Subject:
Knee Braces
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Knee braces may be custom made or available off-the-shelf in a variety of sizes. Knee braces may be intended for rehabilitation, to reduce pain, or to prevent injury in either stable or unstable knees.
Background
Knee braces typically consist of 3 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 4 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 the area of the most common athletic knee injuries.
- 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 off-the-shelf and are not custom made.
- Functional braces are designed to assist or provide stability for unstable knees during activities of daily living or sports and may be either 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 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 knee braces are specifically designed to reduce the pain and disability associated with osteoarthritis of the medial compartment of the knee by bracing the knee in the valgus position to unload the compressive forces on the medial compartment.
Policy:
[INFORMATIONAL NOTE: Pursuant to the New Jersey State Mandate on Orthotic and Prosthetic Appliances (N.J.S.A. 17:48E-35.30, effective April 11, 2008), health benefit plans that provide benefits for orthotic and prosthetic devices are required to provide coverage for expenses incurred in obtaining orthotic and prosthetic appliances from any licensed orthotist, prosthetist, or any certified pedorthist if determined medically necessary by the physician. Please note that with respect to knee braces, they are automatically eligible for coverage under the mandate. ASO/ASC/Self-Funded/Self-Insured accounts are exempt from these State mandated requirements but may choose to include these benefits at their discretion. For those self-insured accounts which opted not to adopt the mandate, the medical necessity criteria as specified below must be applied.
NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
1. Custom-made unloader knee braces are considered medically necessary as a treatment of members with painful osteoarthritis involving the medial compartment of the knee.
2. Off-the-shelf (custom-fitted) functional knee braces are considered medically necessary in members with knee instability due to injury (including patients who have had surgery for the injury) or in patients with painful osteoarthritis of the medial compartment of the knee.
3. Custom-made functional knee braces are generally not considered medically necessary. Custom-fitted prefabricated functional knee braces may be considered medically necessary, when the criteria for a prefabricated (off-the-shelf) functional knee brace have been met, and in circumstances in which an off-the-shelf knee brace would not provide a satisfactory fit, including any of the following (this list may not be all-inclusive):
• Abnormal limb contour (i.e., disproportionate size/shape)
• Knee deformity (i.e., valgus [knock-kneed], varus [bow legged] deformity) minimal muscle mass upon which to suspend the orthosis
4. Prophylactic knee braces are not considered medically necessary.
5. Medically necessary additions to knee braces (e.g., L2397, L2820, and L2830) are separately reimbursable.
(NOTE: Heavy duty knee joint codes (L2385, L2395) are covered only for members who weigh more than 300 pounds.)
6. Replacement of a previously covered knee brace is limited to the following conditions:
- Reasonable and useful lifetime (RUL) has been exceeded (see chart below); or
- When still within the RUL:
- irreparable damage;
- wear;
- a change in the member's condition or
- when necessitated due to growth.
The following chart reflects the reasonable useful lifetime of prefabricated knee orthoses:
| K0901 | 3 years |
| K0902 | 3 years |
| L1810 | 1 year |
| L1812 | 1 year |
| L1820 | 1 year |
| L1830 | 1 year |
| L1831 | 2 years |
| L1832 | 2 years |
| L1833 | 2 years |
| L1836 | 3 years |
| L1843 | 3 years |
| L1845 | 3 years |
| L1850 | 2 years |
The reasonable useful lifetime of custom-fabricated orthoses is 3 years.
7. Miscellaneous:
- Elastic support garments (e.g. made of material such as neoprene or spandex [elastane, Lycra®]) are not eligible for coverage since they do not meet the definition of a brace or an orthosis, and they are over-the-counter items. According to the NJ Orthotic and Prosthetic Appliances Mandate, an "orthotic appliance" is a brace or support but does not include fabric elastic supports, corsets, arch supports, trusses, elastic hose, canes, crutches, cervical collars, dental appliances or other similar devices carried in stock and sold by drug stores, department stores, corset shops or surgical supply facilities".
- Coverage of a removable soft interface (K0672) is limited to a maximum of two (2) per year beginning one (1) year after the date of service for initial issuance of the orthosis.
Medicare Coverage:
Medicare Advantage Products differs from the Horizon BCBSNJ Medical Policy. A knee orthosis is covered when LCD L33318 criteria and Article A52465 criteria are met.
Per LCD L33318, there is no proven clinical benefit to the inflatable air bladder incorporated into the design of HCPCS code L1847 and L1848; therefore, claims for HCPCS codes L1847 and L1848 will be denied.
For HCPCS codes L1832, L1833, L1843, L1845, L1850, L1851, and L1852, knee instability must be documented by examination of the beneficiary and objective description of joint laxity (for example, varus/valgus instability, anterior/posterior Drawer test).
Items requiring more than minimal self-adjustment by a qualified practitioner are coded as custom fitted (HCPCS codes L1810, L1832, L1843, L1845, L1847). Documentation must be sufficiently detailed to include, but is not limited to, a detailed description of the modifications necessary at the time of fitting the orthosis to the beneficiary. This information must be available upon request.
Suppliers
For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD) the following are required:
· The supplier must have received a signed Standard Written Order (SWO) from the treating practitioner before the DMEPOS item is delivered to a beneficiary. A valid treating practitioner’s order includes all elements required by regulation, Medicare program, manuals, and Medicare Administrative Contractor (MAC) specific guidelines
· Proof of delivery available upon request
· Clinical documentation to support the medical necessity of the DME item
For additional information, refer to Local Coverage Determination (LCD): Knee Orthoses (L33318) and Local Coverage Article: Knee Orthoses - Policy Article (A52465). Available to be accessed at Noridian Healthcare Services, LLC, (DME MAC), Local Coverage Determinations (LCDs) search page: https://www.cms.gov/medicare-coverage-database/indexes/lcd-list.aspx?Cntrctr=389&ContrVer=1&CntrctrSelected=389*1&s=38&DocType=All&bc=AggAAAAAAAAAAA%3d%3d&#ResultsAnchor.
Medicaid Coverage:
FIDE-SNP:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
[INFORMATIONAL NOTE: At the time this policy was created, no data in the published peer-reviewed literature showed that custom-made functional knee braces offered any benefit over off-the-shelf braces in terms of activities of daily living. Many of the custom-made functional knee braces were designed specifically for participation in elective sports and thus would be considered not medically necessary. Research on unloader knee braces for osteoarthritis had focused on custom-made knee braces, and there were minimal data on off-the-shelf unloader knee braces, although several case series suggested that unloader knee braces were associated with a reduction in pain in patients with painful osteoarthritis of the medial compartment.
Osteoarthritis
In 1999, Kirkley and colleagues reported on a controlled trial that randomly assigned 119 patients with medial compartment osteoarthritis to receive standard medical management, medical management plus a polychloroprene (Neoprene) sleeve, or medical management plus an unloader knee brace. Compared to the control group, the unloader knee brace group was associated with a significant improvement in quality of life and function. In comparing the unloader knee brace with the Neoprene sleeve, there was a significant difference in functional outcomes favoring the unloader knee, but no significant difference in terms of quality of life measures.
In a 2005 Cochrane review of braces and othoses for treating osteoarthritis of the knee, Brouwer et al. concluded that there was limited evidence in favor of an unloader knee brace. In 2006, Brouwer and colleagues reported a randomized multicenter trial of 117 patients that compared off-the-shelf unloading braces and conservative therapy with conservative therapy alone for unicompartmental (valgus or varus) osteoarthritis of the knee. The addition of a brace resulted in a slight increase in reported walking distances at 3, 6, and 12 months (effect size of 0.4), with trends for improvement in subjective pain (-0.63 on a 10-point visual analogue scale) and knee function (3 points on a 100-point Hospital for Special Surgery score). Quality of life did not differ between the two groups. The authors noted that adherence to the brace was low, with 16 of 60 patients (27%) discontinuing by 3 months and another 9 (15%) stopping treatment by 12 months. Patient-reported reasons for discontinuing use of the unloading brace were lack of benefit and adverse effects (i.e., skin irritation, bad fit).
Another study from 2006 compared custom-made and off-the-shelf bracing for varus gonarthrosis. Ten patients wore each type of brace for 4-5 weeks (approximately 9 hours per day) in a randomized order. Pain scores were reduced from 197 mm (500 mm maximum) to 71 mm with the custom brace and 120 mm with the off-the-shelf brace. Stiffness was reduced from 91 mm (200 mm maximum) to 36 mm with the custom brace and 63 mm with the off-the-shelf brace. Function was improved from 664 mm (1700 mm maximum) to 248 mm with the custom brace, whereas the off-the-shelf brace did not significantly affect function. Kinematic analysis showed a reduction in peak knee adduction moments during gait and stair-stepping and reduced varus angulation by 1.5 degrees, compared with baseline with the custom brace. The off-the-shelf brace did not reduce the varus angle.
A French clinical practice guideline committee evaluated evidence on the use of braces in knee osteoarthritis in 2009. The review found mainly low-quality evidence in support of valgus knee braces for symptomatic medial femoro-tibial osteoarthritis with short- and mid-term reduction of pain and disability. Adverse effects included venous thromboembolic events. No additional controlled trials were identified in a 2010 review of bracing in the management of knee osteoarthritis.
A 2010 study compared use of insoles or off-the-shelf braces for medial knee osteoarthritis in a randomized trial of 91 patients with medial compartmental knee osteoarthritis. Pain severity, measured by a 10-point visual analog scale (VAS), improved by 0.9 in the insole group and 1.0 for the brace group in intent-to-treat analysis. Function on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) improved by 4.2 and 4.0 points, respectively, out of 100. There was no significant effect on the hip-knee-ankle angle for either device. Compliance was 45% for the brace group, with a mean wearing time of 39 hours (standard deviation [SD] 32 hours). After 6 months of use, neither insoles nor off-the-shelf braces resulted in clinically significant changes in varus angle, pain, or function.
Ligamentous Instability of the Knee
Soma and colleagues compared the performance of custom-made and off-the-shelf functional knee braces from 4 manufacturers in 2004. As a group, the custom-made knee braces restrained anterior displacement better than the off-the-shelf models by a mean difference of 0.84 mm. The clinical significance of this minimal but statistically significant, difference is questionable.
A 2007 systematic review of 12 randomized controlled trials of bracing for rehabilitation following anterior cruciate ligament (ACL) reconstruction “found no evidence supporting the routine use of functional or rehabilitative bracing in a patient with a reconstructed ACL. In particular no study demonstrated a clinically important finding of improved range of motion, decreased pain, improved graft stability, or decreased complications and reinjuries.”
In 2008, Birmingham and colleagues reported a randomized controlled trial that compared the use of an off-the-shelf functional knee brace or Neoprene sleeve beginning 6 weeks after ACL reconstruction. Of 150 patients randomly assigned to a brace or sleeve after surgery, 127 (85%) completed 24-month follow-up. Compliance was similar for the 2 groups, and 3 patients from each group had graft failures and revision surgeries. Confidence in the knee was rated higher for the brace (70 vs. 55, respectively out of 100), as was the rating of help in returning to sport (66 vs. 53, respectively). No other outcome measures differed between the groups, including the ACL-quality of life questionnaire, highest activity level, satisfaction with the brace/sleeve, side-to-side laxity, or functional tests. As this report described evaluators as blinded to the patient’s group allocation, it does not appear that the patients were wearing the brace or sleeve at the time of functional testing.
Patellofemoral Pain Syndrome
In 2008, Warden et al. reported a meta-analysis of 16 randomized or quasi-randomized studies assessing patellar taping or bracing effects on chronic knee pain. Thirteen trials investigated taping or bracing for anterior knee pain and 3 investigated taping for osteoarthritis. The authors concluded there was limited evidence to demonstrate the efficacy of patellar bracing. They reported high heterogeneity between study outcomes and significant publication bias in the studies.
Summary
Evidence of efficacy of off-the-shelf bracing is limited for osteoarthritis of the medial compartment, ligamentous instability, or patellofemoral pain.
Technology Assessments, Guidelines and Position Statements
The American Academy of Orthopaedic Surgeons (AAOS) provided a 2009 clinical practice guideline on the nonarthroplasty treatment of osteoarthritis of the knee. The AAOS was unable to make a recommendation for or against the use of a brace with a varus- or valgus-directing force for patients with medial or lateral unicompartmental osteoarthritis of the knee, based on limited evidence for the effectiveness of knee braces.]
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Knee Braces
Braces, Knee
Orthotics, Knee
Elastic Support Garments
References:
1. Liu SH, Mirzayan R. Current review. Functional knee bracing. Clin Orthop Relat Res 1995; (317):273-81.
2. Beynnon BD, Pope MH, Wertheimer CM et al. The effect of functional knee-braces on strain on the anterior cruciate ligament in vivo. J Bone Joint Surg Am 1992; 74(9):1298-312.
3. 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.
4. Kirkley A, Webster-Bogaert S, Litchfield R et al. The effect of bracing on varus gonarthrosis. J Bone Joint Surg Am 1999; 81(4):539-48.
5. Brouwer RW, Jakma TS, Verhagen AP et al. Braces and orthoses for treating osteoarthritis of the knee. Cochrane Database Syst Rev 2005; (1):CD004020.
6. Brouwer RW, van Raaij TM, Verhaar JA et al. Brace treatment for osteoarthritis of the knee: a prospective randomized multi-centre trial. Osteoarthritis Cartilage 2006; 14(8):777-83.
7. Draganich L, Reider B, Rimington T et al. The effectiveness of self-adjustable custom and off-the-shelf bracing in the treatment of varus gonarthrosis. J Bone Joint Surg Am 2006; 88(12):2645-52.
8. Beaudreuil J, Bendaya S, Faucher M et al. Clinical practice guidelines for rest orthosis, knee sleeves, and unloading knee braces in knee osteoarthritis. Joint Bone Spine 2009; 76(6):629-36.
9. Rannou F, Poiraudeau S, Beaudreuil J. Role of bracing in the management of knee osteoarthritis. Curr Opin Rheumatol 2010; 22(2):218-22.
10. van Raaij TM, Reijman M, Brouwer RW et al. Medial Knee Osteoarthritis Treated by Insoles or Braces: A Randomized Trial. Clin Orthop Relat Res 2010.
11. Soma CA, Cawley PW, Liu S et al. Custom-fit versus premanufactured braces. Orthopedics 2004; 27(3):307-10.
12. Wright RW, Fetzer GB. Bracing after ACL reconstruction: a systematic review. Clin Orthop Relat Res 2007; 455:162-8.
13. Birmingham TB, Bryant DM, Giffin JR et al. A randomized controlled trial comparing the effectiveness of functional knee brace and neoprene sleeve use after anterior cruciate ligament reconstruction. Am J Sports Med 2008; 36(4):648-55.
14. Warden SJ, Hinman RS, Watson MA, Jr. et al. Patellar taping and bracing for the treatment of chronic knee pain: a systematic review and meta-analysis. Arthritis Rheum 2008; 59(1):73-83.
15. Richmond J, Hunter D, Irrgang J et al. Treatment of osteoarthritis of the knee (nonarthroplasty). J Am Acad Orthop Surg 2009; 17(9):591-600.
16. Raja K, Dewan N. Efficacy of knee braces and foot orthoses in conservative management of knee osteoarthritis: a systematic review. Am J Phys Med Rehabil 2011;90(3):247-262.
17. Maak TG, Marx RG, Wickiewicz TL. Management of chronic tibial subluxation in the multiple-ligament injured knee. Sports Med Arthrosc 2011;19(2):147-152.
18. Jacobi M, Reischi N, Wahl P, et al. Acute isolated injury of the posterior cruciate ligament treated by a dynamic anterior drawer brace; a preliminary report. J Bone Joint Surg Br 2010;92(10):1381-1384.
19. Giotis D, Zampeli F, Pappas E, et al. The effect of knee braces on tibial rotation in anterior cruciate ligament-deficient knees during high-demand athletic activities. Clin J Sport Med 2013 Jan 23. [Epub ahead of print].
20. American Academy of Orthopaedic Surgeons (AAOS). Guideline on the treatment of osteoarthritis of the knee (non-arthroplasty). December 6, 2008. Available at: http://www.aaos.org/research/guidelines/guide.asp
21. Nelson AE, Allen KD, Golightly YM, et al. A systematic review of recommendations and guidelines for the management of osteoarthritis: The Chronic Osteoarthritis Management Initiative of the U.S. Bone and Joint Initiative. Semin Arthritis Rheum 2013 Dec 4 [Epub ahead of print].
22. Smith TO, Drew BT, Meek TH, et al. Knee orthoses for treating patellofemoral pain syndrome. Cochrane Database Syst Rev. 2015 Dec 8;12:CD010513.
23. Bennell KL, Hall M, Hinman RS. Osteoarthritis year in review 2015: rehabilitation and outcomes. Osteoarthritis Cartilage. 2016 Jan;24(1):58-70.
24. Petersen W, Ellermann A, Zantop T, et al. Biomechanical effect of unloader braces for medial osteoarthritis of the knee: a systematic review (CRD42015026136). Arch Orthop Trauma Surg. 2016 Jan 6. [Epub ahead of print]
25. Deveza LA. Overview of the management of osteoarthritis. In: UpToDate, Hunter D, Curtis MR (Eds), UpToDate, Waltham, MA. (Accessed on May 9, 2017.)
26. Deveza LA, Bennell K. Management of moderate to severe knee osteoarthritis. In: UpToDate, Hunter D, Curtis MR (Eds), UpToDate, Waltham, MA. (Accessed on May 9, 2017.)
27. Deveza LA. Overview of the management of osteoarthritis. In: UpToDate, Curtis MR (Eds), UpToDate, Waltham, MA. (Accessed on April 5, 2018.)
28. Deveza LA, Bennell K. Management of moderate to severe knee osteoarthritis. In: UpToDate, Curtis MR (Eds), UpToDate, Waltham, MA. (Accessed on April 5, 2018.)
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
K0901
K0902
L1810
L1820
L1830
L1831
L1832
L1834
L1836
L1840
L1843
L1844
L1845
L1846
L1847
L1850
L1860
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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