CG-OR-PR-03 Custom-made Knee Braces

This document addresses the intended use of custom-made (that is, custom fabricated, custom molded) functional and unloader knee braces. This document does not address custom-fitted, prefabricated knee braces.

Note: Please refer to the following document for additional information concerning knee braces:

Custom-made (custom molded, custom fabricated) knee braces, functional or unloader, are considered not medically necessary when the above criteria are not met.

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.

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met.

*Note: The code L1844 may be used either for a medically necessary custom-made unloader knee brace (only considered medically necessary in members with osteoarthritis) or it may be used to describe either a non-covered custom-made functional or rehabilitation (used in a postoperative setting) knee brace.

Knee braces can be subdivided into four categories based on their intended use: prophylactic braces, rehabilitation braces, functional braces, and unloader knee braces. One category of braces, unloader knee braces, is specifically designed to provide pain relief in arthritic knees. Unloader knee braces, also referred to as off-loader knee braces, are typically custom-made (custom fabricated, custom molded) and are considered for individuals who are unable to be fitted with a prefabricated (off-the-shelf) knee brace.

The United States Food and Drug Administration (FDA, 2022) defines a brace as “device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.” Knee braces are classified as a Class 1 device by the FDA and are exempt from a premarket notification application (PMA) requirement prior to marketing any device.

Individuals with osteoarthritis of the knee with varus or valgus deformity often develop increased pain in the affected compartment due to increased mechanical loading. Unloader knee braces are designed and constructed to reduce the asymmetric loading in such knees. In order to decrease the weight on a painful knee joint, an unloader knee brace is designed to provide stability during activities of daily living. There is biomechanical data demonstrating reduction in adduction movement in varus knees when the appropriate unloader brace is used. In a systematic review of the literature, Raja and Dewan (2011) identified the existence of a number of high-quality clinical studies that recommend the use of an unloader knee brace as conservative management in the relief of signs and symptoms associated with medial compartment knee osteoarthritis.

Functional knee braces are defined as braces designed to assist or provide stability for the anterior cruciate ligament (ACL) or other ligament deficient knees, and provide protection for the ACL or other ligaments after knee repairs or reconstructions. Functional knee braces are worn throughout the day for unstable knees during activities of daily living or sports and may be either prefabricated (off-the-shelf) or custom-made. Derotation braces are typically used after injuries to ligaments and have medial and lateral bars with varying hinge and strap designs. These derotation braces are designed to permit significant motion and in many instances the braces are worn only during elective activities, such as sports. Braces made of graphite, titanium, or other lightweight materials are specifically designed for high-performance sports. Functional knee braces have also been used in individuals with osteoarthritis in order to decrease the weight on painful joints. Custom-made functional knee braces may be prescribed as an alternative to a prefabricated, custom-fitted knee brace when an individual has a deformity of the knee or leg that interferes with fitting, such as a disproportionate thigh and calf; or minimal muscle mass upon which to suspend an orthosis. Height (exceptionally tall or short stature) or weight (obesity) alone are insufficient reasons for a custom-made functional knee brace. These individuals can be fitted with a prefabricated (custom-fitted) knee brace with the following adjustments: extensions for an unusually tall person, a pediatric model for a person of short stature, or extra-large straps for an obese person.

Custom-made (custom molded, custom fabricated) unloader knee braces are fabricated specifically for an individual. These braces generally use basic materials, including, but not limited to, plastic, metal, leather, or cloth in the form of sheets or bars. Fabrication involves substantial work such as cutting, bending, molding, or sewing and may involve the incorporation of some prefabricated components. Constructing a custom-made knee brace involves much more work than a predominantly prefabricated item. A molded-to-member-model orthosis is a particular type of custom-made orthosis in which an impression of the specific body part is made by means of a plaster cast or computer aided design/computer aided manufacturing (CAD-CAM) technology. This impression is then used to make a positive model of plaster or other material of the body part. The orthosis is then molded on this positive model.

Cartilage: A cellular tissue in adults that is specific to joints. A tough, fibrous material with high collagen content, such as found in the meniscus of the knee.

Instability: Looseness, unsteadiness, or an inability to withstand normal physiologic loading without mechanical deformation.

Knee brace: A limb orthosis or device intended for medical purposes that is worn on the lower extremity to support, to correct, or to prevent deformities, or to align body structures for functional improvement.

Meniscus: A soft-tissue structure that lines some joints and provides load distribution, shock absorption, and lubrication.

Osteoarthritis (OA): A deterioration of the weight bearing surface distinguished by destruction of the hyaline cartilage and narrowing at the joint space.

Unicompartmental osteoarthritis of the knee: A condition characterized by degenerative articular cartilage in the medial or lateral aspect of the tibiofemoral joint; may be associated with meniscal disruption, ligamentous instability, and malalignment.

Valgus deformity: Angulation of a distal bone away from the midline in relation to its proximal partner; also referred to as “bow-legged.”

Varus deformity: Angulation of a distal bone toward the midline in relation to its proximal partner; also referred to as “knock-kneed.”

Custom Fabricated Knee Brace
Custom-made Functional Knee Brace
Custom-molded Knee Brace
Offloader Knee Brace
Unloader Knee Brace

Federal and State law, as well as contract language, and Medical Policy take precedence over Clinical UM Guidelines. We reserve the right to review and update Clinical UM Guidelines periodically. Clinical guidelines approved by the Medical Policy & Technology Assessment Committee are available for general adoption by plans or lines of business for consistent review of the medical necessity of services related to the clinical guideline when the plan performs utilization review for the subject. Due to variances in utilization patterns, each plan may choose whether 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 member's card.

Alternatively, commercial or FEP plans or lines of business which determine there is not a need to adopt the guideline to review services generally across all providers delivering services to Plan’s or line of business’s members may instead use the clinical guideline for provider education and/or to review the medical necessity of services for any provider who has been notified that his/her/its claims will be reviewed for medical necessity due to billing practices or claims that are not consistent with other providers, in terms of frequency or in some other manner.

No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

Subject: Custom-made Knee Braces
Guideline #: CG-OR-PR-03	Publish Date: 01/03/2024
Status: Reviewed	Last Review Date: 11/09/2023

HCPCS
L1834	Knee orthosis; without knee joint, rigid, custom fabricated
L1840	Knee orthosis; derotation, medial-lateral, anterior cruciate ligament, custom fabricated
L1844	Knee orthosis, single upright, thigh and calf, with adjustable flexion and extension joint (unicentric or polycentric), medial-lateral and rotation control, with or without varus/valgus adjustment; custom fabricated
L1846	Knee orthosis; double upright, thigh and calf, with adjustable flexion and extension joint (unicentric or polycentric), medial-lateral and rotation control, with or without varus/valgus adjustment, custom fabricated
L1860	Knee orthosis; modification of supracondylar prosthetic socket, custom fabricated (SK)
L2861	Addition to lower extremity joint, knee or ankle, concentric adjustable torsion style mechanism for custom fabricated orthotics only, each [when specified as knee]

ICD-10 Diagnosis
	All diagnoses

Status	Date	Action
Reviewed	11/09/2023	Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Discussion/General Information and References sections.
Reviewed	11/10/2022	MPTAC review. Updated Discussion/General Information and References sections.
Reviewed	11/11/2021	MPTAC review. Updated References section.
Reviewed	11/05/2020	MPTAC review. Updated Table 1 in Discussion/General Information section. Updated References section. Reformatted Coding section.
Reviewed	11/07/2019	MPTAC review. Updated References section.
Reviewed	01/24/2019	MPTAC review.
Reviewed	03/22/2018	MPTAC review. The document header wording updated from “Current Effective Date” to “Publish Date.” Updated Discussion/General Information, References, and Websites sections.
Reviewed	05/04/2017	MPTAC review. Updated References section.
Reviewed	05/05/2016	MPTAC review. Updated Description, Table 2 and References section. Removed ICD-9 codes from Coding section.
Reviewed	05/07/2015	MPTAC review. Updated Discussion/General Information, References and Websites sections.
Reviewed	05/15/2014	MPTAC review. Updated References section.
Reviewed	05/09/2013	MPTAC review. Updated Table 2, References and Index.
Reviewed	05/10/2012	MPTAC review. Updated Discussion, Product Table and References.
Reviewed	05/19/2011	MPTAC review. Updated Product Table, Definitions, Coding and References.
Reviewed	05/13/2010	MPTAC review. Updated Discussion and References.
	01/01/2010	Updated Coding section with 01/01/2010 HCPCS changes.
Reviewed	08/27/2009	MPTAC review. Updated Product Table and References.
Revised	08/28/2008	MPTAC review. Revised medically necessary Clinical Indications to address custom-made functional knee braces as an alternative to prefabricated knee braces when specific criteria are met. Clarified not medically necessary statement to include “functional or unloader” to describe the custom-made knee braces that are not medically necessary when criteria are not met. Updated Discussion, Coding and References.
New	05/15/2008	MPTAC review. Archived CG-DME-02, addressing custom-made knees braces as a separate and new clinical UM guideline. Clarified Clinical Indications. Revised the Discussion, Definitions (AAOS), and Index. References and Product Table updated.
Pre-Merger Organizations			Last Review Date	Document Number	Title
Anthem, Inc.			04/28/2005	DME.021	Knee Braces
WellPoint Health Networks, Inc.			09/23/2004	9.07.02	Knee Braces