Therapeutic Shoes
Documentation Requirements Include:
- Prescribing physician's detailed written order
- Completed, signed and dated statement from the certifying physician (physician managing the beneficiary's systemic diabetes condition) specifying that the beneficiary has diabetes and:
- Previous amputation of the other foot, or part of either foot, or
- History of previous foot ulceration of either foot, or
- History of pre-ulcerative calluses of either foot, or
- Peripheral neuropathy with evidence of callus formation of either foot, or
- Foot deformity of either foot, or
- Poor circulation in either foot, and is being treated under a comprehensive plan of care for his/her diabetes, and needs diabetic shoes.
- Clinical evaluation, performed by the certifying physician within six (6) months prior to delivery, that addresses the beneficiary's diabetes management.
- Relevant medical records where the certifying physician either personally documented that the beneficiary met one or more of criteria 2a - 2f or obtained documentation from another clinician documenting the beneficiary met one or more of criteria 2a - 2f and the certifying physician indicated agreement with the information by initialing and dating the record
- Supplier in-person evaluation conducted prior to selection of items that documents an examination of the beneficiary's feet with a description of the abnormalities that will need to be accommodated by the shoes/inserts/modification
- In-person visit, at the time of delivery, which assesses the fit of the shoes and inserts with the beneficiary wearing them
- Delivery documentation with the beneficiary's name and address and the description of the items provided
- Any other pertinent records.
- ABN on file should be submitted with other requested documentation.
Relevant medical records consist of physician notes, non-physician clinical notes, and non-physician clinical evaluations that verify that the patient's condition meets coverage criteria for therapeutic shoes for persons with diabetes.
The source of these records may be a physician's office, hospital, nursing home, home health agency, wound clinic, etc. evaluations used to determine coverage must have been performed and recorded prior to delivery and performed by a clinician who does not have a financial relationship with the supplier.

