FOR DIABETICS ONLY, FITTING (INCLUDING FOLLOW-UP), CUSTOM PREPARATION AND SUPPLY OF SHOE MOLDED FROM CAST(S) OF PATIENT'S FOOT (CUSTOM MOLDED SHOE), PER SHOE
Long description on the CMS LCD code table, this read.
Data read from the CMS Coverage API on 2026-10-13. The LCD version is the current final DME MAC LCD on that read. Text below is quoted from those CMS documents. Nothing here is a coverage rule Verzi wrote.
Coverage, in CMS's words
Local coverage indication
A custom molded shoe (A5501) is covered when the beneficiary has a foot deformity that cannot be accommodated by a depth shoe. The nature and severity of the deformity must be well documented in the supplier's records and available upon request. If a custom molded shoe is provided but the medical record does not document why that item is medically necessary, it will be denied as not reasonable and necessary. For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD), the supplier must have received a signed Standard Written Order (SWO) before the DMEPOS item is delivered to a beneficiary. If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Refer to the LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section. For DMEPOS base items that require a WOPD, and also require separately billed associated options, accessories, and/or supplies, the supplier must have received a WOPD which lists the base item and which may list all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items. In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary. An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded. Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made available to the Medicare contractor upon request.
Excerpt from LCD L33369 version 26, effective 01/01/2020. CMS LCD L33369.
Governing LCD
L33369 · Therapeutic Shoes for Persons with Diabetes
Version 26. CMS effective date 01/01/2020. CMS updated 02/28/2020. Contractors on the CMS report: CGS Administrators (DME MAC) and Noridian Healthcare Solutions (DME MAC).
CMS coverage policy citation on the LCD. Medicare Benefit Policy Manual (IOM 100-02), Chapter 15, Section 140
In addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD. Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below. An order for each item billed must be signed and dated by the prescribing practitioner, kept on file by the supplier, and made available upon request. Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected HCPCS code. If the prescribing practitioner is the supplier, a separate order is not required, but the item provided must be clearly noted in the beneficiary's record. A new order is not required for the replacement of an insert or modification within one year of the order on file. However, the supplier's records should document the reason for the replacement. A new order is required for the replacement of any shoe. A new order is also required for the replacement of an insert or modification more than one year from the most recent order on file.
From A55426, Standard Documentation Requirements for All Claims Submitted to DME MACs
GENERAL There are numerous CMS manual requirements, reasonable and necessary (R&N) requirements, benefit category, and other statutory and regulatory requirements that must be met in order for payment to be justified. In the event of a claim review, a DMEPOS supplier must provide sufficient information to demonstrate that the applicable criteria have been met thus justifying payment. Before submitting a claim to Medicare, the DMEPOS supplier must have on file an SWO, a WOPD (if applicable), information from the treating practitioner concerning the patient's diagnosis, and any information required for the use of specific
If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Source: L33369
In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary. Source: L33369
All services that do not have appropriate proof of delivery from the supplier shall be denied as not reasonable and necessary. Source: L33369
If the supplier bills for an item without first receiving the SWO, the item will be denied as statutorily noncovered. Source: L33369
Get the signed answer via API
The signed answer is the receipt for this code on a date of service: the rule that was in force, with a hash you can replay. The call needs an API key. The source archive and as-of resolution are public.
The current DME MAC LCD L33369, Therapeutic Shoes for Persons with Diabetes, version 26, effective 01/01/2020.
What denial language does CMS publish for A5501?
If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary.
How do I get a signed answer for A5501?
Request a free API key and call the signed-answer endpoint with the HCPCS code, a date of service, the supplier NPI, and a state. The response is a receipt for the published rule on that date, not a guarantee of payment.