CMS Expands Definition for Therapeutic Shoes, Inserts

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The Centers for Medicare & Medicaid Services (CMS) has published final changes to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Quality Standards that adds to its definitions of the molded-to-patient-model and how positive models can be created. The change to the standards may affect any custom-fabricated or custom-fitted orthosis or prosthesis, among other devices, but relates most closely to the recent issue of how therapeutic shoes and inserts must be molded.

In Appendix C, as part of the definition of custom fabricated, the molded-to-patient model section now includes the following: 

"For inserts used with therapeutic shoes for diabetes, a digital image of the patient's body part is made using CAD-CAM systems software. This technology includes specialized probes/digitizers and scanners that create a computerized positive model, and then direct milling equipment to carve a beneficiary-specific insert."

The quality standard also now includes that the use of a foam box impression is an acceptable for creating an impression of the patient's foot for use in the creation of a positive model of the patient's foot.

The section that describes how a positive model of the patient is created now includes:

"For inserts used with therapeutic shoes for diabetes, a CAD-CAM system, by use of digitizers, transmits surface contour data to software that the practitioner uses to rectify or modify the model on the computer screen. The data depicting the rectified model is electronically transmitted to a commercial milling machine that carves the patient-specific insert."

The American Orthotic & Prosthetic Association (AOPA) said that it is "generally pleased" with the changes to the Quality Standards. However, it "remains concerned" that reimbursement for direct-milled inserts could be at a rate that is 14 percent lower than inserts made from a physical model of a patient's foot as described by Healthcare Common Procedure Coding System code A-5513 (for diabetics only, multiple density insert, custom molded from model of patient's foot, total contact with patient's foot, including arch, base layer minimum of 3/16-inch material of shore [a 35 durometer or higher], includes arch filler and other shaping material, custom fabricated, each). 

According to AOPA, in response to comments regarding the reimbursement rate, CMS stated that, "The first step CMS must take is to finalize the DMEPOS Quality Standards. Once that step is completed, CMS can assess what needs to be done in order to implement any changes to the quality standards."

For background on the topic, visit "Let Me Be Direct: A-5513 Coding Clarification & The Future Of CAD/CAM Direct-Milled Inserts" in the November 2017 issue of The O&P EDGE.