Rule 5160-10-35. DMEPOS: cranial remolding devices

119.03 (A) No particular form or format is specified for the certification of medical necessity. (B) Payment may be made only for a cranial remolding device that meets the standards established by the United States food and drug administration for a class II medical device. (C) Payment may be made for the purchase of a cranial remolding device to treat any of the following conditions if the associated criteria are met. (1) Positional (non-synostotic) plagiocephaly: (a) The individual is at least three months old but not older than eighteen months; (b) Any of the following asymmetries is present: (i) A right/left discrepancy in the skull base of at least six millimeters, measured subnasally to the tragus; (ii) A right/left discrepancy in the cranial vault of at least ten millimeters, measured from the frontozygomaticus point to the euryon; or (iii) A right/left discrepancy in the orbitotragial distances of at least four millimeters; and (c) The asymmetry has not substantially improved after two months of conservative cranial repositioning therapy or physical therapy. (2) Positional (non-synostotic) braciocephaly: The cephalic index (the ratio of the maximum width of the head to its maximum length) is greater than ninety-one per cent. (3) Positional (non-synostotic) scaphocephaly: The cephalic index is less than seventy-five per cent. (4) Synostotic deformity: (a) The individual is not older than eighteen months; (b) Premature closing of the cranial structures has been documented; and (c) Surgery with post-operative remolding is medically indicated. Last updated January 2, 2024 at 9:00 AM Supplemental Information Authorized By: 5164.02 Amplifies: 5164.02 1/1/2029