RETIRED - Correct Coding - Submitting Diabetic Shoe Inserts for HCPCS Coding - PDAC Coding Application Instruction - JD DME

This article is retired effective February 1, 2018. Current direction on correct coding as well as revised information about the Coding Verification Review project process are included in the article titled: Correct Coding – Inserts Used with Therapeutic Shoes for Persons with Diabetes (A5512, A5513, K0903), published February 1, 2018.

DME MAC Joint Publication

Posted on August 10, 2017

This revision adds information about the DMEPOS Quality Standards, Appendix C requirements for custom fabrication of A5513.

Inserts used with therapeutic shoes for persons with diabetes coded as A5512 and A5513 must meet certain specifications outlined in the Therapeutic Shoes for Persons with Diabetes Local Coverage Determination and related Policy Articles as well as the requirements for custom fabrication set out in the DMEPOS Quality Standards, Appendix C for A5513. This article provides guidance regarding the information necessary to be included with a HCPCS coding application submitted to the Pricing, Data Analysis, and Coding (PDAC) contractor.

A5512

[FOR DIABETICS, ONLY, MULTIPLE DENSITY INSERT, DIRECT FORMED, MOLDED TO FOOT AFTER EXTERNAL HEAT SOURCE OF 230 DEGREES FAHRENHEIT OR HIGHER, TOTAL CONTACT WITH PATIENT'S FOOT, INCLUDING ARCH, BASE LAYER MINIMUM OF 1/4 INCH MATERIAL OF SHORE A 35 DUROMETER OR 3/16 INCH MATERIAL OF SHORE A 40 DUROMETER (OR HIGHER), PREFABRICATED, EACH]

The current Coding Guidelines for A5512 say:

Code A5512 describes a total contact, multiple density, prefabricated removable inlay that is directly molded to the beneficiary's foot. Direct molded means it has been conformed by molding directly to match the plantar surface of the individual beneficiary's foot. Total contact means it makes and retains actual and continuous physical contact with the weight-bearing portions of the foot, including the arch throughout the standing and walking phases of gait.

The insert must retain its shape during use for the life of the insert. The layer responsible for shape retention is called the "base layer" in the code descriptor. This material usually constitutes the bottom layer of the device and must be of a sufficient thickness and durometer to maintain its shape during use (i.e., at least ¼ inch of 35 Shore A or higher or at least 3/16 inch of 40 Shore A or higher). The material responsible for maintaining the shape of the device must be heat moldable. The specified thickness of the base layer must extend from the heel through the distal metatarsals and may be absent at the toes.

For an insert to be coded as A5512, the criteria listed in the code narrative and in the coding guideline must be met. A PDAC coding application must include sufficient and clear detail to demonstrate that all criteria are met. To assist applicants PDAC has reformatted the requirements into a list to aid manufacturer and practitioners in verifying that each criterion has been addressed in their coding application. To be assigned to HCPCS code A5512 information must be included showing that the product:

• Is a prefabricated, multiple density insert
• Is direct formed by being molded to the beneficiary's foot with an external heat source of 230 degrees Fahrenheit or higher
• Has total contact with beneficiary's foot, including the arch
• Has a base layer that has a minimum
  • 1/4-inch material of Shore A 35 durometer or
  • 3/16-inch material of Shore A 40 durometer (or higher),
• Has the specified thickness of the base layer extend from the heel through the distal metatarsals. (May be absent at the toes)
• Retains its shape during use for the life of the insert

A sample pair of inserts must be submitted with the Coding Verification Application. Applications are available on the PDAC website.

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

The current Coding Guidelines for A5513 say:

Code A5513 describes a total contact, custom fabricated, multiple density, removable inlay that is molded to a model of the beneficiary's foot so that it conforms to the plantar surface and makes total contact with the foot, including the arch. A custom fabricated device is made from materials that do not have predefined trim lines for heel cup height, arch height and length, or toe shape.

The insert must retain its shape during use for the life of the insert. The base layer of the device must be at least 3/16 inch of 35 Shore A or higher material. The base layer is allowed to be thinner in the custom fabricated device because appropriate arch fill or other additional material will be layered up individually to maintain shape and achieve total contact and accommodate each beneficiary's specific needs. The central portion of the base layer of the heel may be thinner (but at least 1/16 inch) to allow for greater pressure reduction. The specified thickness of the lateral portions of the base layer must extend from the heel through the distal metatarsals and may be absent at the toes. The top layer of the device may be of a lower durometer and must also be heat moldable. The materials used should be suitable with regards to the beneficiary's condition.

For an insert to be coded as A5513, the criteria listed in the code narrative and in the coding guideline must be met. In addition, the custom fabrication set out in the DMEPOS Quality Standards, Appendix C must be met. A PDAC coding application must include sufficient and clear detail to demonstrate that all criteria are met. To assist applicants PDAC has reformatted the requirements into a list to aid manufacturer and practitioners in verifying that each criterion has been addressed in their coding application. To be assigned to HCPCS code A5513 information must be included showing that the product:

• Is a custom fabricated, multiple density insert
• Is molded to a beneficiary-specific, physical model and made from basic materials
• Has total contact with beneficiary's foot, including the arch
• Has a base layer that has a minimum 3/16-inch material of Shore A 35 durometer (The central portion of the heel may be not be less than 1/16 inch thick)
• Has the specified thickness of the base layer extend from the heel through the distal metatarsals. (May be absent at the toes)
• Has a heat-moldable top layer
• Retains its shape during use for the life of the insert

Manufacturers/central fabrication facilities must submit: (1) a 4 x 4 x ½ inch sample of base layer material(s), (2) a sample pair of inserts, and (3) a narrative description and photographs and/or videos of the manufacturing process with the Coding Verification Application. Applications are available on the PDAC website.

A copy of the PDAC Coding Verification Letter to the manufacturer / central fabrication facility, approving the product as A5513, must be kept on file and be available to distributors, suppliers, and CMS contractors upon request.

Practitioners who create custom fabricated inserts from raw materials for dispensing directly to the end user (the beneficiary) are not required to have their insert listed on the PDAC website to bill using code A5513. However, a coding verification request may be submitted to the PDAC to ensure accuracy of the code for the item provided. If a Coding Verification Review is requested, the information described above for manufacturers/ central fabrication facilities must be provided.

Refer to the Therapeutic Shoes for Persons with Diabetes LCD and related Policy Article for information about coverage, documentation, and coding for these items.

Suppliers are reminded to access the PDACs Durable Medical Equipment Coding System (DMECS) for any questions regarding the correct coding of products or call the PDAC Contact Center at 877-735-1326 between the hours of 8:30 a.m. and 4:00 p.m. CT.

Publication History

Publication Date: August 10, 2017
Revised: Adds information about the DMEPOS Quality Standards, Appendix C requirements for custom fabrication of A5513.
Originally Published September 2010