Adjustable Cranial Orthoses for Positional Plagiocephaly and Craniosynostoses

POLICY NUMBER

A.1.01.11

DESCRIPTION

Cranial orthoses involve an adjustable helmet or band 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 cranial orthotic device may be used to treat postsurgical synostosis or positional plagiocephaly in pediatric patients.

Craniosynostoses

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 increased 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 a 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 indicated that premature fusion of one or more cranial vault sutures occurs in approximately 1 in 2,500 births. Of these craniosynostoses, asymmetric deformities involving the cranial vault and base (e.g., unilateral coronal synostosis) will have a higher rate of postoperative deformity, which would require additional surgical treatment. Persing suggested that use of cranial orthoses postoperatively may serve two 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, 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.

Multiple cranial orthoses (helmets) have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process and 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. Multiple marketed devices are labeled for use in children with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic- and brachycephatic-shaped heads.

POLICY

Use of an adjustable cranial orthosis may be considered medically necessary following cranial vault remodeling surgery for synostosis.

Use of an adjustable cranial orthosis for synostosis in the absence of cranial vault remodeling surgery is considered investigational.

Use of an adjustable cranial orthosis as a treatment of persistent plagiocephaly or brachycephaly without synostosis may be considered medically necessary when all of the following conditions have been met:

• the individual is between 3 and 18 months old

• documented failure of conservative therapy (repositioning and physical therapy) of at least 2 months duration

• the individual has a cephalic index that is at least two standard deviations above or below the mean for the appropriate gender and age.

Use of an adjustable cranial orthosis is considered investigational for all other indications not outlined above.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

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 (i.e., improve health outcomes). In this policy, 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.

Assessment of plagiocephaly in research studies may be based on anthropomorphic measures of the head, using anatomic and bony landmarks. Although there is no accepted minimum objective level of asymmetry for a plagiocephaly diagnosis, there are definitions that have been adopted by convention:

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

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

• Cephalic index: The cephalic index, which describes a ratio of the maximum width to the head length expressed as a percentage, is used to assess abnormal head shapes without asymmetry. The maximum width is measured between the most lateral points of the head located in the parietal region (i.e., euryon). The head length is measured from the most prominent point in the median sagittal plane between the supraorbital ridges (i.e., glabella) to the most prominent posterior point of the occiput (i.e., the opisthocranion), expressed as a percentage. The cephalic index can then be compared to normative measures for age and gender. See Table 1 (as developed by American Academy of Orthotists and Prosthetists 2004). The policy criteria requiring an individual to have a cephalic index of 2 standard deviations above or below the mean for the use of an adjustable cranial orthosis as a treatment of persistent plagiocephaly or brachycephaly was based on populations included within the evidence base.

• Cranial Vault Asymmetry: is assessed by measuring from the frontozygomaticus point (identified by palpation of the suture line above the upper outer corner of the orbit) to the euryon, defined as the most lateral point on the head located in the parietal region. The cranial vault asymmetry index (CAVI) can be used to assess cranial shape and is calculated by taking the difference between the diagonals of the head (measured from the anthropometric points), dividing by the larger diagonal, and multiplying by 100 to get a percentage. The Children's Healthcare of Atlanta plagiocephaly severity scale, based on clinical presentation and CAVI, was developed in 2017 to assist with clinical treatment recommendations and is shown in Table 2.

• Plagiocephaly: Flattening of the skull on the back or one side of the head.

• Sagittal suture: Skull joint that separates the left and right halves of the skull.

Table 1. Cephalic Index

SD: standard deviation

Table 2. Children's Healthcare of Atlanta Plagiocephaly Severity Scale

CVAI: Cranial Vault Asymmetry Index.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

11/1997: Approved by Medical Policy Advisory Committee (MPAC), Code Reference section completed, CPT code 97799, 97703, ICD-9 procedure code 93.29, ICD-9 diagnosis code 754.0, HCPCS L0100, L0110

8/2000: Reviewed by Medical Policy Advisory Committee (MPAC), investigational status maintained.

10/17/2001: Sources and Code Reference sections updated

2/11/2002: Investigational definition added

4/26/2002: Type of Service and Place of Service deleted

9/20/2002: Policy statement revised

10/11/2002: HCPCS S1040 added

5/20/2004: Code Reference section updated, CPT code 97799 deleted, HCPCS L0100, L0110 description revised

6/24/2004: Policy reviewed, Description section revised to be consistent with BCBSA policy # 1.01.11

8/5/2005: Code Reference section updated, ICD-9 procedure code 93.29 deleted

3/22/2006: Coding updated. CPT4 2006 revisions added to policy

3/28/2006: Policy reviewed, no changes

12/27/2006: Code Reference section updated per the 2007 CPT/HCPCS revisions

4/24/2007: Policy reviewed, no changes

12/22/2008: Policy reviewed, the following removed from the policy statement, "As an adjunctive postsurgical therapy for synostotic plagiocephaly, dynamic orthotic cranioplasty is considered investigational."

06/23/2010: Policy title changed from “Adjustable Banding as a Treatment of Plagiocephaly” to “Adjustable Cranial Orthoses for Positional Plagiocephaly and Craniosynostoses.” Policy description updated regarding treatment approaches and craniosynostoses. Added policy statements on craniosynostoses, which is considered medically necessary following cranial vault remodeling surgery. Reworded policy statement regarding nonsynostotic plagiocephaly/ brachycephaly; intent unchanged. Deleted outdated references from the Sources section. Based on the medically necessary policy statement, moved 97762 and S1040 from non-covered to covered. ICD-9 code 754.0 removed from the codes table as this indication remains non-covered. Removed deleted CPT code L0100 and L0110 from the codes table as they were deleted on 12/31/2006.

06/08/2011: Policy reviewed; no changes.

04/19/2012: Policy reviewed; no changes.

04/19/2013: Policy reviewed; no changes.

07/09/2014: Policy reviewed; no changes.

07/02/2015: Code Reference section updated for ICD-10.

09/16/2015: Policy description updated regarding devices. Policy statements unchanged. Policy Guidelines section updated to add medically necessary and investigative definitions.

05/26/2016: Policy number A.1.01.11 added.

11/30/2016: Policy description updated regarding treatment of craniosynostosis. Policy statements unchanged.

08/29/2017: Policy description updated. Policy statements unchanged. Policy Guidelines updated to remove table on studies presenting normative values and mean pretreatment asymmetries.

12/22/2017: Code Reference section updated to make note of deleted CPT code 97762.

03/28/2018: Policy reviewed; no changes.

01/04/2021: Policy description updated regarding devices. Revised policy statement to state that the use of an adjustable cranial orthosis as a treatment of persistent plagiocephaly or brachycephaly without synostosis may be considered medically necessary when the specified conditions have been met. The use of an adjustable cranial orthosis is considered not medically necessary for all other indications not outlined above. Policy Guidelines updated to add definitions and the cephalic index table. Code Reference section updated to add ICD-10 diagnosis codes Q67.3 and Q75.0. Removed deleted CPT code 97762.

05/21/2021: Policy reviewed; no changes.

04/26/2022: Policy reviewed; no changes.

04/11/2023: Policy reviewed. Policy statements updated to change "not medically necessary" to "investigational" and "patients" to "individuals." Policy Guidelines updated.

09/29/2023: Code Reference section updated to add new ICD-10 diagnosis codes Q75.001, Q75.002, Q75.009, Q75.01, Q75.021, Q75.022, Q75.029, Q75.03, Q75.041, Q75.042, Q75.049, Q75.052, Q75.058, and Q75.08, effective 10/01/2023.

04/11/2024: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to add table and information regarding cephalic index and cranial vault asymmetry.

04/24/2025: Policy reviewed. Policy statements unchanged. Code Reference section updated to remove deleted ICD-10 diagnosis code Q75.0.

SOURCE(S)

Blue Cross & Blue Shield Association Policy #1.01.11

CODE REFERENCE

This is not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.