This policy addresses the use of the adjustable band as a non-invasive treatment for non-synostotic plagiocephaly (asymmetrically shaped head) and brachycephaly (abnormally shaped head; shortened in antero-posterior dimension without asymmetry) in infants. The adjustable band involves the use of a custom-molded orthotic, either a helmet or a band that can progressively mold the shape of the cranium. Treatment is typically initiated around 5-6 months of age and continues for an average of 4 to 5 months.

Not Medically Necessary:

The use of the adjustable band is considered not medically necessary for all non-synostotic plagiocephaly related indications.

Reconstructive:

The use of the adjustable band as a treatment for moderate to severe nonsynostotic plagiocephaly may be considered reconstructive 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 > 6 months of age, repositioning therapy is not effective and a trial of repositioning is not indicated; AND
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; or
   • 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.

Investigational/Not Medically Necessary:

The adjustable band is considered investigational/not medically necessary  as a treatment of brachycephaly.
 

Multiple case series have demonstrated that the adjustable band can reshape non-synostotic plageocephalic cranial asymmetries.  These asymmetries may involve the cranial base, the cranial vault and the orbitotragial distance.

The evaluation of the medical necessity of the adjustable band for cranial asymmetries requires data that support 1) that nonsynostotic plagiocephaly is associated with a functional impairment; and 2) that dynamic orthotic plagiocephaly results in an improvement in the functional impairment.  Potential functional impairments include learning disabilities, ocular dysfunction and jaw malocclusion.  To date, there is inadequate data to support that plagiocephaly results in functional impairments.  For example, Miller and colleagues (2000) examined the long-term development outcomes in patients with deformational plagiocephaly in a case series of 181 children with positional plagiocephaly; families were invited to participate in a telephone interview regarding developmental outcomes.   A total of 63 of the 181 contacted families agreed to participate in the interview; 39.7% of the children had received special help in primary school.  Given the approximate 33% participation rate in this survey, no conclusions can be drawn. In addition, 27 of the 63 respondents had used helmet therapy as part of the treatment. Gupta and colleagues (2003) reported on the ophthalmologic findings in 93 patients with deformational plagiocephaly; 24% had unilateral or bilateral astigmatism compared with 19% prevalence in the normal population.   This study did not indicate whether the participants did or did not undergo helmet therapy. Balan and colleagues (2002) examined auditory event-related potentials in 10 infants with deformational plagiocephaly compared to 15 sex- and age-matched controls. The infants with plagiocephaly exhibited smaller amplitudes in response.  Again, this study did not indicate whether the participants had used helmet therapy.  In summary, no controlled trials have documented functional impairments in infants with plagiocephaly and whether or not these impairments are improved with helmet therapy.  Therefore, the treatment of nonsynostotic plagiocephaly using the adjustable band is considered not medically necessary.  Brachycephaly described a head shape, that although symmetrical, is considered abnormal.  

Nevertheless, the adjustable band may be considered eligible for coverage under reconstructive benefits, based on available data that the therapy can indeed reshape the cranium to a more normal contour. If the adjustable band is considered eligible for coverage under the reconstructive benefit, the following issues are relevant.

1.  What degree of asymmetry would warrant correction?

Studies of helmet therapy typically describe 3 different types of asymmetry; asymmetry of the cranial base, cranial vault, and orbitotragial distance. All 3 result in visible facial asymmetry. The degree of asymmetry that would warrant correction is not well addressed in the published medical literature. However, one can examine the degree of asymmetry reported in case series of patients undergoing adjustable banding. The following table presents the mean pretreatment asymmetries reported in large case series.

STUDY	Cranial Base (mm)	Cranial Vault (mm)	Orbitotragial Distance (mm)
Littlefield	6.17	8.50	4.36
Moss	NR	9.2	7.1*
Teichgraeber	7.08	8.53	3.12

* In this report, the asymmetry was measured from the tragus to the frontozygomatic point instead of the excanthion

The study by Moss and colleagues (1997) was the only article that attempted to distinguish degrees of asymmetry. Mild to moderate asymmetry was defined as 12 mm or less, while moderate to severe asymmetry was defined as greater than 12 mm. Treatment with a helmet therapy was offered to those with moderate to severe asymmetry, while the rest were treated with repositioning therapy.

2.  What is the optimal timing of helmet therapy?

Again, this issue is not specifically addressed in the literature, but some providers would consider helmet therapy only after a failure of an initial trial of repositioning.  For example, Pollack et al. (1997) recommended a 2- to 3-month trial of repositioning therapy.   In their series of 69 children, 39 failed repositioning therapy and thus were subsequently treated with helmet therapy.  However, some providers may suggest an earlier intervention of helmet therapy may be warranted in older children.  For example, helmet therapy may be increasingly less effective in older children as the synostoses begin to close.  Therefore, requiring a 2- to 3-month trial of repositioning therapy in children 6 to 9 months old may limit the effectiveness of a subsequent trial of helmet therapy. Furthermore, repositioning therapy may be less effective in older children who are increasingly mobile and do not maintain a single sleeping position.  In 2003 the American Academy of Pediatrics (AAP) issued a policy indicating that improvement in skull shape is usually seen in 2–3 months with exercise and repositioning of the infant.   The AAP indicated that the use of skull-molding helmets seems to be beneficial primarily when there has been a lack of response to mechanical adjustments and exercises.  However, the AAP noted further studies are needed to identify outcomes with and without the use of mechanical skull-molding helmets. Furthermore, the AAP did not report on any functional impairment associated with plagiocephaly.

 3.  What is the stopping point of therapy?

This issue is not well addressed in the published literature.  Presumably the stopping point is when symmetry is achieved, however even the nonsynostotic skull will have some degree of minor asymmetry, which would be considered within normal limits.  The issue may arise when providers request a second device for ongoing correction of asymmetry.  The manufacturer suggests that helmets are designed for approximately 2-4 months of use, after which point a child might “outgrow” the device.  If symmetry has not been achieved within this time frame, a provider may request a second device. The manufacturer (Cranial Technologies, Inc.) estimates that this occurs in about 20% of cases. 

Brachycephaly describes a head, that although symmetric, which is abnormally shaped (flattened), and is assessed using the cephalic index (CI).  Medical dictionaries and anthropologic sources define brachycephaly as a cranial index (width divided by length x 100%) greater than 81%.  A literature search did not identify randomized prospective comparative clinical trials which establish the efficacy of cranial remodeling bands and helmets as a treatment of brachycephaly. 

In a retrospective chart-review study, Teichgraeber et al (2004) evaluated treatment outcomes in groups of children with positional brachycephaly and plagiocephaly and concluded that the use of a cranial orthotic device was effective for both groups, but that more children in the plagiocephaly group were normalized after treatment.  In this study infants were treated with either repositioning (n=132) or with the DOC™ band (n=292).  Of the 292 treated with a molding orthotic, 64 were brachycephalic and 228 had plagiocephaly.  Of 64 patients with brachycephaly treated with banding, 33 met specific inclusion criteria:  charted diagnosis of brachycephaly, age 12 months or less, and complete anthropomorphic measurements recorded in the record.  In the brachycephalic group, significant improvement occurred in the CI (P<0.01) after treatment with the DOC™ band but infants were described as still significantly different from age and sex adjusted norms.  Only one child in this group normalized to within 1 SD of the norm by the end of treatment.  In this study, cranial orthotic treatment was reported as more effective in treating posterior plagiocephaly than brachycephaly, but specific data with benchmark norms were not provided.  The limitations of this study included its retrospective design and the lack of reporting of comparative data from the group treated with positioning alone.

A more recent study by Graham et al (2005) compared the effect of repositioning versus helmet therapy on CI in infants referred for brachycephaly.  This study collected longitudinal data on 193 infants referred and treated for abnormal head shapes at a single institution between 1997 and 2001.  The CI was compared before and after treatment with either repositioning or helmet therapy.  In a subgroup of infants (n= 92) with severe brachycephaly (CI ≥ 90%), the authors concluded that although both groups (repositioning and orthotic) improved, repositioning was less effective than cranial orthotic therapy based on reduction in CI (2.5% vs 5.3%). The limitations of this study include a lack of randomized design, baseline differences in initial mean age and cephalic index, and differences in mean duration of therapy between the two treatment groups.

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 initiated in 1992 by the American Academy of Pediatrics (AAP), in which a supine sleeping position is recommended to reduce the risk of sudden infant death syndrome (SIDS). It is estimated that one 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 band. 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. The adjustable band 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.

Brachycephaly describes a head shape that is symmetric and disproportionately wide, (width ÷ length x 100%) ≥ 81%.

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).

Cranial index: The cranial 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 ophisthocranion), expressed as a percentage. The cranial index can then be compared to normative measures.

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.

Non-synostotic plagiocephaly: a condition where an infant’s head becomes deformed due to external forces; in nonsynostotic plagiocephaly the joints between the skull bone plates (sutures) remain open, allowing non-surgical correction; this condition is also known as positional plagiocephaly

Orbitotragial depth: Asymmetry of the orbitotragial depth is measured from the exocanthion (outer corner of the eye fissure where the eyelids meet) to the tragus (the cartilaginous projection in front of the external auditory canal).

Orthotic cranioplasty: a method to correct nonsynostotic plagiocephaly through the wearing of a custom-fitted helmet or head band which places constant gentle pressure on the patient’s head to assume a more natural skull shape

Plagiocephaly: a condition characterized by an abnormal head shape

The following codes for treatments and procedures applicable to this policy are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

Services are Not Medically Necessary:

HCPCS

ICD-9 Diagnosis

Services may be Reconstructive, when criteria are met:

For the procedure and diagnosis codes listed above, services may be considered Reconstructive when criteria are met

Services are Investigational/Not Medically Necessary:

For the procedure codes listed above, for the following diagnosis code when specified as brachycephaly, or when the code describes a procedure indicated in the Policy section as investigational/not medically necessary.

ICD-9 Diagnosis

1. Balan P, Kushnerenko E, Sahlin P, et al. Auditory ERPs reveal brain dysfunction in infants with plagiocephaly. J Craniofac Surg. 2002; 13(4):520-5.
2. Graham J, Kreutzman J. Deformational Brachycephaly in Supine-Sleeping Infants. Journal of Pediatrics. 2005; 254-257.
3. Gupta PC, Foster J, Crowe S, et al. Ophthalmologic findings in patients with nonsyndromic plagiocephaly. J Craniofac Surg. 2003; 14(4):529-32. 
4. 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):970-80.
5. Littlefield TR, Beals SP, Manwaring KH, et al.  Treatment of craniofacial asymmetry with dynamic orthotic cranioplasty.  J Craniofacial Surg. 1998;  9(1):11-17.  
6. Miller RI, Clarren SK. Long-Term developmental outcomes in patients with deformational plagiocephaly. Pediatrics.  2000; 105(2):E26.
7. Moss, DS.  Nonsurgical nonorthotic treatment of occipital plagiocephaly:  What is the natural history of the misshapen neonatal head?  J Neurosurg. 1997; 87:667-670.
8. Pollak IF, et al.  Diagnosis and management of posterior plagiocephaly.  Pediatrics. 1997; 99(2):180-185.
9. Teichgraeber JF, Ault JK, et al. Deformational posterior plagiocephaly: diagnosis and treatment. Cleft Palate Craniofac J. 2002; 39(6):582-6.

Government Agency, Medical Society, and Other Authoritative Publications:

1. 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. American Academy of Pediatrics Committee on Practice and Ambulatory Medicine, Section on Plastic Surgery and Section on Neurological Surgery. Pediatrics. 2003; 112(1 Pt 1):199-202. 
2. Hayes Inc. Hayes Medical Technology Directory. Cranial Orthotic Device. Lansdale, PA: Hayes Inc.; March 2004. Search updated April 2006.

1. American Association of Neurological Surgeons. Shape of Your Baby's Head: Parents Should Check Shape of Baby's Head, Vary Sleeping Positions. Available at:   http://www.medem.com/MedLB/article_detaillb.cfm?article_ID=ZZZ2OP87Q9C&sub_cat=108.  Accessed on August 30, 2006.
2. National Library of Medicine. Medical Encyclopedia. Cranial Sutures. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/002320.htm. Accessed August 30, 2006.
   

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™

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

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