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Myoelectric prostheses are powered by electric motors with an external power source. The joint movement of an upper-limb prosthesis (e.g., hand, wrist, and/or elbow) is driven by microchip-processed electrical activity in the muscles of the remaining limb stump.
Upper-limb prostheses are used for amputations at any level, from the hand to the shoulder. The need for a prosthesis can occur for a number of reasons, including trauma, surgery, or congenital anomalies. The primary goals of the upper-limb prostheses 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 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 over 30 years; each possesses unique advantages and disadvantages.
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 (DARPA), 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 reinervation 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 DEKA Arm System, developed in a joint effort with DARPA and approved by the Food and Drug Administration in May 2014, 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 EMG electrodes, the DEKA Arm System contains a combination of mechanisms including switches, movement sensors, and force sensors.
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.
Available myoelectric devices include ProDigits™ and i-limb™ (Touch Bionics), the SensorHand™ Speed and Michelangelo® Hand (Otto Bock), the LTI Boston Digital Arm™ System (Liberating Technologies), the Utah Arm Systems (Motion Control), and bebionic (steeper).
In 2014, the DEKA Arm System, now called the LUKE™ arm (DEKA Integrated Solutions, now DEKA Research & Development) was cleared for marketing by FDA through the de novo 513(f)(2) classification process for some novel low- to moderate-risk medical devices that are first-of-a-kind.
Also, see the related medical policies, Microprocessor-Controlled Prosthetic Knees and Functional Neuromuscular Stimulation to Provide Ambulation.
POLICYMyoelectric upper-limb prosthetic components may be considered medically necessary when the following conditions are met:
A prosthesis with individually powered digits, including but not limited to a partial hand prosthesis, is considered investigational.
Myoelectric upper-limb prosthetic components are considered not medically necessary under all other conditions.
POLICY EXCEPTIONSFederal 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.
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 Nervous/Mental Conditions, 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 Medically Necessary, “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 HISTORY2/4/2009: 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.
SOURCESBlue Cross Blue Shield Association policy # 1.04.04
CODE REFERENCEThis 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.
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