PDAC Coding Guidelines for Off-the-Shelf Diabetic Shoes (A5500)

The information presented in this article comes from the Therapeutic Shoes for Persons with Diabetes Local Coverage Determination (L33369) and related Policy Article (A52501), coding language, coding guidelines, and assessment of samples that have been submitted to the PDAC for Code Verification Review.

Based on recent submissions of diabetic shoes for code review to the Pricing, Data Analysis, and Coding (PDAC) contractor, the PDAC would like to clarify coding requirements and submission instructions for diabetic shoes. Coding guidelines can be found in the Therapeutic Shoes for Persons with Diabetes Policy Article (A52501).

Requirements (specified in Policy Article A52501) for a product to be assigned A5500 For Diabetics only, Fitting (Including Follow-Up), Custom Preparation and Supply of Off-the-Shelf Depth-Inlay Shoe Manufactured to Accommodate Multi-Density Insert(s), Per Shoe, consist of the following:

1. Has a full length, heel-to-toe filler that when removed provides a minimum of 3/16” of additional depth used to accommodate custom-molded or customized inserts; and
2. Is made from leather or other suitable material of equal quality; and
3. Has some form of shoe closure; and
4. Is available in full and half sizes with a minimum of three (3) widths so that the sole is graded to the size and width of the upper portions of the shoe according to the American Standard Last Sizing Schedule or its equivalent. (The American Last Sizing Schedule is the numerical sizing standard used for shoes in the United States.)

This article is intended to educate manufacturers and suppliers on required characteristics of diabetic shoes to be assigned code A5500 and to clarify each of the requirements stated in the policy article.

Requirement 1: Has a full length, heel-to-toe filler that when removed provides a minimum of 3/16” of additional depth used to accommodate custom-molded or customized insert

Review Criteria: The three-sixteenths of an inch (3/16”) additional depth requirement is to allow for the extra depth needed in the shoe for the placement of a diabetic insert. The source of the extra depth is derived from the American Last Sizing Schedule used for shoes in the United Sates. A standard depth shoe that would fit the same patient would not be able to accommodate the protective insert, so extra depth is molded into the shoe. Once the insert is placed into the shoe, there should still be adequate (standard) space for the beneficiary’s foot. The presence of this additional depth must be proven in the application, or the shoes will not be assigned code A5500. The method of evidence is up to the submitter.

Requirement 2: Is made from leather or other suitable material of equal quality

Review Criteria: “Suitable material” is considered to be leather or leather-like material with a composition capable of providing adequate protection and support for the beneficiary’s foot. Suitable material must exhibit protective qualities comparable to leather, and also water resistance, durability of wear, and ability to hold its form as a leather equivalent shoe. The final configuration of the leather or leather-like material upper must create a toe box and heel counter to provide protection for the toe and heel areas. These are the most common locations for medical foot issues for the diabetic beneficiary and therefore must provide adequate protection. The applicant must present qualitative and/or quantitative information that the material composition of the shoe meets the equivalency characteristics noted above and provides adequate support.

Requirement 3: Has some form of shoe closure

Review Criteria: As most individuals being appropriately supplied diabetic shoes lack protective sensation in their feet, adequate forms of closure must be present (such as adjustable fastenings or laces) and the shoe must completely envelope the foot. Sandals and open toed shoes do not meet requirements for coding as therapeutic shoes for diabetics. If the foot is exposed to the elements, the risk of ulcers is increased, and the exposure may hamper or prevent adequate treatment of the beneficiary’s foot. The closure must be functional and allow for tightening and loosening of the opening to accommodate foot swelling during the day and still provide a good fit and support. This combination of an enveloping shoe and functional closure not only ensures a secure fit that prevents intrusion from small objects, but also reduces shear forces that can lead to worsening of medical condition(s).

Requirement 4: Is available in full and half sizes with a minimum of three (3) widths so that the sole is graded to the size and width of the upper portions of the shoe according to the American Last Sizing Schedule or its equivalent

Review Criteria: Manufacturers must be able to demonstrate that their product(s) can accommodate for a broad range of foot shapes to account for the various foot related issues associated with diabetes. As foot swelling is a common issue in many diabetics, the shoes should be available in wide and standard widths to accommodate for this.

To aid applicants submitting for A5500, the following suggestions are offered regarding the required sample:

1. When submitting your sample, please submit a US Men’s Size 9 or US Women’s Size 7 shoe(s) or equivalent. As shoe depth varies across different shoe sizes, providing a uniform size to the PDAC will aid in a more accurate and universal assessment of the depth of your sample.
2. If your company uses a last system other than the American Last Sizing Schedule, your equivalent shoe size may be larger or smaller.
3. Sample must be appropriate for a Medicare patient with diabetes and foot related problems.

Finally, the PDAC would like to remind submitters that in addition to the completed application and required documentation, please provide any relevant information that can further validate the requested code in your submission. The PDAC’s review and code decision is based on the information provided by the applicant.

If you have questions, please contact the PDAC HCPCS Helpline at (877) 735-1326 during the hours of 9:30 a.m. to 5:00 p.m. ET, Monday through Friday. You may also visit our website to chat with a representative or select the Contact Us button at the top of the page for email inquiry, FAX or postal mail information.