• For HCPCS codes L4392, L4396 and L4397 - Group 1 Ankle-Foot/Knee-Ankle-Foot Orthoses Policy Article
• For HCPCS code L4631 - Group 2 Ankle-Foot/Knee-Ankle-Foot Orthoses Policy Article

• Suppliers may be reimbursed for the labor and parts involved in customization when an order is canceled, or the beneficiary expires prior to delivery. When billing, include a claim narrative explaining reason for cancellation (e.g., death, canceled, etc.) in Item 19 of CMS-1500 claim form or NTE segment of loop 2400 on an electronic claim. Date of service (DOS) on claim must be date order was canceled or date of beneficiary death. Please refer to the CMS Internet Only Manual (IOM), Publication 100-02, Chapter 15, Section 20.3 for more information.

The only products which may be billed using the following list of HCPCS codes are those for which a written coding verification review (CVR) has been made by the PDAC contractor and subsequently published on the Product Classification List (PCL)

Knee Orthoses

• L1845 - Effective for claims with dates of service on or after July 01, 2008
• L1852 - Effective for claims with dates of service on or after January 1, 2017
• L1832, L1833 and L1851 - Effective for claims with dates of service on or after October 10, 2022

Spinal Orthoses

• L0450, L0454, L0456, L0458, L0460, L0462, L0464, L0466, L0468, L0470, L0472, L0488, L0490, L0491, L0492, L0625, L0626, L0627, L0628, L0630, L0631, L0633, L0635, L0637, L0639 - Effective for claims with dates of service on or after July 1, 2010
• L0455, L0457, L0467, L0469, L0641, L0642, L0643, L0648, L0649, L0650, L0651 - Effective for claims with dates of service on or after January 1, 2014
• There are two categories of custom fabricated spinal orthoses (codes L0452, L0480, L0482, L0484, L0486, L0629, L0632, L0634, L0636, L0638, and L0640)
• Orthoses that are custom fabricated by a manufacturer/central fabrication facility and then sent to someone other than the beneficiary.
  • Effective for claims with dates of service on or after July 1, 2010, these items may be billed using one of these codes only if they are listed in the Product Classification List on the PDAC web site

• All Medicare Round 2021 Durable Medical Equipment, Prosthetics, Orthotics, & Supplies (DMEPOS) Competitive Bidding Program (CBP) Contracts for off-the-shelf (OTS) back braces and OTS knee braces expire on December 31, 2023. Starting January 1, 2024, there will be a temporary gap in the DMEPOS CBP.
• Round 2021 of the DMEPOS Competitive Bidding Program began on January 1, 2021 and includes off-the-shelf (OTS) back braces and OTS knee braces product categories.

• Refer to the Correct Billing for Custom Fitted Orthotics when no Custom Fitting is Completed with no Off the Shelf Equivalent webpage for more information on billing these claims accurately
• Utilize the Off-The-Shelf or Custom-Fitted Orthotic Lookup Tool to identify affected codes
• Joint Article by the DME MAC and PDAC: Custom Fitted Orthotic HCPCS Codes Without a Corresponding Off-the-Shelf Code - Correct Coding

• A custom fabricated orthosis is one which is individually made for a specific beneficiary (no other beneficiary would be able to use this orthosis) starting with basic materials including, but not limited to, plastic, metal, leather, or cloth in the form of sheets, bars, etc. It involves substantial work such as vacuum forming, cutting, bending, molding, sewing, etc. It requires more than trimming, bending, or making other modifications to a prefabricated item.
• To support medical necessity of custom fabricated rather than a prefabricated orthosis, include detailed documentation in treating physician's records. This information will be corroborated by functional evaluation in orthotist or prosthetist's records and must be available upon request
• Billing Not Otherwise Classified (NOC) custom fabricated - If the item is custom fabricated and does not have a specific HCPCS code a narrative must be added to the claim.
  • Narrative added to claim:
    • Description of the item or service
    • Manufacturer name
    • Product name, model name and number
    • Supplier Price List (PL) amount (this is the same amount billed on the claim line)
    • HCPCS code of related item (if applicable)
    • If Repair part, HCPCS code of item being repaired
• If claim is denied, request redetermination with all documentation to support medical necessity
  • Medical necessity for item (medical records)
  • If item is custom-fabricated, provide complete and clear description of item including:
    • What makes item unique
    • Breakdown of charges (materials and labor)

• Want to know more about DMEPOS Deliveries before Inpatient Discharge? Please refer to the Medicare DMEPOS Payments While Inpatient MLN Fact Sheet

• For HCPCS codes L1831 and L1836 - Group 1 Knee Orthoses Policy Article
• For HCPCS Codes L1830, L1832, L1833, and L1834 - Group 2 Knee Orthoses Policy Article
• For HCPCS Codes L1840 - Group 3 Knee Orthoses Policy Article
• For HCPCS Codes L1832, L1833, L1843, L1844, L1845, L1846, L1851 and L1852 - Group 4 Knee Orthoses Policy Article
• For HCPCS Codes L1850, L1860 - Group 5 Knee Orthoses Policy Article

• Off-the-Shelf - Minimal self-adjustment refers to adjustments that can be made by the beneficiary, their caregiver, or the supplier, such as assembling, trimming, or adjusting straps. Minimal self-adjustment does not require any expertise in trimming, molding, assembling, or customizing to fit to the individual; therefore, the adjustment does not need to be performed by a certified orthotist or an individual with specialized training.
• Custom Fitted - More than minimal self-adjustment is when an item must be trimmed, bent, molded, or otherwise modified for an individualized fit. These kinds of alterations require the expertise of a certified orthotist or someone with specialized training in the provisions of orthoses to fit the item to the beneficiary.

• Off-the-Shelf - If an orthosis needs only minimal self-adjustment for fitting at the time of delivery, it is considered off-the-shelf.
• Custom Fitted - If an orthosis requires more than minimal self-adjustment, it is considered custom fitted. A certified orthotist or an individual who has equivalent specialized training can perform more than minimal modifications for a custom fitted prefabricated orthotic. (e.g., physician, treating practitioner, physical therapist, or occupation therapist in compliance with all applicable federal and state licensure and regulatory requirements). See article Definitions Used for Off-the-Shelf versus Custom Fitted Prefabricated Orthotics (Braces) - Correct Coding - Revised

• Need prior to surgery - Items can be provided and billed prior to surgery when item is medically necessary and the brace is required to be worn prior to surgery, coverage criteria is met, and documentation to substantiate the need is included in ordering physician’s medical record.
• Need after surgery - If there is no medical need to wear the brace until after surgery, item should not be provided until after the surgery has been performed and medical need exists.

Repairs to Orthotic

• Labor and minor parts HCPCS Codes
  • L4205 - Repair of orthotic device, labor component, per 15 minutes
    • Claim line for code L4205 narrative must include:
      • Explanation of what is being repaired
  • L4210 - Repair of orthotic device, repair or replace minor parts (e.g., those without specific HCPCS codes). Supplier Price List (PL) amount is the amount the supplier is charging on the claim line.
    • Claim line for code L4210 narrative must include:
      • HCPCS code of item being repaired
      • Description of each item that is billed

Replacement

Replacement Same or Similar

• Allowed due to loss, theft, or irreparable damage or when reasonable useful lifetime (RUL) of original orthosis is met. RUL for DMEPOS items is five years unless specific LCD/PA specify otherwise
• See Medical Director written Billing Instructions - LSO and TLSO
• See Medical Director written Orthoses: Replacement of Components Clarification - Republished

• Suppliers must bill each item on two separate claim lines using the RT and LT modifiers and 1 UOS on each claim line. Claim lines for HCPCS codes requiring use of the RT and LT modifiers, billed without the RT and/or LT modifiers or with the RTLT on a single claim line, will be rejected as incorrect coding.

Medicare Coverage for Shoes - Correct Coding - Revised

Therapeutic Shoes vs Orthopedic Footwear

Medicare has limited coverage provisions for shoes, inserts, and shoe modifications used by beneficiaries. In order to be eligible for coverage, such items must qualify in either:

1. The benefit category for therapeutic shoes provisioned in the treatment of a diabetes-related condition(s) or
2. The benefit category for leg braces (to which the shoes and related items would be considered for coverage as integral components of the leg brace).

Therapeutic Shoes vs Orthopedic Footwear -

Shoes, inserts, modifications covered in limited circumstances

• Coverage includes select diabetic beneficiaries
  • To prevent/treat diabetic foot ulcers
  • View Therapeutic Shoes for Persons with Diabetes Policy Article A52501 for appropriate codes
• Orthopedic shoes covered if integral part of covered leg brace
  • Search applicable brace codes in Orthopedic Footwear Policy Article A52481
  • Shoes incorporated into a brace must be billed by same supplier billing for brace
    • When initially providing brace
  • Shoes billed separately (i.e., not as part of brace) deny noncovered
• Shoes/related modifications, inserts, heel/sole replacements, shoe transfers
  • Only covered when shoe is integral part of covered leg brace
  • Must be medically necessary for proper functioning of brace
  • Must be billed with KX modifier or will deny noncovered, statutorily excluded

• Correct coding is an essential element for correct claim payment. The DME MACs and Pricing, Data Analysis and Coding (PDAC) contractor maintain a variety of resources to assist suppliers in determining the appropriate code for billing upper extremity braces. Please refer to the joint article, Correct Coding of Finger, Hand, Hand-Finger and Wrist-Hand- Finger Braces (Orthoses) - Revised and Correct Coding of Elbow, Shoulder, Shoulder-Elbow-Wrist-Hand and Shoulder- Elbow-Wrist-Hand-Finger Braces (Orthoses) for additional information.