CurrentUnitedHealthcarePolicy 2025T0031FF

Plagiocephaly and Craniosynostosis Treatment

This policy governs coverage and clinical guidance for evaluation and treatment of plagiocephaly and craniosynostosis, including use of cranial orthoses and references to surgical repair, for UnitedHealthcare members to whom the policy applies.

Policy Summary

PayerUnitedHealthcare

PolicyPlagiocephaly and Craniosynostosis Treatment

Policy CodePolicy 2025T0031FF

Change TypeNo material changes

Effective DateMay 1, 2025

Next Review Date

Key ActionObtain prior authorization or medical policy referral for surgical repair of craniosynostosis and follow the referenced InterQual criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

05/01/2025policy effective date

FDA Class IIclassification

InterQualsurgical criteria

Coverage Criteria

Coverage references and device intent

Policy references external surgical criteria and provides FDA device intent and age range for cranial orthoses.

Policy Summary

PayerUnitedHealthcare

PolicyPlagiocephaly and Craniosynostosis Treatment

Policy CodePolicy 2025T0031FF

Change TypeNo material changes

Effective DateMay 1, 2025

Next Review Date

Key ActionObtain prior authorization or medical policy referral for surgical repair of craniosynostosis and follow the referenced InterQual criteria.

SourceLink

On This Page

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Cranial orthosis use: Cranial orthoses are FDA Class II prescription devices intended to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry and/or shape in infants aged 3 to 18 months with moderate to severe nonsynostotic positional plagiocephaly (including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads).age 3-18 months

Device classification and intended use are informational; coverage determination remains subject to the member's benefit plan and applicable policies (including Durable Medical Equipment, Orthotics, Medical Supplies, and Repairs/Replacements).

Coding

CDT/HCPCS referenced codes for cranial devicesmixed

D5924	Cranial prosthesis
L0112	Cranial cervical orthosis, congenital torticollis type, with or without soft interface material, adjustable range of motion joint, custom fabricated
L0113	Cranial cervical orthotic, torticollis type, with or without joint, with or without soft interface material, prefabricated, includes fitting and adjustment
S1040	Cranial remolding orthotic, pediatric, rigid, with soft interface material, custom fabricated, includes fitting and adjustment(s)

Surgical CPTCPT

21175

Surgical treatment to repair craniosynostosis (refer to Cosmetic and Reconstructive Procedures policy)

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for surgical treatment to repair craniosynostosis (CPT 21175). Refer to the Medical Policy titled Cosmetic and Reconstructive Procedures for prior authorization submission requirements and clinical criteria. For repair or replacement of cranial orthoses, see the Medical Policy titled Durable Medical Equipment, Orthotics, Medical Supplies, and Repairs/Replacements for applicable prior authorization and coverage rules.

Surgery prior authorization required for CPT 21175 per referenced policy
Repairs/replacements of cranial orthoses subject to DME policy rules

Note

Device Prescription Context (FDA)

Cranial orthoses are FDA-classified prescription devices (Class II) intended for infants approximately 3 to 18 months with moderate to severe nonsynostotic positional deformity. Device selection and fitting must follow the manufacturer's prescription, labeling, and instructions, and prescribing clinicians should document medical necessity and device details in the medical record.

Intended age range: infants 3 to 18 months
Indication: moderate to severe nonsynostotic positional plagiocephaly/brachycephaly/scaphocephaly
Device is prescription-only per FDA special controls

Documentation Required

Medical Records for Review

Documented medical records must support any request for coverage or prior authorization. Include clinical evaluation, onset and severity of head deformity, prior conservative care (positioning, physical therapy) and dates, imaging or specialist consultation if applicable, device prescription details (make/model/size), and operative reports for surgical claims.

Clinical evaluation and severity documentation
Conservative treatments tried and dates (positioning, therapy)
Device prescription details: make/model/size and prescribing clinician
Operative reports and surgeon documentation for CPT 21175

Denial Risk

Coverage Depends on Member Benefit

Inclusion of a code or mention of a service in this policy does not guarantee coverage. Coverage is determined by the member-specific benefit plan document, applicable regulatory requirements, and any other relevant UnitedHealthcare policies. Providers should verify benefits and obtain required authorizations prior to providing services.

Verify member benefits and eligibility prior to service
Policy code lists are informational only and not a guarantee of payment

Definitions

Cranial orthoses — key definition noting FDA Class II, intended age range and purpose

FDA device classificationClass II device requiring special controls (prescription use, biocompatibility testing, and labeling with contraindications, warnings, precautions, adverse events, and instructions)

Intended age rangeInfants 3 to 18 months of age

Intended clinical purposeApply pressure to prominent regions of an infant's cranium to improve cranial symmetry and/or shape

Indicated conditionsModerate to severe nonsynostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads

Regulatory product code referenceProduct code MVA (additional device approvals listed by FDA)

OpenPayer

Plagiocephaly and Craniosynostosis Treatment

Coverage Criteria

Coding

Provider Actions and Requirements

Background

Definitions