CurrentUnitedHealthcarePolicy CS095.S

Plagiocephaly and Craniosynostosis Treatment

Defines coverage stance for cranial orthotic devices and references surgical repair guidance for craniosynostosis; applies to UnitedHealthcare standard benefit plans except where state-specific policies exist.

Policy Summary

PayerUnitedHealthcare

PolicyPlagiocephaly and Craniosynostosis Treatment

Policy CodePolicy CS095.S

Change TypeApplication updates and documentation clarification

Effective DateJan 1, 2025

Next Review Date

Key ActionFollow InterQual Durable Medical Equipment, Orthoses, Cranial Remodeling criteria and obtain medical records as needed for prior authorization.

SourceLink

POLICY UPDATE CHANGES

Application: This Medical Policy does not apply to the states listed below; refer to the state-specific policy/guideline, if noted.

Medical records documentation may be required to assess whether the member meets the clinical criteria for coverage but does not guarantee coverage of the service requested.

Class IIFDA classification for cranial orthoses

3-18 moFDA intended age range

InterQualClinical criteria source

21175Referenced surgical code

Policy Summary

PayerUnitedHealthcare

PolicyPlagiocephaly and Craniosynostosis Treatment

Policy CodePolicy CS095.S

Change TypeApplication updates and documentation clarification

Effective DateJan 1, 2025

Next Review Date

Key ActionFollow InterQual Durable Medical Equipment, Orthoses, Cranial Remodeling criteria and obtain medical records as needed for prior authorization.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Medical necessity for cranial orthoses

Covered when ALL of the following are met:

Main coverage: Cranial orthotic devices are proven and medically necessary for treating infants following craniosynostosis surgery OR for nonsynostotic (nonfusion) deformational or positional plagiocephaly.Refer to InterQual CP: Durable Medical Equipment, Orthoses, Cranial Remodeling for specific clinical criteria

For surgical treatment to repair craniosynostosis (CPT 21175), see the Cosmetic and Reconstructive Procedures policy. Repairs or replacements follow the Durable Medical Equipment, Orthotics, Medical Supplies, and Repairs/Replacements policy.

Listing of a code in this policy is for reference only and does not imply that the service described by the code is a covered or non-covered health service. Benefit coverage is determined by applicable federal, state, or contractual requirements and laws and may vary by plan; inclusion of a code in this document does not guarantee reimbursement or payment. Other policies and guidelines may apply and should be consulted as needed.

When determining medical necessity for cranial orthoses, coverage follows the clinical criteria referenced from InterQual® Durable Medical Equipment, Orthoses, Cranial Remodeling. Specific conditions that would be considered Not Medically Necessary or that require additional clinical detail are governed by those InterQual criteria; the policy does not list explicit NMN conditions itself and requests that InterQual be consulted for the additional specificity needed for coverage decisions.

Coding and Regulatory Details

CDT Codesmixed

D5924

Cranial prosthesis

HCPCS/CDT Orthotic CodesHCPCS

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)

Referenced CPT for surgical repairCPT

21175

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

FDA age range

FDA intended age range3–18 months

FDA device classificationClass II (special controls required; prescription use, biocompatibility testing, labeling)

Indication per FDA wordingIntended to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry and/or shape

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization and Clinical Criteria Reference

Prior authorization may be required. Refer to InterQual CP: Durable Medical Equipment, Orthoses, Cranial Remodeling for medical necessity criteria and prior authorization guidance for cranial orthoses and related services.

See Medical Policy titled Cosmetic and Reconstructive Procedures for surgical repair (CPT 21175).
See Medical Policy titled Durable Medical Equipment, Orthotics, Medical Supplies, and Repairs/Replacements for repair or replacement of cranial orthoses.

Note

Provider note: follow the source guidance when submitting requests and retain any original documentation used to support clinical necessity determinations.

Documentation Required

Medical Records May Be Required

Medical records documentation may be required to verify that clinical criteria are met during review. Submission of records does not guarantee coverage; benefit determination is subject to contract, state, and federal requirements.

Billing Rule

Codes Listed for Reference Only

Code listing is informational only and does not guarantee coverage or payment. Benefit coverage is determined by federal, state, or contractual requirements and applicable laws; other policies may apply.

Examples from source: CDT D5924 (Cranial prosthesis), L0112, L0113, S1040

Background

Craniosynostosis is the premature fusion of one or more cranial sutures and may require surgical repair in affected infants. By contrast, nonsynostotic positional plagiocephaly is a deformation of skull shape without suture fusion. Cranial orthoses are rigid pediatric cranial remolding devices intended to apply pressure to prominent regions of an infant’s cranium to improve symmetry and shape; they are used for infants with moderate to severe nonsynostotic positional plagiocephaly and for cranial remodeling following surgery. The U.S. Food and Drug Administration classifies these devices as Class II and the typical intended age range noted is 3–18 months.

Definitions

Definition of cranial orthoses (FDA Class II pediatric cranial remolding devices)

DefinitionRigid pediatric cranial remolding devices intended to apply pressure to prominent regions of an infant's cranium to improve symmetry and shape

FDA classificationClass II device (requires special controls including prescription use, biocompatibility testing, and labeling)

Typical clinical useFor infants with moderate to severe nonsynostotic positional plagiocephaly and for postoperative cranial remodeling following craniosynostosis surgery

Regulatory referenceFDA product code MVA; multiple cranial orthoses approved (see FDA PMN database)

OpenPayer

Plagiocephaly and Craniosynostosis Treatment

Coverage Criteria for Cranial Orthoses

Coding and Regulatory Details

Provider Actions, Authorization, and Documentation

Background

Definitions