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Correct Coding - A5513 Custom Molding Requirements

DME MAC Joint Publication

Medicare provides coverage for therapeutic shoes and related inserts for beneficiaries with diabetes. Custom molded inserts are billed using HCPCS code A5513 [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]. Inserts billed with A5513 must be made in compliance with criteria specified in the code narrative described above, the coding guidelines section of the LCD related Policy Article, and the DMEPOS Quality Standards. Suppliers of these inserts must assure themselves that the products provided meet the requirements for classification as A5513 before billing this HCPCS code.

The HCPCS code narrative passage, "…CUSTOM MOLDED FROM MODEL OF PATIENT'S FOOT…", requires that a physical model of the beneficiary's foot must be produced and that the insert be individually molded to the physical model.  Some manufacturers do not produce an actual physical model of the individual beneficiary's foot.  Instead, a CAD-CAM system creates an electronic positive model derived from specific patient measurements, i.e. a "virtual model", or use a library of generic models to fabricate an insert.  Inserts produced using these or similar techniques must not be coded as A5513 for Medicare billing.

The Medicare Benefit Policy Manual (Internet Only Manual 100-2) chapter 15, §140 describes the benefit requirements associated with therapeutic shoes.  It describes a covered insert.  The section says, in relevant part:

The Therapeutic Shoes for Persons with Diabetes LCD related Policy Article coding guidelines section says:

The DMEPOS Quality Standards Appendix C (42 CFR 424.57) defines custom fabrication for these items and requires that custom fabricated inserts be made to a physical model of the individual beneficiary's foot.  Appendix C says, in relevant part:

1. Custom Fabricated: A custom fabricated item is one that is individually made for a specific Patient. No other patient would be able to use this item…

These standards are not met by:

Therapeutic shoe inserts produced from virtual or generic models must be billed to Medicare using HCPCS code A9270 [NON-COVERED ITEM OR SERVICE].
Refer to the Therapeutic Shoes for Persons with Diabetes LCD and related Policy Article for additional information about coverage, coding, and documentation.

For questions about correct coding, contact the Pricing, Data Analysis, and Coding (PDAC) contractor at (877) 735-1326 during the hours of 8:30 a.m. to 4:00 p.m. CT, Monday through Friday, or e-mail the PDAC by completing the DME PDAC Contact Form at https://www.dmepdac.com/

Date Posted 07/31/17