The custom post-operative cranial remolding orthosis (cranial helmet) is a Class II device regulated by the FDA, which requires stringent quality, safety, and labeling information. Cranial helmets can only be manufactured by companies that have 510k clearance from the FDA. In June of 2009, Orthomerica Products, Inc was awarded FDA clearance for its cranial helmets. It is important to note that the FDA does not consider these devices to be investigational.

Your infant’s cranial helmet treatment will be provided by the STAR Cranial Center of Excellence. The STAR Cranial Center of Excellence exclusively utilizes cranial helmets manufactured by Orthomerica Products, Inc, the largest cranial remolding manufacturer in the world. Currently, Orthomerica is one of only two manufacturers that have FDA clearance to fabricate cranial helmets. These highly specialized custom cranial helmets require multiple design options, clinical expertise, and technology in order to achieve optimal clinical outcomes for this vulnerable patient population. The STAR Cranial Center of Excellence has a working relationship with UT Health Science Center (UTHSC) but is not associated with UTHSC.

Initial Consultation and Evaluation

The initial consultation and evaluation appointment can take up to one hour. During this appointment, your infant will be seen by a STAR Cranial Remolding Specialist, and a quick scan will be taken with the STARscanner laser data acquisition system to collect detailed anthropometric measurements. These measurements will illustrate the asymmetries and variances in your infant’s head shape, as well as, compare and document your infant’s head shape improvements throughout the treatment process.

The STARscanner was cleared by the FDA as an accessory to manufacture cranial helmets and replaces the traditional casting process. It utilizes eye-safe lasers and digital cameras to capture an infant’s 3D head shape data in less than two seconds. The STARscanner provides more accurate measurements than traditional manual measurements. In addition, the STARscanner produces detailed reports that are helpful in analyzing infant head shape changes over time.

Initial Fitting of the Post-Op Cranial Remolding Orthosis (Cranial Helmet)

The initial fitting appointment may take up to one hour. During this visit, the STAR Cranial Remolding Specialist will fit your infant with their custom cranial helmet, evaluate the fit, and make any necessary adjustments to ensure proper fit. Parents/caregivers will also be educated on how to help prevent skin irritations, wearing instructions, and care of the cranial helmet.

Follow-up Appointments

A follow-up appointment is typically scheduled 1-2 weeks following the initial fitting to ensure appropriate fit and functionality of the cranial helmet.

Subsequent Follow-up Appointments

Follow-up appointments are scheduled regularly to adjust the overall fit and functionality of the orthosis. An infant's skull is very malleable allowing for rapid growth during the first year of life. As a result, comprehensive supervision of the orthotic treatment is critical to promote symmetrical growth and prevent any unwanted skin irritations.

Since infants are rapidly growing at this stage in life, additional unscheduled visits may be necessary to address any areas of redness, swelling, or unwanted pressure. 

Insurance Claims Processing and Submission

Some insurance companies require pre-certification or pre-authorization before we can order the cranial helmet. This will depend on the benefits, coverage, deductible, and co- insurance of your specific health plan. Please note that pre-authorization is not a guarantee of payment and is subject to your Medical Policy Guidelines! In many cases, custom orthotic devices fall under the benefit category Durable Medical Equipment (DME). Please check with your insurance provider to see if custom cranial helmets billed under HCPCS code S1040 are covered under your medical benefits. The STAR Cranial Center works with many commercial and Medicaid insurance carriers to minimize your out-of-pocket expenses. Since our list of contracted insurance carriers may change, please contact us for more information regarding your insurance plan and benefits.

Insurance Approval

Cranial helmets must be fit within one week of surgery for optimal clinical outcomes. Since it is very possible that some insurance companies require up to 30 days for authorization, it is likely that you will need to make financial arrangements prior to ordering the cranial helmet. If you pay for the cranial helmet and the STAR Cranial Center also receives payment from your insurance company, a refund check will be issued to the appropriate party.

Insurance Denial  

Payment in full will be expected at the time of order for each cranial helmet if pre-authorization or pre-certification is not approved by the insurance. The STAR Cranial Center also offers interest-free financing options using Care Credit to minimize your out-of-pocket expenses if approved by Care Credit. If requested, the STAR Cranial Center will file a courtesy claim to your insurance company. The STAR Cranial Center will provide you with all the necessary information to help you get reimbursed from your insurance company. However, it is your responsibility to be proactive and follow up with your insurance company since you or your spouse/guardian are the customer - not the STAR Cranial Center. In some cases, parents work with the Human Resources Department of their employer to assist in these efforts since many health plans are self insured. As a result, they can get denials overturned and approved for payment.

Pricing for the cranial helmet may vary depending on the insurance carrier and your specific benefits plan, as well as out-of-pocket deductibles/co-payments of your individual policy. We offer a significant discount if multiple helmets are needed for treatment and your insurance company is not contracted with the STAR Cranial Center. Under this program, the price for a cranial helmet is $2,600 each. We accept all major credit cards including Discover, American Express, Visa, MasterCard and Care Credit.

For any further question in regards to the cranial remolding treatment, please contact :
STAR Cranial Center Of Excellence
4204 Gardendale Street, San Antonio, TX 78229
Office:  (210) 615-7827
Toll-Free:   (877) 225-0575