Latest Review Date: March 2024

Category: Durable Medical Equipment(DME)                                

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 not medically necessary.

Use of an adjustable cranial orthosis as a treatment of persistent plagiocephaly or brachycephaly without synostosis may be considered medically necessary when all 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.

DESCRIPTION OF PROCEDURE OR SERVICE:

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 requested for the treatment of positional plagiocephaly or postsurgical synostosis 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 increasing intracranial pressure in an abnormally or asymmetrically shaped cranium. The type and degree of craniofacial deformity depend on the type of synostosis. The most common is scaphocephaly, which describes a narrowed and elongated head resulting from synostosis of the sagittal suture, while premature fusion of the metopic suture results in a triangular shape of the forehead known as trigonocephaly. Unilateral synostosis of the coronal suture results in an asymmetric distortion of the forehead termed plagiocephaly, and fusion of both coronal sutures results in brachycephaly. Combinations of these 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 one or more cranial vault sutures occurs in approximately one in 2500 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 (2008) 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 (SIDS). It is hoped that increasing awareness of identified risk factors and early implementation of good practices will reduce the development of deformational plagiocephaly.

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.

Brachycephaly: 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.

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

Cranial index: The cranial index, which describes a ratio of the maximum width to the head length expressed as a percentage, is used to assess abnormal head shapes without asymmetry. The maximum width is measured between the most lateral points of the head located in the parietal region (i.e., euryon). The head length is measured from the most prominent point in the median sagittal plane between the supraorbital ridges (i.e., glabella) to the most prominent posterior point of the occiput (i.e., the opisthocranion), expressed as a percentage. The cranial index can then be compared to normative measures for age and gender. See Table 1 (as developed by AAOP 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.

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.

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

Table PG1. Cephalic Index

Sex	Age	-2SD	-1SD	Mean	+1SD	+2SD
Male	16 days to 6 months	63.7	68.7	73.7	78.7	83.7
Male	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
Female	6 to 12 months	69.5	74.0	78.5	83.0	87.5

Table PG2. Children's Healthcare of Atlanta Plagiocephaly Severity Scale

Level	Clinical Presentation	Recommendation	CVAI
1	All symmetry within normal limits	No treatment required	<3.5
2	Minimal asymmetry in one posterior quadrant No secondary changes	Repositioning program	3.5 to 6.25
3	Two quadrant involvement Moderate to severe posterior quadrant flattening Minimal ear shift and/or anterior involvement	Conservative treatment:Repositioning Cranial remolding orthosis (based on age and history)	6.25 to 8.75
4	Two or three quadrant involvement Severe posterior quadrant flattening Moderate ear shift Anterior involvement including noticeable orbit asymmetry	Conservative treatment:Cranial remolding orthosis	8.75 to 11
5	Three or four quadrant involvement Severe posterior quadrant flattening Severe ear shift Anterior involvement including orbit and cheek asymmetry	Conservative treatment:Cranial remolding orthosis	> 11

KEY POINTS:

Literature updates using the PubMed database are performed on a periodic basis.  The most recent literature review was performed through January 30, 2024.

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 an 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 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 low likelihood of development of high level evidence from controlled studies, the scientific literature is limited in support of an effect of deformational plagiocephaly on functional health outcomes. 

PRACTICE GUIDELINES AND POSITION STATEMENTS:

Congress of Neurological Surgeons and Section on Pediatric Neurosurgery

In 2016, the Congress of Neurological Surgeons and the Section on Pediatric Neurosurgery published a joint evidence-based guideline on the role of cranial molding orthosis therapy for patients with positional plagiocephaly. The guideline was endorsed by the Joint Guidelines Committee of the American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS) and American Academy of Pediatrics (AAP).

The guideline 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 randomized controlled trial, 5 prospective comparative studies, and 9 retrospective comparative studies (all rated as class II evidence).

National Institute of Neurological Disorders and Stroke

In 2019, the National Institute of Neurological Disorders and Stroke states 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."

 

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Dynamic Orthotic Cranioplasty, Cranial Banding, Craniosynostosis, Head banding,  Skull molding, Plagiocephaly without synostosis, PWS, synostosis plagiocephaly, positional plagiocephaly, non-synostic plagiocephaly, dynamic cranial helmet, deformational plagiocephaly, 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™, adjustable cranial orthosis, helmet therapy, skull molding caps

APPROVED BY GOVERNING BODIES:

Multiple cranial orthoses (helmets) have been cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process and are intended to apply passive pressure to prominent regions of an infants 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.

BENEFIT APPLICATION

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Covered if covered by the Participating Home Plan

FEP: Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING:

CPT :

97763

Orthotic(s)/prosthetic(s) management and/or training, upper extremity(ies), lower extremity(ies), and/or trunk, subsequent orthotic(s)/prosthetic(s) encounter, each 15 minutes (Effective 01/01/2018)

 

HCPCS:

S1040

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

REFERENCES:

1. AAP Publications Reaffirmed or Retired. Pediatrics Jul 2018, 142 (1) e20181297; DOI: 10.1542/peds.2018-1297
2. 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. Pediatrics. November 1, 2011 2011; 128 (5):1030-1039.
3. 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 2013; 24(1):170- 4.
4. 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.
5. Gociman B, Marengo J, Ying J et al. Minimally invasive strip craniectomy for sagittal synostosis. J Craniofac Surg 2012; 23(3):825-8.
6. Honeycutt JH. Endoscopic-assisted craniosynostosis surgery. Semin Plast Surg. Aug 2014; 28(3):144-149.
7. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
8. Jimenez DF, Barone CM. Endoscopic technique for sagittal synostosis. Childs Nerv Syst 2012; 28(9):1333-9.
9. Jimenez DF, Barone CM. Multiple-suture nonsyndromic craniosynostosis: early and effective management using endoscopic techniques. J Neurosurg Pediatr 2010; 5(3):223-31.
10. 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.
11. MacKinnon, MS et al. Improving ophthalmic outcomes in children with unilateral coronal synostosis by treatment with endoscopic strip craniectomy and helmet therapy rather than fronto-orbital advancement. Journal of AAPOS, June 2013; 17(3): 259-65.
12. Moon RY, Moon RY, Darnall RA, et al. SIDS and other sleep-related infant deaths: expansion of recommendations for a safe infant sleeping environment. Pediatrics. Nov 2011; 128(5): 1030-9.
13. National Institute of Neurological Disorders and Stroke (NINDS). Craniosynostosis Information Page. 2019; www.ninds.nih.gov/Disorders/All-Disorders/Craniosynostosis-Information-Page. 
14. 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 2011; 8(2):165-70.
15. Shamji MF, Fric-Shamji EC, Merchant P, et al. Cosmetic and cognitive outcomes of positional plagiocephaly treatment. Clin Invest Med. 2012; 35(5):E266.
16. Tamber MS, Nikas D, Beier A, et al. The Role of Cranial Molding Orthosis (Helmet) Therapy. 2016; www.cns.org/guidelines/browse-guidelines-detail/5-role-of-cranial-molding-orthosis-helmet-therapy
17. 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-E633.
18. Task Force on Sudden Infant Death Syndrome; Moon RY. SIDS and other sleep-related infant deaths: expansion of recommendations for a safe infant sleeping environment. Pediatrics. Nov 2011; 128(5):1030-1039.
19. van Wijk RM, van Vlimmeren LA, Groothuis-Oudshoorn CG et al. Helmet therapy in infants with positional skull deformation: randomized controlled trial. BMJ 2014; 348:g2741.
20. Vogel TW, Woo, AS et al. A comparison of costs associated with endoscope-assisted craniectomy versus open cranial vault repair for infants with sagittal synostosis. J Neurosurg Pediatrics 2014; (13):324-31.

POLICY HISTORY:

Medical Policy Group, July 2001

Medical Policy Administration Committee, August 2001
Medical Policy Group, July 2003 (1)

Medical Policy Group, May 2005 (2)

Medical Policy Administration Committee, May 2005

Available for comment June 2-July 13, 2005

Medical Policy Group, May 2007 (1)

Medical Policy Group, May 2009 (1)

Medical Policy Panel February 2010

Medical Policy Group, October 2010 (2)

Medical Policy Group, November 2010 (2)

Medical Policy Administration Committee, December 2010

Available for comment December 2, 2010 through January 16, 2011

Medical Policy Panel, March 2012

Medical Policy Group, September 2012 (2):  Key Points, Key Words, References Updated

Medical Policy Panel, May 2014

Medical Policy Group, May 2014 (5):  Key points updated and rearranged; References updated.

Medical Policy Group, February 2015 (6):  Updated References and rearranged information in Policy section; no changes in policy statement/intent.

Medical Policy Panel, May 2015

Medical Policy Group, May 2015 (6):  Updated Key Points, Approved by Governing Bodies and References; no changes to policy statement.

Medical Policy Panel, November 2016

Medical Policy Group, December 2016 (6): Updated Key Points, Summary of Evidence, Coding and References; no change to policy statement.

Medical Policy Panel, August 2017

Medical Policy Group, September 2017 (6): Updates to Description, Governing Bodies and Key Points.

Medical Policy Group, December 2017: Annual Coding Update 2018.  Added new CPT code 97763 to Current Coding.  Created Previous Coding section and moved deleted code 97762 to this section.

Medical Policy Panel, March 2018

Medical Policy Group, March 2018 (6): Updates to Key Points and Practice Guidelines.

Medical Policy Panel, July 2019

Medical Policy Group, July 2019 (6): Updates to Key Points, Practice Guidelines and Governing Bodies. Policy statement updated.

Medical Policy Panel, July 2020

Medical Policy Group, July 2020 (6): Updates to Description, Key Points, Practice Guidelines and References.

Medical Policy Panel, March 2021

Medical Policy Group, March 2021 (6): Updates to Description, Key Points and References.

Medical Policy Panel, March 2022

Medical Policy Group, March 2022 (6): Updates to Key Points and References.

Medical Policy Panel, March 2023

Medical Policy Group, March 2023 (6) Updates to Key Points, Practice Guidelines and References.

Medical Policy Panel, March 2024

Medical Policy Group, March 2024 (6): Updates to Description and Key Points.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent  

      therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.