5101:3-10-35 Cranial orthotic remolding devices.

Any provider seeking reimbursement for this service must meet the provisions contained within Chapter 4779. of the Revised Code in order to be eligible for reimbursement for services provided.

(A) Definitions

(1) A cranial orthotic remolding device is an orthotic helmet that can progressively mold the shape of the cranium. Treatment is typically initiated around five to six months of age and continues for an average of four to six months.

(2) Cephalic index is the ratio of the maximum width of the head multiplied by one hundred divided by its maximum length (i.e., in the horizontal plane, or front to back).

(B) Coverage determination

(1) A cranial orthotic remolding device is covered for treatment of positional (non-synostotic) plagiocephaly only if all of the following criteria are met:

(a) Consumer is at least three months of age but not greater than eighteen months of age; and

(b) Marked asymmetry has not been substantially improved following conservative therapy of at least two months duration with cranial repositioning therapy and/or physical therapy; and

(c) Asymmetry of the cranial base as documented by any of the following:

(i) Skull base asymmetry: At least six millimeter (mm) right/left discrepancy measured subnasally to the tragus, defined as the cartilaginous projection of the auricle at the front of the ear; or

(ii) Cranial vault asymmetry: At least a ten mm right/left discrepancy measured from the frontozygomaticus point (identified by palpation of the suture line above the upper outer corner of theorbit) to the euryon, defined as the most lateral point on the head located in the parietal region; or

(iii) Asymmetry of the orbitotragial distances, as documented by at least a four mm right/left asymmetry.

(2) A cranial orthotic remolding device is covered for treatment of positional (non-synostotic) braciocephaly if the cephallic index is greater than ninety-one per cent.

(3) A cranial orthotic remolding device is covered for the treatment of positional (non-synostotic) scaphocephaly if the cephallic index is less than seventy-five per cent.

(4) A cranial orthotic remolding device is covered for treatment of synostotic deformity if all of the following criteria are met:

(a) Consumer is between the ages of birth and eighteen months; and

(b) Premature closing of the cranial structures is documented by treating prescriber and surgery with post-operative treatment including remolding orthotic helmeting is medically indicated and documented in the consumers medical record.

(5) All documentation supporting the above medical criteria must be kept in the provider's file and be available for review at the request of the Ohio department of job and family services (ODJFS).

(6) Cranial orthotic remolding devices must be prescribed by a prescriber actively involved in managing the consumer's medical care through a comprehensive plan of care which addresses the need for a cranial orthotic remolding device. This prescription must contain the original signature of the ordering prescriber that attests to medical necessity of this device.

(C) Non-coverage determination

A cranial orthotic remolding device is non covered for consumers who cannot document an appropriate medical need based on the provisions of this rule.

(D) Prior authorization

No prior authorization is necessary for the dispensing of a cranial orthotic remolding device.

(E) Dispensing

(1) The following components are considered "inclusive" with any payment made by the department for a cranial orthotic remolding device on behalf of a consumer, cannot be submitted to the department for separate reimbursement and must be dispensed and/or maintained by the billing provider:

(a) Labor;

(b) Orthotic remolding device;

(c) Casting, fitting, or measuring fees;

(d) Charges for travel; and

(e) Charges for shipping and mailing.

(2) Providers must document that the consumer's primary care giver is instructed as to the proper use and wear of the cranial orthotic remolding device and documentation of this instruction must be kept in the provider's file.

(3) Any dispensed cranial orthotic remolding device must be of a type and fabricated at a facility approved for consumer use as an approved class II medical device by the food and drug administration (FDA).

(4) Any provider dispensing and fitting a cranial remolding orthotic device must have the appropriate documentation on file that demonstrates the appropriate training necessary to fit the device properly.

(5) Consumers are eligible for only one cranial orthotic remolding device per lifetime.

(F) Reimbursement

Cranial orthotic remolding devices are reimbursed according to the department fee schedule contained in appendix DD to rule 5101:3-1-60 of the Administrative Code or the providers usual and customary charge, whichever is less.

Effective: 09/01/2011
R.C. 119.032 review dates: 09/01/2016
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01, 5111.02, 5111.021