Spinal Orthoses: TLSO and LSO - Policy Article

Revision Effective Date: 01/23/2024
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Revised: “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.” to “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.,” as clarification


04/09/2026: 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.

Revision Effective Date: 01/23/2024
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Added: “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.” as clarification
04/03/2025: 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.

Revision Effective Date: 01/23/2024
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Removed: “Fabrication of an orthosis using CAD/CAM or similar technology without the creation of a positive model with minimal self-adjustment at delivery is considered as OTS.”
CODING GUIDELINES:
Added: “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.”
Removed: “An orthosis that is fabricated from a mold, CAD/CAM, or similar technology but without the creation of a positive model is considered a prefabricated orthosis.”
Added: “Additive Manufacturing” with a description
Added: “Additive manufacturing is an acceptable custom fabrication technique as long as it adheres to the CMS DMEPOS Quality Standards, Appendix C.”
Removed: “Use of CAD/CAM or similar technology to create an orthosis without a positive model of the patient is considered as OTS if the final fitting upon delivery to the patient requires minimal self-adjustment not requiring expertise as described in this section.”
Removed: “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.”


03/07/2024: 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.

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.

Revision Effective Date: 07/07/2022
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Revised: “coding guideline” and “Coding Guidelines” to “CODING GUIDELINES” in reference to section
Removed: Statement that pertained to the effective date for coding verification review requirement and to statutory denial
Revised: “CAD-CAM” to “computer-aided design/computer-aided manufacturing (CAD/CAM)”
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Revised: “off-the-shelf” to “OTS”
Revised: “Coding Guidelines” to “CODING GUIDELINES” in reference to section
Removed: Information pertaining to that which suppliers must do when providing these items
CODING GUIDELINES:
Revised: “three point” to “three-point”
Revised: “L codes” to “L-codes”
Removed: Statement that referred to Documentation Requirements section of the LCD for instructions concerning use of the CG modifier
Removed: Statement that pertained to billing when CAD/CAM technology used to fabricate an orthosis
CODING VERIFICATION REVIEW:
Added: Section header and PDAC coding verification review information
Revised: Reference to the coding verification review effective date for HCPCS codes L0455, L0457, L0467, L0469, L0641, L0642, L0643, L0648, L0649, L0650, L0651
07/07/2022: 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.

Revision Effective Date: 02/01/2021
REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 FED. REG VOL 217):
Removed: “The link will be located here once it is available.”
Added: “The required Face-to-Face Encounter and Written Order Prior to Delivery List is available here.” with a hyperlink to the list


04/14/2022: 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.

Revision Effective Date: 02/01/2021
CODING GUIDELINES:
Removed: Reference to L0640 from list of prefabricated orthoses
Removed: HCPCS codes L0622 and L0624 from list of custom fabricated orthoses for which all products must be listed on the PCL
Added: “(PCL)” after reference to “Product Classification List”
Revised: Coding verification review information, to include incorrect coding denial language for products billed using HCPCS that require written coding verification review
03/11/2021: 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.

Revision Effective Date: 02/01/2021
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Revised: Prefabricated orthoses (OTS or custom-fit) incorrect coding denial language, by removing “with a statutory denial”
Added: Definitions of prefabricated and custom fabricated orthoses
Clarified: Billing of custom fabricated additions
11/19/2020: 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.

Revision Effective Date: 01/01/2020
REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 Fed. Reg Vol 217):
Added: Section and related information based on Final Rule 1713
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Revised: “ordering physician” to “treating practitioner”
Revised: “prescribing practitioner” to “treating practitioner”
CODING GUIDELINES:
Revised: Format of HCPCS code references, from code ‘spans’ to individually-listed HCPCS
Revised: HCPCS codes referenced for body jacket type orthoses, to include L0651
 Revised: HCPCS codes referenced for billing of prefabricated orthoses, to include L0640, L0641, L0642, L0643, L0648, L0649, L0650, and L0651
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Revised: Section header “ICD-10 Codes that are Covered” updated to “ICD-10 Codes that Support Medical Necessity”
ICD-10 CODES THAT DO NOT SUPPORT MEDICAL NECESSITY:
Revised: Section header “ICD-10 Codes that are Not Covered” updated to “ICD-10 Codes that DO NOT Support Medical Necessity”

03/05/2020: 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.

Revision Effective Date: 01/01/2019
CODING GUIDELINES:
Clarified: Custom fit requirements

03/28/2019: 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.

Revision Effective Date: 01/01/2019
CODING GUIDELINES:
Revised: Coding instructions for prefabricated orthoses without distinction of OTS or custom-fit.

02/14/2019: 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.

Revision Effective Date: 01/01/2018
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Added: HCPCS codes L0622 and L0624 to custom fabricated codes
CODING GUIDELINES:
Added: Coding guidelines for maternity support garments
Added: HCPCS codes L0622 and L0624 to custom fabricated codes


04/19/2018: At this time 21st Century Cures Act applies to new and revised LCDs that restrict coverage, which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2017
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Revised: Brace Benefit explanation to remove reference to “counterforce” that is no longer applicable
Revised: Prefabricated and OTS “minimal self-adjustment” regulatory definition discussion to improve consistency with regulatory definition of minimal self-adjustment
Deleted: A4466
Added: A4467
Added: Policy specific documentation requirements from LCD
CODING GUIDELINES:
Removed: Reference to classification algorithm summary
Revised: OTS and custom-fit definitions to improve consistency with regulatory definition of “minimal self-adjustment”
Added: Section on coding of elastic and similar materials
Deleted: A4466
Added: A4467
RELATED LOCAL COVERAGE DOCUMENTS:
Added: LCD-related Standard Documentation Requirements Language Article

Effective July 1, 2016 oversight for DME MAC Articles is the responsibility of CGS Administrators, LLC 18003 and 17013 and Noridian Healthcare Solutions, LLC 19003 and 16013. No other changes have been made to the Articles.

Revision Effective Date: 10/31/2014
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES
CODING GUIDELINES:
Added: L0455 added to paragraph regarding items made of primarily nonelastic material