Article Detail - JA DME

Joint DME MAC Publication

Outlined below are the principal changes to the DME MAC Policy Articles (PAs) that have been revised and posted. The policies included are Ankle-Foot/Knee-Ankle-Foot Orthoses, Knee Orthoses, and Spinal Orthoses: TLSO and LSO. Please review the entire Local Coverage Determinations (LCDs) and related PAs for complete information.

Ankle-Foot/Knee-Ankle-Foot Orthoses

PA

Revision Effective Date: 02/01/2021

NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:

Removed: Language that describes prefabricated and custom fabricated orthoses

Revised: "This minimal self-adjustment does not require the services of a certified orthotist or an individual who has specialized training." to "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)."

Revised: HCPCS referenced as custom fabricated orthoses, to include "L1900"

Revised: "This information will be corroborated by the functional evaluation in the orthotist or prosthetist’s records." to "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."

MODIFIERS:

Removed: "refer to the CODING GUIDELINES section for additional information" pertaining to RT and LT modifiers

Added: RT and LT modifier information (relocated from the CODING GUIDELINES section)

MISCELLANEOUS:

Added: "(Refer to the REPAIR/REPLACEMENT section for more information regarding billing of L4205 and L4210 HCPCS codes.)"

CODING GUIDELINES:

Added: "CUSTOM FABRICATED"

Added: "Custom-fabricated additions are appropriate only for custom-fabricated base orthotics and should not be billed with prefabricated base orthotics" (relocated from the NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section)

Added: Language that describes custom fabricated orthoses, molded-to-patient-model custom fabrication, and positive model of the patient

Added: "Specialized Training" and the definition of specialized training

Added: "PREFABRICATED" and language that describes prefabricated orthoses

Removed: "However, for certain types of orthoses, the HCPCS code narrative that best describes the product does not make a distinction between prefabricated orthoses that are provided as custom-fit or OTS. These code narratives are correct and must be used for Medicare billing, without regard to how the product is provided to the beneficiary at the final delivery." (Effective March 11, 2021)

Added: "Corresponding HCPCS Code Sets"

Revised: "parallel" to "corresponding" in regard to HCPCS codes

Removed: "(e.g., L4360, L4361, L4386, L4387, L4396 and L4397)" from the sentence that pertains to corresponding sets of HCPCS codes

Added: HCPCS codes L4360, L4361, L4386, L4387, L4396, and L4397 to a table that pertains to corresponding sets of HCPCS codes

Added: Information that pertains to the coding of a prefabricated orthosis when a corresponding HCPCS code set is not available and the unique HCPCS code describes a custom fitted item, including "Code the product using the unique HCPCS code, if the product was custom fitted at the time of delivery to the beneficiary" and "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." (Effective March 11, 2021)

Revised: "Elastic and Similar Stretchable Materials" to "ELASTIC AND SIMILAR STRETCHABLE MATERIALS"

Added: "ANKLE-FOOT ORTHOSES," "KNEE-ANKLE-FOOT ORTHOSES," "POSITIONING DEVICES," "SHOE INSERTS," "CONCENTRIC TORSION JOINTS," "WALKING BOOTS," "OTHER DEVICES," and "REPAIR/REPLACEMENT"

Added: Coding guideline information for HCPCS codes L2034, L2036, L2200, L2210, L2220, L2280, L2330, and L2820

Added: "LOWER EXTREMITY ADDITIONS" and language that describes custom-fabricated additions

Removed: Language that referred to the HCPCS codes which describe custom fabricated and prefabricated orthoses

Removed: Language that referred to the HCPCS codes which describe orthoses worn when a beneficiary is ambulatory, non-ambulatory, or minimally ambulatory

Revised: Language that pertains to shoes, inserts, and shoe modifications that are integral components of a leg brace and the pertinent HCPCS codes

Removed: RT and LT modifier information

12/07/2023: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Knee Orthoses

PA

  Revision Effective Date: 07/20/2023

NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:

Removed: Language that describes prefabricated and custom fabricated orthoses

Removed: Reasonable and useful lifetime (RUL) language and chart of knee orthoses codes with RUL guidelines

Removed: Language pertaining to noncoverage of L-coded additions when the base orthosis is noncovered

Removed: "Brace sleeves (A9270) used in conjunction with orthoses are noncovered because they are not used to support a weak or deformed body member or to restrict or eliminate motion in a diseased or injured part of the body (i.e., it does not meet the definition of a brace)."

Removed: Repair information

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:

Added: "General Requirements"

Added: "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."

Added: "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."

Revised: "prescribing practitioner" to "treating practitioner"

Removed: "The beneficiary’s condition (diagnosis code) that necessitates the need for the knee orthosis must be included on the claim."

Added: Prefabricated orthoses HCPCS codes to language that pertains to coding of prefabricated orthoses

Revised: "This information will be corroborated by the functional evaluation in the orthotist’s or prosthetist’s records." to "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."

MODIFIERS:

Removed: "(refer to the CODING GUIDELINES section for additional information)" pertaining to RT and LT modifiers

Added: RT and LT modifier information (relocated from the CODING GUIDELINES section)

MISCELLANEOUS:

Added: Language pertaining to information for inclusion in claims for codes L4205 and L4210

CODING GUIDELINES:

Removed: "Definitions," language pertaining to terms used to describe devices in the Policy Article, and brace definition language

Revised: "Custom Fabricated" to "CUSTOM FABRICATED"

Added: "Custom-fabricated additions are appropriate only for custom-fabricated base orthotics and should not be billed with prefabricated base orthotics" (relocated from the NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section)

Added: Updated language that describes custom fabricated orthoses, molded-to-patient-model custom fabrication, and positive model of the patient

Added: "PREFABRICATED" and language that describes prefabricated orthoses

Revised: "More than minimal self-adjustment is defined as changes made to achieve an individualized fit of the item that 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." to "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 specialized training in the provision of orthotics in compliance with all applicable Federal and State licensure and regulatory requirements."

Added: "Use of CAD/CAM or similar technology to create an orthosis without a positive model of the patient is considered as custom fitted if the final fitting at the time of delivery to the patient requires more than minimal self-adjustment requiring expertise as described in this section."

Removed: "However, for certain types of orthoses, the HCPCS code narrative that best describes the product does not make a distinction between prefabricated orthoses that are provided as custom-fit or OTS. These code narratives are correct and must be used for Medicare billing, without regard to how the product is provided to the beneficiary at the final delivery." (Effective March 11, 2021)

Added: "Corresponding HCPCS Code Sets"

Revised: "parallel" to "corresponding" in regard to HCPCS codes

Removed: "(e.g., L1832, L1833, L1845, L1846, L1847, and L1848)" from the sentence that pertains to corresponding sets of HCPCS codes

Added: HCPCS codes L1810, L1812, L1832, L1833, L1843, L1845, L1847, L1848, L1851, L1852 to a table that pertains to corresponding sets of HCPCS codes

Added: Information that pertains to the coding of a prefabricated orthosis when a corresponding HCPCS code set is not available and the unique HCPCS code describes a custom fitted item, including "Code the product using the unique HCPCS code, if the product was custom fitted at the time of delivery to the beneficiary" and "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 knee orthoses is HCPCS code L2999." (Effective March 11, 2021)

Revised: "Elastic and Similar Stretchable Materials" to "ELASTIC AND SIMILAR STRETCHABLE MATERIALS"

Added: "KNEE ORTHOSES"

Removed: "(respectively)" from the description of codes L1843, L1844, L1845, L1846, L1851 and L1852

Added: "LOWER EXTREMITY ADDITIONS" and language that describes custom-fabricated additions

Revised: "Not medically necessary" to "Not reasonable and necessary" in regard to the four (4) categories into which addition codes are grouped

Added: Reasonable and useful lifetime (RUL) language and chart of knee orthoses codes with RUL guidelines (relocated from the NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section)

Added: Language pertaining to noncoverage of L-coded additions when the base orthosis is noncovered (relocated from the NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section)

Added: "CONCENTRIC TORSION JOINTS" and "REPAIR/REPLACEMENT"

Revised: "dynamic adjustable knee extension/flexion device" to "DYNAMIC ADJUSTABLE KNEE EXTENSION/FLEXION DEVICE, INCLUDES SOFT INTERFACE MATERIAL"

Removed: "Code L4002 (REPLACEMENT STRAP, ANY ORTHOSIS, INCLUDES ALL COMPONENTS, ANY LENGTH, ANY TYPE) is for billing of replacement component(s) and is not payable at initial issue of a base orthosis. When code L4002 is billed at the time of initial issue of a base orthosis, it will be denied as not separately payable."

Removed: RT and LT modifier information

Added: Reasonable and useful lifetime (RUL) language and chart of knee orthoses codes with RUL guidelines (relocated from the NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section)

Added: "Addition codes K0672, L2390, L2750, L2780, L4002 are for billing of replacement component(s) and are not payable at initial issue of a base orthosis. When code L4002 is billed at the time of initial issue of a base orthosis, it will be denied as not separately payable."

Added: "Some replacement items have unique Healthcare Common Procedure Coding System (HCPCS) codes. Replacement components that do not have a unique HCPCS code must be billed with a "not otherwise specified" code - L2999. Items that have unique codes must not be billed using a NOC code."

12/07/2023: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Spinal Orthoses: TLSO and LSO

PA

Revision Effective Date: 07/07/2022

NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:

Removed: Language that describes prefabricated and custom fabricated orthoses

Revised: "This minimal self-adjustment does not require the services of a certified orthotist or an individual who has specialized training." to "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)."

Revised: "This information will be corroborated by the functional evaluation in the orthotist’s or prosthetist’s records." to "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."

CODING GUIDELINES:

Added: "CUSTOM FABRICATED"

Added: "Custom-fabricated additions are appropriate only for custom-fabricated base orthotics and should not be billed with prefabricated base orthotics" (relocated from the NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section)

Added: Updated language that describes custom fabricated orthoses, molded-to-patient-model custom fabrication, and positive model of the patient

Added: "Specialized Training" and the definition of specialized training

Added: "PREFABRICATED" and language that describes prefabricated orthoses

Removed: "However, for certain types of orthoses, the HCPCS code narrative that best describes the product does not make a distinction between prefabricated orthoses that are provided as custom-fit or OTS. These code narratives are correct and must be used for Medicare billing, without regard to how the product is provided to the beneficiary at the final delivery." (Effective March 11, 2021)

Added: "Use of CAD/CAM or similar technology to create an orthosis without a positive model of the patient is considered as custom fitted if the final fitting at the time of delivery to the patient requires more than minimal self-adjustment requiring expertise as described in this section."

Added: "Corresponding HCPCS Code Sets"

Revised: "parallel" to "corresponding" in regard to HCPCS codes

Added: HCPCS codes L0454, L0455, L0456, L0457, L0466, L0467, L0468, L0469, L0626, L0641, L0627, L0642, L0630, L0643, L0631, L0648, L0633, L0649, L0637, L0650, L0639, and L0651 to a table that pertains to corresponding sets of HCPCS codes

Added: Information that pertains to the coding of a prefabricated orthosis when a corresponding HCPCS code set is not available and the unique HCPCS code describes a custom fitted item, including "Code the product using the unique HCPCS code, if the product was custom fitted at the time of delivery to the beneficiary" and "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 spinal orthoses is HCPCS code L1499." (Effective March 11, 2021)

Added: "SPINAL ORTHOSES"

Revised: "Elastic and Similar Stretchable Materials" to "ELASTIC AND SIMILAR STRETCHABLE MATERIALS"

12/07/2023: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Note: The information contained in this article is only a summary of revisions to the LCDs and/or PAs. For complete information on any topic, you must review the LCDs and/or PAs.

With the update(s) listed above, Noridian would like to remind users how to find the policy that was previously effective. When billing, the supplier should follow guidance that was effective on the date of service. The below steps can be followed to find all previous policies:

1. Open the currently effective policy on the Medical Coverage Database (MCD)
   1. Links to the MCD can be found on the Active LCDs page on the Noridian website
      1. There is a link at the top of the Active LCD page that goes to a full list of the LCDs or PAs, depending on which link is selected OR
      2. There are direct links to all LCDs under the ‘LCD ID number and Effective Date’ column
2. Scroll down to the bottom of the policy
3. Find the section labeled Public Version(s)
4. Look for the link to the policy that was effective on the dates of service in question.
5. Click on hyperlink to go to the policy.