Lower Extremity Prosthetics – Commercial and Individual Exchange Medical Policy – Commercial and Individual Exchange Medical Policy

Lower Extremity Prosthetics

Page 1 of 18

UnitedHealthcare Commercial and Individual Exchange Medical Policy

Effective 04/01/2024

UnitedHealthcare

Commercial and Individual Exchange

Medical Policy

Lower Extremity Prosthetics

Policy Number: 2024T0645E

Effective Date: April 1, 2024



Instructions for Use

Table of Contents Page

Application ..................................................................................... 1

Coverage Rationale ....................................................................... 1

Documentation Requirements ...................................................... 2

Definitions ...................................................................................... 2

Applicable Codes .......................................................................... 4

Description of Services ................................................................. 9

Benefit Considerations ................................................................ 10

Clinical Evidence ......................................................................... 10

U.S. Food and Drug Administration ........................................... 16

References ................................................................................... 16

Policy History/Revision Information ........................................... 18

Instructions for Use ..................................................................... 18

Application

UnitedHealthcare Commercial

This Medical Policy applies to all UnitedHealthcare Commercial benefit plans.

UnitedHealthcare Individual Exchange

This Medical Policy applies to Individual Exchange benefit plans in all states except for Colorado.

Coverage Rationale

 See Benefit Considerations

A lower extremity prosthetic for amputations is proven and Medically Necessary in certain circumstances. For medical

necessity clinical coverage criteria, refer to the InterQual

CP: Durable Medical Equipment, Prosthetics, Lower Extremity.

Click here

to view the InterQual

criteria.

A bone anchored percutaneous limb Prosthesis [e.g., Osseoanchored Prostheses for the Rehabilitation of Amputees

(OPRA) Implant System] is unproven and not Medically Necessary

due to insufficient evidence of efficacy.

An endoskeletal knee-shin system with microprocessor control feature (swing/stance phase) is unproven and not

Medically Necessary due to insufficient evidence of efficacy for the following:

• Amputee with functional classification status of K1 or K2; and

• One of the following:

o Transfemoral [above knee (AK)] amputation (includes knee disarticulation); or

o Hip disarticulation or hemipelvectomy

Related Commercial/Individual Exchange Policy

• Upper Extremity Prosthetic Devices

Community Plan Policy

•

Lower Extremity Prosthetics

Medicare Advantage Coverage Summary

• Durable Medical Equipment (DME), Prosthetics,

Orthotics (Non-Foot Orthotics), Nutritional Therapy,

and Medical Supplies Grid

Lower Extremity Prosthetics

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UnitedHealthcare Commercial and Individual Exchange Medical Policy

Effective 04/01/2024

A combined microprocessor-controlled ankle foot system with power assist is unproven and not Medically Necessary

due to insufficient evidence of efficacy for the following:

• Transfemoral [above knee (AK)] amputation (includes knee disarticulation)

• Transtibial [below knee (BK)] amputation

• Hip disarticulation or hemipelvectomy

Documentation Requirements

Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may

require coverage for a specific service. The documentation requirements outlined below are used to assess whether the

member meets the clinical criteria for coverage but do not guarantee coverage of the service requested.

HCPCS Codes*

Required Clinical Information

Lower Extremity Prosthetics

L5010, L5050,

L5060, L5100,

L5105, L5150,

L5160, L5200,

L5210, L5230,

L5250, L5270,

L5280, L5301,

L5321, L5331,

L5400, L5420,

L5530, L5535,

L5540, L5585,

L5590, L5616,

L5639, L5643,

L5649, L5651,

L5681, L5683,

L5703, L5707,

L5724, L5726,

L5728, L5780,

L5795, L5814,

L5818, L5822,

L5824, L5826,

L5828, L5830,

L5840, L5845,

L5848, L5856,

L5858, L5930,

L5960, L5966,

L5968, L5973,

L5979, L5980,

L5981, L5987,

L5988.

Medical notes documenting the following, when applicable:

• Vendor coversheet with the narrative describing the request

• Vendor invoice listing the HCPCS codes, make, model, and description; indicate if the item is right

or left

• Other healthcare professional notes (i.e., physical therapist)

• Current prescription

• Physician office notes including documentation of:

o History related to the prosthetic request

o Examination findings to include strength, range of motion (ROM), condition of the contralateral

limb, residual limb length and shape, and skin integrity of residual limb

o Co-morbidities

o Specify absent limb, including the date, level, and etiology of amputation

o Current functional classification level; include specific examples and expected rehabilitation

potential

o Describe limitations to Activities Of Daily Living (ADLs); include assistive devices to facilitate

ambulation within and outside the home

o Surfaces normally traversed include distance and environment

o Prosthetist notes to include medical justification for each of the requested prosthetic

components

• Specify if the request is for initial prosthetic, preparatory prosthetic, definitive prosthetic,

replacement of the entire prosthetic leg, replacement of the prosthetic components/accessories, or

request for additional components and accessories

• For replacement Prosthesis, also include:

o The age of the current Prosthesis and reason for replacement

o The components on the current Prosthesis, including socket, knee, foot, ankle, sock ply, and

liner thickness

o Describe changes in limb including, but not limited to, comparative residual limb measurements

• For socket replacement also describe what adjustments have been tried and failed

*For code descriptions, refer to the Applicable Codes section.

Definitions

Activities of Daily Living (ADLs): Basic tasks people need to do to function and interact such as bathing, grooming, dressing,

toilet use, eating, and physical ambulation. (Mlinac and Feng, 2016, Edemekong et al., 2022)

Lower Extremity Prosthetics

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UnitedHealthcare Commercial and Individual Exchange Medical Policy

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Instrumental Activities of Daily Living (IADLs): A higher cognitive and complex activity related to independent living such as

shopping, transportation, meal preparation, housecleaning, managing finances and managing medications. (Mlinac and Feng,

2016, Edemekong et al., 2022)

CMS Modifiers/Medicare Functional Classification Level (MFCL): A clinical assessment of member rehabilitation potential

must be based on the following classification levels:

• Modifier K0 (MFLC-0): Does not have the ability or potential to ambulate or transfer safely with or without assistance and

Prosthesis does not enhance their quality of life or mobility.

• Modifier K1 (MFLC-1): Has the ability or potential to use Prosthesis for transfers or ambulation on level surfaces at fixed

cadence. Typical of the limited and unlimited household ambulator.

• Modifier K2 (MFLC-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.

• Modifier K3 (MFLC-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.

• Modifier K4 (MFLC-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.

(CMS Health Care Procedures Coding System (HCPCS)/Theevan et al. (2011))

Medically Necessary: Health care services that are all of the following as determined by us or our designee:

• In accordance with Generally Accepted Standards of Medical Practice.

• Clinically appropriate, in terms of type, frequency, extent, service site and duration, and considered effective for your

Sickness, Injury, Mental Illness, substance-related and addictive disorders, disease or its symptoms.

• Not mainly for your convenience or that of your doctor or other health care provider.

• Not more costly than an alternative drug, service(s), service site or supply that is at least as likely to produce equivalent

therapeutic or diagnostic results as to the diagnosis or treatment of your Sickness, Injury, disease, or symptoms.

(Certificate of Coverage 2018)

Microprocessor Controlled Ankle Foot Prosthesis: (e.g., Proprio Foot) Is able to actively change the ankle angle and to

identify sloping gradients and ascent or descent of stairs as the result of microprocessor-control and sensor technology.

Microprocessor Controlled Lower Limb Prostheses: Microprocessor controlled knees offer dynamic control through sensors

in the Device. Microprocessor controlled knees attempt to simulate normal biological knee function by offering variable

resistance control to the swing or stance phases of the gait cycle. The swing-rate adjustments allow the knee to respond to

rapid changes in cadence. Microprocessor controlled knee flexion enhances the stumble recovery capability. Prosthetic knees

such as the microprocessor-controlled knee that focus on better control of flexion abilities without reducing stability have the

potential to improve gait pattern, wearer confidence, and safety of ambulation. Available devices include but are not limited to

Otto-Bock C-Leg device

, the Ossur RheoKnee

or the Endolite Intelligent Prosthesis

Modifier: A two-position code that is added to the end of a code to clarify the services being billed (CMS Health Care

Procedures Coding System (HCPCS)). K0 through K4 are HCPCS level II Modifiers.

Myoelectric Prosthetic: A prosthetic device operated by battery-powered electric motors that are activated through electrodes

by the myoelectric potentials provided by muscles (Medical Dictionary).

Prosthesis: A man-made substitute for a missing body part (American Cancer Society

Prosthetist: A healthcare professional who makes and fits artificial limbs (prostheses) for people with disabilities. This includes

artificial legs and arms for people who have had amputations due to conditions such as cancer, diabetes, or injury (John

Hopkins Medicine).

Lower Extremity Prosthetics

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UnitedHealthcare Commercial and Individual Exchange Medical Policy

Effective 04/01/2024

Applicable Codes

The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive.

Listing of a code in this policy does not imply that the service described by the code is a covered or non-covered health service.

Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may

require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim

payment. Other Policies and Guidelines may apply.

CPT Code

Description

L5000 Partial foot, shoe insert with longitudinal arch, toe filler

L5010 Partial foot, molded socket, ankle height, with toe filler

L5050 Ankle, Symes, molded socket, SACH foot

L5060 Ankle, Symes, metal frame, molded leather socket, articulated ankle/foot (SACH)

L5100 Below knee (BK), molded socket, shin, SACH foot

L5105 Below knee (BK), plastic socket, joints and thigh lacer, SACH foot

L5150 Knee disarticulation (or through knee), molded socket, external knee joints, shin, SACH foot

L5160 Knee disarticulation (or through knee), molded socket, bent knee configuration, external knee joints,

shin, SACH foot

L5200 Above knee (AK), molded socket, single axis constant friction knee, shin, SACH foot

L5210 Above knee (AK), short prosthesis, no knee joint (stubbies), with foot blocks, no ankle joints, each

L5220 Above knee (AK), short prosthesis, no knee joint (stubbies), with articulated ankle/foot, dynamically

aligned, each

L5230 Above knee (AK), for proximal femoral focal deficiency, constant friction knee, shin, SACH foot

L5250 Hip disarticulation, canadian type; molded socket, hip joint, single axis constant friction knee, shin,

SACH foot

L5270

Hip disarticulation, tilt table type; molded socket, locking hip joint, single axis constant friction knee,

shin, SACH foot

L5280 Hemipelvectomy, canadian type; molded socket, hip joint, single axis constant friction knee, shin, SACH

foot

L5301 Below knee (BK), molded socket, shin, SACH foot, endoskeletal system

L5312 Knee disarticulation (or through knee), molded socket, single axis knee, pylon, SACH foot, endoskeletal

system

L5321 Above knee (AK), molded socket, open end, SACH foot, endoskeletal system, single axis knee

L5331

Hip disarticulation, canadian type, molded socket, endoskeletal system, hip joint, single axis knee, SACH

foot

L5341 Hemipelvectomy, canadian type, molded socket, endoskeletal system, hip joint, single axis knee, SACH

foot

L5400

Immediate postsurgical or early fitting, application of initial rigid dressing, including fitting, alignment,

suspension, and one cast change, below knee (BK)

L5410 Immediate postsurgical or early fitting, application of initial rigid dressing, including fitting, alignment and

suspension, below knee (BK), each additional cast change and realignment

L5420

Immediate postsurgical or early fitting, application of initial rigid dressing, including fitting, alignment and

suspension and one cast change 'ak' or knee disarticulation

L5430 Immediate postsurgical or early fitting, application of initial rigid dressing, including fitting, alignment and

supension, above knee (AK) or knee disarticulation, each additional cast change and realignment

L5450 Immediate postsurgical or early fitting, application of non-weight bearing rigid dressing, below knee (BK)

L5460 Immediate postsurgical or early fitting, application of non-weight bearing rigid dressing, above knee (AK)

Lower Extremity Prosthetics

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UnitedHealthcare Commercial and Individual Exchange Medical Policy

Effective 04/01/2024

CPT Code

Description

L5500 Initial, below knee (BK) PTB type socket, nonalignable system, pylon, no cover, SACH foot, plaster

socket, direct formed

L5505 Initial, above knee (AK), knee disarticulation, ischial level socket, non-alignable system, pylon, no cover,

SACH foot, plaster socket, direct formed

L5510 Preparatory, below knee (BK) PTB type socket, nonalignable system, pylon, no cover, SACH foot, plaster

socket, molded to model

L5520 Preparatory, below knee (BK) PTB type socket, nonalignable system, pylon, no cover, SACH foot,

thermoplastic or equal, direct formed

L5530 Preparatory, below knee (BK) PTB type socket, nonalignable system, pylon, no cover, SACH foot,

thermoplastic or equal, molded to model

L5535 Preparatory, below knee (BK) PTB type socket, nonalignable system, no cover, SACH foot,

prefabricated, adjustable open-end socket

L5540 Preparatory, below knee (BK) PTB type socket, nonalignable system, pylon, no cover, SACH foot,

laminated socket, molded to model

L5560 Preparatory, above knee (AK)- knee disarticulation, ischial level socket, nonalignable system, pylon, no

cover, SACH foot, plaster socket, molded to model

L5570 Preparatory, above knee (AK) - knee disarticulation, ischial level socket, nonalignable system, pylon, no

cover, SACH foot, thermoplastic or equal, direct formed

L5580 Preparatory, above knee (AK) - knee disarticulation ischial level socket, nonalignable system, pylon, no

cover, SACH foot, thermoplastic or equal, molded to model

L5585 Preparatory, above knee (AK) - knee disarticulation, ischial level socket, nonalignable system, pylon, no

cover, SACH foot, prefabricated adjustable open-end socket

L5590 Preparatory, above knee (AK) - knee disarticulation ischial level socket, nonalignable system, pylon no

cover, SACH foot, laminated socket, molded to model

L5595 Preparatory, hip disarticulation-hemipelvectomy, pylon, no cover, SACH foot, thermoplastic or equal,

molded to patient model

L5600 Preparatory, hip disarticulation-hemipelvectomy, pylon, no cover, SACH foot, laminated socket, molded

to patient model

L5610 Addition to lower extremity, endoskeletal system, above knee (AK), hydracadence system

L5611 Addition to lower extremity, endoskeletal system, above knee (AK), knee disarticulation, four-bar linkage,

with friction swing phase control

L5613

Addition to lower extremity, endoskeletal system, above knee (AK), knee disarticulation, four-bar linkage,

with hydraulic swing phase control

L5614 Addition to lower extremity, exoskeletal system, above knee (AK), knee disarticulation, four-bar linkage,

with pneumatic swing phase control

L5615

Addition, endoskeletal knee-shin system, 4 bar linkage or multiaxial, fluid swing and stance phase

control

L5616 Addition to lower extremity, endoskeletal system, above knee (AK), universal multiplex system, friction

swing phase control

L5617 Addition to lower extremity, quick change self-aligning unit, above knee (AK) or below knee (BK), each

L5618 Addition to lower extremity, test socket, Symes

L5620 Addition to lower extremity, test socket, below knee (BK)

L5622 Addition to lower extremity, test socket, knee disarticulation

L5624 Addition to lower extremity, test socket, above knee (AK)

L5626 Addition to lower extremity, test socket, hip disarticulation

L5628 Addition to lower extremity, test socket, hemipelvectomy

Lower Extremity Prosthetics

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UnitedHealthcare Commercial and Individual Exchange Medical Policy

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CPT Code

Description

L5629 Addition to lower extremity, below knee (BK), acrylic socket

L5630 Addition to lower extremity, Symes type, expandable wall socket

L5631 Addition to lower extremity, above knee (AK) or knee disarticulation, acrylic socket

L5632 Addition to lower extremity, Symes type, 'ptb' brim design socket

L5634 Addition to lower extremity, Symes type, posterior opening (canadian) socket

L5636 Addition to lower extremity, Symes type, medial opening socket

L5637 Addition to lower extremity, below knee (BK), total contact

L5638 Addition to lower extremity, below knee (BK), leather socket

L5639 Addition to lower extremity, below knee (BK), wood socket

L5640 Addition to lower extremity, knee disarticulation, leather socket

L5642 Addition to lower extremity, above knee (AK), leather socket

L5643 Addition to lower extremity, hip disarticulation, flexible inner socket, external frame

L5644 Addition to lower extremity, above knee (AK), wood socket

L5645 Addition to lower extremity, below knee (BK), flexible inner socket, external frame

L5646 Addition to lower extremity, below knee (BK), air, fluid, gel or equal, cushion socket

L5647 Addition to lower extremity, below knee (BK) suction socket

L5648 Addition to lower extremity, above knee (AK), air, fluid, gel or equal, cushion socket

L5649 Addition to lower extremity, ischial containment/narrow M-L socket

L5650 Additions to lower extremity, total contact, above knee (AK) or knee disarticulation socket

L5651 Addition to lower extremity, above knee (AK), flexible inner socket, external frame

L5652 Addition to lower extremity, suction suspension, above knee (AK) or knee disarticulation socket

L5653 Addition to lower extremity, knee disarticulation, expandable wall socket

L5654 Addition to lower extremity, socket insert, Symes, (kemblo, pelite, aliplast, plastazote or equal)

L5655 Addition to lower extremity, socket insert, below knee (BK) (kemblo, pelite, aliplast, plastazote or equal)

L5656 Addition to lower extremity, socket insert, knee disarticulation (kemblo, pelite, aliplast, plastazote or

equal)

L5658 Addition to lower extremity, socket insert, above knee (AK) (kemblo, pelite, aliplast, plastazote or equal)

L5661 Addition to lower extremity, socket insert, multidurometer Symes

L5665 Addition to lower extremity, socket insert, multidurometer, below knee (BK)

L5666 Addition to lower extremity, below knee (BK), cuff suspension

L5668 Addition to lower extremity, below knee (BK), molded distal cushion

L5670 Addition to lower extremity, below knee (BK), molded supracondylar suspension (PTS or similar)

L5671 Addition to lower extremity, below knee (BK)/above knee (AK) suspension locking mechanism (shuttle,

lanyard or equal), excludes socket insert

L5672 Addition to lower extremity, below knee (BK), removable medial brim suspension

L5673 Addition to lower extremity, below knee (BK)/above knee (AK), custom fabricated from existing mold or

prefabricated, socket insert, silicone gel, elastomeric or equal, for use with locking mechanism

L5676 Additions to lower extremity, below knee (BK), knee joints, single axis, pair

L5677 Additions to lower extremity, below knee (BK), knee joints, polycentric, pair

L5678 Additions to lower extremity, below knee (BK), joint covers, pair

L5679

Addition to lower extremity, below knee (BK)/above knee (AK), custom fabricated from existing mold or

prefabricated, socket insert, silicone gel, elastomeric or equal, not for use with locking mechanism

L5680 Addition to lower extremity, below knee (BK), thigh lacer, nonmolded

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CPT Code

Description

L5681 Addition to lower extremity, below knee (BK)/above knee (AK), custom fabricated socket insert for

congenital or atypical traumatic amputee, silicone gel, elastomeric or equal, for use with or without

locking mechanism, initial only (for other than initial, use code L5673 or L5679)

L5682 Addition to lower extremity, below knee (BK), thigh lacer, gluteal/ischial, molded

L5683 Addition to lower extremity, below knee (BK)/above knee (AK), custom fabricated socket insert for other

than congenital or atypical traumatic amputee, silicone gel, elastomeric or equal, for use with or without

locking mechanism, initial only (for other than initial, use code l5673 or l5679)

L5684 Addition to lower extremity, below knee (BK), fork strap

L5685 Addition to lower extremity prosthesis, below knee (BK), suspension/sealing sleeve, with or without

valve, any material, each

L5686 Addition to lower extremity, below knee (BK), back check (extension control)

L5688 Addition to lower extremity, below knee (BK), waist belt, webbing

L5690 Addition to lower extremity, below knee (BK), waist belt, padded and lined

L5692 Addition to lower extremity, above knee (AK), pelvic control belt, light

L5694 Addition to lower extremity, above knee (AK), pelvic control belt, padded and lined

L5695 Addition to lower extremity, above knee (AK), pelvic control, sleeve suspension, neoprene or equal, each

L5696 Addition to lower extremity, above knee (AK) or knee disarticulation, pelvic joint

L5697 Addition to lower extremity, above knee (AK) or knee disarticulation, pelvic band

L5698 Addition to lower extremity, above knee (AK) or knee disarticulation, Silesian bandage

L5699 All lower extremity prostheses, shoulder harness

L5700 Replacement, socket, below knee (BK), molded to patient model

L5701 Replacement, socket, above knee (AK)/knee disarticulation, including attachment plate, molded to

patient model

L5702 Replacement, socket, hip disarticulation, including hip joint, molded to patient model

L5703 Ankle, Symes, molded to patient model, socket without solid ankle cushion heel (SACH) foot,

replacement only

L5704 Custom shaped protective cover, below knee (BK)

L5705 Custom shaped protective cover, above knee (AK)

L5706 Custom shaped protective cover, knee disarticulation

L5707 Custom shaped protective cover, hip disarticulation

L5710 Addition, exoskeletal knee-shin system, single axis, manual lock

L5711 Additions exoskeletal knee-shin system, single axis, manual lock, ultra-light material

L5712 Addition, exoskeletal knee-shin system, single axis, friction swing and stance phase control (safety knee)

L5714 Addition, exoskeletal knee-shin system, single axis, variable friction swing phase control

L5716 Addition, exoskeletal knee-shin system, polycentric, mechanical stance phase lock

L5718 Addition, exoskeletal knee-shin system, polycentric, friction swing and stance phase control

L5722 Addition, exoskeletal knee-shin system, single axis, pneumatic swing, friction stance phase control

L5724 Addition, exoskeletal knee-shin system, single axis, fluid swing phase control

L5726 Addition, exoskeletal knee-shin system, single axis, external joints fluid swing phase control

L5728 Addition, exoskeletal knee-shin system, single axis, fluid swing and stance phase control

L5780 Addition, exoskeletal knee-shin system, single axis, pneumatic/hydra pneumatic swing phase control

L5785 Addition, exoskeletal system, below knee (BK), ultra-light material (titanium, carbon fiber or equal)

L5790 Addition, exoskeletal system, above knee (AK), ultra-light material (titanium, carbon fiber or equal)

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CPT Code

Description

L5795 Addition, exoskeletal system, hip disarticulation, ultra-light material (titanium, carbon fiber or equal)

L5810 Addition, endoskeletal knee-shin system, single axis, manual lock

L5811 Addition, endoskeletal knee-shin system, single axis, manual lock, ultra-light material

L5812 Addition, endoskeletal knee-shin system, single axis, friction swing and stance phase control (safety

knee)

L5814 Addition, endoskeletal knee-shin system, polycentric, hydraulic swing phase control, mechanical stance

phase lock

L5816 Addition, endoskeletal knee-shin system, polycentric, mechanical stance phase lock

L5818 Addition, endoskeletal knee-shin system, polycentric, friction swing, and stance phase control

L5822 Addition, endoskeletal knee-shin system, single axis, pneumatic swing, friction stance phase control

L5824 Addition, endoskeletal knee-shin system, single axis, fluid swing phase control

L5826 Addition, endoskeletal knee-shin system, single axis, hydraulic swing phase control, with miniature high

activity frame

L5828 Addition, endoskeletal knee-shin system, single axis, fluid swing and stance phase control

L5830 Addition, endoskeletal knee-shin system, single axis, pneumatic/ swing phase control

L5840 Addition, endoskeletal knee/shin system, 4-bar linkage or multiaxial, pneumatic swing phase control

L5845 Addition, endoskeletal, knee-shin system, stance flexion feature, adjustable

L5848 Addition to endoskeletal knee-shin system, fluid stance extension, dampening feature, with or without

adjustability

L5850 Addition, endoskeletal system, above knee (AK) or hip disarticulation, knee extension assist

L5855 Addition, endoskeletal system, hip disarticulation, mechanical hip extension assist

L5856 Addition to lower extremity prosthesis, endoskeletal knee-shin system, microprocessor control feature,

swing and stance phase, includes electronic sensor(s), any type

L5857

Addition to lower extremity prosthesis, endoskeletal knee-shin system, microprocessor control feature,

swing phase only, includes electronic sensor(s), any type

L5858 Addition to lower extremity prosthesis, endoskeletal knee shin system, microprocessor control feature,

stance phase only, includes electronic sensor(s), any type

L5859

Addition to lower extremity prosthesis, endoskeletal knee-shin system, powered and programmable

flexion/extension assist control, includes any type motor(s)

L5910 Addition, endoskeletal system, below knee (BK), alignable system

L5920 Addition, endoskeletal system, above knee (AK) or hip disarticulation, alignable system

L5925 Addition, endoskeletal system, above knee (AK), knee disarticulation or hip disarticulation, manual lock

L5926 Addition to lower extremity prosthesis, endoskeletal, knee disarticulation, above knee, hip disarticulation,

positional rotation unit, any type

L5930 Addition, endoskeletal system, high activity knee control frame

L5940 Addition, endoskeletal system, below knee (BK), ultra-light material (titanium, carbon fiber or equal)

L5950 Addition, endoskeletal system, above knee (AK), ultra-light material (titanium, carbon fiber or equal)

L5960 Addition, endoskeletal system, hip disarticulation, ultra-light material (titanium, carbon fiber or equal)

L5961 Addition, endoskeletal system, polycentric hip joint, pneumatic or hydraulic control, rotation control, with

or without flexion and/or extension control

L5962 Addition, endoskeletal system, below knee (BK), flexible protective outer surface covering system

L5964 Addition, endoskeletal system, above knee (AK), flexible protective outer surface covering system

L5966 Addition, endoskeletal system, hip disarticulation, flexible protective outer surface covering system

L5968 Addition to lower limb prosthesis, multiaxial ankle with swing phase active dorsiflexion feature

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CPT Code

Description

L5969 Addition, endoskeletal ankle-foot or ankle system, power assist, includes any type motor(s)

L5970 All lower extremity prostheses, foot, external keel, SACH foot

L5971 All lower extremity prosthesis, solid ankle cushion heel (SACH) foot, replacement only

L5972 All lower extremity prostheses, foot, flexible keel

L5973 Endoskeletal ankle foot system, microprocessor-controlled feature, dorsiflexion and/or plantar flexion

control, includes power source

L5974 All lower extremity prostheses, foot, single axis ankle/foot

L5975 All lower extremity prosthesis, combination single axis ankle and flexible keel foot

L5976 All lower extremity prostheses, energy storing foot (seattle carbon copy ii or equal)

L5978 All lower extremity prostheses, foot, multiaxial ankle/foot

L5979 All lower extremity prosthesis, multiaxial ankle, dynamic response foot, one piece system

L5980 All lower extremity prostheses, flex foot system

L5981 All lower extremity prostheses, flex-walk system or equal

L5982 All exoskeletal lower extremity prostheses, axial rotation unit

L5984 All endoskeletal lower extremity prosthesis, axial rotation unit, with or without adjustability

L5985 All endoskeletal lower extremity prostheses, dynamic prosthetic pylon

L5986 All lower extremity prostheses, multiaxial rotation unit (MCP or equal)

L5987 All lower extremity prosthesis, shank foot system with vertical loading pylon

L5988 Addition to lower limb prosthesis, vertical shock reducing pylon feature

L5990 Addition to lower extremity prosthesis, user adjustable heel height

L5991 Addition to lower extremity prostheses, osseointegrated external prosthetic connector

L5999 Lower extremity prosthesis, not otherwise specified

L7367 Lithium-ion battery, rechargeable, replacement

L7368 Lithium-ion battery charger, replacement only

L7600 Prosthetic donning sleeve, any material, each

L7700 Gasket or seal, for use with prosthetic socket insert, any type, each

L8400 Prosthetic sheath, below knee (BK), each

L8410 Prosthetic sheath, above knee (AK), each

L8417 Prosthetic sheath/sock, including a gel cushion layer, below knee (BK) or above knee (AK), each

L8420 Prosthetic sock, multiple ply, below knee (BK), each

L8430 Prosthetic sock, multiple ply, above knee (AK), each

L8440 Prosthetic shrinker, below knee (BK), each

L8460 Prosthetic shrinker, above knee (AK), each

L8470 Prosthetic sock, single ply, fitting, below knee (BK), each

L8480 Prosthetic sock, single ply, fitting, above knee (AK), each

CPT

is a registered trademark of the American Medical Association

Description of Services

A Prosthesis is an artificial device used to replace all or part a missing body part and is intended to restore normal function.

Meier and Melton (2014) identify the most common levels of amputations for the lower limb are the transtibial (TT) (below knee,

BK) and the transfemoral (TF) (above knee, AK).The Prosthesis is a tool that helps the single-limb amputee gain functional

independence. Ideally, lower limb amputees should be able to accomplish things such as ambulation with Prosthesis on level

and uneven surfaces, stairs, ramps, and curbs, independent with dressing and return to work with or without modifications.

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Benefit Considerations

Prosthetic Devices

An initial or replacement prosthetic device is a covered health care service when all of the following criteria are met:

• The prosthetic device replaces a limb or a body part, limited to:

o Artificial arms, legs, feet, and hands

and

• The prosthetic device is Medically Necessary

, as defined in the member’s specific benefit plan document; and

• The prosthetic device is not subject to a coverage exclusion in the member’s specific benefit plan document

Benefits are provided only for external prosthetic devices and do not include any device that is fully implanted into the body.

Internal prosthetics are a covered health care service for which benefits are available under the applicable medical/surgical

covered health care service categories in the certificate.

If more than one prosthetic device can meet the member’s functional needs, benefits are available only for the prosthetic

device that meets the minimum specifications for the member’s needs. If the member purchases a prosthetic device that

exceeds these minimum specifications, payment will only be the amount that would have paid for the prosthetic that meets the

minimum specifications, and the member will be responsible for paying any difference in cost.

Exclusions and Limitations

• Devices used as safety items or to help performance in sports-related activities

• Repair or replacement of prosthetic devices due to misuse, malicious damage or gross neglect or to replace lost or stolen

items

Clinical Evidence

Bone Anchored Percutaneous Limb Prostheses

A Hayes report (2023) reviewed the evidence and found no clear support for use of the Osseoanchored Prostheses for the

Rehabilitation of Amputees (OPRA) Implant System (Integrum Inc.) in patients with transfemoral (above the knee) amputation

(TFA). The reported benefits for the implant should be reviewed with caution due to high attrition rates, potential harm to the

patient, and high rates of revision after the procedure was performed.

In a 2022 ECRI clinical assessment, the evidence is inconclusive for the OPRA (Osseointegrated Prostheses for the

Rehabilitation of Amputees) Implant System. The OPRA is a bone anchored percutaneous limb prosthesis intended for

skeletally mature patients with transfemoral amputations due to trauma or cancer. Evidence from two systematic reviews, two

before and after studies and two case series is limited and of low quality. The studies report that while OPRA restores mobility

and improves the patient’s quality of life (QOL), serious complications, such as infection and implant loosening, have been

frequently reported and thus the risk-benefit balance remains unclear.

Sinclair et al. (2022) evaluated the safety and efficacy of the percutaneous osseointegrated prosthesis (POP) in ten unilateral

transfemoral amputees. This single center, prospective study was conducted with FDA Investigational Device Exemption (IDE)

and Institutional Review Board approval. A two-staged surgical protocol was used; the first surgery included resection of the

residual femur to accommodate the length of the device and prosthetic components, and the second surgery addressed

attachment of the percutaneous post. Rehabilitation started with physical therapy postop day one and then continued with

supervised sessions twice a week for a minimum of at least 10 days. DEXA scans and radiography were performed to observe

the bone response to the device and determine its safety. Functional use of the device was assessed by timing participants

while they put the device on and off, evaluation of distance walked over a 6-minute timeframe and collection of patient reported

outcomes on the Questionnaire for Persons with a Transfemoral Amputation (Q-TFA). Adverse events (AEs) included one

device loosening and needed removal at 5 weeks; a second device was removed at approximately 7 months due to a

periprosthetic fracture after a non-device-related fall; a third patient was treated for postoperative infection not related to the

device implant; and other various minor AEs included musculoskeletal pain, stoma irritation and a loose outer adaptor bolt for

three patients. The authors concluded that the POP offers a promising alternative for transfemoral amputees who have

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dissatisfaction with socket prostheses. Limitations included small sample size, two of ten participants were lost to follow-up due

to device removal, lack of female participants and limited number of surgeons in the single center where the study took place.

In a cohort study of 111 participants, Hagberg et al. (2020) reported on device and patient outcomes for unilateral transfemoral

amputees treated with a bone-anchored, transcutaneous prosthesis. The patients were treated for the first time with the

Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA) implant system and all consented to a longitudinal

follow-up that occurred over 18 years. Treatment consisted of a two-stage surgery approach followed by a rehabilitation

protocol. The primary outcome was to describe patient reported outcome measures (PROMs) which were captured using the

questionnaire for Persons with Transfemoral Amputation (Q-TFA); the secondary outcome was to relate the mechanical failures

to the demographic data, activity level, and PROMs. The authors found at two, five, seven, and ten years, respectively, the Q-

TFA scores demonstrated far more prosthetic use, improved mobility, and fewer problems. The authors discovered 55% of

patients had at least one mechanical complication, almost 20% of patients had six or more complication events, and

approximately 40% of patients had repeated episodes of fractures. These drawbacks were contributed to a higher prosthetic

activity level with more demanding physical activities. It was concluded that over a 15-year period, the fixture remained stable

and was able to transfer loads to an artificial limb anchored to the fixture via the abutment. Limitations included lack of control

group, missing data due to 15 year follow-up, lack of investigation into the mechanical failures, and lack of association between

patient outcome, mechanical complications, and infection.

Brånemark et al. (2019) conducted a nonrandomized study on fifty-one transfemoral amputees that were treated with the OPRA

implant system. Inclusion criteria consisted of patients with issues related to using a conventional socket-suspended prosthesis,

the inability to use a prosthesis, or not using one at all. Exclusion criteria consisted of amputation due to severe peripheral

vascular disease (PVD) and/or diabetes mellitus (DM), skin diseases on the amputated limb, pregnancy, and current treatment

with systemic corticosteroids, chemotherapeutic agents, or other drugs that could adversely affect the treatment. The implant

system consists of three main components (the fixture, the abutment and the external prosthesis) and involves two separate

surgeries separated by 6 months and followed by a rehabilitation program. Clinical examination for safety assessment was

completed at 3, 6, 12, and 24 months. The Transfemoral Amputation (Q-TFA) and the Short Form 36 (SF-36) Health Survey were

given to the participants before the first surgery and again at one year, two year and 5 years following the second surgery. From

the original fifty one patients, only forty made it through to five years for analysis. Adverse events were numerous and included

34 patients with multiple superficial skin infections, 14 deep infections on eleven patients, and 43 mechanical complications in

fifteen patients which resulted in replacement of the damaged abutment and/or the abutment screw. Details of prosthetic use

demonstrated 29 out of 42 participants used their prostheses on a daily basis for at least 13 hours; at five years, it was 28 out of

40 that showed continued use of at least 13 hours. The authors found at the 5-year mark, patients demonstrated a continuous

cumulative fixture (bone anchorage) survival rate of 92%, but the increased number of mechanical complications and the

increase in deep infections was troublesome; further research and investigation regarding this is warranted. Limitations

included small sample size, four patients withdrew from the study, three patients were lost to follow-up and the adverse

outcomes were numerous.

Microprocessor Controlled Knee Prostheses

Although there is ample clinical literature to support the efficacy of microprocessor knees with community ambulators

(Medicare functional classification level [MFCL] K3), there is insufficient evidence to support suitability of microprocessor knees

for patients with lower functional classification levels.

Alzeer et al. (2022) assessed the impact of using a microprocessor-controlled prosthetic knee (MCPK) and compared it to a

non-microprocessor-controlled prosthetic knee (NMCPK) in 76 adult unilateral transfemoral amputees. In this hospital-based

comparative study, the participants were put into one of two groups: 38 were part of the MCPK group and the other 38 were put

into the NMCPK group. Inclusion criteria consisted of participants aged 18-60 years old, medically stable, able to perform

outdoor ambulation at a mobility level of K3 and K4, and intact cognition. Outcomes were measured by self-reporting responses

via the Prosthetic Evaluation Questionnaire (PEQ), which consisted of scores for ambulation (AM), appearance (AP), frustration

(FR), perceived response (PR), residual limb health (RL), social burden (SB), sounds (SO), utility (UT), and quality of life (QoL).

Data results suggest the MCPK prostheses improved gait, daily activities, and overall positive experience in transfemoral

amputee. The authors found participants with MCPK experienced higher prosthetic satisfaction, improved QoL and body

image, and greater well-being when compared to those with NMCPK. Limitations of this study included a homogeneous

population, self-reporting data, and a modified PEQ scale with inability to compare results to other PEQ scales. Future studies

with larger sample sizes are warranted to check the efficacies of different MCPK types.

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Jayaraman et al. (2021) conducted a 13-month longitudinal crossover randomized clinical trial that included 10 individuals with

unilateral transfemoral amputation due to vascular conditions designated as Medicare functional classification level (MFCL) K2

to evaluate gait performance and safety with a microprocessor-controlled knee (MPK). Participants were randomized to one of

two groups, either an intervention with a MPK with a standardized 1M10 foot or with then non-microprocessor-controlled knee

(NMPK) with a standardized 1M10 foot. Inclusion criteria were dysvascular or diabetic unilateral transfemoral amputation; at

least 6 months or more post-prosthetic fitting; currently using an NMPK appropriate foot; and household or limited ambulator

post-amputation (MFCL K1 or K2 level). Exclusion criteria were individuals with amputation secondary to trauma, cancer, or

congenital causes; skin ulcers or lesions on the residual limb that may prevent fitting the prosthesis or from physical activity;

and visual impairments or cognitive deficits that may impair ability to give informed consent or follow simple instructions during

the study. Clinical outcomes and self-reported outcomes were collected at the end of 6-month interventions. Some limitations of

this study include small sample size, the mean age of study participants is 63 ±9 years (which is relatively young when

compared to the typical age range (70–75 years) of transfemoral amputation due to vascular complications in the United

States), consideration of comorbidities, and the use of assistance devices in the home. The authors concluded that individuals

with transfemoral amputation from dysvascular conditions at a MFCL K2 designation benefited from using an MPK with

appropriate foot in gait speed, balance, self-reported mobility and fall safety.

A systematic review and meta-analysis were conducted by Hahn et al. (2021) to update a previous 2014 analysis of benefits in

safety, performance-based, and patient-reported outcomes the use of microprocess-controlled prosthetic knees (MPKs) in

limited community ambulators. The investigators searched Medline, Cochrane Library, CINAHL Complete, EMBASE, and

Google Scholar and found 13 research projects (n = 704 participants classified as limited community ambulators). Two

reviewers independently rated relevant publications for their methodological quality. According to the investigators, limitations

of this analysis include the challenge of effective blinding to meet the formal criteria of high-quality research, some studies

suffered high attrition that limit generalizability but may also reflect the challenge of natural progression of underlying conditions

(e.g., vascular disease, diabetes) over longer observation periods, all studies reported some outcomes did not improve as

expected, and the vast variety of parameters characterizing clinical outcomes. The investigators of this review are also noted as

employed by a manufacture of MPKs. The authors concluded that the review suggests that limited community ambulators may

experience reduced fall, fear of falling, and risk of falling, and improve mobility but indicate further research to study specific

needs and characteristics of this population should be considered.

Deems-Dluhy et al. (2021) evaluated the potential of the microprocessor swing and stance-controlled knee-ankle-foot orthosis

(MPO) on improving balance, functional mobility, and quality of life (QOL) in 18 individuals with lower-extremity impairments as

compared to a stance-control-orthosis (SCO) and conventional knee-ankle-foot orthosis (KAFO) over 30 days of use.

Assessments were done at baseline with the participants own device and again after training and use of each of the study

devices. Performance-based outcome measures included walking endurance, gait speed, balance, functional sit to stand and

outdoor ambulation; patient reported outcome measures included the Modified Falls Efficacy Scale (mFES) and the Orthotic

and Prosthetic User’s Survey (OPUS). Clinic visits included reports of any falls and adverse events. The results identified several

performance-based measures improved significantly from baseline scores to post testing scores with the participants that wore

the C-Brace but not with the SCO. In addition, the ability to descend hills measured by hill assessment index showed the MPO

group performed better and were able to walk significantly farther. The authors found improvements in both static and dynamic

balance, gait speed, walking endurance, stair descent, and self-reported falls while using the MPO but not the SCO. Limitations

included small sample size, inability to blind participants due to device type and short time frame of study.

Mileusnic et al. (2021) conducted a systematic review to evaluate the effect of the Genium knee on ambulation, mobility,

activities of daily living (ADLs) and quality of life compared to standard MPKs. A search was conducted using PubMed, Cinahl

and Cochrane Database of Systematic Reviews and returned 12 publications. Six publications contained randomized control

cross-over design, five publications before-and-after design and one study used a cross-sectional design. Participant sample

sizes ranged from 10 to 25 patients and follow up was anywhere from two days to three months. The overall quality of evidence

was moderate to high except for one article. Data was gathered on how the Genium was assessed for walking, ramps and

stairs. The authors found that while mobility and functional levels were both significantly improved and there were positive

effects on the performance and safety of ADLs, it is unclear if the results can be generalized beyond community ambulators

with a transfemoral amputation. Limitations included absence of blinding in all studies, short acclimation period for the patient

with the prosthetic and small sample sizes.

Stevens and Wurdeman (2019) published clinical recommendations on prosthetic knee selection for unilateral amputees at the

knee and transfemoral level. The following are the proposed recommendations:

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• Fluid knee benefits and indications: knees with hydraulic or pneumatic swing resistance are indicated for active walkers,

permitting increased walking comfort, speed, and symmetry.

• Microprocessor knee benefits when compared with non-microprocessor knees:

o With respect to self-report indices and measures, microprocessor knees are indicated to reduce stumbles, falls, and

associated frustrations as well as the cognitive demands of ambulation.

o With respect to self-report indices and measures, microprocessor knees are indicated to increase confidence while

walking, self-reported mobility, satisfaction, well-being, and quality of life.

o With respect to physical performance indices and measures, microprocessor knees are indicated to increase self-

selected walking speed, walking speed on uneven terrain, and metabolic efficiency during gait.

• Microprocessor knee equivalence: given the comparable values observed with the use of microprocessor and non-

microprocessor knees with regard to daily step counts, temporal and spatial gait symmetry, self-reported general health,

and total costs of prosthetic rehabilitation, these parameters may not be primary indications in prosthetic knee joint

selection.

• Microprocessor knees for limited community ambulators: among limited community ambulators, microprocessor knees are

indicated to enable increases in level ground walking speed and walking speed on uneven terrain while substantially

reducing uncontrolled falls and increasing both measured and perceived balance.

Kaufman et al. (2018, included in the Hahn et al. (2021) systematic review above) conducted a prospective non-randomized

cross-over clinical trial with repetition to evaluate if limited community ambulators would benefit from a microprocessor-

controlled knee (MPK). The aim of the study was to compare functional efficacy, patient satisfaction, and safety of MPK vs

NMPK. The study included 50 unilateral transfemoral amputees (TFA) with a mean age of 69 (range 55-93) and a MFCL of K2 (n

= 48) or K3 (n = 2) that were tested with current non-microprocessor knee (NMPK), then tested with a MPK after 10 weeks of

acclimation. Participants were then retested with their original mechanical NMPK after 4 weeks of re-acclimation. Participants

were excluded if on dialysis, contained a history of acute or chronic residual limb skin breakdown or had a prosthetic socket

adjustment within the previous 90 days. Participants self-assessed on nine validated scales for ambulation, appearance,

frustration, perceived response, residual limb health, social burden, sounds, utility and well-being. Limitations of the study

include safety data is directly linked to the ability to accurately monitor falls, increased burden on participants, use of recall that

is limited by the extent of memory decay over time or under or over estimation, and intervention bias. A number of subjects (n =

21) did not complete the final data capture. The authors concluded that this trial confirmed that MPK use to patients with a TFA

and MFCL K2 results in improved function in the free-living environment, a reduction in fall and improved patient satisfaction.

The Agency for Healthcare Research and Quality (AHRQ) conducted an effectiveness review (2018) on Lower Limb Prostheses

(LLP) (Balk et al., 2018). A literature search was conducted in PubMed

, both the Cochrane Central Trials Registry and

Cochrane Database of Systematic Reviews, Embase

, and CINAHL

/PsycINFO

databases and identified 77 articles for review;

52 articles addressed key questions (KQ) 1-3, fifteen articles addressed KQ 4, one article addressed KQ 6, nine articles

addressed KQ 7, and no articles were found for KQ 5.

• What assessment techniques used to measure functional ability of adults with major lower limb amputation have been

evaluated in the published literature?

• What prediction tools used to predict functional outcomes in adults with major lower limb amputation have been evaluated

in the published literature?

• What functional outcome measurement tools used to assess adults who use an LLP have been evaluated in the published

literature?

• In adults who use a lower limb prosthesis, how do ambulatory, functional, and patient-centered outcomes with different

prosthesis components vary based on study participant characteristics?

• How do study participants’ pre prescription expectations of ambulation align with their functional outcomes?

• What is the level of patient satisfaction with the process of accessing an LLP?

• At 6 months, 1 year, and 5 years after receipt of an LLP, (accounting for intervening mortality, subsequent surgeries, or

injuries) what percentage of individuals maintain ambulation, continue to use their prosthesis as intended, have

abandoned their prosthesis or have encountered major problems?

The following key findings were found:

• Since many specific measures can be used for at all stages of evaluation of function for amputees, it is difficult to effectively

make the distinction between assessment techniques, prediction tools, and outcome measures.

• Among the 50 instruments found to assess the psychometric properties, 41 had evidence of test validity, 35 had evidence

of reliability, and 28 had evidence of both test validity and reliability.

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• 14 studies were found that compared LLP components along with provided data to compare differences in effect among

different subgroups, however, most studies were small, underpowered, nonrandomized, reported only participant-level

data, and did not evaluate heterogeneity of treatment effect. In addition, most of these studies evaluated knee components

and most included younger men at K2 or K3 level, with unilateral transfemoral amputations with traumatic etiologies; only

one study addressed a mean age greater than 65 years.

• No evidence was found that addressed how study participants’ pre prescription expectations of ambulation aligned with

their functional outcomes.

• As far as long-term follow-up, eight studies with at least 100 participants were found that addressed follow-up of at least 6

months after prescribed LLP, but only one of these studies was conducted in the United States and most (including the

U.S. study) were published more than 10 years ago. There is insufficient or low evidence:

o Regarding failure to maintain bipedal ambulation.

o Regarding use of prostheses only for transfers.

o Regarding reasons why LLP amputees have poor outcomes in terms of their prostheses use.

o Regarding rationale of amputees and why they have abandoned use of their prostheses at 1 year.

Limitations of this review included that most studies were observational, evaluated only a limited set of patient characteristics

lacking heterogeneity, and most long-term studies were conducted outside the U.S. which addressed a different healthcare

system. Future research should include robust studies including amputation level and etiology, baseline K level or equivalent,

living situation, and other participant functional status.

Kannenberg et al. (2014, included in Hahn et. al. (2021) systematic review above) conducted a systematic review on behalf of

the manufacturer to evaluate if there is support that limited community ambulators (Medicare Functional Classification Level

[MFCL]-2) may benefit from using a microprocessor-controlled prosthetic knee (MPK) in safety, performance-based function

and mobility, and perceived function and satisfaction. The investigators searched the Medline, EMBASE, PsychInfo, Cochrane

Library, CINAHL, DARE, Cirrie, OTseeker, PEDro, and RECAL Legacy for terms related to MPKs and individuals with a unilateral

transfemoral amputation (TFA) and MFCL-2 mobility grade. Two reviewers independently screened studies, extracted data, and

assessed for relevance. Of 986 articles screened, 3 studies were eligible for final inclusion for safety outcomes (n = 27 with

MFCL-2 mobility grade); 6 studies for performance-based function and mobility outcomes (n = 57 with MFCL-2 mobility grade);

5 articles on perceived function and satisfaction (n = 57 with MFCL-2 mobility grade). The authors concluded that the results of

this systematic review of clinical trials of individuals with a unilateral TFA on interventions with MPKs suggest MPK use may

significantly reduce uncontrolled falls by up to 80% and significant improved fall risk. Performance-based outcome measures

suggest individuals with MFCL-2 mobility grade may be able to walk about 14% - 25% faster on level ground, be around 20%

quicker on uneven surfaces and descend a slop almost 30% faster when using an MPK. Trial fitting may be used to determine

whether or not individuals with TFA and MFCL-2 mobility grade benefit from MPK use is also suggested by this systematic

review. According to the authors, limitations of this systematic review was that the results of the studies were derived with low to

moderate methodological quality in a limited number of patients, trial fittings with different types of MPKs and that the criteria

for appraising success or failure of the trial fitting have been suggested. The authors indicate that the current general and

ambiguous definitions of the MFCLs are a challenge and that an evidence-based and unambiguous quantifiable functional

classification would help better define patient groups for clinical research.

Theeven et al. (2011) conducted a randomized cross-over trial on 41 participants to assess the effects of using a

microprocessor-controlled prosthetic knee joint on the functional performance of ADLs in persons with a unilateral above-knee

or knee disarticulation limb loss above knee(AK) leg amputation, classified as Medicare Functional Classification Level-2

(MFCL-2). The patients were tested in 3 different prosthetic knee joint conditions: 1) with their current mechanically controlled

knee joint or manual locking knee, 2) with a knee joint featuring a microprocessor-controlled stance and swing phase (MPK-A),

and 3) with a knee joint featuring a microprocessor-controlled stance phase (MPK-B). Baseline data was collected for the

mechanically controlled knee joint condition and then performance using both MPK devices was compared to the use of the

patient’s mechanically controlled knee. After 13 participants dropped out, MPKs were randomly assigned to the remaining 28

participants by a blinded assessor. The test circuit utilized consisted of 11 circuit stations, where the participants were tested

on 17 simulated daily activities. For each activity the performance time was recorded, and with the visual analogue scale (VAS),

participants rated the perceived level of difficulty for each circuit station; 0 was deemed very easy to 100 which was considered

very difficult. At the end of the study the participants were asked which type of knee joint they preferred in daily life. The authors

found some participants preferred and benefited from the MPK-A, some participants preferred and benefited from the MPK-B

and one patient preferred their own mechanically controlled prosthesis. These results illustrate a singular prosthesis may not be

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the best choice for an entire group of amputees; utilization of tests such as the ADAPT help to personalize the choice for the

patient since each individual responds differently to a specific prosthesis.

Powered Microprocessor Prosthetic Ankles

There is insufficient evidence in the clinical literature demonstrating support for the use of powered microprocessor prosthetic

ankles (MPAs) for transtibial amputations.

An evolving evidence review from Hayes (2022, updated 2023) focused specifically on the evidence to support the use of

powered MPAs for transtibial amputations. There were no systematic reviews identified and a few poor-quality studies with

variable outcomes. There were no professional guidelines identified.

Thomas-Pohl et al. (2021) investigated the relevance of microprocessor prosthetic ankles (MPAs) on six participants with

transtibial amputation that currently wear an energy storing and returning (ESR) foot; the ability to stand on both level and

inclined surfaces was evaluated. The study evaluated three MPAs: ElanVR Endolite (MPA1), MeridiumVR Ottobock (MPA2),

ProprioFootVR Ossur (MPA3). All participants completed the simplified Activities-Specific Balance Confidence scale (ABC)

questionnaire and underwent balance and mobility tests (the Berg Balance (BBS) scale and the 2-min walk test (2MWT)).

Instrumental analysis was completed by furnishing the subjects in reflective markers and performance of several walking tasks;

lower limb angular position and moment, Centre of Pressure (CoP) position, Ground Reaction Forces (GRF) and functional

scores were collected stationary, on level ground and at 12% inclined slope. The authors concluded that increased ankle

mobility is associated with better posture and slope balance and that the benefits of wearing MPAs had a direct relation to their

design. Limitations included small sample size and lack of comparison group.

Kim et al. (2021) Twelve individuals with unilateral transtibial amputations (TTA) participated in a randomized clinical trial

comparing unpowered prosthesis against the BiOM powered prosthesis. 7 people were randomly assigned to the powered

prosthesis group and the other 5 were part of the unpowered prosthesis group; 10 participants completed the full study.

Inclusion criteria for the participants consisted of patients aged 21years or older and had a unilateral TTA with prosthetic use

for at least six months. The authors collected data on metabolic costs, walking speeds in-lab and in daily life, step count, step

count away from home, perceived mobility, and preference between powered and unpowered prostheses. Participants

completed the Prosthesis Evaluation Questionnaire (PEQ) which captured their mobility experience and quality of life. The

authors concluded there was no significance between the two groups; wearing the powered prosthesis did not significantly

decrease metabolic costs, increase physical activity or walking speed, or increase the individual’s perceived mobility. Yet

participants with the powered prosthesis reported they felt they could walk faster and with more ease but did complain about

the battery life and weight of the prosthesis. Limitations included small sample size, lab environment assessments which

contributed to the absence of real-world situations, and inaccurate data for the power operated device due to dead battery.

Future studies with larger cohorts are warranted.

Kaluf et al. (2020) examined the differences in patient reported balance, mobility, socket comfort, and preference between a

fixed-ankle energy-storing-and-returning (ESAR) foot and an MPA. 23 participants at a K3 level with unilateral transtibial

amputation (UTA) were randomly assigned into two groups. Group AB received the MPA to use during the first 4-week period

and Group BA received the ESAR foot; both groups then switched. A certified prosthetist performed all the fitting and

alignment of each participant's prosthetic. At each visit, participants filled out patient reported outcome measures (PROM)

which included the Activities Specific Balance Confidence Scale (ABC), Prosthesis Evaluation Questionnaire–Mobility Subscale

(PEQ-MS), and Prosthetic Limb User Survey of Mobility (PLUS-M), Socket Comfort Score (SCS). At the end of study, each

subject was interviewed by the research prosthetist and asked what they liked and disliked about both devices, and which

would be their choice for their daily prosthetic. The authors found the MPA showed significantly better patient reported

outcomes when it came to walking and standing on sloped surfaces. Limitations included small sample size, male gender

participants only and participants with K3 level functioning or higher. Future studies should examine type of ankle-foot system

and type of socket suspension, physical therapy training, comparison groups along with including patients with lower

classification levels.

Struchkov and Buckley (2016) studied nine unilateral trans-tibial amputees to determine whether use of a microprocessor-

controlled passive-articulating (MPC) hydraulic ankle–foot device improved the gait biomechanics when compared to

conventional ankle–foot mechanisms. Out of the nine participants, which were all classified as K3 users, 4 of them used an

Elan, 4 an Echelon VT and one a Re-flex Rotate; all were familiarized with using an articulating ankle–foot device. The ramp

used was custom made with a 5-degree incline and 2.8 m long/1 m wide walking surface. The participants completed trials at

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two speeds walking down the ramp with both active and inactive MPC and the comparable elastic foot device. Residual limb

kinematics, joint moments/powers and prosthetic foot power absorption/return were compared across all ankle types using

analysis of variance (ANOVA). The authors found that use of a MPC hydraulic foot reduced the biomechanical compensations

used to walk down slopes. Limitations included small sample size, lack of comparison group, and limited education and use for

the non-hydraulic foot may have skewed certain values/results.

Clinical Practice Guidelines

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

In a 2017 Clinical Practice Guideline for Rehabilitation of Individuals with Lower Limb Amputation, the following is

recommended:

• Assessment of behavioral health and psychosocial functioning at every phase of amputation management and

rehabilitation. (Weak recommendation)

• Institute rehabilitation training interventions, using both open and closed chain exercises and progressive resistance to

improve gait, mobility, strength, cardiovascular fitness and activities of daily living performance in order to maximize

function. (Strong recommendation)

• Microprocessor knee units over non-microprocessor knee units for ambulation to reduce risk of falls and maximize patient

satisfaction. There is insufficient evidence to recommend for or against any particular socket design, prosthetic foot

categories, and suspensions and interfaces. (Weak recommendation)

• Use of valid, reliable, and responsive functional outcome measures, including, but not limited to, the Comprehensive High-

level Activity Mobility Predictor, Amputee Mobility Predictor, 10-meter walk test, and 6-minute walk test. (Strong

recommendation)

U.S. Food and Drug Administration (FDA)

This section is to be used for informational purposes only. FDA approval alone is not a basis for coverage.

Prosthetic devices and components are classified by the FDA as Class I medical devices. Class I devices have the least amount

of regulatory control; manufacturers of these devices are exempt from the premarket notification procedures and are not

required to provide safety and effectiveness data prior to marketing. Examples of these devices include “ankle, foot, hip, knee,

and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable

and prosthesis suction valves.” Additional information is available at: https://www.fda.gov/medical-devices

(Accessed October 19, 2023)

The OPRA

™

Implant System is an Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) device and composed

of parts that allow a prosthesis to attach directly to the femur (thigh bone). The device was granted FDA premarket approval on

December 18, 2020. Additional information is available at:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190009.

(Accessed October 19, 2023)

References

Alzeer AM, Bhaskar Raj N, Shahine EM, et al. Impacts of microprocessor-controlled versus non-microprocessor-controlled

prosthetic knee joints among transfemoral amputees on functional outcomes: a comparative study. Cureus. 2022 Apr

21;14(4):e24331.

Balk EM, Gazula A, Markozannes G, et al. Lower Limb Prostheses: Measurement Instruments, Comparison of Component

Effects by Subgroups, and Long-Term Outcomes [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US);

2018 Sep. Report No.: 18-EHC017-EF. https://www.ncbi.nlm.nih.gov/books/NBK531523/. Accessed October 19, 2023.

Brånemark RP, Hagberg K, Kulbacka-Ortiz K, et al. Osseointegrated percutaneous prosthetic system for the treatment of

patients with transfemoral amputation: a prospective five-year follow-up of patient-reported outcomes and complications. J Am

Acad Orthop Surg. 2019 Aug 15;27(16):e743-e751.

Centers for Medicare and Medicaid Services (CMS). Health Care Procedure Coding System (HCPCS). Available at:

https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/HCPCS-Quarterly-Update

. Accessed October 19, 2023.

Lower Extremity Prosthetics

Page 17 of 18

UnitedHealthcare Commercial and Individual Exchange Medical Policy

Effective 04/01/2024

Deems-Dluhy S, Hoppe-Ludwig S, Mummidisetty CK, et al. Microprocessor controlled knee ankle foot orthosis (KAFO) vs

stance control vs locked KAFO: a randomized controlled trial. Arch Phys Med Rehabil. 2021 Feb;102(2):233-244.

Department of Veterans Affairs Department of Defense. VA/DoD Clinical Practice Guideline for Rehabilitation of Individuals with

Lower Limb Amputation. 2017. Available at:

https://www.healthquality.va.gov/guidelines/Rehab/amp/VADoDLLACPGPatientSummary092817.pdf

. Accessed October 19,

2023.

ECRI Institute. Clinical Evidence Assessment. OPRA Osseointegrated Implant System (Integrum AB) for Lower-limb Amputees.

May 2022.

Edemekong PF, Bomgaars DL, Sukumaran S, et al. Activities of Daily Living. 2022 Jul 3. In: StatPearls [Internet]. Treasure Island

(FL): StatPearls Publishing; 2022 Jan.

Hahn A, Bueschges S, Prager M, et al. The effect of microprocessor controlled exo-prosthetic knees on limited community

ambulators: systematic review and meta-analysis. Disabil Rehabil. 2021 Oct 25:1-19.

Hayes, Inc., Evolving Evidence Review. OPRA Implant System (Integrum Inc.) in Patients With Transfemoral Amputation.

Lansdale PA: Hayes, Inc., February 2023.

Hayes, Inc., Evolving Evidence Review. Powered Microprocessor Prosthetic Ankles in Patients with Transtibial Amputation.

Lansdale PA: Hayes, Inc., February 2022; updated April 2023.

Jayaraman C, Mummidisetty CK, Albert MV, et al. Using a microprocessor knee (C-Leg) with appropriate foot transitioned

individuals with dysvascular transfemoral amputations to higher performance levels: a longitudinal randomized clinical trial. J

Neuroeng Rehabil. 2021 May 25;18(1):88.

Kannenberg A, Zacharias B, Pröbsting E. Benefits of microprocessor-controlled prosthetic knees to limited community

ambulators: systematic review. J Rehabil Res Dev. 2014;51(10):1469-96.

Kaluf, B., Duncan, A., Bridges, W. Comparative effectiveness of microprocessor-controlled and carbon-fiber energy-storing-and-

returning prosthetic feet in persons with unilateral transtibial amputation: patient-reported outcome measures. Journal of

Prosthetics and Orthotics 32 (2020): 214 - 221.

Kaufman KR, Bernhardt KA, Symms K. Functional assessment and satisfaction of transfemoral amputees with low mobility

(FASTK2): A clinical trial of microprocessor-controlled vs. non-microprocessor-controlled knees. Clin Biomech (Bristol, Avon).

2018 Oct;58:116-122.

Kim J, Wensman J, Colabianchi N, et al. The influence of powered prostheses on user perspectives, metabolics, and activity: a

randomized crossover trial. J Neuroeng Rehabil. 2021 Mar 16;18(1):49.

Meier RH 3rd, Melton D. Ideal functional outcomes for amputation levels. Phys Med Rehabil Clin N Am. 2014 Feb;25(1):199-

212.

Mileusnic MP, Rettinger L, Highsmith MJ, et al. Benefits of the Genium microprocessor controlled prosthetic knee on

ambulation, mobility, activities of daily living and quality of life: a systematic literature review. Disabil Rehabil Assist Technol.

2021 Jul;16(5):453-464.

Mlinac ME, Feng MC. Assessment of Activities of Daily Living, Self-Care, and Independence. Arch Clin Neuropsychol. 2016

Sep;31(6):506-16. doi: 10.1093/arclin/acw049. Epub 2016 Jul 29.

Sinclair S, Beck JP, Webster J, et al. The first FDA approved early feasibility study of a novel percutaneous bone anchored

prosthesis for transfemoral amputees: a prospective 1-year follow-up cohort study. Arch Phys Med Rehabil. 2022

Nov;103(11):2092-2104.

Stevens PM, Wurdeman SR. Prosthetic Knee Selection for Individuals with Unilateral Transfemoral Amputation: A Clinical

Practice Guideline. J Prosthet Orthot. 2019 Jan;31(1):2-8.

Struchkov V, Buckley JG. Biomechanics of ramp descent in unilateral trans-tibial amputees: Comparison of a microprocessor-

controlled foot with conventional ankle-foot mechanisms. Clin Biomech (Bristol, Avon). 2016 Feb;32:164-70.

Theeven P, Hemmen B, Rings F, et al. Functional added value of microprocessor-controlled knee joints in daily life performance

of Medicare Functional Classification Level-2 amputees. J Rehabil Med. 2011 Oct;43(10):906-15.

Lower Extremity Prosthetics

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UnitedHealthcare Commercial and Individual Exchange Medical Policy

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Thomas-Pohl M, Villa C, Davot J, et al. Microprocessor prosthetic ankles: comparative biomechanical evaluation of people with

transtibial traumatic amputation during standing on level ground and slope. Disabil Rehabil Assist Technol. 2021 Jan;16(1):17-

26.

Policy History/Revision Information

Date

Summary of Changes

04/01/2024

Coverage Rationale

• Added language to indicate a bone anchored percutaneous limb prosthesis [e.g., Osseoanchored

Prostheses for the Rehabilitation of Amputees (OPRA) Implant System] is unproven and not

Medically Necessary due to insufficient evidence of efficacy

Applicable Codes

• Added HCPCS code L5991

• Removed HCPCS codes L5781 and L5782

Supporting Information

• Updated

Clinical

Evidence

and

References

sections to reflect the most current information

•

Archived previous policy version 2024T0645D

Instructions for Use

This Medical Policy provides assistance in interpreting UnitedHealthcare standard benefit plans. When deciding coverage, the

member specific benefit plan document must be referenced as the terms of the member specific benefit plan may differ from

the standard plan. In the event of a conflict, the member specific benefit plan document governs. Before using this policy,

please check the member specific benefit plan document and any applicable federal or state mandates. UnitedHealthcare

reserves the right to modify its Policies and Guidelines as necessary. This Medical Policy is provided for informational

purposes. It does not constitute medical advice.

This Medical Policy may also be applied to Medicare Advantage plans in certain instances. In the absence of a Medicare

National Coverage Determination (NCD), Local Coverage Determination (LCD), or other Medicare coverage guidance, CMS

allows a Medicare Advantage Organization (MAO) to create its own coverage determinations, using objective evidence-based

rationale relying on authoritative evidence (Medicare IOM Pub. No. 100-16, Ch. 4, §90.5

UnitedHealthcare may also use tools developed by third parties, such as the InterQual

criteria, to assist us in administering

health benefits. UnitedHealthcare Medical Policies are intended to be used in connection with the independent professional

medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice.