CMS Pub. 100-02, ch. 15, § 140

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 Medicare

Administrative Contractors (DME MACs).

Therapeutic shoes for diabetics are not DME and are not considered DME nor orthotics,

but a separate category of coverage under Medicare Part B. (See §1861(s)(12) and

§1833(o) of the Act.)

A. 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 or directly carved from a patient-specific, rectified electronic model 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).

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.

3. Substitution of Modifications for Inserts

An individual may substitute modification(s) of custom-molded or depth shoes

instead of obtaining a pair(s) of inserts in any combination. Payment for the

modification(s) may not exceed the limit set for the inserts for which the individual is

entitled. The following is a list of the most common shoe modifications available, but

it is not meant as an exhaustive list of the modifications available for diabetic shoes:

• Rigid Rocker Bottoms - These are exterior elevations with apex positions for

51 percent to 75 percent distance measured from the back end of the heel.

The apex is a narrowed or pointed end of an anatomical structure. The apex

must be positioned behind the metatarsal heads and tapered off sharply to the

front tip of the sole. Apex height helps to eliminate pressure at the metatarsal

heads. Rigidity is ensured by the steel in the shoe. The heel of the shoe tapers

off in the back in order to cause the heel to strike in the middle of the heel;

• Roller Bottoms (Sole or Bar) - These are the same as rocker bottoms, but the

heel is tapered from the apex to the front tip of the sole;

• Metatarsal Bars - An exterior bar is placed behind the metatarsal heads in

order to remove pressure from the metatarsal heads. The bars are of various

shapes, heights, and construction depending on the exact purpose;

• Wedges (Posting) - Wedges are either of hind foot, fore foot, or both and may

be in the middle or to the side. The function is to shift or transfer weight

bearing upon standing or during ambulation to the opposite side for added

support, stabilization, equalized weight distribution, or balance; and

• Offset Heels - This is a heel flanged at its base either in the middle, to the

side, or a combination, that is then extended upward to the shoe in order to

stabilize extreme positions of the hind foot.

Other modifications to diabetic shoes include, but are not limited to flared heels,

Velcro closures, and inserts for missing toes.

4. Separate Inserts

Inserts may be covered and dispensed independently of diabetic shoes if the supplier

of the shoes verifies in writing that the patient has appropriate footwear into which

the insert can be placed. This footwear must meet the definitions found above for

depth shoes and custom-molded shoes.

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 A/B MAC (B) to determine the meaning of

“in the area.”