Medical Policy: 01.01.05 

Original Effective Date: August 2000 

Reviewed: January 2021 

Revised: January 2021 

 

Notice:

This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.

 

Benefit Application:

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.

 

Description:

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/helmets, 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.

 

Literature

Studies are limited, the one and only RCT states: The investigators concluded, based on the equal effectiveness of helmet therapy and skull deformation following its natural course, high prevalence of side effects, and high costs associated with helmet therapy, we discourage the use of a helmet as a standard treatment for healthy infants with moderate to severe skull deformation.

 

Taking into consideration the limited number of publications over the past decade and the likelihood of both study and publication bias in uncontrolled studies, the scientific literature does not support an effect of deformational plagiocephaly on functional health outcomes. There is a lack of evidence that plagiocephaly will have any lasting effects on neurological development. It is estimated that about two-thirds of plagiocephaly cases may auto-correct spontaneously after regular changes in sleeping position or following phsyical therapy aimed at correcting neck muscle imbalance. Helmet therapy has been shown to influence the rate of improvement of asymmetry but not its final outcome. The primary beneficial outcome of helmet treatment for positional plagiocephaly is aesthetic improvement of the shape of the head.

 

Practice Guidelines and Position Statements

Canadian Pediatric Society

In the Canadian Pediatric Society Practice Points (2016) on positional plagiocephaly, the Society’s recommendations stated that repositioning therapy plus physiotherapy as needed are the interventions of choice in most children with mild or moderate positional plagiocephaly. They also stated that moulding or helmet therapy may be considered for children with severe asymmetry. In these children, helmet therapy has been shown to influence the rate of improvement of asymmetry but not its final outcome. The evidence is insufficient to recommend helmet therapy for mild or moderate asymmetry.

 

Congress of Neurological Surgeons Joint Statement

In 2016, the Congress of Neurological Surgeons and 3 other medical associations published a joint evidence-based guideline on the role of cranial molding orthosis therapy for patients with positional plagiocephaly. They provided level II recommendations (uncertain clinical certainty) on the use of helmet therapy “for infants with persistent moderate to severe plagiocephaly after a course of conservative treatment (repositioning and/or physical therapy)” and “for infants with moderate to severe plagiocephaly presenting at an advanced age.” The recommendations were based on a randomized controlled trial, 5 prospective comparative studies, and 9 retrospective comparative studies (all rated as class II evidence).

 

American Academy of Pediatrics (2011)

Management of positional skull deformity involves preventive counseling for parents, mechanical adjustments, and exercises. Parental compliance with the management plan is pivotal in lessening the likelihood and severity of positional skull deformity. Skull-molding helmets are an option for patients with severe deformity or skull shape that is refractory to therapeutic physical adjustments and position changes.

 

Prior Approval:

For service on or after February 1, 2021 Prior approval will be required. 

 

Policy:

  • Use of adjustable cranial banding/cranial helmet may be considered medically necessary only following surgical correction of craniosynostosis.
  • Use of adjustable cranial banding/cranial helmet for synostosis in the absence of surgical correction is considered not medically necessary
  • Pre-operative molding helmet therapy for the treatment of craniosynostosis is considered investigational because the effectiveness of helmet therapy prior to surgery has not been established.
  • Adjustable cranial banding as a treatment of plagiocephaly without synostosis (positional plagiocephaly) is considered not medically necessary.
  • The use of sleep positioning wrap for the treatment of infants with positional head deformities/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.

 

*Please note that a remolding helmet, congenital torticollis type (HCPCS code L0112 and L0113) is not managed by this policy.

 

Overall, evidence on an association between positional plagiocephaly and health outcomes is limited. 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, and the study has not had replication at this time. The correction of plagiocephaly in the absence of synostosis, also called positional plagiocephaly, is considered not medically necessary.

 

Policy Guidelines

Brachiocephaly: Shortened front to back dimension of the skull that results from premature fusion of the coronal suture.

 

Cranial base: Asymmetry of the cranial base is measured from the subnasal point (midline under the nose) to the tragus (the cartilaginous projection in front of the external auditory canal.

 

Cephalic index: The cephalic index, which describes a ratio of the maximum width to the head length expressed as a percentage, is used to assess abnormal head shapes without asymmetry. The maximum width is measured between the most lateral points of the head located in the parietal region (i.e., euryon). The head length is measured from the most prominent point in the median sagittal plane between the supraorbital ridges (i.e., glabella) to the most prominent posterior point of the occiput (i.e., the opisthocranion), expressed as a percentage. The cephalic index can then be compared to normative measures for age and gender. See Table 1 (as developed by AAOP 2004).

 

Cranial Vault Asymmetry: is assessed by measuring from the frontozygomaticus point (identified by palpation of the suture line above the upper outer corner of the orbit) to the euryon, defined as the most lateral point on the head located in the parietal region.

 

Plagiocephaly: Flattening of the skull on the back or one side of the head. Sagittal suture: Skull joint that separates the left and right halves of the skull.

 

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.

 

Selected References:

  • Littlefield TR. Food and Drug Administration Regulation of Orthotic Cranioplasty. Cleft Palate-Craniofacial Journal, July 2001;38(4):337-340.
  • Institute for Clinical Systems Improvement. Cranial orthosis for deformational plagiocephaly. ICSI Technology Assessment Abstract #82;March 2004.
  • 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.
  • American Academy of Orthotists and Prosthetists (AAOP).  Standard deviation table for cephalic index
  • 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.
  • National Institute of Neurological Disorders and Stroke (NINDS). Craniosynostosis InformationPage. 2016
  • Klimo P Jr, Lingo PR, Baird LC, et al. Congress of Neurological Surgeons Systematic Review and Evidence-Based Guideline on the Management of Patients With Positional Plagiocephaly: The Role of Repositioning. Neurosurgery 2016; 79:E627.
  • Tamber MS, Nikas D, Beier A, et al. The Role of Cranial Molding Orthosis (Helmet) Therapy. 2016; 
  • Canadian Pediatric Society. Practice Point. Positional plagiocephaly. Oct 1, 1011: Reaffirmed Feb 1, 2016. 
  • Cognitive Outcomes and Positional Plagiocephaly. Collett BR, Wallace ER, Kartin D, Cunningham ML, Speltz ML. Pediatrics. 2019 Jan 11. pii: e20182373. doi: 10.1542/peds.2018-2373. [Epub ahead of print]. 
  • Safiri S, Khazaei S, Ayubi E. J Plast Analysis of the correlation between deformational plagiocephaly and neurodevelopment delay: Methodological issues. Reconstr Aesthet Surg. 2018 Feb;71(2):264-265. doi: 10.1016/j.bjps.2017.10.031. Epub 2017 Nov 28. 
  • Ballardini E, Sisti M, Basaglia N, Benedetto M, Baldan A, Borgna-Pignatti C, Garani G. Prevalence and characteristics of positional plagiocephaly in healthy full-term infants at 8-12 weeks of life. Eur J Pediatr. 2018 Oct;177(10):1547-1554. doi: 10.1007/s00431-018-3212-0. Epub 2018 Jul 20.
  • Kelly, K. M., Joganic, E. F., Beals, S. P., Riggs, J. A., McGuire, M. K., & Littlefield, T. R. (2018). Helmet Treatment of Infants With Deformational Brachycephaly. Global Pediatric Health. 
  • Baird, L., Kilmo, P, et al. Congress of Neurological Surgeons Systematic Review and Evidence-Based Guidelines on the Management of Patients with Positional Plagiocephaly: Neurosurgery:the role of physical therapy. 2016.
  • Dorphage, K. Beck-BroichsitterB. et al. Therapy effects of head orthoses in positional plagiocephaly. Journal of  Cranio-maxillo-facial surgery. (2016).
  • Holowka, M., Reisner, A., et al. Plagiocephaly severity scale to aid in clinical treatment recommendations. Journal of Craniofacial Surgery. 2017; Jan 30. 
  • Lam, S., Pan, I., et al. Factors influencing outcomes in the treatment of positional plagiocephaly in infants: A 7 year experience. Journal of Neurosur Pediatrics. 2017; Mar; 19(3) 282-288).

 

Policy History:

  • January 2021 - Interim Review, Policy Revised
  • March 2020 - Annual Review, Policy Revised
  • March 2019 - Annual Review, Policy Revised
  • March 2018 - Annual Review, Policy Revised
  • March 2017 - Annual Review, Policy Renewed
  • 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 partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

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