The following is an excerpt from the Medicare Benefits Policy Manual, Chapter 15, pertaining to Therapeutic Shoes for individuals with Diabetes.  If your practice provides shoe inserts for patients, your billing department should be fully aware of all the related coverage issues.  It is also important that you properly enroll with Medicare to be able to bill for these products.  The complete Medicare coverage manual can be found at http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c15.pdf

140 -Therapeutic Shoes for Individuals with Diabetes
(Rev. 1, 10-01-03)
B3-2134
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 equirements 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).  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 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- Thisis 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 callusformation;
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.”