An orthosis (brace) is a rigid or semi-rigid device which 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 either prefabricated or custom-fabricated.

For any item to be covered, it must: 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable statutory and regulatory requirements.  For the items addressed in this medical policy, the criteria for "reasonable and necessary" are defined by the following indications and limitations of coverage.

For an item to be covered by Medicare, a written signed and dated order must be received by the supplier before a claim is submitted.  If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not medically necessary.

Prefabricated Knee Orthoses (L1810, L1820, L1830-L1832, L1836, L1843, L1845, L1847, L1850)

A knee flexion contracture is a condition in which there is shortening of the muscles and/or tendons with the resulting inability to bring the knee to 0 degrees extension or greater (i.e., hyperextension) by passive range of motion.  (0 degrees knee extension is when the femur and tibia are in alignment in a horizontal plane).  A knee extension contracture is a condition in which there is shortening of the muscles and/or tendons with the resulting inability to bring the knee to 80 degrees flexion or greater by passive range of motion.  A contracture is distinguished from the temporary loss of range of motion of a joint following injury, surgery, casting or other immobilization.

A knee orthosis with joints (L1810) or knee orthosis with condylar pads and joints with or without patellar control (L1820) are covered for ambulatory patients who have weakness or deformity of the knee and require stabilization.  If an L1810 or L1820 is provided but the criteria above are not met, the orthosis will be denied as not medically necessary. 

A knee orthosis with a locking knee joint (L1831) or a rigid knee orthosis (L1836) is covered for patients with flexion or extension contractures of the knee with movement on passive range of motion testing of at least 10 degrees (i.e., a nonfixed contracture).

If an L1831 or L1836 orthosis is provided but the criterion above is not met, the orthosis will be denied as not medically necessary.

There is no proven clinical benefit to the inflatable air bladder incorporated into the design of code L1847; therefore, claims for code L1847 will be denied as not medically necessary.

A knee immobilizer without joints (L1830) or a knee orthosis with adjustable knee joints (L1832) is covered if the patient has had recent injury to or a surgical procedure on the knee(s) and has one of the following diagnoses:

• Rheumatoid arthritis
• Osteoarthritis
• Meniscal cartilage derangement
• Chondromalacia of patella
• Knee ligamentous disruption
• Rupture of tendon, nontraumatic - quadriceps tendon
• Pathologic fracture of femur
• Pathologic fracture of tibia or fibula
• Aseptic necrosis of tibia or fibula
• Stress fracture of tibia or fibula
• Congenital deformity of knee
• Fracture of femur - lower end
• Fracture of patella
• Fracture of tibia and/or fibula - upper end
• Dislocation of knee
• Sprains and strains of knee
• Failed total knee arthroplasty

An L1832 is also covered for a patient who is ambulatory and has knee instability due to a condition specified in one of the following diagnoses:

Any diagnosis listed above; or:

• Multiple sclerosis
• Hemiplegia, unspecified
• Infantile cerebral palsy, unspecified
• Paraplegia of both lower limbs
• Mononeuritis of lower limb, unspecified

NOTE:

This is not an all inclusive list. Please see diagnosis section for additional diagnoses.

A knee orthosis, with an adjustable flexion and extension joint that provides both medial-lateral and rotation control (L1843, L1845) is covered for a patient who is ambulatory and has knee instability due to a condition specified by one of the diagnoses for L1832 listed above.

A knee orthosis, Swedish type, prefabricated (L1850) is covered for a patient who is ambulatory and has knee instability due to genu recurvatum - hyperextended knee.

For codes L1832, L1843, L1845 and L1850, 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).

Claims for L1832, L1843, L1845 or L1850 will be denied as not medically necessary when the patient does not meet the above criteria for coverage.  For example, they will be denied if only pain or a subjective description of joint instability is documented.

“Addition” codes are grouped into four (4) categories in relation to knee orthosis base codes.

• Eligible for separate payment
• Not medically necessary
• Not separately payable
• Incompatible

Addition codes in the first two categories are addressed in the following tables of the policy. Addition codes in the latter two categories are addressed in the Coding Guidelines section of the policy.

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:

• They are provided with the related base code orthosis; and
• The base orthosis is medically necessary; and
• The addition is medically necessary.

Addition codes will be denied as not medically necessary if the base orthosis is not medically necessary or the addition is not medically necessary.

The following table lists addition codes which describe components or features that can be physically incorporated in the specified prefabricated base orthosis but are considered not medically necessary. These addition codes, if they are billed with the related base code, will be denied as not medically necessary. 

Refer to the Coding Guidelines for information on addition codes that are considered not separately payable or incompatible with prefabricated knee orthosis base codes.

Custom Fabricated Knee Orthoses (L1834, L1840, L1844, L1846, L1860)

A custom fabricated orthosis is covered when there is a documented physical characteristic which requires the use of a custom fabricated orthosis instead of a prefabricated orthosis. Examples of situations which meet the criterion for a custom fabricated orthosis include, but are not limited to:

1. Deformity of the leg or knee;
2. Size of thigh and calf;
3. Minimal muscle mass upon which to suspend an orthosis.

Although these are examples of potential situations where a custom fabricated orthosis may be appropriate, suppliers must consider prefabricated alternatives such as pediatric knee orthoses in patients with small limbs, straps with additional length for large limbs, etc.

If a custom fabricated orthosis is provided but the medical record does not document why that item is medically necessary instead of a prefabricated orthosis, the custom fabricated orthosis will be denied as not medically necessary.

Custom fabricated orthoses are not medically necessary in the treatment of knee contractures in cases where the patient is nonambulatory.

A custom fabricated knee immobilizer without joints (L1834) is covered if criteria 1 and 2 are met:

1. The coverage criteria for the prefabricated orthosis codes L1830 are met; and
2. The general criterion for a custom fabricated orthosis is met.

If an L1834 orthosis is provided and both criteria 1 and 2 are not met, the orthosis will be denied as not medically necessary.

A custom fabricated derotation knee orthosis (L1840) is covered for instability due to internal ligamentous disruption of the knee.

A custom fabricated knee orthosis with an adjustable flexion and extension joint (L1844, L1846) is covered if criteria 1 and 2 are met:

1. The coverage criteria for the prefabricated orthosis codes L1843 and L1845 are met; and
2. The general criterion for a custom fabricated orthosis is met.

If an L1844 or L1846 orthosis is provided and both criteria 1 and 2 are not met, the orthosis will be denied as not medically necessary.

A custom fabricated knee orthosis with a modified supracondylar prosthetic socket (L1860) is covered for a patient who is ambulatory and has knee instability due to genu recurvatum - hyperextended knee.

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:

• They are provided with the related base code orthosis; and
• The base orthosis is medically necessary; and
• The addition is medically necessary.

Addition codes will be denied as not medically necessary if the base orthosis is not medically necessary or the addition is not medically necessary.

The following table lists addition codes which describe components or features that can be physically incorporated in the specified custom fabricated base orthosis but are considered not medically necessary. These addition codes, if they are billed with the related base code, will be denied as not medically necessary. 

Miscellaneous

Heavy duty knee joint codes (L2385, L2395) are covered only for patients who weigh more than 300 pounds.

Coverage of a removable soft interface (K0672) is limited to a maximum of two (2) per year beginning one (1) year after the date of service for initial issuance of the orthosis. Additional replacement interfaces will be denied as not medically necessary. Refer to the Coding Guidelines section of the policy for information on denial of removable soft interfaces that are billed separately at the time of initial issue of the orthosis.

Reasons for Noncoverage

For an item to be considered for coverage under the Brace benefit category, it must be a rigid or semi-rigid device which 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. Items that do not meet the definition of a brace are non-covered.

Elastic support garments do not meet the statutory definition of a brace because they are not rigid or semi-rigid devices.  Devices that are rigid or semi-rigid must be coded A4466.  Code A4466 will be denied as non-covered.  The provider can bill the member for the non-covered device.

The following chart reflects the reasonable useful lifetime of prefabricated knee orthoses:

L1810 – 1 year
L1820 – 1 year
L1830 – 1 year
L1831 – 2 years
L1832 – 2 years
L1836 – 3 years
L1843 – 3 years
L1845 – 3 years
L1850 – 2 years

The reasonable useful lifetime of custom fabricated orthoses is three years.

Replacement during the “reasonable useful lifetime,” is covered if the item is lost or irreparably damaged. Replacement for other reasons, including but not limited to irreparable wear, during the period of reasonable useful lifetime is denied as non-covered. The provider can bill the member for the denied service.  L-coded additions to knee orthoses (L2275 - L2830, K0672) will be denied as non-covered when the base orthosis is non-covered.  The provider can bill the member for the non-covered service.

Brace sleeves (A9270) used in conjunction with orthoses are non-covered because they are not used to support a weak or deformed body member or to restrict or eliminate motion in a diseased or injured part of the body (i.e., it does not meet the definition of a brace). The provider can bill the member for the non-covered service.

Repairs to a covered orthosis 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.

Services that do not meet the medical necessity criteria on this policy will be considered not medically necessary. A provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

Documentation Requirements

It is expected that the patient’s medical records will reflect the need for the care provided. The patient’s medical records include the physician’s office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

An order for all items must be signed and dated by the treating physician, kept on file by the supplier, and made available upon request. Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected procedure code.

Orders must be sufficiently detailed including all options or additional features that will be separately billed. Written orders for custom fabricated orthoses must specifically state “custom fabricated” or specify a brand name and model that is only available as a custom fabricated product.

The diagnosis code that justifies the need for the item must be included on the claim.

KX, GA, GZ Modifiers

Suppliers must add a KX modifier to knee orthosis, base and addition codes only if all of the coverage criteria in the “Indications and Limitations of Coverage” section of this policy have been met and evidence of such is retained in the supplier’s files and available upon request. 

If all of the criteria in the medical policy have not been met, the GA or GZ modifier must be added to the code.  When there is an expectation of a medical necessity denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Pre-Service Denial Notice or the GZ modifier if they have not obtained a valid Pre-Service Denial Notice. The provider can bill the member if the GA modifier is entered on the claim.  The provider cannot bill the member if the GZ modifier is entered on the claim.  Claims lines billed with codes without a KX, GA or GZ modifier will be rejected as missing information.

Claim lines billed with codes without a KX, GA or GZ modifier will be rejected as missing information.

For custom fabricated orthoses (L1834, L1840, L1844, L1846, L1860), there must be detailed documentation in the orthotist’s records to support the medical necessity of custom fabricated rather than a prefabricated orthosis. This information must be available upon request.

When billing L2999, the following information should accompany the claim: manufacturer's name; product name; justification of patient's medical necessity for the item. In addition, if the item is custom fabricated, a complete and clear description of the item, including what makes this item unique, and a breakdown of charges (material and labor used in fabrication) must be included with the claim.

An order is not necessary for the repair of an orthosis; however, claims for code L4210 must be accompanied by a description of the part that is being repaired or replaced. This information should be entered into the narrative field on an electronic claim.

“Addition” codes are grouped into four (4) categories in relation to knee orthosis base codes.

• Eligible for separate payment
• Not medically necessary
• Not separately payable
• Incompatible

Addition codes in the first two categories are addressed in the policy. Addition codes that are not separately payable are addressed in the tables below.

The following table lists addition codes which describe components or features that can be physically incorporated in the specified prefabricated base orthosis but are considered to be included in the allowance for the orthosis. The addition codes will be denied as not separately payable if they are billed with the related base code.

The following table lists addition codes which describe components or features that can be physically incorporated in the specified custom fabricated base orthosis but that are considered to be included in the allowance for the orthosis.  The addition codes will be denied as not separately payable if they are billed with the related base code.

All addition codes that are not listed as either separately payable or not medically necessary in the tables in the policy 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 is it only used with custom fabricated orthoses). These incompatible addition codes will be rejected as incorrect coding.

A replacement removable soft interface for a knee orthosis is billed with code K0672 (lower extremity orthosis, not otherwise specified). 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, L2830) 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 and L2330 (non-molded and molded lacers, respectively) may only be billed as replacement items.

Claims for prefabricated or custom-fabricated devices that contain a concentric adjustable torsion style mechanism in the knee joint should be coded as E1810 (dynamic adjustable knee extension/flexion device, includes soft interface material).  All lines on claims billed with L-codes for devices incorporating a concentric adjustable torsion style mechanism in the knee joint will be rejected as incorrect coding.

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 is separately payable in addition to the allowance for that component.

Code L4002 is for billing of replacement component(s) and is 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.

The right (RT) and/or left (LT) modifiers must be used when billing for orthosis base codes, additions and replacement parts. When the same code for bilateral items (left and right) is billed on the same date of service, bill for both items on the same claim line using the RTLT modifiers and 2 units of service. Claims billed without modifiers RT and/or LT will denied or rejected as incorrect coding.

Code L2999 (lower extremity orthosis, not otherwise specified) should be used only when billing for item(s) that do not meet the definition of an existing code(s).

Code L4205 (Repair of orthotic device, labor component, per 15 minutes) may only be billed for time involved with the actual repair of an orthosis or for medically necessary adjustments made more than 90 days after delivery. Code L4205 must not be used to bill for time involved with other professional services including, but not limited to:

• Evaluating the patient
• Taking measurements, making a cast, making a model, use of CAD/CAM
• Making modifications to a prefabricated item to fit it to the individual patient
• Follow-up visits
• Making adjustments at the time of or within 90 days after delivery

Reimbursement for these services is included in the allowance for the procedure codes which describe the orthosis.

Similarly, code L4210 (Repair of orthotic device, repair or replace minor parts) must not be used for casting supplies or other materials used in the fitting or fabrication of an orthosis.

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 L code) must be used. Code L9900 is denied as not separately payable.

The only products which may be billed using code L1845 are those for which a written coding verification has been made by the Pricing, Data Analysis, and Coding (PDAC) contractor.  Information concerning the documentation that must be submitted to the PDAC for a Coding  Verification Request can be found on the PDAC web site or by contacting the PDAC.  A Product Classification List with products which have received a coding verification can be found on the PDAC we site.

Provider News

06/2010, More criteria added to Medicare Advantage knee orthosis coverage guidelines
02/2011, Elimination of least costly alternative for Medicare Advantage

For procedure codes L1831 and L1836:

For procedure codes L1830 and L1834:

For procedure code L1840:

For procedure codes L1832, L1843, L1844, L1845 and L1846:

For procedure codes L1850 and L1860: