Lower Limb Prostheses - Medical Clinical Policy Bulletins

Number: 0578

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Table Of Contents

Policy

Applicable CPT / HCPCS / ICD-10 Codes

Background

References

Policy

Scope of Policy

This Clinical Policy Bulletin addresses lower limb prostheses.

1. Medical Necessity

   1. Criteria for Lower Limb Prostheses

      Aetna considers an orthosis (orthopedic brace) and/or prosthesis medically necessary when:

      1. Care is prescribed by a physician, nurse practitioner, podiatrist or other health professional who is qualified to prescribe orthotics and/or prosthetics according to State law; and
      2. The orthosis or prosthesis will significantly improve or restore physical functions required for mobility related activities of daily living (MRADL's); and
      3. The member’s participating physician or licensed health care practitioner has determined that the orthosis or prosthesis will allow the member to perform ADLs based on physical examination of the member; and
      4. The orthosis or prosthesis is provided within six months of the date of prescription; and
      5. The orthotic or prosthetic services are performed by a duly licensed and/or certified, if applicable, orthotic and/or prosthetic provider. (All services provided must be within the applicable scope of practice for the provider in their licensed jurisdiction where the services are provided); and
      6. The services provided are of the complexity and nature to require being provided by a licensed or certified professional orthotist and/or prosthetist or provided under their direct supervision by a licensed ancillary person as permitted under state laws. (Services may be provided personally by physicians and performed by personnel under their direct supervision as permitted under state laws, as physicians are not licensed as orthotists and/or prosthetists); and
      7. The certified professional orthotist or prosthetist must be in good standing with one or more of the following:
         
         
         1. American Board for Certification (orthotics, prosthetics, pedorthics) (ABC); or
         2. Board of Certification/Accreditation (prosthetics, orthotics) (BOC); or
         3. licensed by the state in which services are provided (where legally required).

      Aetna considers lower limb prostheses medically necessary for performing normal daily activities when the following criteria are met:

      1. Member is motivated to ambulate; and
      2. Member meets the specific criteria for lower limb prostheses set forth below; and
      3. Member will reach or maintain a defined functional state within a reasonable period of time.

      Aetna does not consider a replacement prosthesis medically necessary unless the member's medical needs are not being met by the current prosthetic or it is broken and unrepairable.

      Clinical assessments of a member’s rehabilitation potential should be based on the following classification levels.

      Table: Classification levels and Clinical assessments of a member’s rehabilitation potential Levels Clinical Assessments of Member Rehabilitation Potential Level 0 Does not have the ability or potential to ambulate or transfer safely with or without assistance and a prosthesis does not enhance their quality of life or mobility. Level 1 Has the ability or potential to use a prosthesis for transfers or ambulation on level surfaces at fixed cadence. Typical of the limited and unlimited household ambulator. Level 2 Has the ability or potential for ambulation with the ability to traverse low level environmental barriers such as curbs, stairs or uneven surfaces. Typical of the limited community ambulator. Level 3 Has the ability or potential for ambulation with variable cadence. Typical of the community ambulator who has the ability to traverse most environmental barriers and may have vocational, therapeutic, or exercise activity that demands prosthetic utilization beyond simple locomotion. Level 4 Has the ability or potential for prosthetic ambulation that exceeds basic ambulation skills, exhibiting high impact, stress, or energy levels. Typical of the prosthetic demands of the child, active adult, or athlete.

      This expectation of functional ability information must be clearly documented and retained in the prosthetist's records. The simple entry of a K modifier in those records is not sufficient. For K3 or above functional levels, there must be documented evaluation from physical therapist to establish functional levels and activities. There must be information about the member’s history and current condition that supports the designation of the functional level by the prosthetist and physical therapist.

   2. Medically Necessary Prostheses and Accessories

      Aetna considers the following medically necessary:

      1. Foot Prosthesis

         1. A solid ankle-cushion heel (SACH) foot for persons whose functional level is 1 or above;
         2. An external keel SACH foot or single axis ankle/foot for persons whose functional level is 1 or above;
         3. A flexible-keel foot or multi-axial ankle/foot for persons whose functional level is 2 or above;
         4. A flex foot system, energy storing foot, multi-axial ankle/foot, dynamic response foot with multi-axial ankle, shank foot system with vertical-loaded pylon or flex-walk system or equal for persons whose functional level is 3 or above;
         5. A user-adjustable heel height feature is considered not medically necessary;

         Note: Foot covers (foot shells) are included in the reimbursement for a prosthetic foot component and are not separately payable. Repair or replacement of a foot cover for appearance, comfort, convenience or individual abuse, misuse or neglect is considered not medically necessary. Repair or replacement of a damaged foot cover should be billed using HCPCS repair code L7510. No more than 1 foot cover replacement per prosthetic foot is considered medically necessary once per year.

      2. Knee Prosthesis

         1. A fluid or pneumatic knee for persons whose functional level is 3 or above;
         2. A single axis constant friction knee and other basic knee systems for persons whose functional level is 1 or above;
         3. A high-activity knee control frame for members whose function level is 4;
         4. A fluid, pneumatic, or electronic/microprocessor knee for members with a knee disarticulation amputation, a trans-femoral amputation or a hip disarticulation amputation whose functional level is 3 or above.

      3. Ankle Prosthesis

         An axial rotation unit for persons whose functional level is 2 or above;

         Note: Only one axial rotation is considered medically necessary per ankle device/prosthesis.

      4. Hip Prosthesis

         A pneumatic or hydraulic polycentric hip joint for members whose functional level is 3 or above;

      5. Sockets

         1. Two test (diagnostic) sockets for an individual prosthetic; additional documentation of medical necessity is required for more than 2 test sockets;
         2. No more than 2 socket inserts per individual prosthesis at the same time are considered medically necessary;
         3. Socket replacements are considered medically necessary if there is adequate documentation of functional and/or physiological need, including but is not limited to: changes in the residual limb; functional need changes; or irreparable damage or wear/tear due to excessive weight or prosthetic demands of very active amputees.

         Test (diagnostic) sockets for immediate post-surgical or early-fitted prostheses are considered not medically necessary. 

         Prostheses have no proven value for persons whose potential functional level is 0.

         Note: When replacing the socket on an existing prosthesis, socket replacement codes (L5700, L5701, L5702, L5703) should be used as base code.  These socket replacement codes should not be used when replacing an entire prosthesis (e.g., a socket with a foot, knee and/or other components that would substantially make an entire prosthesis). Use of socket replacement codes are considered duplicative and not medically necessary when an entire prosthesis, such as feet and knees, are billed with a socket replacement code.

      6. Accessories

         1. The following are considered medically necessary:

            1. Stump stockings and harnesses (including replacements) when they are essential to the effective use of the artificial limb;
            2. No more than one harness/suspension system per limb;
            3. Prosthetic sheaths/socks, including a gel cushion layer (prosthetic gel stockings; 12 in 12 months);
            4. No more than 2 socket inserts per individual prosthesis;
            5. No more than two replacement liners per prosthesis in 12 months;

         2. The following are considered not medically necessary or cosmetic:

            1. A prosthetic donning sleeve is considered not medically necessary;
            2. Passive/restorative devices (such as silicone devices) to make the limb more lifelike are considered cosmetic;
            3. Custom-shaped prosthetic covers are considered cosmetic unless there is medical function and documentation of medical need. Custom-made prosthetic covers are typically made of foam that is cosmetically shaped to the person's limb;

      7. Microprocessor-Controlled Lower Limb Prostheses

         1. Microprocessor-controlled leg prostheses (“Addition to lower extremity prosthesis, endoskeletal knee-shin system, microprocessor control feature, swing and stance phase, includes electronic sensor(s), any type”) (e.g.,Otto Bock C-Leg; Otto-Bock Genium Bionic Prosthetic System (Otto Bock HealthCare, Minneapolis, MN), Intelligent Prosthesis (Endoliete North America, Centerville, OH), and Ossur Rheo Knee/Ossur RKXC Knee (Ossur-Flexfoot, Aliso Viejo, CA)) in otherwise healthy, active community ambulating members (functional K level 3 or above) with a knee disarticulation amputation or a trans-femoral amputation from a non-vascular cause (usually trauma or tumor) for whom this prosthesis can be fitted and programmed by a qualified prosthetist trained to do so;
         2. A powered flexion-extension assist ("Addition to lower extremity prosthesis, endoskeletal knee-shin system, powered and programmable flexion/extension assist control, includes any type of motor(s)" ) when the member meets all of the criteria below:
            
            
            1. Has a microprocessor (swing and stance phase type) controlled (electronic) knee; and
            2. K3 functional level only ; and
            3. Weight greater than 110 lbs and less than 275 lbs; and
            4. Has a documented comorbidity of the spine and/or sound limb affecting hip extension and/or quadriceps function that impairs K-3 level function with the use of a microprocessor-controlled knee alone; and
            5. Is able to make use of a product that requires daily charging; and
            6. Is able to understand and respond to error alerts and alarms indicating problems with the function of the unit;

            Note: With the exception of items described by specific HCPCS codes, there should be no separate billing and there is no separate payment for a component or feature of a microprocessor controlled knee, including but not limited to real time gait analysis, continuous gait assessment, or electronically controlled static stance regulator.

      8. Microprocessor-Controlled Ankle

         1. Microprocessor-controlled ankle-foot prostheses (e.g., PowerFoot BiOM, iWalk, Bedford, MA; Proprio Foot, Ossur, Aliso Viejo, CA) for members whose functional level is 3 or above;
         2. Prosthetic shoe for a partial foot amputation when the prosthetic shoe is an integral part of a covered basic lower limb prosthetic device.

      9. Protective Outer Surface Covering Systems

         Protective outer surface covering systems (L5962, L5964, and L5966) are specialized covers intended to be worn over an existing prosthesis. They are considered medically necessary for members who have special needs for protection against unusually harsh environmental situations where it is necessary to protect the lower limb prosthesis beyond the level of protection that is afforded by covers described by HCPCS codes L5704 - L5707. They are not for cosmetic or convenience reasons, or for everyday usage in a typical environment. Protective outer surface coverings are different from the covering that is already reimbursed as part of the covers described by HCPCS codes L5704 - L5707. When billing for the protective outer surface covering systems (L5962, L5964 and L5966), information regarding the type of protective cover provided (i.e., manufacturer name, make, model or type) must be included in practitioner’s notes in order to ensure correct coding.

   3. Non-Medically Necessary Prostheses

      Aetna considers the following not medically necessary:

      1. Duplication or upgrade of a functional prosthesis; or
      2. Lower limb prosthesis for a functional level of 0; or
      3. Otto Bock Kenevo microprocessor-controlled knee for persons whose functional level is 3 or above; or
      4. Prosthetic devices or prosthetic components that are primarily for cosmesis; or
      5. Prosthetics used for activities other than normal daily living, including, but may not be limited to, those utilized for leisure or sporting activities such as skiing or swimming; or
      6. Repair or replacement of a prosthesis for appearance, comfort, convenience or individual abuse, misuse or neglect; or
      7. Repair or replacement of parts of a duplicate prosthesis; or
      8. Test sockets for an immediate prosthesis; or
      9. Water prosthesis (designed to be used for showering, swimming, etc.).   

2. Experimental and Investigational

   Aetna considers the following to be experimental and investigational:

   1. Adjustable click prostheses (e.g., Revo and Boa click systems) because of insufficient published evidence of their safety and effectiveness.
   2. Lower limb prostheses for all other indications because of insufficient evidence in the peer-reviewed literature when these criteria are not met;
   3. Microprocessor-controlled leg prostheses (e.g., Otto Bock C-Leg, Otto-Bock Genium Bionic Prosthetic System, Intelligent Prosthesis, and Ossur Rheo Knee) for gait management in spinal cord injury because of insufficient evidence in the peer-reviewed literature;
   4. Osseointegrated lower limb prosthetic devices (with or without microprocessor-control);
   5. Otto Bock Kenevo microprocessor-controlled knee for members with functional level 2 or below;
   6. Robotic lower body exoskeleton suits (e.g., the ReWalk, Argo Medical Technologies Ltd, Marlborough, MA) because there is inadequate evidence of their effectiveness;
   7. The C-Leg Protector because its clinical value has not been established;
   8. The Ossur Symbiotic Leg because its clinical value has not been established.

3. Cosmetic

   Aetna considers the following to be cosmetic:

   1. Passive/restorative devices (such as silicone devices) to make the limb more life-like;
   2. Custom-shaped prosthetic covers unless there is medical function and documentation of medical need. Custom-made prosthetic covers are typically made of foam that is cosmetically shaped to the person's limb.

4. Plan Limitations and Exclusions

   Evaluation of the member, measurement and/or casting, and fitting/adjustments of the prosthesis are included in the allowance for the prosthesis. There is no separate payment for these services.

   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.

   Powered base items are those that contain the power source (battery). At the time that a base item is billed, all necessary batteries and/or battery chargers are considered as included in the payment for the powered base item. There is no separate payment for batteries (L7360, L7364, and L7367) and/or battery chargers (L7362, L7366, and L7368) billed concurrently with a powered base item.

   Aetna does not consider warranties or