusions are limited due to the disparity of user groups studied. Recommendations are made for further work to explore understandings of these constructs in relation to upper limb prosthesis use.

Pan et al (2015) published this study which explored transcranial direct current stimulation (tDCS) to modulate brain activity and enhance EMG quality to improve clinical performance of myoelectric control. The study tested six unilateral transradial amputees by applying active and sham anodal tDCS separately on two different days. Surface EMG signals were acquired from the affected and intact sides for 11 hand and wrist motions in the pre-tDCS and post-tDCS sessions. Autoregression coefficients and linear discriminant analysis classifiers were used to process the EMG data for pattern recognition of the 11 motions. For the affected side, active anodal tDCS significantly reduced the average classification error rate (CER) by 10.1%, while sham tDCS had no such effect. For the intact side, the average CER did not change on the day of sham tDCS but increased on the day of active tDCS. According to the authors, these results demonstrated that tDCS could modulate brain function and improve EMG-based classification performance for amputees. It has great potential in reducing the length of learning process of amputees for effectively using myoelectrically controlled multifunctional prostheses.

Adewuyi et al (2017) published this study to evaluate strategies that allow partial-hand amputees to control a prosthetic hand while allowing retain wrist function. EMG data was recorded from the extrinsic and intrinsic hand muscles of six non-amputees and two partial-hand amputees while they performed 4 hand motions in 13 different wrist positions. The performance of 4 classification schemes using EMG data alone and EMG data combined with wrist positional information was evaluated. Using recorded wrist positional data, the relationship between EMG features and wrist position was modeled and used to develop a wrist position-independent classification scheme. A multi-layer perceptron artificial neural network classifier was better able to discriminate four hand motion classes in 13 wrist positions than a linear discriminant analysis classifier (p = 0.006), quadratic discriminant analysis classifier (p < 0.0001) and a linear perceptron artificial neural network classifier (p = 0.04). The addition of wrist position data to EMG data significantly improved performance (p < 0.001). Training the classifier with the combination of extrinsic and intrinsic muscle EMG data performed significantly better than using intrinsic (p < 0.0001) or extrinsic muscle EMG data alone (p < 0.0001), and training with intrinsic muscle EMG data performed significantly better than extrinsic muscle EMG data alone (p < 0.001). The same trends were observed for amputees, except training with intrinsic muscle EMG data, on average, performed worse than the extrinsic muscle EMG data. The authors proposed a wrist position-independent controller that simulates data from multiple wrist positions and is able to significantly improve performance by 48-74% (p < 0.05) for non-amputees and by 45-66% for partial-hand amputees, compared to a classifier trained only with data from a neutral wrist position and tested with data from multiple positions. They concluded thar sensor fusion (using EMG and wrist position information), non-linear artificial neural networks, combining EMG data across multiple muscle sources, and simulating data from different wrist positions are effective strategies for mitigating the wrist position effect and improving classification performance.

Kuiken et al (2017) state that Myoelectric devices are controlled by electromyographic signals generated by contraction of residual muscles, which thus serve as biological amplifiers of neural control signals. Although nerves severed by amputation continue to carry motor control information intended for the missing limb, loss of muscle effectors due to amputation prevents access to this important control information. Targeted Muscle Reinnervation (TMR) was developed as a novel strategy to improve control of myoelectric upper limb prostheses. Severed motor nerves are surgically transferred to the motor points of denervated target muscles, which, after reinnervation, contract in response to neural control signals for the missing limb. TMR creates additional control sites, eliminating the need to switch the prosthesis between different control modes. In addition, contraction of target muscles, and operation of the prosthesis, occurs in response to attempts to move the missing limb, making control easier and more intuitive. The authors state that TMR has been performed extensively in individuals with high-level upper limb amputations and has been shown to improve functional prosthesis control. The benefits of TMR are being studied in individuals with transradial amputations and lower limb amputations. TMR is also being investigated in an ongoing clinical trial as a method to prevent or treat painful amputation neuromas.

Whelan et al (2018) published a case series on functional outcomes with externally powered partial hand prostheses. The purpose was to explore how using an externally powered partial hand prosthesis contributes to the completion of functional tasks. Fifteen individuals being fit with i-digits partial hand prostheses were evaluated using the Southampton Hand Assessment Procedure (SHAP) and Patient-Specific Functional Scale (PSFS). The individuals were each fit during a 1-week condensed fitting and training process and received 10 to 15 hours of therapy between the prefitting and postfitting testing. Twelve male and three female clients with four- (with thumb remaining) or five-digit partial hand limb loss or deficiency participated. Average age was 42 years, and 87% had acquired amputations an average of 2.44 years before the fitting. All subjects demonstrated clinically significant change scores on both the PSFS and the SHAP. The individuals with five-digit absence demonstrated marked improvement in comparison with those with four-digit absence; however, both were far superior to the minimal detectable change score for the SHAP, with 42.33 and 19.16 average improvement scores, respectively. The authors conclude that subjects fit with four- or five-digit externally powered partial hand prostheses demonstrated significant functional improvements in objective hand function and individualized goals. The remnant thumbs of users fit with four-digit systems sometimes exhibited limitations on range of motion or strength. Despite this, their evaluation scores still showed significant improvement; in fact, almost 10 times the minimal detectable change score. For those with five-digit absence, the change was 20 times the minimal threshold. These results suggest the benefit of the i-digits partial hand prosthesis as contributing to the function of individuals with partial hand limb loss or deficiency, particularly with the individuals' priority functional goals.

Stein et al (2007) published a pilot study conducted using the controlled exoskeletal robotic brace for the elbow (the active joint brace) for exercise training in individuals with chronic hemiparesis after stroke. Eight stroke survivors with severe chronic hemiparesis were enrolled in this pilot study. One subject withdrew from the study because of scheduling conflicts. A second subject was unable to participate in the training protocol because of insufficient surface EMG activity to control the active joint brace. The six remaining subjects each underwent 18 hrs of exercise training using the device for a period of 6 wks. Outcome measures included the upper-extremity component of the Fugl-Meyer scale and the modified Ashworth scale of muscle hypertonicity. Analysis revealed that the mean upper-extremity component of the Fugl-Meyer scale increased from 15.5 (SD 3.88) to 19 (SD 3.95) (P = 0.04) at the conclusion of training for the six subjects who completed training. Combined (summated) modified Ashworth scale for the elbow flexors and extensors improved from 4.67 (+/-1.2 SD) to 2.33 (+/-0.653 SD) (P = 0.009) and improved for the entire upper limb as well. All subjects tolerated the device, and no complications occurred. The authors concluded that EMG-controlled powered elbow orthoses can be successfully controlled by severely impaired hemiparetic stroke survivors. This technique shows promise as a new modality for assisted exercise training after stroke.

Chang et al (2007) published a study analyzing the effects of conventional rehabilitation combined with bilateral force-induced isokinetic arm movement training on paretic upper-limb motor recovery in patients with chronic stroke. In this single-cohort, pre- and postretention study, participants included twenty subjects who had unilateral strokes at least 6 months before enrolling in the study. A training program (40min/session, 3 sessions/wk for 8wk) consisting of 10 minutes of conventional rehabilitation and 30 minutes of robot-aided, bilateral force-induced, isokinetic arm movement training to improve paretic upper-limb motor function. The interval of pretest, post-test, and retention test was set at 8 weeks. Clinical arm motor function (Fugl-Meyer Assessment [FMA], upper-limb motor function, Frenchay Arm Test, Modified Ashworth Scale), paretic upper-limb strength (grip strength, arm push and pull strength), and reaching kinematics analysis (peak velocity, percentage of time to peak velocity, movement time, normalized jerk score) were used as outcome measures. After comparing the sets of scores, the authors found that the post-test and retention test in arm motor function significantly improved in terms of grip (P=.009), push (P=.001), and pull (P=.001) strengths, and FMA upper-limb scale (P<.001). Reaching kinematics significantly improved in terms of movement time (P=.015), peak velocity (P=.035), percentage of time to peak velocity (P=.004), and normalized jerk score (P=.008). Improvement in reaching ability was not sustained in the retention test. They concluded that preliminary results showed that conventional rehabilitation combined with robot-aided, bilateral force-induced, isokinetic arm training might enhance the recovery of strength and motor control ability in the paretic upper limb of patients with chronic stroke.

Kwakkel et al (2008) published a systematic review of studies that investigate the effects of robot-assisted therapy on motor and functional recovery in patients with stroke. A database of articles published up to October 2006 was compiled using the following Medline key words: cerebral vascular accident, cerebral vascular disorders, stroke, paresis, hemiplegia, upper extremity, arm, and robot. References listed in relevant publications were also screened. Studies that satisfied the following selection criteria were included: (1) patients were diagnosed with cerebral vascular accident; (2) effects of robot-assisted therapy for the upper limb were investigated; (3) the outcome was measured in terms of motor and/or functional recovery of the upper paretic limb; and (4) the study was a randomized clinical trial (RCT). For each outcome measure, the estimated effect size (ES) and the summary effect size (SES) expressed in standard deviation units (SDU) were calculated for motor recovery and functional ability (activities of daily living [ADLs]) using fixed and random effect models. Ten studies, involving 218 patients, were included in the synthesis. Their methodological quality ranged from 4 to 8 on a (maximum) 10-point scale. Meta-analysis showed a nonsignificant heterogeneous SES in terms of upper limb motor recovery. Sensitivity analysis of studies involving only shoulder-elbow robotics subsequently demonstrated a significant homogeneous SES for motor recovery of the upper paretic limb. No significant SES was observed for functional ability (ADL). The authors concluded that as a result of marked heterogeneity in studies between distal and proximal arm robotics, no overall significant effect in favor of robot-assisted therapy was found in the present meta-analysis. However, subsequent sensitivity analysis showed a significant improvement in upper limb motor function after stroke for upper arm robotics. No significant improvement was found in ADL function. However, the administered ADL scales in the reviewed studies fail to adequately reflect recovery of the paretic upper limb, whereas valid instruments that measure outcome of dexterity of the paretic arm and hand are mostly absent in selected studies. Future research into the effects of robot-assisted therapy should therefore distinguish between upper and lower robotics arm training and concentrate on kinematical analysis to differentiate between genuine upper limb motor recovery and functional recovery due to compensation strategies by proximal control of the trunk and upper limb.

Mehrholz et al (2008) published a cochrane systematic review assessing the effectiveness of electromechanical and robot‐assisted arm training for improving activities of daily living and arm function and motor strength of patients after stroke, and the acceptability and safety of the therapy. The authors searched the Cochrane Stroke Group Trials Register (last searched October 2007), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 3, 2007), MEDLINE (1950 to October 2007), EMBASE (1980 to October 2007), CINAHL (1982 to October 2007), AMED (1985 to October 2007), SPORTDiscus (1949 to October 2007), PEDro (searched October 2007), COMPENDEX (1972 to October 2007) and INSPEC (1969 to October 2007). They also hand searched relevant conference proceedings, searched trials and research registers, checked reference lists, and contacted trialists, experts and researchers in our field, and manufacturers of commercial devices. The selection criteria was randomized controlled trials comparing electromechanical and robot‐assisted arm training for recovery of arm function with other rehabilitation interventions or no treatment for patients after stroke. Two review authors independently selected trials for inclusion, assessed trial quality and extracted data. They contacted trialists for additional information and analyzed the results as standardized mean differences (SMDs) for continuous variables and relative risk differences (RD) for dichotomous variables. They included 11 trials (328 participants) in this review. Electromechanical and robot‐assisted arm training did not improve activities of daily living (SMD = 0.29; 95% confidence interval (CI) ‐0.47 to 1.06; P = 0.45; I2 = 85%). Arm motor function and arm motor strength improved (SMD = 0.68, 95% CI 0.24 to 1.11; P = 0.002; I2 = 56% and SMD = 01.03, 95% CI 0.29 to 1.78; P = 0.007; I2 = 79% respectively). Electromechanical and robot‐assisted arm training did not increase the risk of patients to drop out (RD) (fixed‐effect model) = 0.01; 95% CI ‐0.05 to 0.06; P = 0.77; I2 = 0.0%) and adverse events were rare. The authors concluded that patients who receive electromechanical and robot‐assisted arm training after stroke are not more likely to improve their activities of daily living, but arm motor function and strength of the paretic arm may improve. However, the results must be interpreted with caution because there were variations between the trials in the duration, amount of training and type of treatment, and in the patient characteristics.

Page et al (2020) published a randomized controlled trial determining the efficacy of regimens comprised of: Myomo + repetitive, task-specific practice; repetitive, task-specific practice only; and Myomo only on outcomes for hemiplegic arm. Using a randomized, controlled, single-blinded design, 34 subjects (20 males; mean age 55.8 years), exhibiting chronic, moderate, stable, post-stroke, upper extremity hemiparesis, were included. Participants were randomized to one of the above conditions and administered treatment for 1 h/day on 3 days/week over an 8-week period. The primary outcome measure was the upper extremity section of the Fugl-Meyer Impairment Scale (FM); the secondary measurement was the Arm Motor Activity Test (AMAT). The groups exhibited similar score increases of approximately +2 points, resulting in no differences in the amount of change on the FM (H= 0.376, = 0.83) and AMAT (H= 0.978 = 0.61). The results suggest that a therapeutic approach integrating myoelectric bracing yields highly comparable outcomes to those derived from repetitive, task-specific practice-only. Myoelectric bracing could be used as alternative for labor-intensive upper extremity training due to its equivalent efficacy to hands-on manual therapy with moderately impaired stroke survivors.

Chang et al (2023) published an observational study comparing task performance in individuals with upper limb impairments with and without a myoelectric arm orthosis. This was a three-month observational study. Participants met at 4 time points after receiving their myoelectric orthosis (2- Weeks, Month-1, Month-2, Month-3) to complete 4 standardized common daily tasks. Nationwide, the sessions were completed remotely over videoconference calls at home. Study participants were adults with upper limb impairment due to stroke who were in the process of being fit with a myoelectric arm orthosis as a first-time user. The orthosis was a custom-fabricated myoelectric arm orthosis called the MyoPro®. The main outcome measures were functional tasks completed at each session with and without the MyoPro. Participants were evaluated on their success and the time required to complete each functional task. Longitudinal mixed and longitudinal mixed logistic regression models were analyzed. Eighteen individuals with chronic arm weakness due to stroke were included in the analysis. Statistically significant and clinically meaningful improvements were observed on the functional tasks in the participants' homes. By 3 months, participants successfully used the MyoPro to accomplish the tasks, reduced the amount of time spent to complete the tasks, and had a higher probability of success as compared with at 2 weeks. With the MyoPro, participants showed significant improvement in overall task completion and completed the tasks in a significantly decreased time as compared with without the MyoPro. The authors concluded that the MyoPro provides a stabilizing support to the weak arm of individuals after stroke and enables individuals to use their impaired arm to complete functional tasks independently in the home environment.

Chang et al (2024) published a retrospective study evaluating the outcomes and clinical benefits provided by the MyoPro® orthosis in individuals 65 years and older with upper limb impairment secondary to a stroke. The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire was administered to individuals who have chronic stroke both before and after receiving their myoelectric orthosis. A Generalized Estimating Equation model was analyzed. After using the MyoPro, 19 individuals with chronic stroke had a mean improvement (decrease) in DASH score of 18.07, 95% CI = (-25.41, -10.72), adjusted for 8 covariates. This large change in DASH score was statistically significant and clinically meaningful as participants self-reported an improvement with engagement in functional tasks. The authors concluded that the use of the MyoPro increases independence in functional tasks as reported by the validated DASH outcome measure for older participants with chronic stroke.

Two new Minnesota state statutes will be effective on 1/1/2025: Minn. Stats. §62Q.665 Coverage for Orthotic and Prosthetic Devices and §62Q.6651 Medical Necessity and Nondiscrimination Standards for Coverage of Prosthetics or Orthotics. Minn. Stat. §62Q.665 Article 57, Sec. 41. Subd. 2a, d, e, and f state the following: Subd. 2. Coverage (a) A health plan must provide coverage for orthotic and prosthetic devices, supplies, and services, including repair and replacement, at least equal to the coverage provided under federal law for health insurance for the aged and disabled under sections 1832, 1833, and 1834 of the Social Security Act, United States Code, title 42, sections 1395k, 1395l, and 1395m, but only to the extent consistent with this section; (d) A health plan must cover orthoses and prostheses when furnished under an order by a prescribing physician or licensed health care prescriber who has authority in Minnesota to prescribe orthoses and prostheses, and that coverage for orthotic and prosthetic devices, supplies, accessories, and services must include those devices or device systems, supplies, accessories, and services that are customized to the covered individual's needs; (e) A health plan must cover orthoses and prostheses determined by the enrollee's provider to be the most appropriate model that meets the medical needs of the enrollee for purposes of performing physical activities, as applicable, including but not limited to running, biking, and swimming, and maximizing the enrollee's limb function; (f) A health plan must cover orthoses and prostheses for showering or bathing.

Minn. Stat. §62Q.6651 Medical Necessity and Nondiscrimination Standards for Coverage of Prosthetics or Orthotics (2) is effective January 1, 2025, and applies to health plans offered, issued, or sold on or after that date. Minn. Stat. §62Q.6651 Article 57, Sec. 42. a, b, c, f, and g state that (a) When performing a utilization review for a request for coverage of prosthetic or orthotic benefits, a health plan company shall apply the most recent version of evidence-based treatment, and fit criteria as recognized by relevant clinical specialists; (b) A health plan company shall render utilization review determinations in a nondiscriminatory manner and shall not deny coverage for habilitative or rehabilitative benefits, including prosthetics or orthotics, solely on the basis of an enrollee's actual or perceived disability; (c) A health plan company shall not deny a prosthetic or orthotic benefit for an individual with limb loss or absence that would otherwise be covered for a nondisabled person seeking medical or surgical intervention to restore or maintain the ability to perform the same physical activity; (f) If coverage for prosthetic or custom orthotic devices is provided, payment shall be made for the replacement of a prosthetic or custom orthotic device or for the replacement of any part of the devices, without regard to continuous use or useful lifetime restrictions, if an ordering health care provider determines that the provision of a replacement device, or a replacement part of a device, is necessary because (1) of a change in the physiological condition of the patient; (2) of an irreparable change in the condition of the device or in a part of the device; or (3) the condition of the device, or the part of the device, requires repairs and the cost of the repairs would be more than 60 percent of the cost of a replacement device or of the part being replaced. (g) Confirmation from a prescribing health care provider may be required if the prosthetic or custom orthotic device or part being replaced is less than three years old.

The Management of Upper Limb Amputation Rehabilitation Work Group in the Department of Veterans Affairs and the Department of Defense VA/DoD clinical guideline for the management of upper limb amputation rehabilitation state that the initial prosthesis prescription should be developed with input from all members of the care team and individualized for the patient based on the patient’s specific needs and goals related to prosthesis use. A comprehensive prescription for an upper limb prosthesis should include- Design (e.g., preparatory versus definitive); control strategy (e.g., passive, externally powered, body powered, task specific); The anatomical side and amputation level of the prosthesis; Type of socket interface (e.g., soft insert, elastomer liner, flexible thermoplastic); Type of socket frame (e.g., thermoplastic or laminated); Suspension mechanism (e.g., harness, suction, anatomical); Terminal device (TD); Wrist unit (if applicable); Elbow unit (if applicable); Shoulder unit (if applicable). Components of their comprehensive assessment include- Present health status; Level of function; Modifiable/controllable health risk factors; Pain assessment; Cognition and behavioral health; Personal, family, social, and cultural context; Learning assessment; Residual limb assessment; Non- amputated limb and trunk assessment; Prosthetic assessment (if applicable); Vocational assessment. The authors make a weak (for) recommendation that, “for patients with major unilateral upper limb amputation (i.e., through or proximal to the wrist), we suggest use of a body- powered or externally powered prosthesis to improve independence and reduce disability.” Neither for nor against recommendation that, “there is insufficient evidence to recommend for or against any specific control strategy, socket design, suspension method, or component.”

Summary of Evidence:

For patients with an amputation or missing limb at the wrist or above (e.g., forearm, elbow, shoulder), the evidence includes a systematic review and comparative studies. The outcomes of interest include function and performance of activities of daily living (ADLs), quality of life (QOL), community integration, and patient satisfaction with the device. The evidence hints that, when compared with body-powered prostheses, myoelectric components possess the similar capability to perform light work. Although, performance reduction may be seen in heavy workload environments. The evidence is sufficient to evaluate the benefits and improvements in patient outcomes brought by the technology. For patients with an amputation or missing limb distal to the wrist and receiving a myoelectric prosthesis with individually powered digits, there are no studies assessing the outcomes in them. The evidence is insufficient to evaluate the benefits and improvements brought by the technology. For myoelectric controlled upper-limb orthotic for home use, the evidence is limited. And the results are inconsistent. Studies with larger sample size that show consistent improvements in patient outcome measures are needed. There is insufficient evidence to evaluate their benefits and improvement in outcomes.

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:

REFERENCES:

1. Adewuyi AA, Hargrove LJ, Kuiken TA. Resolving the effect of wrist position on myoelectric pattern recognition control. J Neuroeng Rehabil.2017;14(1):39. Published 2017 May 4. doi:10.1186/s12984-017-0246-x
2. Carey SL, Lura DJ, Highsmith MJ; CP; FAAOP. Differences in myoelectric and body-powered upper-limb prostheses: Systematic literature review. J Rehabil Res Dev. 2015;52(3):247-262. doi:10.1682/JRRD.2014.08.0192
3. Chang JJ, Tung WL, Wu WL, Huang MH, Su FC. Effects of robot-aided bilateral force-induced isokinetic arm training combined with conventional rehabilitation on arm motor function in patients with chronic stroke. Arch Phys Med Rehabil. 2007;88(10):1332-1338. doi:10.1016/j.apmr.2007.07.016
4. Chang SR, Hofland N, Chen Z, et al. Myoelectric Arm Orthosis Assists Functional Activities: A 3-Month Home Use Outcome Report. Arch Rehabil Res Clin Transl. 2023;5(3):100279. Published 2023 Jul 13. doi:10.1016/j.arrct.2023.100279
5. Chang SR, Hofland N, Chen Z, Kovelman H, Wittenberg GF, Naft J. Improved Disabilities of the Arm, Shoulder and Hand scores after myoelectric arm orthosis use at home in chronic stroke: A retrospective study. Prosthet Orthot Int. 2024;48(3):267-275. doi:10.1097/PXR.0000000000000341
6. Department of Veterans Affairs and the Department of Defense. VA/DoD CLINICAL Practice Guideline For The Management Of Upper Limb Amputation Rehabilitation. Version 2.0 2022. Available at: https://www.healthquality.va.gov/guidelines/Rehab/ULA/. Accessed on July 24, 2024.
7. Kuiken TA, Barlow AK, Hargrove L, Dumanian GA. Targeted Muscle Reinnervation for the Upper and Lower Extremity. Tech Orthop. 2017;32(2):109-116. doi:10.1097/BTO.0000000000000194
8. Kwakkel G, Kollen BJ, Krebs HI. Effects of robot-assisted therapy on upper limb recovery after stroke: a systematic review. Neurorehabil Neural Repair. 2008;22(2):111-121. doi:10.1177/1545968307305457
9. Mehrholz J, Platz T, Kugler J, Pohl M. Electromechanical and robot-assisted arm training for improving arm function and activities of daily living after stroke. Cochrane Database Syst Rev. 2008;(4):CD006876. Published 2008 Oct 8. doi:10.1002/14651858.CD006876.pub2
10. Minn. Stat. §62Q.6651 Medical Necessity and Nondiscrimination Standards for Coverage of Prosthetics or Orthotics.
11. Minn Stats. §62Q.6651 Coverage for Orthotic and Prosthetic Devices.
12. Page S, Griffin C, White S. Efficacy of myoelectric bracing in moderately impaired stroke survivors: A randomized, controlled trial. J Rehabil Med. 2020;52(2):jrm00017. Published 2020 Feb 7. doi:10.2340/16501977-2644
13. Pan L, Zhang D, Sheng X, Zhu X. Improving Myoelectric Control for Amputees through Transcranial Direct Current Stimulation. IEEE Trans Biomed Eng. 2015;62(8):1927-1936. doi:10.1109/TBME.2015.2407491
14. Resnik L, Borgia M, Clark M. Function and Quality of Life of Unilateral Major Upper Limb Amputees: Effect of Prosthesis Use and Type. Arch Phys Med Rehabil. 2020;101(8):1396-1406. doi:10.1016/j.apmr.2020.04.003
15. Resnik LJ, Borgia ML, Acluche F, Cancio JM, Latlief G, Sasson N. How do the outcomes of the DEKA Arm compare to conventional prostheses?. PLoS One. 2018;13(1):e0191326. Published 2018 Jan 17. doi:10.1371/journal.pone.0191326
16. Resnik LJ, Borgia ML, Clark MA, Heinemann AW, Ni P. Measuring Satisfaction With Upper Limb Prostheses: Orthotics and Prosthetics User Survey Revision That Includes Issues of Concern to Women. Arch Phys Med Rehabil. 2022;103(12):2316-2324. doi:10.1016/j.apmr.2022.05.008
17. Ritchie S, Wiggins S, Sanford A. Perceptions of cosmesis and function in adults with upper limb prostheses: a systematic literature review. Prosthet Orthot Int. 2011;35(4):332-341. doi:10.1177/0309364611420326
18. Stein J, Narendran K, McBean J, Krebs K, Hughes R. Electromyography-controlled exoskeletal upper-limb-powered orthosis for exercise training after stroke [published correction appears in Am J Phys Med Rehabil. 2008 Aug;87(8):689]. Am J Phys Med Rehabil. 2007;86(4):255-261. doi:10.1097/PHM.0b013e3180383cc5
19. Whelan, Lynsay R. MS, OTR/L; Farley, Jeremy BS, CPO/L. Functional Outcomes with Externally Powered Partial Hand Prostheses. Journal of Prosthetics and Orthotics 30(2):p 69-73, April 2018. | DOI: 10.1097/JPO.0000000000000180

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.

April 2025: Updates to Key Points and References. Quarterly HCPCS coding update. Added L6700.