A joint publication has been issued by the Durable Medical Equipment Medicare Administrative Contractors with guidelines for suppliers providing off-the-shelf orthoses with parallel codes for custom-fitted versions of the same products. As part of the January 2014 Healthcare Common Procedure Coding System updates, code descriptors for 23 orthoses were split to describe the two delivery methods.
When providing either off-the-shelf (OTS) or custom fitted orthoses, 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 and method of fitting;
- be sure only to use the code that accurately reflects both the type of orthosis and the appropriate level of fitting;
- have detailed documentation that justifies the code selected for custom fitted vs. OTS codes.
The publication also included correct coding definitions of OTS orthoses and custom fit orthoses. According to the guidelines, OTS orthoses:
- are prefabricated, may or may not be supplied as a kit that requires some assembly;
- require minimal self-adjustment for fitting at the time of delivery for appropriate use;
- do not require expertise in trimming, bending, molding, assembling or customizing to fit an individual;
- do not require expertise of a certified orthotist or an individual with equivalent specialized training in orthotics.
Custom fit orthoses:
- are prefabricated;
- may or may not be supplied as a kit that requires some assembly, although assembly of the item or installation of add-on components or the use of some basic materials to prepare the device does not change classification from OTS to custom fitted;
- require substantial modification for fitting at the time of delivery to provide an individualized fit;
- require expertise of a certified orthotist or an individual with equivalent specialized training in orthotics.
Fabrication of an orthosis using CAD/CAM or similar technology without the creation of a positive model with minimal self-adjustment at delivery is considered OTS, according to the guidelines. However, if the orthosis requires substantial modification for the final fitting upon delivery, requiring the expertise of a certified orthotist or specially trained individual, the device may be considered as custom fitted.
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