Comprehensive Diabetic Foot Exam (CDFE): Required Medicare Compliance Documentation for Therapeutic Shoes and Inserts

What is included in a Comprehensive Diabetic Foot Exam (CDFE) 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 Comprehensive Diabetic Foot Exam (CDFE):

The Supplier is the person or entity that actually furnishes the shoe and inserts to the beneficiary and bills Medicare. The supplier may be a podiatrist, pedorthist, orthotist, prosthetist or other qualified individual.

Prior to selecting the specific items that will be provided, the supplier must conduct and document an in-person evaluation of the beneficiary. (Refer to the related Local Coverage Determination, Documentation Requirements section, for additional information.)

The in-person evaluation of the beneficiary by the supplier at the time of selecting the items that will be provided (refer to related Policy Article, Non-Medical Necessity Coverage and Payment Rules, criterion 4) must include the following:

  1. An examination of the beneficiary’s feet with a description of the abnormalities that will need to be accommodated by the shoes/inserts/modifications.
  2. Measurements of the beneficiary’s feet.
  3. For custom molded shoes (A5501) and custom molded (A5513) or custom direct milled inserts (K0903), taking impressions, making casts, or obtaining CAD-CAM images of the beneficiary’s feet that will be used in creating positive models of the feet.

While Medicare does not require use of the SafeStep CDFE form, it does provide the podiatrist/ supplier with following benefits:

  • Satisfies Medicare requirement that there be a supplier evaluation prior to selection of shoes and inserts.
  • Documents medical necessity as basis for prescription.
  • Documents necessity for replacement shoes
  • Documents necessity for custom versus prefabricated inserts and / or shoes.
  • Can support a billable visit if DPM determines that there is change in patient’s condition since previous evaluation.
  • Satisfies requirement for PQRS measures helping DPM to avoid 2% end of year penalty.
  • Creates opportunity to determine indication for non-invasive vascular testing and / or fall risk assessment.

For additional information, see:

Medicare Documentation Checklist

Medicare LCD and Policy Article

And also watch this short video:

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