Coverage of therapeutic shoes (depth or custom-molded) along with inserts for individuals with diabetes is available as of May 1, 1993. These diabetic shoes are covered if the requirements as specified in this section concerning certification and prescription are fulfilled. In addition, this benefit provides for a pair of diabetic shoes even if only one foot suffers from diabetic foot disease. Each shoe is equally equipped so that the affected limb, as well as the remaining limb, is protected. Claims for therapeutic shoes for diabetics are processed by the Durable Medical Equipment Regional Carriers (DMERCs).

Definitions
The following items may be covered under the diabetic shoe benefit:

1. Custom-Molded Shoes
Custom-molded shoes are shoes that:
• Are constructed over a positive model of the patient’s foot;
• Are made from leather or other suitable material of equal quality;
• Have removable inserts that can be altered or replaced as the patient’s condition warrants; and
• Have some form of shoe closure.

2. Depth Shoes


Depth shoes are shoes that:
• Have a full length, heel-to-toe filler that, when removed, provides a minimum of 3/16 inch of additional depth used to accommodate custom-molded or customized inserts;
• Are made from leather or other suitable material of equal quality;
• Have some form of shoe closure; and
• Are available in full and half sizes with a minimum of three widths so that the sole is graded to the size and width of the upper portions of the shoes according to the American standard last sizing schedule or its equivalent. (The American standard last sizing schedule is the numerical shoe sizing system used for shoes sold in the United States.)

3. Inserts
Inserts are total contact, multiple density, removable inlays that are directly molded to the patient’s foot or a model of the patient’s foot and that are made of a suitable material with regard to the patient’s condition.

B. Coverage

1. Limitations
For each individual, coverage of the footwear and inserts is limited to one of the following within one calendar year:
• No more than one pair of custom-molded shoes (including inserts provided with such shoes) and two additional pairs of inserts; or
• No more than one pair of depth shoes and three pairs of inserts (not including the noncustomized removable inserts provided with such shoes).

B. Coverage

1. Limitations
For each individual, coverage of the footwear and inserts is limited to one of the following within one calendar year:
• No more than one pair of custom-molded shoes (including inserts provided with such shoes) and two additional pairs of inserts; or
• No more than one pair of depth shoes and three pairs of inserts (not including the noncustomized removable inserts provided with such shoes).

2. Coverage of Diabetic Shoes and Brace
Orthopedic shoes, as stated in the Medicare Claims Processing Manual, Chapter 20, “Durable Medical Equipment, Surgical Dressings and Casts, Orthotics and Artificial Limbs, and Prosthetic Devices,” generally are not covered. This exclusion does not apply to orthopedic shoes that are an integral part of a leg brace. In situations in which an individual qualifies for both diabetic shoes and a leg brace, these items are covered separately. Thus, the diabetic shoes may be covered if the requirements for this section are met, while the brace may be covered if the requirements of §130 are met.

C. Certification


The need for diabetic shoes must be certified by a physician who is a doctor of medicine or a doctor of osteopathy and who is responsible for diagnosing and treating the patient’s diabetic systemic condition through a comprehensive plan of care. This managing physician must:
• Document in the patient’s medical record that the patient has diabetes;
• Certify that the patient is being treated under a comprehensive plan of care for diabetes, and that the patient needs diabetic shoes; and
• Document in the patient’s record that the patient has one or more of the following conditions:
o Peripheral neuropathy with evidence of callus formation;
o History of pre-ulcerative calluses;
o History of previous ulceration;
o Foot deformity;
o Previous amputation of the foot or part of the foot; or
o Poor circulation.

D. Prescription
Following certification by the physician managing the patient’s systemic diabetic condition, a podiatrist or other qualified physician who is knowledgeable in the fitting of diabetic shoes and inserts may prescribe the particular type of footwear necessary.

E. Furnishing Footwear
The footwear must be fitted and furnished by a podiatrist or other qualified individual such as a pedorthist, an orthotist, or a prosthetist. The certifying physician may not furnish the diabetic shoes unless the certifying physician is the only qualified individual in the area. It is left to the discretion of each carrier to determine the meaning of “in the area.”