Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Microprocessor-Controlled Prostheses for Lower-Extremity Amputees

Policy #:11.14.21g

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract. State mandates do not automatically apply to self-funded groups; therefore, individual group benefits must be verified.

MEDICALLY NECESSARY

MICROPROCESSOR-CONTROLLED PROSTHETIC KNEES
The microprocessor-controlled prosthetic knee system is considered medically necessary and, therefore, covered as a component fitting in a lower-limb prosthesis for individuals who meet all of the following criteria:
  • The individual is motivated to ambulate.
  • The individual has high mobility and stance stability needs and is at a functional level of 3 or 4 according to Medicare's classification scale of patient potential functional ability as described below:
    • Level 0: Does not have the ability or potential to ambulate or transfer safely with or without assistance, and a prosthesis does not enhance their quality of life or mobility. (Level K0)
    • Level 1: Has the ability or potential to use a prosthesis for transfers or ambulation on level surfaces at fixed cadence. Typical of the limited and unlimited household ambulator. (Level K1)
    • Level 2: Has the ability or potential for prosthetic ambulation with the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces. Typical of the limited community ambulator. (Level K2)
    • Level 3: Has the ability or potential for prosthetic 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 K3)
    • 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 demand of the child, active adult, or athlete. (Level K4)

NOT MEDICALLY NECESSARY

All other uses for a microprocessor-controlled prosthetic knee not meeting the above criteria are considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support their use in the treatment of illness or injury.

EXPERIMENTAL/INVESTIGATIONAL

POWERED AND PROGRAMMABLE FLEXION/EXTENSION ASSIST-CONTROL PROSTHETIC KNEES
A powered and programmable flexion/extension assist-control prosthetic knee is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

MICROPROCESSOR-CONTROLLED PROSTHETIC ANKLE-FOOT SYSTEMS
The microprocessor-controlled prosthetic ankle-foot system is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this device has not been established by review of the available published peer-reviewed literature.

POWER-ASSIST ANKLE-FOOT PROSTHETIC SYSTEMS
The power-assist ankle-foot prosthetic system is considered experimental/investigational, and, therefore, not covered because the safety and/or effectiveness of this device has not been established by review of the available published peer-reviewed literature.

NEW JERSEY MEMBERS

In accordance with the State of New Jersey's orthotic and prosthetic appliances mandate, members who are enrolled in New Jersey products may obtain a microprocessor-controlled prosthetic knee, powered and programmable flexion/extension assist-control prosthetic knee, or microprocessor-controlled ankle-foot system, and power-assist ankle-foot prosthetic system from any licensed orthotist or prosthetist or certified pedorthotist, as determined medically necessary by the covered member's physician.

REPAIR AND REPLACEMENT

For information on the repair and/or replacement of prostheses, refer to the Company's policy on the repair and replacement of external prosthetic devices.

The repair or replacement of a microprocessor-controlled prosthetic knee, a powered and programmable flexion/extension assist-control knee prosthesis, or one or more of its components (parts) is considered noncovered and not eligible for reimbursement when the request is for a technologically advanced or newly released upgrade to an original device that still functions properly and/or there is no significant change in the individual's condition.

Requests for a different type of a microprocessor-controlled prosthetic knee, a powered and programmable flexion/extension assist-control knee prosthesis, or one or more of its components (parts) due to a change in medical and/or functional status, such that the prosthesis can no longer meet the individual’s needs for control, durability (maintenance), function (speed, work capability), and usability are considered new requests, not requests for replacement. These requests are evaluated against the medical necessity criteria for the new type of prosthesis requested.

The Company may determine the reasonable useful lifetime of a specific external prosthetic device based on the manufacturer's recommendation or the Food and Drug Administration (FDA)--approved labeling.

In the absence of manufacturer's recommendations or FDA labeling, the Company may determine the reasonable useful lifetime of a specific external prosthetic device, but is generally not less than five years. Replacement due to misuse, abuse, or failure to adequately maintain or care for the item is excluded from coverage.

REQUIRED DOCUMENTATION

Reimbursement for devices will be made only if there is sufficient documentation in the individual's medical record showing current functional capabilities and functional need for the technological or design features. Documentation should also include expected functional potential and an explanation if there is a difference between the individual's current status and expected potential. This information must be retained in the professional provider's or prosthetist's files, and be available upon request.

Documentation should also include identification and compliance with all the qualifications for utilization of a microprocessor-controlled prosthetic knee listed in this policy, which conform with the recommendations of the Veterans Health Administration Prosthetic Clinical Management Program Clinical Practice Recommendations for Microprocessor Knees (2000).

The prosthetist must retain documentation in the medical record of the prosthesis or prosthetic component replaced, the reason for replacement, and a description of the labor involved. It is recognized that there are situations where the reason for replacement includes but is 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 highly mobile amputees.

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports.

PRESCRIPTION (ORDER) REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective order at the time of an audit or after an audit for submission as an original order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY
Medical record documentation must include a contemporaneously prepared delivery confirmation or member’s receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES
The durable medical equipment (DME) supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately seven days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual’s medical record. Delivery of the supplies should not be done earlier than approximately five days before the individual would exhaust their on-hand supply.

If required documentation is not available on file to support a claim at the time of an audit or record request, the durable medical equipment (DME) supplier may be required to reimburse the Company for overpayments.

BILLING REQUIREMENTS

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

There are specific HCPCS codes that describe microprocessor-controlled knee prostheses. Reimbursement for additional features, functions, or components of a microprocessor-controlled knee prosthesis are included in the allowance of the existing specific HCPCS codes described in this policy.
Guidelines

A microprocessor-controlled prosthesis is prescribed with the goal of enabling an individual with a lower-limb amputation to return to, and engage in, their activities of daily living. This entails the procurement of a prosthetic device that is appropriate for their individual level of activity, ability, and weight.

Qualifications for utilization of microprocessor-controlled prosthetic knees should include all of the following:
  • The individual is an active walker (e.g., more than three miles per day) and requires a device that reduces energy consumption to permit longer distances with less fatigue.
  • The individual requires a prosthesis that can accommodate sudden changes in direction and speed for work or home activities, with the potential or ability for improved gait quality and speed (e.g., faster than three miles per hour).
  • The individual participates in daily activities or job tasks that do not permit full attention on knee control and stability (e.g., repetitive lifting and/or carrying, frequent negotiation of uneven terrain, ramps, curbs, and stairs).
  • The prosthesis should not be initially prescribed or utilized primarily for athletic purposes.
  • The individual has adequate cognitive ability to master the technology and gait requirements of the prosthesis.
  • The individual has adequate cardiovascular and pulmonary reserve to ambulate at variable cadence while using the prosthesis.
  • The individual does not have a documented comorbid condition that would interfere with maintaining functional level 3 or 4 (e.g., peripheral vascular, neuromuscular, or musculoskeletal [other than amputation]).
  • The individual has adequate strength, balance, and stride to activate the knee unit.
  • The individual does not exceed the weight or height restrictions of the device.
  • Use of the prosthesis gives the individual the potential to return to an active lifestyle.
  • Individuals with a hemipelvectomy through knee disarticulation level of amputation, including bilateral lower-extremity amputees, are candidates if they meet the functional medically necessary criteria.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, a microprocessor-controlled prosthetic knee is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

However, devices that are identified in this policy as experimental/investigational are not eligible for coverage or reimbursement by the Company.

NEW JERSEY MEMBERS
Subject to the terms and conditions of the applicable benefit contract, a microprocessor-controlled prosthetic knee, a powered and programmable flexion/extension assist-control knee prosthesis, a microprocessor-controlled ankle-foot system, and a power-assist ankle-foot prosthetic system are covered in accordance with the State of New Jersey's orthotic and prosthetic appliances mandate, for members who are enrolled in New Jersey products.

REPAIR OR REPLACEMENT
Coverage of the repair or replacement of prosthetic devices and associated supplies and components (parts) may vary by product and/or group contract. Therefore, individual member benefits must be verified.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous devices approved by the FDA for use as microprocessor-controlled knee prosthetic.

The only microprocessor-controlled ankle-foot prosthesis that is commercially available at this time is the Proprio Foot® by Ossur. This is a class I device that is exempt from 510(k) marketing clearance and has been registered with the restorative devices branch of the FDA.

MANDATES

This policy is consistent with applicable state mandates. The laws of the state in which the group benefit contract is issued determine the applicable, legislatively mandated coverage.

The State of New Jersey mandates coverage of prostheses for individuals enrolled in New Jersey commercial products when such items are determined to be medically necessary by the individual's physician. This mandate is effective for all newly issued contracts and contracts renewed on or after April 11, 2008.

Description

Following a lower-limb amputation and after the appropriate healing of the surgical site, an individual may consider the use of a prosthetic leg to begin rehabilitation efforts in learning to ambulate. There are many different component types of a prosthetic limb, with more than 100 different prosthetic knee devices currently available on the market, and still other devices are under investigation.

MICROPROCESSOR-CONTROLLED PROSTHETIC KNEES

Multiple prosthetic devices are available that use varying degrees of computer technology to enhance basic mechanical knee designs. Recently, prosthetic devices with a microprocessor-controlled knee have become available, including the C-Leg® and Genium™ Bionic Prosthetic System (Otto Bock Orthopedic Industry, Minneapolis, MN), the Intelligent Prosthesis (IP) (Blatchford & Sons, UK), the Rheo Knee ® (Ossur, Iceland), and Seattle Powered Knees (3 models include Single Axis, 4-bar and Fusion, from Seattle Systems). These devices are equipped with a sensor that can detect when the knee is in full extension and automatically adjust the swing phase of the individual's gait, allowing for a more natural walking pattern at varying speeds. The C-Leg® is also designed to improve stance control. In addition, sensors may be able to detect a stumble and stiffen the knee to avoid a fall.

Hafner et al (2007) investigated the differences in function, performance, and preference between mechanical and microprocessor-controlled prosthetic knees for transfemoral amputees. Subjects were fully accustomed to a mechanical knee system (various types) and were required to show proficiency in ambulating on level ground, inclines, stairs, and uneven terrain prior to enrollment. Of the 17 subjects (81 percent) who completed the study, patient satisfaction was significantly better with the microprocessor-controlled prosthesis as measured by the Prosthesis Evaluation Questionnaire (PEQ). In addition, subjects reported fewer falls, reduced frustration with falls, and improved concentration on tasks other than knee control and stability while walking. Average performance on stair descent improved from a step-to pattern with a rail to a step-over-step pattern with a rail and assistive device. Also, the C-Leg® improved hill descent from requiring an assistive device to using a step-to pattern without an assistive device.

All lower-limb amputees returning from Operation Iraqi Freedom and Operation Enduring Freedom currently receive a C-Leg® from the Department of Veterans Affairs (VA). Subjective assessment revealed a perceived reduction in attention to walking while performing the cognitive test (effect size of 0.79) and a reduction in cognitive burden with the microprocessor-controlled prosthesis (effect size of 0.90). Seven of the eight subjects preferred to keep the microprocessor-controlled prosthesis at the end of the study. The authors noted that without any prompting, all of the subjects had mentioned that stumble recovery was their favorite feature of the C-Leg®.

Although it is similar to the C-Leg®, the Intelligent Prosthesis (IP) is not currently distributed in the United States. One study (Kirker, et al) reported on the gait symmetry, energy expenditure, and the subjective impression of the IP with 16 subjects who presented with an above-the-knee (AK) amputation related to trauma or congenital anomaly. These individuals had been functioning adequately with a pneumatic swing phase control unit and were offered a trial of the IP. At the commencement of the study, they had been using the IP for between one and nine months. A questionnaire was provided to the individuals to rate how much effort was required to walk at slow, normal, and fast speeds on multiple surfaces (e.g., smooth level, outdoors or at work, up and down a slope, up and down the stairs). The individuals indicated an overall preference for the IP over the pneumatic swing phase unit. They reported that considerably less effort was required when using the IP to walk at normal or high speeds, but no difference was noted for a slow gait. Reduced effort was required when the IP was used outdoors or at work.

Literature researching microprocessor-controlled prosthetic knees indicates that selected individuals strongly prefer prosthetic knees that control both stance and swing, with perceived benefits such as a decrease in falls, an increase in stability, and a decrease in the cognitive burden or effort associated with monitoring the prosthesis. The VA short report states: “Users’ perceptions may be particularly important for evaluating a lower limb prosthesis, given the magnitude of the loss involved. A difference between prostheses sufficient to be perceived as distinctly positive to the amputee may represent the difference between coping and a level of function recognizably closer to the preamputation level.”

Microprocessor-controlled prosthetic knees may provide incremental benefits for individuals who meet the need for the technological or design features of the device. Individuals who are considered most likely to benefit from this prosthesis have both the potential and the need for frequent ambulation at variable cadence, frequent negotiation of uneven terrain, and/or recurrent usage of stairs. The potential to achieve a high functional level with a microprocessor-controlled prosthetic knee requires the appropriate physical and cognitive abilities to utilize the advanced technology.

POWERED AND PROGRAMMABLE FLEXION/EXTENSION ASSIST-CONTROL PROSTHETIC KNEES

In development are lower-limb prostheses that also replace muscle activity in order to bend and straighten the prosthetic joint. For example, according to the manufacturer, the Power Knee (Ossur Foothill Ranch, CA), is designed to replace muscle activity of the quadriceps. It is proposed that the Power Knee delivers active lifting power for stairs, resistance for downhill slopes and gentle propulsion for level ground walking. These devices use artificial proprioception with sensors similar to the Proprio Foot® (Ossur, Alsio Viejo, CA) in order to anticipate and respond with the appropriate movement required for the next step in time and space. The Power Knee is currently in the initial launch phase in the United States.

MICROPROCESSOR-CONTROLLED PROSTHETIC ANKLE-FOOT SYSTEMS

Microprocessor-controlled prosthetic ankle-foot systems for lower-extremity amputees are devices designed to adjust to environmental impediments such as uneven terrain, inclines, and stairs. The device usually consists of four parts; a power storing foot, a lithium battery and charger, a battery-powered prosthetic flexing ankle, and a microprocessor with Terrain Logic that controls both dorsiflexion and plantarflexion in response to changing landscape conditions. The Proprio Foot® (Ossur, Alsio Viejo, CA) is currently available for low- to moderate-impact use for transtibial amputees who are classified as Level K3 (ie, community ambulatory, with the ability or potential for ambulation with variable cadence). Available published peer-reviewed literature evaluating the use of microprocessor-controlled prosthetic ankle-foot systems is limited and consists mainly of pilot studies and case series involving small samples sizes (Fradet et al 2010, Alimsuaj et al 2009, Wolf et al 2009).

POWER-ASSIST ANKLE-FOOT PROSTHETIC SYSTEMS

Power-assist ankle-foot prosthetic systems replace muscle activity of the foot, Achilles tendon, and calf muscle in order to bend and straighten the prosthetic joint. For example, transtibial amputees use muscle activity from the remaining limb for the control of ankle movement. Power-assist ankle-foot prosthetic systems are designed to propel the foot forward as it pushes off the ground during the gait cycle, which is proposed to improve efficiency, and has the potential to reduce hip and back problems arising from an unnatural gait with use of passive prostheses. This power-assist technology may be limited by the size and the weight required for a motor and batteries in the prosthesis.

The limited evidence with small sample size in available published peer-reviewed literature does not support an improvement in functional outcomes with a power-assist ankle-foot prosthetic system compared to standard prostheses (Gates et al 2013, Aldridge et al 2013).
References


Alimusaj M, Fradet L, Braatz F, et al. Kinematics and kinetics with an adaptive ankle foot system during stair ambulation of transtibial amputees. Gait Posture. 2009;30(3):356-63.

Au S, Berniker M, Herr H. Powered ankle-foot prosthesis to assist level-ground and stair-descent gaits. Neural Netw. 2008; 21(4):654-666.

Bellmann M, Schmalz T, Ludwigs E et al. Immediate effects of a new microprocessor-controlled prosthetic knee joint: a comparative biomechanical evaluation. Arch Phys Med Rehabil. 2012; 93(3):541-549.

Buckley JG, Spence WD, Solomonidis SE. Energy cost of walking: Comparison of “intelligent prosthesis” with conventional mechanism. Arch Phys Med Rehabil. 1997;78(3):330-333.

Burnfield JM, Eberly VJ, Gronely JK, et al. Impact of stance phase microprocessor-controlled knee prosthesis on ramp negotiation and community walking function in K2 level transfemoral amputees. Prosthet Orthot Int. 2012;36(1):95-104.

Datta D, Heller B, Howitt J. A comparative evaluation of oxygen consumption and gait pattern in amputees using Intelligent Prostheses and conventionally damped knee swing-phase control. Clin Rehabil. 2005;19(4):398-403.

Datta D, Howitt J. Conventional versus microchip controlled pneumatic swing phase control for trans-femoral amputees: User’s verdict. Prosthet Orthot Int. 1998;22(2):129-135.

Darter BJ, Wilken JM. Energetic consequences of using a prosthesis with adaptive ankle motion during slope walking in persons with a transtibial amputation. Prosthet Orthot Int. Feb 2014;38(1):5-11.

Delussu AS, Brunelli S, Paradisi F, et al. Assessment of the effects of carbon fiber and bionic foot during overground and treadmill walking in transtibial amputees. Gait Posture. Sep 2013;38(4):876-882

Eberly VJ, Mulroy SJ, Gronley JK, et al. Impact of a stance phase microprocessor-controlled knee prosthesis on level walking in lower functioning individuals with a transfemoral amputation. Prosthet Orthot Int. Dec 2014; 38(6):447-455.

Ferris AE, Aldridge JM, Rabago CA et al. Evaluation of a powered ankle-foot prosthetic system during walking. Arch Phys Med Rehabil. 2012; 93(11):1911-1918.

Fradet L, Alimusaj M, Braatz F, et al. Biomechanical analysis of ramp ambulation of transtibial amputees with an adaptive ankle foot system. Gait Posture. 2010;32(2):191-198.

Gailey RS, Gaunaurd I, Agrawal V et al. Application of self-report and performance-based outcome measures to determine functional differences between four categories of prosthetic feet. J Rehabil Res Dev. 2012; 49(4):597-612.

Gates DH, Aldridge JM, Wilken JM. Kinematic comparison of walking on uneven ground using powered and unpowered prostheses. Clin Biomech.2013;28(4):467-472.

Hafner BJ, Smith DG. Differences in function and safety between Medicare Functional Classification Level-2 and -3 transfemoral amputees and influence of prosthetic knee joint control. J Rehabil Res Dev. 2009;46(3):417-433.

Hafner BJ, Willingham LL, Buell NC, et al. Evaluation of function, performance, and preference as transfemoral amputees transition from mechanical to microprocessor control of the prosthetic knee. Arch Phys Med Rehabil. 2007;88(2):207-217.

Herr HM, Grabowski AM. Bionic ankle-foot prosthesis normalizes walking gait for persons with leg amputation. Proc Biol Sci. 2012; 279(1728):457-464.

Highsmith MJ, Kahle JT, Bongiorni DR, et al. Safety, energy efficiency, and cost efficacy of the C-Leg for transfemoral amputees: A review of the literature. Prosthet Orthot Int. 2010;34(4):362-377.

Highsmith MJ, Kahle JT, Miro RM et al. Ramp descent performance with the C-Leg and interrater reliability of the Hill Assessment Index. Prosthet Orthot Int. 2013 [Epub ahead of print].

Hofstad C, Linde H, Limbeek J, et al. Prescription of prosthetic ankle-foot mechanisms after lower limb amputation. Cochrane Database Syst Rev. 2004;(1):CD003978.

Johansson JL, Sherrill DM, Riley PO, et al. A clinical comparison of variable-damping and mechanically passive prosthetic knee devices. Am J Phys Med Rehabil. 2005;84(8):563-575.

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. Available at: http://www.rehab.research.va.gov/jour/2014/5110/jrrd-2014-05-0118.html. Accessed November 6, 2018.

Kaufman KR, Levine JA, Brey RH, et al. Energy expenditure and activity of transfemoral amputees using mechanical and microprocessor-controlled prosthetic knees. Arch Phys Med Rehabil. 2008;89(7):1380-5.

Kaufman KR, Levine JA, Brey RH, et al. Gait and balance of transfemoral amputees using passive mechanical and microprocessor-controlled prosthetic knees. Gait Posture. 2007; 26(4):489-93.

Kirker S, Keymer S, Talbot J, et al. An assessment of the intelligent knee prosthesis. Clin Rehabil.1996;10(3):267-273.

Klute GK, Berge JS, Orendurff MS, et al. Prosthetic intervention effects on activity of lower-extremity amputees. Arch Phys Med Rehabil. 2006;87(5):717-722.

Mancinelli C, Patritti BL, Tropea P, et al. Comparing a passive-elastic and a powered prosthesis in transtibial amputees. Conf Proc IEEE Eng Med Biol Soc. 2011; 2011:8255-8.

New Jersey (NJ) Legislature. P.L. 2007, Chapter 345. Senate No. 502. Requires health benefits coverage by health insurers and SHBP for orthotic and prosthetic appliances and provides reimbursement. [NJ State Legislature Web site]. 01/13/08. (N.J.S.A. 17:48E-35.30, effective April 11, 2008) Available at: http://www.njleg.state.nj.us/2006/Bills/PL07/345_.PDF. Accessed November 6, 2018.

Noridian. Local Coverage Determination (LCA). A52946: Lower limb prostheses. [Noridian website]. Original 10/01/2015. (Revised 01/01/2018). Available at: https://med.noridianmedicare.com/documents/2230703/7218263/Lower+Limb+Prostheses+LCD+and+PA/d3244c51-74d3-4214-a789-7481bc2e03d5. Accessed November 6, 2018.

Noridian. Local Coverage Determination (LCD). L33787: Lower limb prostheses. [Noridian website]. Original 10/01/2015. (Revised 11/01/2018). Available at: https://med.noridianmedicare.com/documents/2230703/7218263/Lower+Limb+Prostheses+LCD+and+PA/d3244c51-74d3-4214-a789-7481bc2e03d5. Accessed November 6, 2018.

Orendurff MS, Segal AD, Klute GK, et al. Gait efficiency using the C-Leg. J Rehabil Res Dev. 2006;43(2):239-246.

Prinsen EC, Nederhand MJ, Olsman J, et al. Influence of a user-adaptive prosthetic knee on quality of life, balance confidence, and measures of mobility: a randomised cross-over trial. Clin Rehabil. Oct 6 2014.

Seymour R, Engbretson B, Kott K, et al. Comparison between the C-leg microprocessor-controlled prosthetic knee and non-microprocessor control prosthetic knees: A preliminary study of energy expenditure, obstacle course performance, and quality of life survey. Prosthet Orthot Int. 2007;31(1):51-61.

Swanson E, Stube J, Edman P. Function and body image levels in individuals with transfemoral amputations using the C-Leg. J Prosthet Orthot. 2005;17(3): 80-84.

Taylor MB, Clark E, Offord EA, Baxter C. A comparison of energy expenditure by a high level trans-femoral amputee using the Intelligent Prosthesis and conventionally damped prosthetic limbs. Prosthet Orthot Int.1996;20(2):116-121.

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;43(10):906-15.

Theeven PJ, Hemmen B, Geers RP et al. Influence of advanced prosthetic knee joints on perceived performance and everyday life activity level of low-functional persons with a transfemoral amputation or knee disarticulation. J Rehabil Med. 2012; 44(5):454-61.

US Department of Veterans Affairs, Veterans Health Administration. Office of Research and Development, Health Service Research and Development Service, Management Decision and Research Center, Technology Assessment Program. Computerized lower limb prosthesis. VA Technology Assessment Program Short Report No. 2. 2000. Available at: https://www.research.va.gov/resources/pubs/docs/ta_short_3_00.pdf. Accessed November 6, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. C-Leg® (3C100). 510(k) summary. [FDA Web site]. 07/08/99. Available at:
http://www.accessdata.fda.gov/cdrh_docs/pdf/k991590.pdf. Accessed November 6, 2018.

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. Accessed November 6, 2018.

Veterans Health Administration. Prosthetic clinical management program (PCMP). Clinical practice recommendations: Microprocessor knees. 2004. See: Berry D. Microprocessor prosthetic knees. Phys Med Rehabil Clin N Am. 2006; 17:91-113.

VHA Prosthetic Clinical Management Program (PCMP). Clinical practice recommendations: microprocessor knees, 2004. See: Berry D. Microprocessor prosthetic knees. Phys Med Rehabil Clin N A. 2006;17:91-113.

Williams RM, Turner AP, Orendurff M, et al. Does having a computerized prosthetic knee influence cognitive performance during amputee walking? Arch Phys Med Rehabil. 2006;87(7):989-994.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

N/A


HCPCS Level II Code Number(s)



MEDICALLY NECESSARY

THE FOLLOWING CODES ARE USED TO REPRESENT A MICROPROCESSOR-CONTROLLED PROSTHETIC KNEE:

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


EXPERIMENTAL/INVESTIGATIONAL

THE FOLLOWING CODE IS USED TO REPRESENT POWERED AND PROGRAMMABLE FLEXION/EXTENSION ASSIST CONTROL PROSTHETIC KNEE:

L5859 Addition to lower extremity prosthesis, endoskeletal knee-shin system, powered and programmable flexion/extension assist control, includes any type motor(s)

THE FOLLOWING CODE IS USED TO REPRESENT A POWER ASSIST ANKLE-FOOT PROSTHETIC SYSTEM:

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

THE FOLLOWING CODE IS USED TO REPRESENT A MICROPROCESSOR-CONTROLLED ANKLE-FOOT SYSTEM:

L5973 Endoskeletal ankle foot system, microprocessor controlled feature, dorsiflexion and/or plantar flexion control, includes power source




Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

11.14.21g:
01/14/2019This version of the policy will become effective 01/14/2019.

The intent of this policy has not changed. Billing requirements have been incorporated to clarify reimbursement for additional features, functions, or components of a microprocessor-controlled knee prosthesis.


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 01/14/2019
Version Issued Date: 01/14/2019
Version Reissued Date: N/A

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