Durable Medical Equipment Section - Functional Knee Braces
| Topic: Functional Knee Braces | Date of Origin: 04/1998 |
| Section: DME | Policy No: 46 |
| Approved Date: 09/07/2004 | Effective Date: 09/07/2004 |
| Next Review Date: 09/2005 | |
IMPORTANT REMINDER
This Medical Policy has been developed through consideration of medical necessity,
generally accepted standards of medical practice, and review of medical literature
and government approval status.
Benefit determinations should be based in all cases on
the applicable contract language. To the extent there are any conflicts
between these guidelines and the contract language, the contract language will
control.
The purpose of medical policy is to provide a guide to coverage. Medical Policy
is not intended to dictate to providers how to practice medicine. Providers
are expected to exercise their medical judgment in providing the most appropriate
care.
Description
Knee braces typically 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 subdivided into three categories
that are based on their intended use:
Prophylactic braces are those that attempt to prevent or reduce the severity of knee ligament injuries. These braces are primarily designed to prevent injuries to the medial collateral ligament, which is among the most common athletic knee injury.
Rehabilitation braces are designed to allow protected motion of injured knees that have been treated operatively or non-operatively. These braces allow for controlled joint motion and typically consist of hinges that can be locked into place to limit range of motion. Rehabilitation braces are commonly used for 6 to 12 weeks after injury. Rehabilitation braces are usually purchased prefabricated off-the-shelf and not custom-fabricated.
Functional braces are designed to assist or provide stability for unstable knees during activities of daily living or sports and may be either prefabricated off-the-shelf or custom-fabricated. Derotation braces or stabilizing knee 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 speed; 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 patients with osteoarthritis to decrease the weight on painful joints.
Unloader braces are designed specifically to reduce the pain and disability associated with 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.
The Kellgren-Lawrence scale is used to assess the severity of articular cartilage changes of osteoarthritis. The scale emphasizes patellofemoral joint space narrowing and presence of osteophytes as determined by radiographs:
Kellgren-Lawrence
Scale |
|
| 0 |
No osteophytes |
| 1 |
Doubtful osteophytes |
2 |
Minimal osteophytes, possible narrowing, cysts, and sclerosis |
3 |
Moderate or definite osteophytes with moderate joint space narrowing |
4 |
Severe with large osteophytes and definite joint space narrowing |
According to the HCPCS codes, "custom fabricated" describes a brace that is individually custom-made according to precise measurements or molds/casts of an individual patient. A custom fabricated brace may be used only by the individual patient. Off-the-shelf knee braces are described as "prefabricated" in HCPCS coding. These braces are fitted only to the extent that the patient is fitted to a limited selection of sizes, e.g., small, medium, large, etc. A prefabricated brace may be initially fitted by an orthotist, but this involves simple adjustments.
Policy/Criteria
Prefabricated knee braces may be considered medically
necessary in patients with one of the following conditions:
Custom-fabricated knee braces may be considered medically necessary for patients with the following conditions which may preclude the use of a prefabricated model:
A. Valgus [bow-legged] limb
B. Varus [knock-kneed] limb
C. Tibial varum
D. Disproportionate thigh and calf (example: large thigh and small calf)
E. Minimal muscle mass on which to suspend a brace
Skin changes, such as:
A. Excessive redundant soft skin
B. Thin skin with risk of breakdown (example: chronic steroid medication)
Severe osteoarthritis (grade III or IV)
Many functional knee braces are designed specifically for participation in elective sports and thus would be considered not medically necessary.
Prophylactic knee braces are considered not medically necessary.
Scientific Background
There are no data in the published peer-reviewed literature
that shows that custom-fabricated functional knee braces
offer any benefit over prefabricated, off-the-shelf
braces in terms of activities of daily living. In addition,
many of the custom-fabricated functional knee braces
are designed specifically for participation in elective
sports and thus would be considered not medically necessary.
(2,3)
Research on the unloader knee braces for osteoarthritis has focused on the custom-made knee braces. There are minimal data on prefabricated unloader knee braces. Several case series suggest that unloader knee braces appear to be associated with a reduction in pain in patients with painful osteoarthritis of the medial compartment. (4, 5) Kirkley and colleagues published the results of a controlled trial that randomized 119 patients with medial compartment osteoarthritis to receive either standard medical management, medical management plus a Neoprene sleeve, or medical management plus an unloader knee brace. (6) The patients were evaluated at multiple points during the 6-month follow-up study period for the following outcomes: disease-specific quality of life, 6-minute walk, 30-second stair climb, and varus deformity as assessed by x-ray. The unloader knee brace group reported statistically significant improvements in pain, stiffness, and physical function. Pollo and colleagues reported outcomes of valgus bracing in eleven patients with pain and restricted mobility due to knee osteoarthritis. (7) During gait analysis, valgus bracing reduced varus movement by 13% and medial compartment load by an average 11% the result being improvement in pain and activity levels in all patients.
A search of the MEDLINE database through August 2004 did not identify any new published studies that would alter the above conclusions. Specifically, there were no controlled trials that compared the performance of custom-fabricated and prefabricated, custom-fitted functional knee braces for use after reconstructive knee surgery.
References
Cross References
None
| Codes | Number | Description |
| CPT | No code | |
| HCPCS | L1800 | Knee orthosis (KO); elastic with stays, prefabricated, includes fitting and adjustment |
| L1810 | KO; elastic with joints, prefabricated, includes fitting and adjustment | |
| L1815 | KO; elastic or other elastic type material with condylar pad(s), prefabricated, includes fitting and adjustment | |
| L1820 | KO; elastic with condylar pads and joints, prefabricated, includes fitting and adjustment | |
| L1825 | KO; elastic knee cap, prefabricated, includes fitting and adjustment | |
| L1830 | KO; immobilizer, canvas longitudinal, prefabricated, includes fitting and adjustment | |
| L1831 | KO; locking knee joint(s), positional orthosis, prefabricated, includes fitting and adjustment | |
| L1832 | KO; adjustable knee joints, positional orthosis, rigid support, prefabricated, includes fitting and adjustment | |
| L1834 | KO; without knee joint, rigid, custom fabricated | |
| L1836 | Knee orthosis, rigid, without joint(s), includes soft interface material, prefabricated, includes fitting and adjustment | |
| L1840 | Knee orthosis, derotation, medial-lateral, anterior cruciate ligament, custom fabricated | |
| L1843 | Knee orthosis, single upright, thigh and calf, with adjustable flexion and extension joint, medial-lateral and rotation control, includes varus/valgus adjustment; prefabricated, includes fitting and adjustment | |
| L1844 | Knee orthosis, single upright, thigh and calf, with adjustable flexion and extension joint, medial-lateral and rotation control, includes varus/valgus adjustment; custom fabricated | |
| L1845 | Knee orthosis, double upright, thigh and calf, with adjustable flexion and extension joint, medial-lateral and rotation control, prefabricated, includes fitting and adjustment | |
| L1846 | Knee orthosis, double upright, thigh and calf, with adjustable flexion and extension joint, medial-lateral and rotation control, custom fabricated | |
| L1847 | Knee orthosis, double upright with adjustable joint, with inflatable air support chamber(s), prefabricated, includes fitting and adjustment | |
| L1850 | Knee orthosis, Swedish type, prefabricated, includes fitting and adjustment | |
| L1855 | Knee orthosis, molded plastic, thigh and calf sections, with double upright knee joints, custom fabricated | |
| L1858 | Knee orthosis, molded plastic, polycentric knee joints, pneumatic knee pads (CTI), custom fabricated | |
| L1860 | Knee orthosis, modification of supracondylar prosthetic socket, custom fabricated (SK) | |
| L1870 | Knee orthosis, double upright, thigh and calf lacers, with knee joint, custom fabricated | |
| L1880 | Knee orthosis, double upright, non-molded thigh and calf cuffs/lacers with knee joints, custom fabricated |
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