In the United States the prevalence of Diabetes mellitus is
approximately 6.3% of its population or 18 million people and each year over
1 million new cases of Diabetes mellitus are reported. A major adverse
outcome for people with Diabetes mellitus is lower leg amputation. Diabetic
lower extremity sequelae and foot ulcers account for approximately, 15 to 20
percent of hospitalizations during the course of the illness. Diabetic
individuals are at 15 times the risk of experiencing lower extremity
amputations following an initial injury when compared with non-diabetic
individuals. Footwear is a key element in managing the diabetic foot.
Therapeutic footwear protects the foot from external trauma and probably
prevents plantar ulcers by reduction of abnormal pressures. Available
medical literature have shown that protective footwear when available and
when used can prevent re-ulceration in 60-85% of patients with previous foot
ulcers. A proper fitting shoe leads to better treatment results.

The American Diabetes Association drafted the original Diabetes Foot
Disease Prevention Act in 1985 introduce by Representative Chris Smith
(Republican from New Jersey). Its intention was to provide for Medicare
coverage of therapeutic shoes for persons with significant foot disease.
As a result of the Office of Management and Budget questioning the programs
cost-effectiveness, the American Diabetes Association gathered more
information over 2 years describing a cost savings estimate by the
Congressional Budget Office of million dollars. The Medicare
Therapeutic Shoe Bill was passed in 1993.

The Medicare Therapeutic Shoe Bill provides partial reimbursement
for depth shoes, custom molded shoes and shoe inserts or modifications to
those who qualify for part B of Medicare. A physician must certify that a
therapeutic shoe is needed to restore the patient to the previous level of
functioning or impedes risk of developing further problems. Within a
calendar year a patient can receive up to 80% reimbursement of Medicare cost
for one pair of custom molded shoes (including inserts) and two additional
pairs of inserts, or one pair of depth shoes and 3 pairs of inserts.

Once the patient has both the certifying statement and a footwear
prescription has been obtained, the footwear must be fitted to the patient
and furnished by a podiatrist, pedorthist, orthotists, prosthelist, or other
qualified individual.