CurrentUnitedHealthcarePolicy CS095PA.R

Plagiocephaly and Craniosynostosis Treatment (for Pennsylvania Only)

Policy governing coverage and clinical use of cranial orthotic devices (cranial remolding helmets) for infants in Pennsylvania, including post-surgical use following craniosynostosis repair and treatment of nonsynostotic positional plagiocephaly.

Policy Summary

PayerUnitedHealthcare

PolicyPlagiocephaly and Craniosynostosis Treatment (for Pennsylvania Only)

Policy CodePolicy CS095PA.R

Change TypeRevised coding description

Effective DateFeb 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization referencing InterQual clinical criteria and applicable HCPCS/CDT codes (e.g., S1040, L0112, L0113, D5924).

SourceLink

POLICY UPDATE CHANGES

Revised description for HCPCS code S1040.

Class IIFDA device classification

3-18 moIntended age range

S1040, L0112, L0113, D5924Codes listed

PennsylvaniaState applicability

Coverage & Clinical Criteria

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Medical necessity (general)

Covered when ALL of the following are met:

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

Policy references InterQual CP: Durable Medical Equipment, Orthoses, Cranial Remodeling for detailed clinical criteria and applicability.

Coverage determinations for cranial orthotic devices follow the InterQual® clinical coverage criteria referenced in this policy. Medical necessity is determined by meeting those InterQual criteria for Durable Medical Equipment, Orthoses, Cranial Remodeling; services that do not meet InterQual criteria will be reviewed on a case-by-case basis and may be excluded.

This policy does not enumerate specific non-medical-necessity scenarios but makes clear that services failing to meet the InterQual clinical coverage criteria may not be considered medically necessary. Requests that do not meet InterQual criteria will be evaluated individually, and determinations (including denials) will be made on a case-by-case basis.

Billing Codes & Regulatory Info

CDT Codesmixed

D5924

Cranial prosthesis

HCPCS 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)

inv-06: FDA intended age range

FDA intended age range3-18 months

Indicated populationInfants with moderate to severe nonsynostotic positional plagiocephaly and related head shapes (plagiocephalic, brachycephalic, scaphocephalic)

FDA regulatory classClass II device — special controls required (prescription use, biocompatibility testing, labeling)

Provider Requirements & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests will be reviewed using InterQual® CP: Durable Medical Equipment, Orthoses, Cranial Remodeling criteria; submit complete clinical documentation to support medical necessity.

Provider must obtain prior authorization before dispensing cranial orthoses
Include InterQual criteria references and relevant clinical notes/imaging
Affected codes: CDT D5924; L0112, L0113, S1040

Prior Authorization

Provider Submission Requirements

Submit the order, model/measurement details, and fitting notes with the authorization request. Ensure CPT/CDT and supply codes match the product provided.

Attach prescription/order with start date and duration
Include device type (custom vs prefabricated) and fitting/adjustment documentation
List the specific CDT or HCPCS code submitted

Documentation Required

Required Documentation

Documentation supporting medical necessity is required for authorization and claims processing. This includes clinical evaluation, diagnosis (positional plagiocephaly vs craniosynostosis), growth measurements, photographs, and any imaging or surgical reports if applicable.

Clinical evaluation notes with diagnosis and severity
Photographs demonstrating head shape and measurements
Imaging or surgical reports when relevant (e.g., post-craniosynostosis repair)

Denial Risk

Denial Risk if Criteria Not Met

If the InterQual criteria are not met, the request may be denied or reviewed on a case-by-case basis. Failure to provide required documentation or to meet clinical thresholds can result in claim denial.

Denial likely when InterQual clinical criteria are not satisfied
Case-by-case reviews may be performed with additional documentation or peer-to-peer discussion

Definitions & Device Description

inv-12: Cranial orthoses 2d definition and FDA class/intended use

DefinitionCranial orthoses (cranial remolding helmets) are medical devices intended to remodel an infant’s cranium shape by applying pressure to prominent regions of the skull to improve cranial symmetry and/or shape.

FDA class and controlsClass II device; subject to special controls including prescription use, biocompatibility testing, and specific labeling (contraindications, warnings, precautions, adverse events, instructions).

Clinical context for useUsed for infants from 3 to 18 months with moderate to severe nonsynostotic positional plagiocephaly and as medically necessary following craniosynostosis surgery (see InterQual for clinical criteria).

Detailed Medical Necessity Rules

DME medical necessity

Medical necessity requires meeting InterQual clinical coverage criteria and ONE of the following indications:

Indications: Postoperative use following craniosynostosis surgery.

See InterQual CP: Durable Medical Equipment, Orthoses, Cranial Remodeling for clinical applicability and measurement thresholds.

Indications: Moderate to severe nonsynostotic positional (deformational) plagiocephaly, including plagiocephalic, brachycephalic, or scaphocephalic head shapes.

See InterQual for measurement thresholds and timing.

Equipment	Rental / Purchase Rule	Notes
Cranial orthoses (cranial remolding helmets, cranial prosthesis)
refer to Durable Medical Equipment, Orthotics, Medical Supplies, and Repairs/Replacements policy
Coverage and repair/replacement determinations are governed by the referenced DME policy; see InterQual CP: Durable Medical Equipment, Orthoses, Cranial Remodeling for clinical criteria

Replacement & Repair

inv-15: cranial orthoses 2d replacement rules / timeline

Replacement/repair policy referenceRefer to the Medical Policy titled ‘Durable Medical Equipment, Orthotics, Medical Supplies, and Repairs/Replacements (for Pennsylvania Only)’ for repair or replacement timing and rules.

Postoperative useCranial orthoses are recognized as medically necessary for postoperative management following craniosynostosis surgery; replacement needs should follow DME repair/replacement policy and clinical course.

Prior authorization and documentationSubmit clinical documentation per InterQual CP: Durable Medical Equipment, Orthoses, Cranial Remodeling; include applicable device coding when requesting repairs or replacements.

Required Documentation

Documentation Required

Submit InterQual-based clinical documentation with device codes

When submitting documentation, include clinical information in accordance with the InterQual CP and list the applicable HCPCS/CDT codes (S1040, L0112, L0113, D5924) for the device being requested.

Reference InterQual CP: Durable Medical Equipment, Orthoses, Cranial Remodeling in the submission.
Include the specific device codes: S1040; L0112; L0113; D5924.

Background

Cranial orthotic devices (cranial remolding helmets) are medical devices used to apply pressure to prominent regions of an infant's skull to improve cranial symmetry and shape. They are indicated as medically necessary for infants following craniosynostosis surgery and for treatment of moderate to severe nonsynostotic (deformational/positional) plagiocephaly, including plagiocephalic, brachycephalic, and scaphocephalic head shapes. The FDA classifies these devices as Class II and notes they are intended for infants approximately 3 to 18 months of age.

Policy Summary

PayerUnitedHealthcare

PolicyPlagiocephaly and Craniosynostosis Treatment (for Pennsylvania Only)

Policy CodePolicy CS095PA.R

Change TypeRevised coding description

Effective DateFeb 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization referencing InterQual clinical criteria and applicable HCPCS/CDT codes (e.g., S1040, L0112, L0113, D5924).

SourceLink

On This Page

OpenPayer

Plagiocephaly and Craniosynostosis Treatment (for Pennsylvania Only)

Coverage & Clinical Criteria

Billing Codes & Regulatory Info

Provider Requirements & Prior Authorization

Definitions & Device Description

Detailed Medical Necessity Rules

Rental, Purchase & Payment Rules

Replacement & Repair

Required Documentation

Non-Covered Items / Limitations

Background