Comments to Proposed Policy Article for Knee Orthoses
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES
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:L1800 Â– 6 months L1810 – 6 months L1815 – 6 months L1820 – 6 months L1825 – 6 months L1830 – 6 months 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 3 years.
Response: As described below in this draft policy, L1832 describes a prefabricated knee orthosis that is “typically used for early rehabilitation following surgery.” This device is most often used for a few weeks to a few months following surgery and typically cannot withstand day to day usage for longer than 6 months. The Velcro closures and padding often wear-out during usage. Although the medial-lateral stability is provided by double metal uprights, the anterior-posterior control and medial-lateral containment is provided by soft materials that wear out much quicker than 2 years. Accordingly, the useful lifetime for L1832 should be 6 months. Similary, L1836 is also used frequently for post-operative positioning or post injury support. Because it is made using a soft interface material, it soils and wears easily. A three year lifetime is unreasonable. Rather, it should be six months, similar to L1830 (which also uses a soft interface material).
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 – L2830, Kxxx1) will be denied as noncovered when the base orthosis is noncovered.
Socks (L2840, L2850) or 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.
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.
Response: We believe that the above definition reference to “counterforce” is both confusing and inappropriate. The magnitude of the counterforce should never be “at least as great” as a rigid support. To do so would cause tissue injury. Furthermore, for the counterforce to be “at least as great” as a semi-rigid support would lead to fatigue stress of the materials and lead to early failure of the orthosis.
A prefabricated orthosis is one which is manufactured in quantity without a specific patient in mind. A prefabricated orthosis may be trimmed, bent, molded (with or without heat), or otherwise modified for use by a specific patient (i.e., custom fitted). An orthosis that is assembled from prefabricated components is considered prefabricated. Any orthosis that does not meet the definition of a custom-fabricated orthosis is considered prefabricated.
A custom-fabricated orthosis is one which is individually made for a specific patient starting with basic materials including, but not limited to, plastic, metal, leather, or cloth in the form of sheets, bars, etc. It involves substantial work such as cutting, bending, molding, sewing, etc. It may involve the incorporation of some prefabricated components. It involves more than trimming, bending, or making other modifications to a substantially prefabricated item.
A molded-to-patient-model orthosis is a particular type of custom-fabricated orthosis in which an impression of the specific body part is made (by means of a plaster cast, CAD-CAM technology, etc.) and this impression is then used to make a positive model (of plaster or other material) of the body part. The orthosis is then molded on this positive model.
Code L1800 describes a prefabricated knee orthosis constructed of latex, neoprene, spandex or other elastic material. There are flexible stays located medially and/or laterally. There are no condylar pads. There are no hinges or joints.
Code L1810 describes a prefabricated knee orthosis constructed of latex, neoprene, spandex or other elastic material. There are no condylar pads. There are hinges or joints.
Code L1815 describes a prefabricated knee orthosis constructed of latex, neoprene, spandex or other elastic material. There may be flexible stays located medially and/or laterally. There are also medial and lateral condylar pads. There are no 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. There are hinges or joints.
Code L1825 describes a prefabricated knee orthosis constructed of latex, neoprene, spandex or other elastic material. A patellar buttress may be present. There are no stays, condylar pads, hinges or joints.
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. Response: It is inappropriate to limit L1830 to only those orthoses that haveonly lateral and posterior stays, as many orthoses described by this code have medial and lateral as well as posterior.
Codes L1831 and L1847 describe prefabricated knee orthoses with joint(s) which lock the knee into a particular position. Code L1847 is distinguished from L1831 by the addition of an air bladder in the space behind the knee. These orthoses are designed for patients who are nonambulatory. They are typically used to treat a flexion contracture of the knee.
Response: The air bladder used in the space behind the knee is to provide comfortable immobilization. It is not typically used to treat knee flexion contractures because the counterforce would increase the amount of flexion, instead of reducing it. Also, these orthoses are not limited to non-ambulatory patients. Many times the patients are non, or partial, weight bearing; using crutches or other means for ambulatory assistance in situations involving post-operative positioning and post-injury support.
An adjustable flexion and extension joint is one which enables the practitioner to set limits on flexion and extension but allows the patient 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.
Code L1832 describes a prefabricated knee orthosis that has double uprights and adjustable flexion and extension joints. Medial-lateral control of the knee is accomplished by way of the solid metal (or similar material) structure of the double uprights. It may have condylar pads. This orthosis is designed for a patient who can bear weight on the knee and is capable of ambulation. It is typically used for early rehabilitation following knee surgery.
Codes L1843 and L1844 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 patients who are fully ambulatory.
Response: It is excessively restrictive to limit the use of L1843 and L1844 to “fully ambulatory” patients. Many patients use these types of orthoses to facilitate limited ambulation, exercise therapy, and transfer activities.
Codes L1845 and L1846 describe prefabricated and custom fabricated (respectively) knee orthosis that have double uprights, condylar pads, and an adjustable flexion and extension joint and provides 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 portion of the thigh and calf cuffs and (2) the condylar pads. These orthoses are designed for patients who are fully ambulatory.
Response: It is excessively restrictive to limit the use of L1845 and L1846 to “fully ambulatory” patients. Many patients use these types of orthoses to facilitate limited ambulation, exercise therapy, and transfer activities.
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 patients.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 patients.
The following listing indicates the correct coding of base prefabricated orthosis codes and orthosis addition codes. Certain L-coded additions are considered included in the allowance for the specific base orthotic code. Claims for L-coded additions considered included in the base orthotic code are denied as not separately payable. See local coverage determination (LCD) for Knee Orthoses for L-coded additions considered not medically necessary.Base CodeAdd-On Code(s) IncludedL1800NoneL1810L2385, L2390, L2425, L2435, L2750, L2755L1815L2795, L2800, L2810L1820L2385, L2390, L2425, L2435, L2750, L2755, L2795, L2800, L2810L1825L2795, L2800, L2810L1830NoneL1831L2385, L2390, L2425, L2435, L2750, L2755, L2795, L2800, L2810, L2820, L2830, Kxxx1L1832L2385, L2390, L2425, L2435, L2750, L2755, L2795, L2800, L2810, L2820, L2830, Kxxx1L1836L2820, L2830, Kxxx1L1843L2275, L2385, L2390, L2425, L2435, L2750, L2755, L2795, L2800, L2810, L2820, L2830, Kxxx1L1845L2275, L2385, L2390, L2425, L2435, L2750, L2755, L2795, L2800, L2810, L2820, L2830, Kxxx1L1847L2385, L2390, L2425, L2435, L2750, L2755, L2795, L2800, L2810, L2820, L2830, Kxxx1L1850L2275, L2385, L2390, L2425, L2435, L2750, L2755, L2795, L2800, L2810, L2820, L2830, Kxxx1
For all custom fabricated orthoses, codes L2320, L2330, L2335, L2340, L2750 and L2780 are considered included in the allowance for the base orthotic code. In addition for code L1858 only, code L2435 is also included in the allowance for the base orthotic code.
Claims for L-coded additions considered included in the base orthotic code are denied as not separately payable. See local coverage determination (LCD) for Knee Orthoses for L-coded additions considered not medically necessary.
Response: Please clarify that this policy applies only to all custom fabricated knee orthoses, instead of “all custom fabricated orthoses.”
Code Kxxx1 describes a removable soft interface for a knee orthosis. 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 (Kxxx1) are included in the code for a prefabricated orthosis.
Codes L2320, L2330, L2335 and L2340 (non-molded and molded lacers, anterior swing band and pretibial shell, respectively) may only be billed as replacement items.
Response: If codes L2320, L2330, L2335 and L2340 (non-molded and molded lacers, anterior swing band and pretibial shell understood on non-molded/molded lacers) are only considered replacements, then this acknowledges that the base codes to which they would apply should contain them as descriptors (or they should be billable separately as additions). If this is the case, the fee schedule amounts for these base codes should be adjusted to include these components. They should be kept as separate add-on codes for both new orthoses and replacements, as originally intended when they were issued as new L codes.
Code L2755 (addition to lower extremity orthosis, high strength, lightweight material, all hybrid lamination/prepreg composite, per segment) describes the materials carbon graphite, composite carbon fiber, kevlar and titanium. These are the only materials considered high strength and light weight that may be billed using code L2755.
Code L2755 has a unit of service “per segment.” For the purposes of this policy, a segment is defined as above and below the knee. Therefore, for any knee orthosis, the maximum number of segments of code L2755 that may be reimbursed is two (2). Claims for additional units of service of code L2755 will be rejected or denied as incorrect coding.
Code L2770 (addition to lower extremity orthosis, any material, per bar or joint) is invalid for claim submission to the DMERC. Claims for code L2770 will be denied as an invalid code.
Response: This addition code is vital to accurately describe the material upgrade that may be needed to insure proper structural integrity of devices.Currently, when a device is fabricated out of Stainless Steel, Titanium, Carbon Fiber/Epoxy, or significantly larger aluminum, this code is used to describe the added cost and effort to fabricate the clinically appropriate orthosis. This code is reserved for use with the uprights/sidebars, bands, and/or joints. L2770 should not be confused with L2755 (Addition to lower extremity orthosis, high strength, lightweight material, all hybrid lamination/prepreg composite, per segment), which is reserved for lamination type fabrication of the “shells” of a lower extremity orthosis. While ambiguity in the code description of L2770 has been a problem for sometime, the appropriate corrective action is revision of the HCPC code descriptor to “Addition to lower extremity orthosis, high strength, lightweight material, Stainless Steel, Carbon Fiber/Epoxy, Titanium or equal, per bar or joint.”
Code L2860 (addition to lower extremity joint, knee or ankle, concentric adjustable torsion style mechanism, each) is invalid for claim submission to the DMERC. Claims for code L2860 will be denied as an invalid code. 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.
Response: A concentric adjustable torsion style mechanism is a particular device which provides precise healing, stress/resistive strengthening (on a knee orthosis) to either the quadriceps or hamstring groups and to related musculature. They are incorporated into either custom-fitted (prefabricated) or molded-to-patient-model knee orthoses. On custom fitted models, substantial adjustments are made to the brace by qualified practitioners to meet the needs and/or unique shape of an individual patient. This includes fitting the body interface by permanently contouring metal uprights and sizing cuffs and straps for optimal positioning. Custom molded models are made for a specific patient. A patient model of the knee complex is made from a negative cast impression. The model is modified to accommodate anatomical trouble areas and for the proper distribution of force. Plastic and metal are formed to the patient model using exacting orthometric measurements to complete the brace.
E1810 is intended for rental to multiple users (it is a capped rental item). Such a policy cannot be justified for a brace with a concentric torsion mechanism, since each such brace, prefabricated or custom molded, is designed for one and only one patient. The devices incorporating concentric adjustable torsion style mechanisms fit perfectly into the definition of orthosis that is set forth above in this Policy Article. The addition of one component (concentric torsion mechanism) should not change the Medicare benefit category for the device. These devices are orthoses and should therefore be coded with L codes. Many knee orthoses are provided to Medicare beneficiaries to assure stability in sitting, standing and ambulation, with the base orthoses and components prescribed by a physician in a detailed physician order. By adding a modular and removable L2860 component to this design, one orthosis can address concomitant quadriceps weakness for gait assist and address contracture so that ambulatory status is maintained. This is much less expensive than providing one custom brace for stability and one DME rental for contracture. Furthermore, a single device makes is much easier for the patient, thereby improving compliance with the proper use of the device.The four DMERC medical directors previously recognized that a concentric adjustable torsion style mechanism is appropriately coded as an L code: “[i]f a concentric adjustable torsion style mechanism in the knee or ankle joint is being used for a custom fabricated Orthosis to provide an assist function to joint motion during ambulation, it should be coded as L2999.” Accordingly, L2860 should be a valid code that is covered by Medicare.
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
Making adjustments at the time of or within 90 days after delivery
Response: We believe that code L4205 should include professional time in evaluating a patient for repairs, adjustments or modifications to an orthosis.This is important because, in some instances, considerable time is spent evaluating the patient for the problems they have encountered. In some situations, for example, an excessive pressure area may be the result of a change in the patient’s physical or medical condition, progress in the rehabilitation phase of recovery, altered environmental conditions and/or the progressive nature of a chronic medical condition. Once the initial adjustments and modifications have been completed their efficacy must be evaluated before the patient is released. Many times, secondary and tertiary adjustments and/or modifications are required to completely resolve the problems that patients encounter.
Reimbursement for these services is included in the allowance for the HCPCS 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 HCPCS L code) must be used. Code L9900 is denied as not separately payable.
Suppliers should contact the Statistical Analysis Durable Medical Equipment Regional Carrier (SADMERC) for guidance on the correct coding of these items.