The Pricing, Data Analysis and Coding (PDAC) Contractor and Durable Medical Equipment Medicare Administrative Contractors (DME MACs) addressed inquiries and concerns regarding additive manufacturing (i.e., 3D printing) of orthotic devices.
To conform to the CMS standards for custom-fabricated orthoses, the manufacturing process must be in strict compliance with the requirements stated in the Centers for Medicare & Medicaid Services (CMS) Durable Medical Equipment, Prosthetics, Orthotics, and Supplies 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 by the DME MACs.]
Orthotic devices may be coded with the appropriate custom fabricated Healthcare Common Procedure Coding System 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.
