Clinical UM Guideline
|Subject:||Cranial Remodeling Bands and Helmets (Cranial Orthotics)|
|Guideline #:||CG-OR-PR-04||Current Effective Date:||04/05/2016|
|Status:||Reviewed||Last Review Date:||02/04/2016|
This document addresses the use of the adjustable band or helmet cranial orthoses as a treatment of craniosynostosis, non-synostotic plagiocephaly (asymmetrically shaped posterior head), scaphocephaly (abnormally shaped narrow head), and brachycephaly (abnormally shaped head; shortened in antero-posterior dimension without asymmetry) in infants.
Cosmetic: In this document, procedures are considered cosmetic when intended to change a physical appearance that would be considered within normal human anatomic variation. Cosmetic services are often described as those which are primarily intended to preserve or improve appearance.
Medically Necessary: In this document, procedures are considered medically necessary if there is a significant physical functional impairment AND the procedure can be reasonably expected to improve the physical functional impairment.
Note: Not all benefit contracts include benefits for reconstructive services as defined by this document. Benefit language supersedes this document.
Not Medically Necessary:
The use of cranial orthoses is considered not medically necessary when criteria have not been met.
Initial application of cranial orthosis for infants over the age of 12 months is considered not medically necessary.
Continued use of cranial orthosis after 18 months of age is considered not medically necessary.
Cosmetic and Not Medically Necessary:
The use of cranial orthoses is considered cosmetic and not medically necessary for non-surgical treatment of synostotic skull deformities.
The following codes for treatments and procedures applicable to this document 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.
|L0112||Cranial cervical orthosis, congenital torticollis type, with or without soft interface material, adjustable range of motion joint, custom fabricated|
|S1040||Cranial remolding orthosis, pediatric, rigid, with soft interface material, custom fabricated, includes fitting and adjustment(s)|
|P13.1||Fracture of skull due to birth injury|
|P15.2||Sternomastoid injury due to birth injury|
|Q67.4||Other congenital deformities of skull, face and jaw|
|Q68.0||Congenital deformity of sternocleidomastoid muscle (congenital torticollis)|
|Q75.9||Congenital malformation of skull and face bones, unspecified|
Plagiocephaly, which refers to an asymmetrically shaped head, can be subdivided into synostotic and non-synostotic types.
Synostotic plagiocephaly or craniosynostosis describes an asymmetrically shaped head due to premature closure of the sutures of the cranium. Craniosynostosis may require surgery to reopen the closed sutures. Surgery can be performed by an open or endoscopic technique, depending upon the type and extent of the synostosis.
The open approach requires an incision and may involve removal, reshaping or replacing the deformed cranial bone. For this extensive surgery, dissolving plates and screws are used to maintain the reshaped cranium post operatively. In a review of surgical approaches for craniosynostosis, Metha and colleagues (2010) addressed open procedures where complex calvarial vault remodeling was required for immediate deformity correction to prevent impending neurological dysfunction. Since cranial shape correction was accomplished with the surgery, a postoperative helmet was not required.
The endoscopic procedure is a minimally invasive technique where bone segments are removed, releasing the fusion. Since no plates or screws are inserted, cranial orthotics can be used to maintain the surgical correction postoperatively.
In plagiocephaly without synostosis, also referred to as non-synostotic plagiocephaly, the sutures of the skull remain open. This type of plagiocephaly can also be referred to as positional or deformational plagiocephaly when it is due to environmental factors including, but not limited to, premature birth, restrictive intrauterine environment, birth trauma, torticollis, cervical anomalies, and sleeping position.
Plagiocephaly, regardless of suture closure status, can be classified as either brachycephaly or scaphocephaly. Brachycephaly refers to a head shape that is not asymmetric but is disproportionately short, with the head being abnormally wide. Scaphocephaly is the opposite, with the head being abnormally narrow.
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 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 three basic options for treating non-synostotic plagiocephaly; no therapy, repositioning therapy, and the use of cranial orthoses. 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. Treatment with a cranial orthoses involves the use of an adjustable band or helmet that is custom-molded to the infant's head and can progressively mold the shape of the cranium by applying corrective forces to the frontal and occipital prominences, leaving room for growth in the adjacent flattened areas. Treatment with cranial orthoses is typically initiated around 4 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 to be worn 15-22 hours per day with treatment extending over 3 to 4 months. Daily time without the orthotic, usually at least 1 hour, is required for skin care and hygiene.
At this time, only one randomized prospective comparative clinical trial with blinded assessment has been conducted comparing the use of cranial helmet therapy vs. the natural progression of the condition. van Wijk and colleagues (2014) reported on the results of a single-blind randomized controlled trial (RCT) involving infants aged 5 to 6 months with moderate to severe skull deformation, who were born after 36 weeks of gestation with no muscular torticollis, craniosynostosis, or dysmorphic features. Out of 403 possible subjects, parents of 84 infants agreed to participate (20.8%). Subjects were assigned to receive helmet therapy (n=42) or to a control group with the natural course of the condition (n=42). At baseline, the control group subjects had significantly more plagiocephaly (p<0.05), while the helmet group had significantly more subjects with brachycephaly (p<0.05). At 24 months, 79 (94%) subjects were available for final assessment. Only 10 of the helmet group subjects used the helmet until 12-months of age, as specified by the protocol. Of the remaining 20 helmet group subjects, 8 ceased treatment early due to satisfaction with treatment outcomes, 10 stopped due to side effects, and 1 was not satisfied with the results. Details from the last subject were not available. Fitting problems with the helmet were described in 22 of the 30 (73%) helmet subjects that completed the 24 month follow-up. Between groups, no differences were noted for oblique diameter difference (p=0.8), cranial proportional index (p=0.81), in the number of infants with a full recovery (odds ratio [OR]=1.2). No significant differences were found in outcomes when the intent to treat analysis was compared to the per protocol analysis. The authors reported no differences between groups with regard to motor development, sleep quality, or duration of crying. All helmet group parents reported some side effects, including skin irritation, augmented sweating, helmet odor, and helmet associated pain. The authors acknowledge several limitations in this study, including a significant difference between groups with regard to the severity of skull deformation, a low participation rate ("not powered for equivalence"), difference in education level between parents participating in the study and those who refused, and no true assessment of daily helmet wear times. Despite the acknowledged study shortcomings, the authors conclude that helmet therapy is not superior to natural course of therapy.
There are many other less rigorously designed studies available which address this issue. In a retrospective, nonrandomized controlled study, Teichgraeber et al. (2002) 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 Dynamic Orthotic Cranioplasty band (DOC Band®, n=292). Of the 292 treated with a molding orthotic, 64 were brachycephalic and 228 had plagiocephaly. Of the 64 infants with brachycephaly who were 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 cephalic index (p<0.01) after treatment with the DOC Band, but infants were described as still significantly different from age and sex adjusted norms. Only 1 child in this group normalized to within 1 standard deviation (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 study by Graham et al. (2005) compared the effect of repositioning versus helmet therapy on the cephalic index in infants referred for brachycephaly. This nonrandomized controlled study collected longitudinal data on 193 infants referred and treated for abnormal head shapes at a single institution between 1997 and 2001. The cephalic index was compared before and after treatment with either repositioning or helmet therapy. In a subgroup of infants (n=92) with severe brachycephaly (cephalic index greater than or equal to 90%), the authors concluded that although both groups (repositioning and orthotic) improved, repositioning was less effective than cranial orthotic therapy based on reduction in cephalic index (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.
The use of cranial orthotics was evaluated in a small study by Seymour-Dempsey and colleagues (2002). In this study they compared the operative outcomes of infants treated with and without cranial banding following surgery for craniosynostosis. This small, nonrandomized, retrospective study included 21 children with sagittal craniosynostosis treated surgically between 1994 and 2001. Six infants were treated with surgery alone and 15 were treated with surgery and postoperative cranial banding with the DOC Band. The investigators recorded anthropomorphic measurements pre-operatively, post-surgery, and post-orthotic treatment. They found that the postoperative cephalic index, when compared with preoperative cephalic index, improved in both groups. While surgical improvement was seen in both groups, the orthotic group demonstrated a continued correction toward a more normal cephalic index not seen in the non-orthotic group. The authors concluded that the use of an orthosis maintains the initial surgical correction and promotes more normal cranial growth patterns. Based on this small retrospective analysis, the authors recommend the use of cranial orthoses as an adjunct to surgery for sagittal synostosis. Kaufman et al. reported a small (n=12) case series comparing outcomes of an open craniectomy for sagittal synostosis utilizing a postoperative cranial orthotic (2004). In this group, immediate and 1 year postoperative CTs did not reveal a statistically significant improvement in cephalic index (preoperative cephalic index, 65 ± 3.4; range, 58 to 70; post-treatment cephalic index, 74 ± 4.3; range, 68 to 80). However, visually, the head shape was improved. The results of this study yielded similar results when compared to historic outcomes without the use of cranial orthotics postoperatively.
Hutchison et al. conducted a prospective case series study of 161 subjects with deformational plagio- or brachycephaly (2011). At baseline, 47% of subjects were in the severe range, 31% were in the moderate range and 22% were in the mild range. At follow-up, 77 (61%) of the subjects had achieved the normal range for head shape, and only 5 (4%) were in the severe range. The authors report that they saw reductions in overall severity levels and that many subjects with severe initial conditions were in the normal range at follow-up.
Seruya and others (2013) conducted a prospective case series study of 346 subjects with nonsynostotic plagiocephaly undergoing cranial orthotic therapy. Their analysis involved stratification of subjects into seven different age groups, beginning with those under 20 weeks to those greater than 40 weeks. Duration of therapy was found to be positively correlated with age of treatment initiation (r=0.089, p<0.05). The authors report that normalization of head shape was fastest in the youngest cohort (Group 1 [less than 20 weeks], n=26). The rate of change in transcranial difference measurements was negatively correlated with age of treatment initiation (r=-0.88, p<0.05). As such, the later a subject had treatment initiated, the longer it took to achieve normalization. This is supported by the observation of a logarithmic decrease in rate of asymmetry improvement with increasing age. Furthermore, children in the two oldest groups, Group 6 (ages 36-40 weeks, n=29) and Group 7 (greater than 40 weeks, n=43), did not achieve full correction despite similar treatment duration and compliance to the other groups. In the discussion section, the authors postulated that, given the data presented, treatment with cranial orthotics could conceivably be used in toddlers. However, success is likely to be negatively impacted by the requirement of long treatment times and problems with compliance in older children. The durability of improvement was not reported.
A large retrospective case series study was conducted by Couture (2013) and involved 1050 subjects. In addition to stratifying the results by subject age, stratification was also done according to the severity of plagiocephaly as measured by Argenta classification. The results indicated that the degree of head deformation significantly impacted treatment times, with Type III, IV, and V deformities having significantly longer times to correction (53%, 75%, 81% longer, respectively; p<0.0001). In contrast to the results reported by Seruya, no differences were reported with regard to the time to correction according to age group. In this study, subjects in the oldest age group (greater than 12 months) did not have a statistically significant longer time to improvement when compared to the youngest age group (less than 3 months). As with the Seruya study, the authors reported that children up to 18 months of age can benefit from correction, although their findings indicate that these older subjects would have similar treatment duration to younger children. The authors commented that they suspect that the older groups had such positive outcomes mostly due to highly motivated parents overseeing compliance. Finally, the devices used in this trial were off the shelf models, and it was pointed out that they demonstrated outcomes similar to those previously reported with custom made models. The authors state that this indicates that the use of more complicated custom orthotics is not needed to achieve positive outcomes.
The American Academy of Pediatrics (AAP) states that there is no evidence that molding helmets work any better than repositioning therapy for infants with mild to moderate skull deformity (Laughlin, 2011). They recommend repositioning as the initial treatment for infants younger than 6 months. For infants with severe deformity the AAP states that the use of skull-molding helmets is most effective between the ages of 4-12 months. They indicate that beyond the age of 12 months cranial remodeling is less, and compliance issues increase.
It should be noted that the use of cranial orthoses is not risk-free. Wilbrand and colleagues conducted a retrospective case series study involving 410 subjects with moderate to severe non-synostotic plagiocephaly (2012). The authors reported a significant number of complications in this population, including pressure sores (10.5%), ethanol erythema (6.3%), skin infections (1.2%), and bacterial abscess (0.2%). They also reported a 1.5% treatment failure rate. The use of cranial banding is also contraindicated for individuals with hydrocephalus.
Under normal circumstances, a baby's weight may triple in size between birth and 9 months. This significant growth rate is reflected by a concomitant and proportional increase in cranial size that may result in an improperly fitting or ineffective cranial orthosis. Under such circumstances, it is reasonable to provide the child with a new orthosis when continued significant improvement in cranial shape is anticipated.
Postoperative cranial banding is frequently used to maintain reshaping following endoscopic surgery for craniostenosis. Only a few published, uncontrolled case series studies have described the use of postoperative cranial orthoses as an adjunct to surgery (Cohen, 2004; Jimenez, 2007; Jimenez, 2010; Murad, 2005). These investigators propose that postoperative cranial orthoses are a valuable tool in enhancing the surgical outcome.
In compliance with federal Early and Periodic Screening, Diagnosis and Treatment (EPSDT) requirements to provide "other necessary health care, diagnostic services, treatment, and other measures described in section 1905(a) to correct or ameliorate defects and physical and mental illnesses and conditions discovered by the screening services", it is acknowledged that cranial orthosis may be considered medically necessary when provided for children with the most severe skull deformities, particularly when coexistent with medical conditions associated with limited mobility. The application of the cranial orthosis does not replace the need for appropriate counter positioning education for caregivers and provision of skilled physical therapy when indicated.
Asymmetry of 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).
Asymmetry of cranial vault: This 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.
Asymmetry of orbitotragial depth: An asymmetry of the orbitotragial depth that 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).
Brachycephaly: A condition characterized by a head shape that is symmetric and disproportionately wide, (width ÷ length x 100%) ≥ 81%. This may be caused by abnormal growth rates of the skull bone plates, or may be due to an infant being placed in the same position for prolonged periods of time. The latter is referred to as "positional brachycephaly."
Cephalic index (CI): A ratio of the maximum width to the head length expressed as a percentage, which 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 (that is, the ophisthocranion), expressed as a percentage. The cranial index can then be compared to normative measures.
Craniosynostosis: A congenital deformity of the infant skull that occurs when the fibrous joints between the bones of the skull (called cranial sutures) close prematurely.
Developmental quotient: A number derived by dividing an individual's developmental age over their chronological age.
Non-synostotic plagiocephaly: A condition where an infant's head becomes deformed due to external forces. In non-synostotic plagiocephaly the joints between the skull bone plates (sutures) remain open, allowing non-surgical correction. This condition is also known as positional plagiocephaly.
Orthotic cranioplasty: A method to correct non-synostotic plagiocephaly through the wearing of a custom-fitted helmet or head band which places constant gentle pressure on the infant's head to assume a more natural skull shape.
Plagiocephaly: A condition characterized by an abnormal head shape, usually flattening on one side of the back of the head, and may be caused by abnormal growth rates of the skull bone plates, or may be due to an infant being placed in the same position for prolonged periods of time. The latter is referred to as "positional plagiocephaly."
Scaphocephaly: A condition characterized by a head shape that is symmetric and disproportionately narrow. May be caused by abnormal growth rates of the skull bone plates, or may be due to an infant being placed in the same position for prolonged periods of time.
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
|Websites for Additional Information|
Ballert Cranial Molding Helmet™
Cranial Shaping Helmet™
Cranial Solutions Orthosis CSO™
Cranial Symmetry System™
Hanger Cranial Band™
O & P Cranial Molding Helmet™
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.
|Reviewed||02/04/2016||Medical Policy and Technology Assessment Committee (MPTAC) review. Removed ICD-9 codes from Coding section.|
|Revised||02/05/2015||MPTAC review. Added medically necessary language for new orthosis when inadequate therapeutic positioning occurs due to head growth and continued benefit is anticipated. Updated Discussion, References, and Definitions sections.|
|Reviewed||02/13/2014||MPTAC review. Updated Discussion and Reference sections.|
|New||02/14/2013||MPTAC review. Initial document development.|