Medical Policy: 01.03.01
Original Effective Date: November 1995
Reviewed: April 2016
Revised: April 2016
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:
Braces can further be divided into two categories
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:
|XS (X=1)||13"- 15.5"
( 33 - 39 cm)
12" - 13"
|10" - 12"
(25.5 - 30.5 cm)
|S (X=2)||15.5" - 18.5"
(39 - 47 cm)
|13" - 14"
(33 - 35.5 cm)
|12" - 14"
(30.5 - 35.5 cm)
|M (X=3)||18.5" - 21"
(47 - 53.25 cm)
|14" - 15"
(35.5 - 38 cm)
|14" -1 6"
(35.5 - 40.5 cm)
|L (X=4)||21" - 23.5"
(53.25 - 59.5 cm)
|15" - 17"
(38 - 43 cm)
|16" - 18"
(40.5 - 47 cm)
|XL (X=5)||23.5" -2 6.5"
(59.5 - 67.25 cm)
|17" - 19
"(43 - 48.25 cm)
|18" - 20"
(47 - 50.75 cm)
|XXL (X=6)||26.5" - 29.5"
(67.25 - 75 cm)
|19" - 21"
(48.25 - 53.25 cm)
|20" - 22"
(50.75 - 56 cm)
|XXXL (X=7)||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:
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:
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 following 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:
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. Custom-fabricated orthoses are not considered medically necessary for treatment of knee contractures.
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.
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.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.