Section 5160-10-35 - DMEPOS: cranial remolding devices(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.Ohio Admin. Code 5160-10-35
Effective: 1/1/2024
Five Year Review (FYR) Dates: 10/17/2023 and 01/01/2029
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 09/01/2011, 07/16/2018