3-D Printed Orthotic Devices - Correct Coding - JA DME

Joint DME MAC and PDAC Publication
Posted February 1, 2024

The Pricing, Data Analysis and Coding (PDAC) Contractor and Durable Medical Equipment Medicare Administrative Contractors (DME MACs) would like to address recent inquiries and concerns regarding additive manufacturing (i.e., 3D printing) of orthotic devices. This advanced technology constructs three-dimensional items modeled and designed from Computer-Aided Design (CAD) software and/or from digital scanning. The Centers for Medicare & Medicaid Services (CMS) has provided guidance to the DME MACs and PDAC that additive manufacturing is an acceptable custom fabrication technique as long as it adheres to the CMS DMEPOS Quality Standards, Appendix C.

To conform to the CMS standards for custom-fabricated orthoses, the manufacturing process must be in strict compliance with the requirements stated in CMS’s 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. [emphasis added]

Orthotic devices may be coded with the appropriate custom fabricated Healthcare Common Procedure Coding System (HCPCS) code when produced with additive manufacturing that complies with the CMS standards for custom fabrication.
The DME MACs will be updating the impacted local coverage determinations and related policy articles in the coming weeks. Updates will be posted on the DME MAC websites and the Medicare Coverage Database.

Correct coding is an essential element for correct claim payment. The PDAC contractor maintains a variety of resources to assist suppliers in determining the appropriate code for Medicare billing. For questions about correct coding, contact the PDAC HCPCS Helpline at (877) 735-1326 during the hours of 9:30 a.m. to 5:00 p.m. ET, Monday through Friday. You may also visit the PDAC website to chat with a representative, or select the Contact Us website button at the top of the PDAC website for email, FAX, or postal mail information.

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