Diabetic Therapeutic Shoes and Inserts — Coverage Criteria
Defines medical necessity criteria for coverage of diabetic footwear and inserts for members with diabetes in the Georgia Region; intended for Quality Resource Management staff and treating providers evaluating requests.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
Medical necessity criteria for diabetic footwear and inserts
Covered when ALL of the following are met:
supports eligibility
listed qualifiers
clinical evaluation required
Annual quantity limits
Coverage quantity limits (per CMS, per calendar year)
per calendar year
per calendar year
Deluxe upgrades to diabetic footwear that alter non-clinical features — including style, color, or type of leather — are not medically necessary and are the patient's personal expense.
Multi-density shoe inserts (HCPCS A5510) that achieve their shape via compression molding during wear and are not customized to the patient at the time of fitting are not considered therapeutic shoe inserts for coverage purposes.
Covered Codes
| A5500 | Exact code as listed in document (A5500-01; grouped listing) |
| A5503 | Exact code as listed in document (A5503-08; grouped listing) |
| A5510 | Exact code as listed in document (A5510-A5513; grouped listing) |
| A5511 | Exact code as listed in document |
| A5512 | Exact code as listed in document |
| A5513 | Exact code as listed in document |
Prior Authorization, Evaluation, and Documentation Requirements
Prior Authorization Required
Prior authorization is required for diabetic footwear and inserts when submitting claims for the listed HCPCS codes. Obtain authorization before providing services to avoid claim denials.
- Affected HCPCS codes: A5500-A5513
- Limit: one pair of custom-molded shoes (with inserts) and two additional pairs of inserts OR one pair of depth shoes and three pairs of inserts per calendar year per CMS guidance
Clinical Evaluation Requirement
A clinical evaluation by a podiatrist or a physician with equivalent podiatric expertise is required to determine the medical necessity of custom-molded shoes, extra-depth shoes, and/or therapeutic removable inserts. Documentation should specify the type of footwear/inserts recommended and the clinical rationale.
- Evaluation must be performed by a podiatrist or similarly qualified clinician
- Assessment must state whether custom-molded shoes, depth shoes, or removable/customized inserts are needed
Clinical Documentation Required
Clinical documentation must demonstrate that the member has diabetes mellitus under active diabetic management and show evidence of at least one qualifying diabetic foot complication (e.g., foot ulcer, prior foot amputation related to diabetes, peripheral neuropathy with callus formation, foot deformity such as Charcot foot, or peripheral vascular disease). Include relevant clinical findings, treating provider notes, and prior treatments. Requests that exceed the quantity limits per calendar year may be denied.
- Document diabetes is under management by PCP or endocrinologist
- Document at least one qualifying complication: foot ulcer; prior amputation due to diabetes; peripheral neuropathy with callus formation; foot deformity (e.g., rocker-bottom, Charcot); vascular disease in foot/feet
- Include provider assessment, shoe/insert measurements, and justification for custom vs. non-custom products
- Note: Requests exceeding annual quantity limits (see policy) may be denied
Background
Therapeutic footwear — including custom-molded shoes, extra/depth shoes, and removable customized inserts — is intended to prevent further foot compromise in patients with diabetes who have qualifying foot conditions. A podiatrist or similarly qualified clinician must determine the need and the appropriate type of device. Custom-molded shoes are constructed over a positive model of the patient’s foot and include removable inserts that can be replaced as the patient’s condition changes. Extra/depth shoes provide additional internal length (approximately an extra 3/16 inch when the full-length filler is removed) to accommodate custom or customized inserts. Multi-density inserts that form by heat and pressure from wearing are not customized at fitting and therefore are not considered therapeutic inserts.
Definitions
Policy Revision History
Policy became effective.
Expert opinion from Dr. Howard Pike (TSPMG Chief of Foot and Ankle Surgery) provided commentary on fitting and referral practices for diabetic shoes and inserts.
Policy last reviewed/revised by the Utilization Management Committee.
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