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 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 minimal self-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; and 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: The orthosis is provided to a beneficiary during an inpatient hospital or Part A covered SNF stay prior to the day of discharge; and 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: The orthosis is medically necessary for a beneficiary after discharge from a hospital or Part A covered SNF stay; and The orthosis is provided to the beneficiary within two days prior to discharge to home; and 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 provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is available here . 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 For a knee orthosis with adjustable knee joints or a prefabricated Swedish type knee orthosis (L1832, L1833, L1850), the medical records must include documentation of the beneficiary’s physical examination of the affected knee(s), including all of the following: The joint laxity test(s) performed; and, A description of the exam findings that support objective joint laxity. For a knee orthosis with single or double upright, adjustable flexion and extension joint, medial-lateral and rotation control, with or without varus/valgus adjustment (L1843, L1844, L1845, L1846, L1851, L1852) for the management of an ambulatory beneficiary with knee instability, the medical records must include documentation of all of the following: The beneficiary’s ambulatory status; and, A physical examination of the affected knee(s), including all of the following: The joint laxity test(s) performed; and, A description of the exam findings that support objective joint laxity. For a knee orthosis with single or double upright, adjustable flexion and extension joint, medial-lateral and rotation control, with varus or valgus adjustment (L1843, L1844, L1845, L1846, L1851, L1852) used for the management of pain affecting mobility and/or function due to medial or lateral tibiofemoral osteoarthritis, the beneficiary’s medical records must include documentation of all of the following: The beneficiary’s ambulatory status; and, The beneficiary’s pain symptoms, or mobility and/or functional reduction due to the medial or lateral tibiofemoral osteoarthritis; and, A physical examination of the beneficiary’s affected knee(s); and, An imaging report (e.g., x-ray, CT scan, MRI) that describes arthritic changes (e.g., joint space narrowing, bone spurs, cysts) consistent with medial or lateral compartment tibiofemoral osteoarthritis; and, The beneficiary’s willingness to use the knee orthosis. 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. Based on Social Security Act §1834(h)(5), for purposes of determining the reasonableness and medical necessity of orthotics and prosthetics, documentation created by an orthotist or prosthetist shall be considered part of the individual’s medical record to support documentation created by the treating practitioner. General Requirements The 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 Be sure that the treating 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 For prefabricated orthoses (L1810, L1812, L1820, L1821, 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, L1820, L1832, L1843, L1845, L