Clinical UM Guideline |
Subject: Lower Limb Prosthesis | |
Guideline #: CG-DME-13 | Publish Date: 10/01/2024 |
Status: Reviewed | Last Review Date: 08/08/2024 |
Description |
This document addresses the use of lower limb prostheses required to replace the function of a lower limb loss due to trauma, disease, or a congenital condition.
Note: For information addressing microprocessor-controlled leg or foot-ankle prosthesis please refer to:
Clinical Indications |
I. Lower Limb: Prosthesis Fitting and Selection
Medically Necessary:
A lower limb prosthesis is considered medically necessary when all the following are met and are documented in the medical record:
Not Medically Necessary:
A lower limb prosthesis is considered not medically necessary when the criteria above have not been met.
A lower limb prosthesis is considered not medically necessary for individuals with a functional level of 0.
Prosthetics utilized primarily for leisure or sporting activities are considered not medically necessary.
Test (diagnostic) sockets for immediate post-surgical or early fitting prostheses are considered not medically necessary.
More than two test (diagnostic) sockets for an individual prosthesis are considered not medically necessary without additional documentation of need.
More than two of the same socket inserts are considered not medically necessary per individual prosthesis at the same time.
II. Lower Limb: Accessories, Maintenance, Repairs and Replacement
Medically Necessary:
Accessories (for example, stump stocking for the residual limb, harness, etc.) are considered medically necessary when these appliances aid in, or are essential to, the effective use of the artificial limb.
Repairs to a prosthesis are considered medically necessary when necessary to make the prosthesis functional.
Maintenance that may be necessitated by manufacturer’s recommendations or the construction of the prosthesis and must be performed by the prosthetist is considered medically necessary as a repair.
Adjustments to a prosthesis required by wear and tear or change in an individual’s condition are considered medically necessary.
Replacement of a prosthesis or prosthetic component is considered medically necessary if the treating physician orders a replacement device or part because of either of the following:
Not Medically Necessary:
Prosthetic accessories, additions, or components used primarily for leisure or sporting activities are considered not medically necessary under all conditions.
Coding |
The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
Prostheses
When services may be Medically Necessary when criteria are met:
HCPCS |
|
L5000-L5020 | Partial foot prostheses [includes codes L5000, L5010, L5020] |
L5050-L5060 | Ankle prostheses [includes codes L5050, L5060] |
L5100-L5105 | Below knee prostheses [includes codes L5100, L5105] |
L5150-L5160 | Knee disarticulation (or through knee) prostheses [includes codes L5150, L5160] |
L5200-L5230 | Above knee prostheses [includes codes L5200, L5210, L5220, L5230] |
L5250-L5270 | Hip disarticulation prostheses [includes codes L5250, L5270] |
L5280 | Hemipelvectomy, Canadian type: molded socket, hip joint, single axis constant friction knee, shin, SACH foot |
L5301 | Below knee, molded socket, shin, each 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-L5460 | Immediate post surgical or early fitting prostheses [includes codes L5400, L5410, L5420, L5430, L5450, L5460] |
L5500-L5505 | Initial prostheses [includes codes L5500, L5505] |
L5510-L5600 | Preparatory prostheses [includes codes L5510, L5520, L5530, L5535, L5540, L5560, L5570, L5580, L5585, L5590, L5595, L5600] |
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ICD-10 Diagnosis |
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| All diagnoses |
When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met or for situations designated in the Clinical Indications section as not medically necessary.
Additions/Repair/Accessories
When services may be Medically Necessary when criteria are met:
HCPCS |
|
L5610-L5617 | Additions to lower extremity prostheses [includes codes L5610, L5611, L5613, L5614, L5616, L5617] |
L5618-L5628 | Additions to lower extremity prostheses, test sockets [includes codes L5618, L5620, L5622, L5624, L5626, L5628] |
L5629-L5653 | Additions to lower extremity prostheses, socket variations [includes codes L5629, L5630, L5631, L5632, L5634, L5636, L5637, L5638, L5639, L5640, L5642, L5643, L5644, L5645, L5646, L5647, L5648, L5649, L5650, L5651, L5652, L5653] |
L5654-L5699 | Additions to lower extremity prostheses, socket inserts and suspension [includes codes L5654, L5655, L5656, L5658, L5661, L5665, L5666, L5668, L5670, L5671, L5672, L5673, L5676, L5677, L5678, L5679, L5680, L5681, L5682, L5683, L5684, L5685, L5686, L5688, L5690, L5692, L5694, L5695, L5696, L5697, L5698, L5699] |
L5700-L5703 | Replacement sockets for lower extremity prostheses [includes codes L5700, L5701, L5702, L5703] |
L5704-L5707 | Custom shaped protective covers [includes codes L5704, L5705, L5706, L5707] |
L5710-L5780 | Additions to lower extremity prostheses, exoskeletal knee-shin system [includes codes L5710, L5711, L5712, L5714, L5716, L5718, L5722, L5724, L5726, L5728, L5780] |
L5781-L5782 | Addition to lower limb prosthesis, vacuum pump, residual limb volume management and moisture evacuation system [includes codes L5781. L5782] |
L5783 | Addition to lower extremity, user adjustable, mechanical, residual limb volume management system |
L5785-L5795 | Addition, exoskeletal system, ultra-light material [includes codes L5785, L5790, L5795] |
L5810-L5848 | Additions to lower extremity prostheses, endoskeletal knee-shin system [includes codes L5810, L5811, L5812, L5814, L5816, L5818, L5822, L5824, L5826, L5828, L5830, L5840, L5841, L5845, L5848] |
L5850 | Addition, endoskeletal system, above knee or hip disarticulation |
L5855 | Addition, endoskeletal system, hip disarticulation |
L5910-L5966 | Additions to lower extremity prostheses, endoskeletal system [includes codes L5910, L5920, L5925, L5926, L5930, L5940, L5950, L5960, L5961, L5962, L5964, L5966] |
L5968-L5990 | Additions to lower extremity prostheses, ankle and/or foot [includes codes L5968, L5970, L5971, L5972, L5974, L5975, L5976, L5978, L5979, L5980, L5981, L5982, L5984, L5985, L5986, L5987, L5988, L5990] |
L5999 | Addition to lower extremity prosthesis, not otherwise specified |
L7510-L7520 | Repair of prosthetic device [includes codes L7510, L7520] |
L8400-L8410 | Prosthetic sheath [includes codes L8400, L8410] |
L8417 | Prosthetic sheath/sock, including a gel cushion layer, below knee or above knee |
L8420-L8430 | Prosthetic sock, multiple ply [includes codes L8420, L8430] |
L8440-L8460 | Prosthetic shrinker [includes codes L8440, L8460] |
L8470-L8480 | Prosthetic sock, single ply [includes codes L8470, L8480] |
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|
ICD-10 Diagnosis |
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| All diagnoses |
Discussion/General Information |
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.
Potential functional ability is based upon many factors, including but not limited to:
Functional Levels, also known as ‘K Levels’, are used to guide the appropriateness of lower limb prosthesis (Balk, 2018). Please note that within the functional classification hierarchy, bilateral amputees often cannot be strictly bound by functional level classifications.
Level 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.
Level 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.
Level 2: Has the ability or potential for ambulation with the ability to traverse low-level environmental barriers such as curbs, stairs or uneven surfaces. Typical of the limited community ambulator.
Level 3: Has the ability or potential for ambulation with variable cadence. Typical of the community ambulator who has the ability to traverse most environmental barriers and may have vocational, therapeutic, or exercise activity that demands prosthetic utilization beyond simple locomotion.
Level 4: Has the ability or potential for prosthetic ambulation that exceeds basic ambulation skills, exhibiting high impact, stress, or energy levels. Typical of the prosthetic demands of the child, active adult, or athlete.
Hofstad and colleagues (2004) published a systematic review evaluating prosthetic ankle-foot mechanisms and the impact of daily functioning of individuals with lower limb amputation. A total of 26 studies were included, with a total of 245 individuals. The data indicated there may be a slight advantage in stride length and energy cost for individuals with transfemoral amputation utilizing the Flex-foot on level walking ground. However, the authors concluded that overall, there is insufficient evidence to conclude that one prosthetic design is superior to another, such as the Flex-foot versus the SACH (solid ankle, cushioned heel) foot.
Balk and colleagues (2018) published the results of a comparative effectiveness review of lower limb prostheses and what factors best determine the prosthetic configuration that is optimal for an individual with an amputation. The authors reviewed assessment techniques, prediction tools, and functional outcome measurement tools through 80 eligible studies with a focus on tools that are generalizable to the Medicare population. For all outcomes evaluated, the authors concluded that there is low or insufficient evidence. The studies that were available had methodological limitations, inconsistent findings, and few studies reported outcomes of interest. There is insufficient evidence to predict success and added benefit from a specific prosthesis, including components and configuration, for subgroups of amputees. Furthermore, no assessment instruments have been identified that reliably predict individual success based on prosthesis configuration.
In 2017 the Veteran’s Affairs and Department of Defense (VA/DoD) published their clinical practice guideline for rehabilitation of individuals with lower limb amputation. This document provides guidance on prosthesis selection and states the following:
There are inconclusive studies regarding differences in socket design, prosthetic foot categories, as well as advantages and disadvantages of various types of suspensions and interfaces. Each component of a prosthetic prescription should be carefully selected based on the capabilities and anticipated compliance of the user as well as the integrity and shape of the residual limb. Patient desired outcomes, patient goals, and the compatibility of the entire prosthetic system should also be a consideration when prescribing prosthetic components
Additionally, they recommend full consideration of the individual’s health status when relevant to prosthetic use outcomes:
8. We recommend an assessment of factors that are associated with poorer outcomes following acquired limb loss, such as smoking, comorbid injuries or illnesses, psychosocial functioning, and pain.
Some prosthetics and prosthetic accessories are designed specifically for use during leisure or sporting activities such as running, biking, or swimming. Such devices provide functionality above what may be considered necessary for routine daily activities for an individual or may be beyond what may be considered clinically appropriate for an individual. The use of a prosthetic device designed and intended specifically for use during leisure or sporting activities does not primarily serve a medical purpose. That use is thus considered not medically necessary.
Overall, the available evidence for the selection of prosthetic devices is poor, and the available recommendations emphasize a holistic approach taking multiple factors into consideration, including the individual’s health and functional status, as well as potential functional abilities and use.
References |
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
Index |
Lower Leg
Prosthesis
SACH Foot
The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.
History |
Status | Date | Action |
Reviewed | 08/08/2024 | Medical Policy & Technology Assessment Committee (MPTAC) review. Revised References section. Revised Coding section, added L5783, L5841. |
| 12/28/2023 | Updated Coding section with 01/01/2024 HCPCS changes, added L5926 replacing K1022 deleted as of 01/01/2024. |
Reviewed | 08/10/2023 | MPTAC review. Revised Background and References sections. |
Revised | 08/11/2022 | MPTAC review. Added new NMN statements addressing prosthetics utilized primarily for leisure or sporting activities. Updated Discussion and References sections. |
Revised | 11/11/2021 | MPTAC review. Moved Functional Level information from Clinical Indications section to Discussion section. Updated Discussion/General Information and References sections. |
| 10/01/2021 | Updated Coding section with 10/01/2021 HCPCS changes; added K1022. |
Reviewed | 11/05/2020 | MPTAC review. Updated Discussion/General Information and References sections. Reformatted Coding section. |
Reviewed | 11/07/2019 | MPTAC review. |
Reviewed | 01/24/2019 | MPTAC review. |
Reviewed | 02/27/2018 | MPTAC review. The document header wording updated from “Current Effective Date” to “Publish Date.” |
Revised | 02/02/2017 | MPTAC review. Revised Replacement criteria in Clinical Indications section. |
Reviewed | 11/03/2016 | MPTAC review. Updated formatting in Clinical Indications section. Updated references section. |
Revised | 11/05/2015 | MPTAC review. Minor clarifications made to Clinical Indications section. Removed ICD-9 codes from Coding section. |
Reviewed | 11/13/2014 | MPTAC review. |
Reviewed | 11/14/2013 | MPTAC review. |
Reviewed | 11/08/2012 | MPTAC review. Updated References section. Updated coding section with 01/01/2012 HCPCS changes; removed code L7500 deleted 12/31/2011. |
Reviewed | 11/17/2011 | MPTAC review. Updated Coding section with 01/01/2012 HCPCS changes; removed code L5311 deleted 12/31/2011. |
Reviewed | 11/18/2010 | MPTAC review. Updated Coding section with 01/01/2011 HCPCS changes. |
Reviewed | 11/19/2009 | MPTAC review. |
Reviewed | 11/20/2008 | MPTAC review. |
Reviewed | 11/29/2007 | MPTAC review. |
Reviewed | 12/07/2006 | MPTAC review. |
New | 12/01/2005 | MPTAC initial guideline development. |
Pre-Merger Organizations | Last Review Date | Policy/Guideline Number | Title |
Anthem Connecticut | 09/01/2004 |
| CT DME Coverage Guidelines, Section G: Prostheses: Upper and Lower Limb |
Anthem West | 10/29/2004 | DME.706 | West Region: Lower Limb Prostheses |
Anthem MidWest | 11/05/2004 | DME-005 | Midwest Region: Lower Limb Prosthesis |
WellPoint Health Networks, Inc. |
| None |
|
Federal and State law, as well as contract language including definitions and specific coverage provisions/exclusions, and Medical Policy take precedence over Clinical UM Guidelines and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Clinical UM Guidelines, which address medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Clinical UM Guidelines periodically. Clinical UM guidelines are used when the plan performs utilization review for the subject. Due to variances in utilization patterns, each plan may choose whether or not to adopt a particular Clinical UM Guideline. To determine if review is required for this Clinical UM Guideline, please contact the customer service number on the back of the member's card.
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