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MEDICAL POLICY – 1.03.501 Knee Braces Effective Date: June 1, 2017 Last Revised: May 23, 2017 Replaces: 1.03.02 RELATED MEDICAL POLICIES: 1.01.529 Durable Medical Equipment 7.01.15 Meniscal Allograft and Other Meniscus Implants 7.01.549 Knee Arthroscopy in Adults Select a hyperlink below to be directed to that section. POLICY CRITERIA | CODING | RELATED INFORMATION EVIDENCE REVIEW | REFERENCES | HISTORY Clicking this icon returns you to the hyperlinks menu above. Introduction Knee braces are devices worn to support the knee joint. They are made by combining pieces of metal, foam, plastic, elastic materials and straps. The typical knee brace parts can be combined such that most people will get a comfortable fit. In rare cases, a custom-built brace might be needed if the knee and leg have an unusual shape. An injury, knee surgery or severe arthritis of the knee may be reasons why a knee brace might be used. A knee brace may be useful when the knee is unstable or “gives out“. Special knee braces, called “unloader braces,” may help decrease pain for people who have severe arthritis. Knee braces that are worn to protect the knee and prevent injuries during sports/athletic activities are not covered by medical insurance. This policy describes the type of knee braces that are covered by the plan, as well as the type of knee braces that need to be approved before they are covered. Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered. Policy Coverage Criteria

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  • MEDICAL POLICY 1.03.501

    Knee Braces

    Effective Date: June 1, 2017

    Last Revised: May 23, 2017

    Replaces: 1.03.02

    RELATED MEDICAL POLICIES:

    1.01.529 Durable Medical Equipment

    7.01.15 Meniscal Allograft and Other Meniscus Implants

    7.01.549 Knee Arthroscopy in Adults

    Select a hyperlink below to be directed to that section.

    POLICY CRITERIA | CODING | RELATED INFORMATION

    EVIDENCE REVIEW | REFERENCES | HISTORY

    Clicking this icon returns you to the hyperlinks menu above.

    Introduction

    Knee braces are devices worn to support the knee joint. They are made by combining pieces of

    metal, foam, plastic, elastic materials and straps. The typical knee brace parts can be combined

    such that most people will get a comfortable fit. In rare cases, a custom-built brace might be

    needed if the knee and leg have an unusual shape.

    An injury, knee surgery or severe arthritis of the knee may be reasons why a knee brace might

    be used. A knee brace may be useful when the knee is unstable or gives out. Special knee

    braces, called unloader braces, may help decrease pain for people who have severe arthritis.

    Knee braces that are worn to protect the knee and prevent injuries during sports/athletic

    activities are not covered by medical insurance. This policy describes the type of knee braces

    that are covered by the plan, as well as the type of knee braces that need to be approved before

    they are covered.

    Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the

    policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a

    person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a

    hospital, clinic, or lab. This policy informs them about when a service may be covered.

    Policy Coverage Criteria

    https://www.premera.com/medicalpolicies/1.01.529.pdfhttps://www.premera.com/medicalpolicies/1.01.529.pdfhttps://www.premera.com/medicalpolicies/7.01.15.pdfhttps://www.premera.com/medicalpolicies/7.01.549.pdf

  • Page | 2 of 12

    Type of Brace Coverage Criteria

    Unloader Knee Brace Custom-made knee braces

    (custom fabricated, custom

    molded)

    Note: These braces must be

    designed and fit by a board certified

    prosthetist/orthotist or an individual

    who has equivalent specialized training

    in the provision of orthotics such as a

    physician, treating practitioner, an

    occupational therapist, or physical

    therapist in compliance with all

    applicable Federal and State licensure

    and regulatory requirements. A

    certified orthotist is defined as an

    individual who is certified by the

    American Board for Certification in

    Orthotics and prosthetics, Ins., or by the

    Board for Orthotist/Prosthetist

    Certification.

    Custom-made unloader knee braces may be considered

    medically necessary when all of the following criteria are met:

    The patient has painful osteoarthritis involving the medial

    compartment of the knee (causing a varus deformity) or the

    lateral compartment of the knee (causing a valgus deformity).

    AND

    A prefabricated brace was tried and did not fit due to one of

    the following:

    o Abnormal limb contour exists that interferes with fitting

    (disproportionate size of thigh and/or calf)

    OR

    o Knee deformity is present that interferes with fitting of the

    brace

    varus = knee joint is outward compared to the foot

    valgus = knee joint is inward compared to the foot)

    OR

    o The knee anatomy has minimal muscle mass that interferes

    with fitting

    Custom-made unloader knee braces are considered not

    medically necessary when:

    A prefabricated unloader knee brace can be custom fit and

    adjusted for the patient.

    Custom-made unloader knee braces for any condition other

    than osteoarthritis is considered a contract exclusion because

    it is considered a special or extra cost convenience feature

    under the durable medical equipment/medical supplies benefit

    in most contracts.

    Note: Clinical notes should document that an effort to adjust a prefabricated brace was

    made. For example, use of a pediatric sized knee brace for patients with small legs,

    the use of extra-long straps for patients with large limbs or addition of extension

    segments for tall patients. The knee brace request should include the patients

    thigh measurement and the size of thigh the manufacturers largest knee brace

    will fit.

  • Page | 3 of 12

    Type of Brace Coverage Criteria Prefabricated unloader

    knee brace (off-the-shelf,

    ready-made, custom-

    fitted)

    Prefabricated unloader knee braces may be considered

    medically necessary for patients with painful osteoarthritis of

    the medial or lateral compartment of the knee.

    Prefabricated unloader knee braces for any condition other

    than osteoarthritis is considered a contract exclusion because

    it is considered a special or extra cost convenience feature

    under the durable medical equipment/medical supplies benefit

    in most contracts.

    Functional Knee Brace Prefabricated functional

    knee brace (off-the-shelf,

    ready-made, custom-

    fitted)

    Prefabricated functional knee braces may be considered

    medically necessary when all of the following criteria are met:

    The patient is ambulatory

    AND has one of the following:

    Knee instability due to a knee injury (fracture, ligament tear) is

    documented on a physical exam

    OR

    Knee instability due to recent knee surgery (rehab braces are

    used short-term, usually 6-12 weeks after surgery)

    OR

    Knee instability due to a knee deformity such as contracture or

    genu varum/valgum (bow legged/ knocked kneed) is present

    Prefabricated functional knee braces are considered not

    medically necessary when criteria are not met.

    Custom-made functional

    knee brace

    Note: These braces must be

    designed and fit by a board certified

    prosthetist/orthotist or an individual

    who has equivalent specialized training

    in the provision of orthotics such as a

    physician, treating practitioner, an

    occupational therapist, or physical

    therapist in compliance with all

    applicable Federal and State licensure

    and regulatory requirements. A

    certified orthotist is defined as an

    individual who is certified by the

    Custom-made functional knee braces may be considered

    medically necessary when the criteria are met for a

    prefabricated functional brace, but a prefabricated functional

    brace was tried and did not fit due to one of the following:

    Abnormal limb contour that interferes with fitting

    (disproportionate size of thigh and/or calf)

    OR

    Knee deformity is present that interferes with fitting such as

    contracture or genu varum/valgum (bow legged/ knocked

    kneed)

    OR

    The knee anatomy has minimal muscle mass that interferes

  • Page | 4 of 12

    Type of Brace Coverage Criteria American Board for Certification in

    Orthotics and prosthetics, Ins., or by the

    Board for Orthotist/Prosthetist

    Certification.

    with fitting

    Note: Clinical notes should document that an effort to adjust a prefabricated brace was

    made. For example, use of a pediatric sized knee brace for patients with small

    legs, the use of extra-long straps for patients with large limbs or addition of

    extension segments for tall patients. The knee brace request should include the

    patients thigh measurement and the size of thigh the manufacturers largest knee

    brace will fit.

    Custom-made functional knee braces that do not meet the

    above criteria are considered a contract exclusion because it is

    considered a special or extra cost convenience feature under

    the durable medical equipment/medical supplies benefit in

    most contracts.

    Prophylactic Knee Brace Prophylactic knee braces

    (custom or prefabricated)

    Prophylactic knee braces are considered not medically

    necessary for all indications.

    Prophylactic knee braces are frequently used for sport or

    recreational activities to prevent an injury. (Using a brace for

    this indication has not been proven in the literature.)

    Coding

    HCPCS 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

    L1847 Knee orthosis, double upright with adjustable joint, with inflatable air support

    chamber(s), prefabricated item that has been trimmed, bent, molded, assembled, or

    otherwise customized to fit a specific patient by an individual with expertise

  • Page | 5 of 12

    L1860 Knee orthotic (KO), modification of supracondylar prosthetic socket, custom fabricated

    (SK)

    Notes: Skin protectors like brace sleeves are considered medically necessary supplies when used in conjunction with knee

    braces/knee orthoses.

    CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS codes,

    descriptions and materials are copyrighted by Centers for Medicare Services (CMS).

    Related Information

    Definition of Terms

    Custom-made knee brace: Braces built for one patient according to precise measurements or

    molds/casts of the individual. A custom-made brace is used by only one specific patient and will

    not be useful to another patient. The certified orthotist provides the initial functional assessment

    and fit and builds the knee brace, which may include custom fabrication of parts.

    Functional knee braces/orthosis: A type of knee brace used for knee instability. Examples of

    when this type of brace may be used are after knee injury, repairs, or reconstructions. Functional

    knee braces are worn during the day to stabilize and restrain the knee joint to prevent abnormal

    movement (rotation) during activities of daily living or sports. These knee braces are commonly

    used for a long time and may be either prefabricated/off-the-shelf, or in rare cases they may be

    custom-made.

    Instability: An unsteadiness when bearing weight on the knee joint without an actual giving

    way, or causing an unexpected fall.

    Osteoarthritis (OA): Also known as degenerative joint disease (DJD), OA in the knee happens

    due to overuse or injury of the joint. This overuse or injury breaks down the tissues (cartilage)

    that cushion the ends of the bones which make up the knee joint. These bones are the thigh

    bone or femur, the shin bone or tibia, and the knee cap or patella. The breakdown is usually on

    one side or the other where the bones come together. The breakdown of one side of the joint

    causes the knee to shift toward the opposite side, either towards the inside or the outside of the

    leg. That is, if the breakdown is on the inside of the knee joint, the knee shifts to the outside

    causing a bowlegged appearance. The deformity causes pain and affects the ability to move the

    knee joint and to walk.

    Over-the-counter (OTC) knee braces: Elastic sleeve-like garments that provide minimal rigid

    supports to protect the knee and are usually made of neoprene or spandex. These elastic knee

  • Page | 6 of 12

    sleeve supports are available without a prescription at many retail outlets. These items do not

    meet the definition of durable medical equipment (DME).

    Pre-fabricated/Off-the-shelf knee brace: Braces that are mass-produced and come pre-sized

    in small, medium, large, etc. The certified orthotist provides the initial functional assessment and

    fit, as well as makes substantial modifications for a customized fit, without having to wait for a

    custom-made brace.

    Prophylactic knee braces/orthosis: A type of brace used to protect uninjured knees from

    ligament injuries. These braces are primarily used in recreational or organized sports to prevent

    injury from occurring. However, no conclusive evidence supports their effectiveness and they are

    not recommended for regular use.

    Unloader knee braces: A type of knee brace used to treat patients with painful osteoarthritis.

    These braces shift (unload) the body weight onto a different part of the knee than where the

    arthritis is located, for example, from the medial compartment to the lateral compartment.

    Documentation

    Clinical information to document the medical condition that requires the use of a knee brace

    may be requested. Information in the clinical record should include:

    A physical examination and an objective description of the knee joint instability

    A statement that the patient can walk (is ambulatory)

    The medical condition that indicates why use of a brace will benefit the patient

    Report from any imaging studies that were done

    Information about attempts to adjust a prefabricated brace to fit the patient. For example:

    o Use of pediatric knee orthoses in individuals with small limbs

    o Use of straps with additional length for individuals with larger limbs

    o Use of extensions for very tall individuals

    o The patients thigh measurement that exceeds the size of thigh the manufacturers

    largest prefabricated brace is designed to fit

  • Page | 7 of 12

    Evidence Review

    Practice Guidelines and Position Statements

    American Academy of Orthopaedic Surgeons (AAOS)

    The AAOS provided a 2009 clinical practice guideline on the non-surgical treatment of

    osteoarthritis of the knee.15 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.4,6

    The AAOS published clinical practice guideline in 2014 31-33 on the management of anterior

    cruciate ligament injuries that includes these recommendations:

    ACL prophylactic braces: Limited evidence does not support prescribing prophylactic knee

    braces to prevent ACL injury because they do not reduce the risk for ACL injury.

    ACL post-op functional braces: Moderate evidence does not support the routine use of

    functional knee bracing after isolated ACL reconstruction because there is no demonstrated

    efficacy.

    The American Academy of Orthopaedic Surgeons and the American

    Academy of Pediatrics

    The AAOS and AAP have determined that prophylactic knee braces lack sufficient evidence of

    effectiveness in reducing the frequency or severity of knee ligament injuries. A prophylactic knee

    brace may offer a subjective sense of protection, but it is unable to protect the medial collateral

    ligament (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. The regular use of a prophylactic knee brace at any level of athletic

    competition is not currently recommended.34,35

    The Osteoarthritis Research Society International (OARSI)

  • Page | 8 of 12

    The OARSI treatment guidelines from 2008 recommend the following: In patients with knee OA

    and mild/moderate varus or valgus instability, a knee brace can reduce pain, improve stability

    and diminish the risk of falling. This guideline is based in part on the Brower study in which

    there was a small but significant effect with unloading knee braces for patients with mild or

    moderate varus or valgus instability.6 In this study, the patients had medial or lateral

    osteoarthritis and the unloading knee brace was adapted to each kind of compartment. A

    slightly better effect was shown for the varus group.

    References

    1. Liu SH, Mirzayan R. Functional knee bracing. Clin Ortho Rel Research 1995; 317:273-281.

    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):1298-1312. PMID: 1429785

    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):745-749. PMID 9228878

    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):539-548. PMID 10225800

    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):777-783. PMID: 16563810

    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):2645-2652. PMID 17142415

    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):629-636. PMID 19467901

    9. Rannou F, Poiraudeau S, Beaudreuil J. Role of bracing in the management of knee osteoarthritis. Curr Opin Rheumatol 2010;

    22(2):218-222. PMID 20035222

    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 Jul; 468(&): 1926-1932. PMID 20177839

    11. Soma CA, Cawley PW, Liu S et al. Custom-fit versus premanufactured braces. Orthopedics 2004; 27(3):307-310. PMID 15058453

    12. Wright RW, Fetzer GB. Bracing after ACL reconstruction: a systematic review. Clin Orthop Relat Res 2007; 455:162-168. PMID

    17279043

    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):648-655. PMID 18192493

    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. PMID 18163413

    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. PMID 19726743

  • Page | 9 of 12

    16. Zhang, W, Moskowitz RW, Nuki G et al. OARSI recommendations for the management of hip and knee osteoarthritis, Part II:

    OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage 2008; 16:137-162. PMID 18279766

    17. Hunter DJ, Harvey W, Gross KD et al. A randomized trial of patellofemoral bracing for treatment of patellofemoral osteoarthritis.

    Osteoarthritis Cartilage 2011; 19(7) 792-800. PMID 21232620

    18. Pietrosimone BG, Grindstaff TL, Linens SW, Uczekaj E, Hertel J. A systematic review of prophylactic braces in the prevention of

    knee ligament injuries in collegiate football players. Journal of Athletic Training 2008 Jul-Aug;43(4):409-415. PMID 18668174

    19. Wright RW, et al. A systematic review of anterior cruciate ligament reconstruction rehabilitation: part I: continuous passive

    motion, early weight bearing, postoperative bracing, and home-based rehabilitation. Journal of Knee Surgery 2008;21(3):217-

    224. PMID 18686484

    20. Smith SD, Laprade RF, et al. Functional bracing of ACL injuries: current state and future directions. Knee Surg Sports Traumatol

    Arthrosc. 2014 May;22(5):1131-1141. PMID 23624655

    21. Andersson D, Samuelsson K, Karlsson J. Treatment of anterior cruciate ligament injuries with special reference to surgical

    technique and rehabilitation: an assessment of randomized controlled trials. Arthroscopy 2009;25(6):653-685. PMID 19501297

    22. Ahn JH, Chang MH, Lee YS, Koh KH, Park YS, Eun SS. Non-operative treatment of ACL rupture with mild instability. Archives of

    Orthopaedic and Trauma Surgeyr 2010; 130(8):1001-1006. PMID 20336305

    23. Birmingham TB, et al. A randomized controlled trial comparing the effectiveness of functional knee brace and neoprene sleeve

    use after anterior cruciate ligament reconstruction. American Journal of Sports Medicine 2008;36(4):648-655. PMID 18192493

    24. Kruse LM, Gray BL, Wright RW. Anterior cruciate ligament reconstruction rehabilitation in the pediatric population. Clinics in

    Sports Medicine 2011;30(4):817-824. PMID 22018322

    25. Rishiraj N, Taunton JE, Lloyd-Smith R, Woollard R, Regan W, Clement DB. The potential role of prophylactic/functional knee

    bracing in preventing knee ligament injury. Sports Medicine 2009;39(11):937-960. PMID19827861

    26. Stanley CJ, Creighton RA, Gross MT, Garrett WE, Yu B. Effects of a knee extension constraint brace on lower extremity

    movements after ACL reconstruction. Clinical Orthopaedics and Related Research 2011;469(6):1774-1780. PMID 21046300

    27. Albright JC, Crepeau AE. Functional bracing and return to play after anterior cruciate ligament reconstruction in the pediatric

    and adolescent patient. Clinics in Sports Medicine 2011;30(4):811-815. PMID 22018321

    28. Noridian Healthcare Solutions. Local Coverage Determination for Knee Orthoses (L33318), effective October 1, 2015. Available

    online at: https://med.noridianmedicare.com/documents/2230703/7218263/Knee+Orthoses/ Accessed May 2017.

    29. Paluska S., McKeag D. Knee braces: current evidence and clinical recommendations for their use. American Family Medicine.

    2000; 61(2):411-418, 423-424. PMID 10670507

    30. National Institute for Health and Care Excellence (NICE). Osteoarthritis Care and Management in Adults. Issued February 2014.

    NICE Guideline 177. Available online at: https://www.nice.org.uk/guidance/cg177. Accessed May 2017.

    31. National Institutes of Health (NIH): MedlinePlus. Knee braces-unloading. Updated on August 8, 2013. Source URL:

    http://www.nlm.nih.gov/medlineplus/ency/patientinstructions/000372.htm. Accessed May 2017.

    32. American Orthopaedic Society for Sports Medicine (AOSSM), ACL Bracing Update. Sports Medicine Update

    November/December 2011: 2-5. Source URL:

    https://www.sportsmed.org/AOSSMIMIS/members/downloads/SMU/2011NovDec.pdf. Accessed May 2017.

    33. American Association of Orthopaedic Surgeons (AAOS), Clinical practice guideline: management of anterior cruciate ligament

    injuries. 2014. http://www.aaos.org/guidelines/?ssopc=1. And

    http://www.aaos.org/Research/guidelines/ACLGuidelineFINAL.pdf. Accessed May 2017.

    34. 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):503-507. PMID 11483826

    35. Paluska SA, McKeag DB. Knee Braces: current evidence and clinical recommendations for their use. Am Fam Physician. 2000 Jan

    15;61(2):411-8,423-424. PMID 10670507

    https://med.noridianmedicare.com/documents/2230703/7218263/Knee+Orthoses/https://www.nice.org.uk/guidance/cg177http://www.nlm.nih.gov/medlineplus/ency/patientinstructions/000372.htmhttps://www.sportsmed.org/AOSSMIMIS/members/downloads/SMU/2011NovDec.pdfhttp://www.aaos.org/guidelines/?ssopc=1http://www.aaos.org/Research/guidelines/ACLGuidelineFINAL.pdf

  • Page | 10 of 12

    History

    Date Comments 06/25/98 Add to Durable Medical Equipment Section - New Policy

    11/05/99 Replace Policy - Description revised.

    09/11/01 Replace Policy - Scheduled update

    10/09/01 Replace Policy - HCPCS codes added; reviewed by Care Management staff.

    05/14/02 Replace Policy - Benefits Application Section updated.

    10/08/02 Replace Policy - Policy reviewed; policy statement unchanged. Additional references

    added.

    12/10/02 Replace Policy - Policy reviewed; reimbursement for custom brace language updated.

    12/09/03 Replace Policy - Policy reviewed; policy statement added concerning elective sports

    braces. Additional references and HCPC codes added.

    01/01/04 Replace Policy - HCPC code update only.

    07/13/04 Replace Policy - Policy reviewed; policy statement unchanged. Tables, Rationale and

    References updated.

    09/01/04 Replace Policy - Policy renumbered from PR.1.03.100. No date changes.

    09/14/04 Replace Policy - Policy reviewed; policy statement unchanged. Benefit Application and

    Rationale updated.

    09/13/05 Replace Policy - Policy statement revised to indicate that custom knee braces not

    meeting criteria are considered an extra cost convenience feature excluded under

    most contract provisions. Rationale and References updated.

    02/06/06 Codes updated - No other changes.

    06/23/06 Update Scope and Disclaimer - No other changes.

    09/12/06 Replace Policy - Policy reviewed with literature search; references added; no change in

    policy statement.

    08/14/07 Replace Policy - Policy updated with literature review; references added. No change in

    policy statement.

    08/12/08 Replace Policy - Policy updated with literature search; no change to the policy

    statement.

    08/11/09 New BC - Policy updated with literature search and converted to BC version. Replaces

    PR.1.03.500. Policy statement reworded but essentially unchanged.

  • Page | 11 of 12

    Date Comments 09/14/10 New PR Policy - Policy updated with literature search; references added and reordered.

    Policy statements changed to allow unloader bracing for lateral compartment of

    knee, in addition to medial. A new PR policy has been developed to replace BC.1.03.02

    07/12/11 Replace Policy - Policy updated with literature review; reference added. 2011 update

    added to osteoarthritis section. No change to the policy statement.

    07/20/12 Replace policy. No change in policy statement.

    07/24/13 Replace policy. Policy reviewed. Minor edits for readability. A review of the literature

    through April 2013 did not prompt any additions to the references. Policy statement

    unchanged.

    10/14/13 Replace policy. Removed Policy guideline stating When the patients clinical condition

    meets the requirement for an off-the-shelf (prefabricated) knee brace but the patient

    prefers a custom knee brace, payment for the most common type of off-the-shelf knee

    brace (L1845) may be allowed toward that purchase. Moved codes from benefit

    application to Policy Guidelines following the descriptions of the types of knee braces.

    A review of the literature through August 2013 did not prompt any additions to the

    references. Policy statement unchanged.

    05/12/14 Annual Review. Policy statements extensively revised. Functional knee braces for knee

    instability due to injury or surgery, previously considered medically necessary is now

    considered not medically necessary. Added references 18-27. Coding update: ICD

    diagnosis codes removed; HCPCS codes L1810-L1812 (these apply to a separate

    medical policy) and L1820-32, 34-36 removed as they do not apply to this policy.

    07/24/14 Update Related Policies. Change title to 7.01.549.

    08/18/14 Coding update. HCPCS codes L1844 and L1846 reversed in coding table within Policy

    Guidelines section. In the previous version; they have been corrected.

    11/10/14 Interim review. Clarifications to policy statements: Custom made contract exclusion

    policy statement split into two. Prophylactic policy statement reworded. HCPC codes

    added to policy statements. Manufacturing and classification of knee braces

    definitions added to policy guidelines section. HCPCS code E1810 removed; it relates

    to another policy (1.01.514).

    03/11/15 Update Related Policies. Add 1.01.529.

    03/24/15 Update Related Policies. Change title to 7.01.549.

    05/27/15 Annual Review. Added an off the shelf knee brace sizing chart to the Policy Guidelines

    section.

    04/01/16 Annual Review, approved March 8, 2016. Added Definition of Terms to Policy

    Guidelines. CPT code L1850 removed from policy these are not covered under the

    benefit and are out of the scope of the policy.

    04/14/16 Coding Update. Removed prefabricated codes from policy.

    05/15/16 Formatting edit. Moved the codes listed within the policy section to the main header

  • Page | 12 of 12

    Date Comments title, as they apply to the entire section, Custom-made Knee Brace/Knee Orthosis

    (L1834, L1840, L1844, L1846, L1860) not just to unloader knee braces as had been

    previously listed.

    11/01/16 Interim update, approved October 11, 2016. Policy updated with review through

    September 2016, references added. Policy statements revised for clarity and usability.

    All tables of braces types and sizing were deleted. Policy moved into new template.

    06/01/17 Annual review, approved May 23, 2017. No changes to policy statement. Coverage

    criteria clarified with grammatical corrections.

    Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The

    Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and

    local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review

    and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit

    booklet or contact a member service representative to determine coverage for a specific medical service or supply.

    CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). 2017 Premera

    All Rights Reserved.

    Scope: Medical policies are systematically developed guidelines that serve as a resource for Company staff when

    determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to

    the limits and conditions of the member benefit plan. Members and their providers should consult the member

    benefit booklet or contact a customer service representative to determine whether there are any benefit limitations

    applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

  • 037338 (07-2016)

    Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. Premera does not exclude people or treat them differently because of race, color, national origin, age, disability or sex. Premera: Provides free aids and services to people with disabilities to communicate

    effectively with us, such as: Qualified sign language interpreters Written information in other formats (large print, audio, accessible

    electronic formats, other formats) Provides free language services to people whose primary language is not

    English, such as: Qualified interpreters Information written in other languages

    If you need these services, contact the Civil Rights Coordinator. If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator - Complaints and Appeals PO Box 91102, Seattle, WA 98111 Toll free 855-332-4535, Fax 425-918-5592, TTY 800-842-5357 Email [email protected] You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue SW, Room 509F, HHH Building Washington, D.C. 20201, 1-800-368-1019, 800-537-7697 (TDD) Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html. Getting Help in Other Languages This Notice has Important Information. This notice may have important information about your application or coverage through Premera Blue Cross. There may be key dates in this notice. You may need to take action by certain deadlines to keep your health coverage or help with costs. You have the right to get this information and help in your language at no cost. Call 800-722-1471 (TTY: 800-842-5357). (Amharic): Premera Blue Cross 800-722-1471 (TTY: 800-842-5357)

    :(Arabic) .

    Premera Blue Cross. . . . (TTY: 800-842-5357) 1471-722-800

    (Chinese): Premera Blue Cross

    800-722-1471 (TTY: 800-842-5357)

    Oromoo (Cushite): Beeksisni kun odeeffannoo barbaachisaa qaba. Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandaa. Guyyaawwan murteessaa taan beeksisa kana keessatti ilaalaa. Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandaa. Kaffaltii irraa bilisa haala taeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu. Lakkoofsa bilbilaa 800-722-1471 (TTY: 800-842-5357) tii bilbilaa. Franais (French): Cet avis a d'importantes informations. Cet avis peut avoir d'importantes informations sur votre demande ou la couverture par l'intermdiaire de Premera Blue Cross. Le prsent avis peut contenir des dates cls. Vous devrez peut-tre prendre des mesures par certains dlais pour maintenir votre couverture de sant ou d'aide avec les cots. Vous avez le droit d'obtenir cette information et de laide dans votre langue aucun cot. Appelez le 800-722-1471 (TTY: 800-842-5357). Kreyl ayisyen (Creole): Avi sila a gen Enfmasyon Enptan ladann. Avi sila a kapab genyen enfmasyon enptan konsnan aplikasyon w lan oswa konsnan kouvti asirans lan atrav Premera Blue Cross. Kapab genyen dat ki enptan nan avi sila a. Ou ka gen pou pran kk aksyon avan sten dat limit pou ka kenbe kouvti asirans sante w la oswa pou yo ka ede w avk depans yo. Se dwa w pou resevwa enfmasyon sa a ak asistans nan lang ou pale a, san ou pa gen pou peye pou sa. Rele nan 800-722-1471 (TTY: 800-842-5357). Deutsche (German): Diese Benachrichtigung enthlt wichtige Informationen. Diese Benachrichtigung enthlt unter Umstnden wichtige Informationen bezglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross. Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung. Sie knnten bis zu bestimmten Stichtagen handeln mssen, um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten. Sie haben das Recht, kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten. Rufen Sie an unter 800-722-1471 (TTY: 800-842-5357). Hmoob (Hmong): Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb. Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross. Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no. Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd. Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj. Hu rau 800-722-1471 (TTY: 800-842-5357). Iloko (Ilocano): Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion. Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross. Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar. Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos. Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo. Tumawag iti numero nga 800-722-1471 (TTY: 800-842-5357). Italiano (Italian): Questo avviso contiene informazioni importanti. Questo avviso pu contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross. Potrebbero esserci date chiave in questo avviso. Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione. Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente. Chiama 800-722-1471 (TTY: 800-842-5357).

  • (Japanese): Premera Blue Cross

    800-722-1471 (TTY: 800-842-5357) (Korean): . Premera Blue Cross . . . . 800-722-1471 (TTY: 800-842-5357) . (Lao): . Premera Blue Cross. . . . 800-722-1471 (TTY: 800-842-5357). (Khmer):

    Premera Blue Cross

    800-722-1471 (TTY: 800-842-5357) (Punjabi): . Premera Blue Cross . . , , 800-722-1471 (TTY: 800-842-5357).

    :(Farsi) .

    . Premera Blue Cross .

    . .

    )800-842-5357 TTY( 800-722-1471 .

    Polskie (Polish): To ogoszenie moe zawiera wane informacje. To ogoszenie moe zawiera wane informacje odnonie Pastwa wniosku lub zakresu wiadcze poprzez Premera Blue Cross. Prosimy zwrcic uwag na kluczowe daty, ktre mog by zawarte w tym ogoszeniu aby nie przekroczy terminw w przypadku utrzymania polisy ubezpieczeniowej lub pomocy zwizanej z kosztami. Macie Pastwo prawo do bezpatnej informacji we wasnym jzyku. Zadzwocie pod 800-722-1471 (TTY: 800-842-5357). Portugus (Portuguese): Este aviso contm informaes importantes. Este aviso poder conter informaes importantes a respeito de sua aplicao ou cobertura por meio do Premera Blue Cross. Podero existir datas importantes neste aviso. Talvez seja necessrio que voc tome providncias dentro de determinados prazos para manter sua cobertura de sade ou ajuda de custos. Voc tem o direito de obter esta informao e ajuda em seu idioma e sem custos. Ligue para 800-722-1471 (TTY: 800-842-5357).

    Romn (Romanian): Prezenta notificare conine informaii importante. Aceast notificare poate conine informaii importante privind cererea sau acoperirea asigurrii dumneavoastre de sntate prin Premera Blue Cross. Pot exista date cheie n aceast notificare. Este posibil s fie nevoie s acionai pn la anumite termene limit pentru a v menine acoperirea asigurrii de sntate sau asistena privitoare la costuri. Avei dreptul de a obine gratuit aceste informaii i ajutor n limba dumneavoastr. Sunai la 800-722-1471 (TTY: 800-842-5357). P (Russian): . Premera Blue Cross. . , , . . 800-722-1471 (TTY: 800-842-5357). Faasamoa (Samoan): Atonu ua iai i lenei faasilasilaga ni faamatalaga e sili ona taua e tatau ona e malamalama i ai. O lenei faasilasilaga o se fesoasoani e faamatala atili i ai i le tulaga o le polokalame, Premera Blue Cross, ua e tau fia maua atu i ai. Faamolemole, ia e iloilo faalelei i aso faapitoa oloo iai i lenei faasilasilaga taua. Masalo o lea iai ni feau e tatau ona e faia ao lei aulia le aso ua taua i lenei faasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo oloo e iai i ai. Oloo iai iate oe le aia tatau e maua atu i lenei faasilasilaga ma lenei famatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe. Vili atu i le telefoni 800-722-1471 (TTY: 800-842-5357). Espaol (Spanish): Este Aviso contiene informacin importante. Es posible que este aviso contenga informacin importante acerca de su solicitud o cobertura a travs de Premera Blue Cross. Es posible que haya fechas clave en este aviso. Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura mdica o ayuda con los costos. Usted tiene derecho a recibir esta informacin y ayuda en su idioma sin costo alguno. Llame al 800-722-1471 (TTY: 800-842-5357). Tagalog (Tagalog): Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos. May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag sa 800-722-1471 (TTY: 800-842-5357). (Thai): Premera Blue Cross 800-722-1471 (TTY: 800-842-5357) (Ukrainian): . Premera Blue Cross. , . , , . . 800-722-1471 (TTY: 800-842-5357). Ting Vit (Vietnamese): Thng bo ny cung cp thng tin quan trng. Thng bo ny c thng tin quan trng v n xin tham gia hoc hp ng bo him ca qu v qua chng trnh Premera Blue Cross. Xin xem ngy quan trng trong thng bo ny. Qu v c th phi thc hin theo thng bo ng trong thi hn duy tr bo him sc khe hoc c tr gip thm v chi ph. Qu v c quyn c bit thng tin ny v c tr gip bng ngn ng ca mnh min ph. Xin gi s 800-722-1471 (TTY: 800-842-5357).