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Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. 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.

09-L0000-06

Original Effective Date: 02/15/04

Reviewed: 04/26/12

Revised: 01/01/14

Subject: Lower Limb Microprocessor-Controlled Prosthetics

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
Other References Updates  

DESCRIPTION:

There are over 100 different prosthetic knee designs currently available. The choice of the most appropriate design depends on the patient’s underlying activity level, i.e., the requirements of a prosthetic knee in an elderly, largely homebound individual will be quite different than a younger, active individual.

In general, key elements of a prosthetic design involve providing stability during both the stance and swing phase of the gait. Prosthetic knees also vary in their ability to alter the pace of the gait, or the ability to walk on rough or uneven surfaces. In contrast to simpler designs that are designed to function optimally at one walking pace, fluid and hydraulic-controlled devices are designed to allow the amputee to vary their walking speed by matching the movement of the shin portion of the prosthesis to the movement of the upper leg. For example, the rate at which the knee flexes after “toe-off” and then extends before heel strike depends in part on the mechanical characteristics of the prosthetic knee joint. If the resistance to flexion and extension of the joint does not vary with gait speed, the prosthetic knee extends too quickly or too slowly relative to the heel strike if the cadence is altered. When properly controlled, hydraulic or pneumatic swing phase controls allow the amputee to set a pace from very slow to a race walking pace.

Hydraulic prostheses are heavier than other options and require gait training; therefore, these prostheses are generally prescribed to athletic or physically fit individuals. Other design features include multiple centers of rotation, referred to as “polycentric knees”. The mechanical complexity of these devices allows engineers to optimize selected stance and swing phase features.

Microprocessor controlled (computerized) prosthetic knees most recently becoming available, include the Intelligent Prosthesis (Blatchford, United Kingdom), the Adaptive (Endolite, England), the Rheo (Ossur, Iceland) and the C-LEG® (Otto Bock Orthopedic Industry, Minneapolis, MN). These devices are equipped with a sensor that detects when the knee is in full extension and adjusts the swing phase automatically, permitting a more natural walking pattern of varying speeds. For example, the prosthetist can specify several different optimal adjustments that the computer later selects and applies according to the pace of ambulation. The C-LEG is also designed to improve the stance control. For example, it may be possible for the sensors to recognize a stumble, stiffen the knee, and avoid a fall.

Microprocessor-controlled ankle-foot prostheses are being developed for transtibial amputees. These include the Proprio Foot® (Ossur) and the iPED (developed by Martin Bionics LLC and licensed to College Park Industries). 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 in patients ranging from the young active amputee to the elderly diabetic patient. The Proprio Foot® is the only microprocessor-controlled foot prosthesis that is commercially available at this time, and is a class I device that is exempt from 510(k) marketing clearance. The manufacturer must register the prosthesis with the restorative devices branch of the FDA and keep a record of any complaints, but does not have to undergo a full review.

POSITION STATEMENT:

A microprocessor-controlled knee meets the definition of medical necessity when ALL of the following criteria are met:

A microprocessor-controlled knee does not meet the definition of medical necessity when the above criteria are not met.

A powered knee (myoelectric lower limb prosthetic designed to replace muscle activity of the quadriceps and uses artificial proprioception with sensors) is considered experimental or investigational. There is insufficient published clinical evidence to support the efficacy of these prosthetic devices or their effects on health outcomes.

A microprocessor-controlled or powered ankle-foot is considered experimental or investigational. The available clinical evidence is insufficient to evaluate the health benefits of microprocessor-controlled ankle-foot prostheses.

BILLING/CODING INFORMATION:

HCPCS Coding:

L5856

Addition to lower extremity prosthesis, endoskeletal knee-shin system, microprocessor control feature, swing and stance phase, includes electronic sensor(s), any type

L5857

Addition to lower extremity prosthesis, endoskeletal knee-shin system, microprocessor control feature, swing phase only, includes electronic sensor(s), any type

L5858

Addition to lower extremity prosthesis, endoskeletal knee shin system, microprocessor control feature, stance phase only, includes electronic sensor(s), any type

L5859

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

L5969

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

L5973

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

LOINC Codes:

Documentation Table

LOINC Codes

LOINC
Time Frame
Modifier Code

LOINC Time Frame Modifier Codes Narrative

Physician history and physical

28626-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Attending physician progress note

18741-9

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Physician operative note

28573-4

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products:

The following Durable Medical Equipment Regional Carrier (DMERC) Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Lower Limb Prosthetics (L11442) located at cgsmedicare.com.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

None applicable.

OTHER:

Index terms:

Note: 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.

C-LEG
Intelligent Prosthesis
Microprocessor-controlled knee prosthesis
Otto Bock C-LEG Knee-Shin System

REFERENCES:

  1. Blue Cross Blue Shield Association Medical Policy Reference Manual 1.01.25, Microprocessor-Controlled Prosthetic Knees, (06/09/11).
  2. ECRI Hotline Response article: “Microprocessor-controlled Lower Extremity Prostheses”; last updated 08/21/06; updated 04/10/08.
  3. Kaufman KR, Levine JA, Brey RH, McCrady SK, Padgett DJ, Joyner MJ. Energy expenditure and activity of transfemoral amputees using mechanical and microprocessor-controlled prosthetic knees. Arch Phys Med Rehabil. 2008 Jul;89(7):1380-5.
  4. Martin CW, Senior Medical Advisor for the WCB Evidence Based Practice Group. Otto Bock C-leg: a review of its effectiveness for Special Care Services. WorkSafe Workers' Compensation Board of British Columbia. Compensation and Rehabilitation Services Division. 2003:30.
  5. Medicare Region C DMERC Local Coverage Determination (L11442) for Lower Limb Prosthetics (last revised 08/04/11).
  6. National Amputee Centre. The War Amps. Prosthetics Knees for Adults. Accessed 04/05/10.
  7. Orendurff MS, Segal AD, Klute GK, McDowell ML, Pecoraro JA, Czerniecki JM. Gait efficiency using the C-Leg. J Rehabil Res Dev. 2006; 43(2): 239-46. PubMed 16847790.
  8. Otto Bock Microprocessor Knees. Website accessed 02/28/12.
  9. Region C DMERC DMEPOS Supplier Manual; CERT Educational Sheet: Lower Limb Prostheses; Excerpt from Chapter 53 – Lower Limb Prostheses. Accessed 02/15/07.
  10. State of Washington Department of Labor and Industries, Office of the Medical Directory, Technology Assessment: Microprocessor-Controlled Prosthetic Knees. Last revised. 08/16/02.
  11. U.S. Food & Drug Administration approval notice for Otto Bock C-LEG device, 07/08/99.
  12. US Department of Veterans Affairs (VA). VA Technology Assessment Program. Short report – computerized lower limb prostheses. 03/00.
  13. United Stated Department of Veteran Affairs (VA) Website. Veteran Affairs/Department of Defense clinical practice guideline for rehabilitation of lower limb amputation. 2007. Accessed 02/27/12.
  14. United States Department of Veteran Affairs (VA) Website. VA center of excellence for limb loss prevention and prosthetic engineering. February 2011. Accessed 02/27/12.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 04/26/12.

GUIDELINE UPDATE INFORMATION:

02/15/04

New Medical Coverage Guideline.

03/15/05

Scheduled review; no change in coverage statement.

04/01/05

2nd quarter HCPCS coding update; added K0670.

01/01/06

Annual HCPCS coding update; added L5858, and removed K0670.

03/15/06

Scheduled review; no change in coverage statement.

05/15/07

Scheduled review; reformatted guideline; coverage position changed from investigational; added criteria for medical necessary.

05/15/08

Schedule review; no charge in position statement; references updated.

01/01/10

Annual HCPCS coding update: title change to include other lower limb microprocessor-controlled prosthetics; added new code L5973.

05/15/10

Scheduled review; position statement unchanged; descriptive information added for microprocessor-controlled ankle/foot prosthetics; references updated.

05/15/12

Scheduled review; position statement revised; Program Exception added for Medicare Advantage products; references updated.

01/01/13

Annual HCPCS coding update: added L5859.

01/01/14

Annual HCPCS coding update: added L5969. Updated Program Exceptions section.

Date Printed: October 20, 2017: 11:52 AM