CurrentUnitedHealthcarePolicy CS095PA.S

Plagiocephaly and Craniosynostosis Treatment (for Pennsylvania Only)

Defines UnitedHealthcare coverage rationale and documentation requirements for cranial orthotic devices and related surgical referrals for members in Pennsylvania; applies to providers requesting services for infants with plagiocephaly or craniosynostosis in PA.

Policy Summary

PayerUnitedHealthcare

PolicyPlagiocephaly and Craniosynostosis Treatment (for Pennsylvania Only)

Policy CodePolicy CS095PA.S

Change TypeDocumentation requirements added

Effective DateMay 1, 2026

Next Review Date

Key ActionProvide complete medical record documentation (history, exam, and diagnostic test results) to support medical necessity and make it available upon request.

SourceLink

POLICY UPDATE CHANGES

Added detailed language about medical records documentation requirements that must support medical necessity and may be requested for review.

Class IIFDA device classification for cranial orthoses

3-18 monthsAge range indicated by FDA for cranial orthosis use

4Applicable codes referenced (examples)

PennsylvaniaGeographic applicability

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Coverage Criteria for Cranial Orthoses

Medical Necessity Coverage

Covered when meeting medical necessity and referenced criteria:

Medical Necessity Coverage: Cranial orthotic devices are considered proven and medically necessary for infants following craniosynostosis surgery OR for nonsynostotic (deformational or positional) plagiocephaly when clinical coverage criteria are met per InterQual CP: Durable Medical Equipment, Orthoses, Cranial Remodeling.see InterQual criteria

Refer to InterQual for specific clinical thresholds and narrative criteria; surgical repair (CPT 21175) is addressed under the Cosmetic and Reconstructive Procedures policy.

Coverage of cranial orthotic devices is based on established medical necessity criteria. Cranial orthoses are considered proven and medically necessary for infants following craniosynostosis surgery and for infants with nonsynostotic (deformational or positional) plagiocephaly when the clinical coverage criteria are met. For the specific clinical thresholds and narrative criteria that determine medical necessity, providers must refer to InterQual® CP: Durable Medical Equipment, Orthoses, Cranial Remodeling.

This policy does not list specific examples of conditions or situations that are explicitly categorized as not medically necessary. Instead, coverage determinations follow the InterQual criteria and related UnitedHealthcare medical policies. For surgical repair of craniosynostosis (CPT 21175) see the Medical Policy titled Cosmetic and Reconstructive Procedures (for Pennsylvania Only), and for repair or replacement of cranial orthoses refer to the Medical Policy titled Durable Medical Equipment, Orthotics, Medical Supplies, and Repairs/Replacements (for Pennsylvania Only).

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization and Applicable Codes

Prior authorization and the policy’s medical necessity criteria control coverage determination. Refer to InterQual® CP: Durable Medical Equipment, Orthoses, Cranial Remodeling for the clinical criteria that govern approval.

Prior authorization may be required per member contract and state-specific requirements.
Applicable HCPCS codes (e.g., D5924, L0112, L0113, S1040) are provided for reference; listing does not guarantee coverage.

Note

Provider Action — Prior Authorization Submission

Submit a complete prior authorization request when seeking coverage for cranial orthoses or post‑operative cranial devices. Include the clinical rationale tying the request to the InterQual criteria and reference any related UnitedHealthcare medical policies (for repairs/replacements or surgical CPTs where applicable).

If the request is for craniosynostosis surgery (e.g., CPT 21175), consult the Cosmetic and Reconstructive Procedures policy (Pennsylvania only) as applicable.
For repairs or replacements, consult the Durable Medical Equipment, Orthotics, Medical Supplies, and Repairs/Replacements policy (Pennsylvania only).

Documentation Required

Required Medical Records Documentation

The member’s medical record must contain documentation that fully supports medical necessity for the requested device or service. Required elements should be legible, maintained in the patient’s record, and made available upon request.

Relevant medical history documenting the condition and prior conservative management (if applicable).
Focused physical examination findings describing head shape, asymmetry, or signs related to craniosynostosis or deformational plagiocephaly.
Results of pertinent diagnostic tests or imaging (e.g., skull radiographs, CT, or specialist assessments) when used to support the diagnosis.
Operative reports when the device is requested post‑surgically.
Notes linking the requested device to the InterQual clinical criteria for cranial remodeling.

Denial Risk

Documentation-Related Denial Risk

Coverage decisions may be denied if the medical record does not support the medical necessity criteria. Ensure documentation explicitly demonstrates how the request meets the InterQual criteria and any state or contract-specific coverage mandates.

Absence of relevant history, exam findings, or diagnostic test results increases risk of denial.
Incomplete, illegible, or unavailable records at the time of review may result in denial of the request.

Key Definitions

Cranial orthoses — definition and FDA classification

Device descriptionDevice intended to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry and/or shape; intended for infants approximately 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly (including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads)

FDA classificationU.S. Food and Drug Administration (FDA) classifies cranial orthoses as Class II devices (product code MVA)

Regulatory controlsClass II classification requires special controls including prescription use, biocompatibility testing, and labeling (contraindications, warnings, precautions, adverse events, and instructions for physicians and parents)

Intended age range3 to 18 months of age

Reference for product codeAdditional information available under FDA product code MVA (link provided in source)

Craniosynostosis surgical repair (CPT 21175) — definition and referral

Procedure definitionSurgical treatment to repair craniosynostosis (CPT code 21175)

Coverage routingFor CPT 21175, refer to the Medical Policy titled 'Cosmetic and Reconstructive Procedures (for Pennsylvania Only)' for coverage details

Related policy referencesSee also Durable Medical Equipment, Orthotics, Medical Supplies, and Repairs/Replacements policy for repair or replacement of cranial orthoses

Clinical criteria noteCranial orthotic devices are considered medically necessary for infants following craniosynostosis surgery when criteria are met; InterQual CP: Durable Medical Equipment, Orthoses, Cranial Remodeling provides clinical coverage criteria

OpenPayer

Plagiocephaly and Craniosynostosis Treatment (for Pennsylvania Only)

Coverage Criteria for Cranial Orthoses

Applicable Codes and Coding References

Provider Actions, Authorization, and Documentation

Background and Clinical Context

Key Definitions

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).