Spinal Orthoses: TLSO and LSO - 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”). In order 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. Lumbar-sacral orthoses (LSO) and thoracic-lumbar-sacral orthoses (TLSO) 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. 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. 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 a spinal orthosis 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. A protective body sock (L0984) does not meet the definition of a brace and is noncovered. 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 a spinal orthosis is included in the payment to a hospital or 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 spinal surgery). A claim should not be submitted to the DME MAC in this situation. Payment for a spinal orthosis is 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 a spinal orthosis 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, it will be eligible for coverage. POLICY SPECIFIC DOCUMENTATION REQUIREMENTS 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. 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 the supplier’s record that justifies the code selected For prefabricated orthoses, there is no physical difference between orthoses coded as custom fitted versus those coded as OTS. The differentiating factor for proper coding (refer to the 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 are coded as custom fitted (L0454, L0456, L0458, L0460, L0462, L0464, L0466, L0468, L0470, L0472, L0488, L0490, L0491, L0492, L0626, L0627, L0630, L0631, L0633, L0635, L0637 and L0639). Documentation must be sufficiently detailed to include, but is not limited to, a detailed description of why the modifications are necessary and what modifications were performed at the time of fitting the orthosis to the beneficiary. This information must be available upon request. For a custom fabricated orthosis (L0452, L0480, L0482, L0484, L0486, L0622, L0624, L0629, L0632, L0634, L0636, L0638 and L0640), there must be detailed documentation in the treating practitioner’s 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 orthotist’s records and the method of custom fabrication should adhere to the DMEPOS Quality Standards, Appendix C. This information must be available upon request. MODIFIERS CG Modifier The CG modifier must be added to code L0450, L0454, L0455, L0621, L0625, or L0628 only if it is one made primarily of nonelastic material (e.g., canvas, cotton or nylon) or having a rigid posterior panel. (Refer to the Coding Guidelines section below for instructions on the use of code A4467 for elastic spinal garments.) CODING GUIDELINES CUSTOM FABRICATED A 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