evekhm/cms_iom_500 huggingface dataset:
Article - Knee Orthoses - Policy Article (A52465)
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 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 practitioner
Article - Knee Orthoses - Policy Article (A52465)
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 selected
Article - Knee Orthoses - Policy Article (A52465)
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.
Article - Knee Orthoses - Policy Article (A52465)
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.
Article - Knee Orthoses - Policy Article (A52465)
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:
Article - Knee Orthoses - Policy Article (A52465)
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.Direct formed model, in which the patient serves as the positive model. The device is constructed over the patient's model, and is then fabricated to the patient. The completed custom fabrication is checked and all necessary adjustments are made.
Article - Knee Orthoses - Policy Article (A52465)
Direct formed model, in which the patient serves as the positive model. The device is constructed over the patient's 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 the knowledge, skills, and experience in theprovision 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, 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.
Article - Knee Orthoses - Policy Article (A52465)
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. 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-adjustmentat 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.
Article - Knee Orthoses - Policy Article (A52465)
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 minimalself-adjustment"is defined as changes made to achieve an individualized fit during the final fittingat the time of delivery of the itemthat 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.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 whenmore than minimal self-adjustmentis 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 IIL1810L1812L1832L1833L1843L1851L1845L1852L1847L1848
Article - Knee Orthoses - Policy Article (A52465)
Column IColumn IIL1810L1812L1832L1833L1843L1851L1845L1852L1847L1848For 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 KOs 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).
Article - Knee Orthoses - Policy Article (A52465)
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.
Article - Knee Orthoses - Policy Article (A52465)
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 (NON-COVERED ITEM OR SERVICE).
Article - Knee Orthoses - Policy Article (A52465)
KNEE ORTHOSESCodes L1810 (KNEE ORTHOSIS, ELASTIC WITH JOINTS, PREFABRICATED ITEM THAT HAS BEEN TRIMMED, BENT, MOLDED, ASSEMBLED, OR OTHERWISE CUSTOMIZED TO FIT A SPECIFIC PATIENT BY AN INDIVIDUAL WITH EXPERTISE) and L1812 (KNEE ORTHOSIS, ELASTIC WITH JOINTS, PREFABRICATED, OFF-THE-SHELF) 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 (KNEE ORTHOSIS, ELASTIC WITH CONDYLAR PADS AND JOINTS, WITH OR WITHOUT PATELLAR CONTROL, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT) 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 (KNEE ORTHOSIS, IMMOBILIZER, CANVAS LONGITUDINAL, PREFABRICATED, OFF-THE-SHELF) 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 Velcrostraps or equal. The orthosis immobilizes the knee joint and prevents flexion or extension. There are no hinges or joints.
Article - Knee Orthoses - Policy Article (A52465)
Codes L1831 (KNEE ORTHOSIS, LOCKING KNEE JOINT(S), POSITIONAL ORTHOSIS, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT), L1847 (KNEE ORTHOSIS, DOUBLE UPRIGHT WITH ADJUSTABLE JOINT, WITH INFLATABLE AIR SUPPLY CHAMBER(S), PREFABRICATED ITEM THAT HAS BEEN TRIMMED, BENT, MOLDED, ASSEMBLED, OR OTHERWISE CUSTOMIZED TO FIT A SPECIFIC PATIENT BY AN INDIVIDUAL WITH EXPERTISE) and L1848 (KNEE ORTHOSIS, DOUBLE UPRIGHT WITH ADJUSTABLE JOINT, WITH INFLATABLE AIR SUPPLY CHAMBER(S), PREFABRICATED, OFF-THE-SHELF) 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 (KNEE ORTHOSIS, ADJUSTABLE KNEE JOINTS (UNICENTRIC OR POLYCENTRIC), POSITIONAL ORTHOSIS, RIGID SUPPORT, PREFABRICATED ITEM THAT HAS BEEN TRIMMED, BENT, MOLDED, ASSEMBLED, OR OTHERWISE CUSTOMIZED TO FIT A SPECIFIC PATIENT BY AN INDIVIDUAL WITH EXPERTISE) and L1833 (KNEE ORTHOSIS, ADJUSTABLE KNEE JOINTS (UNICENTRIC OR POLYCENTRIC), POSITIONAL ORTHOSIS, RIGID SUPPORT, PREFABRICATED, OFF-THE-SHELF) 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.