Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Upper Limb Prostheses
Policy #:MA05.057c

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and to the member’s medical needs and condition.

MEDICALLY NECESSARY

Passive (manual) or body-powered (harness and cable) upper limb prostheses are considered medically necessary and, therefore, covered when all of the following criteria are met:
  • The individual has an amputation or a loss of an upper limb that occurs at any level from the finger to the shoulder.
  • A comprehensive evaluation is performed by a licensed professional provider and prosthetist.
    • An evaluation by a physical, occupational, or certified hand therapist is strongly encouraged.
  • The prosthesis is prescribed by a licensed professional provider.
  • The prosthesis is fitted and made by a certified or licensed prosthetist.

Externally powered (e.g., myoelectric) upper limb prostheses (including those parts of a hybrid system) are considered medically necessary and, therefore, covered when all of the following criteria are met:
  • The individual has an amputation or loss of an upper limb at the transmetacarpal level, wrist disarticulation, or proximal (above).
  • A comprehensive evaluation is performed by a licensed professional provider and prosthetist.
    • An evaluation by a physical, occupational, or certified hand therapist is strongly encouraged.
  • The prosthesis is prescribed by a licensed professional provider.
  • The prosthesis is fitted and made by a certified or licensed prosthetist.
  • A standard body-powered prosthetic device cannot be used or is insufficient to meet the functional needs of the individual in performing activities of daily living.
  • The individual with an upper limb amputation has the capacity to operate an externally powered upper limb prosthesis through myoelectric control (has demonstrated the capacity to generate the minimum microvolt threshold) and/or through alternate input mechanisms.
  • A functional evaluation indicates that, with training, the 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’s needs for control, durability (maintenance), function (speed, work capability), and usability.

Terminal devices are considered medically necessary and, therefore, covered when used to perform an essential activity of daily living.

NOT MEDICALLY NECESSARY

All other uses for an upper limb prosthetic and/or components not meeting the above criteria are considered not medically necessary and, therefore, not covered.

Terminal devices are considered not medically necessary and, therefore, not covered when used solely for activities not essential to an activity of daily living, such as, but not limited to, sports, recreation or employment.

EXPERIMENTAL/INVESTIGATIONAL

An upper limb prosthesis with individually powered digits, including but not limited to a partial hand prosthesis, is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

REPAIR AND REPLACEMENT

For information on the repair and/or replacement of prostheses, refer to the Company's policy on the repair and replacement of external prosthetic devices.

The repair or replacement of upper limb prostheses, supplies, or one or more of its components (parts) is covered and eligible for reimbursement consideration by the Company when the upper limb prosthesis itself is covered under the individual's medical benefits and all of the requirements for a repair or replacement are met.

The repair or replacement of upper limb prostheses or one or more of its components (parts) is considered non-covered and not eligible for reimbursement when the request is for a technologically advanced or newly released upgrade to an original device that still functions properly and/or there is no significant change in the individual's condition.

Requests for a different type of upper limb prosthesis or one or more of its components (parts) due to a change in medical and/or functional status, such that the upper limb prosthesis can no longer meet the individual’s needs for control, durability (maintenance), function (speed, work capability), and usability are considered new requests, not requests for replacement. These requests are evaluated against the medical necessity criteria for the new type of upper limb prostheses requested.

The Company may determine the reasonable useful lifetime of a specific external prosthetic device based on the manufacturer's recommendation or the Food and Drug Administration (FDA)--approved labeling.

In the absence of manufacturer's recommendations or FDA labeling, the Company may determine the reasonable useful lifetime of a specific external prosthetic device, but is generally not less than five years. Replacement due to misuse, abuse, or failure to adequately maintain or care for the item is excluded from coverage.

REQUIRED DOCUMENTATION

A specialty evaluation must be performed by a professional provider, including a physician and a prosthetist with specific training and experience in rehabilitation involving upper limb prostheses evaluations, who document the need for the prosthesis and or accessories. In addition, specialty evaluations should be performed by a licensed/certified physical therapist (PT), occupational therapist (OT), or Certified Hand Therapist (CHT) for externally powered upper limb prostheses.

Reimbursement for devices will be made only if there is sufficient documentation in the individual's medical record showing current functional capabilities and functional need for the technological or design features. Documentation should also include expected functional potential and an explanation if there is a difference between the individual's current status and expected potential. This information must be retained in the professional provider's or prosthetist's files, and be available upon request.

The prosthetist must retain documentation in the medical record of the prosthesis or prosthetic component replaced, the reason for replacement, and a description of the labor involved. It is recognized that there are situations where the reason for replacement includes but is not limited to: changes in the residual limb, functional need changes, or irreparable damage or wear/tear due to excessive patient weight or prosthetic demands of highly mobile amputees.

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports. This policy is consistent with Medicare's documentation requirements, including the following required documentation:

PRESCRIPTION (ORDER) REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective order at the time of an audit or after an audit for submission as an original order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY
Medical record documentation must include a contemporaneously prepared delivery confirmation or member’s receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES
The supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately seven days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual’s medical record. Delivery of the supplies should not be done earlier than approximately five days before the individual would exhaust their on-hand supply.

If required documentation is not available on file to support a claim at the time of an audit or record request, the supplier may be required to reimburse the Company for overpayments.
Policy Guidelines

There is no Medicare coverage determination addressing upper-limb prostheses; therefore, the Company policy is applicable.

The upper limb prosthesis must be prescribed and ordered by a qualified professional who is able to determine the most appropriate prosthetic components and control mechanism (e.g., passive, body-powered, myoelectric, or hybrid). A trial period may be indicated to evaluate the tolerability and efficacy of the prosthesis in a real-life setting.

The following should be considered when determining type of prosthesis:
  • The individual has demonstrated sufficient neurological and cognitive function to operate the prosthesis effectively.
  • The individual is free of comorbidities that could interfere with function of the prosthesis (neuromuscular disease, etc).

AMPUTATION LEVELS
  • Transphalangeal amputation: resection of the thumb or fingers at distal interphalangeal (DIP), proximal interphalangeal (PIP), or metacarpophalangeal (MCP) levels or at any level in between.
  • Transmetacarpal amputation: resection through the metacarpals.
  • Transcarpal amputation: resection through the carpal bones.
    • Transmetacarpal and transcarpal amputations are less advised because, except for select circumstances, they provide for decreased functional outcomes.
  • Wrist disarticulation: transection between the carpals and radius/ulna.
  • Transradial amputation: below-elbow amputation (may be classified as long, medium, or short).
  • Elbow disarticulation: transection through the elbow joint.
  • Transhumeral amputation: above-elbow (standard length is 50 percent to 90 percent of humeral length).
  • Shoulder disarticulation: transection through the shoulder joint.
  • Interscapulothoracic disarticulation (forequarter): amputation removing the entire shoulder girdle (scapula and all or part of the clavicle) (some surgeons choose to leave part of the medial clavicle).

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, upper-limb prostheses are covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as experimental/investigational or not medically necessary are not eligible for coverage or reimbursement by the Company.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Manufacturers must register prostheses with the restorative devices branch of the US Food and Drug Administration (FDA) and keep a record of any complaints, but do not have to undergo a full FDA review.


Description

An upper limb amputation is much less common than a lower limb amputation. The upper limb amputation is considered to be any amputation that occurs in the upper limb from an individual finger to the shoulder complex. The preferred level of amputation for the highest level of functional recovery is the below-elbow amputation (transradial). A prosthesis is a device that is designed to restore natural appearance and function of a missing limb or body part.

Upper limb prostheses are used for amputations that can occur at any level from finger or partial hand to the shoulder. The need for an upper limb prosthesis can result from congenital limb deficiencies or amputations secondary to tumors, medical diseases, elective surgery, or trauma. Most congenital deformities at birth do not adversely affect lifespan, so an individual with a congenital deformity may require prosthetic rehabilitation at any age. Amputations from tumors are most common among rapidly growing individuals during their teen years. Amputations as a result of trauma, the most common cause for upper limb amputations, usually occur in individuals from 15 years to 45 years of age. Upper-extremity amputations tend to be rare in individuals older than 60 years, but may be required secondary to tumor or medical disease.

The type of functional prosthesis available for people with upper limb amputations is dictated by their level of amputation. Furthermore, consideration must be given to associated co-morbidities, especially if the individual has bilateral upper limb amputations.

CATEGORIES OF UPPER LIMB PROSTHESES

There are five main categories of upper limb prostheses: passive (or functional aesthetic), body-powered, externally powered (e.g., myoelectric), hybrid-powered (e.g., a combination of body-powered and myoelectric components), and activity-specific (e.g., terminal devices).

PASSIVE PROSTHESES
The passive, also known as a functional aesthetic, prosthesis is the lightest in weight and is described as the most comfortable. Functional aesthetic prostheses are available as finger prostheses, partial-hand prostheses, hand prostheses all the way proximal to shoulder disarticulation, and interscapulothoracic prostheses. For individuals with digital and partial-hand amputations, these devices can provide desensitization, edema management, and restoration of the ability to grip surfaces in the affected hand, in addition to restoration of a natural appearance. For individuals with amputations at the wrist and proximal (above), a passive prosthesis must be positioned manually with the opposite arm. While a defining feature of functional aesthetic prostheses is that they have no active prehension at the hand, most have the ability to hold objects with a passive grasp when items are placed into the hand. This type of prosthesis restores the appearance of absent anatomy and provides the functional benefit of bimanual activities and support of an unaffected limb. Passive prostheses are generally contraindicated for people with bilateral upper limb amputations.

BODY-POWERED PROSTHESES
The body-powered prosthesis uses a harness and cable system to provide direct activation of prosthetic components. Voluntary movement of the shoulders and/or residual limb pull on a cable (or cables), which then transmits force to prosthetic components. Body-powered prostheses are available for individuals with amputations at the metacarpal phalangeal level and proximal (above). An advantage of a body-powered prosthesis is that wearers describe a direct biofeedback link between their motion and the device operation without delay. Body-powered prostheses have proven to be reliable and can be made to withstand heavy-duty activities, as well as rugged environments. For body-powered systems, the most functional terminal device is a split hook or prehensor, rather than a mechanical hand, because mechanical prosthetic hands are visually obstructive and lack fine tip prehension.

EXTERNALLY POWERED PROSTHESES
Externally powered prostheses (e.g., myoelectric and some terminal devices) obtain input from the wearer to generate electrical signals, which are in turn used to operate battery-powered components, including terminal devices, wrists, and elbows, as well as elbow and shoulder joint locks. Externally powered prostheses are available for individuals with transmetacarpal amputations and proximal. The primary method of input for an externally powered prosthesis is via muscle-activated, surface-mounted electrodes; however, switches, pressure pads, and buttons are also available as input sources.

In a myoelectric prosthesis, electromyographic (EMG) signals from the residual limb musculature 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 can be limited to one joint at a time, myoelectric control of movement may be considered the most physiologically natural. Other advantages of externally powered devices are that they allow for reduction or elimination of harnessing, and can provide a strong grip and near-natural appearance and function.

Recent advances in prosthetic hand technology for individuals with partial hand and/or digit loss now allow for externally powered prosthetic hands to be programmed by a software interface that communicate via a Bluetooth® connection and can allow adjustments to be made to the prosthesis through a series of setting options that provide a highly functional compliant grip whereby the individual fingers of the device wrap around the object being grasped. Examples of these externally powered prosthetic hands are: the i-Limb™ Ultra, i-LIMB™ PULSE hand (Touch Bionics, Columbus,OH) and the BeBionics™ Hand (SteeperUSA, San Antonio), ProDigits™ (Touch Bionics, Columbus,OH).

HYBRID-POWERED PROSTHESES
A hybrid prosthesis combines the use of body-powered (harness and cable) and externally powered (e.g., myoelectric) control strategies. Hybrid prostheses are available for individuals with amputations at the elbow disarticulation level and proximal. The hybrid system allows for control of two components simultaneously; for example, the terminal device may be controlled myoelectrically, and the elbow may be operated through a body-powered harness/cabling system. Hybrid prostheses may be lighter in weight than prostheses that are entirely externally powered.

ACTIVITY-SPECIFIC PROSTHESES
Activity-specific prostheses are devices designed for a specific functional, vocational, or avocational activity. Because they are designed for a specific functional task, they do not restore an aesthetic/natural appearance. An example of an activity-specific prosthesis would be one for operating a particular piece of machinery or equipment, for swimming, for weight-lifting, or for a particular sport such as golfing or ball sports.

PROSTHETIC COMPONENTS

TERMINAL DEVICES
Terminal devices are the component at the end of a prosthesis that is designed to substitute hand function or to perform a specific function. Terminal devices can be classified as hooks, prehensors, or hands, and are either active or passive. Hooks and prehensors can be either body-powered or externally powered, and are very functional for grasping activities because they offer minimal visual obstruction. However, they may be rejected by individuals on the basis of their appearance. Body-powered hooks and prehensors can be further subdivided into voluntary opening (VO: pull-to-open with elastic closure) or voluntary closing (VC: pull-to-close with elastic opening).

PROSTHETIC HANDS
Prosthetic hands can be passive, body-powered, or externally powered. Passive terminal devices restore an aesthetic appearance and can be used to stabilize objects during bimanual activities. Body-powered (also known as mechanical) hands may also be either VO or VC in operation. Both body-powered and externally powered prosthetic hands restore natural appearance, but they tend to be heavy and more costly. Most prosthetic hands require gloves for protection and aesthetics that need to be replaced periodically. The terminal device chosen is based on the individual and the intended function. As no one individual terminal device can replace the multiple deficits associated with hand loss, provision of more than one terminal device may be indicated depending on the individual's unique presentation, vocation, and life circumstances.

WRIST UNITS
Wrist units included in upper limb prostheses come in different shapes and offer a number of functional features, including wrist flexion/extension, pronation/supination, and quick disconnect. Wrist flexion/extension and pronation/supination are valuable features because they allow for the terminal device to be optimally positioned for grasping and object-manipulation tasks. The quick-disconnect feature of a wrist unit allows for multiple terminal devices to be easily exchanged so that a single prosthesis can utilize a hook, prehensor, or prosthetic hand, depending on the activity in which the wearer is engaged. Body-powered prostheses can have wrist units with wrist flexion/extension, pronation/supination, and/or quick-disconnect, as long as the amputation is transradial (below elbow) or proximal. Externally powered prostheses can have wrist units with powered wrist pronation/supination or with quick-disconnect features. Powered wrist flexion/extension prostheses are currently not available.

PROSTHETIC ELBOWS
Prosthetic elbows are passive, body-powered, or externally powered. Passive elbows are lightweight and light-to-moderate duty and require the unaffected hand for positioning and locking. Body-powered elbows are reliable, require minimal maintenance, and can be operated through body motions. They tend to have limited life lift capacity but once positioned can withstand loading. Externally powered elbows can be operated myoelectrically or through switches and can have a live lift capacity of up to 13 pounds.

TECHNOLOGY DEVELOPMENT

Prosthetic research and development are rapidly changing due to advances in biomedical engineering and funding by the U.S. Department of Defense Advanced Research Projects Agency (DARPA). Some areas being developed are skin-like silicone elastomer gloves, "artificial muscles," and sensory feedback, in addition to smaller motors, implantable myoelectric sensors, and reinnervation of remaining muscle fibers to allow improved fine motor control. Lighter batteries and newer materials are being incorporated into myoelectric prosthetics to improve individual comfort. Restoring sensation to the prosthetic limb remains a major challenge to full integration of the limb into the individual's self image.

PREPROSTHETIC EVALUATION AND MANAGEMENT

Preprosthetic evaluation and management of a new upper limb amputee is vital for optimal rehabilitation outcomes. The cause of the amputation will determine the best approach for preprosthetic management. Care is coordinated by a multidisciplinary team approach, which may involve a prosthetist, a surgeon, nurses, physical and occupational therapists, and others as needed. Most preprosthetic evaluation and management is initiated following wound closure for someone with a new upper-extremity amputation.

Components of a preprosthetic evaluation and management program may include the following:
  • Completing a comprehensive evaluation to guide the team in determining an appropriate prosthetic plan
  • Shaping and controlling volume of the residual limb effectively
  • Minimizing scar tissue
  • Desensitizing the limb in preparation for wearing the prosthetic device
  • Achieving full range of motion in remaining joints of the residual limb
  • Strengthening the muscles of the residual limb to maximize potential for effective prosthetic use
  • Developing appropriate interventions for rehabilitation of associated injuries
  • Assisting the individual in developing some independence in performing basic activities of daily living

SCIENTIFIC EVIDENCE

There are significant challenges emerging that are unique to implementing the use of advanced upper limb prosthetic technology, such as upper limb prostheses with individually powered digits, including the myoelectric hand with individual control of digits. Currently, there is insufficient available published peer-reviewed literature that examines clinical value (e.g., improved function and health-related quality of life) of upper limb prostheses with individually powered digits. Although the availability of a myoelectric hand with individual control of digits has been reported in lay technology reports, video clips, and basic science reports, there is no currently available published peer-reviewed literature found to evaluate functional outcomes of individual digit control in amputees. According to the American Academy of Orthotists and Prosthetists (Wright 2009), in the research and development phase in the adult literature in particular, there has been a clear focus on biomechanical or impairment-based evaluations of innovative prosthetic hands; however, with a few exceptions, there is little accompanying evidence of the validation status of the hand function tools used. Although the assessment emphasis on hand skills is appropriate given the complexity and uniqueness of many of the prostheses being evaluated and the need to identify which features work and which ones need refinement, it fails to bridge the important link to higher level upper limb function. Lack of use of validated instruments also limits the interpretability of the results. Lake (2009) provided a review of progressive partial hand prosthetic management. Lake concluded that externally powered myoelectric prosthetic management requires specialized care that does not have its foundation rooted in any of the current, though progressive, upper limb protocols used today. Future research will include fitting protocols and techniques, fabrication, surgical considerations, and electronic handling, along with opportunities to formulate research methods and protocols from the ground up, rather than retrospective clinical findings.
References

American Academy of Orthotists and Prosthetists (AAOP). Differences in Myoelectric and body-powered upper limb prostheses. [AAOP Web site]. 2015. Available at: https://www.oandp.org/resource/resmgr/Files/Evidence_Notes/Evidence_Note_Myo_BP_Carey.pdf. Accessed December 31, 2019.

American Academy of Orthotists and Prosthetists (AAOP). Upper-limb prosthetic outcome measures. [AAOP Web site]. 2013. Available at: https://www.oandp.org/resource/resmgr/Files/Evidence_Notes/upper-limb_prosthetic_outcome.pdf. Accessed December 31, 2019.

American Board for Certification in Orthotics, Prosthetics & Pedorthics (ABC). ABC Orthotics and Prosthetics Scope of Practice 2018-V2. [ABC Web site]. 2018. Available at:
https://www.abcop.org/maintain-certification/Documents/Scope%20of%20Practice%20Final.pdf#page=6. Accessed December 31, 2019.

Biddiss E, Chau T. Upper-limb prosthetics: critical factors in device abandonment. Am J Phys Med Rehabil. 2007;86(12):977-87.

Biddiss EA, Chau TT. Upper limb prosthesis use and abandonment: a survey of the last 25 years. Prosthet Orthot Int. 2007;31(3):236-57.

Carey, SL. PhD; Derek J. Lura, DJ. PhD, Highsmith MJ. DPT, PhD, CP, FAAOP .Differences in myoelectric and body-powered upper-limb prostheses: Systematic literature review. J. Rehabil. Res. Dev. Vol.52. Number 3, 2015. Pages 247— 262. website; [Department of Veterans Affairs. Department of Defense]. Available at: http://www.rehab.research.va.gov/jour/2015/523/JRRD-2014-08-0192.html. Accessed December 31, 2019.

Department of Veterans Affairs (VA). Department of Defense (DoD). VA/DoD Clinical Practice Guideline for the Management of Upper Extremity Amputation Rehabilitation.Version 1.0 – 2014. Available at: http://www.healthquality.va.gov/guidelines/Rehab/UEAR/VADoDCPGManagementOfUEAR090214FINAL2508.pdf. Accessed December 31, 2019.

Dietl H. New developments in upper limb prosthetics. In: Smith DG, Michale JW, Bowker JH. eds. Atlas of Amputations and Limb Deficiencies: Surgical, Prosthetic and Rehabilitation Principles. 3rd ed. Rosemont, IL American Academy of Orthopedic Surgeons.; 2004: 343-349.

Dillingham T, Pezzin L, MacKenzie E. Limb amputation and limb deficiency: epidemiology and recent trends in the United States. South Med J. 2002;95:875-83.

Edelstein JE. Rehabilitation for children with limb deficiencies. In: Lusardi MM, Nielsen CC. eds. Orthotics and Prosthetics in Rehabilitation. 2nd ed. St. Louis, Missouri: Elsevier Inc.; 2007: 817-836.

Edelstein JE, Berger N. Performance comparison among children fitted with myoelectric and body-powered hands. Arch Phys Med Rehabil. 1993;74(4):376-80.

Egermann M, Kasten P, Thomsen M. Myoelectric hand prostheses in very young children. Int Orthop. 2009;33(4):1101-5.

Edwards SG. Elbow and Above-Elbow Amputations. Medscape [online]. Updated: October 2, 2019.
Available at: http://emedicine.medscape.com/article/1237886-overview. Accessed December 31, 2019.

Fougner A. Control of upper limb prostheses: terminology and proportional myoelectric control-a review. IEEE Trans Neural Syst Rehabil En.2012;20(5):663-677.

James MA, Bagley AM, Brasington K, et al. Impact of prostheses on function and quality of life for children with unilateral congenital below-the-elbow deficiency. J Bone Joint Surg Am. 2006;88(11):2356-65. Also available at: http://www.iprmd.org/downloads/publications/james/29_Impact.pdf. Accessed December 31, 2019.

Kruger LM, Fishman S. Myoelectric and body-powered prostheses. J Pediatr Orthop. 1993;13(1):68-75.

Lake C. Experience with electric prostheses for the partial hand presentation: An eight-year retrospective. J Prosthet Orthot. 2009;21(2):125-130.

Lindner HY, Linacre JM, Norling Hermansson LM. Assessment of capacity for myoelectric control: evaluation of construct and rating scale. J Rehabil Med. 2009;41(6):467-74.

Miguelez, JM. CP, Miguelez, MD. JD, Alley RD., CP. American Academy of Orthopaedic Surgeons. Chapter 21. Page 263-273.[online]. Amputations About the Shoulder: Prosthetic Management. Available at: https://www.armdynamics.com/research-and-technology/published-journal-articles/amputations-about-the-shoulder-prosthetic-management Accessed December 31, 2019.

McFarland LV, Hubbard Winkler SL, Heinemann AW, et al. Unilateral upper-limb loss: satisfaction and prosthetic-device use in veterans and service members from Vietnam and OIF/OEF conflicts. J Rehabil Res Dev. 2010; 47(4):299-316.

Natural Academies of Sciences, Engineering and Medicine and Health and Medicine Division. Upper Extremity Prostheses. In: Jette AM, Spicer CM, et al., eds. The promise of assistive technology to enhance activity and work participation. 1st ed. Washington, DC: National Academies Press; 2017: 99-163.

Passero T, Doolan K. Aesthetic prostheses. In: Smith DG, Michale JW, Bowker JH. eds. Atlas of Amputations and Limb Deficiencies: Surgical, Prosthetic and Rehabilitation Principles. 3rd ed. Rosemont, IL American Academy of Orthopedic Surgeons.; 2004: 303-310.

Pylatiuk C, Schulz S, Doderlein L. Results of an Internet survey of myoelectric prosthetic hand users. Prosthet Orthot Int. 2007;31(4):362-70.

Radocy R. Prosthetic adaptations in competitive sports and recreation. In: Smith DG, Michale JW, Bowker JH. eds. Atlas of Amputations and Limb Deficiencies: Surgical, Prosthetic and Rehabilitation Principles. 3rd ed. Rosemont, IL American Academy of Orthopedic Surgeons.; 2004: 327-337.

Reddy MP. Nerve entrapment syndromes in the upper extremity contralateral to amputation. Arch Phys Med Rehab. 1984;65:24-6.

Schultz AE . Neural interfaces for control of upper limb prostheses: the state of the art and future possibilities. PM R.2011;3(1):55-67.

Silcox DH 3rd, Rooks MD, Vogel RR, et al. Myoelectric prostheses. A long-term follow-up and a study of the use of alternate prostheses. J Bone Joint Surg Am. 1993;75(12):1781-9.

Sjoberg L, Lindner H, Hermansson L. Long-term results of early myoelectric prosthesis fittings: A prospective case-control study. Prosthet Orthot Int. 2018;42(5): 527-533.

Uellendahl JE. Bilateral upper limb prostheses. In: Smith DG, Michale JW, Bowker JH. eds. Atlas of Amputations and Limb Deficiencies: Surgical, Prosthetic and Rehabilitation Principles. 3rd ed. Rosemont, IL American Academy of Orthopedic Surgeons.; 2004: 311-325.

US Department of Veterans Affairs Rehabilitation and Prosthetic Services. (VA). Amputation system of care (ASoC). [VA prosthetics Web site]. Available at: https://www.prosthetics.va.gov. Accessed December 31, 2019.

US Food and Drug Administration (FDA). Medical Devices. Physical Medicine Devices. [FDA Website]. 01/13/2020. Available at:https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=bd16b79337110dfded3bff9700e9f9a8&ty=HTML&h=L&mc=true&n=pt21.8.890&r=PART. Accessed January 15, 2020.

Zenie JR. Prosthetics Options for persons with upper limb extremity amputation. In: Lusardi MM, Nielsen CC. eds. Orthotics and Prosthetics in Rehabilitation. 2nd ed. St. Louis, Missouri: Elsevier Inc.; 2007: 837-858.


Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

N/A


HCPCS Level II Code Number(s)

See Attachment A


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment A: Upper Limb Prostheses
Description: HCPCS Codes that Describe Upper-Limb Prosthesis







Policy History

MA05.057c
04/08/2020The policy has been reviewed and reissued to communicate the Company’s continuing position on Upper Limb Prostheses.

MA05.057c
04/15/2019 The version of this policy will become effective 04/15/2019.
  • The policy has been updated in consideration of revision of language within the US Food and Drug Administration.
  • The following criteria has been added to this policy for the Repair and Replacement an upper limb prosthesis: The repair or replacement of upper limb prostheses, supplies, or one or more of its components (parts) is covered and eligible for reimbursement consideration by the Company when the upper limb prosthesis itself is covered under the individual's medical benefits and all of the requirements for a repair or replacement are met.
  • The following CPT code has been deleted from this policy: L7368.

MA05.057b
01/01/2018This policy has been identified for the HCPCS code update, effective 01/01/2018.

The following HCPCS codes have been added to this policy:
  • L7700 Gasket or seal, for use with prosthetic socket insert, any type, each

MA05.057a
05/10/2017The policy has been reviewed and reissued to communicate the Company’s continuing position on Upper-Limb Prostheses
07/01/2016
  • This policy was updated to clarify the Company's coverage criteria for terminal devices.
    • Policy statement revised on terminal devices.
    • Therefore, the following code was changed to not medically necessary; L6704 Terminal device, sport/recreational/work attachment, any material, any size.

MA05.057
01/21/2015The policy has been reviewed and reissued to communicate the Company’s continuing position on Upper-Limb Prostheses
01/01/2015This is a new policy.






Version Effective Date: 04/15/2019
Version Issued Date: 04/15/2019
Version Reissued Date: 04/08/2020