CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Cranial Orthoses (Adjustable) for Positional Plagiocephaly and Craniosynostoses

This policy governs medical coverage and clinical stance on adjustable cranial orthoses (remolding helmets) for treatment of positional plagiocephaly, brachycephaly, and for postoperative use after cranial vault remodeling for craniosynostosis for Blue Cross Blue Shield - Rhode Island members.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyCranial Orthoses (Adjustable) for Positional Plagiocephaly and Craniosynostoses

Policy CodePolicy N/A

Change TypeNo material change

Effective Date02|03|2015

Next Review DateN/A

Key ActionVerify member benefits and eligibility with the provider call center before submitting claims.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

S1040HCPCS code listed

Q67.3, Q75.0Covered ICD-10

Not requiredPrior authorization

510(k)FDA pathway

1Disclaimer present

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Coverage criteria and policy stance

Coverage by indication

Coverage stance differs by indication and product:

Postoperative cranial orthosis for synostosis: Use of an adjustable cranial orthosis may be considered medically necessary following cranial vault remodeling surgery for synostosis.

Evidence supports meaningful improvement in net health outcome after cranial vault remodeling when an orthosis is used postoperatively; orthoses may protect the brain in areas of bony defect and help remodel asymmetries.

Synostosis without surgery: Use of an adjustable cranial orthosis for synostosis in the absence of cranial vault remodeling surgery.

Considered not covered for Medicare Advantage Plans and not medically necessary for Commercial Products due to insufficient evidence to determine effects on health outcomes.

Positional plagiocephaly/brachycephaly: Use of an adjustable cranial orthosis may be considered for treatment of persistent positional plagiocephaly or brachycephaly without synostosis after conservative measures (eg, repositioning, physical therapy) have failed.

Randomized trial data suggest helmets may not differ from the natural course for moderate–severe cases; evidence is limited (adherence issues, lack of data for very severe cases), though professional society input endorses guideline-based use.

Other indications: Use of an adjustable cranial orthosis for indications not outlined above.

Not covered for Medicare Advantage Plans and not medically necessary for Commercial Products because evidence is insufficient to determine effects on health outcomes.

Use of an adjustable cranial orthosis for synostosis without prior cranial vault remodeling surgery is specifically addressed: it is not covered for Medicare Advantage Plans and is considered not medically necessary for Commercial Products due to insufficient evidence regarding effects on health outcomes.

Benefits and eligibility for services described in this policy are determined by the member's subscriber agreement, member certificate, and/or employer agreement, which supersede this medical policy. Providers should verify member-specific benefits with the provider call center before delivering services.

Not covered uses include the use of an adjustable cranial orthosis for synostosis in the absence of cranial vault remodeling surgery (not covered for Medicare Advantage; not medically necessary for Commercial Products). In addition, for all other indications not specifically outlined in the coverage criteria, the device is not covered for Medicare Advantage Plans and not medically necessary for Commercial Products.

Billing and coding

Covered HCPCS CodesHCPCSCovered

S1040

Cranial remolding orthosis, rigid, with soft interface material, custom fabricated, includes fitting and adjustment(s).

Covered ICD-10 DiagnosesICD-10Covered

Q67.3
Q75.0

What providers should do

Prior Authorization

Prior authorization review is not required.

Step Therapy

Conservative therapy prior to orthosis

It is estimated that about two-thirds of plagiocephaly cases may auto-correct spontaneously after regular changes in sleeping position or following physical therapy aimed at correcting neck muscle imbalance. A cranial orthotic device is usually requested after a trial of repositioning fails to correct the asymmetry, or if the child is too immobile for repositioning.

Billing Rule

Billing note

Background

Cranial orthoses are adjustable helmets that progressively mold an infant's cranium by applying pressure to areas of prominence and allowing growth in flattened regions. They may be used postoperatively following cranial vault remodeling for synostosis and for persistent positional plagiocephaly or brachycephaly when conservative measures have failed.

Key definitions

inv-16: Craniosynostosis — definition and clinical significance

DefinitionPremature closure of one or more cranial sutures (synostosis) resulting in abnormal skull shape; types include scaphocephaly, trigonocephaly, unilateral coronal synostosis (plagiocephaly), and brachycephaly.

Clinical significanceMay lead to functional deficits from increased intracranial pressure and progressive craniofacial deformity; severity and deformity pattern depend on which suture(s) fuse prematurely.

Common typesScaphocephaly (sagittal suture), trigonocephaly (metopic suture), unilateral coronal synostosis (asymmetric forehead/plagiocephaly), bicoronal synostosis (brachycephaly).

inv-17: Positional (deformational) plagiocephaly — definition and common causes

DefinitionAsymmetric occipital flattening without suture fusion (positional or deformational plagiocephaly), often related to environmental factors.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyCranial Orthoses (Adjustable) for Positional Plagiocephaly and Craniosynostoses

Policy CodePolicy N/A

Change TypeNo material change

Effective Date02|03|2015

Next Review DateN/A

Key ActionVerify member benefits and eligibility with the provider call center before submitting claims.

SourceLink

On This Page

The following HCPCS code(s) is medically necessary when filed with a covered diagnosis: S1040 Cranial remolding orthosis, rigid, with soft interface material, custom fabricated, includes fitting and adjustment(s). Covered ICD-10 Diagnoses: Q67.3, Q75.0

Note

Check member benefits

Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement; those documents supersede this medical policy. For member-specific benefits and verification of eligibility and participation, call the provider call center.

Denial Risk

Coverage limitations

Use of an adjustable cranial orthosis for synostosis in the absence of cranial vault remodeling surgery is not covered for Medicare Advantage Plans and not medically necessary for Commercial Products. For other indications not outlined as covered, the use of an adjustable cranial orthosis is not covered for Medicare Advantage Plans and not medically necessary for Commercial Products.

Denial Risk

Member financial responsibility

If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for applicable provisions.

Supine sleeping position, limited 'tummy time', torticollis, premature birth, restrictive intrauterine environment, birth trauma, cervical anomalies, bottle feeding, low awake prone time, multiple gestation, delayed motor milestones.

Clinical courseOften improves with repositioning and physical therapy; once flattening occurs it may become self-perpetuating because the infant may avoid turning to the opposite side.

inv-18: Cranial molding orthosis (helmet) therapy — definition and guideline references

DefinitionA non‑surgical intervention using an adjustable helmet or band that molds the infant cranium by applying corrective forces to prominences while allowing growth in flattened areas (cranial molding orthosis or helmet therapy).

Indications referencedUsed for positional plagiocephaly and may be used postoperatively after cranial vault remodeling for synostosis; society guidelines and systematic reviews describe its role.

Guideline and evidence sourcesReferenced sources include Congress of Neurological Surgeons guideline and systematic review (Tamber et al. 2016), AAP guidance and multiple systematic reviews and trials cited in references.