Therapeutic Shoes for Persons with Diabetes: Decision-Making and Ordering - JF Part B

Roles of various practitioners involved in the decision-making and provision process for diabetic shoes.

• Certifying Physician: The practitioner actively treating and managing the patient's systemic diabetic condition. This practitioner must be an M.D. (Doctor of Medicine) or D.O. (Doctor of Osteopathy) as outlined in the Social Security Act §1861(s) (12).
• Prescribing Practitioner: The Certifying Physician, a different MD or DO, physician's assistant (PA), nurse practitioner NP), clinical nurse specialist (CNS), or podiatrist (DPM). One of these practitioners may conduct the foot exam and write the detailed written orders required for Medicare's coverage of Therapeutic Shoes for Persons with Diabetes if the Certifying Physician does not complete the foot exam.
• Supplier: The person or entity that provides the shoes and/or inserts to the Medicare beneficiary and bills the Medicare program. A supplier may be a podiatrist, pedorthist, orthotist, prosthetist or other qualified individual. The Prescribing Practitioner may be the supplier.

Therapeutic shoes, inserts and/or modifications to therapeutic shoes are covered if all the below criteria are met.

1. The beneficiary has diabetes mellitus (Reference diagnosis code section in the DME Policy Article (A52501)); and
2. The certifying physician has documented in the beneficiary's medical record one or more of the following conditions:
   • 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
3. The certifying physician has certified that indications (1) and (2) are met and that he/she is treating the beneficiary under a comprehensive plan of care for his/her diabetes and that the beneficiary needs diabetic shoes. The Certifying Physician must:
   • Have an in-person visit with the beneficiary during which diabetes management is addressed within six months prior to delivery of the shoes/inserts; and
   • Sign the certification statement on or after the date of the in-person visit and within three months prior to delivery of the shoes/inserts.
4. Prior to selecting the specific items that will be provided; the supplier must conduct and document an in-person evaluation of the beneficiary.
5. At the time of in-person delivery to the beneficiary of the items selected, the supplier must conduct an objective assessment of the fit of the shoe and inserts and document the results.

The Certifying Physician must either:

• Personally, document one or more of the qualifying foot conditions above in the medical record of an in-person visit within six months prior to delivery of the shoes/inserts; or
• Obtain, initial, date (prior to signing the certification statement), and indicate agreement with information from the medical records of an in-person visit with a podiatrist, other M.D. or D.O., physician assistant, nurse practitioner, or clinical nurse specialist that is within six months prior to delivery of the shoes/inserts. In this scenario, a different practitioner conducts the foot examination.

The certification statement must be completed on or after the date of the in-person visit and within three months prior to delivery of the diabetic shoes by the supplier. The documentation in the medical record must support the information on the certification statement. The certification statement by itself is not sufficient to meet the required documentation in the medical record and must be corroborated by the medical record.

Just a few reminders:

• The Certifying Physician must be an MD or DO that is managing the beneficiary's systemic diabetic condition.
• Another practitioner may conduct the foot exam that includes evidence of at least one of the qualifying foot issues. If this happens, the Certifying Physician must obtain a copy of that medical record, indicate agreement, sign and date it.
• The certification statement must be completed before the orders for the diabetic shoes.
• The Diabetic Shoe benefit is an annual benefit. Medicare will consider payment for one pair of diabetic shoes and up to three pairs of insoles per calendar year.
• The supplier must have valid detailed written orders in their possession prior to submitting the claim to the DME MAC.

All orders and medical records must meet CMS Signature Requirements. See CMS Medicare Learning Network (MLN) Matters (MM) 6698.

Following this guidance will help patients and the Medicare program by verifying there is medical documentation to support the provisions for Therapeutic Shoes for Persons with Diabetes, allow patients to receive the items necessary to treat his/her diabetic condition, and allow Medicare to pay claims appropriately. See the DME Therapeutic Shoes for Persons with Diabetes Local Coverage Determination (LCD) (L33369) for coverage details.