LEEDer Group Inc.
8508 North West 66th St.
Miami, Florida 33166 USA

Phone Toll-free: 866.814.0192 or 305.436.5030
Fax Toll-free: 866.818.0373 or 305.436.0086
E-mail Address: orders {at] LEEDerGroup [dot] com

2014-02 Correct Coding - Definitions Used for Off-the-Shelf, Custom Fitted and Custom Fab

KYDEX-PRO

STRONGER

SAFER

LEEDerGroup.com

Correct Coding – Definitions Used for Off-the-Shelf, Custom Fitted and Custom Fabricated Orthotics (Braces) – Joint DME MAC Publication

Posted February 27, 2014 (O&P) [Link to original article below]

  • As part of the January 2014 HCPCS update codes were created describing certain off-the-shelf (OTS) orthotics. Some of these OTS 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, i.e. (1) type of orthosis and (2) method of fitting and/or fabrication (OTS, custom fitted or custom fabricated).

• Be sure that the medical record justifies the need for the type of product (prefabricated versus custom fabricated)

• Have detailed documentation in your records that justifies the code selected (e.g., fabrication methods and materials used, appropriate level of fitting and credentials of the individual fabricating and fitting the item).

The following definitions will be used for correct coding of these items. Off-the-shelf (OTS) orthotics are:

• Items that are prefabricated.
• Items that require minimal self-adjustment for fitting at the time of delivery for appropriate use by the beneficiary. This fitting does not require the expertise of a qualified practitioner (see definition below).
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 does not require the services of a qualified practitioner. For example, adjustment of straps and closures, bending or trimming for final fit or comfort (not all-inclusive) fall into this category. Provision of a prefabricated item requiring minimal self-adjustment for fitting at delivery is considered as OTS.

Custom fitted orthotics are:

• Items that are prefabricated.
• Items that require substantial modification for fitting at the time of delivery in order to provide an individualized fit. This fitting does require the expertise of a qualified practitioner (see definition below).
Substantial modification is defined as changes made to achieve an individualized fit of the item that requires the expertise of a qualified practitioner i.e., the item must be trimmed, bent, molded (with or without heat), or otherwise modified resulting in alterations beyond minimal self-adjustment. Provision of a prefabricated item that requires substantial modification at delivery is considered as custom fitted.

Custom fabricated orthotics are:

• Items that are uniquely made for an individual beneficiary. No other beneficiary would be able to use this specific item.
• Items that are individually made from basic raw 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 beneficiary.
• Items that must be individually fabricated over a positive model of the beneficiary. A positive model may be created using various methods e.g., traditional casting methodologies or using CAD/CAM or similar technology (not all-inclusive). In all cases, in order to be considered as custom fabricated, the item must be created over an actual physical model of the body part.
• Items that require the expertise of a qualified practitioner (see definition below) to custom-fabricate.
The selection and assembly of prefabricated components does not meet the definition of custom fabricated as set out in 1834(h)(1)(F) of the Act. The fabrication requirements specified above, i.e. using raw materials assembled over a model of the individual beneficiary by a qualified practitioner, are the key determinants for the selection of a custom fabricated HCPCS code. Assembly of the item and/or installation of add-on components and/or the use of some basic materials in fabrication/preparation of the item does not change classification from prefabricated (OTS or custom fitted) to custom fabricated.

Kits are:

• A collection of components, materials and parts that require further assembly before delivery of the final product.
• Packaged and completed from a single source or may be an assemblage of separate components from multiple sources by the supplier.
Note: Incorporating some basic materials as part of the kit does not change the classification of the orthosis from prefabricated (OTS or custom fitted) to custom fabricated.

Prefabricated items are:

• Items that are a finished or completed final products fabricated from raw materials and parts by the supplier or at a central fabrication facility
• Items that may or may not be supplied as a kit. Assembly of the item and/or installation of add-on
components and/or the use of some basic materials in preparation of the item prior to final fitting does not change the classification from prefabricated (OTS or custom fitted) to custom fabricated.
Note: Fabrication methods, other than those described in the custom fabricated definition, do not affect the classification of an orthosis as prefabricated. In addition, the site of fabrication of an orthosis (e.g., central fabrication facility vs. supplier’s fabrication lab) does not affect the classification as prefabricated.

Qualified Practitioners are:

• Licensed physicians.
• Licensed physical or occupational therapists.
• Licensed in orthotics or prosthetics by the state in which the item is supplied when the state requires the licensing of orthotics and prosthetics practitioners.
• In states that do not require licensing of orthotics and prosthetics practitioners, a qualified practitioner must be specifically trained and educated to provide or manage the provision of custom fabricated orthotics, and is certified by the American Board for Certification in Orthotics and Prosthetics, Inc. or by the Board for Orthotist/Prosthetist Certification, or is an individual who has equivalent specialized training in the provision of custom fabricated orthoses.

  • A summary classification algorithm is included at the end of this document to assist in 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 PDAC Contact Center at (877) 735-1326 during the hours of 8:30 a.m. to 4:00 p.m. CT, Monday through Friday, or e-mail the PDAC by completing the DME PDAC Contact Form located on the PDAC website: https://www.dmepdac.com/
Classification Algorithm – Overview of Criteria

Determining Proper Coding of Orthotics
There are two (2) questions to answer, in order:
Question 1: Is the item prefabricated or custom fabricated?
Answer: All three (3) elements on the left side of the algorithm (expertise, raw materials and use of a positive patient model) are required in order for the item to be considered custom fabricated. Fail any one and the item is classified as prefabricated.
Question 2: If the item is prefabricated, is it custom fitted or 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 substantial modification 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.

CLICK-HERE TO SEE ORIGINAL ARTICLE