Article Detail - JD DME

Original Effective Date: 07/01/2010
Revision Effective Date: 11/01/2013

Appendix C of the DMEPOS Quality Standards published in October 2008 addresses specific requirements for orthoses, prostheses, prosthetic devices, and therapeutic shoes. Those standards include requirements for "an in-person diagnosis-specific functional clinical examination" by the supplier to determine the need for a particular item as well as "face-to-face fitting/delivery" by the supplier. Therefore, in order for therapeutic shoes, inserts, and shoe modifications to be covered, both of the following criteria must be met:

• Prior to selecting the specific items that will be provided, the supplier must conduct and document an in-person evaluation of the patient; and
• At the time of delivery of the items selected, the supplier must conduct and document an in-person visit with the patient to ensure that the shoes/inserts/modifications are properly fit and meet the beneficiary's needs.
  • In order to meet these criteria, effective for claims with dates of service on or after July 1, 2010, the following documentation requirements must be met:
• The in-person evaluation prior to selecting the items must include at least an examination of the patient's feet with a description of the abnormalities that will need to be accommodated by the shoes/inserts/modifications. For all shoes, it must include taking measurements of the patient's feet. For custom molded shoes (A5501) and inserts (A5513), this visit must also include taking impressions, making casts, or obtaining CAD-CAM images of the patient's feet that will be used in creating positive models of the feet.
• The in-person visit at the time of delivery must include an assessment of the fit of the shoes and inserts with the patient wearing them.

Depending on the items ordered, both the evaluation and delivery could occur on the same day if the supplier had both a sufficient array of sizes and types of shoes/inserts and adequate equipment on site to provide the items that meet the beneficiary's needs. Both components of the visit (criteria 1 and 2 above) must be clearly documented.

Documentation of these visits must be available to the DME MAC, ZPIC, RAC, or CERT contractor on request. If one or more of these requirements are not met, the claim will be denied as statutorily noncovered.

This information will be incorporated in a future revision of the Therapeutic Shoes policy. Refer to the Therapeutic Shoes Local Coverage Determination and Policy Article for additional information regarding coverage, coding, and documentation.

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