441—78.15 (249A) Orthopedic shoes. Payment shall be approved only for depth or custom-molded orthopedic shoes, inserts, and modifications, subject to the following definitions and conditions.
	 78.15(1) Definitions.
“Custom-molded shoe” means a shoe that:
	  1. 	 Has been constructed over a cast or model of the recipient’s foot;
	  2. 	 Is made of leather or another suitable material of equal quality;
	  3. 	 Has inserts that can be removed, altered, or replaced according to the recipient’s conditions and needs; and
	  4. 	 Has some form of closure.
“Depth shoe” means a shoe that:
	  1. 	 Has a full length, heel-to-toe filler that when removed provides a minimum of 3/16 inch of additional depth used to accommodate custom-molded or customized inserts;
	  2. 	 Is made from leather or another suitable material of equal quality;
	  3. 	 Has some form of closure; and
	  4. 	 Is available in full and half sizes with a minimum of three widths, so that the sole is graded to the size and width of the upper portions of the shoe according to the American Standard last sizing schedule or its equivalent.
“Insert” means a foot mold or orthosis constructed of more than one layer of a material that:
	  1. 	 Is soft enough and firm enough to take and hold an impression during use, and
	  2. 	 Is molded to the recipient’s foot or is made over a model of the foot.
	 78.15(2) Prescription. The recipient shall present to the provider a written prescription by a physician, a podiatrist, a physician assistant, or an advanced registered nurse practitioner that includes all of the following:
	  1. 	 The date.
	  2. 	 The patient’s diagnosis.
	  3. 	 The reason orthopedic shoes are needed.
	  4. 	 The probable duration of need.
	  5. 	 A specific description of any required modification of the shoes.
	 78.15(3) Diagnosis. The recipient shall have a diagnosis of an orthopedic, neuromuscular, vascular, or insensate foot condition, supported by applicable codes from the current version of the International Classification of Diseases (ICD). A diagnosis of flat feet is not covered.
	  a.   	 A recipient with diabetes must meet the Medicare criteria for therapeutic depth and custom-molded shoes.
	  b.   	 Custom-molded shoes are covered only when the recipient has a foot deformity and the provider has documentation of all of the following:
	 (1) 	 The reasons the recipient cannot be fitted with a depth shoe.
	 (2) 	 Pain.
	 (3) 	 Tissue breakdown or a high probability of tissue breakdown.
	 (4) 	 Any limitation on walking.
	 78.15(4) Frequency. Only two pairs of orthopedic shoes are allowed per recipient in a 12-month period unless documentation of change in size or evidence of excessive wear is submitted. EXCEPTION: School-aged children under the age of 21 may obtain athletic shoes in addition to the two pairs of shoes in a 12-month period.
This rule is intended to implement Iowa Code section 249A.4.