CurrentColorado Rocky Mountain Health PlansPolicy CS095.T

Plagiocephaly and Craniosynostosis Treatment

Coverage policy for use of cranial orthoses and surgical treatment related to plagiocephaly and craniosynostosis for members of Colorado Rocky Mountain Health Plans, with references to state-specific variations.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPlagiocephaly and Craniosynostosis Treatment

Policy CodePolicy CS095.T

Change TypeRoutine reviewtemplate update

Effective DateFeb 1, 2026

Next Review Date

Key ActionObtain prior authorization per InterQual CP criteria and provide medical records documentation when requested to demonstrate the member meets clinical criteria.

SourceLink

POLICY UPDATE CHANGES

Removed content/language pertaining to the state of Louisiana.

Routine review; no content changes. Archived previous policy version CS095.S

Class IIFDA device classification for cranial orthoses

3-18 monthsFDA intended infant age range for cranial orthoses

CS095.TPolicy identifier

InterQualMedical necessity reference

Coverage Criteria

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Medical necessity for cranial orthoses

Covered when ALL of the following are met

Cranial orthoses coverage: Cranial orthotic devices are proven and medically necessary for treating infants following craniosynostosis surgery OR for nonsynostotic (nonfusion) deformational or positional plagiocephaly.

Medical necessity clinical coverage criteria reference InterQual CP: Durable Medical Equipment, Orthoses, Cranial Remodeling.

Surgical treatment

Coding

Applicable HCPCS / D codesHCPCS

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).

inv-06: FDA age range — 3-18 months

FDA intended infant age range3–18 months

FDA device classificationClass II

Indication per device labelingInfants with moderate to severe nonsynostotic positional plagiocephaly

Provider Actions

Prior Authorization

Prior Authorization Required

Prior authorization may be required. Coverage follows the InterQual® CP: Durable Medical Equipment, Orthoses, Cranial Remodeling; submit prior authorization requests per InterQual criteria.

Prior Authorization per InterQual — submit requests according to InterQual CP

Documentation Required

Documentation May Be Required

Medical records documentation may be required to determine whether the member meets clinical criteria for coverage. Provide complete clinical documentation with the prior authorization request or upon request to support medical necessity.

Include relevant history, physical exam findings, imaging, and treatment attempts as applicable

Denial Risk

Documentation-based Denial Risk

Lack of required medical records or insufficient documentation may result in denial of the request. Ensure requested records are submitted timely and meet the Medical Records Documentation guidance.

Documentation-based denial risk — missing or incomplete records can trigger denial

Note

Provider Responsibilities / Related Policies

Provider action related content: follow plan-specific instructions and related policy cross-references (e.g., Cosmetic and Reconstructive Procedures; Durable Medical Equipment, Orthotics, Medical Supplies, and Repairs/Replacements).

Refer to related policies for surgical CPT 21175 and for repairs/replacements

Background

Craniosynostosis is a cranial suture fusion condition that may require surgical repair; treatment related to craniosynostosis surgery can include use of cranial orthoses postoperatively. In contrast, nonsynostotic positional (deformational) plagiocephaly is not caused by suture fusion and is typically managed non-surgically. Cranial orthoses are devices designed to apply corrective pressure to an infant's cranium to improve shape and symmetry and are intended for infants generally within the FDA-labeled age range of 3–18 months for treatment of moderate to severe deformational plagiocephaly.

Definitions

inv-12: Device definition — cranial orthoses description, FDA Class II, intended infant age 3–18 months

Device descriptionDevices intended to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry and/or shape

FDA classificationClass II (special controls: prescription use, biocompatibility testing, labeling requirements)

Intended infant age3–18 months

Clinical indicationModerate to severe nonsynostotic positional plagiocephaly (including plagiocephalic, brachycephalic, scaphocephalic head shapes)

Medical Necessity

Cranial orthoses medical necessity

Cranial orthoses are considered medically necessary when:

General necessity: Used to treat infants after craniosynostosis surgery OR infants with moderate to severe nonsynostotic positional plagiocephaly as defined by InterQual CP: Durable Medical Equipment, Orthoses, Cranial Remodeling.FDA age 3-18 months applies per device labeling

Refer to InterQual for specific measurable criteria.

Rental & Purchase Rules

Equipment	Rule / Reference
Cranial remolding orthotic (S1040)	Refer to the Durable Medical Equipment, Orthotics, Medical Supplies, and Repairs/Replacements policy for repair, replacement, and rental vs. purchase rules (see related policy linkage).
Cranial prosthesis (D5924)	Refer to the Durable Medical Equipment, Orthotics, Medical Supplies, and Repairs/Replacements policy for repair, replacement, and rental vs. purchase rules (see related policy linkage).
Cranial cervical orthosis, congenital torticollis type, custom fabricated (L0112)	Refer to the Durable Medical Equipment, Orthotics, Medical Supplies, and Repairs/Replacements policy for repair, replacement, and rental vs. purchase rules (see related policy linkage).
Cranial cervical orthotic, prefabricated (L0113)	Refer to the Durable Medical Equipment, Orthotics, Medical Supplies, and Repairs/Replacements policy for repair, replacement, and rental vs. purchase rules (see related policy linkage).

Replacement

inv-15: Cranial orthoses — see Durable Medical Equipment, Orthotics, Medical Supplies, and Repairs/Replacements policy

Replacement/repair rules referenceSee Durable Medical Equipment, Orthotics, Medical Supplies, and Repairs/Replacements policy for repair or replacement rules

Related surgical policyFor surgical repair of craniosynostosis (CPT 21175), refer to Cosmetic and Reconstructive Procedures policy

Applicable D/HCPCS codes (see coding section)S1040, D5924, L0112, L0113

Documentation