Latest Review Date: August 2024

Category: Durable Medical Equipment (DME)      

POLICY:

Upper limb prosthesis may be considered medically necessary when all the following criteria are met:

• Individual has a traumatic or surgical amputation of upper extremity or a congenital absence or defect; and
• Prosthetic replaces all or part of a missing limb; and
• Prosthetic will help the member regain or maintain function; and
• Prosthetic device is ordered by or under the direction of a physician; and
• Prosthetic needs evaluated for individual by a healthcare professional with appropriate prosthetic qualifications and training under the supervision of the ordering physician; and
• Individual is willing and able to participate in the training for the use of the prosthetic; and
• Individual with expected rehabilitation potential undergoes functional assessment, including Activities of Daily Living (ADLs)

Lifelike components/high definition silicone (i.e., silicone covered prosthesis) are considered investigational and cosmetic. 

Custom, rugged partial hand or partial finger :Naked Prosthetics (PIP Driver, MCP Driver, Thumb Driver), Partial M-Fingers, Titan and Point Designs Prosthetics (Point Thumb, Point Partial, Point Digit Mini), or X-Finger prosthetics, are considered an upgrade and investigational.

The following items are convenience/upgraded additions and considered investigational:

• Water resistance feature or water prosthesis
• TRS Black Iron Trainer weightlifting attachment
• Multi-durometer custom silicone socket interface
• Multiaxial wrist locking feature
• Custom synthetic chloroprene harness
• Anatomically contoured interface
• Heavy-duty materials, feature or processes to increase durability of prosthetic
• Sports or recreational activity additions
• Back up prosthetics
• Prosthetic components that are primarily for cosmesis
• Adjustable click systems (e.g., Revo and Boa click systems)
• Drive ring attachment

There is no separate payment if CAD-CAM technology is used to fabricate a prosthesis. Reimbursement is included in the allowance of the codes for a prosthesis.

Sockets:

No more than 2 socket inserts per individual prosthesis are considered medically necessary at the same time.

Test sockets for permanent prostheses may be considered medically necessary when policy criteria for the prosthetic is met.

Test (diagnostic) sockets for immediate post-surgical or early fitted prostheses are considered investigational. Immediate prostheses are considered investigational.

Socket replacements may be considered medically necessary when there is adequate documentation of functional and/or physiological need such as, but 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 very active amputees.

Replacement or Repair:

Replacement or repair of prosthetic parts or prosthesis may be considered medically necessary when there is adequate documentation of functional and/or physiological need such as, but not limited to:

• Changes in the residual limb
• Functional need changes
• Irreparable damage or wear/tear due to excessive individual weight
• Prosthetic demands of very active amputees

Repair of prosthetic parts or prosthesis may be considered medically necessary when ALL the following are met:

• Equipment or external prosthesis not currently covered by warranty and is owned by the individual;

• Required repairs are not the result of malicious damage, culpable neglect or wrongful disposition of the equipment;
• Expense of the repairs does not exceed the expense of purchasing a new piece of equipment or prosthesis;
• Payments for repair and maintenance do not include parts and labor covered under a manufacturer's or supplier's warranty.

If the individual-owned DME is being repaired, up to one month's rental for that piece of DME may be considered medically necessary.

Repair or replacement of a prosthesis for appearance, comfort, convenience or individual abuse, misuse or neglect or repair or replacement of parts of a duplicate prosthesis are non-covered and considered investigational.

Upgrade of a functional prosthesis is considered investigational.

Refer to medical policy #352 Repair of Durable Medical Equipment (DME) and External Prosthetic Devices

In reference to myoelectric prosthetics, refer to medical policy #124 Myoelectric Prosthetic and Orthotic Components for the Upper Limb

DESCRIPTION OF PROCEDURE OR SERVICE:

A prosthesis is an artificial device used to replace all or part a missing body part and is intended to restore normal function. The most common levels of amputations for the upper limb are the transradial (TR) (below elbow, BE) and the transhumeral (TH) (above elbow, AE). The prosthesis is a tool that helps the single-limb amputee gain functional independence. Ideally, upper limb unilateral amputees should be able to accomplish things such as wearing the prosthetic during waking hours, perform basic ADLs, and return to work whenever possible.

Upper limb Prosthesis can be classified into four categories of prosthesis:

• Passive Prosthesis is the lightest of all the prosthesis and often termed as cosmetic. It has no motors and contains limited mechanical features.
• Body-powered Prosthesis comes from the individual’s movements and utilizes a body harness and strap which connects to a cable system that operates the device. Advantages include lightweight, durable and may be waterproof; disadvantages include a required harness, strength and range of motion capability from user.
• Externally powered Prosthesis is powered by batteries contained within the system and controlled by EMG signals, force-sensing resistors, and pull/push switches and most often reserved for high-level amputees. Advantages include little or no harnessing of the device, generate more force and appear more cosmetic; disadvantages include battery life and daily charging, not waterproof, more complex and therefore prone to breakage and repair.*
• Hybrid Prosthesis combines body-powered components and myoelectric/externally powered components in one device. This type of prosthesis is most commonly used by transhumeral and shoulder disarticulation amputees and reserved for high-level amputees.*

*For myoelectric prosthetics, refer to medical policy #124 Myoelectric Prosthetic and Orthotic Components for the Upper Limb

KEY POINTS:

This evidence review was created and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through July 20, 2024.

Summary of Evidence:

Appropriate selection of componentry for prosthetic restoration of the amputee is an extremely important and challenging task in view of the variety and complexity of available prosthetic devices and the functional requirements of individuals. After prescription and fitting of the device, training is indispensable and should include prosthetic management and functional training with the goal of achieving community reintegration. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

Department of Veterans Affairs(VA)/Department of Defense (DoD)

In a VA/DoD 2022 Clinical Practice Guideline for rehabilitation of individuals with lower limb amputation, the following is recommended:

Pre-Prosthetic Training Recommendation:

• The care team should ensure that patients undergo pre-prosthetic training to help determine the most appropriate type of device to achieve functional goals. [Expert Opinion]
• The care team should conduct a comprehensive assessment to determine the most appropriate types of prostheses to prescribe along with educating the patient and/or caregiver(s) on the various types of available prostheses

Components of a 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

Prosthesis Prescription:

• Once the appropriate type of prosthesis is identified, the care team should write a prescription for the device, including all necessary components. [Expert Opinion]
• Prescriptions for upper extremity prostheses should be based on a collaborative decision between the patient and the care team. Input should be received 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. Components for an upper extremity prosthesis should include:
  • Design (e.g., preparatory vs. 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
  • Wrist unit (if applicable)
  • Elbow unit (if applicable)
  • Shoulder unit (if applicable)

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Prosthetic, prosthetic arm, passive prosthesis, body powered prosthesis

APPROVED BY GOVERNING BODIES:

Prostheses are class I devices exempt from U.S. Food and Drug Administration (FDA) review. For additional information, use product codes: GXY, IQZ.

BENEFIT APPLICATION:

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

ITS: Covered if covered by the Participating Home Plan

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

CURRENT CODING: 

CPT codes:   

HCPCS codes:

REFERENCES:

1. Carey SL, Lura DJ, Highsmith MJ. Differences in myoelectric and body-powered upper-limb prostheses: Systematic literature review. J Rehabil Res Dev. 2015;52(3):247-62.
2. Crandall RC, Tomhave W. Pediatric unilateral below-elbow amputees: retrospective analysis of 34 patients given multiple prosthetic options. J Pediatr Orthop. 2002 May-Jun;22(3):380-3.
3. Meier RH 3rd, Melton D. Ideal functional outcomes for amputation levels. Phys Med Rehabil Clin N Am. 2014 Feb;25(1):199-212.
4. Mlinac ME, Feng MC. Assessment of Activities of Daily Living, Self-Care, and Independence. Arch Clin Neuropsychol. 2016 Sep;31(6):506-16.
5. National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Care Services; Committee on the Use of Selected Assistive Products and Technologies in Eliminating or Reducing the Effects of Impairments; Flaubert JL, Spicer CM, Jette AM, editors. The Promise of Assistive Technology to Enhance Activity and Work Participation. Washington (DC): National Academies Press (US); 2017 May 9. 4, Upper-Extremity Prostheses.
6. Resnik L, Adams L, Borgia M, et al. Development and evaluation of the activities measure for upper limb amputees. Arch Phys Med Rehabil. 2013 Mar;94(3):488-494.e4.
7. Veterans Affairs and Department of Defense (VA/DoD) Clinical Practice Guidelines: The Management of upper extremity amputation rehabilitation. Version 2.0. 2022.
8. Wang S, Hsu CJ, Trent L, et al. Evaluation of Performance-Based Outcome Measures for the Upper Limb: A Comprehensive Narrative Review. PM R. 2018 Sep;10(9):951-962.e3.

POLICY HISTORY:

Medical Policy Group, August 2024 (6): New medical policy. On Draft 8/1/24-9/15/24. Non-covered items previously non-covered per MP 495 Investigational Criteria.

MPAC July 2024

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

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

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

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

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

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

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

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.