Medical Policy: 01.03.01
Original Effective Date: November 1995
Reviewed: April 2017
Revised: January 2018
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy 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 will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Knee braces are useful in the treatment of knee ligament injuries, primarily anterior cruciate ligament injuries. They may be used by the patients who have not had surgical treatment and also in post surgical patients.
Knee braces consist of three components: a superstructure (usually a rigid shell), a hinge, and a strap system. The superstructure extends proximally and distally to a hinge centered around the knee axis of motion. The strapping system secures the brace to the limb.
Knee braces can be divided into four categories:
- Prophylactic braces attempt to prevent or reduce the severity of knee ligament injuries, and are primarily used in recreational or organized sports.
- Rehabilitation braces are designed to allow protected motion of injured knees that have been treated operatively or non-operatively, are usually purchased off the shelf and used for 6-12 weeks after injury.
- Functional braces are designed to assist or provide stability for unstable knees during activities of daily living or vocational or avocational activities.
- Unloader knee braces are specifically designed to reduce the pain and disability associated with severe osteoarthritis of the medial compartment of the knee by bracing the knee in the valgus position in order to unload the compressive forces on the medial compartment.
Braces can further be divided into two categories
- Prefabricated braces or off the shelf braces
- Custom fabricated braces
The prefabricated functional brace comes in various sizes and fit most patients reasonably well. The custom fabricated brace, however, requires either a cast mold or extensive measurements, which are provided to the manufacturer so that the brace can be fabricated. The peer reviewed medical literature does not show significant difference in the efficacy of the two categories.
The measurements for pre-fabricated braces:
( 33 - 39 cm)
12" - 13"
(30.5 - 33 cm)
|10" - 12"
(25.5 - 30.5 cm)
||15.5" - 18.5"
(39 - 47 cm)
|13" - 14"
(33 - 35.5 cm)
|12" - 14"
(30.5 - 35.5 cm)
||18.5" - 21"
(47 - 53.25 cm)
|14" - 15"
(35.5 - 38 cm)
|14" -1 6"
(35.5 - 40.5 cm)
||21" - 23.5"
(53.25 - 59.5 cm)
|15" - 17"
(38 - 43 cm)
|16" - 18"
(40.5 - 47 cm)
||23.5" -2 6.5"
(59.5 - 67.25 cm)
|17" - 19
"(43 - 48.25 cm)
|18" - 20"
(47 - 50.75 cm)
||26.5" - 29.5"
(67.25 - 75 cm)
|19" - 21"
(48.25 - 53.25 cm)
|20" - 22"
(50.75 - 56 cm)
||29.5" - 32"
(75 - 81.25 cm)
|21" - 23"
(56 - 61 cm)
|22" - 24"
(53.25 - 58.5 cm)
Custom fabricated braces are available when members are unable to use an off the shelf brace. There is little amount of scientific literature that proves the use of custom vs prefabricated braces is more beneficial in the long-term. The inability to fit a prefabricated brace would be the only reason a custom brace should be considered.
Custom-fabricated functional knee braces include, but are not limited to, the following device trade names:
- DonJoy CE 2000, Defiance, Monarch
- Generation II GII Sports Brace
- Innovation Sports CTi2 OA Custom
- Innovation Sports CTi Pro Sport
- Innovation Sports CTi Standard
- Lennox Hill Regular, Light, Spectralite
- MedTechna Can Am
- Omni Scientific Elite, TS-7
- Orthotech Oti Performer
- Spademan Custom
- Sutter Talon
- Townsend Design Air Custom, Original
- Vixie Enterprise MKS2 Custom, MKS2 PCL
- Zimmer Sports Caster I, Sports Caster II
- Axion OA-Custom (Axion series), OA AIR-Custom, Thruster RLF, Z-12 OA
- CTi® OA models (Pro Sport, Standard, Vapor®), Custom OA Unloader® models (ADJ®, LP®, One®, Select®, XT®)
The American Academy of Orthopaedic Surgeons and the American Academy of Pediatrics have concluded that prophylactic knee braces lack sufficient evidence of efficacy in reducing the incidence or severity of ligamentous knee injuries. A prophylactic knee brace may offer a subjective sense of protection, but it is unable to protect an MCL during a direct lateral impact. Researchers have found that prophylactic brace usage is less important in MCL injury prevention than strength training, conditioning, technique refinement and flexibility.10 Additional well-designed studies are needed to identify the proper role for prophylactic braces. Currently, the regular use of a prophylactic knee brace at any level of athletic competition is not recommended.
One of the following criteria must be met:
- Prefabricated functional knee braces may be considered medically necessary in members with documented:
- knee instability due to injury or after surgery
- painful osteoarthritis of the medial compartment of the knee
- neurological weakness requiring stabilization of the knee
- member must be ambulatory
- documented history of falls or gait disturbance
- documented knee instability by physical exam
- knee contracture
- must be non-fixed flexion or extension contracture
- knee deformity requiring stabilization
- member must be ambulatory
- documented knee instability by physical exam
- Custom fabricated knee braces may be considered medically necessary for members who meet the medical necessity criteria above for a prefabricated functional knee brace and there is an inability to use a prefabricated brace due to:
- Abnormal limb contour (disproportionate size of thigh and calf): or
- Knee deformity that interferes with fitting (valgus or varus limb): or
- There is minimal muscle mass upon which to suspend a brace.
Documentation to support medical necessity must include measurements that would support the abnormal limb contour or minimal muscle mass.
Studies comparing prefabricated and custom braces have found few significant clinical differences, presized braces may be better when cost or rapid availability is important. It would be the expectation that in the medical documentation every effort is made to use a prefabricated brace. This can be accomplished by using strap extenders or pediatric sized braces.
Note: Individuals with height (taller or short stature) or weight (obesity), can be fitted with prefabricated (custom fitted) knee braces with the below adjustments, and there should be evidence that there was effort in modifying a prefabricated knee brace prior to the use of a custom fabricated knee brace:
- extra large straps; or
- a pediatric model for a person with short stature; or
- extensions for an unusually tall person, and
Custom fabricated knee braces are considered not medically necessary when the above criteria is not met. There is not significant evidence available that the use of custom braces over prefabricated braces are more effective. Exceptionally tall or short stature or obesity does not, by itself, establish the medical necessity for custom-made functional knee braces. Exceptionally tall persons can usually be fitted with a prefabricated brace with extensions, short persons can usually be fitted with a pediatric prefabricated brace, and obese persons can usually be fitted with a prefabricated knee brace with extra-large straps. Prophylactic knee braces for all indications are considered not medically necessary.
- Prophylactic braces are used frequently for sports and recreation and are thought to prevent injury before and after surgery. This has not been proven in literature. The use of braces when an injury is not present is considered not medically necessary.
- Functional knee braces of any kind with the primary use for recreation or sports participation or to improve athletic performance are considered not medically necessary.
Based on peer reviewed literature the research is limited on the use of knee braces (prophylactic and functional) especially regarding the prevention of knee ligament injury in the non-injured population to include non-injured athletes. Based on this limited research these types of knee braces have not been shown to improve patient health outcomes and therefore are considered not medically necessary.
Procedure Codes and Billing Guidelines:
To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- L1834 Knee orthotic (KO), without knee joint, rigid, custom fabricated
- L1840 Knee orthotic (KO), derotation, medial-lateral, anterior cruciate ligament, custom fabricated
- L1844 Knee orthotic (KO), 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 orthotic, 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 orthotic (KO), modification of supracondylar prosthetic socket, custom fabricated (SK)
- The Medical Policy Reference Manual (MPRM) developed by the Blue Cross Blue Shield Association Health Management Systems, based on Technology Evaluation Center (TEC) criteria.
- Wojtys EM, Huston LJ. "Custom-fit: versus "off-the-shelf" ACL functional braces. American Journal of Knee Surgery 2001 Summer; 14(3): 157-62.
- Bimingham TB, Kramer JF, Kirkley A, Inglis JT, Spaulding SJ, Vandervoort AA. Knee bracing for medial compartment osteoarthritis: effects on proprioception and postural control. Rheumatology(Oxford)2001;40(3):285-289
- Martin TJ. Committee on Sports Medicine and Fitness. American Academy of Pediatrics: Technical report: knee brace use in the young athlete. Pediatrics. 2001 Aug;108(2):503-7
- Paluska SA, McKeag DB. Knee Braces: current evidence and clinical recommendations for their use. Am Fam Physician. 2000 Jan 15;61(2):411-8,423-4.
- Matsuno H, Kadowaki KM, Tsuji H. Generation II knee bracing for severe medial compartment osteoarthritis of the knee. Arch Phys Med Rehabil 1997; 78(7):745-9.
- Kirkley A, Webster-Bogaert S, Litchfield R et al. The effect of bracing on varus gonarthrosis. JBone Joint Surg Am 1999; 81(4):539-48.
- Swart NM, van Linschoten R, Bierma-Zeinstra SM, van Middelkoop M. The additional effect of orthotic devices on exercise therapy for patients with patellofemoral pain syndrome: a systematic review. Br J Sports Med. 2012 Jun; 46(8):570-7.
- Jessee AD, Gourley MM, Valovich McLeod TC. Bracing and taping techniques and patellofemoral pain syndrome. J Athl Train. 2012; 47(3):358-9.
- Mayr H, Stueken P. et al. Brace or no brace after ACL graft? Four year results of a prospective clinical trial. Knee Surgery, Sports Traumatology 2013 Jun 10.1007/s00167-013-2564-2.
- PubMed. The Potential Role of Prophylactic/Functional Knee Bracing in Preventing Knee Ligament Injury. Sports Med. 2009;39(11):937-60
- American Orthopaedic Society for Sports Medicine (AOSSM), ACL Bracing Update. Sports Medicine Update November/December 2011
- National Guideline Clearinghouse. Knee Disorders. American College of Occupational and Environmental Medicine (ACOEM); 2011. P. 1-503.
- National Institute for Health and Care Excellence (NICE). Osteoarthritis Care and Management in Adults. Issued February 2014. NICE Guideline 177.
- American Academy of Orthopaedic Surgeons. The use of knee braces. Document number 1124. Retrieved November 24, 1999, from the World Wide Web.
- Beynnon BD, Pope MH, Wertheimer CM, Johnson RJ, Fleming BC, Nichols CE, et al. The effect of functional knee-braces on strain on the anterior cruciate ligament in vivo. J Bone Joint Surg [Am]. 1992;74:1298–312.
- Knee Braces: Current Evidence and Clinical Recommendations for Their Use
- SCOTT A. PALUSKA, M.D.,and DOUGLAS B. MCKEAG, M.D., M.S., University of Pittsburgh Medical Center–Shadyside, Pittsburgh, Pennsylvania Am Fam Physician. 2000 Jan 15;61(2):411-418.
- Moyer RF, Birmingham TB, Bryant DM, Giffin JR, Marriott KA, Leitch KM. Valgus bracing for knee osteoarthritis: a meta-analysis of randomized trials
- Arthritis Care Res (Hoboken). 2015 Apr;67(4):493-501.
- American Academy of Orthopaedic Surgeons (AAOS). Guideline on the treatment of osteoarthritis of the knee (non-arthroplasty). May 18, 2013.
- Duivenvoorden T, Brouwer RW, van Raaij TM, et al. Braces and orthoses for treating osteoarthritis of the knee. Cochrane Database Syst Rev. 2015;(3):CD004020.
- January 2018 - Interim Review, Policy Revised
- April 2017 - Annual Review, Policy Revised
- April 2016 - Annual Review, Policy Revised
- May 2015 - Annual Review, Policy Revised
- June 2014 - Annual Review, Policy Revised
- September 2013 - Annual Review, Policy Revised
- September 2012 - Annual Review, Policy Renewed
- September 2011 - Annual Review, Policy Renewed
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*CPT® is a registered trademark of the American Medical Association.