5160-10-35. DMEPOS: cranial remolding devices


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  • (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


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