Rule 5160-10-31 | DMEPOS: footwear and foot orthoses.
(A) Orthopedic shoes.
(1) No particular form or format is specified for the certification of medical necessity.
(2) Payment may be made for an orthopedic shoe only if at least one of the following conditions is met:
(a) The shoe is an integral part of an orthotic device (brace);
(b) The shoe has been molded specifically for the individual;
(c) The shoe is one of a mismated pair;
(d) The shoe is used to treat talipes equino varus (club foot);
(e) For an individual younger than eight years of age, the shoe is used independently of an orthotic device for one of the following purposes:
(i) Treatment of metatarsus adductus, femoral torsion, tibial torsion, vertical talus, fracture of a major bone, or osteochondrosis; or
(ii) Post-surgical control;
(f) For an individual eight years of age or older, the shoe is used for treatment of moderate or severe peripheral neuropathy or peripheral arterial disease; or
(g) A modification or addition to the shoe is medically necessary and has been prescribed by a physician, an advanced practice registered nurse, or a physician assistant.
(3) Greater frequency of shoe replacement may be allowed for individuals younger than eight years of age. Payment for shoe replacement beyond an established frequency for individuals younger than twenty-one years of age is subject to prior authorization (PA).
(4) No payment is made for an orthopedic shoe that is to be worn over a prosthesis.
(5) Payment for a foot orthosis includes the acquisition (by casting or other means) of the model on which the orthosis is constructed.
(B) Specialized non-orthopedic shoes. Payment may be made for a specially constructed non-orthopedic shoe for an individual younger than twenty-one years of age only if both of the following conditions are met:
(1) The shoe is to be worn over an orthotic device; and
(2) Commercially available shoes that fit over the orthotic device would be unacceptably long or otherwise ill-suited to ambulation.
(C) Therapeutic footwear for individuals with diabetes.
(1) The default certificate of medical necessity (CMN) form is the ODM 01912, "Certificate of Medical Necessity: Therapeutic Footwear for Individuals with Diabetes" (rev. 7/2018). The CMN includes an attestation that all of the following statements are true:
(a) The individual has diabetes mellitus;
(b) The conditions of coverage are met;
(c) The prescriber is treating the individual for diabetes under a comprehensive plan of care;
(d) Therapeutic footwear is medically necessary for the individual because of diabetes; and
(e) All relevant information is documented in the individual's medical record.
(2) Therapeutic footwear may be prescribed only by a podiatrist, pedorthist, orthotist, prosthetist, or other qualified practitioner who manages the individual's diabetes.
(3) Therapeutic footwear may be fitted and dispensed only by a podiatrist, pedorthist, orthotist, or prosthetist.
(4) Payment may be made for therapeutic footwear (shoes, inserts, or shoe modifications) only if the individual has diabetes mellitus and at least one of the following conditions is met:
(a) Either an entire foot or part of either foot has been amputated; or
(b) In either foot, the individual has a history of ulceration, pre-ulcerative calluses, peripheral neuropathy with evidence of callus formation, foot deformity, or poor circulation.
(5) Payment may be made for a custom-molded shoe only if the individual has a foot deformity that cannot be accommodated by a depth shoe. The nature and severity of the deformity is to be well documented in the provider's records. If there is insufficient evidence of need for a custom-molded shoe, then payment will be limited to the cost of the least expensive medically appropriate alternative.
(6) No payment is made for the following items:
(a) Inserts that are compression-molded to the foot over time by the heat and pressure of being worn inside a shoe;
(b) Inserts used in noncovered shoes; and
(c) Deluxe features.
(7) Payment for a therapeutic shoe includes fitting, necessary inserts, and any necessary modification. Separate payment may be made for inserts if the provider confirms in writing that the individual has appropriate footwear meeting the industry definition of a depth or custom-molded shoe, into which the insert can be placed.
Last updated January 2, 2024 at 8:59 AM
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