Latest Review Date: August 2024                 

Category: Durable Medical Equipment (DME)

NOTE: Coverage may be subject to legislative mandates, including but not limited to the following, which applies prior to the policy statements:

• Minnesota Statute §62Q.665 Coverage for Orthotic and Prosthetic Devices
• Minnesota Statute §62Q.6651 Medical Necessity and Nondiscrimination Standards for Coverage of Prosthetics or Orthotics

POLICY:

Effective for dates of service January 6, 2025, and after:

I. Microprocessor-controlled Knee

The use of a microprocessor-controlled knee may be considered medically necessary for individuals with transfemoral or knee disarticulation amputation who meet ALL the following criteria:

• Demonstrated need for long distance ambulation greater than 400 cumulative yards at variable rates on a daily basis OR demonstrated need for regular ambulation on uneven terrain or for regular use on stairs.; AND
• Individual has a functional ambulation level of K3 or K4
  • Level K3: Has ability or potential for ambulation at 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 K4: Has ability or potential for prosthetic ambulation that exceeds basic ambulation skills such as those exhibiting high impact, stress, or energy levels typical of the prosthetic demands of an active adult or athlete; AND

• Meets requirements of the device specified by the manufacturer; AND
• Physical ability, including adequate cardiovascular and pulmonary reserve, for ambulation; AND
• Cognitive ability to understand gait sequencing, use and care requirements for the technology; AND
• Functional evaluation indicates that with training, use of a microprocessor-controlled knee is likely to meet the maximum functional mobility and/or physical activity needs of the individual (e.g., ADLs, running, biking, swimming). This evaluation should consider the individual’s needs for control, durability (maintenance), function (speed, work capability), and usability; AND
• Individual has demonstrated improved mobility or stability using a temporary microprocessor device, or when unable to complete such a trial, the prosthetics provider documents or attests that there is a reasonable likelihood of improved mobility or stability.

 II. Microprocessor Knee Prosthesis with Polycentric 3-D Hip Joint

The microprocessor knee prosthesis with polycentric 3-D hip joint system may be considered medically necessary for individuals who have sustained either a hip disarticulation amputation or hemipelvectomy when BOTH of the following are met:

• Meets all indications for a microprocessor-controlled knee prosthesis outlined in section I above; AND
• Currently utilizes a microprocessor-controlled knee or is being fitted for a microprocessor-controlled knee at the time of 3-D hip joint system fitting.

 III. Microprocessor-controlled Ankle/Foot

The microprocessor-controlled ankle/foot system may be considered medically necessary for individuals with transtibial or transfemoral amputation when ONE of the following criteria are met: with functional ambulation level of 3 or 4.

IV. Repair or Replacement

Repair of a microprocessor lower-limb prosthesis device and/or component may be considered  medically necessary when ALL of the following are met:*

• Individual meets medical necessity criteria for the current device; AND
• Repair required to make the prosthesis serviceable; AND
• Expenses for repairs do not exceed the estimated expense of purchasing another prosthesis; AND
• The component is not covered under warranty.

Replacement of a microprocessor lower-limb prosthesis device and/or component may be considered medically necessary when ALL of the following are met:*

• Individual meets medical necessity criteria for the current device; AND
• At least one of the following is met:
  • Change in the physiologic condition or functional level of the individual which necessitates replacement of the requested component(s); OR
  • There is an irreparable change in the condition of the component(s) that is not a result of misuse or neglect; AND

• The condition of the component(s) requires repairs which would exceed the estimated expense of purchasing a new prosthesis; AND
• The component is not covered under warranty.

V. Not Medically Necessary

Use of a microprocessor-controlled knee prosthesis with or without a polycentric 3-D hip joint system is considered not medically necessary for any of the following:

• Individual does not meet medical necessity criteria in Section I or II of the policy;
• Duplication (e.g., back-up prosthetic device) or upgrade of a functional prosthesis;
• Repair or replacement of parts for a duplicate microprocessor lower limb prosthesis;
• Repair or replacement of a microprocessor lower limb prosthesis for any of the following:
  • Appearance or convenience;
  • Malicious damage or neglect;
  • Use in environments that limit functional life of the device (e.g., excessive moisture, dust or other conditions not recommended by manufacturer).

VI. Experimental/ Investigative

The following are considered investigational due to the lack of clinical evidence demonstrating an impact on improved health outcomes:

• Use of a powered knee;
• Use of a powered ankle/foot;
• Use of an integrated/hybrid product with powered knee or powered ankle/foot;
• Use of a user-adjustable heel height feature.

Documentation Submission

Documentation supporting the medical necessity criteria described in the policy must be included in the prior authorization, when prior authorization is required. In addition, the following documentation must be submitted by the treating physician, or a prosthetist experienced in fitting microprocessor lower-limb prostheses, including the following: 

1.         Clinical notes confirming:

• The individual meets the requirements of the device specified by the manufacturer;
• Evidence of functional evaluation demonstrating the individual’s cognitive ability, strength, and balance to safely use the prosthesis;
• Functional ambulation level;
• Results of device trial including changes in mobility or stability; or evidence demonstrating the individual’s ability to adequately control and use the prosthetic device;

2.         If requesting repair or replacement, documentation of reason for repair and/or replacement.

Effective for dates of service prior to January 6, 2025:

A microprocessor-controlled knee may be considered medically necessary in individuals with transfemoral amputation, and ALL the following indications are met:

• Physical ability, including adequate cardiovascular and pulmonary reserve, for ambulation at faster than normal walking speed, with at least a potential Functional Level 3 or 4;
• The individual has the appropriate cognitive abilities to master use and care requirements for the technology;
• The individual does not have additional medical problems that would interfere with maintaining functional level 3 or 4: i.e., disabling cardiovascular, neuromuscular, peripheral vascular, or musculoskeletal (other than amputation) conditions.

A microprocessor-controlled knee is contraindicated when:

• Individual is historically non-ambulatory or has a potential functional level below 3.
• Individual has demonstrated a lack of proper care for existing equipment.
• Individual is not motivated.
• *Individual lives or works in a wet environment.

*Exception: Requested MPK has standard water-resistant features included in the base model.

No separate reimbursement is allowable for upgraded water-resistant features.

Coverage may be provided for one microprocessor-controlled knee per limb per five years when medically indicated. Coverage will not be provided if the prosthesis is functioning properly and in good general condition.

A high activity knee control frame (L5930) is only covered for individuals whose functional level is K4.

A powered knee is considered investigational.

A microprocessor-controlled or powered foot is considered investigational. 

A combination microprocessor-controlled powered foot and microprocessor-controlled knee prosthesis is considered investigational.

A combination microprocessor-controlled knee/ankle/foot (e.g., Linx) is considered investigational.

Additions or upgrades to the prosthetic for convenience, sports or recreational activities are considered not medically necessary.

Refer to Coding Section for guidelines regarding the Ottobock Genium® MPK

DESCRIPTION OF PROCEDURE OR SERVICE:

Microprocessor-controlled prostheses use feedback from sensors to adjust joint movement on a real-time as-needed basis. Active joint control is intended to improve safety and function, particularly for individuals who are able to maneuver on uneven terrain or with variable gait. Manufacturers must register prostheses with the restorative devices branch of the U.S. Food and Drug Administration (FDA) and keep a record of any complaints but are not required to undergo a full FDA review. 

Microprocessor-controlled Prosthetic Knees

Microprocessor-controlled prosthetic knees (MPKs) are equipped with sensors that detect when the knee is in full extension and adjusts the swing phase automatically, permitting a more natural walking pattern at varying speeds and preventing buckling while standing or shifting weight. The MPK is programmed by a prosthetist using a laptop computer and blue-tooth technology to allow the device to adjust to the pace of ambulation, shifting of weight, walking up or down inclines or stairs, rough or smooth surfaces. Available devices include but are not limited to the C-Leg®, C-Leg® Compact, the Genium™ Bionic Prosthetic System, Genium™ X2® and X3® devices (Otto Bock), the RheoKnee® (Ossur), the Smart IP (Endolite) and Intelligent Prosthesis (Blatchford Group).

Microprocessor Ankle-foot Prostheses

Microprocessor-controlled ankle-foot prostheses developed for individuals with transtibial amputation. Sensors in the feet determine the direction and speed of the foot’s movement, allowing the foot to lift during the swing phase and adjust to changes in force, speed and terrain during the step phase. The intent of the technology is to make ambulation more efficient and prevent falls. The Proprio Foot® (Ossur) and the élan foot (Endolite) are commercially available.

Microprocessor Knee Prosthesis with Polycentric 3-D Hip Joint System

A polycentric three-dimensional hip joint system, the Helix-3D Hip Joint (Otto Bock) is designed for use with the C-Leg® or Genium™ microprocessor knee. The prosthesis is based on a spring-hydraulic system designed to store energy generated during the stance phase of ambulation to be transferred to the swing phase, helping to compensate for lacking hip muscles and to reduce the amount of energy needed for walking. The system produces a three-dimensional hip movement to facilitate a symmetrical and natural gait.

Powered Prostheses

Lower-limb powered prostheses are in development. The Power Knee® (Ossur) is a myoelectric device designed to replace muscle activity of the quadriceps that also uses artificial proprioception with sensors to anticipate and respond with the appropriate movement required for the next step. The Power Foot Biom (developed at the Massachusetts Institute of Technology and licensed to iWalk) is a myoelectric prosthesis for individuals with transtibial amputation that uses muscle activity from the remaining limb for the control of ankle movement. This prosthesis is designed to propel the foot forward as it pushes off the ground during the gait cycle and may potentially reduce hip and back problems arising from an unnatural gait arising from use of a passive prosthesis.

Integrated/Hybrid Systems

Systems that combine microprocessor knees with enhanced ankle/foot prosthetics are commercially available. One is the LINX® limb system (Endolite). The system incorporates an integrated response system, using sensors and hydraulics to assist with balance, standing and sitting support. The SYMBIONIC® LEG 3 by Osssur is an integrated prosthesis that combines a microprocessor knee and powered microprocessor ankle.

Functional Ambulation Levels

The U.S. Centers for Medicare and Medicaid Services (CMS) has developed a classification system for rehabilitation of individuals with lower limb amputation based on ambulation potential. The five-level system includes the following classes:

• Level K0:  Lacks ability or potential to ambulate or transfer safely with or without assistance and a prosthesis does not enhance quality of life or mobility.
• Level K1:  Has 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 K2:  Has ability or potential to ambulate with the ability to traverse low level environmental barriers such as curbs, stairs, or uneven surfaces (typical of the limited community ambulator).
• Level K3:  Has ability or potential for ambulation at 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 K4:  Has ability or potential for prosthetic ambulation that exceeds basic ambulation skills such as those exhibiting high impact, stress, or energy levels typical of the prosthetic demands of a child, active adult, or athlete.

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

CURRENT CODING: 

HCPCS Codes:

POLICY HISTORY:

October 2021: Annual review completed. Updates to Key Points. Policy statement updated to remove “not medically necessary,” no change to policy intent. Added new code K1014 to Current Coding.

March 2022: Annual review completed. Updates to Policy statement, Description, Key Points, Practice Guidelines and References. No change to policy intent.

April 2023: Annual review completed. Updates to Key Points, Key Words, Benefit Application and References.

May 2023: Updates to Policy statement to include coverage of prosthetic with water-resistant features if included in base prosthetic. No separate reimbursement allowable.

December 2023: 2024 Annual HCPCS Coding Update. Added L5615, L5926. K1014 deleted and moved to Previous Coding section.

March 2024: Annual review completed. Updates to Description, Key Points and Practice Guidelines.

October 2024: Updated Key Words (Genium X4) and expanded coding example for L5999 in Current Coding.

November 2024. Annual review completed. Updates to Policy statement, Description, Key Points, Governing Bodies, Practice Guidelines, Current Coding and References.

On Draft 11/18/24-12/5/25.