Policy Article Updates: 3D Printed Orthoses

What You Need to Know

Over the past several years, orthotic fabrication technologies have continued to advance. More and more providers are using 3D scanners and CAD/CAM software to capture patient anatomy and make modifications for custom-fabricated devices. As these digital techniques become more widespread, new fabrication techniques become available, such as additive manufacturing (i.e., 3D printing). As more manufacturers and even some providers start to use 3D printers to create definitive orthoses for patients, there have been concerns about whether this fabrication technique is considered custom fabricated or prefabricated due to specific language in the Policy Articles.  

Effective January 23, 2024, the DME MACs published revisions to their Policy Articles for AFOs/KAFOs, knee orthoses, and spinal orthoses after receiving guidance from CMS. Under the Coding Guidelines section, they included information specific to additive manufacturing, which states the following:

Additive manufacturing (such as 3D printing) is an advanced technology that constructs three-dimensional items modeled and designed from CAD software and/or from digital scanning. Additive manufacturing is an acceptable custom fabrication technique as long as it adheres to the CMS DMEPOS Quality Standards, Appendix C.

This addition to the orthotic Policy Articles confirms that 3D printed orthoses can be billed using custom orthotic HCPCS codes, but they clarify that the "use of an additive manufacturing technique, CAD/CAM, or a similar manufacturing technique is not the sole requirement for a product to be designated as custom fabricated."

 Along with adding information about additive manufacturing to the Policy Articles, the DME MACs also removed several statements relating to the need for a "positive model" in order to be considered custom fabricated. For example, they removed the statement, "an orthosis that is fabricated from a mold, CAD/CAM, or similar technology but without the creation of a positive model is considered a prefabricated orthosis." Historically, truly custom devices could only be fabricated using a physical model of the patient, such as a plaster mold created from a cast or a foam mold created from a CAD/CAM file. In contrast, additive manufacturing streamlines the fabrication process and uses the CAD/CAM file directly to create a custom device without the need for a positive model. The DME MACs recognized this discrepancy and removed language that was no longer accurate.

What this Means for You

When deciding on the proper HCPCS code to bill for an orthotic device, it is important to understand the fabrication process as a whole and not just the technique used to create the final product. We now have clarification from the DME MACs that additive manufacturing is an acceptable custom fabrication technique, but that does not mean that all 3D printed orthoses are custom fabricated. To determine whether a product is custom fabricated or prefabricated, you must follow the guidelines established in the CMS DMEPOS Quality Standards, Appendix C:

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 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.

If the orthosis that you are providing does not meet the criteria listed above, then you should use a prefabricated HCPCS code to bill for the device, even if it was created using a 3D printer.

 You can find a complete list of all the changes made to each Policy Article on both the CGS and Noridian websites.