Adjustable Cranial Orthoses for Positional Plagiocephaly and Craniosynostoses Corporate Medical Policy File name: Adjustable Cranial Orthoses for Positional Plagiocephaly and Craniosynostoses File code: UM.DME.13 Origination: 11/2011 Last Review: 08/2015 Next Review: 08/2016 Effective Date: 2/1/2016 Description An asymmetrically shaped head may be synostotic or nonsynostotic. Synostosis, defined as premature closure of the sutures of the cranium, may result in functional deficits secondary to increasing intracranial pressure in an abnormally or asymmetrically shaped cranium. The type and degree of craniofacial deformity depends on the type of synostosis. The most common is scaphocephaly, which describes a narrowed and elongated head resulting from synostosis of the sagittal suture, while premature fusion of the metopic suture results in a triangular shape of the forehead known as trigonocephaly. Unilateral synostosis of the coronal suture results in an asymmetric distortion of the forehead termed plagiocephaly, and fusion of both coronal sutures results in brachycephaly. Combinations of these may also occur. Synostotic deformities associated with functional deficits are addressed by surgical remodeling of the cranial vault. The remodeling (reshaping) is accomplished by opening and expanding the abnormally fused bone. Plagiocephaly without synostosis, also called positional or deformational plagiocephaly, 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. Positional plagiocephaly typically consists of right or left occipital flattening with advancement of the ipsilateral ear and ipsilateral frontal bone protrusion, resulting in visible facial asymmetry. Occipital flattening may be self-perpetuating, in that once it occurs, it may be increasingly difficult for the infant to turn and sleep on the other side. Bottle feeding, a low proportion of tummy time while awake, multiple gestations, and slow achievement of motor milestones may contribute to positional plagiocephaly. The incidence of plagiocephaly has increased rapidly in recent years; this is believed to be a result of the Back to Sleep campaign recommended by the American Academy of Pediatrics, in which a supine sleeping position is recommended to reduce the risk of sudden infant death syndrome (SIDS). It is hoped that increasing awareness of identified risk factors and early implementation of good practices will reduce the development of deformational plagiocephaly. It is estimated that about two-thirds of cases may correct spontaneously after regular changes in sleeping position or following physiotherapy aimed at correcting neck Page 1 of 7
muscle imbalance. A cranial orthotic device is usually requested after a trial of repositioning fails to correct the asymmetry, or if the child is too mobile for repositioning. The cranial orthosis, either a helmet or a band, can progressively mold the shape of the cranium. This document addresses the use of the adjustable band or helmet as a postoperative treatment of craniosynostosis or as nonoperative treatment for non-synostotic plagiocephaly (asymmetrically shaped head) and brachycephaly (abnormally shaped head; shortened in antero-posterior dimension without asymmetry) in infants. Such devices may include (may not be all inclusive): Ballert Cranial Molding Helmet Clarren Helmet Cranial Shaping Helmet Cranial Solutions Orthosis CSO Cranial Symmetry System DOC Band Hanger Cranial Band O & P Cranial Molding Helmet P.A.P. Orthosis Plagiocephalic Applied Pressure Orthosis RHS Cranial helmet STARband Cranial Remolding Orthosis STARlight Cranial Remolding Orthosis Static Cranioplasty Orthosis Policy Coding Information Click the links below for attachments, coding tables & instructions. Attachment I- CPT code table & instructions Attachment II- ICD codes When a service may be considered medically necessary The use of an adjustable cranial orthosis is considered medically necessary as part of the post operative management of craniosynostosis. The use of an adjustable cranial orthosis as a treatment for moderate to severe nonsynostotic plagiocephaly may be considered medically necessary as a reconstructive treatment when ALL of the following criteria are met: 1. Patient is at least 3 months of age but not greater than 18 months of age; AND 2. Marked asymmetry has not been substantially improved following conservative therapy of at least 2 months duration with cranial repositioning therapy (with or without physical therapy). Note: Due to the mobility of children > 4 months of age, repositioning therapy is not effective and thus, a trial of repositioning is not indicated; AND Page 2 of 7
3. Asymmetry of the cranial base as documented by any of the following: Skull Base Asymmetry: At least 6 mm right/left discrepancy measured subnasally to the tip of the tragus (cartilaginous projection of the auricle at the front of the ear); or Cranial Vault Asymmetry: At least a 8 mm right/left discrepancy, measured from the frontozygomaticus point (identified by palpation of the suture line above the upper outer corner of the orbit) to the contralateral euryon, defined as the most lateral point on the head located in the parietal region; Asymmetry of the orbitotragial distances, as documented by at least a 4 mm right/left asymmetry measured from the lateral aspect of orbit to tip of ipsilateral tragus. The custom molded orthotic is designed to fit a child s head from 2-4 months. A second helmet or band may be required if the asymmetry has not resolved or significantly improved after 2-4 months. When a service is considered investigational The use of an adjustable cranial orthosis is considered investigational as a treatment of brachycephaly. Benefit Determination Guidance Administrative and Contractual Guidance Prior approval is required and benefits are subject to all terms, limitations and conditions of the subscriber contract. An approved referral authorization for members of the New England Health Plan (NEHP) is required. A prior approval for Access Blue New England (ABNE) members is required. NEHP/ABNE members may have different benefits for services listed in this policy. To confirm benefits, please contact the customer service department at the member s health plan. Federal Employee Program (FEP) members may have different benefits that apply. For further information please contact FEP customer service or refer to the FEP Service Benefit Plan Brochure. Coverage varies according to the member s group or individual contract. Not all groups are required to follow the Vermont legislative mandates. Member Contract language takes precedence over medical policy when there is a conflict. If the member receives benefits through a self-funded (ASO) group, benefits may vary or not apply. To verify benefit information, please refer to the member s plan documents or contact the customer service department. Page 3 of 7
Document Precedence Blue Cross and Blue Shield of Vermont (BCBSVT) Medical Policies are developed to provide clinical guidance and are based on research of current medical literature and review of common medical practices in the treatment and diagnosis of disease. The applicable group/individual contract and member certificate language determines benefits that are in effect at the time of service. Since medical practices and knowledge are constantly evolving, BCBSVT reserves the right to review and revise its medical policies periodically. To the extent that there may be any conflict between medical policy and contract language, the member s contract language takes precedence. Audit Information BCBSVT reserves the right to conduct audits on any provider and/or facility to ensure compliance with the guidelines stated in the medical policy. If an audit identifies instances of non-compliance with this medical policy, BCBSVT reserves the right to recoup all noncompliant payments. Eligible Providers Durable Medical Equipment (DME) suppliers of Prosthetics and Orthotics Related Policies NA Policy Implementation/Update information 11/2011 New policy. Coder reviewed and approved codes. 02/2014 ICD-10 remediation only. RLJ 08/2015 No language updates. No coding changes. RLG Reference Resources BCBSA Policy 1.01.11 Adjustable Cranial Orthoses for Positional Plagiocephaly and Craniosynostoses 1. Balan P, Kushnerenko E, Sahlin P, et al. Auditory ERPs reveal brain dysfunction in infants with plagiocephaly. J Craniofac Surg. 2002; 13(4):520-525. 2. Barringer W. The use of postoperative cranial orthoses in the management of craniosynostosis. J Prosth and Orthotics. 2004; 16(45):56-58. 3. Graham J, Kreutzman J. Deformational Brachycephaly in Supine-Sleeping Infants. Journal of Pediatrics. 2005; 254-257. 4. Gupta PC, Foster J, Crowe S, et al. Ophthalmologic findings in patients with nonsyndromic plagiocephaly. J Craniofac Surg. 2003; 14(4):529-532. 5. Hutchison BL, Hutchison LA, Thompson JM, Mitchell EA. Plagiocephaly and brachycephaly in the first two years of life: a prospective cohort study. Pediatrics. 2004; 114(4):970-980. Page 4 of 7
6. Jimenez DF, Barone CM, Cartwright CC, Baker L. Early management of craniosynostosis using endoscopic assisted strip craniectomies and cranial orthotic molding therapy. Pediatrics. 2002; 110(1):97-104. 7. Joganic EF, Beals SP, Ripley CE, et al. Enhancement of craniofacial reconstruction by dynamic orthotic cranioplasty. In: Marchac D, ed. Craniofacial Surgery. Bologna, Italy: Monduzzi Editore; 1995:151 153. 8. Kabbani H, Raghuveer TS. Craniosynostosis. Am Fam Physician. 2004; 69(12):2863-2870. 9. Kordestani RK, Patel S, Bard DE et al. Neurodevelopmental delays in children with deformational plagiocephaly. Plast Reconstr Surg 2006; 117(1):207-218 10. Littlefield TR, Beals SP, Manwaring KH, et al. Treatment of craniofacial asymmetry with dynamic orthotic cranioplasty. J Craniofacial Surg. 1998; 9(1):11-17. 11. Kaufman BA, Muszynski CA, Matthews A, Etter N. The circle of sagittal synostosis surgery. Semin Pediatr Neurol. 2004; 11(4):243-248. 12. Miller RI, Clarren SK. Long-Term developmental outcomes in patients with deformational plagiocephaly. Pediatrics. 2000; 105(2):E26. 13. Moss, DS. Nonsurgical nonorthotic treatment of occipital plagiocephaly: What is the natural history of the misshapen neonatal head? J Neurosurg. 1997; 87:667-670. 14. Pollak IF, et al. Diagnosis and management of posterior plagiocephaly. Pediatrics. 1997; 99(2):180-185. 15. Pomatto J, Beals S, Joganic E. Preliminary results and new treatment protocol for cranial banding following endoscopic-assisted craniectomy for sagittal synostosis. J Craniofac Surg 2001;9:47 49. 16. Seymour-Dempsey K, Baumgartner JE, Teichgraeber JF, et al. Molding helmet therapy in the management of sagittal synostosis. J Craniofac Surg 2002;13:631 635. 17. Teichgraeber JF, Ault JK, et al. Deformational posterior plagiocephaly: diagnosis and treatment. Cleft Palate Craniofac J. 2002; 39(6):582-586. Government Agency, Medical Society, and Other Authoritative Publications: 1. American Academy of Neurological Surgeons (AANS). Craniosynostosis and Craniofacial Disorders. Available at: http://www.neurosurgerytoday.org/what/patient_e/craniosynostosis.asp?showmenu=false&s howprint=false 2. American Academy of Neurological Surgeons (AANS). Positional Plagiocephaly. Available at: http://www.neurosurgerytoday.org/what/patient_e/positional_plagiocephaly.asp. 3. Hayes Inc. Hayes Medical Technology Directory. Cranial Orthotic Device. Lansdale, PA: Hayes Inc.; March 2004. 4. National Institute of Neurological Disorders and Stroke (NINDS). Craniosynostosis Information Page. Available at: http://www.ninds.nih.gov/disorders/craniosynostosis/craniosynostosis.htm 5. Persing J, James H, Swanson J, Kattwinkel J. American Academy of Pediatrics Committee on Practice and Ambulatory Medicine, Section on Plastic Surgery and Section on Neurological Surgery. Prevention and management of positional skull deformities in infants. Pediatrics. 2003; 112(1 Pt 1):199-202. Page 5 of 7
Approved by BCBSVT Medical Directors Date Approved Joshua Plavin MD Senior Medical Director Chair, Medical Policy Committee Robert Wheeler MD Chief Medical Officer Attachment I CPT Codes and Instructions Code Type Number Brief Description Policy Instructions The following codes will be considered as medically necessary when applicable criteria have been met. HCPCS L0112 Cranial cervical orthosis, congenital torticollis type, with or without soft interface material, adjustable range of motion joint, custom fabricated See prior approval list for instructions HCPCS L0113 Cranial cervical orthosis, torticollis type, with or without joint, with or without soft interface material, prefabricated, includes fitting and adjustment See prior approval list for instructions HCPCS S1040 Type of Service Cranial remolding orthosis, pediatric, rigid, with soft interface material, custom fabricated, includes fitting and adjustment(s) Durable medical equipment See prior approval list for instructions Page 6 of 7
Attachment II ICD Codes Code Type Number Code description The following diagnosis codes will be considered as medically necessary when applicable criteria have been met. ICD10 Q67.3 Plagiocephaly ICD10 Q75.0 Craniosynostosis 082015RLG Page 7 of 7