On April 30, the four Durable Medical Equipment Medicare Administrative Contractors (DME MACs) issued a joint publication, called “Correct Coding – Definitions Used for Off-the-Shelf versus Custom Fitted Prefabricated Orthotics (Braces) – Revised – Joint DME MAC Publication,” that provides guidelines for suppliers providing off-the-shelf (OTS) orthoses with parallel codes for custom-fitted versions of the same items. The joint publication also provides coding definitions for the OTS and custom orthoses.
When providing these items suppliers must:
- Provide the product that is specified by the ordering physician
- Be sure that the medical record justifies the need for the type of product (i.e., prefabricated versus custom fabricated)
- Only bill for the Healthcare Common Procedure Coding System (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 OTS orthotics:
- 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 the expertise of a certified orthotist or an individual who has equivalent 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 or an individual who has specialized training.
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 substantial modification for fitting 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 equivalent specialized training in the provision of orthosis to fit the item to the individual beneficiary.
Substantial modification 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 equivalent specialized training in the provision of orthotics such as a physician, treating practitioner, an occupational therapist, or physical therapist in compliance with all applicable federal and state licensure and regulatory requirements.
The joint publication also notes that 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 substantial modification requiring expertise as described.
