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.

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 a locking knee joint (L1831, L1847) or a rigid knee orthosis (L1836) is covered for patients with flexion or extension contractures of the knee (718.46) with movement on passive range of motion testing of at least 10 degrees (i.e., a nonfixed contracture).

If an L1831, L1836, or L1847 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, if the criterion above is met, payment will be based on the allowance for the least costly medically appropriate alternative, code L1831.

A knee immobilizer without joints (L1830) or a knee orthosis with adjustable knee joints (L1832) is covered if all of the following criteria are met:

1. The patient has had a recent injury to or surgical procedure on the knee; and
2. The patient requires a brace with range of motion limitations; and
3. The patient has one of the following diagnoses:

Rheumatoid arthritis (714.0 – 714.4)
Osteoarthritis (715.16, 715.26, 715.36, 715.96)
Meniscal cartilage derangement (717.0 – 717.5)
Chondromalacia of patella (717.7)
Knee ligamentous disruption (717.81 – 717.9)
Rupture of tendon, nontraumatic - quadriceps tendon (727.65)
Pathologic fracture of femur (733.15)
Pathologic fracture of tibia or fibula (733.16)
Aseptic necrosis of tibia or fibula (733.49)
Stress fracture of tibia or fibula (733.93)
Congenital deformity of knee (755.64)
Fracture of femur - lower end (821.20 – 821.39)
Fracture of patella (822.0, 822.1)
Fracture of tibia and/or fibula - upper end (823.00 – 823.42)
Dislocation of knee (836.0 – 836.69)
Sprains and strains of knee (844.0-844.2)
Failed total knee arthroplasty (996.40-996.49, 996.66, 996.77, V43.65)

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 in one of the following diagnoses:

Multiple sclerosis (340)
Hemiplegia, unspecified (342.90)
Infantile cerebral palsy, unspecified (343.9)
Paraplegia of both lower limbs (344.1)
Mononeuritis of lower limb, unspecified (355.0, 355.2)
Any diagnosis listed above for L1830/L1832

NOTE:

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

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 (736.5).

If code L1830, L1832, L1843, L1845, or L1850 is provided but the patient does not meet the criteria for coverage, the orthosis will be denied as not medically necessary.

“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.

They 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 the medical necessity for a custom fabricated orthosis is not met, but the criteria for a prefabricated orthosis is met, payment will be based on the allowance for the least costly medically appropriate alternative, a prefabricated orthosis.

If a claim for a custom fabricated orthosis is not supported by a written order specifying custom fabricated, payment will be based on the allowance for the least costly medically appropriate alternative, a prefabricated orthosis.

Custom fabricated orthoses are not medically necessary in the treatment of knee contractures in cases where the patient is nonambulatory. If a custom fabricated knee orthosis (L1834, L1840, L1844, L1846, L1860) is used in the treatment of a contracture in a nonambulatory patient and criterion for a prefabricated knee orthosis with a locking joint (L1831) is met, payment will be based on the allowance for the least costly medically appropriate alternative, L1831.

A custom fabricated knee immobilizer without joints (L1834) is covered if all of the following criteria 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 the coverage criteria for L1830 are not met and the criterion for a contracture treatment orthosis (L1831) is not met, the orthosis will be denied as not medically necessary. If the criteria for L1830 are met but the patient does not meet the criteria for a custom fabricated knee orthosis, payment will be based on the allowance for the least costly medically appropriate alternative, L1830.

A custom fabricated derotation knee orthosis (L1840) is covered for instability due to internal ligamentous disruption of the knee (717.81 – 717.9).

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

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 the coverage criteria for L1843 and L1845 are not met and the criterion for a contracture treatment orthosis (L1831) is not met, the orthosis will be denied as not medically necessary. If the criteria for L1843 and L1845 are met but the patient does not meet the criteria for a custom fabricated knee orthosis, payment will be based on the allowance for the least costly medically appropriate alternative, L1843 or L1845, respectively.

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 (736.5).

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.

They 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.

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

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 noncovered.

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

L1847 – 2 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 noncovered. The provider can bill the member for the denied service.  L-coded additions to knee orthoses (L2275 - L2830, K0672) will be denied as noncovered when the base orthosis is noncovered.  The provider can bill the member for the denied service.

Brace sleeves (A9270) used in conjunction with orthoses are noncovered 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 denied 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.

A participating, preferred, or network 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 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.

Suppliers must add a KX modifier to knee orthoses 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 the requirements for the KX modifier are not met, the KX modifier must not be used.

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.

Coding Guidelines 

“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.

Knee orthoses incorporating a concentric adjustable torsion style mechanism must be billed with code E1810 (dynamic adjustable knee extension/flexion device, includes soft interface material). Claims for knee orthoses incorporating a concentric adjustable torsion style mechanisms billed with code L2999 will be rejected or denied 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.

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.

This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits, or a contract. Benefits are determined by the Federal Employee Program.

DME MAC Jurisdiction A - L27263
Medicare Coverage Database LCD for DME MAC Regions A, B, C, and D

For procedure codes L1831, L1836 and L1847:

718.46

For procedure codes L1830, L1832 and L1834:

714.0-714.4
715.16
715.26
715.36
715.96
717.0-717.5
717.7
717.81-717.9
727.65
733.15
733.16
733.49
733.93
755.64
821.20-821.39
822.0-822.1
823.00-823.42
836.0-836.69
844.0-844.2
966.40-996.49
996.66
996.77
V43.65

For procedure code L1840:

718.81-717.9

For procedures codes L1843, L1844, L1845 and L1846:

340
342.90
343.9
344.1
355.0
355.2
714.0-714.4
715.16
715.26
715.36
715.96
717.0-717.5
717.7
717.81-717.9
727.65
733.15
733.16
733.49
733.93
755.64
821.20-821.39
822.0-822.1
823.00-823.42
836.0-836.69
844.0-844.2
996.40-996.49
996.66
996.77
V43.65

For procedure codes L1850 and L1860:

736.5