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Date Printed: August 18, 2017: 08:02 PM

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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-L0000-08

Original Effective Date: 02/15/11

Reviewed: 06/27/13

Revised: 07/15/13

Subject: Stance-Control Orthoses

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   Previous Information

DESCRIPTION:

A stance-control orthosis (SCO) is an orthotic knee joint or custom-fabricated knee-ankle-foot orthosis (KAFO) that allows swing-phase knee flexion. The knee joint locks to provide stance phase stability when bearing weight. When unweighted, it unlocks to allow a swinging motion of the knee. The stance-control components allow the patient to swing the impaired limb with sufficient ground clearance to provide a more normal gait. While there are no specific patient criteria, it is intended for use in patients with lower extremity weakness and who demonstrate some control of hip muscles. Individuals who may benefit from this type of device typically have conditions such as polio, post-polio syndrome, spinal cord injuries, multiple sclerosis, stroke or trauma.

There are three classifications of SCOs with specific criteria for each type of SCO:

  1. Ankle driven SCO (examples: UTX, Full Stride, Safety Stride and Free Walk): requires ankle motion to lock and unlock the knee joint.
  2. Gait driven SCO (example: SPL): requires that the individual have the ability to reach full hip extension in stance and full knee extension in swing in order to unlock and lock the knee joint. If the individual does not have ankle motion, then a Gait Driven SCO is considered.
  3. Weight driven SCO (example: Horton SCOKJ): If the individual does not have the ability and control at both the hip and knee, then a Weight driven SCO is considered. Two of the three available Weight Driven SCOs lock the knee joint when weight is transferred on the foot plate and unlock the knee joint by a knee extension force at terminal stance. The third Weight driven SCO locks the knee joint when weight is transferred on the foot plate and unlocks the knee joint when no weight is on it, which provides stumble recovery.

Stance-control orthotic devices may be mechanical or electronic (i.e., myoelectric):

POSITION STATEMENT:

Stance-control orthoses (mechanical or electronic) do not meet the definition of medical necessity as there is insufficient clinical evidence published in the peer-reviewed literature that shows stance-control orthotic devices provide any significant benefit over standard knee-ankle-foot orthoses. Additionally, there are no long-term studies comparing one design to another or evaluating the degenerative changes in the contralateral limb and lower back with use of a standard device compared to use of a stance-control orthotic.

BILLING/CODING INFORMATION:

There is no specific code describing electronic stance-control orthoses. The following code describes mechanical stance-control orthoses.

HCPCS Coding:

L2005

Knee- ankle- foot orthosis (KAFO), any material, single or double upright, stance control, automatic lock and swing phase release, any type activation, includes ankle joint, any type, custom fabricated. (noncovered)

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: Ankle-Foot/Knee-Ankle-Foot Orthosis (L11517) located at cgsmedicare.com.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Orthotics, 09-L0000-03

OTHER:

Examples of stance-control orthoses:

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.

Becker E-Knee
E- Mag Active Knee Joint System
Fillauer Swing Phase Lock
Horton Stance Control Orthotic Knee Joint
Sensor Walk

REFERENCES:

  1. ClinicalTrials.gov. Efficacy of the WalkAide and AFOs for CVA. ClinicalTrials.gov Identifier: NCT00216320). (Accessed 12/15/10)
  2. ClinicalTrials.gov. WalkAide Compared to Ankle-Foot Orthosis (AFO) in Stroke Patients. ClinicalTrials.gov Identifier: NCT01087957. (Accessed 12/15/10)
  3. Davis PC, Bach TM, Pereira DM. The effect of stance control orthoses on gait characteristics and energy expenditure in knee-ankle-foot orthosis users. Prosthet Orthot mt. 2010 Jun;34(2):206-15.
  4. Irby SE, Bernhardt KA, Kauft,an KR. Gait changes over time in stance control orthosis users. Prosthet Orthot Int. 2007 Dec;31(4):353-61.
  5. Irby SE, Bernhardt KA, Kauft,an KR. Gait of stance control orthosis users: the dynamic knee brace system. Prosthet Orthot Int. 2005 Dec;29(3):269-82.
  6. Lemaire ED, Goudreau L, Yakimovich T, Koft,an J. Angular-velocity control approach for stance-control orthoses. IEEE Trans Neural Syst Rehabil Eng. 2009 Oct;1 7(5):497-503.
  7. Mayo Clinic Study. Biomechanics and Motion Analysis Laboratories. Application of stance control orthosis inpatients with inclusion body myositis. (Accessed 09/14/10).
  8. Medicare Durable Medical Equipment Regional Carrier (DMERC) Local Coverage Determination (LCD) for Ankle-Foot/Knee-Ankle-Foot Orthosis (L11517) (07/01/12).
  9. Yakimovich T, Lemaire ED, Kofman J. Engineering design review of stance-control knee-ankle-foot orthoses. J Rehabil Res Dev. 2009;46(2):257-67.
  10. Zacharias B, Kannenberg A. “Clinical Benefits of Stance Control Orthosis Systems: An Analysis of the Scientific Literature.” J Prosthet Orthot 2012 19(1):2.
  11. Zissimopoulos A, Fatone S, Gard SA. Biomechanical and energetic effects of a stance-control orthotic knee joint. J Rehabil Res Dev. 2007;44(4):503-513.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 06/27/13.

GUIDELINE UPDATE INFORMATION:

02/15/11

New Medical Coverage Guideline.

01/01/12

Annual HCPCS coding update: revised description for L2005.

04/15/12

Annual review; positions statement unchanged; references updated.

08/15/12

Accelerated review; description revised; position statement revised; Program Exception added; references updated.

07/15/13

Annual review; position statement unchanged; Program Exceptions section updated.

Date Printed: August 18, 2017: 08:02 PM