For nearly a decade, the Centers for Medicare & Medicaid Services (CMS) and physicians believed diabetic footwear prevented costly amputations.

However, in a study published in the May 15, 2002, Journal of the American Medical Association,¹ researchers reported that diabetic footwear may not be as effective as previously thought in preventing the foot ulcers that often lead to amputations.

This concerns some diabetic footwear providers because it could mean Medicare may look more closely at what they are reimbursing in this product category. Two procedural land mines already await those suppliers who provide diabetic shoes—tricky proper certification/prescription procedures and a loose definition of who is qualified to fit and furnish diabetic footwear—so greater scrutiny could mean double trouble.

What CMS Believes
Congress created the diabetic footwear benefit in 1993 after a 4-year demonstration project with CMS (then known as the Health Care Financing Administration) showed the cost-effectiveness of providing protective shoe gear for diabetic individuals. The Therapeutic Shoe Bill it passed provides coverage of therapeutic shoes (extra depth or custom molded), along with inserts, for Medicare beneficiaries with diabetes.

Currently, Medicare Part B coverage of diabetic footwear and orthotics is limited to one of the following within each calendar year:

• One pair of custom-molded shoes (including inserts provided with these shoes) and two additional pairs of inserts; or

• One pair of depth shoes (not including the noncustomized removable inserts provided with such shoes) and three pairs of inserts.

Medicare will also cover a modification (eg, rigid rocker bottom, roller bottoms, wedges, metatarsal bars, or offset heels) of a custom-molded or depth shoe as a substitute for an insert. It also may cover separate inserts 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, the footwear meets the definitions of depth shoes or custom-molded shoes found in the Supplier’s Manual policy, and the inserts meet the Supplier’s Manual policy definition. Finally, Medicare covers a custom-molded shoe when the patient has a well-documented foot deformity that cannot be accommodated by a depth shoe.

Foot ulcers and other foot problems are a major cause of morbidity, mortality, and disability in people with diabetes. Patients are at high risk to develop foot ulcers or infection if they have any of the following conditions: neuropathy, vascular disease, structural deformities, abnormal gait, skin or nail deformities, or a history of previous ulcers or infections. Researchers have estimated that some degree of neuropathy is present in up to 60% of all diabetic feet, particularly if diabetes has been present for more than 20 years or is poorly controlled. This helps make diabetes the most frequent cause of nontraumatic lower limb amputations.

Double Trouble
Clinicians who treat diabetic foot problems can recommend therapeutic shoes as part of their patient’s comprehensive diabetic care plan. But for a supplier to avoid jeopardy in a Durable Medical Equipment Regional Carrier (DMERC) audit, he or she must remember that a physician responsible for diagnosing and treating the patient’s diabetic systemic condition through a comprehensive plan of care must certify the need for the diabetic footwear before it can be reimbursed.

Failure to strictly adhere to Medicare’s coverage and limitations requirements could result in significant overpayments. Therefore, the presence in the physician’s medical record of the patient’s diabetic condition and certification that the patient is being treated under a comprehensive plan of care is crucial in documenting medical necessity. If this certification is not obtained before making a claim, then the diabetic footwear will not be reimbursed (or payment will be refunded in the event of a retrospective DMERC audit).

Following this certification by the physician managing the patient’s diabetes, a podiatrist or other qualified physician knowledgeable in fitting diabetic shoes may prescribe the necessary footwear. This prescribing physician (podiatrist, medical doctor, or doctor of orthopedics) may also be the supplier. However, the certifying physician may not furnish the footwear unless that physician is practicing in a defined rural area or a defined health professional shortage area.

Once properly certified and prescribed, the diabetic footwear “must be fitted and furnished by a podiatrist, or other qualified individual such as a pedorthist, an orthotist, or a prosthetist,” according to the Medicare Carrier’s Manual, Coverage and Limitations, Section 2134 (emphasis added). Because the “other qualified individual” phrase is open-ended, some battle lines are about to be drawn between the federal government and the suppliers of diabetic shoes over who is qualified to fit diabetic shoes.

Some suppliers have sent employees to manufacturers’ 1-day or weekend courses to learn how to fit diabetic shoes. Others have new employees receive training on the job. The suppliers want these specially trained employees to be recognized as part of the other qualified individual group, but CMS is wary.

Based on our firm’s interaction with federal regulatory officials, this limited training may be unacceptable and reimbursement paid for diabetic footwear fitted by these individuals may be retroactively disallowed. The federal government is reviewing reimbursement to diabetic shoe suppliers, and we anticipate that this scrutiny may also ultimately include a review of fitters’ qualifications.

While the DMERCs may very well take the position that a 1-day or weekend training course is not the functional equivalent of the breadth, depth, and length of training typically associated with a podiatrist, pedorthist, orthotist, or prosthetist, there is no published standard that supports this interpretation. If the DMERCs take this position, hearings, appeals, and, perhaps, court actions are almost guaranteed.

It is important that the diabetic shoe industry convince the DMERCs that if such interpretation is necessary, that it be applicable only to future claims; otherwise, significant overpayments are on the horizon. Most important, the Medicare patient’s access to this benefit would be severely curtailed due to the scarcity of qualified fitters.

Darrel J. Scott, JD, FACHE, is an attorney with the Health Care Group of Brown & Fortunato, PC, Amarillo, Tex. He can be reached at (806) 345-6308 or dscott@bf-law.com. 

Reference
1. Reiber GE, Smith DG, Wallace C, et al. Effect of therapeutic footwear on foot reulceration in patients with diabetes: a randomized controlled trial. JAMA. 2002;287:2552.