Medical Policy: 01.01.05
Original Effective Date: August 2000
Reviewed: March 2016
Revised: March 2016
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Plagiocephaly, which refers to an asymmetrically shaped head, can be subdivided into synostotic and non-synostotic types. Synostotic plagiocephaly describes an asymmetrically shaped head due to premature closure of the sutures of the cranium. In plagiocephaly without synostosis, the sutures remain open. 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. Brachycephaly refers to a head shape that is not asymmetric but is disproportionately short. The incidence of plagiocephaly and brachycephaly has increased rapidly in recent years as 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 estimated that 1 of every 60 neonates may have some degree of plagiocephaly or brachycephaly. Positional plagiocephaly typically consists of right or left occipital flattening with advancement of the ipsilateral ear and prominence of the ipsilateral frontal region, 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. Assessment of plagiocephaly and brachycephaly are based on anthropomorphic measures of the head, using anatomical and bony landmarks.
There are 3 basic options for treating plagiocephaly and brachycephaly; no therapy, repositioning therapy, and adjustable banding, which may be referred to as dynamic orthotic cranioplasty (DOC). Repositioning therapy includes supervised "tummy time," or placement of the child in a half supine position with a towel or blanket roll behind the shoulder to position the occiput away from the flat side. Physical therapy may also be recommended, particularly if there is shortening or tightening of the sternocleidomastoid muscle. Adjustable banding involves use of a custom-molded orthotic, either a helmet or band that can progressively mold the shape of the cranium by applying corrective forces to the frontal and occipital prominences while leaving room for growth in the adjacent flattened areas. Treatment is typically initiated around 5 to 6 months of age, frequently after a prior trial of repositioning therapy, and continues for an average of 4 to 5 months. Both helmets and cranial bands are recommended for wear 23 hours per day, with 1 hour off for skin care and hygiene. There has been no benefit shown for children past 24 months of age.
Recent studies comparing treatment with and without helmet therapy in those with plagiocephaly without synostosis, also called positional plagiocephaly, “discourages the use of a helmet as a standard treatment for healthy infants with moderate to severe skuill deformation.”
- Use of adjustable cranial banding may be considered medically necessary only following surgical correction of craniosynostosis.
- Use of adjustable cranial banding for synostosis in the absence of surgical correction is considered not medically necessary
- Adjustable cranial banding as a treatment of plagiocephaly without synostosis (positional plagiocephaly) is considered not medically necessary.
- Please note that a protective helmet (HCPCS code A8000–A8004) is not a cranial remolding device. It is considered a safety device worn to prevent injury to the head rather than a device needed for active treatment.
There is a lack of studies that prove non-synostosis plagiocephaly causes functional impairments. The one completed randomized clinical trial concluded that helmet therapy is not superior to natural courses of therapy. The results suggest that in a practical setting, effectiveness of a cranial orthoses may not differ from the natural course of development for infants with moderate to severe plagiocephaly and brachycephaly. Infants with very severe plagiocephaly is not addressed by this study. The correction of plagiocephaly in the absence of synostosis, also called positional plagiocephaly, is considered not medically necessary.
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- S1040 cranial molding orthosis, rigid, with soft interface material, custom fabricated, includes fitting and adjustments.
- Pollack IF, Losken HW, Fasick P. Diagnosis and management of posterior plagiocephaly. Pediatrics. 1997 Feb;99(2):180-5.
- Littlefield TR, Beals SP, Manwaring KH, et al. Treatment of craniofacial asymmetry with dynamic orthotic cranioplasty. Journal of Craniofacial Surgery 1998;9:11-17.
- Littlefield TR. Food and Drug Administration Regulation of Orthotic Cranioplasty. Cleft Palate-Craniofacial Journal, July 2001;38(4):337-340.
- Loveday BP, de Chalain TB. Active counter positioning or orthotic device to treat positional plagiocephaly? J Craniofac Surg. 2001 Jul;12(4):308-13.
- Persing J, Swanson J, Kattwinkel J; American Academy of Pediatrics Committee on Practice and Ambulatory Medicine; Prevention and Management of Positional Skull Deformities in Infants Pediatrics 112 Number 1 July 2003.
- Teichgraeber JF, Seymour-Dempsey K, et al. Molding helmet therapy in the treatment of brachycephaly and plagiocephaly. J Craniofac Surg. 2004 Jan;15(1):118-23.
- ECRI. Cranial orthosis for the treatment of deformational plagiocephaly. Plymouth Meeting (PA): ECRI Health Technology Assessment Information Service; November 2005, Issue No. 131. (Windows on medical technology; No. 131).
- Institute for Clinical Systems ImprovementExternal Site Cranial orthosis for deformational plagiocephaly. ICSI Technology Assessment Abstract #82;March 2004.
- de Ribaupierre S, Vernet O, et al. Posterior positional plagiocephaly treated with cranial remodeling orthosis. Swiss Med Weekly. 2007 Jun 30; 137 (25-2): 368-72.
- Laughlin J, Luerssen TG, Dias MS, Committee on Practice and Ambulatory Medicine Section on Neurological Surgery. Prevention and management of positional skull deformities in infants. Pediatrics. 2011 Dec;128(6):1236-41.
- Warren SM, Proctor MR, Bartlett SP, et al. Parameters of care for craniosynostosis: craniofacial and neurologic surgery perspectives. Plast Reconstr Surg. 2012 Mar;129(3):731-7.
- Best Evidence Statement. Prognosis of infant development with plagiocephaly, torticollis. Cincinnati Children's Hospital Medical Center. Best evidence statement (BESt). Prognosis of infant development with plagiocephaly, torticollis. Cincinnati (OH): Cincinnati Children's Hospital Medical Center; 2011 Jun 3.
- Rogers GF. Deformational Plagiocephaly, Brachycephaly, and Scaphocephaly. Part II: Prevention and Treatment. J Craniofac Surg. 2011 Jan;22(1):17-23.
- American Academy of Orthotists and Prosthetists (AAOP). Orthotic Treatment of Deformational Plagiocephaly, Brachycephaly and Scaphocephaly. Clinical Standards of Practice (CSOP) Consensus Conference on Orthotic Management of PlagiocephalyExternal Site, 2004.
- American Academy of Orthotists and Prosthetists (AAOP). Standard deviation table for cephalic indexExternal Site.
- Van Wijk R, Van Vlimmeren L, et al. Helmet therapy in infants with positional skull deformation: randomized controlled trial. BMJ 2014;348:g2741
- Kluba S, Kraut W, Calgeer B et al. Treatment of positional plagiocephaly - Helmet or no helmet? J Craniomaxillofac Surg 2013.
- Lee MC, et al. Three-dimensional analysis of cranial and facial asymmetry after helmet therapy for positional plagiocephaly. Child Nerv Syst 2015 Jul;31(7):1113-20.
March 2016 - Annual Review, Policy Revised
April 2015 - Annual Review, Policy Renewed
May 2014 - Annual Review, Policy Renewed
July 2013 - Annual Review, Policy Renewed
October 2012 - Annual Review, Policy Renewed
October 2011 - Annual Review, Policy Renewed
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
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and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
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advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.