Does not apply to BlueCare and TennCareSelect, please refer to the BlueCare and TennCareSelect policy.
DESCRIPTION
Cranial orthosis (e.g., DOC™band, STARband™) have been used as a non-invasive treatment of plagiocephaly or brachycephaly without synostosis. 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 incidence of plagiocephaly has increased 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.
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.
Plagiocephaly 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.
Non-synostotic plagiocephaly is where 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. 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, and 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.
POLICY
The use of an adjustable cranial orthosis following cranial vault remodeling surgery for synostosis is considered medically necessary.
The use of an adjustable cranial orthosis for synostosis in the absence of cranial vault remodeling surgery is considered not medically necessary.
An adjustable cranial orthosis as a treatment of plagiocephaly or brachycephaly without synostosis is considered not medically necessary.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Evidence remains insufficient to determine if adjustable cranial orthoses is more effective than repositioning over the same time period nor have cranial devices shown to improve functional outcomes for positional plagiocephaly without synostosis.
SOURCES
American Academy of Pediatrics. (2009, January). Policy statement. The changing concept of sudden infant death syndrome: Diagnostic coding shifts, controversies regarding the sleeping environment, and new variables to consider in reducing risk. Retrieved April 21, 2011 from http://aappolicy.aappublications.org/cgi/content/full/pediatrics;116/5/1245.
BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2011). Adjustable cranial orthoses for positional plagiocephaly and craniosynostoses (1.01.11). Retrieved May 12, 2011 from BlueWeb. (28 articles and/or guidelines reviewed)
BlueCross BlueShield of Tennessee network providers. January 2005.
BlueCross BlueShield of Tennessee network providers. November 2004.
BlueCross BlueShield of Tennessee network providers. January 2002.
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. (Level 2 Evidence - Independent study)
ECRI Institute. Health Technology Information Service. Evidence Reports. (2005, November). Cranial orthosis for the treatment of deformational plagiocephaly. Retrieved April 1, 2011 from ECRI Institute. (78 articles and/or guidelines reviewed)
Esparza, J., Hinojosa, J., Garcia-Recuero, I., Romance, A., Pascual, B., & Martinez de Aragon, A. (2008). Surgical treatment of isolated and syndrome craniosynostosis. Results and complications in 283 consecutive cases. Neurocirugia, 19 (6), 509-529. (Level 3 Evidence - Independent study)
Jimenez, D. F., & Barone, C. M. (2010). Multiple-suture nonsyndromic craniosynostosis: Early and effective management using endoscopic techniques. Journal of Neurosurgery/Pediatrics, 5 (3), 223-231.
Kanev, P.M. (2007). Congenital malformations of the skull and meninges. Otolaryngologic Clinics of North America, 40 (1), 9-26.
Koh, J. L., & Gries, H. (2007). Perioperative management of pediatric patients with craniosynostosis. Anesthesiology Clinics, 25 (3), 465-481.
Mehta, V. A., Bettegowda, C., Jallo, G. I., & Ahn, E. S. (2010). The evolution of surgical management for craniosynostosis. Neurosurgical Focus, 29 (6), E5.
National Institute for Health and Clinical Excellence (NICE). (2010, June). Moulding helmets/cranial banding for plagiocephaly. Retrieved March 5, 2010 from http://guidance.nice.org.uk/index.jsp?action=byID&o=11217.
National Institute of Neurological Disorders and Stroke. (2010, October). NINDS craniosynostosis information page. Retrieved April 21, 2011 from http://www.ninds.nih.gov/disorders/craniosynostosis/craniosynostosis.htm.
NHS Quality Improvement Scotland. (2007). Evidence note 16: The use of cranial orthosis treatment for infant deformational plagiocephaly. Retrieved March 5, 2010 from http://www.nhshealthquality.org/nhsqis/files/Infant%20plagiocephaly%20final%20May%202007.pdf.
Sheiner, E. & Abramowicz, J. S. (2008). Ultrasound of the fetal cranium: Review of current literature. Ultrasound Clinics, 3 (4), 583-594.
U. S. Food and Drug Administration. (2009, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K090587. Retrieved March 5, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf9/K090587.pdf.
U. S. Food and Drug Administration. (2008, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K082950. Retrieved March 5, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf8/K082950.pdf.
U. S. Food and Drug Administration. (2008, January). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K072862. Retrieved March 5, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf7/K072862.pdf.
U. S. Food and Drug Administration. (2002, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K021221. Retrieved March 5, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf2/K021221.pdf.
U. S. Food and Drug Administration .(2010, April). Code of Federal Regulations: Title 21, Volume 8. Section 882.5970. Cranial orthosis. Retrieved April 21, 2011 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=882.5970.
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. (Level 2 Evidence - Independent study)
Winifred S. Hayes, Inc. Medical Technology Directory. (2010, March). Cranial orthotic devices. Retrieved May 4, 2010 from www.Hayesinc.com/subscribers. (68 articles and/or guidelines reviewed)
Xia, J. J., Kennedy, K. A., Teichgraeber, J. F., Wu, K. Q., Baumgartner, J. B., & Gateno, J. (2008). Nonsurgical treatment of deformational plagiocephaly. A systematic review. Archives of Pediatric Adolescent Medicine, 162 (8), 719-727. (Level 4 Evidence - Independent study)
ORIGINAL EFFECTIVE DATE: 12/1/2002
MOST RECENT REVIEW DATE: 9/11/2011
ID_BA
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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