Delivery Documentation and Break in Instructions: Required Medicare Compliance Documentation for Therapeutic Shoes and Inserts

What one needs in Delivery Documentation and Break-in Instructions of diabetic shoes, as it relates to the Required Medicare Compliance Documentation for Therapeutic Shoes and Inserts

Medicare compliance rules can be confusing. A number of different forms must be completed by each of several practitioner who are all required to be part of the process. Fundamental to the program is the assumption that prevention of diabetic wounds can be best prevented when patients have a team approach to their care. As such, the Medicare shoe program requires the participation of, and makes clear the responsibilities of the:

  • Prescriber who writes the order (prescription) for therapeutic shoes and inserts.
  • Supplier who fits the footwear, and
  • Certifying Physician who manages patients’ diabetes care.

Over the past few years, the incidence of Medicare pre-payment reviews and inconsistency of enforcement caused many practitioners to stop fitting shoes. Fortunately, this has ended for the most part. Practitioners are encouraged to identify patients at risk for ulceration and ensure they get fit with the shoes they need.

Here’s a clear explanation of the Delivery Documentation and Break-in Instructions to follow:

Suppliers may deliver directly to the beneficiary or the designee. In this case, proof of delivery (POD) to a beneficiary must be a signed and dated delivery slip. The POD record must include:

  • Beneficiary’s name
  • Delivery address
  • Sufficiently detailed description to identify the item(s) being delivered (e.g., brand name, serial number, narrative description)
  • Quantity delivered
  • Date delivered
  • Beneficiary (or designee) signature and date of signature

The date of signature on the delivery slip must be the date that the DMEPOS item was received by the beneficiary or designee. In instances where the item is delivered directly by the supplier, the date the beneficiary received the DMEPOS item must be the date of service on the claim. 

The in-person evaluation of the beneficiary by the supplier at the time of delivery (refer to related Policy Article, Non-Medical Necessity Coverage and Payment Rules, criterion 5) must be conducted with the beneficiary wearing the shoes and inserts and must document that the shoes/inserts/modifications fit properly.


  • Meets Proof of Delivery (POD) requirement.
  • Delivery Address is the where the items were provided.  If a house call, should indicate the patient’s address.
  • SafeStep WorryFree DME documentation generated based on data entry by supplier
  • The date dispensed is the Date of Service and when items should be billed to Medicare.
  • An office visit should NOT be billed for time spent fitting shoes.  
  • A podiatrist MAY bill for another unrelated service on the same day and if does, should use the -25 modifier.
  • Subsequent visits for adjustments to shoes / inserts are considered to be covered by payment when shoes dispensed and should NOT be billed in addition.

For more information, also see:

Medicare Documentation Checklist

Medicare LCD and Policy Article

And also watch this short video:

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