Does Your Patient Need Diabetic Therapeutic Footwear? (Where Benefit, Evidence, and Bureaucracy Collide)

I n 2012, the estimated incremental burden of diabetic foot ulceration in all Medicare and non-Medicare patients in the United States was $9.1– 13 billion (1). These costs do not include the suffering of patients and families, loss of income, loss of mobility , and predicted increased mortality. Coverage for extra-depth or custom molded therapeutic shoes and inserts for individuals with diabetes became a Medicare benefit on 1 May 1993. Within 5 years of the benefit's availability, a report from the Office of the Inspector General of the United States found that 57% of paid claims for therapeutic shoes had missing or inadequate documentation. An audit of beneficiaries found that 3% did not report having diabetes, 12% did not report any of the qualifying conditions, and 47% denied having a foot deformity or previous amputation (2). As with any government program, instances of fraud and abuse have been reported. Dr. Comfort shoes paid a fine of $27 million for providing inserts that did not meet Medicare standards (3). A provider in California was accused of entering an extended-care facility and offering free shoes to residents, telling them the government wanted them to have shoes. Individuals who did not walk were told the shoes would help them walk (4). To qualify for footwear coverage, Medicare beneficiaries must have diabetes plus one of the following conditions: neuropathy with evidence of callus, previous or current ulcer, previous or current pre-ulcerative callus, previous amputation, foot deformities, or poor circulation. How Medicare defines neuropathy (e.g., does it require an insensitive limb?), pre-ulcerative callus, foot deformity, or poor circulation is unclear. The Centers for Medicare & Medicaid Services requires that the treating physician (MD or DO) must be managing the patient's diabetes under a comprehensive plan of care and must certify that the patient has diabetes and needs therapeutic shoes. Podiatrists, physician's assistants, nurse practitioners, and clinical nurse specialists can write prescriptions for therapeutic footwear. However, certifying physicians must provide documentation that they personally examined a patient's feet or otherwise verify the exam performed by one of these other care providers. This documentation must be kept in the managing physician's patient chart and must be made available to the footwear provider; this practice is sanctioned as a compliant release of information under the federal Health Insurance Portability and Accountability Act. Scientific evidence regarding the benefit of therapeutic footwear is not clear. A meta-analysis demonstrated that therapeutic …