Therapeutic Shoes/Inserts Documentation (Diabetes)

Packet Header

Patient: [Full name]  |  DOB: [Date of birth]  |  MRN/MBI: [Medical record number or Medicare Beneficiary Identifier]

Packet Year: [Calendar year of benefit]

Packet Version Date: [Date/time of this packet version]

Benefit Type: [annual benefit / replacement / additional inserts]

Responsible Parties:

• Certifying Clinician (diabetes management): [Name], [Credentials], NPI: [Number / pending]
• Prescribing Practitioner: [Name], [Credentials], NPI: [Number / pending]
• Supplier/Fitter: [Entity name], [Staff member(s)]

(If any NPI is unknown at documentation time, enter "pending" and flag for completion prior to claim submission.)

Coverage Timeline & Compliance Checklist

(Populate dates and documentation locations. Verify each event meets Medicare timing and in-person requirements relative to the delivery date.)

Event	Date	Meets Requirement (Y/N)	Documentation Location
1. Diabetes management visit (in-person, within 6 months of delivery)	[Date]	[Y / N]	[Note title/EMR location]
2. Qualifying foot condition documentation (in-person, within 6 months of delivery)	[Date]	[Y / N]	[Note title/EMR location]
3. Certifying statement signature (on or after diabetes visit, within 3 months of delivery)	[Date]	[Y / N]	[Certification section]
4. Prescribing practitioner visit (in-person)	[Date]	[Y / N]	[Prescribing evaluation note]
5. Standard Written Order signature	[Date]	[Y / N]	[SWO document]
6. Supplier pre-selection evaluation (in-person, before item selection)	[Date]	[Y / N]	[Supplier evaluation form]
7. Delivery (in-person)	[Date]	[Y / N]	[Delivery/fit assessment]
8. Proof of delivery completed	[Date]	[Y / N]	[POD form]

(Include only if any required event is missing or outside required timeframe:)

COVERAGE SUPPORT INCOMPLETE — do not dispense/bill with KX modifier. Remediation needed: [Specify missing or non-compliant elements]

Benefit Selection

• Selected benefit: [depth shoes + inserts / custom-molded shoes + inserts / inserts only / shoe modifications in lieu of inserts]
• Insert count for the year: [Number of pairs/units]
• For inserts only — appropriate footwear confirmed: [Yes / Not applicable]
• Planned shoe modifications: [List modifications / None]
• Prior therapeutic footwear/inserts this calendar year: [Details / None / Patient uncertain — supplier to verify claim history]

Roles & Responsibilities

• Certifying clinician: [Name] — certifies diabetes diagnosis, qualifying foot condition(s), and need for therapeutic footwear.
• Prescribing practitioner: [Name] — evaluates, selects footwear type, and completes SWO.
• Supplier/fitter: [Entity/staff] — performs pre-selection evaluation, measurements, delivery, fit assessment, and proof of delivery.

(Include only if an NP/PA serves as certifying clinician under incident-to requirements:)

Incident-to supervision: [Supervising physician name, credentials, NPI] provided required supervision; direct involvement in diabetes management documented.

Clinical Documentation

Diabetes & Eligibility Summary

[Diabetes mellitus diagnosis and type]. [Evidence of active diabetes management: current care plan, medications, A1c monitoring, follow-up schedule]. Therapeutic footwear is part of the comprehensive diabetes care plan.

Qualifying foot condition(s): (Document at least one with specificity and laterality. Do not infer eligibility from diabetes alone. If no qualifying condition is present, document "Does not meet therapeutic shoe coverage criteria" and stop the workflow.)

• Previous amputation: [Level, laterality]
• History of foot ulceration: [Location, laterality, approximate date/current status]
• Pre-ulcerative callus: [Location, description, laterality]
• Peripheral neuropathy with callus formation: [Protective sensation findings] AND [Callus locations, laterality] (Both elements required.)
• Foot deformity: [Type], [Laterality], [Severity/accommodation needs]
• Poor circulation: [Objective findings], [Laterality]

Foot Evaluation Findings

(Include when this packet establishes eligibility via direct examination. Document findings per foot.)

Right foot:

• Skin: [Calluses, pre-ulcerative lesions, ulcers with location/size/stage, maceration, fissures, infection signs]
• Deformity: [Bunion / hammertoes / Charcot changes / prominent metatarsal heads / pes planus / pes cavus / partial toe loss / other]
• Neurologic: [Protective sensation method and results], [Neuropathic symptoms]
• Vascular: [Pedal pulses, capillary refill, temperature, dependent rubor, edema, known PAD]
• Footwear factors: [Inability to accommodate in standard footwear, recurrent pressure areas]

Left foot:

• Skin: [Calluses, pre-ulcerative lesions, ulcers with location/size/stage, maceration, fissures, infection signs]
• Deformity: [Bunion / hammertoes / Charcot changes / prominent metatarsal heads / pes planus / pes cavus / partial toe loss / other]
• Neurologic: [Protective sensation method and results], [Neuropathic symptoms]
• Vascular: [Pedal pulses, capillary refill, temperature, dependent rubor, edema, known PAD]
• Footwear factors: [Inability to accommodate in standard footwear, recurrent pressure areas]

Eligibility linkage: Patient meets qualifying condition(s) for therapeutic shoes/inserts: [Specific criterion/criteria met with laterality].

External Foot Findings Endorsement

(Include only when the certifying clinician did not personally document the qualifying foot condition.)

• External note: [Author, credentials, date of service, note title/attachment reference]
• Attestation: "I have reviewed the above note and agree with the documented findings. The encounter was in-person and within the required timeframe."
• Certifying clinician initials and date: [Initials] — [Date]

Certification Statement

(The certification statement must be corroborated by clinical documentation above.)

Certifying that:

• Patient has diabetes mellitus.
• Patient has qualifying condition(s): [Specify condition(s) and laterality].
• Patient is being treated under a comprehensive diabetes care plan.
• Patient needs therapeutic shoes and/or inserts.

Certification date: [Date] (Must be on or after diabetes visit and within 3 months of delivery.)
Signature: [Name, credentials, signature, date/time]

Prescribing Practitioner Evaluation & Order

Clinical Rationale: [Indication for therapeutic footwear]. [Type recommended: depth vs custom-molded, insert type, modifications]. [Fitting constraints: deformities, edema, skin fragility, amputation level].

Standard Written Order: (Must be signed and dated. Do not allow supplier modifications without updated signed order.)

• Patient: [Name, identifier]
• Order date: [Date]
• Item description: [HCPCS code(s), narrative description, brand/model if applicable]
• Quantity: [Pairs/units]
• Laterality: [Left / Right / Bilateral / N/A]
• Prescribing practitioner: [Name, NPI, signature, date]

Supplier Documentation

Pre-Selection Evaluation

(Must be in-person and completed before item selection.)

• Foot abnormalities to accommodate: [Deformities, calluses, pressure areas]
• Measurements: [Length, width, other as applicable]
• Custom modeling: [Capture method: impression / cast / CAD-CAM], [Date], [Technician] (Include if custom-molded shoes or custom inserts.)

Item Selection

• Shoe: [Depth / Custom-molded], [Size], [Width], [Brand/model]
• Inserts: [Prefab / Custom fabricated / CAD-CAM], [Quantity]
• Modifications: [List / None]
• Clinical justification: [Link selections to documented abnormalities]

Delivery & Fit Assessment

(Delivery must be in-person. Patient must be wearing items during assessment. Do not use "feels fine" as sole evidence of fit.)

• Delivery date/time: [Date/time]
• Objective fit: [Length, width, toe box clearance, heel security, pressure points over deformities, insert seating]
• Skin check: [Findings over bony prominences and prior ulcer/callus sites]
• Patient tolerance: [Initial ambulation observation]
• Follow-up plan: [Adjustments needed, skin check schedule]

Proof of Delivery

• Delivery date: [Date]
• Items delivered: [Description matching SWO with HCPCS and quantities]
• Recipient: [Beneficiary or authorized representative name and signature]
• Delivery method: [In-person pickup / Shipped with carrier and tracking]

(If delivery not completed, document reason and maintain packet status as "pending.")

Record Integrity

• All contributors must sign and date their sections. Reference signature log if illegible.
• Late entries or amendments must be labeled with date/time and author; do not overwrite original content.
• If AI/scribe tools are used, clinician authentication is required.
• Coverage-critical facts (qualifying condition, encounter timing, signatures, objective fit) must be explicit and attributable to documented encounters.