The use of diabetic shoes has been steadily increasing since the Medicare Therapeutic Shoe Bill was passed. For some diabetics, these are of vital importance to reduce shoe-related pathology. Unfortunately, the overuse of these prescription devices and fraudulent distribution threatens the long-term viability of this program. This article will discuss the appropriate use of these shoes, the process required for obtaining them, and how you as primary care physicians, internists, or endocrinologists can assure proper utilization and monitoring of these devices. Please note that while diabetic shoes are primarily a Medicare-exclusive initiative, some third party insurers may cover one or more elements of the diabetic shoe system, and Medicaid programs also provide coverage.

The Rationale Behind The Use of Diabetic Shoes

Medicare began this benefit in order to limit the incidence of foot wounds and general injuries caused by the use of improperly fitting shoes. Shoes have been the source of many friction and pressure-related wounds, leading to infection, hospitalization, and possibly amputation. They also have allowed for irritation of foot deformities already present, including bunions and hammertoes. As many diabetics have peripheral neuropathy, shoe irritation pain cannot be readily felt and wounds form easily after a relatively short period of time. Combined with foot deformity like bunions and hammertoes, as well as chronic edema, the potential for the shoe to rub against the skin is dangerously increased. A diabetic shoe is defined as an extra depth shoe (especially in the toe box) to reduce dorsal pressure on the toes, as well as sized appropriately for width to reduce pressure on the medial and lateral foot. This immediately protects feet with digital deformities or bunions and benefits normal feet as well. The shoe material generally should have construction to limit seams within the shoe and should be durable to last one year's worth of daily use. Of vital importance is the inclusion of an insert made mostly of a material called plastizote. This material reduces pressure and shear forces. It can be heat molded to the foot, or in some cases must be custom molded to a foot if severe foot deformity is present. These severe deformities may be from amputation voids or Charcot deformity. Medicare has defined the minimum thickness, or durometer, of this material, and the use of anything less is inappropriate. When the extra depth shoe and plastizote insert are combined, the likelihood of shoe-related pathology is significantly reduced.

How To Obtain These Protective Devices For Your Patients

The process for obtaining diabetic shoes can be slightly confusing, as are many of Medicare's policies regarding durable medical equipment. Understanding the requirements Medicare places on this process is vital in obtaining the appropriate shoe in a timely manner, without contributing to the pervasive fraud committed by many medical supply companies. In essence, not every diabetic requires, or, for the purpose of this article, qualifies for diabetic shoes. A full foot exam is needed to determine this need, evaluating for peripheral neuropathy, hyperkeratosis, PAD, ulceration history or risk, foot deformity (even as simple as a hammertoe or bunion), or previous amputation. If any of these are present, then your patient qualifies for diabetic shoes, and a prescription can be written. From this point, you can personally prescribe diabetic shoes, or you may defer to a podiatrist who supplies diabetic shoes to evaluate further to see if any additional factors need to be considered, such as the need for custom molded inserts over prefabricated heat molded inserts (the norm) due to severe deformity. The podiatrist will then prescribe the shoes on their own without needing one from you. For reference, the standard prescription should appear as such:

Rx: Extra-depth diabetic shoes (1 pair) with multi-laminar plastizote inserts (3 pairs)
Dx: [list the qualifying diagnosis including 250.xx]

At this point, if you are prescribing the shoes yourself, you can send your patient to a podiatrist who supplies diabetic shoes (who may also help modify the prescription if needed). In the rare event, none are available, your patient can present to a prosthetist/orthotist for fabrication. You should avoid sending your patients to a commercial shoe store or pharmacy advertising diabetic shoes, as your patient will likely receive a low-quality product. Usually, shoes from a podiatrist or prosthetic lab take 2-3 weeks to obtain depending on stock/availability, and any modification needed.

The next step in this process is for the supplier to obtain a qualifying statement from you (that will be sent to you for signing) essentially stating that you agree with the qualifying findings of the foot and are indeed treating that patient for diabetes. Without this form, Medicare will not cover the shoes, and they cannot be dispensed without your patient paying cash for the shoes. This form usually is the cause for delay in patients receiving diabetic shoes. You in all likelihood have received many of these forms in the past five years or more without knowing where they came from. When from a podiatrist, the podiatrist has prescribed the shoes him or herself after a thorough exam, and simply needs the certifying letter from you to finish the process independent of you. Obviously, when you prescribe the shoes yourself the supplier will send the form to you soon after your patient presents for fitting. When the letter is sent by a diabetic shoe supplier outside of a podiatrist or a local prosthetist/orthotist you need to carefully review the form. Acceptable forms will come from a local prosthetist/orthotist who are seeing your patients due to a prescription by another one of your patient's specialists or podiatrist who does not supply diabetic shoes him/herself. Any other source needs to be scrutinized more completely. More than likely the alternate sources are from medical supply companies and non-medical entities involved in the distribution of diabetic shoes. A common scenario takes place when patients are cold contacted via mail or phone by these companies (who have names on a calling list due to a diagnosis of diabetes from other suppliers), and an offer is made for a "free" diabetic shoe. These patients are then fitted through the mail based on the shoe size they admit to, or the supplier mails a foam box to take an impression of the foot by the patient who then sends it back to them. Events are also held in which patients go to a hotel or general conference center for a one-day opportunity to be fitted. Rarely is an exam performed by the dispensing company, which rely solely on the certification of the treating physician to be in-line with Medicare documentation requirements. They are relying on physicians being too busy to carefully scrutinize need or the source of the shoes to be Medicare compliant. The patients are then sent the shoes once you provide the certification form, and no follow-up is performed by the company to determine if the fit is appropriate. If problems do develop, no one is available to inspect or modify the shoes. At times, the shoe styles used barely fit the qualifications for a diabetic shoe, as commercially available shoes are often used in place of a dedicated diabetic shoe (for example, New Balance shoes are commonly used), and the inserts used are of poor quality. Some companies will automatically use custom inserts whether or not the patient actually needs them as the custom inserts reimburse higher. All of this is done without the input or expertise of a foot specialist, or even you as the physician managing your patient's diabetes. As if all this was not enough, in many cases companies will write off the 20% Medicare does not cover in the event secondary insurance is not present (or will not cover diabetic shoes), in order to keep the marketing of "free" shoes accurate. This is illegal, as providers and suppliers are obligated to collect this.

The Big Picture

In short, diabetic shoes are highly effective in reducing shoe-related diabetic pathology. The process involves four steps: 1) foot examination and subsequent prescription of the shoes depending on the exam results and qualification by yourself or a podiatrist 2) fitting and selection of the shoes by the supplier and patient 3) your signature on the certification note as the physician who is managing the patient's diabetes 4) dispensing and monitoring of the shoes by the supplier. Medicare requires these steps be followed, and the long term survival of this generous program requires that all involved in this process understand how it is structured if only to prevent fraud and waste.