ModifiedPremera BluecrossPolicy 1.01.506

Adjustable Cranial Orthoses for Positional Plagiocephaly and Craniosynostoses

Defines medical necessity, documentation, and coding for use of adjustable cranial orthoses (custom cranial remolding helmets/bands) for postoperative craniosynostosis care and for treatment of positional plagiocephaly/brachycephaly in pediatric patients; intended for providers and payers.

Policy Summary

PayerPremera Bluecross

PolicyAdjustable Cranial Orthoses for Positional Plagiocephaly and Craniosynostoses

Policy CodePolicy 1.01.506

Change TypeAdded second-orthosis provisionclarified postoperative indication

Effective DateMay 1, 2026

Next Review Date

Key ActionObtain prior authorization for custom cranial remolding orthoses (HCPCS S1040) and document medical necessity, including a 2‑month trial of repositioning/physical therapy when applicable.

SourceLink

POLICY UPDATE CHANGES

Added policy statement allowing a second cranial orthosis for persistent plagiocephaly after 2 months of use of the initial orthosis when criteria are met.

Clarified that a cranial orthosis is considered medically necessary following cranial vault remodeling surgery for synostosis apart from any age criterion.

3-18 moage range for medical necessity for plagiocephaly

≥10 mmthreshold for severe plagiocephaly

S1040HCPCS code (custom orthosis)

2 mo

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required conservative trial

NMIuse without prior cranial vault remodeling for synostosis

Coverage Criteria

Replacement/Second device

Covered when ALL of the following are met

Second cranial orthosis: A second cranial orthosis may be considered medically necessary after two months of use of the initial cranial orthosis if documentation shows there are skin complications or head growth that cannot be managed with refitting of the original orthosis.

Added effective Feb 6, 2026 per history entry.

Postoperative orthosis (craniosynostosis)

Covered when ALL of the following are met:

Postoperative orthosis after craniosynostosis surgery: Individual has open or endoscopic cranial vault remodeling surgery for craniosynostosis and receives a postoperative cranial orthosis to facilitate remodeling

Evidence (case series) supports use; policy states orthosis is considered medically necessary postoperatively regardless of age.

Helmet therapy for positional plagiocephaly

Covered when ALL of the following are met:

Positional plagiocephaly helmet therapy: Infant has persistent moderate to severe positional plagiocephaly or brachycephaly after an adequate course of conservative treatment (a documented 2-month trial of repositioning and/or physical therapy) or presents at an advanced age; AND device is custom made and fitted; AND child is aged 3 to 18 monthsmoderate to severe

Moderate to severe defined by anthropometric measures (≥ 10 mm asymmetry in cranial vault, skull base, or orbitotragial depth) OR cephalic index ≥ 2 standard deviations from mean for age/gender. Guideline (Congress of Neurological Surgeons) provides level II recommendation; overall evidence insufficient to demonstrate improved net health outcome.

Second cranial orthosis

Covered when ALL of the following are met:

Second orthosis for persistent plagiocephaly: A second cranial orthosis may be considered medically necessary for treatment of persistent plagiocephaly after 2 months of use of the initial cranial orthosis when policy criteria are metafter 2 months of use

History notes addition effective Feb 6, 2026.

Use of an adjustable cranial orthosis for synostosis in the absence of prior cranial vault remodeling surgery is not medically necessary. The policy specifies that postoperative orthosis use may be considered medically necessary only following cranial vault remodeling surgery for craniosynostosis; use when that surgery has not been performed is excluded.

Use of an adjustable cranial orthosis for indications not described in this policy is not medically necessary. The policy limits coverage to postoperative care after cranial vault remodeling for synostosis and to specified cases of persistent, severe positional plagiocephaly or brachycephaly that meet the stated criteria.

Use of cranial orthoses for positional plagiocephaly is not supported by sufficient evidence to demonstrate improvement in net health outcomes in the general population of affected infants. Coverage may be limited or denied unless the infant meets the policy’s explicit criteria for helmet therapy (for example, persistent moderate to severe deformity after an adequate course of conservative measures).

An adjustable cranial orthosis for synostosis when cranial vault remodeling surgery has not been performed is considered not medically necessary. All other uses that are not specifically identified as medically necessary in the policy are likewise not covered.

Cranial orthosis therapy for positional plagiocephaly that does not meet the policy criteria is not covered. The policy requires documentation of persistent deformity after a documented two‑month trial of repositioning and/or physical therapy and fulfillment of the anthropometric or age-based thresholds before orthosis coverage will be considered.

Coding and Measurement Criteria

Covered HCPCS CodesHCPCSCovered

S1040

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

Regulatory codesmixed

FDA product code MVA

Cranial orthoses (helmets) cleared via 510(k)

Prior authorization / affected billing codesmixed

affected codes

Policy references requiring prior authorization and coverage criteria (specific CPT/HCPCS codes listed elsewhere in policy not present in this document segment).

Anthropometric asymmetry — thresholds

Anthropometric asymmetry threshold10 mm or more of asymmetry in one of the following measures: cranial vault, skull base, or orbitotragial depth

Cephalic index abnormal thresholdCephalic index at least two standard deviations above or below the mean for the appropriate gender and age

Measurement methodsAnthropometric measures defined as cranial vault, skull base, or orbitotragial depth differences calculated from specified craniofacial landmarks

Cephalic index calculation(Head width [eu-eu] × 100) ÷ Head length (g–op); abnormal if ≥2 SD from mean (Farkas and Munro, 1987)

Provider Actions, Prior Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for custom cranial remolding orthoses billed with HCPCS S1040. The provider must document that medical necessity criteria are met and include required supporting documentation (see Documentation Requirements).

Prior authorization required for HCPCS S1040
Provider must document medical necessity criteria

Step Therapy

Conservative Therapy Prerequisite

A 2-month trial of conservative therapy — repositioning and/or physical therapy — is required and must be documented before approval of a cranial orthosis for positional plagiocephaly or brachycephaly without synostosis. Documentation should show the trial duration and response to therapy.

Conservative therapy trial: minimum 2 months of repositioning and/or physical therapy
Required documentation: evidence of trial duration and clinical response

Background

Plagiocephaly refers to flattening or asymmetry of an infant’s skull often related to positioning. It is typically not associated with developmental impairment. Cranial orthoses (helmets or adjustable bands) are designed to apply passive pressure to remodel skull shape. For craniosynostosis—premature fusion of cranial sutures—surgical cranial vault remodeling is often required to address potential functional deficits; when such surgery is performed, a postoperative cranial orthosis may be considered medically necessary to assist remodeling and protect the postoperative result.

Definitions

Plagiocephaly — definition

DefinitionFlattening of the skull on the back or on one side of the head (positional plagiocephaly)

Typical causeOften related to infant positioning and typically nonsynostotic

Treatment context in policyMay be considered for a custom cranial orthosis when persistent and meeting severity, age, and conservative-therapy failure criteria

Craniosynostosis / Synostosis — definition

DefinitionFusion of skull bones (premature closure of cranial sutures) — craniosynostosis/synostosis

Clinical significanceCan impair skull growth and often requires cranial vault remodeling surgery; postoperative orthosis may be used

Policy Summary

PayerPremera Bluecross

PolicyAdjustable Cranial Orthoses for Positional Plagiocephaly and Craniosynostoses

Policy CodePolicy 1.01.506

Change TypeAdded second-orthosis provisionclarified postoperative indication

Effective DateMay 1, 2026

Next Review Date

Key ActionObtain prior authorization for custom cranial remolding orthoses (HCPCS S1040) and document medical necessity, including a 2‑month trial of repositioning/physical therapy when applicable.

SourceLink

On This Page

Documentation Required

Required Documentation

Medical records must document that one of the following is present: (1) postoperative need after craniosynostosis surgery for postoperative care, or (2) persistent positional plagiocephaly or brachycephaly without synostosis that meets age and severity criteria and has not responded to a 2‑month trial of conservative therapy. Include measurements demonstrating asymmetry (e.g., ≥10 mm asymmetry in cranial vault, skull base, or orbitotragial depth, or cephalic index ≥2 SD from the mean) and device details (custom fabrication and fitting).

Document diagnosis: craniosynostosis with surgery OR positional plagiocephaly/brachycephaly without synostosis
Age documented: 3–18 months for plagiocephaly/brachycephaly cases
Severity measurements: ≥10 mm asymmetry OR cephalic index ≥2 SD from mean
Device documented as custom made and fitted

Denial Risk

Denial Triggers and Risk

Use of an adjustable cranial orthosis for synostosis in the absence of cranial vault remodeling surgery is considered not medically necessary and may be denied. Use of cranial orthoses for positional plagiocephaly without meeting the above criteria (including the conservative therapy prerequisite and severity/age requirements) is not supported by sufficient evidence and may be denied.

Not medically necessary: orthosis for synostosis without cranial vault remodeling surgery
Denial risk when conservative therapy not documented or severity/age criteria not met

Policy noteUse of an adjustable cranial orthosis is medically necessary only following cranial vault remodeling surgery; use without prior surgery is not medically necessary

Brachycephaly — definition

DefinitionShortened front-to-back dimension of the skull (brachycephaly)

CausesMay result from premature fusion of the coronal suture or from positional factors

Policy contextBrachycephaly without synostosis may be considered for a custom cranial orthosis if severe and other criteria met

Cephalic index — definition & abnormal threshold

DefinitionRatio of head width to head length used to evaluate cranial shape (cephalic index)

Calculation(Head width [eu–eu] × 100) ÷ Head length (g–op)

Abnormal thresholdConsidered abnormal if the cephalic index is at least two standard deviations above or below the mean for age and gender

Cranial orthosis — device definition

DefinitionA cranial orthosis is a helmet or adjustable band intended to apply passive pressure to prominent regions of an infant's cranium to improve cranial symmetry and/or shape

Regulatory noteMultiple devices have FDA 510(k) clearance (FDA product code MVA) and are typically labeled for ages 3–18 months

Clinical intentDesigned to remodel skull shape in infants with moderate to severe nonsynostotic positional plagiocephaly or brachycephaly

Helmet therapy recommendation — guideline note

Guideline recommendationConsider helmet (cranial orthosis) therapy for infants with persistent moderate to severe plagiocephaly after a course of conservative treatment (repositioning and/or physical therapy)

Supporting evidence levelCongress of Neurological Surgeons guideline provided level II recommendations based on RCTs and comparative studies

Policy applicationPolicy requires an adequate (2‑month) trial of conservative measures before approving helmet therapy for positional plagiocephaly