Does not apply to TennCare, please refer to the TennCare policy.
DESCRIPTION
Plagiocephaly refers to an asymmetrically shaped head. It can be subdivided into synostotic and non-synostotic types. Synostotic plagiocephaly describes one type of an asymmetrically shaped head. This type of plagiocephaly is due to premature closure of the sutures of the cranium.
In non-synostotic plagiocephaly, the sutures of the cranium remain open. Non-synostotic plagiocephaly is also called positional or deformational plagiocephaly. It 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. The incidence of plagiocephaly 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). If detected during the first few months after birth, frequent repositioning of the baby's head combined with prone positioning during waking hours can correct the condition in the majority of children. Therapy for babies with congenital muscular torticollis, or weakness of the neck muscles, includes physical therapy and massage to lengthen the neck muscles in addition to repositioning. Surgical correction is rarely indicated for babies with non-synostotic plagiocephaly. There is no published data on the effects of non-synostotic plagiocephaly on neuropsychological deficits, developmental delay, or psychosocial concerns related to a perceived abnormal appearance. The major reason for intervention is to optimize the cranial contour to achieve an acceptable appearance, not to prevent or correct adverse developmental consequences.
Cranial orthosis (e.g., DOC™band, STARband™) has been used as a non-invasive treatment of non-synostotic plagiocephaly. This technology involves the use of a specially designed helmet or headband to guide the growth of an infant's head to a normal shape. This therapy has been used on infants with deformational plagiocephaly, a condition caused by the infant's head shape being altered as the result of external molding forces, such as the infant's sleeping position or pressure in the womb. Treatment is typically initiated around 5-6 months of age and continues for an average of 4 to 5 months. The helmets and cranial bands are recommended for wear 23 hours per day with an hour off for exercises and skin care. The use of cranial orthosis has also been proposed as a postoperative adjunct for those undergoing surgery for synostotic plagiocephaly.
POLICY
Cranial orthosis as a non-surgical treatment of plagiocephaly without synostosis is considered cosmetic.
Cranial orthosis as adjunctive postsurgical therapy for synostotic plagiocephaly is considered investigational.
ADDITIONAL INFORMATION
Well-controlled studies in peer-reviewed journals regarding cranial orthosis as adjunctive postsurgical therapy for synostotic plagiocephaly are lacking. Therefore, conclusions cannot be made regarding the benefit and long-term outcome for the use of this technology.
SOURCES
BlueCross BlueShield Association, Medical Policy Reference Manual. (11:2008). Treatment of plagiocephaly without synostosis (1.01.11). Retrieved September 8, 2009 from BlueWeb.
BlueCross BlueShield of Tennessee network providers. 2002, 2004, 2005.
De Ribaupierre, S., Vernet, O., Rilliet, B., Cavin, B., Kalina, D. & Leyvraz, P.F. (2007). Posterior positional plagiocephaly treated by cranial remodelling orthosis. Swiss Medical Weekly, 137 (25-26), 368-372.
ECRI Institute. Health Technology Information Service. Evidence Reports. (November 2005). Cranial orthosis for the treatment of deformational plagiocephaly. Retrieved August 19, 2009 from ECRI Institute. (78 articles and/or guidelines reviewed)
Hayes. Medical Technology Directory. (2005, March). Cranial Orthotic Devices. Retrieved September 19, 2009 from www.Hayesinc.com/subscribers. (41 articles and/or guidelines reviewed)
Kanev, P.M. (2007). Congenital malformations of the skull and meninges. Otolaryngologic Clinics of North America, 40 (1), 9-26.
Persing, J., James, H., Swanson, Kattwinkel, J., & Committee on Practice and Ambulatory Medicine, Section on Plastic Surgery and Section on Neurological Surgery. (2003). Prevention and management of positional skull deformities in infants. Pediatrics, 112 (1), 199-202.
Teichgraeber, J. F., Ault, J. K., Baumgartner, J., Waller, A., Messersmith, M., Gateno, J., et al. (2002). Deformational posterior plagiocephaly: Diagnosis and treatment. The Cleft Palate-Craniofacial Journal, 39 (6), 582-586.
U. S. food and Drug Administration. (2002, July). Center for Devices and Radiological Health. 510(K) summary. Retrieved August 30, 2006 from http://www.accessdata.fda.gov/cdrh_docs/pdf2/K021221.pdf.
van Vlimmeren, L.A., van der Graaf, Y., Boere-Boonekamp, M.M., L’Hoir, M.P., Helders, P.J. & Engelbert, R.H. (2007). Risk factors for deformational plagiocephaly at birth and at 7 weeks of age; a prospective cohort study. Pediatrics, 119 (2), e408-418.
Xia, J.J., Kennedy, K.A., Teichgraeber, J.F., Wu, K.Q., Baumgartner, J.B. et al. (2008). Nonsurgical treatment of deformational plagiocephaly. A systematic review. Archives of Pediatric Adolescent Medicine, 162 (8), 719-727.
ORIGINAL EFFECTIVE DATE: 12/1/2002
MOST RECENT REVIEW DATE: 10/8/2009
ID_BT
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