CurrentKaiser PermanentePolicy No.03-10

Therapeutic diabetic footwear and inserts

Criteria governing medical necessity and coverage of therapeutic shoes, depth shoes, custom-molded shoes, and shoe inserts for patients with diabetes managed by Kaiser Permanente in the Georgia region.

Policy Summary

PayerKaiser Permanente

PolicyTherapeutic diabetic footwear and inserts

Policy CodePolicy No.03-10

Change TypeReviewed/Revised

Effective Date11/3/2005

Next Review Date

Key ActionObtain documentation showing the patient has diabetes under management and at least one diabetic foot complication and submit prior authorization with fitting justification.

SourceLink

1/yrlimit per individual

No.03-10criteria number

8/8/2024last revision

Diabetesprimary diagnosis

Coverage Criteria for Therapeutic Diabetic Footwear

Medical necessity criteria for therapeutic shoes and inserts

Policy Summary

PayerKaiser Permanente

PolicyTherapeutic diabetic footwear and inserts

Policy CodePolicy No.03-10

Change TypeReviewed/Revised

Effective Date11/3/2005

Next Review Date

Key ActionObtain documentation showing the patient has diabetes under management and at least one diabetic foot complication and submit prior authorization with fitting justification.

SourceLink

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Diabetes under management: Patient has Diabetes mellitus and is under Diabetic Management by his PCP or endocrinologist

Documented diabetic foot complication(s): At least one of the following: foot ulcers; previous foot or partial foot amputation due to microvascular disease from diabetes; peripheral neuropathy with callus formation on one or both feet; foot deformity (e.g., rocker bottom, Charcot foot); vascular disease in either or both feet

Supply limits per calendar year: Coverage is limited per individual to one of the following per calendar year (per CMS): either one pair of custom-molded shoes (including inserts provided with such shoes) and up to two additional pairs of inserts, or one pair of depth (extra-depth) shoes and up to three pairs of inserts. Overall limited to one listed footwear option per calendar year.1 per calendar year

Provider Actions, Prior Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required for diabetic shoes and inserts. Prior authorization must be obtained before provision of custom-molded shoes, depth shoes, or therapeutic inserts for members with diabetes.

Applies to custom-molded shoes (with inserts), extra-depth (depth) shoes, and therapeutic removable inserts (per CMS limits).
Coverage limited to one footwear option per calendar year: either one pair of custom-molded shoes (including inserts) plus up to two additional pairs of inserts, or one pair of depth shoes plus up to three pairs of inserts.
Documentation must demonstrate Diabetes mellitus under management by the patient’s PCP or endocrinologist and a qualifying diabetic-related foot condition (e.g., foot ulcer, prior foot/partial foot amputation due to diabetes, peripheral neuropathy with callus formation, foot deformity such as Charcot foot, or vascular disease in one or both feet).
Deluxe/style upgrades (color, leather type, non-therapeutic cosmetic features) are not medically necessary and are the patient’s financial responsibility.

Denial Risk

Denial / Member Financial Responsibility

Denial risk if allowance exceeded or non-covered upgrades billed. Requests exceeding the per-calendar-year footwear and insert limits or requests including non-covered deluxe/style upgrades may be denied or the cost may be billed to the patient.

Per-calendar-year limits: one footwear option (custom-molded shoes or depth shoes) with associated insert allowances as specified by CMS.
Upgrades for style or cosmetic features are patient responsibility and can result in denial of coverage for those elements.

Documentation Required

Required clinical documentation. Submitted prior authorization must include clinical evidence that the member has diabetes under active management and documentation of a qualifying diabetic foot condition as listed in indications.

Statement that Diabetes mellitus is under management by the PCP or endocrinologist.
Documentation of one or more qualifying conditions: foot ulcer; previous foot or partial foot amputation due to diabetes-related microvascular disease; peripheral neuropathy with callus formation; foot deformity (e.g., rocker bottom, Charcot foot); or vascular disease in one or both feet.
Physician determination from a podiatrist or physician with equivalent expertise that special shoes/inserts are medically necessary (custom-molded shoes, depth shoes, or therapeutic removable inserts).
Supporting clinical notes, exam findings, and any prior treatment attempts.

Denial Risk

Supply Limits

Supply limits per calendar year. Coverage is limited to the CMS-specified annual allowance; exceeding these limits may lead to denial.

One of the following per calendar year: either one pair of custom-molded shoes (including their inserts) plus up to two additional pairs of inserts, or one pair of depth shoes plus up to three pairs of inserts.
Non-customized removable inserts provided with depth shoes are included in the footwear benefit and not counted as extra therapeutic insert pairs.
Requests exceeding these quantities require justification and are subject to denial.

Definitions

Custom-molded shoes — definition and key features

DefinitionShoes constructed over a positive model of the patient’s foot that include removable inserts, allowing replacement as the patient’s condition changes.

Key featureConstructed over a positive model (last) of the patient’s foot.

Insert characteristicIncludes removable inserts that can be replaced as the patient’s condition changes.

Fitting requirementNeed for custom-molded shoes determined by a podiatrist or physician with equivalent podiatry knowledge.

Extra-depth (depth) shoes — definition and key features

DefinitionShoes with a longer toe box and a full-length heel-to-toe filler that, when removed, provides approximately 3/16 inch of additional length to accommodate custom or customized inserts.

Key featureLonger toe box to provide extra internal volume for inserts and deformities.

Filler characteristicFull-length heel-to-toe filler removable to create added length for inserts (about 3/16 inch).

Fitting requirementNeed for depth shoes determined by a podiatrist or physician with equivalent podiatry knowledge.

Multi-density shoe inserts (A5510) — definition and note about not customized at time of fitting

DefinitionRemovable inserts that undergo compression molding to the patient’s foot over time through heat and pressure generated by wearing the shoe with the insert present.

HCPCS codeA5510 (multi-density shoe insert).

Customization noteThese inserts are not customized to the patient’s foot at the time of fitting and therefore are not considered therapeutic shoe inserts per the clinical summary.

Clinical implicationCompression molding occurs over time rather than at initial fabrication, distinguishing them from custom-fitted inserts.

Background

Therapeutic footwear and inserts are intended to prevent ongoing foot compromise in patients with diabetes who have microvascular complications. Eligible options include custom-molded shoes (constructed over a positive model of the patient’s foot with removable inserts), extra-depth (depth) shoes (longer toe box with a removable full-length filler to accommodate inserts), and custom or customized removable inserts. These interventions are used to reduce risk of ulceration, accommodate deformity, and protect tissue in members with diabetic-related foot disease.

A5500
A5501
A5503
A5504
A5505
A5506
A5507
A5508
A5510
A5511

OpenPayer

Therapeutic diabetic footwear and inserts

Coverage Criteria for Therapeutic Diabetic Footwear

HCPCS Codes for Therapeutic Footwear and Inserts

Provider Actions, Prior Authorization and Documentation

Definitions

Background

Revision History