Knee Braces
Number: 1094
Table Of Contents
PolicyApplicable CPT / HCPCS / ICD-10 Codes
Background
References
Policy
Scope of Policy
This Clinical Policy Bulletin addresses orthopedic knee braces and prosthesis.
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Medical Necessity
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Orthosis (Orthopedic Brace) and/or Prosthesis
Aetna considers an orthosis (orthopedic brace) and/or prosthesis medically necessary when:
- Care is prescribed by a physician, nurse practitioner, podiatrist or other health professional who is qualified to prescribe orthotics and/or prosthetics according to State law; and
- The orthosis or prosthesis will significantly improve or restore physical functions required for mobility-related activities of daily living (MRADL's); and
- The member’s participating physician or licensed healthcare practitioner has determined that the orthosis or prosthesis will allow the member to perform ADLs based on physical examination of the member; and
- The orthosis or prosthesis is provided within 6 months of the date of prescription; and
- The orthotic or prosthetic services are performed by a duly licensed and/or certified, if applicable, orthotic and/or prosthetic provider (all services provided must be within the applicable scope of practice for the provider in their licensed jurisdiction where the services are provided); and
- The services provided are of the complexity and nature to require being provided by a licensed or certified professional orthotist and/or prosthetist or provided under their direct supervision by a licensed ancillary person as permitted under state laws (services may be provided personally by physicians and performed by personnel under their direct supervision as permitted under state laws, as physicians are not licensed as orthotists and/or prosthetists); and
- The certified professional orthotist or prosthetist must be in good standing with one or more of the following:
- American Board for Certification (orthotics, prosthetics, pedorthics) (ABC); or
- Board of Certification/Accreditation (prosthetics, orthotics) (BOC); or
- Licensed by the state in which services are provided (where legally required);
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Knee Braces
Aetna considers the following medically necessary:
- A prefabricated knee orthosis with joints or knee orthosis with condylar pads and joints with or without patellar control for ambulatory members who have weakness or deformity of the knee and require stabilization;
- A prefabricated knee orthosis with a locking knee joint (i.e., joints that lock a knee into a particular position) or a rigid knee orthosis (knee immobilizer) for members with flexion or extension contractures of the knee with movement on passive range of motion (ROM) testing of at least 10 degrees (i.e., a non-fixed contracture);
- A prefabricated knee immobilizer without joints, or a knee orthosis with adjustable knee joints, or a knee orthosis with an adjustable flexion and extension joint that provides both medial-lateral and rotation control, if the member has had recent injury to or a surgical procedure on the knees (within 6 weeks prior to brace application) requiring ROM limitations. These braces are considered experimental, investigational, or unproven for other indications because their effectiveness for indications other than the one listed above has not been established.
Note: When used for this indication, the knee brace is considered a rehabilitation brace (also known as a post-operative or post-injury brace) and is considered an integral part of the orthopedic surgical or fracture care protocol. Examples include: Bledsoe Postop Brace, DonJoy IROM Brace.
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A prefabricated knee orthosis with double uprights and adjustable knee joints or adjustable flexion and extension joints that provides both medial-lateral and rotation control, for members who are ambulatory and have knee instability due to any of the following:
- Neurologic disorders (e.g., cerebral palsy, hemiplegia, multiple sclerosis, paraplegia)
- Immunologic condition (e.g., juvenile idiopathic arthritis, rheumatoid arthritis)
- Knee arthritis (e.g., chondromalacia patellae, osteoarthritis); aseptic necrosis of the tibia/fibula; knee osteonecrosis
- Dislocations and subluxations affecting the knee
- Congenital disorders and malformations of the knee
- Disruptions of the knee ligaments, articular cartilage and meniscus
- Strains of muscles and tendons of the lower leg
- Disorders of knee joint prostheses or internal fixation devices
- Failed total knee arthroplasty
- Knee fractures (e.g., tibial plateau fracture);
Knee instability must be documented by examination of the member and objective description of joint laxity (e.g., varus/valgus instability, anterior/posterior Drawer test). For persons with these indications, valgus or varus bracing alleviates pressure on the medial or lateral compartment of the knee. Knee braces will be denied if only pain or a subjective description of joint instability is documented.
- A prefabricated knee orthosis, Swedish type (i.e., knee orthoses with double uprights and thigh and calf pads) for a member who is ambulatory and has knee instability due to genu recurvatum - hyperextended knee. Knee instability must be documented by examination of the member and objective description of joint laxity (e.g., varus/valgus instability, anterior/posterior Drawer test);
- Knee braces may be custom-fitted prefabricated or custom-made. Custom-made functional braces (also known as "custom-fabricated" or "molded" knee orthoses) are considered medically necessary if the member meets criteria for a prefabricated knee brace above but is unable to be fitted with a custom-fitted prefabricated knee brace. Examples of situations in which a person may meet criteria for a custom-made knee brace include, but are not limited to:
- A deformity of the knee or leg that interferes with fitting;
- Disproportionate size of thigh and calf;
- Minimal muscle mass upon which to suspend an orthosis;
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 in cases where the member is non-ambulatory. Custom-fabricated orthoses are considered experimental, investigational, or unproven when criteria are not met.
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A custom fabricated knee immobilizer without joints, if both of the following are met:
- Medical necessity criteria for the prefabricated knee orthosis without joints is met; and
- The general criterion defined above for a custom fabricated orthosis is met;
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A custom fabricated derotation knee orthosis for instability due to internal ligamentous disruption of the knee (such as due to ligament deficiency/insufficiency or reconstruction);
Note: When used for this indication, the knee brace is considered a functional (derotational) knee brace and is considered DME. Examples include: Lenox Hill Brace, Boston Knee Brace, DonJoy CI Brace.
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A custom fabricated knee orthosis with an adjustable flexion and extension joint if both criteria are met:
- The medical necessity criteria for the knee orthosis, with an adjustable flexion and extension joint that provides both medial-lateral and rotation control are met; and
- The general criterion defined above for a custom fabricated orthosis is met;
- A custom fabricated knee orthosis with a modified supracondylar prosthetic socket for a member who is ambulatory and has knee instability due to genu recurvatum - hyperextended knee;
- Heavy duty knee joint codes (L2385, L2395) only for members who weigh more than 300 pounds;
- Up to 2 removable soft interfaces per year beginning 1 year after the date of service for initial issuance of the orthosis;
- Concentric adjustable torsion style mechanisms used to assist knee joint extension for members who require knee extension assist in the absence of any co-existing joint contracture (for the use of concentric adjustable torsion style mechanisms used for joint contracture, see CPB 0405 - Mechanical Stretching Devices for Contracture and Joint Stiffness);
- Knee braces composed of high-strength, light-weight material for persons who meet criteria for a knee orthosis and whose weight is greater than 250 lbs. Knee braces composed of high-strength, light-weight material are considered experimental, investigational, or unproven for other indications;
Note: Code L2755 (ADDITION TO LOWER EXTREMITY ORTHOSIS, HIGH STRENGTH, LIGHTWEIGHT MATERIAL, ALL HYBRID LAMINATION/PREPREG COMPOSITE, PER SEGMENT, FOR CUSTOM FABRICATED ORTHOSIS ONLY) describes an addition to a lower extremity orthosis composed of high strength and/or light-weight material such as Kevlar®, carbon fiber or other laminated or impregnated composite material.
- Diagnostic sockets/braces are included in the orthosis fabrication and not separately payable (includes fitting and adjustment);
- Osteoarthritis braces (unloader braces) - prefabricated unloader braces are considered medically necessary DME as an alternative to surgery for members with severe symptomatic osteoarthritis of the knee or patello-femoral osteoarthritis who have pain that has failed to respond to medical therapy and knee bracing with a neoprene sleeve, who have progressive limitation in ADL, and who do not have any of the following:
- Arthritis other than osteoarthritis; or a recent knee operation (within the previous 6 weeks); or
- Diseases that would preclude use of a brace (e.g., skin disease, peripheral vascular disease, or varicose veins); or
- Inability to apply the brace because of physical limitations such as arthritis of the hands or inability to bend over; or
- Paresis or other disease that would preclude ambulation; or
- Severe cardiovascular deficit; or
- Symptomatic disease of the hip, ankle or foot.
Aetna does not consider warranties or guarantees beyond the base warranty included in a device a medical benefit. Additional warranties and guarantees beyond the included base warranty or manufacturer warranty, are considered non-medically necessary convenience items. Items billed for replacement that are still under manufacturer warranty are considered not medically necessary.
Fiberglass versus Plaster Casts: The casting material used in fracture care can be either fiberglass or plaster. The choice of material is dictated by the individual situation and is left to the discretion of the treating practitioner.
A custom-fabricated unloader brace may be considered medically necessary for members who meet criteria for a prefabricated unloader brace and meet medical necessity criteria for a custom-made brace noted in the section on functional and rehabilitation knee braces above. Unloader braces are considered experimental, investigational, or unproven when criteria are not met.
Note: Socks and braces sleeves are not considered medically necessary supplies when used in conjunction with knee orthoses.
Note: Please see Appendix for guidelines on the reasonable usable lifetime of knee orthoses. These guidelines also provide the medically necessary frequency of replacement interfaces.
Knee braces composed of high-strength, light-weight material are not considered medically necessary for persons whose weight is less than 250 lbs. Knee braces composed of high-strength, light-weight material are considered experimental, investigational, or unproven for other indications.
Concentric adjustable torsion style mechanisms used for the treatment of contractures, regardless of any co-existing condition(s), are coded as E1810, E1813, and/or E1814 and are covered under the Durable Medical Equipment (DME) benefit.
Claims for devices incorporating concentric adjustable torsion style mechanisms used for the treatment of any joint contracture and coded as L2999 will be denied as incorrect coding.
There is no separate payment for computer-aided design/computer-aided manufacturing (CAD/CAM) technology when it is used to fabricate an orthosis. Reimbursement of the CAD/CAM technology utilized in the fabrication of an orthosis is included in the allowance of the orthosis HCPCS code.
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Documentation Requirements
In order to justify payment for DME items, suppliers must meet the following requirements:
- Standard Written Order (SWO)
- Medical Record Information (including continued need/use if applicable)
- Correct Coding
- Proof of Delivery.
Treating practitioner means physician as defined in section 1861(r)(1) of the Medicare Act, or physician assistant, nurse practitioner, or clinical nurse specialist, as those terms are defined in section 1861(aa)(5) of the Act.
A Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.
The supplier must have received a SWO, which lists the base item and which lists all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items.
If the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed SWO of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary.
A Standard Written Order must contain all of the following elements:
- Member's Name or ID Number: The full name or Aetna member identification number of the patient,
- Order Date: The date the prescription was written,
- General Description of the Item(s): This can be a general description (e.g., "wheelchair"), a Healthcare Common Procedure Coding System (HCPCS) code, or a specific brand name and model number,
- Quantity: The number of items to be dispensed, if applicable,
- Treating Practitioner Information: The full name or National Provider Identifier (NPI) of the treating practitioner,
- Treating Practitioner Signature: The treating practitioner's signature; this confirms they have reviewed and approved the order.
Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made upon request. All services that do not have appropriate proof of delivery from the supplier shall be denied as not reasonable and necessary.
The Proof of Delivery document must include:
- Member’s name
- A description of the item(s) being delivered. The description can be either a narrative description (e.g., light-weight wheelchair base), a HCPCS code, the long description of a HCPCS code, or a brand name/model number
- Quantity delivered
- Date delivered
- Member (or designee) signature.
The date delivered on the POD must be the date that the DMEPOS item was received by the beneficiary or designee. The date of delivery may be entered by the beneficiary, designee, or the supplier. When the supplier's delivery documents have both a supplier-entered date and a beneficiary or beneficiary's designee signature date on the POD document, the beneficiary (or designee) entered date is the proof of delivery (DOS).
Suppliers, their employees, or anyone else having a financial interest in the delivery of the item(s) are prohibited from signing and accepting an item on behalf of a member (i.e., acting as a designee on behalf of the beneficiary). The relationship of the designee to the beneficiary should be noted on the proof of delivery obtained by the supplier (i.e., spouse, neighbor). The signature of the designee should be legible. If the signature of the designee is not legible, the supplier should note the name of the designee on the proof of delivery.
Product information such as manufacturer, part number or part name must be recorded in the medical records.
An item/service is correctly coded when it meets all the coding guidelines listed in Aetna Policies, CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded.
Some replacement items have unique Healthcare Common Procedure Coding System (HCPCS) codes. Replacement components that do not have a unique HCPCS code must be billed with a "not otherwise specified" code - L2999.
Items that have unique codes must not be billed using a NOC code.
Addition codes K0672, L2390, L2750, L2780, L4002 are for billing of replacement component(s) and are not payable at initial issue of a base orthosis. When code L4002 is billed at the time of initial issue of a base orthosis, it will be denied as not separately payable.
Should a supplier wish to submit a claim for services/items that are included in the allowance for the orthosis, code L9900 (ORTHOTIC AND PROSTHETIC SUPPLY, ACCESSORY, AND/OR SERVICE COMPONENT OF ANOTHER HCPCS "L" CODE) must be used. Code L9900 is denied as not separately payable.
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Experimental and Investigational
The following DME and supplies are considered experimental, investigational, or unproven because the effectiveness for the specified indication(s) has not been established (not an all-inclusive list):
- A prefabricated knee orthosis, double upright with adjustable joint, with inflatable air support chambers because there is no proven clinical benefit to the inflatable air bladder incorporated into their design;
- Prefabricated knee orthoses for other indications because their effectiveness for indications other than the ones listed as medically necessary (above) has not been established;
- Prophylactic knee braces are designed to reduce the likelihood or severity of knee ligament injuries in a relatively normal (stable) knee. Prophylactic knee braces are considered experimental, investigational, or unproven. The American Academy of Orthopedic Surgeons has concluded that prophylactic bracing has not been proven to be effective and, in some cases, may actually contribute to knee injury;
- The Ottobock E-Mag electronically locking knee brace;
- Levitation 2 bionic knee brace;
- Cymedica QB1 knee brace;
- Adjustable click systems (e.g., Revo and Boa click systems).
Note: Prophylactic, inflatable or elastic (neoprene) supports do not meet Aetna's definition of covered DME because they are not durable (not made to withstand prolonged use) and because they are not mainly used in the treatment of disease or injury or to improve body function lost as the result of a disease or injury.
Note: Most Aetna traditional plans cover durable medical equipment (DME) as a standard benefit. Standard Aetna HMO plans do not cover DME without a policy rider. Please check benefit plan descriptions for details. Certain orthopedic casts, braces and splints are covered under HMO plans without the DME rider because their use is integral to the treatment of certain orthopedic fractures and recovery after certain orthopedic procedures.
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Policy Limitations and Exclusions
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Consistent with DME MAC policy:
Treating practitioner means physician (MD or DO) or physician assistant, nurse practitioner, or clinical nurse specialist. A prosthetist, orthotist, orthotic fitter, pedorthotist, physical therapist, or occupational therapist is not considered a treating practitioner.
A new prescription from the treating practitioner is required each time a new device or repair is requisitioned.
There must be sufficient medical information included in the medical record to demonstrate that all applicable coverage criteria are met.
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Consistent with DME MAC policy:
Supplier prepared statements and physician attestations by themselves do not provide sufficient documentation of medical necessity, even if signed by the ordering physician.
"Neither a practitioner’s order, nor a supplier-prepared statement, nor a practitioner’s attestation by itself provides sufficient documentation of medical necessity, even though it is signed by the treating practitioner or supplier. There must be information in the member’s medical record that supports the medical necessity for the item and substantiates the information on a supplier-prepared statement or treating practitioner’s attestation (if applicable)."
"Forms are subject to corroboration with information in the medical record."
Records from suppliers or healthcare professionals with a financial interest in the claim outcome are not considered sufficient by themselves for the purpose of determining that an item is reasonable and necessary.
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Consistent with DME MAC policy
A Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not medically necessary.The SWO must contain all the following elements:
- Member's name or Identification Number
- Order Date
- General description of the item
- The description can be either a HCPCS code, a HCPCS code narrative, or a brand name/model number
- In addition to the description of the base item, the SWO must include all concurrently ordered options, accessories or additional features that are separately billed or require an upgraded code (list each separately).
- For supplies - in addition to the description of the base item, the order/prescription must include all concurrently ordered supplies that are separately billed (iist each separately)
- Each item or service requested must individually list the HCPCS code (Procedure code) and Quantity to be dispensed
- Treating Practitioner Name and National Provider Identifier (NPI)
- Treating practitioner's signature.
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Code Verification Review
Consistent with CMS policy, the only products which may be billed using the following list of HCPCS codes are those for which a written coding verification review (CVR) has been made by the Pricing, Data Analysis, and Coding (PDAC) contractor and subsequently published on the appropriate Product Classification List:
- L1832
- L1833
- L1843
- L1845
- L1851
- L1852
Information concerning the documentation that must be submitted to the PDAC for a CVR can be found on the PDAC website or by contacting the PDAC. A Product Classification List with products which have received a coding verification can be found on the PDAC website.
Product information such as manufacturer, part number or part name must be recorded in the medical records.
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Related Policies
- CPB 0009 - Orthopedic Casts, Braces and Splints
- CPB 0398 - Idiopathic Scoliosis
- CPB 0399 - Upper Limb Prostheses
- CPB 0405 - Mechanical Stretching Devices for Contracture and Joint Stiffness
- CPB 0451 - Foot Orthotics
- CPB 0565 - Ankle Orthoses, Ankle-Foot Orthoses (AFOs), and Knee-Ankle-Foot Orthoses (KAFOs)
- CPB 0578 - Lower Limb Prostheses
Background
This policy is based primarily on Medicare DME MAC criteria for spinal orthoses and knee orthoses.
Prosthetics are devices (other than dental) that replace all or part of an internal body organ (including contiguous tissue), or replace all or part of the function of a permanently inoperative or mal-functioning internal body organ. This does not require a determination that there is no possibility that the patient’s condition may improve sometime in the future. If the medical record, including the judgment of the attending practitioner, indicates that the condition is of long and indefinite duration, the test of permanence is considered met.
An orthosis (brace) is a rigid or semi-rigid device that is used for the purpose of supporting a weak or deformed body member or restricting or eliminating motion in a diseased or injured part of the body. It must provide support and counterforce (i.e., a force in a defined direction of a magnitude at least as great as a rigid or semi-rigid support) on the limb or body part that it is being used to brace. An orthosis can be classified as either prefabricated (off-the-shelf or custom fitted) or custom-fabricated.
A custom fabricated item is one that is individually made for a specific patient. No other patient would be able to use this item. A custom fabricated item is a device which is fabricated based on clinically derived and rectified castings, tracings, measurements, and/or other images (such as X-rays) of the body part. The fabrication may involve using calculations, templates, and components. This process requires the use of basic materials including, but not limited to, plastic, metal, leather, or cloth in the form of uncut or unshaped sheets, bars, or other basic forms and involves substantial work such as vacuum forming, cutting, bending, molding, sewing, drilling, and finishing prior to fitting on the patient.
A molded-to-patient-model is a particular type of custom fabricated device in which either:
- An impression (usually by means of a plaster or fiberglass cast) of the specific body part is made directly on the patient, and this impression is then used to make a positive model of the body part from which the final product is crafted; or
- A digital image of the patient’s body part is made using Computer-Aided Design-Computer-Aided Manufacturing (CAD-CAM) systems software. This technology includes specialized probes/digitizers and scanners that create a computerized positive model, and then direct milling equipment to carve a positive model. The device is then individually fabricated and molded over the positive model of the patient.
- An impression (usually by means of a plaster or fiberglass cast) of the specific body part is made directly on the patient, and this impression is then used to make a positive model of the body part from which the final product is crafted; or
- A digital image of the patient’s body part is made using Computer-Aided Design-Computer-Aided Manufacturing (CAD-CAM) systems software. This technology includes specialized probes/digitizers and scanners that create a computerized positive model, and then direct milling equipment to carve a positive model. The device is then individually fabricated and molded over the positive model of the patient.
Positive Model of the Patient: A molded-to-patient-model is a negative impression taken of the patient’s body member and a positive model rectification is constructed. In positive models, a CAD-CAM system, by use of digitizers, transmits surface contour data to software that the practitioner uses to rectify or modify the model on the computer screen. The data depicting the modified shape is electronically transmitted to a commercial milling machine that carves the rectified model. Alternatively, a direct formed model is one in which the patient serves as the positive model. The device is constructed over the model of the patient and is then fabricated to the patient. The completed custom fabrication is checked and all necessary adjustments are made. There is no separate billing if CAD-CAM technology is used to fabricate an orthosis.
Custom fitted orthotics are defined as devices that are prefabricated. They may or may not be supplied as a kit that requires some assembly. They all require fitting and adjustment (for example, the item must be trimmed, bent, molded [with or without heat], or otherwise modified by an individual with expertise in customizing the fit in order for it to be used by a specific patient). Custom fitted requires modification of the item in order to provide an individualized fit. Modifications must result in alterations in the item beyond simple adjustments made by bending, trimming, and/or molding of the item, installation of add-on components or assembly of the item. Custom fitted orthotics are:
- Devices that are prefabricated.
- They may or may not be supplied as a kit that requires some assembly. Assembly of the item and/or installation of add-on components and/or the use of some basic materials in preparation of the item does not change classification from OTS to custom fitted.
- Classification as custom fitted requires substantial modification for fitting at the time of delivery in order to provide an individualized fit, i.e., the item must be trimmed, bent, molded (with or without heat), or otherwise modified resulting in alterations beyond minimal self-adjustment.
- This fitting at delivery does require expertise of a certified orthotist or an individual who has equivalent specialized training in the provision of orthosis to fit the item to the individual member.
Use of CAD/CAM or similar technology to create an orthosis without a positive model of the patient may be considered as custom fitted if the final fitting upon delivery to the patient requires substantial modification requiring expertise as described in this section.
Off-the-shelf (OTS) orthotics are defined as those prefabricated items which require minimal self-adjustment for appropriate use and do not require expertise in trimming, bending, molding, assembling, or customizing to fit to the individual. Off-the-shelf (OTS) orthotics are:
- Items that are prefabricated.
- They may or may not be supplied as a kit that requires some assembly. Assembly of the item and/or installation of add-on components and/or the use of some basic materials in preparation of the item does not change classification from OTS to custom fitted.
- OTS items require minimal self-adjustment for fitting at the time of delivery for appropriate use and do not require expertise in trimming, bending, molding, assembling, or customizing to fit an individual.
- This fitting does not require expertise of a certified orthotist or an individual who has equivalent specialized training in the provision of orthoses to fit the item to the individual member.
Fabrication of an orthosis using CAD/CAM or similar technology without the creation of a positive model with minimal self-adjustment at delivery is considered as OTS. There is no separate payment if CAD-CAM technology is used to fabricate an orthosis. Reimbursement is included in the allowance of the codes for custom fabricated orthoses.
Substantial modification is defined as changes made to achieve an individualized fit of the item that requires the expertise of a certified 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, Inc., or by the Board for Orthotist/Prosthetist Certification.
Minimal self-adjustment is defined as an adjustment the member, caretaker for the member, or supplier of the device can perform and that does not require the services of a certified orthotist (that is, an individual who is certified by the American Board for Certification in Orthotics and Prosthetics, Inc., or by the Board for Orthotics/Prosthetist Certification) or an individual who has specialized training. For example, adjustment of straps and closures, bending or trimming for final fit or comfort (not all-inclusive) fall into this category.
Specialized Training: Individuals with specialized training necessary to provide custom fitting services for patients with a medical need for orthotics include: a physician, a treating practitioner (a physician assistant, nurse practitioner, or clinical nurse specialist), an occupational therapist, or physical therapist in compliance with all applicable Federal and State licensure and regulatory requirements.
Kits are a collection of components, materials and parts that require further assembly before delivery of the final product. The elements of a kit may be packaged and complete from a single source or may be an assemblage of separate components from multiple sources by the supplier.
Evaluation of the member, measurement and/or casting, diagnostic fittings, diagnostic sockets/braces and fitting/adjustments of the orthosis are included in the allowance for the orthosis. There is no separate payment for these services.
For prefabricated orthoses, there is no physical difference between orthoses coded as custom fitted versus those coded as off-the-shelf. The differentiating factor for proper coding is the need for "minimal self-adjustment" at the time of fitting by the member, caretaker for the member, or supplier. This minimal self-adjustment does not require the services of a certified orthotist or an individual who has specialized training. Items requiring minimal self-adjustment are coded as off-the-shelf orthoses. For example, adjustment of straps and closures, bending or trimming for final fit or comfort (not all-inclusive) fall into this category. Fabrication of an orthosis using CAD/CAM or similar technology without the creation of a positive model with minimal self-adjustment at delivery is considered as OTS. Items requiring substantial modification by a qualified practitioner are coded as custom fitted. For custom fabricated orthoses, there must be detailed documentation in the supplier’s records to support the medical necessity of that type device rather than a prefabricated orthosis.
Knee Orthoses
A prefabricated elastic knee orthosis with joints describes a prefabricated knee orthoses constructed of latex, neoprene, spandex or other elastic material. There are no condylar pads. There are hinges or joints.
A prefabricated elastic knee orthosis with condylar pads and joints describes a prefabricated knee orthosis with hinges or joints, constructed of latex, neoprene, spandex or other elastic material. There are medial and lateral condylar pads.
A prefabricated canvas longitudinal knee immobilizer orthosis describes a prefabricated knee orthosis immobilizer, with rigid metal or plastic stays placed laterally and posteriorly. The interface material is constructed of canvas, closed cell foam or equal. The thigh and calf cuffs are one-piece construction held in place by Velcro straps or equal. The orthosis immobilizes the knee joint and prevents flexion or extension. There are no hinges or joints.
A prefabricated, locking knee joint, positional knee orthosis describes a prefabricated knee orthoses with joint(s) which lock the knee into a particular position. A prefabricated knee orthosis, double upright with adjustable joint, with inflatable air support chambers also have joints which lock the knee into a particular position; in addition, they have an air bladder in the space behind the knee. These orthoses are designed for members who are non-ambulatory. They are typically used to treat flexion/extension contractures of the knee.
An adjustable flexion and extension joint is one which enables the practitioner to set limits on flexion and extension but allows the member free motion of the knee within those limits. The increments of adjustability must be, at a minimum, 15 degrees. The joint may be either unicentric or polycentric.
A rigid prefabricated positional knee orthosis with adjustable knee joints (unicentric or polycentric) describes prefabricated knee orthoses that have double uprights and adjustable flexion and extension joints. Medial-lateral control of the knee is accomplished by the solid metal (or similar material) structure of the double uprights. They may have condylar pads. These orthoses are designed for a member who can bear weight on the knee and is capable of ambulation. They are typically used for early rehabilitation following knee surgery.
Rigid knee orthoses without a knee joints are designed to prevent knee motion. These orthoses are designed for members who can bear weight on the knee, are capable of ambulating, and need additional support provided through immobilization of the knee joint. They may be custom fabricated or prefabricated.
A custom-fabricated knee orthosis, derotation, medial-lateral, anterior cruciate ligament describes a custom fabricated knee orthosis with knee joints designed to protect the ligaments of the knee through medial-lateral torsion, providing stability and preventing rotation.
A knee orthosis (KO), single upright, thigh and calf, with adjustable flexion and extension joint (unicentric or polycentric), medial-lateral and rotational control, with or without varus/valgus adjustment, describes knee orthoses which are constructed of rigid thigh and calf cuffs and a single upright with an adjustable flexion and extension knee joint. It must have condylar pads. They may be prefabricated or custom-fabricated. It must have condylar pads. Through a series of straps/supports that cross over and around the knee joint, rotational control and varus or valgus force is exerted on the knee joint. These orthoses are designed to open the medial or lateral compartment of the knee to provide pain relief due to osteoarthritis. These orthoses are designed for persons who are fully ambulatory.
A knee orthosis, 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, describes knee orthoses that have double uprights, condylar pads, and an adjustable flexion and extension joint and provide both medial-lateral and rotation control. They may be prefabricated or custom-fabricated. Medial-lateral control of the knee is accomplished by the solid metal (or similar material) structure of the double uprights. Rotation control is accomplished by the combination of (i) solid metal (or similar material) in the anterior portion of the thigh and calf cuffs and (ii) the condylar pads. These orthoses are designed for members who are fully ambulatory.
A prefabricated, off-the-shelf, Swedish type knee orthosis describes a prefabricated orthosis with double uprights and thigh and calf pads. It may or may not have joints. These orthoses are used to prevent hyperextension of the knee joint in ambulatory members.
A custom-fabricated knee orthosis, modification of supracondylar prosthetic socket describes a custom fabricated orthosis without joints, constructed of plastic or other similar material. These orthoses are used to prevent hyperextension of the knee joint in ambulatory members.
An addition to lower extremity orthosis, high strength, lightweight material, all hybrid lamination/prepreg composite, per segment, for custom-fabricated orthoses describes an addition to a lower extremity orthosis composed of high strength and/or lightweight material such as kevlar, carbon fiber or other laminated or impregnated composite material.
Knee braces may be custom-fitted or custom-made. A custom-fitted prefabricated brace is one which only measurements and a sizing chart are needed for fitting. A custom-made (custom-fabricated or made-to-order) knee brace is one that requires an initial impression of the knee for fitting. Knee orthoses that are custom-fitted require the assistance of an orthotist in adjusting the brace to the correct size, but do not require an initial impression of the knee for fitting. Custom-made functional knee braces have not been shown to be medically superior to custom-fitted prefabricated functional knee braces. Therefore, use of custom-made functional knee braces is reserved for those patients who are hard to fit because of a deformity of the knee or leg that interferes with fitting. Exceptionally tall persons can be fitted into an custom-fitted prefabricated brace with extensions, short persons can be fitted with a pediatric custom-fitted prefabricated brace, and obese persons can be fitted into an custom-fitted prefabricated knee brace with extra large straps.
A classification scheme devised by the American Academy of Orthopedic Surgeons (AAOS) divides knee braces into 3 categories:
- Prophylactic knee braces are designed to reduce the likelihood of severity of knee ligament injuries in a relatively normal knee.
- Functional knee braces are designed to improve stability for an unstable or postoperative knee in activities of daily living and sports.
- Rehabilitative (or Rehabilitation) knee braces are designed to allow protected motion of an injured knee treated operatively or nonoperatively early after the injury.
Each of these types of braces will be discussed in turn below.
Prophylactic Knee Braces
Prophylactic knee braces and other protective gear (such as helmets, elbow pads, gloves, eye goggles, etc.) are considered safety items and are therefore not covered under terms of Aetna’s policies. Please check benefit plan descriptions.
The common occurrence of medial collateral sprains in football and other sports led to the fabrication of prophylactic hinge braces designed to prevent or attenuate this injury. These braces have lateral or sometimes medial and lateral hinges designed to absorb valgus impact to the knee. Prophylactic knee braces are available custom-fitted prefabricated (not custom-made) and without a prescription.
The effectiveness of prophylactic knee braces for collateral ligament injury to the knee is controversial. Prophylactic knee braces have not been shown to be effective. Indeed, some studies have shown that the risk of knee injury may be increased with use of prophylactic knee braces. Hald and Fandel (1996) explained that recent research has raised questions about the possibility of such braces "preloading" knee structures and predisposing the wearer to an increased risk of ligament injuries. These investigators concluded that "[w]e now feel that time and money might be better spent on preventive conditioning than for braces."
Functional Knee Braces
Functional knee braces are considered medically necessary if they are needed for activities of daily living, such as standing, walking, and climbing stairs, and thus are worn throughout the day. Functional knee braces are considered not medically necessary when used primarily for sports, because participation in sports is considered an elective activity.
Functional knee braces are designed to provide support to the knees made unstable by injury or to provide additional protection following surgery to correct such instabilities. They are usually recommended in the postoperative period and after completion of rehabilitation when full activity is resumed, or for the patient with a diagnosis of anterior cruciate ligament insufficiency in whom a nonoperative approach is used.
Some of these braces are ready-made in sizes to provide for immediate fit (so-called custom-fitted prefabricated braces). Others require custom construction based on some form of cast molding or measurement of the person’s leg (so called custom-made or custom-fabricated braces). Functional braces usually involve some form of hyperextension stop, as well as straps or fitted shells to control rotation. There is no clear-cut advantage of shell braces over strap braces.
Functional knee braces are fabricated from a variety of materials, including carbon composites, aluminum, and kevlar. Despite their relatively high cost, knee braces composed of carbon composites (also known as carbon fiber or graphite) are favored by competitive athletes because of their lightness. There are, however, no medical advantages of carbon fiber braces over braces composed of materials that are heavier, but equally as strong, such as steel or aluminum. A variety of suspension systems and knee joint designs are used in functional knee braces. There is, however, no evidence of medical benefits from one knee joint design over another. Therefore, custom-made braces is considered medically necessary only for persons who cannot be fit into off the shelf braces because deformity. Even persons who are very tall or markedly obese, however, can be fitted with custom-fitted prefabricated functional braces that have been modified with attachments, such as extensions and extra long straps.
Functional knee braces are most commonly used in persons with prior ligamentous knee injuries. The ligaments of the knee include the anterior cruciate ligament (ACL), the posterior cruciate ligament (PCL), the lateral collateral ligament (LCL), and the medial collateral ligament (MCL). The use of functional braces for injuries involving each of these ligaments is described below:
Up to 70 % of acute ACL injuries occur during sports. Episodes occur during sports requiring quick turns, sudden stopping, jumping, or lateral movements (such as football, volleyball, basketball, and racquetball). The diagnosis of an acutely torn anterior cruciate ligament (ACL) is based on the circumstance of the injury as reported by the patient and the stability assessment during the physical examination. Lachman’s test of assessing the anterior translation of the tibia on the femur with the knee in 20 to 30 degrees of flexion is the most accurate diagnostic examination. For patients treated conservatively, optional bracing has been used after rehabilitation to assist patients in returning to low-demand activity. However, neuromuscular rehabilitation and activity modification are far more important.
The use of the functional brace for the ACL-deficient knee remains controversial. Laboratory studies have shown that functional braces do not prevent abnormal tibial displacement, even at physiologic loads. However, persons with prior cruciate ligament injuries subjectively feel more secure in these devices.
Loss of the anterior cruciate ligament has been associated with a loss of ability to detect knee joint motion due to disruption of normal efferent pathways. Some have conjectured that knee braces can substitute for this lost pathway, and that subjective improvements while wearing the brace are due to heightened propioception (position sense), although the evidence supporting this hypothesis is inconclusive. Others feel that psychological support may be the greatest benefit of functional braces. Despite the subject’s subjective improvement, giving away episodes can occur in spite of wearing the functional brace. The AAOS concluded that the “scientific rationale for this ‘security’ is not clear, but perhaps related to the fact that the devices do provide warmth and increased knee awareness” (AAOS, 1991).
No study has demonstrated medically significant advantages of custom-made functional knee braces over custom-fitted prefabricated functional knee braces in patients with knee ligament injuries. Because the benefits of functional knee braces are due to their ability to effect heightened proprioception and to the sense of security the impart, the precise fitting of the brace, as through custom-fabrication or custom-molding, is not essential to its effectiveness.
More than 50 functional braces are on the market, with no clear-cut advantage for any brand. “[B]eing aware of the growing number of ‘off the shelf’ functional braces on the market, physicians and clinicians must decide whether the custom-made brace is worth the extra cost to the athlete or patient if the protection offered is proprioceptive in nature” (Harrelson, 1991). Reider explained that “[w]e currently favor the new generation of custom-fitted prefabricated braces for economic reasons, saving the more expensive custom-molded types for the harder-to-fit athlete” (Reider et al, 1996).
In proving that one brace is superior to another, the manufacturer must demonstrate brace efficacy in studies designed to approximate the in vivo situation. Current studies do not provide adequate evidence to conclude that custom-made functional knee braces result in medical benefits beyond those provided by custom-fitted prefabricated braces. The manufacturer claiming superiority of their brace must be asked to verify claims and to provide documentation of efficacy.
The medial collateral ligament is the most commonly injured knee ligament in sports. Persons with a first-degree MCL sprain need only wear a knee immobilizer for a few days, and no functional brace is necessary.
A first-degree sprain is, by definition, an injury to the ligament in which there is no increased laxity of that ligament. If there is laxity present, then there is either a second- or third-degree sprain. A second-degree sprain is differentiated clinically from a third degree sprain by the feel of the "end-point" on examination and the amount of laxity. A second-degree sprain has a "firm" end point on stressing, as the ligament fibers that were not torn in the injury become taut. A third-degree sprain has a "soft" end point, as translation is gradually stopped when other ligaments and tendon fibers (secondary restraints) become taut.
For the patient with a second-degree MCL sprain (partial tear), it is appropriate to prescribe an custom-fitted prefabricated functional knee brace after the rehabilitative knee brace is removed, and have the patient use this brace for up to 8 weeks after injury.
Isolated third-degree MCL injuries (complete tear) may be treated with a hinged rehabilitative brace, rather than a knee immobilizer, for the first 6 weeks after injury. (An isolated MCL sprain is one where the ACL and PCL (posterior cruciate ligament) have been proven intact by MRI and instrumented laxity testing.) It is recommended that following the acute injury, a functional brace be worn for 4 to 6 months.
The posterior cruciate ligament is infrequently injured. Functional bracing has little role in PCL injuries because there is no clinical benefit or biomechanical evidence for the use of a functional brace in the PCL-injured knee.
The lateral collateral ligament is the least frequently injured of all the knee ligaments in sports because the knee is usually protected from a blow to the medial side by the person's other leg. Treatment for first- and second-degree sprains follows the same program and a very similar time frame that was used for MCL injuries. A custom-fitted prefabricated functional brace is appropriate for the patient that desires early return to activity. Operative referral is necessary for patients with third-degree sprains.
Evidence is insufficient to support the use of knee braces as a treatment for patellofemoral pain syndrome. In a Cochrane review on orthotic devices for treating patello-femoral pain syndrome, D'hondt et al (2002) concluded that the evidence from randomized controlled trials is currently too limited to draw definitive conclusions about the use of knee and foot orthotics for the treatment of patellofemoral pain. The authors stated that future high quality trials in this field are warranted. An earlier systematic evidence review of treatments for patellofemoral pain similarly concluded that, "[d]ue to the low quality and quantity of the current evidence, the use of patellofemoral orthoses ... cannot be supported or refuted" (Crossley et al, 2001). In a review on the management of patients with patello-femoral pain syndrome, Dixit and colleagues (2007) stated that there is little evidence to support the routine use of knee braces or non-steroidal anti-inflammatory drugs.
Rehabilitative (or Rehabilitation) Knee Braces
Rehabilitative (or rehabilitation) braces are used as alternatives to knee immobilizers used immediately after surgery or injury to both control knee motion and protect the knee during rehabilitation. Rehabilitative knee orthoses offer the patient early limited mobility to improve recovery time and decrease the effects of disuse on the graft or reconstructed ligament.
Rehabilitative knee orthoses are custom-fitted prefabricated, and can be ordered either as small, medium, or large, or by a size chart. Most of them can be adjusted within each size to allow for edema or atrophy, and thus can be conveniently stocked in a hospital or clinic for quick fittings.
In collateral ligament injuries that do not involve a complete tear (second degree injuries), the torn fibers are internally splinted from excessive stress by the intact ligament fibers, and the use of the knee immobilizer or rehabilitative brace is only for comfort.
There are few objective studies offering objective data about the stabilizing effects of various types, and no guidelines for choosing any particular rehabilitative knee brace over another. Choice of rehabilitation brace is usually based on availability, ancillary features, and ease of use.
Rehabilitative knee braces do not require precise fitting (and, hence, are never custom-made) because their size must be repeatedly readjusted throughout the course of rehabilitation to accommodate changes in swelling that occur following injury or surgery to the knee.
The Ottobock E-Mag Electronically Locking Knee Brace
The Ottobock E-Mag electronically locking knee brace supposedly offers wearers increased stability when standing and helps patients achieve a more active lifestyle. It features an electronically controlled lock that is activated by a small remote control to provide absolute stability in the stance phase. The lock is activated with the touch of a button, allowing the wearer to support themselves with both arms and stand safely at all times. The Ottobock E-Mag's special feedback system also informs the wearer when the joint is opening.
The WorkSafeBC Evidence-Based Practice Group’s report on the “E-MAG Active” (Edeer and Martin, 2010) stated that “E-MAG Active has recently been introduced by Otto Bock as a SCKAFO [Stance Control Knee Ankle Foot Orthoses] that utilizes an electromagnetic technique (hence, the name E-MAG which refers to this Electronic Magnet). It became available in the market in North America in December 2008 …. To use E-MAG Active the patient is required to have both functional extensors and flexors of the hip with a strength of 3 to 5 (based on the Kendall and Kendall scale). The patient must also have the capacity for full extension of the knee, both prior to the initial contact and at the terminal stance (to lock and unlock the knee) …. Otto Bock recommends E-MAG Active for “patients that present with flaccid paralysis/paresis of the knee extensors coupled with limited ankle ROM” …. Currently, there are no review articles, or any other study papers (case reports, comparative studies, or cost effectiveness studies) specifically about E-MAG Active …. There is no specific coverage policy regarding E-MAG Active at WorkSafeBC …. The policy manual of the US Department of Veterans Affairs contains a section on “orthotics” but does not include a specific policy regarding E-MAG Active or SCKAFOs in general …. We did not come across any specific coverage policy on E-MAG Active from any of the searched workers compensation organizations or health insurance companies”.
Cymedica QB1 Knee Brace
The CyMedica QB1 Knee Brace is used for the treatment of quadriceps muscle atrophy. It employs neuromuscular electrical stimulation (NMES) technology for the treatment of quadriceps muscle atrophy and combines 3 products: a post-operative knee brace, a form-fitting conductive garment, and a NMES control interface. The device simplifies the delivery of "at home" NMES treatment and encourages patient compliance. However, there is a lack of published evidence on the safety and effectiveness of the CyMedica QB1 Knee Brace.
Levitation 2 Bionic Knee Brace
Budarick et al (2020) noted that knee osteoarthritis (OA) is a significant problem in the aging population, causing pain, impaired mobility, and decreased quality of life (QOL). Conservative treatment methods are necessary to reduce rapidly increasing rates of knee joint surgery. Recommended strategies include weight loss and knee bracing to unload knee joint forces. Although weight loss can be beneficial for joint unloading, knee OA patients often find it difficult to lose weight or exercise due to knee pain, and not all patients are over-weight. Uni-compartment off-loader braces can re-distribute joint forces away from 1 tibio-femoral (TF) compartment, however, less than 5 % of patients have uni-compartmental TFOA, while isolated patella-femoral (PF) or multi-compartmental OA are much more common. By absorbing body weight and aiding the knee extension moment using a spring-loaded hinge, sufficiently powerful knee-extension-assist (KEA) braces could be useful for unloading the whole knee. These researchers described the design of a spring-loaded tri-compartment unloader (TCU) knee brace intended to provide unloading in all 3 knee compartments while weight-bearing, measured and compared the force output of the TCU against the only published and commercially available KEA brace, and calculated the static unloading capacity of each device. The TCU and KEA braces delivered maximum assistive moments equivalent to reducing body weight by 45 and 6 lbs, respectively. The authors concluded that sufficiently powerful spring-loaded knee braces showed promise in a new class of multi-compartment unloader knee orthoses, capable of providing a clinically meaningful unloading effect across all 3 knee compartments.
Bracing for Patella-Femoral Osteoarthritis
In a prospective, randomized study, Merino and colleagues (2021) compared the long-term effects of a brace designed to stabilize the patella-femoral (PF) joint in comparison to a standard neoprene sleeve for the knee with patellar hole in patients with patella-femoral osteoarthritis (PFOA). A total of 38 patients with PFOA and co-morbidities received either a functional PF brace (Study Group, SG) or a neoprene sleeve for the knee (Control Group, CG). Both groups received clinical treatment to OA and co-morbidities according to a program from the institution. Patients were examined with Western Ontario and MacMaster (WOMAC) and Lequesne questionnaires, 30-second chair stand test (30CST), Timed Up and Go (TUG), anthropometric measures and self-reported physical activity in minutes/week at inclusion, 1, 3 and 12 months after placing the brace. X-Rays were taken to measure the angles. At 1year there was more abandonment in the CG without differences in weight and body mass index (BMI) between groups during the study. The SG maintained improvements in Lequesne and WOMAC total and subsets during the year, whereas the CG returned to baseline values for pain, function and total (p < 0.01). TUG and 30CST results were always better in the study group without any clinically important improvement in both groups. The authors concluded that long-term use of functional brace added to self-management program improved pain and function in patients with PFOA. Level of Evidence = II.
In a prospective, randomized trial, Yamamoto and associates (2021) compared the effect of a brace designed to stabilize the PF joint to that of a patella-shaped neoprene sleeve with patella cut out in patients with PFOA. A total of 57 patients with PFOA were allocated to 2 groups -- patients with PF functional brace and those with a neoprene knee with a patellar orifice. Both groups underwent clinical treatment of OA and used medications daily 1 month before and up to 3 months after brace placement. They were evaluated with the WOMAC and Lequesne questionnaires and performed 5 times sit to stand test, TUG test, and six-minute walk test (6MWT) immediately before and 1 and 3 months after brace placement. Both groups had improved pain, stiffness, and function with no difference between groups. Drug use decreased in both groups in the 1st month but increased in the 3rd month; naproxen use was progressively higher in the control group. The authors concluded that both knee orthoses improved pain and function and altered drug use only in the 1st month. They stated that functional knee brace provided analgesia without increased use of naproxen. Level of Evidence IB.
Furthermore, an UpToDate review on “Patellofemoral pain” (O'Connor and Mulvaney, 2021) states that “Although the foundation of treatment for PFP remains exercise and strengthening, if a patient cannot participate fully in rehabilitation exercises due to pain or does not make progress, it is reasonable to perform taping or patellofemoral bracing if this improves symptoms”.
Appendix
The following chart reflects the reasonable useful lifetime of prefabricated knee orthoses:
| Knee orthosis | Reasonable useful lifetime |
|---|---|
| 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.
Source: Noridian (2015).
Note: the reasonable useful lifetime of any knee brace for an adult not listed above is 5 years.
Only one knee brace per limb during Reasonable useful lifetime period is considered medically necessary.
A knee brace may be replaced due to documented anatomical growth in children.
The following table lists addition codes which describe components or features that can be and frequently are physically incorporated in the specified prefabricated base orthosis. Addition codes may be separately payable if both the base orthosis and the addition are medically necessary:
| Base Code | Additional codes eligible for separate reimbursement |
|---|---|
| L1810 | None |
| L1812 | None |
| L1820 | None |
| L1830 | None |
| L1831 | None |
| L1832 | L2397, L2795, L2810 |
| L1833 | L2397, L2795, L2810 |
| L1836 | None |
| L1843 | L2385, L2395, L2397 |
| L1845 | L2385, L2395, L2397, L2795 |
| L1847 | None |
| L1848 | None |
| L1850 | L2397 |
| L1851 | L2385, L2395, L2397 |
| L1852 | L2385, L2395, L2397, L2795 |
Source: Noridian, 2019.
The following table lists addition codes which describe components or features that can be and frequently are physically incorporated in the specified custom fabricated base orthosis. Addition codes may be separately payable if both the base orthosis and the addition are medically necessary:
| Base Code | Additional codes eligible for separate reimbursement |
|---|---|
| L1834 | L2795 |
| L1840 | L2385, L2390, L2395, L2397, L2405, L2415, L2425, L2430, L2492, L2755, L2785, L2795 |
| L1844 | L2385, L2390, L2395, L2397, L2405, L2492, L2755, L2785 |
| L1846 | L2385, L2390, L2395, L2397, L2405, L2415, L2492, L2755, L2785, L2795, L2800 |
| L1860 | None |
Source: Noridian, 2019.
All addition codes that are not listed as either separately payable or not reasonable and necessary in the tables in the LCD or as not separately payable in the tables above, describe components or features that either cannot be physically incorporated in the specified base orthosis or whose narrative description is incompatible with base orthosis code (e.g., billing a prefabricated base code with an addition code which specifies that it is only used with custom fabricated orthoses). These incompatible addition codes will be rejected as incorrect coding.
L-coded additions to knee orthoses (L2275, L2320, L2330, L2385, L2390, L2395, L2397, L2405, L2415, L2425, L2430, L2492, L2750, L2755, L2780, L2785, L2795, L2800, L2810, L2820, L2830, K0672) will be denied as noncovered when the base orthosis is noncovered.
A replacement removable soft interface for a knee orthosis is billed with code K0672 (ADDITION TO LOWER EXTREMITY ORTHOSIS, REMOVABLE SOFT INTERFACE, ALL COMPONENTS, REPLACEMENT ONLY, EACH). One unit of service includes all the components that are used at the same time on a single orthosis.
Either a nonremovable soft interface, L2820 (ADDITION TO LOWER EXTREMITY ORTHOSIS, SOFT INTERFACE FOR MOLDED PLASTIC, BELOW KNEE SECTION), L2830 (ADDITION TO LOWER EXTREMITY ORTHOSIS, SOFT INTERFACE FOR MOLDED PLASTIC, ABOVE KNEE SECTION), or two (2) removable soft interfaces (K0672) are included in the allowance for a knee orthosis. Soft interfaces billed separately at the time of initial issue will be denied as not separately payable.
Codes L2320 (ADDITION TO LOWER EXTREMITY, NON-MOLDED LACER, FOR CUSTOM FABRICATED ORTHOSIS ONLY) and L2330 (ADDITION TO LOWER EXTREMITY, LACER MOLDED TO PATIENT MODEL, FOR CUSTOM FABRICATED ORTHOSIS ONLY), non-molded and molded lacers, respectively, may only be billed as replacement items.
Claims for devices that contain a concentric adjustable torsion style mechanism in the knee joint and that are being used to treat any condition other than an assistive function to joint extension motion are not covered under the braces benefit and will be denied as incorrect coding when billed using code L2999.
Medically Necessary Quantity of Orthotics
Repairs to a covered orthosis due to wear or to accidental damage are covered when they are necessary to make the orthosis functional. The reason for the repair must be documented in the supplier's record. If the expense for repairs exceeds the estimated expense of providing another entire orthosis, no payment will be made for the amount in excess.
The allowance for the labor involved in replacing/repairing an orthotic component that is coded with a specific L-code is included in the allowance for that component. The allowance for the labor (L4205) involved in replacing/repairing an orthotic component that is coded with the miscellaneous code L4210 (REPAIR OF ORTHOTIC DEVICE, REPAIR OR REPLACE MINOR PARTS) is separately payable in addition to the allowance for that component. (Code L4210 must not be used for casting supplies or other materials used in the fitting or fabrication of an orthosis.)
The Coverage Table in the following link provides the medically necessary numbers of orthotics (Washington State Health Care Authority, 2022):
Prosthetic and orthotic device quantity limits
The table limits durable orthotics to generally 1 per limb per year.
References
The above policy is based on the following references:
- Albright JP, Saterbak A, Stokes J. Use of knee braces in sport. Current recommendations. Sports Med. 1995;20(5):281-301.
- Alquhaibi MS, Ghaddaf AA, Alomari MS, et al. Short leg cast versus orthotic removable support for the management of pseudo-Jones avulsion fracture: A systematic review and meta-analysis. Injury. 2022;53(2):739-745.
- American Academy of Orthopedic Surgeons. Protective equipment. In: Athletic Training and Sports Medicine. 2nd Edition. Rosemont, IL: American Academy of Orthopedic Surgeons; 1991:705-719.
- American Academy of Orthopedic Surgeons. The use of knee braces. Position statement. Chicago, IL: American Academy of Orthopedic Surgeons; 1987.
- Brouwer RW, Jakma TSC, Verhagen AP, et al. Braces and orthoses for treating osteoarthritis of the knee. Cochrane Database Syst Rev. 2005;(1):CD004020.
- Buckley SL. Current trends in the treatment of femoral shaft fractures in children and adolescents. Clin Orthop. 1997;338:60-73.
- Budarick A, MacKeil B, Fitzgerald S, Cowper-Smith C. Design and mechanical evaluation of a novel multi-compartment unloader knee brace. J Biomech Eng. 2020;142(1):014502 (8 pages).
- Chew KT, Lew HL, Date E, Fredericson M. Current evidence and clinical applications of therapeutic knee braces. Am J Phys Med Rehabil. 2007;86(8):678-686.
- CIGNA HealthCare Medicare Administration. Article for knee orthoses. DRAFT Policy Article (A22446). Philadelphia, PA: CIGNA Medicare; September 10, 2004.
- CIGNA HealthCare Medicare Administration. Knee orthoses - DRAFT (DL18253). Region D DMERC Local Coverage Determination. Philadelphia, PA: CIGNA Medicare; September 10, 2004.
- Crossley K, Bennell K, Green S, McConnell J. A systematic review of physical interventions for patellofemoral pain syndrome. Clin J Sport Med. 2001;11(2):103-110.
- D'hondt NE, Struijs PA, Kerkhoffs GM, et al. Orthotic devices for treating patellofemoral pain syndrome. Cochrane Database Syst Rev 2002;(2):CD002267.
- Dieppe P, Chard J, Faulkner A, et al. Osteoarthritis. In: Clinical Evidence. 2000;4:649-663.
- Dixit S, DiFiori JP, Burton M, Mines B. Management of patellofemoral pain syndrome. Am Fam Physician. 2007;75(2):194-202.
- Hald RD, Fandel DM. Taping and bracing. In: Office Sports Medicine. 2nd Edition. MB Mellion, ed. Philadelphia, PA: Hanley & Belfus, Inc.; 1996:337-354.
- Harrelson GL. Knee rehabilitation. In: Physical Rehabilitation of the Injured Athlete. JR Andrews, GL Harrelson, eds. Philadelphia, PA: W.B. Saunders Co.; 1991:328-329.
- Hewett TE, Noyes RF, Barber-Westin SD, et al. Decrease in knee joint pain and increase in function in patients with medial compartment arthrosis: A prospective analysis of valgus bracing. Orthopedics. 1998;21(2):131-138.
- 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.
- Kramer JF, Dubowitz T, Fowler P, et al. Functional knee braces and dynamic performance: A review. Clin J Sport Med. 1997;7(1):32-39.
- Lindenfeld TN, Hewett TE, Andriacchi TP. Joint loading with valgus bracing in patients with varus gonarthrosis. Clin Orthop. 1997;344:290-297.
- Littenberg B, Weinstein LP, McCarren M, et al. Closed fractures of the tibial shaft. A meta-analysis of three methods of treatment. J Bone Joint Surg Am. 1998;80(2):174-183.
- Liu SH, Mirzayan R. Current review. Functional knee bracing. Clin Orthop. 1995;317:273-281.
- McIvor JB, Ross P, Landry G, Davis LA. Treatment of femoral fractures with the cast brace. Can J Surg. 1984;27(6):592-594.
- Merino MGL, Morale V, Ocampos GP, et al. One-year results of bracing for patello-femoral osteoarthritis. Prospective randomized study. Acta Ortop Bras. 2021;29(3):127-131.
- Noridian Healthcare Solutions, LLC. Local Coverage Determination (LCD): Knee Orthoses (L33318). Durable Medical Equipment Medicare Administrative Contractor (DME MAC) Jurisdiction A/D. Fargo, ND: Noridian; effective January 1, 2019.
- O'Connor FG, Mulvaney SW. Patellofemoral pain. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed November 2021.
- Pollo FE, Jackson RW. Knee bracing for unicompartmental osteoarthritis. J Am Acad Orthop Surg. 2006;14(1):5-11.
- Reider B, Belniak R, Miller DW. Football. In: Sports Medicine: The School-Age Athlete. 2nd Edition. B Reider, ed. Philadelphia, PA: W.B. Saunders Co.; 1996:613-645.
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