• 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, and molding, assembling, or customizing to fit an individual.
• This fitting does not require expertise of a certified orthotist or an individual who has specialized training in the provision of orthoses to fit the item to the individual beneficiary.

The term “minimal self-adjustment” is defined at 42 CFR §414.402 as an adjustment the beneficiary, caregiver for the beneficiary, 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 Orthotist/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.

Use of CAD/CAM or similar technology to create an orthosis without a positive model of the patient may be considered as OTS if the final fitting upon delivery to the patient requires minimal self-adjustment not requiring expertise as described in this section.

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 more than minimal self-adjustment 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 specialized training in the provision of orthosis to fit the item to the individual beneficiary.

In contrast to “minimal self-adjustment,” “more than minimal self-adjustment” is defined as changes made to achieve an individualized fit during the final fitting at the time of delivery of the item that requires the expertise of a certified orthotist or an individual who has equivalent specialized training in the provision of orthotics 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.

In most cases for prefabricated orthoses, the correct coding of the orthosis is dictated by actions that take place at the time of fitting to the beneficiary, either custom-fit (requiring expertise) or OTS (requiring minimal self-adjustment). However, for certain types of orthoses, the HCPCS code narrative that best describes the product does not make a distinction between prefabricated orthoses that are provided as custom-fit or OTS. These code narratives are correct and must be used for Medicare billing, without regard to how the product is provided to the beneficiary at the final delivery.

There are products that may be either fit by the beneficiary or require custom fitting at the time of final delivery. There are parallel sets of HCPCS codes (L4360, L4361, L4386, L4387, L4396 and L4397) that describe identical types of items. The codes are only differentiated based upon the nature of the final fitting performed at the time of delivery. The alternative HCPCS code types are:

HCPCS codes which describe “PREFABRICATED, OFF-THE-SHELF” must be used when minimal self-adjustment is the extent of the fitting performed at delivery.

HCPCS codes which describe “PREFABRICATED ITEM THAT HAS BEEN TRIMMED, BENT, MOLDED, ASSEMBLED, OR OTHERWISE CUSTOMIZED TO FIT A SPECIFIC PATIENT BY AN INDIVIDUAL WITH EXPERTISE” must be used when more than minimal self-adjustment is necessary at delivery.

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 at the time of delivery to the patient requires more than minimal self-adjustment requiring expertise as described in this section.

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.

Elastic and Similar Stretchable Materials

For items where the HCPCS code specifies “elastic” or other similar terminology for stretchable material, use the code that is most applicable to the item. A NOC (Not Otherwise Classified) or miscellaneous HCPCS code must not be used instead of the specific code. 

For items where the HCPCS code does not specify elastic or other similar terminology for stretchable material, the following guidelines apply:

Items that are primarily constructed of elastic or other stretchable materials (e.g. support items made of material such as neoprene or spandex (elastane, Lycra®) (not all-inclusive)) must be coded as A4467 (BELT, STRAP, SLEEVE, GARMENT, OR COVERING, ANY TYPE).

Items that are primarily constructed of elastic or other stretchable materials (e.g. support items made of material such as neoprene or spandex (elastane, Lycra®]) (not all-inclusive)) that contain stays and/or panels must be coded as A4467 (BELT, STRAP, SLEEVE, GARMENT, OR COVERING, ANY TYPE).

Items that are primarily constructed of inelastic material (e.g., canvas, cotton or nylon (not all-inclusive)) that are incapable of providing the necessary immobilization or support to the body part for which it is designed must be coded using A4467 (BELT, STRAP, SLEEVE, GARMENT, OR COVERING, ANY TYPE).

Items that are primarily of constructed inelastic material (e.g., canvas, cotton or nylon (not all-inclusive)) that are incapable of providing the necessary immobilization or support to the body part for which it is designed and that have stays and/or panels capable of providing the required immobilization or support to the body part for which it is designed, must be coded using A4467 (BELT, STRAP, SLEEVE, GARMENT, OR COVERING, ANY TYPE).

Items that are primarily constructed of inelastic material (e.g., canvas, cotton or nylon (not all-inclusive)) capable of providing the necessary immobilization or support to the body part for which it is designed must be coded using the applicable specific HCPCS code for the type of product. A NOC (Not Otherwise Classified) or miscellaneous HCPCS code must not be used instead of the specific code.

Items that are primarily of constructed inelastic material (e.g., canvas, cotton or nylon (not all-inclusive)) capable of providing the necessary immobilization or support to the body part for which it is designed and that have stays and/or panels capable of providing the required immobilization or support to the body part for which it is designed, must be coded using the applicable specific HCPCS code for the type of product. A NOC (Not Otherwise Classified) or miscellaneous HCPCS code must not be used instead of the specific code. 

Items that are not capable of providing the necessary immobilization or support to the body part for which it is designed (regardless of materials) must be coded using A9270 (NONCOVERED ITEM OR SERVICE).

Ankle-foot orthoses described by codes L1900, L1910 – L1990, extend well above the ankle (usually to near the top of the calf) and are fastened around the lower leg above the ankle.

These features distinguish them from foot orthotics which are shoe inserts that do not extend above the ankle and ankle gauntlets described by codes L1902 – L1907.

Code L1906 describes a multiligamentous ankle support that provides control of the ankle joint between the medial and lateral malleoli while allowing for dorsiflexion and plantar flexion by way of a hinge or joint mechanism. This off-the-shelf ankle support includes a rigid stirrup and foot plate which provides functional tracking of the ankle with hind-foot and mid-foot stability during ambulation. This, in conjunction with wrap-around straps and the inherent gauntlet design, offers areas of multiligamentous support as described by the code. There are no additional HCPCS codes for this type of prefabricated ankle orthosis. 

Effective for claims with dates of service on or after April 1, 2012, the only products which may be billed to Medicare using code L1906 are those for which a written coding verification has been made by the Pricing, Data Analysis, and Coding (PDAC) contractor and that are listed in the Product Classification List.

L1960 describes an Ankle Foot Orthosis (AFO) which provides ankle control for beneficiaries with musculoskeletal or neuromuscular dysfunction. The AFO is designed to provide rigid immobilization of the ankle-foot complex in the sagittal, coronal, and transverse planes. The custom fabricated solid ankle AFO can be constructed from thermosetting materials, thermoplastics, or composite type materials.

L2340 is a pre-tibial shell, custom fabricated, that provides a rigid overlapping interlocking anterior tibial control between the tibial tuberosity to a point no greater than 3 inches proximal to the medial malleolus. The pre-tibial shell can be constructed from thermosetting materials, thermoplastics, or composite type materials.

Code L2755 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.

A nonambulatory ankle-foot orthosis may be either an ankle contracture splint, night splint or a foot drop splint.

A static or dynamic positioning ankle-foot orthosis (L4396, L4397) is a prefabricated ankle-foot orthosis which has all of the following characteristics:

Designed to accommodate either plantar fasciitis or an ankle with a plantar flexion contracture up to 45°; and,

Applies a dorsiflexion force to the ankle; and,

Used by a beneficiary who is minimally ambulatory, or nonambulatory; and,

Has a soft interface.

A foot drop splint/recumbent positioning device (L4398) is a prefabricated ankle-foot orthosis which has all of the following characteristics:

Designed to maintain the foot at a fixed position of 0° (i.e., perpendicular to the lower leg); and,

Not designed to accommodate an ankle with a plantar flexion contracture; and,

Used by a beneficiary who is nonambulatory; and,

Has a soft interface.

Code L4631 describes a Charcot’s restraint orthotic walker (CROW) orthosis. Code L4631 is a custom fabricated ankle-foot orthosis which has all of the following characteristics:

Designed to maintain the foot at a fixed position of 0° (i.e., perpendicular to the lower leg); and,

Allows for varus or valgus deformity correction; and,

Contains a rocker bottom sole with a custom arch support; and,

Incorporates a rigid anterior tibial shell; and,

Used by a beneficiary who is ambulatory; and,

Has a soft interface

Totally encapsulated.

Code L4631 includes all additions including straps and closures. No additional codes may be billed with code L4631.

Codes L1900, L1904, L1907, L1920, L1940-L1950, L1960-L1970, L1980-L2034, L2036-L2108, L2126-L2128 and L4631 describe custom-fabricated orthoses. These codes must not be used for prefabricated orthoses.

Codes L1902, L1906, L1910, L1930-L1932, L1951, L1971, L2035, L2112-L2116, L2132-L2136, and L4350-L4398 describe prefabricated orthoses. These codes must not be used for custom-fabricated orthoses.

Codes L1900, L1902-L1990, L2106-L2116, L4350, L4360, L4361, L4386, L4387 and L4631 are used for an ankle-foot orthosis which is worn when a beneficiary is ambulatory.

Codes L4396 and L4397 are used for an ankle-foot orthosis which is worn when a beneficiary is nonambulatory, or minimally ambulatory.

Code L4398 is used for an ankle-foot orthosis which is worn when a beneficiary is nonambulatory.

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.

HCPCS codes L4050 and L4055 do not describe replacement soft interfaces used with contracture orthoses.

Foot orthotics are shoe inserts that do not extend above the ankle. The correct codes for foot orthotics provided for beneficiaries without diabetes are L3000-L3090. 

Multiple density foot orthotics used in the management of diabetic foot problems are coded A5512, A5513, and K0903 (code K0903 effective for DOS on or after 04/01/2018). 

All claims for devices that contain a concentric adjustable torsion style mechanism in the knee joint for any condition other than an assistive function to joint extension motion must be coded as Durable Medical Equipment using code E1810 (DYNAMIC ADJUSTABLE KNEE EXTENSION / FLEXION DEVICE, INCLUDES SOFT INTERFACE MATERIAL). If a concentric adjustable torsion style mechanism in the knee joint is used solely to provide an assistive function for joint extension, it must be coded as L2999.

All claims for devices that contain a concentric adjustable torsion style mechanism in the ankle joint for any condition other than an assistive function to joint plantar- or dorsiflexion motion must be coded as Durable Medical Equipment using code E1815 (DYNAMIC ADJUSTABLE ANKLE EXTENSION/FLEXION DEVICE, INCLUDES SOFT INTERFACE MATERIAL). If a concentric adjustable torsion style mechanism in the ankle joint is used solely to provide an assistive function for joint plantar or dorsiflexion, it must be coded as L2999.

Claims for devices that contain a concentric adjustable torsion style mechanism in the knee or ankle 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.

Code A9283 (FOOT PRESSURE OFF LOADING/SUPPORTIVE DEVICE, ANY TYPE, EACH) is used for an item that is designed primarily to reduce pressure on the sole or heel of the foot. It may be a shoe-like item, an item that is used inside a shoe and may or may not extend outside the shoe, or an item that is attached to a shoe. It may be prefabricated or custom fabricated. Code A9283 does not include items that meet the definition of a therapeutic shoe for diabetes (A5500, A5501).

Prefabricated walking boots are coded using codes L4360, L4361, L4386 or L4387. These codes describe complete products. Claims for add-on codes used with walking boots coded L4360, L4361, L4386 or L4387 will be denied as unbundling.

Certain products may have both covered and non-covered uses, as defined by the Braces benefit category, and must be coded based on the beneficiary’s condition. For example, when used as a brace for the treatment of an orthopedic condition, walking boots are coded L4360, L4361, L4386, L4387 and L4631. However, walking boots must be coded A9283 when used solely for the prevention or treatment of a lower extremity ulcer or pressure reduction.

When using code A9283, there is no separate billing using addition codes. Replacement liners for devices billed with A9283 must be billed with code A9270 (noncovered item or service).

Code A9285 (INVERSION/EVERSION CORRECTION DEVICE) is designed to provide off-loading pressure to the knee for the treatment of knee osteoarthritis. The device is applied at the foot and extends across the ankle to apply pressure to the side of the leg below the knee. It does not provide any support at the ankle.

The right (RT) and left (LT) modifiers must be used with orthosis base codes, additions, and replacement parts. Effective for claims with dates of service (DOS) on or after 3/1/2019, when the same code for bilateral items (left and right) is billed on the same date of service, bill each item on two separate claim lines using the RT and LT modifiers and 1 unit of service (UOS) on each claim line. Do not use the RTLT modifier on the same claim line and billed with 2 UOS. Claims billed without modifiers RT and/or LT, or with RTLT on the same claim line and 2 UOS, will be rejected as incorrect coding.

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

Suppliers must distinguish between repair and replacement of an orthosis. When an orthotic is replaced, there is no separate billing for the above services because reimbursement for these services is included in the allowance for the replacement item.

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 an orthotic component that is coded with a specific L code is included in the allowance for that component. The allowance for the labor involved in replacing an orthotic component that is coded with the miscellaneous code L4210 is separately payable in addition to the allowance for that component.

Addition codes L4002 – L4130, and L4392 are for billing of replacement components and are not payable at initial issue of a base orthosis. When claims for code(s) L4002 – L4130, and L4392 are billed at the time of initial issue of a base orthosis, the addition code(s) will be rejected as incorrect coding.

MODIFIERS

KX, GA, and GZ MODIFIERS:

Suppliers must add a KX modifier to the AFO/KAFO base and addition codes only if all of the coverage criteria in the “Coverage Indications, Limitations and or Medical Necessity” section in the related LCD have been met and evidence of such is retained in the supplier’s files and available to the DME MAC upon request.

If all of the criteria in the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD 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 Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.

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

Suppliers should contact the PDAC contractor for guidance on the correct coding of these items.