Ohio Admin. Code 5160-10-35 - DMEPOS: cranial remolding devices

(A) Any cranial remolding device for which payment is requested must meet the standards established by the United States food and drug administration for a class II medical device.
(B) 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.

Replaces: 5160-10-35


Ohio Admin. Code 5160-10-35
Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 09/01/2011

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