The Durable Medical Equipment Medicare Administrative Contractors (DME MACs) issued a joint publication to further define off-the-shelf (OTS), custom-fitted prefabricated orthoses, and kits. The DME MACs made the latest revisions to add L-1652 and L-1653 as a corresponding code set, and L-1820 and L-1821 as a corresponding code set, which were added in September.
The following definitions should be used for correct coding of these items.
OTS orthotic devices 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, Prosthetics & Pedorthics or the Board of Certification/Accreditation) 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 additive manufacturing techniques alone does not designate a product as custom fabricated.
Custom fitted orthotic devices 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 requires 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 during the final fitting at the time of delivery 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, Prosthetics & Pedorthics or the Board of Certification/Accreditation).
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.
To read about the added code sets, visit “CMS Introduces, Revises O&P HCPCS Codes.”
To read “Definitions Used for Off-the-Shelf versus Custom Fitted Prefabricated Orthotics (Braces)–Correct Coding–Revised,” visit the CGS website.
