CurrentUnitedHealthcarePolicy CSOISLA J

Plagiocephaly and Craniosynostosis Treatment (for Louisiana Only)

Defines UnitedHealthcare coverage stance for cranial orthoses (cranial remolding helmets) used to treat infants with plagiocephaly or following craniosynostosis surgery in the state of Louisiana.

Policy Summary

PayerUnitedHealthcare

PolicyPlagiocephaly and Craniosynostosis Treatment (for Louisiana Only)

Policy CodePolicy CSOISLA J

Change TypeRoutine reviewclarified only

Effective DateMar 1, 2025

Next Review Date

Key ActionRefer to InterQual Durable Medical Equipment; Orthoses, Cranial Remodeling for medical necessity criteria when requesting coverage for cranial orthotic devices.

SourceLink

POLICY UPDATE CHANGES

Routine review; no change to coverage guidelines.

Class IIFDA device classification

3–18 moFDA intended age range

S1040, D5924, L0112, L0113Example codes listed

LouisianaPolicy state

Coverage Criteria

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Medically necessary indications

Covered when clinical criteria are met per InterQual and related policies

Covered indications: Cranial orthotic devices are proven and medically necessary for infants following craniosynostosis surgery OR for nonsynostotic (deformational/positional) plagiocephaly.

Refer to InterQual CP: Durable Medical Equipment; Orthoses, Cranial Remodeling for specific medical necessity criteria and to related UnitedHealthcare policies for surgical repair (CPT 21175) and for repair/replacement rules.

The list of procedure and diagnosis codes included in this policy is provided for reference only. Listing a code does not imply that the service described by the code is a covered or non‑covered health service. Benefit coverage and any reimbursement rights are determined by applicable federal or state laws, contractual plan terms, and other UnitedHealthcare policies and guidelines; applicable rules may require coverage for a specific service even if a code appears here.

This policy underwent a routine review on 03/01/2025 with no change to coverage guidelines. There are no explicit statements within this policy labeling items as “not medically necessary”; continue to follow the clinical criteria referenced by this policy when determining medical necessity.

Coding and Billing Codes

CDT / HCPCS referenced codesmixed

D5924	CDT Code D5924 (listed)
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 and adjustment fitting

HCPCSHCPCS

S1040

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

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization and Criteria Reference

Prior authorization and review for cranial orthotic devices is determined using InterQual criteria. Providers must obtain any required prior authorization before providing services. Documentation submitted with authorization requests should clearly demonstrate that the request meets InterQual medical necessity criteria and the member's benefit plan rules.

InterQual CP: Durable Medical Equipment; Orthoses, Cranial Remodeling (use for clinical coverage criteria)

Step Therapy

Step Therapy / Medical Necessity

InterQual criteria are used to determine medical necessity for treatment and device coverage. This policy does not establish step therapy specifics; meet InterQual requirements and any applicable benefit rules prior to service.

Documentation Required

Documentation and Benefit Verification

Documentation must support compliance with InterQual medical necessity criteria and the member’s specific benefit plan. This includes clinical records, measurements, prior surgical reports (if applicable), and any other information needed to demonstrate criteria are met. Verify member benefits and eligibility before ordering or providing devices.

Include clinical documentation that addresses InterQual required elements
Confirm benefit coverage and any state or contractual requirements before submitting authorization requests

Billing Rule

Coding Inclusion Is Not a Coverage Guarantee

Listing of procedure, supply, or diagnosis codes in this policy is for reference only and does not guarantee coverage or payment. Coverage is determined by the member’s benefit plan, federal/state law, and contract terms. The inclusion of a code does not imply a right to reimbursement; other policies and guidelines may apply.

Codes (e.g., HCPCS S1040, CDT D5924, L0112, L0113) are provided as examples and do not ensure coverage

Background

Cranial orthotic devices (commonly referred to as cranial remolding orthotics, cranial helmets, or cranial prostheses) are custom or prefabricated devices designed to apply pressure to prominent regions of an infant’s cranium to improve symmetry and head shape. These devices are used to treat deformational (nonsynostotic/positional) plagiocephaly and to support head shape following surgical repair of craniosynostosis. Clinical coverage decisions for cranial orthoses are based on medical necessity criteria referenced in this policy.

Definitions

Cranial orthotic device / cranial remolding orthotic — definition

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

Intended patient age rangeInfants approximately 3 to 18 months of age (per FDA informational guidance)

Device descriptionPediatric rigid cranial remolding orthotic with soft interface material, custom fabricated to apply pressure to prominent regions of an infant's cranium to improve symmetry and shape

Clinical uses citedTreatment of infants following craniosynostosis surgery and treatment of moderate to severe nonsynostotic (deformational/positional) plagiocephaly (plagiocephalic, brachycephalic, scaphocephalic head shapes)

Regulatory noteFDA listing/approval of multiple cranial orthoses; FDA information is informational only and not a basis for coverage determinations

Medical Necessity Determination

DME medical necessity — medical necessity determined by InterQual; summary indication

Medical necessity is determined by InterQual criteria; summary indication provided below.

Indications: Infants post-craniosynostosis surgery OR infants with moderate to severe nonsynostotic positional plagiocephaly (positional deformational head shapes including plagiocephalic, brachycephalic, scaphocephalic).age 3-18 months as per FDA informational guidance

Exact clinical thresholds (severity, age cutoffs, trial of conservative measures) are specified in the InterQual criteria referenced by this policy.

Equipment	Rule
Cranial remolding orthotic (cranial orthosis; cranial helmet)
See Durable Medical Equipment; Orthotics, Medical Supplies, and Repairs/Replacements (for Louisiana Only) for rental versus purchase determination and for repair or replacement rules. Fitting and adjustments are included in the HCPCS S1040 description.

Replacement

Cranial remolding orthotic — replacement rules / key values

Replacement authorityRepair or replacement is governed by the UnitedHealthcare Durable Medical Equipment; Orthotics, Medical Supplies, and Repairs/Replacements policy (see related policy)

Fitting and adjustmentsIncluded in the HCPCS S1040 description (custom fabricated device includes fitting and adjustment(s))

When coveredCovered when medical necessity criteria are met per InterQual (post-craniosynostosis surgery or moderate to severe nonsynostotic plagiocephaly)

Documentation requirementSupportive clinical documentation must demonstrate medical necessity per the InterQual cranial remodeling criteria and be consistent with federal/state/contractual benefit terms

Required Documentation