AOPA Letter About Custom Diabetic Inserts Nets CMS Response

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The American Orthotic & Prosthetic Association (AOPA) announced that the Centers for Medicare & Medicaid Services (CMS) is considering a change to the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) quality standards contained in the descriptor for Healthcare Common Procedure Coding System (HCPCS) 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]). CMS' proposed change would include use of digital or virtual models to direct mill custom diabetic inserts as an acceptable method to meet the definition of "molded to patient model" contained in the code language for A-5513.

The CMS response addresses AOPA's concern regarding the recent interpretation of the term "molded to patient model" when describing custom fabricated diabetic shoe inserts by Durable Medical Equipment Medicare Administrative Contractors (DME MACs) and the Pricing, Data Analysis and Coding (PDAC) code verification process. The change to the quality standards would allow for the creation of a digital positive model of the patient's foot using CAD/CAM technology to direct mill a custom-fabricated insert based on the digital model.

The DME MACs and PDAC issued a joint bulletin in July stating that to meet the definition of "molded to patient model" contained in the descriptor for A-5513 diabetic inserts must be fabricated over a physical model of the patient's foot. The bulletin also stated that digital or virtual models that were used to direct mill custom inserts are not considered a positive model and inserts fabricated using this technique do not meet the code requirements of A-5513 and must be billed as A-9270, a statutorily non-covered HCPCS code. AOPA and the American Podiatric Medical Association (APMA) submitted a joint letter to CMS on September 28 listing the organizations' concerns about the bulletin.

CMS will hold an open door forum call November 28 at 2 p.m. ET to discuss the proposed changes and will accept comments on the changes through December 11. Comments can be sent to CMS via email to CMS has indicated it will finalize the proposed changes by January 1, 2018.