Latest Review Date: July 2024

Category: Durable Medical Equipment (DME)                             

POLICY:

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

• The individual will reach or maintain a defined functional state within a reasonable period of time;and
• The individual is motivated to ambulate; and
• The prosthesis is prescribed by a physician.

Determination of medical criteria for coverage for prostheses is also based on the individual’s potential functional level (see Description of Procedure or Service).

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

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

PROSTHETIC FEET

Medical criteria for coverage for selected foot prostheses and components is determined according to potential functional levels.  Determination of the type of prosthetic foot will be made by the prescribing physician and/or prosthetist based on the functional needs of the individual. 

External keel (L5972), SACH foot (L5970) or single axis ankle/foot (L5974) may be considered medically necessary for individuals with functional Level 1 or above.

Flexible-keel foot (L5972) and multiaxial ankle/foot (L5978) may be considered medically necessary for individuals with functional Level 2 or greater.

Flex foot system (L5980), energy storing foot (L5976), multiaxial, dynamic response ankle/foot (L5979), or flex walk system or equal (L5981) or shank foot system with vertical loading pylon (L5987) may be considered medically necessary for individuals with functional Level 3 or above.

PROSTHETIC KNEE

Medical criteria for coverage for selected knee prostheses and components is determined according to potential functional levels.  Determination of the type of prosthetic knee will be made by the prescribing physician and/or prosthetist based on the functional needs of the individual. 

Knee systems L5611, L5616, L5710-L5718, and L5810-L5818 may be considered medically necessary for individuals with functional Level 1 or above. 

Fluid and pneumatic knees (L5610, L5613, L5614, L5722-L5780, L5822-L5840) may be considered medically necessary for individuals with functional Level 3 or above.

See Medical Policy #083 for coverage of Microprocessor/ Computerized Knee Prostheses.

PROSTHETIC ANKLE

Axial rotation units (L5982-L5986) may be considered medically necessary for individuals with functional Level 2 or above.

PROSTHETIC HIP

A pneumatic or hydraulic polycentric hip joint (L5961) is considered medically necessary for individuals whose functional level is 3 or above.

SOCKETS

Test (diagnostic) sockets for immediate post-surgical or early fitted prostheses (L5618-L5628 when used with L5400-L5460) are considered not medically necessary. Immediate prostheses are considered not medically necessary. 

Test sockets for permanent prostheses may be considered medically necessary.

No more than two of the same socket inserts (L5654-L5665,L5673, L5679, L5681, L5683) per individual prosthesis are considered medically necessary at the same time.

Socket replacements may be considered medically necessary when there is adequate documentation of functional and/or physiological need such as, but not limited to; changes in the residual limb, functional need changes, or irreparable damage or wear/tear due to excessive patient weight or prosthetic demands of very active amputees.

Specialized vacuum pump residual limb volume management and moisture evacuation systems (L5781,L5782), may be considered medically necessary for use with lower limb prostheses when there is contraindication to or failure of other socket-suspension systems (e.g., mechanical, passive suction) to adequately secure the limb to the prosthesis AND any of the following criteria are met:

• Excessive pistoning of the socket to residual limb interface that cannot be resolved by adjustments in the current suspension system; or
• Excessive residual limb hyperemia from prior socket use; or
• Excessive skin hyperhidrosis from prior socket use; or
• Multiple documented falls.

Additions or upgrades to the prosthetic for convenience, sports or recreational activities are considered investigational.

Lifelike components (i.e., silicone covered prosthesis) are considered investigational and cosmetic. Consideration will be given for reimbursement of a basic component if the basic component meets medical criteria for coverage.

DESCRIPTION OF PROCEDURE OF SERVICE:

Mechanical prosthetic devices are widely recognized as consistent with generally accepted standards of medical practice for individuals with extremity amputations from any cause. The need for a specific type of mechanical prosthetic limb and related components/additions is based upon demonstrated medical need, ability to utilize a particular device, and the expectations of the ordering provider regarding the likely post-treatment functional level.

Lower Limb Prosthesis

A lower limb prosthesis is designed to replace portions of the lower extremity to improve function. A prosthetic knee performs several functions: it provides support during the stance phase of ambulation, produces smooth control during the swing phase and maintains unrestricted motion for sitting and kneeling. The prosthetic knee may have a single axis with a simple hinge and a single pivot point, or it may have a polycentric axis with multiple centers of rotation, which is more similar to the anatomic human knee. Pylons are the connection between the residual limb and the prosthetic joint.

A basic (i.e., conventional) lower limb prosthetic device consists of the following:

• A socket (connection between the residual limb and prosthesis)
• A suspension mechanism (how the socket is attached to the prosthesis)
• A knee joint (provides support during stance, smooth control during swing phase and unrestricted motion for sitting and kneeling)
• A pylon (a tube or shell that attaches the socket to the terminal device) that is either exoskeleton or endoskeleton
• A terminal device (foot)

Knee Prosthetics

The basic lower-extremity prosthesis includes a single-axis, constant friction knee. This device is a basic knee that acts as a door-and-hinge device, is free-swinging and does not allow stance control. It allows one-speed ambulation and is often used in children. A hydraulic unit that includes piston cylinders and contains either air (i.e., pneumatic) or fluid (i.e., hydraulic) may be added to the knee device to allow swing control as the amputee speeds up or slows down. Swing control may allow the amputee to walk at variable speeds. It is often used in more active amputees. The polycentric knee, a device with multiple rotational axes, is sometimes referred to as the “four bar” knee. It has four points of rotation connected by a linkage bar. The device is asserted to be very stable in early stance and easy to flex in swing phase.

Prosthetic Feet

The prosthetic foot also has several basic functions: provides a stable weight-bearing surface, absorbs shock, replaces lost muscle function and biomechanics of the foot, replicates the anatomic joints of the ankle and foot and restores appearance.

Multiaxial prosthetic feet permit movements in any direction: plantar flexion, dorsiflexion, inversion, eversion and a slight amount of rotation around a vertical axis. Multiaxial feet are appropriate for those who ambulate on uneven terrain, such as community ambulators and active adults or athletes.

The solid ankle cushion heel (SACH) consists of a rigid keel covered by semi-noncompressible foam and a synthetic rubber heel wedge. The cushion heel compresses when weight is applied, allowing the forefoot to approach the floor. The amount of simulated plantar flexion depends on the relative softness of the heel material and weight of the amputee. Because the keel is rigid, the SACH foot does not provide dorsiflexion; this makes its usefulness on uneven surfaces limited.

Potential functional ability is based on the reasonable expectations of the prosthetist and treating physician, considering factors including, but not limited to:

1. The individual's past history (including prior prosthetic use if applicable);
2. The individual's current condition including the status of the residual limb and the nature of other medical problems; and
3. The individual's desire to ambulate. 

Clinical assessments of the individuals rehabilitation potential should be based on the following classification levels.   Medical records should document the individual's current functional capabilities and his/her expected functional potential, including an explanation for the difference, if that is the case.

Functional Levels
Level 0	The patient 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	The patient has the ability or potential to use a prosthesis for transfers or ambulation on level surfaces at fixed cadence. This is typical of a household ambulator or a person who only walks about in their own home.
Level 2	The patient has the ability or potential for ambulation with the ability to traverse low-level environmental barriers such as curbs, stairs or uneven surfaces. This is typical of the limited community ambulator.
Level 3	The patient has the ability or potential for ambulation with variable cadence. A person at level 3 is typically a community ambulator who also has the ability to traverse most environmental barriers and may have vocational, therapeutic or exercise activity that demands prosthetic use beyond simple locomotion.
Level 4	The patient has the ability or potential for prosthetic ambulation that exceeds basic ambulation skills, exhibiting high impact, stress or energy levels. This is 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. There must be information about the individual’s history and current condition which supports the designation of the functional level by the prosthetist.

KEY POINTS:

The most recent literature search for this policy was performed through July 10, 2024. 

SUMMARY OF EVIDENCE:

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

Practice Guidelines and Position Statements

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

In a 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)

The American Academy of Orthotists and Prosthetists AAOP

This 2018 guideline was developed to present current evidence and to provide associated clinical recommendations on prosthetic foot selection for individuals with lower-limb amputation.

• Recommendation 1: For patients ambulating at a single speed who require greater stability during weight acceptance because of weak knee extensors or poor balance, a single-axis foot should be considered.
• Recommendation 2: Patients at elevated risks for overuse injury (i.e., osteoarthritis) to the sound-side lower limb and lower back are indicated for an energy-storage-and-return (ESAR) foot to reduce the magnitude of the cyclical vertical impacts experienced during weight acceptance.
• Recommendation 3: Neither patient age nor amputation etiology should be viewed as primary considerations in prosthetic foot type.
• Recommendation 4: Patients capable of variable speed and/or community ambulation are indicated for ESAR feet.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Prosthetic leg, prosthetic knee, prosthetic ankle, prosthetic foot, leg prosthesis, foot prosthesis, ankle prosthesis, knee prosthesis, artificial leg, artificial knee, artificial ankle, artificial foot, vacuum assisted socket system, VASS, hip prosthetic,socket insert, Harmony® P4 vacuum pump, SACH foot, rotation adapter, ottobock 4R57

APPROVED BY GOVERNING BODIES:

Not applicable

BENEFIT APPLICATION:

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

ITS: Home Policy provisions apply

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

CURRENT CODING:    

HCPCS:

L5000	Partial foot, shoe insert with longitudinal arch, toe filler
L5010	Partial foot, molded socket, ankle height, with toe filler
L5020	Partial foot, molded socket, tibial tubercle height, with toe filler
L5050	Ankle, Symes, molded socket, SACH foot
L5060	Ankle, Symes, metal frame, molded leather socket, articulated ankle/foot
L5100	Below knee, molded socket, shin, SACH foot
L5105	Below knee, plastic socket, joints and thigh lacer, SACH foot
L5150	Knee disarticulation (or through knee), molded socket, bent knee configuration, external knee
L5160	Knee disarticulation (or through knee), molded socket, bent knee configuration, external knee
L5200	Above knee, molded socket, single axis constant friction knee, shin, SACH foot
L5210	Above knee, short prosthesis, no knee joint (stubbies), with foot blocks, no ankle joints, each
L5220	Above knee, short prosthesis, no knee joint (stubbies), with articulated ankle/foot, dynamically aligned, each
L5230	Above knee, 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, 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, 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 post surgical or early fitting, application of initial rigid dressing, including fitting, alignment and suspension, below knee, each additional cast change and realignment
L5410	Immediate post surgical or early fitting, application of initial rigid dressing, including fitting, alignment and suspension, below knee, each additional cast change and realignment
L5420	Immediate post surgical or early fitting, application of initial rigid dressing, including fitting, alignment and suspension and one cast change “AK” or knee disarticulation
L5430	Immediate post surgical or early fitting, application of initial rigid dressing, including fitting, alignment and suspension, “AK” or knee disarticulation, each additional cast change and realignment
L5450	Immediate post surgical or early fitting, application of non-weight bearing rigid dressing, above knee
L5460	Immediate post surgical or early fitting, application of non-weight bearing rigid dressing, above knee
L5500	Initial, below knee ‘PTB’ type socket, non-alignable system, pylon, no cover, SACH foot, plaster socket, direct formed
L5505	Initial, above knee-knee disarticulation, ischial level socket, non-alignable system, pylon, no cover, SACH foot plaster socket, direct formed
L5510	Preparatory, below knee ‘PTB’ type socket, non-alignable system, pylon, no cover, SACH foot, plaster socket, molded to model
L5520	Preparatory, below knee ‘PTB’ type socket, non-alignable system, pylon, no cover, SACH foot, plaster socket, molded to model
L5530	Preparatory, below knee ‘PTB’ type socket, non-alignable system, pylon, no cover, SACH foot, thermoplastic or equal, molded to model.
L5535	Preparatory, below knee ‘PTB’ type socket, non-alignable system, pylon, no cover, SACH foot, prefabricated, adjustable open end socket
L5540	Preparatory, below knee ‘PTB’ type socket, non-alignable system, pylon, no cover, SACH foot, laminated socket, molded to model
L5560	Preparatory, above knee-knee disarticulation, ischial level socket, non-alignable system, pylon, no cover, SACH foot, plaster socket, molded to model
L5570	Preparatory, above knee-knee disarticulation, ischial level socket, non-alignable system, pylon, no cover, SACH foot, thermoplastic or equal, direct formed
L5580	Preparatory, above knee-knee disarticulation, ischial level socket, non-alignable system, pylon, no cover, SACH foot, thermoplastic or equal, molded to model
L5585	Preparatory, above knee-knee disarticulation, ischial level socket, non-alignable system, pylon, no cover, SACH foot, prefabricated adjustable open-end socket
L5590	Preparatory, above knee-knee disarticulation, ischial level socket, non-alignable 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, Hydracadence system
L5611	Addition to lower extremity, endoskeletal system, above knee-knee disarticulation, 4-bar linkage with friction swing phase control
L5613	Addition to lower extremity, endoskeletal system, above knee-knee disarticulation, 4-bar linkage with hydraulic swing phase control
L5614	Addition to lower extremity, exoskeletal system, above knee-knee disarticulation, 4-bar with pneumatic swing phase control

 

L5616	Addition to lower extremity, endoskeletal system, above knee, universal multiplex system, friction swing phase control
L5617	Addition to lower extremity, quick change self-aligning unit, above knee or below knee, each
L5618	Addition to lower extremity, test socket, Symes
L5620	Addition to lower extremity, test socket, below knee
L5622	Addition to lower extremity, test socket, knee disarticulation
L5624	Addition to lower extremity, test socket, above knee
L5626	Addition to lower extremity, test socket, hip disarticulation
L5628	Addition to lower extremity, test socket, hemipelvectomy
L5629	Addition to lower extremity, below knee, acrylic socket
L5630	Addition to lower extremity, Symes type, expandable wall socket
L5631	Addition to lower extremity, above knee 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, total contact
L5638	Addition to lower extremity, below knee, leather socket
L5639	Addition to lower extremity, below knee, wood socket
L5640	Addition to lower extremity, knee disarticulation, leather socket
L5642	Addition to lower extremity, above knee, leather socket
L5643	Addition to lower extremity, hip disarticulation, flexible inner socket, l84
L5644	Addition to lower extremity, above knee, wood socket
L5645	Addition to lower extremity, below knee, flexible inner socket, external frame
L5646	Addition to lower extremity, below knee, air cushion socket
L5647	Addition to lower extremity, below knee, suction socket
L5648	Addition to lower extremity, above knee, air cushion socket
L5649	Addition to lower extremity, ischial containment/narrow M-L socket
L5650	Addition to lower extremity, total contact, above knee or knee disarticulation socket
L5651	Addition to lower extremity, above knee, flexible inner socket, external frame
L5652	Addition to lower extremity, suction suspension, above knee 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 (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 (Kemblo, Pelite, Aliplast, Plastazote or equal)
L5661	Addition to lower extremity, socket insert, multi-durometer Symes
L5665	Addition to lower extremity, socket insert, multi-durometer, below knee
L5666	Addition to lower extremity, below knee, cuff suspension
L5668	Addition to lower extremity, below knee, molded distal cushion
L5670	Addition to lower extremity, below knee, molded supracondylar suspension (“PTS” or similar)
L5671	Addition to lower extremity, below knee/above knee, suspension locking mechanism (shuttle, lanyard, or equal), excludes socket insert
L5672	Addition to lower extremity, below knee, removable medial brim suspension
L5673	Addition to lower extremity, below knee/above knee, 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, knee joints, single axis, pair
L5677	Additions to lower extremity, below knee, knee joints, polycentric, pair
L5678	Additions to lower extremity, below knee, joint covers, pair
L5679	Addition to lower extremity, below knee/above knee, 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, thigh lacer, non-molded
L5681	Addition to lower extremity, below knee/above knee, custom fabricated socket insert for congenital or atypical traumatic amputee, silicone gel, elastomeric or equal, for use with or without locking mechanism, initial only
L5682	Addition to lower extremity, below knee, thigh lacer, gluteal/ischial, molded
L5683	Addition to lower extremity, below knee/above knee, 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
L5684	Addition to lower extremity, below knee, fork strap
L5685	Addition to lower extremity prosthesis, below knee, suspension/sealing sleeve, with or without valve, any material, each
L5686	Addition to lower extremity, below knee, back check (extension control)
L5688	Addition to lower extremity, below knee, waist belt, webbing
L5690	Addition to lower extremity, below knee, waist belt, padded and lined
L5692	Addition to lower extremity, above knee, pelvic control belt, light
L5694	Addition to lower extremity, above knee, pelvic control belt, padded and lined
L5695	Addition to lower extremity, above knee, pelvic control, sleeve suspension, neoprene or equal, each
L5696	Addition to lower extremity, above knee or knee disarticulation, pelvic joint
L5697	Addition to lower extremity, above knee or knee disarticulation, pelvic joint
L5698	Addition to lower extremity, above knee or knee disarticulation, Silesian bandage
L5699	All lower extremity prostheses, shoulder harness
L5700	Replacement, socket, below knee, molded to patient model
L5701	Replacement, socket, above knee/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
L5704	Custom shaped protective cover, below knee
L5705	Custom shaped protective cover, above knee
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	Addition, 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
L5781	Addition to lower limb prosthesis, vacuum pump, residual limb volume management and moisture evacuation system
L5782	Addition to lower limb prosthesis, vacuum pump, residual limb volume management and moisture evacuation system, heavy duty
L5785	Addition, exoskeletal system, below knee, ultra-light material (titanium, carbon fiber or equal)
L5790	Addition, exoskeletal system, above knee, ultra-light material (titanium, carbon fiber or equal)
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 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 or hip disarticulation, knee extension assist
L5855	Addition, endoskeletal system, hip disarticulation, mechanical hip extension assist
L5858	Addition to lower extremity prosthesis, endoskeletal knee shin system, microprocessor control feature, stance phase only, includes electronic sensor(s), any type
L5910	Addition, endoskeletal system, below knee, alignable system
L5920	Addition, endoskeletal system, above knee or hip disarticulation, alignable system
L5925	Addition, endoskeletal system, above knee, 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 (Effective 1/1/24)
L5930	Addition, endoskeletal system, high activity knee control frame
L5940	Addition, endoskeletal system, below knee, ultra-light material (titanium, carbon fiber or equal)
L5950	Addition, endoskeletal system, above knee, 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 flexible protective outer surface covering system
L5964	Addition, endoskeletal system, above knee 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
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, flexible keel foot (Safe, Sten, Bock dynamic or equal)
L5974	All lower extremity prostheses, foot, single axis ankle/foot
L5975	All lower extremity prostheses, 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 prostheses, 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 prostheses, axial rotation unit
L5985	All endoskeletal lower extremity prostheses, dynamic prosthetic pylon
L5986	All lower extremity prostheses, multi-axial rotation unit (“MCP” or equal)
L5987	All lower extremity prostheses, 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
L5999	Lower extremity prosthesis, not otherwise specified
L7510	Repair of prosthetic device, repair or replace minor parts
L7520	Repair prosthetic device, labor component, per 15 minutes
L7700	Gasket or seal, for use with prosthetic socket insert, any type, each
L8400	Prosthetic sheath, below knee, each
L8410	Prosthetic sheath, above knee, each
L8417	Prosthetic sheath/sock, including a gel cushion layer, below knee or above knee, each
L8420	Prosthetic sock, multiple ply, below knee, each
L8430	Prosthetic sock, multiple ply, above knee, each
L8440	Prosthetic shrinker, below knee, each
L8460	Prosthetic shrinker, above knee, each
L8470	Prosthetic sock, single ply, fitting, below knee, each
L8480	Prosthetic sock, single ply, fitting, above knee, each

HCPCS modifiers:     

K0 Functional Level 0

K1 Functional Level 1

K2 Functional Level 2

K3 Functional Level 3

K4 Functional Level 4

PREVIOUS CODING:

K1022

Addition to lower extremity prosthesis, endoskeletal, knee disarticulation, above knee, hip disarticulation, positional rotation unit, any type (Deleted 12/31/23)

REFERENCES:

1. Anzel, Stanford H., Perry, Jacquelin, et al.  Prosthetic design for dysvascular below-knee amputees, Department of Veterans Affairs, VA Rehabilitation Research and Development Service, Project #A735-RA, www.vard.org/prog/94/ch01/pr94020.htm.
2. Anzel, Stanford H., Perry, Jacquelin, et al.  Prosthetic foot design for the dysvascular below-knee amputee, Department of Veterans Affairs, VA Rehabilitation Research and Development Service, Project #A735-RA, www.vard.org/prog/95/ch01/pr95024.htm.
3. Balk EM, Gazula A, Markozannes G, et al. Lower limb prostheses: measurement instruments, comparison of component effects by subgroups, and long-term outcomes. Agency for Healthcare Research and Quality. 2018 September. Available at: https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/cer-213-lower-limb-protheses-report.pdf.
4. Brunelli S, Delussu AS, Paradisi F, Pellegrini R, Traballesi M. A comparison between the suction suspension system and the hypobaric Iceross Seal-In® X5 in transtibial amputees. Prosthet Orthot Int. 2013;37(6):436-444.
5. Fuller M, Luff, Robin, Boom MV. A novel approach to wound management and prosthetic use with concurrent vacuum-assisted closure therapy. Prosthetics and Orthotics International. 2011, 35(2) 246-249.
6. Gholizadeh H, Lemaire ED, Sinitski EH, et al. Transtibial amputee gait with the unity suspension system. Disabil Rehabil Assist Technol. 2019 Feb 27:1-7 [Epub ahead of print].
7. Hoskins RD, Sutton EE, Kinor D, et al. Using vacuum-assisted suspension to manage residual limb wounds in persons with transtibial amputation: A case series. Prosthet Orthot Int. 2014;38(1):68-74.
8. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
9. Klute GK, Berge JS, Biggs W, et al. Vacuum-assisted socket suspension compared with pin suspension for lower extremity amputees: Effect on fit, activity, and limb volume. Arch Phys Med Rehabil. 2011;92(10):1570-1575.
10. Menard, Michael R. and Murray, D. Duncan.  Subjective and objective analysis of an energy-storing prosthetic foot, Journal of Prosthetics and Orthotics, Vol. 1, No. 4, pp. 220-230.
11. Murphy D. Fundamentals of amputation care and prosthetics. New York, NY: Demos Medical Publishing, LLC; 2014.
12. Rink C, Wernke MM, Powell HM, et al. Elevated vacuum suspension preserves residual-limb skin health in people with lower-limb amputation: Randomized clinical trial. J Rehabil Res Dev. 2016;53(6):1121-1132.
13. Rosenblatt NJ, Ehrhardt T. The effect of vacuum assisted socket suspension on prospective, community-based falls by users of lower limb prostheses. Gait Posture. 2017;55:100-103.
14. Samitier CB, Guirao L, Costea M, et al. The benefits of using a vacuum-assisted socket system to improve balance and gait in elderly transtibial amputees. Prosthet Orthot Int. 2016;40(1):83-88.
15. Stevens, Phillip M. MEd, CPO; Rheinstein, John CP; Wurdeman, Shane R. PhD, MSPO, CP. Prosthetic Foot Selection for Individuals with Lower-Limb Amputation: A Clinical Practice Guideline. Journal of Prosthetics and Orthotics 30(4):p 175-180, October 2018.
16. Thibault G, Gholizadeh H, Sinitski E, et al. Effects of the unity vacuum suspension system on transtibial gait for simulated non-level surfaces. PLoS One. 2018;13(6):e0199181.
17. Traballesi M, Delussu AS, Fusco A, et al. Residual limb wounds or ulcers heal in transtibial amputees using an active suction socket system. A randomized controlled study. Eur J Phys Rehabil Med. 2012;48(4):613-623.
18. Veteran’s 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/VADoDLLACPG092817.pdf.

POLICY HISTORY:

Medical Policy Group, February 2003 (2)

Medical Policy Administration Committee, February 2003

Available for comment April 1-May 16, 2003

Medical Policy Group, July 2004

Medical Policy Administration Committee, August 2004

Available for comment August 12-September 25, 2004

Medical Policy Group, January 2006 (1)

Medical Policy Group, August 2006 (2)

Medical Policy Administration Committee, August 2006

Available for comment August 15-September 28, 2006

Medical Policy Group, April 2007 (2)

Medical Policy Administration Committee May 2007

Available for comment May 8-June 21, 2007

Medical Policy Group, August 2007 (3)

Medical Policy Administration Committee, August 2007

Available for comment September 27-November 13, 2007

Medical Policy Group, February 2009 (1)

Medical Policy Group, August 2010 (1) Added non-coverage statement for VASS, Key Points

Medical Policy Administration Committee, August 2010

Available for comment August 6-September 4, 20107700

Medical Policy Administration Committee, September 2010

Available for comment September 4-October 18, 2010

Medical Policy Group, October 2010

Medical Policy Group, December 2011(1): 2012 Code updates; Code L5311 was deleted and Code L5312 was added effective January 1, 2012.

Medical Policy Group, February 2015 (6):  2015 Updates – annual review of policy, cleaned up

coding section – removing deleted codes and adding new codes; no change to policy statement

Medical Policy Group, December 2017: Annual Coding Update 2017.  Added new HCPCS code L7700 to Current Coding.

Medical Policy Group, October 2018 (6): Updates to Description, Key Points and References. No change to policy intent.

Medical Policy Group, April 2020 (6) Updates to Policy to include hip prosthetics, Description, Key Points, Coding (L5961), Key Words (hip prosthetic) and References. No change to policy intent.

Medical Policy Group, May 2020 (6): Updated Policy to include coverage of specialized vacuum pump residual limb volume management and moisture evacuation systems (L5781/L5782) with criteria. Draft through June 15, 2020.

Medical Policy Group, July 2021 (6): Updates to Policy section socket coding, Key Points and Key Words. No change to policy intent.

Medical Policy Group, September 2021 (6): Coding update 10/1/21, Policy statement clarification to include non-coverage for convenience additions, added code K1022. Key Words updated (rotation adapter, ottobock 4R57).

Medical Policy Group, July 2022 (6): Updates to Description, Key Points and References. No change to policy intent.

Medical Policy Group, July 2023 (6): Updates to Description, Key Points, Practice Guidelines, USPSTF and References.

Medical Policy Group, December 2023: 2024 Annual HCPCS Coding Update. Added L5926. K1022 deleted and moved to Previous Coding.

Medical Policy Group, July 2024 (6): Updates to Key Points, Practice Guidelines and References.

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

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

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

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

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

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

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

3. The technology must improve the net health outcome;

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

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

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

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

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

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

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