In 1993, Congress enacted the therapeutic shoe benefit for diabetics. Congress recognized that diabetics are at higher risk for ulcers and amputation due to a lack of sensation in the feet. Diabetic shoe suppliers are in a unique position to work with physicians, podiatrists, other diabetic professionals, and patients to meet the clinical needs of diabetics—particularly in the provision of diabetic shoes and inserts. It is important that suppliers understand the Medicare guidelines for the fitting and provision of diabetic shoes.

DOCUMENTATION REQUIREMENTS

Medicare covers diabetic shoes, inserts, and modifications if:

• the patient has diabetes;
• the patient has one or more of the following conditions: previous amputation of the other foot, or part of either foot; history of previous foot ulceration of either foot; history of preulcerative calluses of either foot; peripheral neuropathy with evidence of callus formation of either foot; foot deformity of either foot; or poor circulation in either foot;
• the certifying physician who is managing the patient's systemic diabetes condition certifies that (i) one or more of the conditions described in the preceding bullet are present; (ii) the patient is being treated under a comprehensive plan of care for diabetes; and (iii) the patient needs diabetic shoes, inserts, or modifications.

The physician's certification statement cannot be signed by a podiatrist; it must be signed by an MD or DO. However, the podiatrist can write the prescription for the diabetic shoes. A new certification statement is required for a shoe, insert, or modification provided more than 1 year from the most recent certification statement on file.

A new order is not required for the replacement of an insert or modification within 1 year of the order on file. However, the supplier's records should document the reason for the replacement. A new order is required for insert/modification replacement if more than 1 year from the most recent order on file. A new order is also required for the replacement of any shoe.

For patients who meet these criteria, coverage is limited to one of the following, within 1 calendar year (January to December):

• one pair of custom-molded shoes, which also includes inserts provided with the shoes, and two additional pairs of inserts; or
• one pair of depth shoes and three pairs of inserts, not including the noncustomized removable inserts provided with such shoes.

The particular type of footwear (shoes, inserts, modifications) that is necessary for the patient must be prescribed by a podiatrist or other qualified physician knowledgeable in the fitting of diabetic shoes and inserts. The footwear must be fitted and furnished by a podiatrist or other qualified individual, such as a pedorthist, orthotist, or prosthetist. The certifying physician (the physician who manages the systemic diabetic condition) may not furnish the footwear unless they practice in a defined rural area, or a defined health professional shortage area. The prescribing physician (podiatrist or other qualified physician) can be the supplier (the one who furnishes the footwear).

The "other qualified individual" language is ambiguous. It has not been defined specifically by CMS or the Medicare Administrative Contractors (MACs). Thus far, the National Supplier Clearinghouse (NSC) has accepted a manufacturer training certificate as proof that a fitter is an "other qualified individual."

STATE LICENSURE

Approximately 15 states have passed orthotics and prosthetics licensing statutes that define who can fit diabetic shoes. Additional states are expected to pass similar licensure statutes. When a diabetic shoe supplier expands into other states, it is important for the supplier to ascertain if the new states have licensure requirements. For example, while New Mexico currently does not have a licensure statute governing diabetic shoe fitters, Texas and Oklahoma do have such statutes.

The Oklahoma Licensed Pedorthists Act (Title 59 OS, Section 2301-2308) provides, in part: Section 2302. Defini­tions. As used in the Oklahoma Licensed Pedorthists Act:

3) "Certified Pedorthist (CPed)" means a professional whose competence in the practice of pedorthics is attested to by issuance of a credential by the Board for Certification in Pedorthics;

6) "Licensed Pedorthist" means a person who is licensed as required by the Oklahoma Licensed Pedorthists Act, who regularly practices pedorthics, and who is therefore entitled to represent himself or herself to the public by a title or description of services that includes the term "pedorthist";

7) "Pedorthic devices" means therapeutic shoes, shoe modifications made for therapeutic purposes, partial foot prostheses and custom made orthoses, inserts, inlays, or variants thereof for use from the ankle and below, but does not include nontherapeutic accommodative inlays or nontherapeutic accommodative footwear, regardless of method of manufacture, unmodified over-the-counter shoes, or prefabricated foot care products.

Section 2306. Licensure and registration—qualifications—alternative qualification contracts—licensure and registration without examination.

A) The State Board of Medical Licensure and Supervision, with the assistance of the Advisory Committee on Pedorthics, shall establish qualifications for licensure and registration under the Oklahoma Licensed Pedorthists Act.

B) To be licensed to practice pedorthics according to standard qualifications, a person shall have passed all examinations required for certification by the Board for Certification in Pedorthics (BCP).

Section 2307. Circumstances under which care or services may be provided; practice without license or registration; and fines.

A) A licensed pedorthist may only provide care or services pursuant to an order from a licensed podiatrist, physician, or chiropractor when addressing a medical condition—or when evaluating, planning treatment, measuring, designing, fabricating, assembling, fitting, adjusting, managing the patient, or servicing a pedorthic device for the prevention or amelioration of painful or disabling conditions of the foot and ankle.

B) Effective January 1, 2002, any person who holds himself or herself out to be a pedorthist, or uses the title pedorthist or common variants of that title without holding an appropriate license issued by the State Board of Medical Licensure and Supervision, or who, without being registered by the Board, dispenses pedorthic devices, or who is in violation of any provision of the Oklahoma Licensed Pedorthists Act, shall be subject to an administrative fine for each day found to be in violation.

OFFER A VARIETY OF SHOES

Certainly, suppliers must offer shoes that meet the patient's therapeutic needs. At the same time, to gain a competitive advantage in the marketplace, suppliers should also offer shoes that meet the aesthetic needs of patients. For example, suppliers can:

• offer a diabetic-type tennis shoe (with both lace and Velcro) for those patients who need to exercise and walk.
• offer a Lycra-type shoe for those patients with severe deformity, or for those who suffer from shoe irritation no matter what type of shoe they wear;
• offer a more dress-type diabetic shoe for patients who must wear this type of shoe for work. There are nice loafers in the marketplace for men, and manufacturers are producing fashionable shoes for women; and
• offer a diabetic boot for those who must work in an environment where boots are required.

MEASURING AND FITTING

It is imperative to have an accurate measuring device. Some diabetic shoe companies have their own specific measuring tools for their shoes; therefore, it is important to measure correctly for the prescribed shoe. When measuring the patient, be sure to measure both feet because sizes may differ. Measure the width of the foot and be aware of shoe types that come in the wider widths.

Most vendors will send information to suppliers, and may send a representative to the suppliers' offices to teach how to accurately measure for shoes. When the patient comes in for fitting, it is important to ensure the shoe fits the foot well. If the shoe does not fit, then the supplier should reorder. The supplier needs to have a policy in place that informs its patients when it will and will not accept returned shoes for replacement.

Be aware of the rules on molding inserts. Medicare will cover only diabetic inserts that are either custom fabricated or heat molded by an external heat source. For heat-molded, prefabricated inserts, Medicare mandates that these inserts must achieve "total contact" with the patient's foot. Keep in mind that many prefabricated inserts sold as heat-moldable diabetic devices do not meet this criterion.

Lastly, know that some patients with certain foot types (cavus foot) will require a custom-made device as opposed to a prefab, heat-molded insert. In addition, patients with severe deformity (Charcot osteoarthropathy, or a partial amputation) should not use a heat-moldable prefab. In these cases, suppliers should take a cast impression and send for a custom insert. In many cases, these types of patients will require custom shoes, as opposed to custom inserts.

AVOID FALSE CLAIMS

Over the past couple of years, the government has brought false claims actions against diabetic shoe suppliers that have allegedly "crossed over the line." For example, in March 2008, Cocco Brothers and Carlo A. Cocco (collectively "Cocco") entered into a civil settlement agreement (SA) with the Department of Justice. The SA states: "The United States contends that it has certain civil claims … against Cocco for engaging in the following conduct during the period from May 4, 2002, to April 21, 2007: Cocco placed a small piece of plastic on the heel area of the Diabetic shoe insert which it supplied to correct the patient's varus/valgus. The correct method of billing Medicare for that modification is to use code A-5507. Instead, Cocco billed Medicare under the code L-2275 three hundred forty four (344) times for the modification. At all times the L-2275 code paid more than the A-5507. …"

Jeffrey S. Baird

Although the SA does not contain an admission of liability by Cocco, Cocco agreed to pay $130,000 to the government to settle the claim. As another example, on July 12, 2006, Godwin Iloka pleaded guilty to the submission of false claims in western Missouri. Iloka admitted that from January 24, 2002, to September 15, 2005, he submitted claims to Medicare for custom-molded diabetic shoes; then, after Medicare paid the claims, he provided beneficiaries with much less expensive standard diabetic shoes.

The message is: When submitting claims to Medicare, bill for only what you provide, and be sure the documentation reflects that the billing is accurate.

Ultimately, as long as the diabetic shoe suppliers understand documentation requirements, understand how to properly fit and mold, and bill for only those products and services provided, then they will be able to meet the needs of patients and avoid legal pitfalls.

Jeffrey S. Baird, JD, is chairman of the Health Care Group at Brown & Fortunato PC, a law firm based in Amarillo, Tex. He represents pharmacies, infusion companies, HME companies, and other health care providers throughout the United States. Baird is Board Certified in Health Law by the Texas Board of Legal Specialization, and can be reached via e-mail: .