Article - Knee Orthoses - Policy Article (A52465)

CMS National Coverage PolicyN/AArticle TextNON-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 beneficiarys orthosis 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 (KO) 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.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 KO 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 in CODING GUIDELINES.)If a custom fit code is billed when minimalself-adjustment was provided at the final delivery, or if an OTS code is billed when more than minimal self-adjustments were made at the final delivery, the claim will be denied as incorrect coding.Elastic or other fabric support garments (A4467 (BELT, STRAP, SLEEVE, GARMENT, OR COVERING, ANY TYPE)) 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 GUIDELINES section below for additional information.There is no separate payment for computer-aided design/computer-aided manufacturing (CAD/CAM) technology when it is used to fabricate an orthosis. Reimbursement, of the CAD/CAM technology utilized in the fabrication of an orthosis, is included in the allowance of the orthosis HCPCS code.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:The orthosis is provided to a beneficiary prior to an inpatient hospital admission or Part A covered SNF stay; andThe 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:The orthosis is provided to a beneficiary during an inpatient hospital or Part A covered SNF stay prior to the day of discharge; andThe 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:The orthosis is medically necessary for a beneficiary after discharge from a hospital or Part A covered SNF stay; andThe orthosis is provided to the beneficiary within two days prior to discharge to home; andThe 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 TOFINAL RULE1713 (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 provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter andWritten Order Prior to DeliveryList is availablehere.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 REQUIREMENTSIn 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.General RequirementsThe supplier must include on the claim line the diagnosis code(s) for HCPCS codes L1830, L1831, L1832, L1833, L1834, L1836, L1840, L1843, L1844, L1845, L1846, L1850, L1851, L1852 and L1860.For a custom-fabricated orthosis, there must be documentation in the supplier's records to support the medical necessity of that type of device rather than a prefabricated orthosis. This information must be available upon request.When providing orthoses suppliers must:Provide the product that is specified by the treating practitionerBe sure that the treating practitioners 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 fittingHave detailed documentation in supplier's records that justifies the code selectedFor prefabricated orthoses (L1810, L1812, L1820, L1830, L1831, L1832, L1833, L1836, L1843, L1845, L1847, L1848, L1850, L1851, L1852), there is no physical difference between orthoses coded as custom fitted versus those coded as OTS. The differentiating factor for proper coding (see definitions in the CODING GUIDELINES section below) 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 (as defined in the CODING GUIDELINES section). Items requiring minimal self-adjustment are coded as OTS orthoses. For example, adjustment of straps and closures, bending or trimming for final fit or comfort (not all-inclusive) fall into this category.Items requiring more than minimal self-adjustment by a qualified practitioner (as defined in the CODING GUIDELINES below) 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 practitioners records to support the medical necessity of the custom fabricated orthosis 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 orthotists records and the method of custom fabrication should adhere to the DMEPOS Quality Standards, Appendix C. This information must be available upon request.MODIFIERSKX, GA, GZ, LT and RT MODIFIERS:Suppliers must add a KX modifier to the KO 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 suppliers 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.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.MISCELLANEOUSIf the item is custom fabricated and does not have a specific HCPCS code, 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) should be entered in the narrative field of an electronic claim or on Item 19 of a paper claim. (Refer to the LCD-related Standard Documentation Requirements article (A55426) for more information regarding billing of items with HCPCS codes that include miscellaneous, NOC, unlisted, or non-specified in their narrative descriptions.)A claim for code L4205 must include an explanation of what is being repaired. A claim for code L4210 must include a description of each item that is billed. This information should be entered in the narrative field of an electronic claim. (Refer to the REPAIR/REPLACEMENT section for more information regarding billing of L4205 and L4210 HCPCS codes.)All codes for orthoses or repairs of orthoses billed with the same date of service must be submitted on the same claim.CODING GUIDELINES:CUSTOM FABRICATEDA 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. Custom-fabricated additions are appropriate only for custom-fabricated base orthotics and should not be billed with prefabricated base orthotics.Use of an additive manufacturing technique, CAD/CAM, or a similar manufacturing technique is not the sole requirement for a product to be designated as custom fabricated.Molded-to-Patient-ModelA 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; orA digital image of the patients body part is made using 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 PatientA positive model is an exact replica of the actual body part for which the custom fabricated item is being constructed. A positive model can be produced by any of these methods:Molded-to-patient-model, which is a negative impression taken of the patients body member and which is used to make a positive model rectification.CAD/CAM software, which uses digitizers to send surface contour data the practitioner uses to rectify or modify the model on the computer screen. The data showing the modified shape goes to a commercial milling machine that carves the rectified model.