Pending Policies - DME


Cranial Remodeling Orthoses (CRO)

Number:DME103.007

Effective Date:08-15-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

As an adjunctive post-surgical therapy for synostotic plagiocephaly or hydrocephalus, a cranial remodeling orthosis (CRO) may be considered medically necessary.

As a non-surgical treatment of non-synostotic positional plagiocephaly, a CRO will be eligible for coverage when banding is initiated at 4 to 18 months of age for moderate to severe positional head deformities.

Required Documentation for Non-Surgical Requests:

All requests seeking coverage (if there are no benefit restrictions) of a CRO for a non-surgical indication must include all required documentation before a medical necessity determination can be made:

Failed conservative therapy of no less than 2 months by:

1. Repositioning the infant’s head to the opposite of the infant’s preferred position when either lying down, reclined, or sitting; and

2. Performing neck exercises at each diaper change; and

3. Repositioning the infant’s bed encouraging the infant to look away from the flattened side to view individuals in the room; and

Either one of the following sets of measurements or indications:

1. Asymmetrical appearance confirmed by a right/left discrepancy of greater than 6 mm in any craniofacial anthropometric measurement; or

2. Brachycephalic or dolichocephalic disproportion (comparison of head length versus head width) confirmed by a cephalic index of 2 standard deviations above mean or 2 standard deviations below mean.

NOTE 1: Measurements are usually obtained by the physician or orthotist fitting the helmet or headband.

EXCEPTION: TEXAS CHIP and Medicaid (STAR) contracts only: The following directives are required when reviewing patients under the Texas Children’s Health Insurance Program (CHIP) or Medicaid State of Texas Access Reform (STAR) Program:

CHIP – Cranial remolding orthotics are a non-covered service or benefit.

Medicaid STAR – Per Texas Medicaid Bulletin Number 240, March/April 2012, page 14, “Cranial remolding orthosis…, is no longer a benefit for the treatment of positional plagiocephaly as position plagiocephaly is considered cosmetic. Cranial remolding orthosis is allowed for synostotic plagiocephaly.

Description:

Cranial remodeling orthoses (CRO) are usually in the shape of an adjustable helmet or headband that progressively molds the shape of the infant cranium by applying corrective forces to prominences while leaving room for growth in the adjacent flattened areas. A CRO device may be requested for the treatment of positional plagiocephaly (craniosynostosis) or post-surgical synostosis (fusion of 2 bones) in pediatric patients.

Craniosynostosis

An asymmetrically shaped head may be synostotic or nonsynostotic. Synostosis, defined as premature closure of the sutures of the cranium, may result in functional deficits secondary to increasing intracranial pressure in an abnormally or asymmetrically shaped cranium. The type and degree of craniofacial deformity depends on the type of synostosis. The most common is scaphocephaly, a narrowed and elongated head resulting from synostosis of the sagittal suture. Trigonocephaly, in contrast, is premature fusion of the metopic suture and results in a triangular shape of the forehead. Unilateral synostosis of the coronal suture results in an asymmetric distortion of the forehead called plagiocephaly, and fusion of both coronal sutures results in brachycephaly. Combinations of these deformities may also occur.

Treatment

Synostotic deformities associated with functional deficits are addressed by surgical remodeling of the cranial vault. The remodeling (reshaping) is accomplished by opening and expanding the abnormally fused bone.

In a review of the treatment of craniosynostosis, Persing (2008) indicated that premature fusion of 1 or more cranial vault sutures occurs in approximately 1 in 2500 births. (1) Of these craniosynostoses, asymmetric deformities involving the cranial vault and base (e.g., unilateral coronal synostosis) will have a higher rate of post-operative deformity, which would require additional surgical treatment. Persing suggested that use of cranial orthoses post-operatively may serve 2 functions:

1. They protect the brain in areas of large bony defects, and

2. They may remodel the asymmetries in skull shape, particularly when the bone segments are more mobile.

Plagiocephaly

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. Positional plagiocephaly typically consists of right or left occipital flattening with advancement of the ipsilateral ear and ipsilateral frontal bone protrusion, resulting in visible facial asymmetry. Occipital flattening may be self-perpetuating in that once it occurs, it may be increasingly difficult for the infant to turn and sleep on the other side. Bottle feeding, a low proportion of “tummy time” while awake, multiple gestations, and slow achievement of motor milestones may contribute to positional plagiocephaly. The incidence of plagiocephaly has increased rapidly in recent years; this is believed to be a result of the “Back to Sleep” campaign recommended by the American Academy of Pediatrics (AAP), in which a supine sleeping position is recommended to reduce the risk of sudden infant death syndrome. It has been suggested that increasing awareness of identified risk factors and early implementation of good practices will reduce the development of deformational plagiocephaly.

Treatment

It is estimated that about two-thirds of plagiocephaly cases may auto-correct spontaneously after regular changes in sleeping position or following physical therapy aimed at correcting neck muscle imbalance. A cranial orthotic device is usually requested after a trial of repositioning fails to correct the asymmetry, or if the child is too immobile for repositioning.

Craniofacial Anthropometric Measurement Determination and Device Customization

Infants with positional plagiocephaly may exhibit complex and multiple asymmetries affecting the cranial vault, skull base, and face, such as unilateral flattening or bossing (protruding) of head areas with or without head tilting. The first step in determining whether a CRO device is needed is to complete craniofacial anthropometric measurements and calculate the cephalic index, in addition to standard or routine measurements of the head circumference. The measurements may be done manually or by using a specialized laser digitalized scanner.

The craniofacial anthropometric measurement of the head (skull and face) is the comparison of right and left sides by measuring the distance in millimeters from one side of the face or skull to another. The primary areas measured and asymmetry (a discrepancy of 6-12 mm) is calculated, as shown in the following Table 1:

Table 1: Craniofacial Anthropometric Measurement. (53)

Craniofacial Area

Anthropometric Measurement

Determines Asymmetry

Calculated

Cranial (skull) base

from right and left subnasal (sn) point (midline under the nose) to tragus (t) (the cartilaginous projection in front of the external auditory canal)

upper jaw depth or right and left face height

sn to left t minus

sn to right t

Cranial vault

from right and left frontozygomaticus (fz) point (forehead just above the eye orbit) to right and left euryon (eu) (most lateral point of the head)

bones of the skull enclosing the brain

left fz to right eu minus right fz to left eu

Orbitotragial depth or distances

from right and left exocanthion (ex) point (outer point of the eye where the eyelids meet) to tragus (t)

cheek bones below the eyes

left ex to left t minus right ex to right t

Table Key (with full explanation following below as part of cephalic index):

sn: subnasal.

t: targus.

fz: frontozygomaticus.

eu: euryon.

ex: exocanthion.

The cephalic index is the ratio of the width of the head to its length, using head width measurement from euryon (eu) on one side of head to eu on other side of head versus head length measurement from glabella (g) point to opisthocranion (op). Expressed in a percentile number, the cephalic index is calculated by head width multiplied by 100 and divided by head length, as shown in the following equation:

“(Head width [eu to eu] x 100) divided by (Head length [g to op])”

The cephalic index is considered abnormal (the head shape may not be asymmetrical) if it is two standard deviations (SD) above or below the mean measurements (mean being appropriate to gender/age). Therefore, cephalic indices are categorized as a measurement of:

Above 80 is considered being brachycephalic or broad (head width wider for head length);

Between 75 and 80 is considered being mesaticephalic (head of medium width and length); and

Below 75 is considered being dolichocephalic or long (head width narrow for head length).

The ± standard deviations with the mean of cephalic indices are shown on the following Table 2:

Table 2: Cephalic Indices (53)

Gender

Age

- 2 SD

- 1 SD

Mean

+ 1 SD

+ 2 SD

Male

16 days to 6 months

63.7

68.7

73.7

78.7

83.7

6 to 12 months

64.8

71.4

78.0

84.6

91.2

Female

16 days to 6 months

63.9

68.6

73.3

78.0

82.7

6 to 12 months

69.5

74.0

78.5

83.0

87.5

Table Key:

SD: Standard deviation.

The cranial index is the same ratio taken on the skull.

The CRO device has also been proposed as a post-operative complement for those patients undergoing surgery for synostotic plagiocephaly or hydrocephalus.

The CRO device is customized to the patient's head shape. It is fabricated either from a plaster of paris impression, or by computer models from scanned measurements using a semi-rigid outer shell bonded to a foam inner lining. This lightweight cranial headband applies dynamic pressure to the elevated areas, while leaving space for growth and remodeling of the flattened areas. The average treatment timeline using a CRO device is approximately four to five months and is typically initiated around five to six months of age. Both helmets and cranial bands are recommended for wear 23 hours per day. As the infant ages, the helmet or band will require adjustments or replacement to accommodate the cranial growth. Throughout the treatment course, the head shape may be compared to a computer model from the manual or scanned measurements. An exit head casting is done at the completion of the therapy course.

Regulatory Status

Several devices cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process are intended to apply passive pressure to prominent regions of an infant’s cranium to improve cranial symmetry and/or shape in infants from 3 to 18 months of age. FDA product code: MVA.

The CRO device is known by several different names, such as:

DOC Band™ (Dynamic Orthotic Cranioplasty Band),

STARband™ or STARlight™,

PAP Orthosis (Plagiocephalic Applied Pressure Orthosis),

CSO (Cranial Solutions Orthosis),

Cranial Shaping/Molding Helmet,

Cranial Band,

Cranial Symmetry System,

CranioCap™.

Rationale:

This policy was created in 1996 based upon scientific literature searches using the MedLine database and professional guidelines; and has been updated regularly. The most recent search of the scientific literature was performed through July 2018. The following is a summary of key literature, clinical input and professional guidelines.

Medical policies assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function--including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

In order to validate this specific treatment, a controlled group case series is considered particularly important to compare outcomes since mild positional molding may self-correct over time or become in apparent due to hair growth. One needs only to examine the heads in the adult population to realize that the number of appreciable asymmetry is far less in this age range than in the neonatal population. The deduction is that the natural remodeling process of the human head must correct many of the deformities seen in childhood. Repositioning has been shown to be as effective in restoring symmetry to the cranium.

There are case studies of infants with mild to moderate abnormalities exhibiting successful correction of asymmetries when using a cranial remodeling orthosis (CRO) device. Moderate to severe abnormalities may require a combination use of surgery and a CRO device to prevent regression of the repair post-operatively. Positional plagiocephaly does not pose a threat to the child's physical health. There are no published data on the effects of positional plagiocephaly on neuropsychological deficits, developmental delay, temporomandibular joint disorders, or psychosocial concerns related to a perceived abnormal appearance. The major reason for intervention is to optimize the cranial contour to achieve an acceptable appearance, not to prevent or correct adverse developmental consequences.

A Blue Cross Blue Shield Association (BCBSA) Technology Evaluation Center (TEC) 1999 Assessment concluded that the evidence regarding adjustable cranial orthoses as a treatment of positional plagiocephaly was insufficient to permit conclusions. (2) Literature has attempted to describe the effectiveness of the CRO device as both an adjunct to infant cranial surgery and as a nonsurgical alternative.

Cranial Orthoses for Craniosynostosis

Early literature consisted of a few case series that described the use of cranial orthoses following either open or endoscopically assisted surgery for craniosynostosis. For example, Kaufman et al. (2004) reported on 12 children who used a cranial orthosis for 1 year after extended strip craniectomy. (3) They found that the orthoses improved Cephalic Index score (100 times the ratio of cranial biparietal diameter and occipitofrontal diameter) more than a similar type of surgery without an orthosis reported elsewhere. The Cephalic Index score improved by 4 (range, 67-71) from baseline to 1 year in studies using surgery alone but improved by 10 (range, 65-75) with combined treatment (Cephalic Index normal range, 75-90). Stevens et al. (2007) reported on a study that evaluated 22 patients from a single institution, on the effect of post-operative remolding orthoses following total cranial vault remodeling. (4) The children’s ages at the time of surgery ranged from 4 to 16 months (average age, 7.5 months). For the 15 (68%) of 22 children treated who completed helmet use and were not lost to follow-up, helmets were worn an average of 134 days. Summary analyses were not provided, because each patient case differed by location of fused suture, extent and duration of the fusion, and surgical methods used.

Jimenez et al. (2002, 2007, 2012) reported on routine use of helmets for 12 months following endoscopically assisted surgery for craniosynostosis in 256 consecutive children. (5-7) Anthropomorphic measurements at 3, 6, 9, and 12 months after surgery showed continued improvement in symmetry in most patients. Jimenez and Barone (2010) reported on treatment of 21 infants with multiple-suture (nonsyndromic) craniosynostosis with endoscopically-assisted craniectomies and post-operative cranial orthoses. (8) Helmet therapy lasted an average of 11 months (range, 10-12 months). The decision to discontinue therapy was based on the child reaching the 12-month post-operative mark or 18 months of age. After the first year post-surgery, patients were followed annually or biannually (range, 3-135 months). The mean preoperative Cephalic Index score was 98. The post-operative Cephalic Index score (>1 year) was 83, a 15% decrease from baseline.

Since these initial reports, literature updates have identified larger series describing endoscopically-assisted strip craniectomy and post-operative helmet therapy for craniosynostosis. They include a series of 97 children with nonsyndromic single-suture synostosis reported by Gociman et al. (2012) and a series of 73 children reported by Honeycutt (2014). (9, 10) Honeycutt asserted that because head-shape correction occurs slowly after surgery, helmet therapy is as important as the surgery to remove the abnormal suture.

Shah et al. (2011) prospectively collected outcomes from endoscopically-assisted versus open repair of sagittal craniosynostosis in 89 children treated between 2003 and 2010. (11) The endoscopic procedure was offered starting in 2006, and has become the most commonly performed approach. The 42 patients treated with open-vault reconstruction had a mean age at surgery of 6.8 months and a mean follow-up of 25 months. Mean age of the 47 endoscopically treated patients at surgery was 3.6 months and a mean follow-up was 13 months. Of the 29 endoscopically treated patients who completed helmet therapy, the mean duration for helmet therapy was 8.7 months. Noncompliance with helmet therapy has also been reported in a substantial proportion of patients. (12)

Section Summary: Cranial Orthoses for Craniosynostosis

The evidence on the efficacy of cranial orthoses following endoscopically assisted or open cranial vault remodeling surgery for craniosynostosis is limited and includes only case series. In the post-operative period after craniosynostosis repair, the role of cranial orthoses is to continue remodeling the skull after surgery. Functional impairments are related to craniosynostosis, including the potential for increased intracranial pressure and risk of harm from additional surgery when severe deformity has not been corrected. This indirect evidence is considered sufficient to suggest an improvement in health outcomes with post-surgical use of cranial orthosis for craniosynostosis.

Cranial Orthoses for Positional Plagiocephaly

Results from a pragmatic multicenter, single-blinded, RCT (HEADS [HElmet therapy Assessment in Deformed Skulls]) were reported in 2014. (13) The trial included 84 infants ages 5 to 6 months with moderate-to-severe skull deformation (oblique diameter difference index ≥108% or cranioproportional index ≥95%) who were randomized to cranial orthoses for 6 months or to the natural course (observation). It should be noted that 3% of infants recruited were excluded from the trial due to very severe deformation (oblique diameter difference index >113% or cranioproportional index >104%). Of the 42 infants randomized to a cranial orthosis, 10 (23%) wore a cranial orthosis until 12 months of age. Parents of 10 infants discontinued treatment before 12 months due to adverse events. The primary outcome (change score for plagiocephaly [oblique diameter difference index] and brachycephaly [cranioproportional index] at 24 months) was similar for the 2 groups. Full recovery was reported for 26% of children in the orthoses group and 23% of children in the observation arm (odds ratio, 1.2; 95% confidence interval, 0.4 to 3.3; p=0.74).

A systematic review by McGarry et al. (2008) described 9 publications involving the use of cranial orthoses. (14) More than half of the studies were retrospective cohorts; none was randomized. For studies comparing orthoses with active counter positioning, one reported greater decreases in posterior cranial asymmetry (from 12 to 0.6 mm) than treatment of infants using repositioning alone (from 12 to 10 mm); other studies found faster, but ultimately similar, reductions in asymmetry with helmets. (15, 16) Another 2008 systematic review identified 7 cohort studies meeting selection criteria. (17) In most studies, physicians offered (and parents elected) the method of treatment, resulting in a bias toward older infants and greater deformity in the molding groups. One study (2005) included 159 infants with molding therapy and 176 treated with repositioning and physical therapy. (18) Molding therapy was recommended for infants older than 6 months with more severe deformity, and repositioning was recommended for infants 4 months or younger. Both treatments were offered for infants between 4 and 6 months of age, although anthropomorphic measurements indicated that molding therapy was effective in 93% of infants, while repositioning was effective in 79% of infants. In this review, the relative risk was 1.3 favoring molding therapy. A prospective longitudinal study by Kluba et al. (2014) evaluated 128 infants treated with or without a helmet; authors found that, although children treated with a helmet had more severe asymmetry originally, they showed significantly more improvement (68% versus 31%). (19) In a study of 1050 infants, Couture et al. (2013) reported on the successful use of off-the-shelf helmet therapy. (20) Infants with an Argenta classification type I (minimal deformity) were treated with repositioning while infants with an Argenta severity rating of II to V were treated with a helmet. Correction (overall rate, 81.6%) took longer in patients with an Argenta severity of III, IV, and V compared with Argenta type II, but was not significantly affected by age.

Positional Plagiocephaly and Functional Outcomes

Since publication of the BCBSA TEC Assessment (1999), few studies have examined the association between positional plagiocephaly and functional impairments. Some, such as that by Fowler et al. (2008), found no difference in the neurologic profile, posture, or behavior of 49 infants with positional plagiocephaly compared with 50 age-matched concurrent controls. (21)

Other studies have compared developmental outcomes in children using positional plagiocephaly with normative values. Panchal et al. (2001) reported that scores from a standardized measure of mental and psychomotor development differed significantly from the expected standardized distribution, with 8.7% of children categorized as severely delayed on the Mental Development Index compared with the expected 2.5%. (22) A study by Miller and Clarren (2000) obtained responses on long-term developmental outcomes in 63 of 181 children asked to participate in this study. (23) Results were limited by the lack of concurrent controls and potential self-selection population bias. In addition, these studies did not evaluate the possible causal relation for the observed association. For example, children with preexisting development delays or weakness might be at a higher risk for plagiocephaly if they were more apt to lie in 1 position for extended periods of time.

The effect of treatment for positional plagiocephaly on health outcomes has also been investigated. For example, Shamij et al. (2012) surveyed parents of 80 children treated for positional plagiocephaly to assess cosmetic outcome, school performance, language skills, cognitive development, and societal function. (24) Analysis indicated that the children of respondents were representative of the total pool. Positional therapy was applied in all children, while 36% also used helmet therapy. At a median follow-up of 9 years, normal head appearance was reported in 75% of cases. Compared with right-sided deformation, left-sided plagiocephaly was associated with a need for special education classes (27% versus 10%), fine motor delay (41% versus 22%), and speech delay (36% versus 16%).

Section Summary: Cranial Orthoses for Positional Plagiocephaly

Results from the HEADS trial have suggested that, in a practice setting, the effectiveness of a cranial orthoses may not differ from the natural course of development for infants with moderate to severe plagiocephaly and brachycephaly. However, the validity of these results is limited by the low percentage of infants who wore the cranial orthoses for the duration of the trial and the relatively low percentage of infants who achieved recovery in either group. In addition, the efficacy of cranial orthoses in infants with very severe plagiocephaly was not addressed. A few reports have assessed the association between positional plagiocephaly and functional impairments. The largest controlled study found no difference in function between infants with plagiocephaly and age-matched concurrent controls. While some series have suggested an association between plagiocephaly and developmental delay, they lacked controls and did not evaluate the possible causal relation to observed association. Results of a study on right-sided versus left-sided plagiocephaly suggested an association between left-sided and functional performance, but these results would need corroboration.

Clinical Input Received from Physician Specialty Societies and Academic Medical Centers

While the BCBSA policy was under review in 2008, clinical input was received from 3 physician specialty societies (4 reviews) and 2 academic medical centers. Input was mixed about whether the use of helmets/adjustable banding for treatment of plagiocephaly or brachycephaly without synostosis should be considered medically necessary or not medically necessary. Clinical input agreed that cranial orthoses may be indicated following cranial vault surgery.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 3.

Table 3. Summary of Key Trials

NCT Number

Trial Name

Planned Enrollment

Completion Date

Unpublished

NCT02370901a

Cranial Orthotic Device Versus Repositioning Techniques for the Management of Plagiocephaly: the CRANIO Randomized Trial

226

Nov 2020

Trial Key:

NCT: National Clinical Trial;

a: Denotes industry-sponsored or cosponsored trial.

Practice Guidelines and Position Statements

Congress of Neurological Surgeons et al.

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. (25, 26) 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 RCT, 5 prospective comparative studies, and 9 retrospective comparative studies (all rated as class II evidence).

National Institute of Neurological Disorders and Stroke (NINDS)

The NINDS (2017) has stated that “Treatment for craniosynostosis generally consists of surgery to improve the symmetry and appearance of the head and to relieve pressure on the brain and the cranial nerves [although] for some children with less severe problems, cranial molds can reshape the skull to accommodate brain growth and improve the appearance of the head.” (27)

National Health Service Quality Improvement

In 2007, Scotland’s National Health Service Quality Improvement issued an evidence note on the use of cranial orthosis treatment for infant deformational plagiocephaly. (28) No evidence-based conclusions could be reached due to the limited methodologic quality of available trials.

American Academy of Pediatrics (AAP)

In 2011, the AAP revised its 2003 policy on the prevention and management of positional skull deformities in infants. (29, 30) The AAP indicated that, in most cases, the diagnosis and successful management of deformational plagiocephaly can be assumed by the pediatrician or primary health care clinician and that mechanical methods, if performed early in life, may prevent further skull deformity and may reverse existing deformity. In most cases, an improvement is seen over a 2- to 3-month period with repositioning and neck exercises, especially if these measures are instituted as soon as the condition is recognized. The AAP indicated that use of helmets and related devices seems to be beneficial primarily when there has been a lack of response to mechanical adjustments and exercises, and the best response to helmets occurs in the age range of 4 to 12 months of age.

In a 2011 policy statement, the AAP indicated that consideration should be given to early referral of infants with plagiocephaly when it is evident that conservative measures have been ineffective, because orthotic devices may help avoid the need for surgery in some cases. (31) The AAP also recommended placing infants on their backs for sleep with supervised “tummy time” for the prevention of plagiocephaly.

Summary of Evidence

For individuals who have open or endoscopic surgery for craniosynostosis who receive a postoperative cranial orthosis, the evidence includes case series. Relevant outcomes are change in disease status, morbid events, functional outcomes, quality of life, and treatment-related morbidity. Overall, the evidence on the efficacy of cranial orthoses following endoscopic-assisted or open cranial vault remodeling surgery for craniosynostosis is limited. However, functional impairments are related to craniosynostosis, and there is a risk of harm from additional surgery when severe deformity has not been corrected. Because cranial orthoses can facilitate remodeling, use of a cranial orthosis is likely to improve outcomes after cranial vault remodeling for synostosis. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have positional plagiocephaly who receive a cranial orthosis, the evidence includes a comparative study and case series. Relevant outcomes are change in disease status, morbid events, functional outcomes, quality of life, and treatment-related morbidity. Overall, evidence on an association between positional plagiocephaly (non-surgical use of cranial remodeling orthoses [CRO] devices) and health outcomes is limited. The largest controlled study found no difference in function between infants with plagiocephaly and age-matched concurrent controls. 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. However, case studies of infants with mild to moderate abnormalities have demonstrated successful correction of asymmetries with CRO device use. Additionally, professional society guidelines indicate that the use of these types of devices in the management of deformational plagiocephaly can be beneficial. The evidence is sufficient to determine the effects of the technology on health outcomes.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage versus. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

97799

HCPCS Codes

S1040

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Persing JA. MOC-PS(SM) CME article: management considerations in the treatment of craniosynostosis. Plast Reconstr Surg. Apr 2008; 121(4 Suppl):1-11. PMID 18379381

2. Cranial Orthosis for Plagiocephaly without Synostosis. Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Center Assessment Program (2000 February) 14(21): 1-21.

3. Kaufman BA, Muszynski CA, Matthews A, et al. The circle of sagittal synostosis surgery. Semin Pediatr Neurol. Dec 2004; 11(4):243-8. PMID 15828707

4. Stevens PM, Hollier LH, Stal S. Post-operative use of remoulding orthoses following cranial vault remodeling: a case series. Prosthet Orthot Int. Dec 2007; 31(4):327-41. PMID 18050005

5. Jimenez DF, Barone CM, Cartwright CC, et al. Early management of craniosynostosis using endoscopic-assisted strip craniectomies and cranial orthotic molding therapy. Pediatrics. Jul 2002; 110(1 Pt 1):97-104. PMID 12093953

6. Jimenez DF, Barone CM. Early treatment of anterior calvarial craniosynostosis using endoscopic-assisted minimally invasive techniques. Childs Nerv Syst. Dec 2007; 23(12):1411-9. PMID 17899128

7. Jimenez DF, Barone CM. Endoscopic technique for sagittal synostosis. Childs Nerv Syst. Sep 2012; 28(9):1333-9. PMID 22872245

8. Jimenez DF, Barone CM. Multiple-suture nonsyndromic craniosynostosis: early and effective management using endoscopic techniques. J Neurosurg Pediatr. Mar 2010; 5(3):223-31. PMID 20192637

9. Gociman B, Marengo J, Ying J, et al. Minimally invasive strip craniectomy for sagittal synostosis. J Craniofac Surg. May 2012; 23(3):825-8. PMID 22565892

10. Honeycutt JH. Endoscopic-assisted craniosynostosis surgery. Semin Plast Surg. Aug 2014; 28(3):144-9. PMID 25210508

11. Shah MN, Kane AA, Petersen JD, et al. Endoscopically assisted versus open repair of sagittal craniosynostosis: the St. Louis Children's Hospital experience. J Neurosurg Pediatr. Aug 2011; 8(2):165-70. PMID 21806358

12. Chan JW, Stewart CL, Stalder MW, et al. Endoscope-assisted versus open repair of craniosynostosis: a comparison of perioperative cost and risk. J Craniofac Surg. Jan 2013; 24(1):170-4. PMID 23348279

13. van Wijk RM, van Vlimmeren LA, Groothuis-Oudshoorn CG, et al. Helmet therapy in infants with positional skull deformation: randomised controlled trial. BMJ. May 1 2014; 348:g2741. PMID 24784879

14. 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. Aug 2008; 50(8):568-76. PMID 18754893

15. Mulliken JB, Vander Woude DL, Hansen M, et al. Analysis of posterior plagiocephaly: deformational versus synostotic. Plast Reconstr Surg. Feb 1999; 103(2):371-80. PMID 9950521

16. Loveday BP, de Chalain TB. Active counterpositioning or orthotic device to treat positional plagiocephaly? J Craniofac Surg. Jul 2001; 12(4):308-13. PMID 11482615

17. Xia JJ, Kennedy KA, Teichgraeber JF, et al. Nonsurgical treatment of deformational plagiocephaly: a systematic review. Arch Pediatr Adolesc Med. Aug 2008; 162(8):719-27. PMID 18678803

18. Graham JM, Jr., Gomez M, Halberg A, et al. Management of deformational plagiocephaly: repositioning versus orthotic therapy. J Pediatr. Feb 2005; 146(2):258-62. PMID 15689920

19. Kluba S, Kraut W, Calgeer B, et al. Treatment of positional plagiocephaly--helmet or no helmet? J Craniomaxillofac Surg. Jul 2014; 42(5):683-8. PMID 24238984

20. Couture DE, Crantford JC, Somasundaram A, et al. Efficacy of passive helmet therapy for deformational plagiocephaly: report of 1050 cases. Neurosurg Focus. Oct 2013; 35(4):E4. PMID 24079783

21. Fowler EA, Becker DB, Pilgram TK, et al. Neurologic findings in infants with deformational plagiocephaly. J Child Neurol. Jul 2008; 23(7):742-7. PMID 18344457

22. Panchal J, Amirsheybani H, Gurwitch R, et al. Neurodevelopment in children with single-suture craniosynostosis and plagiocephaly without synostosis. Plast Reconstr Surg. Nov 2001; 108(6):1492-8; discussion 1499-1500. PMID 11711916

23. Miller RI, Clarren SK. Long-term developmental outcomes in patients with deformational plagiocephaly. Pediatrics. Feb 2000; 105(2):E26. PMID 10654986

24. Shamji MF, Fric-Shamji EC, Merchant P, et al. Cosmetic and cognitive outcomes of positional plagiocephaly treatment. Clin Invest Med. Oct 6 2012; 35(5):E266. PMID 23043707

25. Tamber MS, Nikas D, Beier A, et al. The role of cranial molding orthosis (helmet) therapy (2016). Congress of Neurological Surgeons. Available at: <https://www.cns.org> (Accessed on July 11, 2018).

26. Tamber MS, Nikas D, Beier A, et al. Guidelines: Congress of Neurological Surgeons systematic review and evidence-based guideline on the role of cranial molding orthosis (helmet) therapy for patients with positional plagiocephaly. Neurosurgery. Nov 2016; 79(5):E632-3. PMID 27759675

27. NINDS – Craniosynostosis information page (2017). National Institute of Neurological Disorders and Stroke. Available at: <https://www.ninds.nih.gov> (Accessed on July 11, 2018).

28. The use of cranial orthosis treatment for infant deformational plagiocephaly (Evidence Note No. 16. June 25, 2007, Published May 2007). NHS Quality Improvement Scotland. Available at: <http://www.healthcareimprovementscotland.org> (Accessed on July 11, 2018).

29. Persing J, James H, Swanson J, et al. 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. Pediatr. Jul 2003; 112 (1 Part 1):199-202. PMID 12837890

30. Laughlin J, Luerssen TG, Dias MS, et al. Prevention and management of positional skull deformities in infants. Pediatrics. Dec 2011; 128(6):1236-41. PMID 22123884

31. American Academy of Pediatrics Task Force on Sudden Infant Death Syndrome. SIDS and Other Sleep-Related Infant Deaths: Expansion of Recommendations for a Safe Infant Sleeping Environment. Pediatr. Nov 1 2011; 128 (5):1030-9. PMID 22007004

32. Adjustable Cranial Orthoses for Positional Plagiocephaly and Craniosynostoses. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (March 2018) Durable Medical Equipment 1.01.11.

Policy History:

Date Reason
8/15/2018 Document updated with literature review. Coverage unchanged. References 13-28, and 30 added; numerous references removed.
4/15/2017 Reviewed. No changes.
8/1/2016 Document updated with literature review. Coverage unchanged.
2/1/2015 Reviewed. No changes.
10/15/2013 Literature reviewed. No changes. Title changed from Cranial Remolding Orthosis (CRO) Device.
7/1/2008 Revised/updated entire document
5/1/2007 Coverage revised (photographic evidence requirement removed).
7/1/2005 Revised/updated entire document
8/15/2003 Revised/updated entire document
9/1/1999 Revised/updated entire document
6/1/1999 Revised/updated entire document
5/1/1996 Revised/updated entire document
1/1/1996 New medical document

Archived Document(s):

Title:Effective Date:End Date:
Cranial Remodeling Orthosis (CRO)04-15-201708-14-2018
Cranial Remodeling Orthosis (CRO)08-01-201604-14-2017
Cranial Remodeling Orthosis (CRO)02-01-201507-31-2016
Cranial Remodeling Orthosis (CRO)10-15-201301-31-2015
Cranial Remolding Orthosis (CRO) Device07-01-200810-14-2013
Cranial Remolding Orthosis (CRO) Device05-01-200706-30-2008
Cranial Remolding Orthosis (CRO) Device07-01-200504-30-2007
Cranial Remolding Orthosis (CRO) Device08-15-200306-30-2005
Back to Top