Knee Orthoses - Policy Article

NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:

For any item to be covered by Medicare, 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 Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act §1862(a)(1)(A) provisions (i.e. “reasonable and necessary”).

For a beneficiary’s equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination (LCD) must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.

Knee Orthoses are covered under the Medicare Braces Benefit (Social Security Act §1861(s)(9)). For coverage under this benefit, the orthosis 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. Items that are not sufficiently rigid to be capable of providing the necessary immobilization or support to the body part for which it is designed do not meet the statutory definition of the Braces Benefit. Items that do not meet the definition of a brace are statutorily noncovered, no benefit.

Elastic or other fabric support garments (A4467 (BELT, STRAP, SLEEVE, GARMENT, OR COVERING, ANYTYPE)) with or without stays or panels do not meet the statutory definition of a brace because they are not rigid or semi-rigid devices. Code A4467 is denied as noncovered (no Medicare benefit). Refer to the coding guideline below for additional information.

Both “off-the-shelf” (OTS) and custom-fit items are considered prefabricated braces for Medicare coding purposes. 42 CFR §414.402 establishes that correct coding of knee orthoses items is dependent upon whether there is a need for “minimal self-adjustment” during the final fitting at the time of delivery. (See definitions below.) The following denials apply to incorrectly coded items based upon this regulation:

• Correct coding of prefabricated knee orthoses (L1810, L1812, L1820, L1830, L1831, L1832, L1833, L1836, L1843, L1845, L1847, L1848, L1850, L1851, L1852) is dependent upon whether or not there is a need for “minimal self-adjustment” at the time of fitting by the beneficiary, caretaker for the beneficiary, or supplier that does not require the services of a qualified practitioner (see definitions below).

• Claims for custom fitted orthoses (L1810, L1832, L1843, L1845, L1847) will be denied as incorrect coding when documentation shows that only minimal self-adjustment was required at the time of fitting (see Policy Specific Documentation Requirements section below).

The following chart reflects the reasonable useful lifetime of prefabricated Knee Orthoses:

The reasonable useful lifetime of custom fabricated orthosis is 3 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. 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.

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).

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.

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.

Evaluation of the beneficiary, measurement and/or casting, and fitting/adjustments of the orthosis are included in the allowance for the orthosis. There is no separate payment for these services.

Payment for knee orthoses are included in the payment to a hospital or skilled nursing facility (SNF) if:

1. The orthosis is provided to a beneficiary prior to an inpatient hospital admission or Part A covered SNF stay; and

2. The medical necessity for the orthosis begins during the hospital or SNF stay (e.g., after knee surgery).

A claim should not be submitted to the DME MAC in this situation.

Payment for knee orthoses are also included in the payment to a hospital or a Part A covered SNF stay if:

1. The orthosis is provided to a beneficiary during an inpatient hospital or Part A covered SNF stay prior to the day of discharge; and

2. The beneficiary uses the item for medically necessary inpatient treatment or rehabilitation.

A claim must not be submitted to the DME MAC in this situation.

Payment for knee orthoses delivered to a beneficiary in a hospital or a Part A covered SNF stay is eligible for coverage by the DME MAC if:

1. The orthosis is medically necessary for a beneficiary after discharge from a hospital or Part A covered SNF stay; and

2. The orthosis is provided to the beneficiary within two days prior to discharge to home; and

3. The orthosis is not needed for inpatient treatment or rehabilitation, but is left in the room for the beneficiary to take home.

REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 Fed. Reg Vol 217)

Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provides a list of the specified codes, which is periodically updated. The link will be located here once it is available.

Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD- related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.

If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD prior to delivery, it will be eligible for coverage.

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

In addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.

Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.

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 (see definitions in the Coding Guidelines) is the need for “minimal self-adjustment” at the time of fitting by the beneficiary, caretaker for the beneficiary, 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 more than minimal self-adjustment by a qualified practitioner are coded as custom fitted (L1810, L1832, L1843, L1845, L1847). Documentation must be sufficiently detailed to include, but is not limited to, a detailed description of the modifications necessary at the time of fitting the orthosis to the beneficiary. This information must be available upon request.

For custom fabricated orthoses (L1834, L1840, L1844, L1846, L1860), there must be detailed documentation in the treating practitioner’s records to support the medical necessity of custom fabricated rather than a prefabricated orthosis as described in the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD. This information will be corroborated by the functional evaluation in the orthotist or prosthetist’s records. This information must be available upon request.

When providing these items suppliers must:

• Provide the product that is specified by the prescribing practitioner

• Be sure that the prescribing practitioner’s medical record justifies the need for the type of product (i.e., Prefabricated versus Custom Fabricated)

• Only bill for the HCPCS code that accurately reflects both the type of orthosis and the appropriate level of fitting

• Have detailed documentation in supplier's records that justifies the code selected

The beneficiary’s condition (diagnosis code) that necessitates the need for the knee orthosis must be included on the claim.

KX, GA, and GZ MODIFIERS

Suppliers must add a KX modifier to knee orthoses base and addition codes only if all of the coverage criteria in the “Coverage Indications, Limitations, and/or Medical Necessity” section of 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.

CODING GUIDELINES:

Definitions
The terms below are used to describe the types of devices referred to in this Policy Article and the related Local Coverage Determination. For more information about the terms used, refer to the DMEPOS Quality Standards (42 CFR 424.57) and the definitions for OTS and minimal self-adjustment (42 CFR Section 414.402) and CMS Benefit Policy Manual (Internet Only Manual 100-2) Ch. 15. Brace (Orthosis, Orthotic Device).

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. An orthosis can be classified as either prefabricated (off-the-shelf or custom fitted) or custom-fabricated. Items that are not sufficiently rigid to be capable of providing the necessary immobilization or support to the body part for which it is designed do not meet the statutory definition of the Braces Benefit.

Custom Fabricated
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.

Molded-to-Patient-Model
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.

Positive Model of the Patient
A positive model is an exact replica of the actual body part for which the custom fabricated is being constructed. A positive model can be produced by any of these methods:

• Molded-to-patient-model is a negative impression taken of the patient’s body member and a positive model rectification is constructed;

• 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; or

• 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.

Fabrication of an orthosis using molding, CAD/CAM, or similar technology without the creation of a positive model is considered to be a prefabricated orthosis.

Specialized Training
Specialized training is defined as training that provides the knowledge, skills, and experience in the provision of orthotics in compliance with all applicable Federal and State licensure and regulatory requirements.

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 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, caretaker 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 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 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.

More than minimal self-adjustment 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 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 off-the-shelf (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 where there are parallel sets of HCPCS codes 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.

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. Refer to the long code narrative and any relevant coding guideline for the criteria applicable for each HCPCS 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, ANYTYPE).

• 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, ANYTYPE).

• 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, ANYTYPE).

• 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, ANYTYPE).

• 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. Refer to the long code narrative and any relevant coding guideline for the criteria applicable for each HCPCS 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. Refer to the long code narrative and relevant coding guideline for the criteria applicable for each HCPCS 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).

Codes L1810 and L1812 describe prefabricated knee orthoses constructed of latex, neoprene, spandex or other elastic material. There are no condylar pads. There are hinges or joints.

Code L1820 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.

Code L1830 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.

Codes L1831, L1847 and L1848 describe prefabricated knee orthoses with joint(s) which lock the knee into a particular position. Codes L1847 and L1848 are distinguished from L1831 by the addition of an air bladder in the space behind the knee. These orthoses are designed for beneficiaries who are nonambulatory. They are typically used to treat flexion/extension contractures of the knee.

An adjustable flexion and extension joint is one that enables the practitioner to set limits on flexion and extension but allows the beneficiary 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.

Codes L1832 and L1833 describe 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 beneficiary who can bear weight on the knee and is capable of ambulation. They are typically used for early rehabilitation following knee surgery.

Codes L1834 and L1836 describe rigid knee orthosis without a knee joint. Both are designed to prevent knee motion. These orthoses are designed for beneficiaries who can bear weight on the knee, are capable of ambulating, and need additional support provided through immobilization of the knee joint. Code L1834 refers to a custom fabricated knee orthotic while L1836 refers to one that is pre-fabricated.

Code L1840 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.

Codes L1843, L1844 and L1851 describe prefabricated and custom fabricated (respectively) 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. 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 beneficiaries who are fully ambulatory.

Codes L1845, L1846 and L1852 describe prefabricated and custom fabricated (respectively) knee orthoses that have double uprights, condylar pads, and an adjustable flexion and extension joint and provide both medial-lateral and rotation control. 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 (1) solid metal (or similar material) in the anterior or posterior portion of the thigh and calf cuffs and (2) the condylar pads. These orthoses are designed for beneficiaries who are fully ambulatory.

The only products that may be billed using codes L1845 or L1852 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 Product Classification List (PCL). 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 PCL with products that have received a coding verification can be found on the PDAC web site. If a product is billed to Medicare using a HCPCS code that requires written CVR, but the product is not on the PCL for that particular HCPCS code, then the claim line will be denied as incorrect coding.

Code L1850 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 beneficiaries.

Code L1860 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 beneficiaries.

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.

“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 related LCD. 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 bases orthosis but are considered to be included in the allowance for the orthosis.

The following table lists addition codes which describe components or features that can be physically incorporated in the specified custom fabricated bases 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 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 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 (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, 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.

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 codes E1810 (dynamic adjustable knee extension/flexion device). 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 (See Coverage Indications, Limitations and/or Medical Necessity section of the related LCD).

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 (See Coverage Indications, Limitations and/or Medical Necessity section of the related LCD).

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. 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 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 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.

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

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