Article - Ankle-Foot/Knee-Ankle-Foot Orthoses - Policy Article (A52457)

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.Refer to the Orthopedic Footwear policy for information on documentation requirements for shoes and related items which are an integral part of a brace.CODING GUIDELINESCUSTOM 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; or,A 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.Direct formed model, in which the patient serves as the positive model. The device is constructed over the patients model, and is then fabricated to the patient. The completed custom fabrication is checked and all necessary adjustments are made.Additive ManufacturingAdditive manufacturing (such as 3D printing) is an advanced technology that constructs three-dimensional items modeled and designed from CAD software and/or from digital scanning. Additive manufacturing is an acceptable custom fabrication technique as long as it adheres to the CMS DMEPOS Quality Standards, Appendix C.Specialized TrainingSpecialized training is defined as training that provides knowledge, skills, and experience in the provision of orthotics in compliance with all applicable Federal and State licensure and regulatory requirements.PREFABRICATEDA prefabricated orthosis is an item that is manufactured in quantity without a specific beneficiary in mind. A prefabricated orthosis may be considered an OTS or a custom fitted device that may be trimmed, bent, molded (with or without heat), or otherwise modified for use by a specific beneficiary. An orthosis that is assembled from prefabricated components is considered prefabricated. It is inherent in the definition of prefabricated that a particular item is complete.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, 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. See more than minimal self-adjustment definition below for additional information.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 requiresmore 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 the 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.Correct coding of prefabricated orthoses is dictated by actions that take place at the time of fitting to the beneficiary, either custom-fitted (requiring expertise) or OTS (requiring minimal self-adjustment).Corresponding HCPCS Code SetsFor many prefabricated orthoses, corresponding sets of HCPCS codes are available which describe the identical types of items. The corresponding code sets, when available for identical products, are only differentiated by the nature of the final fitting performed at the time of delivery. The corresponding HCPCS code types are:HCPCS codes which describe PREFABRICATED, OFF-THE-SHELF. These HCPCS codes 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. These HCPCS codes must be used when more than minimal self-adjustment is necessary and performed at delivery.In the following table, the HCPCS codes located in Column I and Column II within the same row are considered a corresponding HCPCS code set. These codes represent identical products which are only differentiated by the nature of the final fitting performed at the time of delivery.Column IColumn IIL4360L4361L4386L4387L4396L4397For some prefabricated orthoses, corresponding sets of HCPCS codes (which describe the identical types of items) are not available. HCPCS codes with long descriptions of PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT describe custom fitted items. For these HCPCS codes there are no corresponding OTS codes. When the unique HCPCS code that most closely describes the product includes PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT in the HCPCS long description, the supplier must:Code the product using the unique HCPCS code, if the product was custom fitted at the time of delivery to the beneficiary; or,Code the product using a miscellaneous HCPCS code, if the product was not custom fitted at delivery to the beneficiary and, instead, was provided as OTS to the beneficiary. The miscellaneous HCPCS code for billing of AFOs and KAFOs is HCPCS code L2999.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 MATERIALSFor 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, 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. 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).