Clinical UM Guideline


Subject: Cranial Remodeling Bands and Helmets (Cranial Orthotics)
Guideline #:  CG-OR-PR-04 Publish Date:    02/27/2019
Status: Reviewed Last Review Date:    01/24/2019


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.

Reconstructive: In this document, procedures are considered reconstructive when intended to address a significant variation from normal related to accidental injury, disease, trauma, treatment of a disease or congenital defect.

Note: Not all benefit contracts include benefits for reconstructive services as defined by this document. Benefit language supersedes this document.

Clinical Indications

Medically Necessary:

The use of an adjustable cranial orthosis is considered medically necessary in the post-operative management of infants following endoscopic repair of craniosynostosis.

The use of cranial orthoses is considered medically necessary as an adjunct to surgical treatment of synostotic skull deformity.


  1. The initial use of cranial orthoses is considered reconstructive:
    1. To treat non-synostotic skull deformity (including plagiocephaly, scaphocephaly, and brachycephaly) when both (1 and 2) of the following apply:
      1. The condition results from disease, trauma, congenital or developmental anomalies, or previous medical therapy; and
      2. The individual meets the following criteria (a) and (b) and (c):
        1. The infant is at least 3 months of age but not greater than 12 months of age; and
        2. Documented failure of at least two (2) months of conservative therapy which includes either (i) or (ii) below:
          1. Two months of physical therapy for infants with associated cervical motion restriction, including initial and final assessment of range of motion; or
          2. Two months of home management with repositioning for infants without cervical motion restriction; and
        3. Anthropomorphic measurements (see discussion section) following conservative management with final measurements indicating ONE of the following:
          1. Symmetry discrepancy of more than 10 mm; or
          2. Cephalic index more than (above or below) two (2) standard deviations from the mean.
  2. A second application of the cranial orthosis is considered reconstructive for infants between 6 and 18 months of age when the following criteria (A and B and C) have been met:
    1. Final post-therapy anthropomorphic measurements (see discussion section) indicating ONE or more of the following (1 or 2):
      1. Symmetry discrepancy of more than 10 mm; or
      2. Cephalic index more than (above or below) two (2) standard deviations from the mean; and
    2. One of the following (1 or 2):
      1. For infants with associated cervical motion restriction, documentation of physical therapy or home exercise program with interval assessment of range of motion since the initial orthotic application; or
      2. For infants without cervical motion restriction, at least two months of home management with repositioning either before or after the initial application; and
    3. If a new orthosis is being requested, documentation of skin complications or inadequate therapeutic positioning due to head growth that cannot be managed or prevented with refitting of the original orthosis, when continued improvement is anticipated.

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.




Cranial cervical orthosis, congenital torticollis type, with or without soft interface material, adjustable range of motion joint, custom fabricated


Cranial remolding orthosis, pediatric, rigid, with soft interface material, custom fabricated, includes fitting and adjustment(s)



ICD-10 Diagnosis



Fracture of skull due to birth injury


Sternomastoid injury due to birth injury




Other congenital deformities of skull, face and jaw


Congenital deformity of sternocleidomastoid muscle (congenital torticollis)




Congenital malformation of skull and face bones, unspecified

Discussion/General Information


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 removing, 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, Mehta 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 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. A total of 6 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 and colleagues (2004) reported a small (n=12) case series comparing outcomes of an open craniectomy for sagittal synostosis utilizing a postoperative cranial orthotic. 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.

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. 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.

Non-Synostotic Plagiocephaly

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.

In a retrospective, nonrandomized controlled study, Teichgraeber and colleagues (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 and colleagues (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.

Hutchison and colleagues (2011) conducted a prospective case series study of 161 subjects with deformational plagio- or brachycephaly. 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 colleagues (2013) conducted a prospective case series study of 346 subjects with nonsynostotic plagiocephaly undergoing cranial orthotic therapy. Their analysis involved stratification of subjects into 7 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 and colleagues (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.

At this time, only one randomized, prospective, comparative clinical trial with blinded assessment has been conducted comparing the use of cranial helmet therapy versus 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.

Freudlsperger and colleagues (2016) conducted a study of 213 infants treated with helmets between 2011 and 2014. The infants were divided into 3 groups by age when therapy was initiated. Group 1 were infants ages 24 weeks or less (n=82), group 2 were infants ages 24-32 weeks (n=75), and group 3 were infants greater than 32 weeks of age (n=56). The groups were then categorized by severity of the Cranial Vault Asymmetry Index (CVAI). The categorization of mild (CVAI 3-7 %), moderate (CVAI 7-12%), and severe (CVAI greater than 12%) were assigned. The duration of treatment on average was 18.1 weeks for Group 1, 18.9 weeks for Group 2, and 19.8 weeks for Group 3. The study indicated Group 1 produced the highest correction rate of 56% and the largest reduction of the initial CVAI was noted in same group of infants with severe plagiocephaly. Group 2 demonstrated an improvement of 59% while Group 3 showed an improvement of 31%. A high statistical significance was observed when the infants were grouped by severity of CVAI (p=0.0001). The authors concluded that starting an early therapy for infants with moderate to severe signs of plagiocephaly is recommended to allow sufficient time for effective helmet therapy.

Han and colleagues (2017) studied the relationship between the starting age of cranial orthotic therapy and effectiveness of treatment in infants with deformational plagiocephaly. The authors retrospectively analyzed the records of 310 infants who underwent cranial-remolding-orthosis therapy between 2010 and 2016. Subjects were categorized by severity of initial plagiocephaly (mild, moderate, and severe) and initiation age (3 months to 9 months). The mean CVAI was the greatest in the 3 month group (10.4 to 3.5%) and shortest in the 9 month group (9.8 to 5.7%). The mean CVAI was significantly lower for the 6-9 month groups than the 3 month group; however, there was not a significant change between the 3-5 month groups. The mean CVAI improvement rate was highest in the 3 month group (67.9%) and lowest in the 9 month group (43.4%). The mean duration of cranial-remolding-orthosis therapy was shortest in the 3 month group (124 days) and longest in the 8 month group (222 days). The authors concluded that starting cranial-remolding-orthosis therapy after 6 months is associated with a longer duration of treatment and decreased rates of CVAI improvement. They found that 5 months was the most optimal age to start treatment for deformational plagiocephaly. The study was limited by the retrospective design, uneven sample size for the different age groups, and lack of strict criteria for treatment termination.

Mackel and colleagues (2017) explored whether cranial helmet therapy initiated before 6 months of age leads to reduced plagiocephaly. The authors retrospectively reviewed the records of 45 infants (age range 3-11 months) who underwent cranial helmet therapy between 2010 and 2015. A total of 21 subjects were < 6 months old at the start of helmet therapy. The CVAI was significantly smaller at the beginning and end of therapy at < 6 months compared to subjects who began therapy after 6 months (7.4 ± 2.9 vs. 9.4 ± 2.1%, p =0.01; 4.5 ± 2.8 vs. 6.4 ± 2.3%, p=0.015). The reduction in CVAI did not significantly vary between groups. The researchers found that an increase in either initial CVAI or age at the initiation of treatment correlated with the final CVAI, but length of helmet wear did not correlate with final CVAI. The authors stated that “among infants who started helmet wear at 4–8 months of age, those who began helmet wear at 6–8 months achieved a similar cranial symmetry in comparison to patients who initiated helmet wear at 4–5 months.” The study was limited by retrospective design, small sample size, and single-center location.

Other Considerations

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.

In a 2016 guideline for the treatment of pediatric positional plagiocephaly, the Congress of Neurological Surgeons (CNS) states:

When judging the totality of the evidence, it appears that currently accepted management of positional plagiocephaly in infants—using conservative therapy (repositioning and physical therapy) for the treatment of mild/moderate deformity in younger infants and reserving helmet therapy for more severe deformity, especially in those older infants who have failed to see improvement with conservative measures—can be justified by the data.

It should be noted that the use of cranial orthoses is not risk-free. Wilbrand and colleagues (2012) conducted a retrospective case series study involving 410 subjects with moderate to severe non-synostotic plagiocephaly. 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.

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 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: Asymmetry 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 (that is, the euryon). The head length is measured from the most prominent point in the median sagittal plane between the supraorbital ridges (that is, the 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.

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:

  1. Balan P, Kushnerenko E, Sahlin P, et al. Auditory ERPs reveal brain dysfunction in infants with plagiocephaly. J Craniofac Surg. 2002; 13(4):520-525.
  2. Cohen SR, Holmes RE, Ozgur BM, et al. Fronto-orbital and cranial osteotomies with resorbable fixation using an endoscopic approach. Clin Plast Surg. 2004; 31(3):429-442.
  3. Couture DE, Crantford JC, Somasundaram A, et al. Efficacy of passive helmet therapy for deformational plagiocephaly: report of 1050 cases. Neurosurg Focus. 2013; 35(4):E4.
  4. Freudlsperger C, Steinmacher S, Saure D, et al. Impact of severity and therapy onset on helmet therapy in positional plagiocephaly. J Craniomaxillofac Surg. 2016; 44(2):110-115.
  5. Govaert B, Michels A, Colla C, van der Hulst R. Molding therapy of positional plagiocephaly: subjective outcome and quality of life. J Craniofac Surg. 2008; 19(1):56-58.
  6. Graham J, Gomez M, Halberg A, et al. Management of deformational plagiocephaly: repositioning versus orthotic therapy. J Pediatr. 2005; 146(2):258-262.
  7. Gupta PC, Foster J, Crowe S, et al. Ophthalmologic findings in patients with nonsyndromic plagiocephaly. J Craniofac Surg. 2003; 14(4):529-532.
  8. Han MH, Kang JY, Han HY, et al. Relationship between starting age of cranial-remolding-orthosis therapy and effectiveness of treatment in children with deformational plagiocephaly. Childs Nerv Syst. 2017; 33(8):1349-1356.
  9. 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):970-980.
  10. Hutchison BL, Stewart AW, Mitchell EA. Deformational plagiocephaly: a follow-up of head shape, parental concern and neurodevelopment at ages 3 and 4 years. Arch Dis Child. 2011; 96(1):85-90.
  11. Jimenez DF, Barone CM, Cartwright CC, Baker L. Early management of craniosynostosis using endoscopic-assisted strip craniectomies and cranial orthotic molding therapy. Pediatrics. 2002; 110(1 Pt 1):97-104.
  12. Jimenez DF, Barone CM. Early treatment of anterior calvarial craniosynostosis using endoscopic-assisted minimally invasive techniques. Childs Nerv Syst. 2007; 23(12):1411-1419.
  13. Kaufman BA, Muszynski CA, Matthews A, Etter N. The circle of sagittal synostosis surgery. Semin Pediatr Neurol. 2004; 11(4):243-248.
  14. Kelly KM, Littlefield TR, Pomatto JK, et al. Importance of early recognition and treatment of deformational plagiocephaly with orthotic cranioplasty. Cleft Palate Craniofac J. 1999; 36(2):127-130.
  15. Kluba S, Kraut W, Reinert S, Krimmel M. What is the optimal time to start helmet therapy in positional plagiocephaly? Plast Reconstr Surg. 2011; 128(2):492-498.
  16. Mackel CE, Bonnar M, Keeny H, et al. The role of age and initial deformation on final cranial asymmetry in infants with plagiocephaly treated with helmet therapy. Pediatr Neurosurg. 2017; 52(5):318-322.
  17. McGarry A, Dixon MT, Greig RJ, et al. Head shape measurement standards and cranial orthoses in the treatment of infants with deformational plagiocephaly. Dev Med Child Neurol. 2008; 50(8):568-576.
  18. Mehta VA, Bettegowda C, Jallo GI, Ahn ES. The evolution of surgical management for craniosynostosis. Neurosurg Focus. 2010; 9(6):E5.
  19. Miller RI, Clarren SK. Long-term developmental outcomes in patients with deformational plagiocephaly. Pediatrics. 2000; 105(2):E26.
  20. Moss, DS. Nonsurgical, nonorthotic treatment of occipital plagiocephaly: what is the natural history of the misshapen neonatal head? J Neurosurg. 1997; 87(5):667-670.
  21. Murad GJ, Clayman M, Seagle MB, et al. Endoscopic-assisted repair of craniosynostosis. Neurosurg Focus. 2005; 19(6):E6.
  22. Ridgway EB, Berry-Candelario J, Grondin RT, et al. The management of sagittal synostosis using endoscopic suturectomy and postoperative helmet therapy. J Neurosurg Pediatr. 2011; 7(6):620-626.
  23. Schweitzer T, Böhm H, Linz C, et al. Three-dimensional analysis of positional plagiocephaly before and after molding helmet therapy in comparison to normal head growth. Childs Nerv Syst. 2013; 29(7):1155-1161.
  24. Seruya M, Oh AK, Taylor JH, et al. Helmet treatment of deformational plagiocephaly: the relationship between age at initiation and rate of correction. Plast Reconstr Surg. 2013; 131(1):55e-61e.
  25. Seymour-Dempsey K, Baumgartner JE, Teichgraeber JF, et al. Molding helmet therapy in the management of sagittal synostosis. J Craniofac Surg. 2002; 13(5):631-635.
  26. Steinbok, P, Lam D, Singh S, et al. Long-term outcome of infants with positional occipital plagiocephaly. Childs Nerv Syst. 2007; 23(11):1275-1283.
  27. Teichgraeber JF, Ault JK, Baumgartner J, et al. Deformational posterior plagiocephaly: diagnosis and treatment. Cleft Palate Craniofac J. 2002; 39(6):582-586.
  28. van Wijk RM, van Vlimmeren LA, Groothuis-Oudshoorn CG, et al. Helmet therapy in infants with positional skull deformation: randomised controlled trial. BMJ. 2014; 348:g2741.
  29. Wilbrand JF, Wilbrand M, Malik CY, et al. Complications in helmet therapy. J Craniomaxillofac Surg. 2012; 40(4):341-346.
  30. Xia JJ, Kennedy KA, Teichgraeber JF, et al. Nonsurgical treatment of deformational plagiocephaly: a systematic review. Arch Pediatr Adolesc Med. 2008; 162(8):719-727.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Academy of Orthotists and Prosthetists (AAOP). Orthotic treatment of deformational plagiocephaly, brachycephaly and scaphocephaly. Clinical Standards of Practice (CSOP) Consensus Conference on Orthotic Management of Plagiocephaly, 2004. For additional information visit the AAOP website: Accessed on November 16, 2017.
  2. American Academy of Orthotists and Prosthetists (AAOP). Standard deviation table for cephalic index. For additional information visit the AAOP website: Accessed on November 16, 2017.
  3. Centers for Medicare and Medicaid Services (CMS). Early and periodic screening, diagnosis & treatment. Available at: Accessed on November 2, 2018.
  4. Flannery AM, Tamber MS, Mazzola C, et al. Congress of Neurological Surgeons systematic review and evidence-based guidelines for the management of patients with positional plagiocephaly: executive summary. Neurosurgery. 2016; 79(5):623-624.
  5. 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; 128(6):1236-1241.
Websites for Additional Information
  1. American Academy of Neurological Surgeons (AANS). Craniosynostosis and craniofacial disorders. Available at:‌Craniosynostosis%20and%20Craniofacial%20Disorders.aspx. Accessed on November 2, 2018.
  2. American Academy of Neurological Surgeons (AANS). Positional plagiocephaly. Available at: Accessed on November 2, 2018.
  3. National Library of Medicine. Medical Encyclopedia. Cranial sutures. Available at: Accessed on November 2, 2018.
  4. National Institute of Neurological Disorders and Stroke (NINDS). Craniosynostosis information page. Available at: Accessed on November 2, 2018.

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. 







Medical Policy & Technology Assessment Committee (MPTAC) review. Updated formatting in Clinical Indications section. Coding, Discussion/General Information, References, and Websites sections updated.



MPTAC review. The document header wording updated from “Current Effective Date” to “Publish Date.” Updated Discussion/General Information, References and Website sections.



MPTAC review. Added “Reconstructive” section and included criteria for non-synostotic skull deformity. In the “Reconstructive” section, the criterion for documentation of gross motor development expressed as developmental quotient during the interval since the initial application was removed and added language of at least two months of home management with repositioning either before or after the initial application for infants without cervical motion restriction. In the “Medically Necessary” section, added language for the use of an adjustable cranial orthosis is considered medically necessary in the post-operative management of infants following endoscopic repair of craniosynostosis. Updated formatting in the “Clinical Indications” section. Updated Discussion and References section.



MPTAC review. Removed ICD-9 codes from Coding section.



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.



MPTAC review. Updated Discussion and Reference sections.



MPTAC review. Initial document development.