Custom Fabricated Durable Medical Equipment (DME) - DME.CU.101.A

Covered: custom-fabricated DME is allowed when made for a specific patient using clinically derived castings/tracings/molds or positive models (including CAD/CAM); excluded are items not based on patient-specific models, devices fabricated without a positive model, and custom additions billed with prefabricated orthoses. Key requirements: basic coverage criteria must be met, the need must be permanent/long‑standing, the patient must require a custom device or be unable to use/have failed a prefabricated device, and documentation must show coverage criteria, permanence, clinical necessity, the patient-specific model or CAD/CAM process, and compliance with DME MAC documentation rules.

"Custom fabricated DME is indicated when basic coverage criteria have been met, the condition requiring the device is anticipated to be permanent or of long-standing duration, and any of the following:"