“Custom Fabrication” in DME Billing

An announcement from the Durable Medical Equipment Medicare Administrative Contractors (DMEMACs) specifies exact coding definitions for custom fabricated equipment like braces (orthoses), which includes of-the-shelf (OTS) and other custom fabricated equipment.

DME suppliers need to comply with certain specifications like:

  • Only products specified (type of DME, fitting method, custom fabricated etc) and prescribed by a physician who places the order should be supplied.
  • Whatever is prescribed by the physician needs to be justified by relevant medical records that justify the need for using a custom fabricated DME as against a prefabricated DME that may be readily available.
  • For whatever code that is selected, there needs to be complete documentation in the medical records that specify the method of fabrication, the raw material inputs, and the level of fitting along with the credentials of the DME supplier/fabricator.

Off-the-Shelf Orthoses

DME equipment that is prefabricated and not custom made, requiring minimum of adjustments at the time of delivery or fitting come under this category. The fabricated DME does not specify the need for a qualified practitioner to be present during fitting.

Custom Fitted Orthoses

In the case of a custom fabricated /fitted orthoses, the DME equipment is prefabricated and may require quite a bit of modification in the fitting during delivery. This is to ensure that the custom fabricated DME ensures a perfect fit for the individual concerned. This type of custom fabricated DME requires a qualified and expert practitioner to be present at the time of fitting.

Custom Fabricated Orthoses

These are classified as items that are specifically made to order for any individual patient. The measurements and fitting specifications are measured and calculated individually at the time of choosing the raw materials and before fitting on the patient. This type of custom fabricated DME is always fabricated based on the model of the actual body part of the beneficiary.


Customized equipment are quite rarely required, hence in order to consider a DME item as custom fabricated it needs to be uniquely constructed according to 42 CFR Section 414.224. If not uniquely constructed it must have undergone substantial modifications, and be meant for a specific beneficiary based on the recommendations and orders of a qualified practitioner. The equipment has to be one-of-a-kind DME equipment fabricated for specific purposes. At the time of fabrication, the important aspects taken into account are the body size of the beneficiary, level of disability, age, weight, approx period for which the custom fabricated DME is required. Mere customization of options and accessories are not sufficient for categorizing the DME equipment as custom fabricated DME. Codes L1900, L1904, L1907, L1920, L1940-L1950, L1960-L1970, L1980-L2030, L2034, L2036-L2108, L2126-L2128, and L4631 describe custom-fabricated orthoses.

Claims for HCPCS codes that describe add-ons for custom-fabricated orthoses will be denied if they are billed with prefabricated Ankle-Foot Orthoses (AFOs) and Knee-Ankle-Foot Orthoses (KAFOs) HCPCS base codes mentioned in the LCD policy. In order to cover custom-fabricated orthoses by Medicare, a detailed documentation to support the medical necessity of a custom-fabricated rather than a prefabricated orthosis, is required. Information corroborated by the functional evaluation in the physician’s records must be available upon request.

Section 414.224 (b) further states that there is provision for making payment that can facilitate a lump sum purchase of the custom fabricated DME depending on the supplier’s consideration and valuation of an amount for every specific custom fabricated item of DME. The provision also includes justification of payment towards labor cost for the customization process, along with the cost of materials. The supplier is required to furnish detailed descriptions at every stage of the fabrication/customization process along with the approximate labor costs in order to arrive at an acceptable and justifiable amount.

Published By - Medical Billers and Coders
Published Date - May-13-2016 Back

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