RETIRED - Correct Coding - Definitions Used for Off-the-Shelf versus Custom Fitted Prefabricated Orthotics (Braces) - Revised - JD DME

Joint DME MAC Publication

Editor's note: Revision from July 5, 2019 corrects HCPCS code crosswalks K0901 and K0902 to L1851 and L1852 respectively.

As part of the 2014 and 2015 HCPCS update, codes were created describing certain off-the-shelf (OTS) orthotics. Some of these codes parallel codes for custom fitted versions of the same items. Refer to the table at the end of this article for a listing of codes.

When providing these items suppliers must:

• Provide the product that is specified by the ordering physician
• Be sure that the ordering physician'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

The following definitions will be used for correct coding of these items.

Off-the-shelf (OTS) orthotics are:

• Items that are prefabricated.
• They may or may not be supplied as a kit that requires some assembly. Assembly of the item and/or installation of add-on components and/or the use of some basic materials in preparation of the item does not change classification from OTS to custom fitted.
• OTS items require minimal self-adjustment for fitting at the time of delivery for appropriate use and do not require expertise in trimming, bending, molding, assembling, or customizing to fit an individual.
• This fitting does not require expertise of a certified orthotist or an individual who has specialized training in the provision of orthoses to fit the item to the individual beneficiary.

The term "minimal self-adjustment" is defined at 42 CFR §414.402 as an adjustment the beneficiary, caretaker for the beneficiary, or supplier of the device can perform and that does not require the services of a certified orthotist (that is, an individual who is certified by the American Board for Certification in Orthotics and Prosthetics, Inc., or by the Board for Orthotist/Prosthetist Certification) or an individual who has specialized training. For example, adjustment of straps and closures, bending or trimming for final fit or comfort (not all-inclusive) fall into this category.

Use of CAD/CAM or similar technology to create an orthosis without a positive model of the patient may be considered as OTS if the final fitting upon delivery to the patient requires minimal self-adjustment as described in this section.

Custom fitted orthotics are:

• Devices that are prefabricated.
• They may or may not be supplied as a kit that requires some assembly. Assembly of the item and/or installation of add-on components and/or the use of some basic materials in preparation of the item does not change classification from OTS to custom fitted.
• Classification as custom fitted requires more than minimal self-adjustment at the time of delivery in order to provide an individualized fit, i.e., the item must be trimmed, bent, molded (with or without heat), or otherwise modified resulting in alterations beyond minimal self-adjustment.
• This fitting at delivery does require expertise of a certified orthotist or an individual who has specialized training in the provision of orthosis to fit the item to the individual beneficiary.

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. A certified orthotist is defined as an individual who is certified by the American Board for Certification in Orthotics and Prosthetics, Inc., or by the Board for Orthotist/Prosthetist Certification.

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

Kits are:

• A collection of components, materials and parts that require further assembly before delivery of the final product.
• The elements of a kit may be packaged and complete from a single source or may be an assemblage of separate components from multiple sources by the supplier.

A summary classification algorithm and table is included at the end of this document to assist with determinations about the type of product and correct code selection.

Refer to the Contractor Supplier Manual, applicable Local Coverage Determination and related Policy Article for additional information about other coverage, coding and documentation requirements.

For questions about correct coding, contact the Pricing, Data Analysis and Coding (PDAC) contractor Contact Center at 877-735-1326.

Classification Algorithm – Overview of Criteria

Determining Proper Coding of Prefabricated Orthotics

The following question and answer relates to whether a prefabricated orthotic is properly billed using a code for a custom fitted orthotic versus one furnished off-the-shelf and does not address medical necessity for the item. The descriptors for the HCPCS codes for custom fitted orthotics include the following nomenclature:

• Off-the-shelf (OTS) - Prefabricated item that requires minimal self-adjustment such as being trimmed, bent, molded, assembled, or otherwise adjusted to fit the beneficiary. Minimal self-adjustment does not require the expertise of a certified orthotist or an individual with specialized training in the provision of orthotics.
• Custom fitted - Prefabricated item that requires more than minimal self-adjustments e.g., has been trimmed, bent, molded, assembled, or otherwise customized to fit a specific patient by a certified orthotist or an individual with specialized training in the provision of orthotics.

Question: Is the prefabricated orthotic furnished with custom fitting that is and can only be provided by an individual with expertise or furnished off-the-shelf (OTS)?

Answer: Classification depends on (1) what must be done at final fitting and (2) who must do it. Expertise of a qualified practitioner and more than minimal self-adjustment at the time of delivery qualify the items for classification as custom fitted. Fail either one of these criteria and the item is classified as off-the-shelf.

How to Decide What Code Type for Prefabricated Orthotic

How to tell if a prefabricated item is off the shelf (OTS) or a custom fitted item.

Start with a prefabricated item. Does the fit require more than minimal self-adjustment?

If no, the item is off the shelf.

If yes, you next ask if the modification requires expertise to be done?

If no, the item is off the shelf.

If yes, the item is custom fitted.

HCPCS Code Table

Note 1: Some Custom Fitted codes do not have corresponding OTS codes. If items described by these codes are furnished off-the-shelf without custom fitting or with fitting performed by someone without expertise in fitting, the corresponding code for the broader category of orthotics not otherwise specified in the HCPCS (e.g., L1499 for Spinal Orthosis, Not Otherwise Specified) should be used. The supplier should indicate in the narrative field for the claim that the orthotic was furnished off-the-shelf.

Note 2: Not all new codes listed have a corresponding medical policy. There are policies for Ankle/Foot and Knee/Ankle/Foot Orthosis, Knee Orthosis and Spinal Orthosis. There are no medical policies for Hip, Wrist, Hand, Finger or Shoulder Orthosis.

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