Non-synostotic Plagiocephaly
Cranial orthotic devices (S1040) used in the treatment of non-synostotic plagiocephaly (754.0) are eligible for reimbursement when ALL of the following criteria are met:

1. The infant must have tried and failed conservative therapy (i.e., repositioning) for a minimum of two months.
2. The infant must be 3 - 18 months of age.
3. The infant must have moderate to severe deformity due to non-synostotic positional plagiocephaly.

Cranial orthosis is considered cosmetic when used in the treatment of non-synostotic plagiocephaly with mild deformity and/or when a minimum trial period of two months of conservative therapy has not been tried. Therefore, these services are not covered. A participating, preferred, or network provider can bill the member for the denied service.

Synostotic Plagiocephaly
Cranial orthotic devices (S1040) used in the post-operative treatment of synostotic plagiocephaly (756.0)(e.g., DOC Band PostOp) are eligible for reimbursement for infants with moderate to severe residual plagiocephaly after surgical correction. A two-month trial of conservative therapy (i.e., repositioning) following surgery must have failed to improve the deformity and must be judged to be unlikely to do so.

When reported as the sole treatment for synostotic plagiocephaly (Craniosynostosis)(756.0), both the helmet (S1040) and the band (S1040) are considered not medically necessary. Effective January 26, 2009, a participating, preferred or network provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost.  The member must agree in writing to assume financial responsibility, in advance of receiving the service.  The signed agreement should be maintained in the provider's records.

Use of this device in the treatment of synostotic plagiocephaly without surgery does not have FDA approval.

NOTE:

Please reference Medical Policy Bulletin E-1 for information on protective helmets.

Coverage for Prosthetics and Orthotics is determined according to individual or group customer benefits.

Description

A cranial orthosis used in the treatment of plagiocephaly is a device intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. Orthotic cranioplasty has been primarily researched as a non-invasive treatment of non-synostotic plagiocephaly. It involves the use of a custom-molded orthotic, either a band or a helmet, to mold the shape of the cranium. Cranial orthotic devices include, but are not limited to, Dynamic Orthotic Cranioplasty (DOC) Band, OPI Band, Hanger Cranial Band, Star Band, and CranioCap.

Plagiocephaly refers to an asymmetrically shaped head. Synostotic plagiocephaly describes an asymmetrically shaped head due to premature closure of the sutures of the cranium. Non-synostotic plagiocephaly, also called positional plagiocephaly, occurs when the sutures remain open. This condition can be secondary to various environmental factors including, but not limited to: premature birth, restrictive intrauterine environment, birth trauma, torticollis, cervical anomalies, and sleeping position.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This medical policy may not apply to FEP.  Medical policy is not an authorization, certification, explanation of benefits, or a contract.  Benefits are determined by the Federal Employee Program.

Consortium Health Plans, Inc.

Analysis of Posterior Plagiocephaly: Deformational vs. Synostotic, Plastic and Reconstructive Surgery, Vol. 103, No. 2, February 1999

Cranial Growth Unrestricted During Treatment of Deformational Plagiocephaly, Pediatric Neurosurg 1999, Vol. 30

Long-Term Developmental Outcomes in Patients with Deformational Plagiocephaly, Pediatrics, Vol. 105, No. 2, February 2000

Dynamic Orthotic Cranioplasty: Treatment of the Older Infant, Neurosurg Focus, Vol. 9, September 2000

Dynamic Orthotic Cranioplasty as a Treatment of Plagiocephaly, Medical Policy Reference Manual, Policy 1.01.11, 04/01/2005

TEC Assessment , Vol. 14, No. 21, February 2000

Early management of craniosynostosis using endoscopic-assisted strip craniectomies and cranial orthotic molding therapy, Pediatrics, 01-JUL-2002; 110(1 Pt 1): 97-104

The misshapen head, Pediatrics,  01-JUL-2002; 110(1 Pt 1): 166-7

Endoscopy-assisted wide-vertex craniectomy, barrel stave osteotomies, and postoperative helmet molding therapy in the management of sagittal suture craniosynostosis,  J Neurosurg, 01-MAY-2004; 100(5 Suppl Pediatrics): 407-17

Design and care of helmets in postoperative craniosynostosis patients: our personal approach, Clin Plast Surg, 01-JUL-2004; 31(3): 481-7, vii

The circle of sagittal synostosis surgery, Semin Pediatr Neurol, 01-DEC-2004; 11(4): 243-8