The Durable Medical Equipment Medicare Administrative Contractors (DME MACs), in conjunction with the Pricing, Data Analysis and Coding (PDAC) contractor, have added coding verification reviews for several custom-fabricated AFOs to the Local Coverage Determinations (LCDs) and related Policy Articles.
A custom-fabricated item is one that is individually made for a specific patient. No other patient would be able to use this item. A custom-fabricated item is a device that is individually made for a specific patient, which is fabricated based on clinically derived and rectified castings, tracings, measurements, and/or other images (such as x-rays) of the body part. The fabrication may involve using calculations, templates, and components. This process requires the use of basic 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 patient.
There are two categories of custom-fabricated items and the requirements for submission of samples differ:
- Custom fabricated by a manufacturer/central fabrication facility: These items are constructed by a manufacturer or central fabrication facility and then sent to someone other than the patient. Manufacturers must send a representative sample of a completed product and a description of their custom manufacturing process to the PDAC. Once reviewed by the PDAC staff and correct coding is determined, this category of custom-fabricated items will be listed on the PDAC’s Durable Medical Equipment Coding System (DMECS).
- Custom fabricated by a supplier: These items are individually fabricated by a supplier from raw materials and are dispensed directly to the patient by the entity that fabricated the orthosis. For coding verification, the supplier must submit written documentation that lists the custom-AFO manufacturing processes and all components that will be a part of the base code for that AFO orthosis. The supplier must provide a narrative description of the item to include anatomical reference points, a list of the materials that were used, and a description of the custom fabrication process (including photos of the process) used for this type of orthosis. These custom-fabricated items must be listed on the PDAC’s DMECS in order to be billed using a custom-fabricated code.
Effective September 1, 2012, custom-fabricated AFOs that require a coding verification review are:
- L-1940 (ankle foot orthosis, plastic or other material, custom-fabricated)
- L-1960 (ankle foot orthosis, posterior solid ankle, plastic, custom-fabricated)
- L-1970 (ankle foot orthosis, plastic with ankle joint, custom-fabricated)
