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Cranial Remolding Orthoses (Helmets)
05.00.25j

Policy

​Pediatric cranial remolding orthoses (helmets) are considered medically necessary and, therefore, covered in either of the following circumstances:
  • Following surgical correction of synostotic or nonsynostotic plagiocephaly
  • When a diagnosis of nonsynostotic plagiocephaly has been documented, and all of the following criteria are met:
    • The infant is 3 to 18 months of age.
    • The infant has not responded to an 8-week trial of head positioning or other conservative therapies (i.e., physical therapy), unless such therapies are contraindicated or considered inappropriate due to other comorbidities.
    • Cranial asymmetry is documented by either of the following:
      • Asymmetry in one of the following anthropometric dimensions:
        • Cranial vault
        • Cranial base
        • Orbitotragial depth
      • Cephalic index measurement at least two standard deviations above or below the mean for the appropriate gender and age​
Subsequent cranial remolding orthoses (helmets) are considered medically necessary and, therefore, covered when they are used in accordance with the medical necessity criteria outlined above, if the cranial asymmetry has not resolved or significantly improved after 2 to 4 months, and there is a change in the individual's condition that requires a replacement remolding helmet (e.g., growth, significant cranial asymmetry).

The use of cranial remolding orthoses (helmets) for any other condition is considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support their use in the treatment of other illness or injury.

REQUIRED DOCUMENTATION

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports.

STANDARD WRITTEN ORDER REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete standard written order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective standard written order at the time of an audit or after an audit for submission as an original standard written order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY REQUIREMENTS
Medical record documentation must include a contemporaneously prepared delivery confirmation or member’s receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the durable medical equipment (DME) supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES (WHEN APPLICABLE)
The DME supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately 7 days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual’s medical record. Delivery of the supplies should not be done earlier than approximately 5 days before the individual would exhaust their on-hand supply.

For specified DME items, documentation of a face-to-face encounter between the treating professional provider and the individual meeting the above requirements, including an assessment of the individual’s clinical condition supporting the need for the prescribed DME item(s), must be provided to and kept on file by the DME supplier.

If required documentation is not available on file to support a claim at the time of an audit or record request, the DME supplier may be required to reimburse the Company for overpayments.​

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, cranial remolding orthoses (helmets) are covered under the medical benefits of the Company's products when the medical necessity criteria listed in this medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The FDA has approved several types of custom cranial remolding orthoses (helmets) under the 510(k) process.

BILLING GUIDELINES

For pediatric cranial remolding orthoses (helmets), providers should report Healthcare Common Procedure Coding System (HCPCS) code S1040. Fitting and adjustments are considered integral to code S1040 and, therefore, are not eligible for separate reimbursement.

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

ANTHROPOMETRIC DIMENSIONS

Comparative Cranial Landmarks
Cranial Vault Left frontozygomatic point (fz) to right euryon (eu) minus right frontozygomatic point (fz) to left euron (eu)
Cranial Base Subnasal point (sn) to left tragus (t) minus subnasal point (sn) to right tragus (t)
Orbitotragial Depth Left exocanthion point (ex) to left tragus (t) minus right exocanthion point (ex) to right tragus (t)

​​​

CEPHALIC INDEX MEASUREMENT
CEPHALIC INDEX: Head width (eu - eu)  ×100
Head length (g - op)

Gender
Age
-2SD
-1SD
Mean
+1SD
+2SD
Male 16 days–6 months
63.7 mm
68.7 mm
73.7 mm
78.7 mm
83.7 mm
6–12 months
64.8 mm
71.4 mm
78.0 mm
84.6 mm
91.2 mm
Female 16 days–6 months
63.9 mm
68.6 mm
73.3 mm
78.0 mm
82.7 mm
6–​12 months
69.5 mm
74.0 mm
78.5 mm
83.0 mm
87.5 mm


Description

The skull consists of several plates of bone that are separated by sutures. As a child grows and develops, the sutures close, forming a solid piece of bone called the cranium. Sometimes the bones fuse incorrectly, resulting in cranial asymmetry; however, abnormalities in head shape (i.e., cranial asymmetry) may develop due to a variety of factors. Plagiocephaly is generally defined as cranial asymmetry and can be subdivided into two types: synostotic and nonsynostotic.

CRANIOSYNOSTOSIS

SYNOSTOTIC PLAGIOCEPHALY
In synostotic plagiocephaly, premature fusing of one or more sutures in a child's cranium restricts skull and brain growth. This may cause increased pressure inside the head and/or cause the cranial or facial bones to be asymmetrical. 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. The diagnosis of synostotic plagiocephaly is made after a clinical evaluation and diagnostic testing. Surgery is typically the recommended treatment involving the surgical remodeling of the cranial vault. Cranial remolding orthoses (helmets) may be used for adjunctive postsurgical therapy. The goal of treatment is to reduce the pressure in the head and to correct the deformities of the face and skull bones. The ideal timing for this type of surgery is prior to 3 months of age. However, there is no upper age limit to surgery, and in some instances children may need minor surgical follow-up at 4 to 5 years of age.

NONSYNOSTOTIC PLAGIOCEPHALY
In nonsynostotic plagiocephaly, also called positional or deformational plagiocephaly, the sutures of the cranium remain open (usually up to 12 months of age). The asymmetry 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. Most of these deformities may autocorrect spontaneously during the first few months of life 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. According to a clinical report published by the American Academy of Pediatrics (AAP) (Laughlin et al., 2011) regarding prevention and management of positional skull deformities in infants, the preventive and treatment modalities for nonsynostotic plagiocephaly include preventive counseling for parents, mechanical adjustments (e.g., head repositioning, exercises [neck exercises]), cranial remolding orthoses (helmets), surgery, or any combination of these. Cranial remolding orthoses (helmets), currently the treatment of choice, may be considered an option for infants with severe deformity or skull shape that is refractory to physical adjustments and positioning between the ages of 3 to 18 months. Beyond the age of 12 months, cranial remodeling is less, and compliance issues increase. However, according to the AAP (Persing et al., 2003; Laughlin et al., 2011), there are rare instances when surgery may be indicated if the nonsynostotic plagiocephaly deformities are severe and/or resistant to nonsurgical measures.

A clinical systematic review in 2016 performed by Baird et al. concluded that physical therapy is significantly more effective than repositioning education as a treatment for positional plagiocephaly. There is no significant difference between physical therapy and a positioning pillow as a treatment for positional plagiocephaly. However, given the AAP's recommendation against soft pillows in cribs to ensure a safe sleeping environment for infants, physical therapy must be recommended over the use of a positioning pillow.

CRANIAL ASYMMETRY

An objective evaluation of cranial asymmetry may be based on anthropometric landmarks and/or the cephalic index. Anthropometric measurements of the cranial vault, cranial base, and orbitotragial depth help to identify asymmetries by evaluating the length from one designated point on the face or cranium to another and comparing right and left sides. The degree of asymmetry also may be assessed by a comparison with normative values using the cephalic index. The cephalic index is the ratio of the maximum width of the cranium to its maximum length multiplied by 100. Additionally, the clinical evaluation of cranial asymmetry is useful to orthotists for fabricating cranial remolding orthoses (helmets) and in documenting treatment outcomes.

CRANIAL REMOLDING ORTHOSES (HELMETS)

A cranial remolding orthosis (helmet), sometimes referred to as a cranial band or dynamic orthotic cranioplasty (DOC), is a noninvasive custom-molded orthotic device that applies pressure to prominent regions of the cranium to progressively improve cranial shape and symmetry. The custom-molded orthotic is designed to be worn 23 hours a day with an hour off for exercise and skin care. The headband or helmet is initiated between 3 and 18 months of age and is worn for an average of 2 to 4 months. Adjustments to the helmet need to be made every 1 to 2 weeks because a baby’s head grows very quickly. This involves adjusting the foam lining and/or portions of the outside plastic helmet. In synostotic plagiocephaly, some evidence suggests that a cranial remolding orthosis improves outcomes following endoscopic suture release. Orthosis use is reportedly a critical part of this treatment. The literature also documents that the use of these remolding helmets reduces asymmetries associated with nonsynostotic plagiocephaly and allows for normal cranial growth (Kelly et al., 1999; Persing et al., 2003; Losee and Mason, 2005).

US FOOD AND DRUG ADMINISTRATION (FDA)

Cranial remolding orthoses (helmets) are regulated by the FDA as Class II medical devices and require 510(k) approval. According to the FDA, these devices are intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age who have moderate to severe nonsynostotic positional plagiocephaly. Also per the FDA, in some cases labeled indications for cranial remolding orthoses (helmets) are intended for adjunctive use following surgery in infants whose synostotic or nonsynostotic plagiocephaly has been surgically corrected. Several FDA-approved cranial remolding orthoses (helmets) are available.

References

American Academy of Neurological Surgeons (AANS). Craniosynostosis and craniofacial disorders. [AANS Website]. 2023. Available at: https://www.aans.org/en/Patients/Neurosurgical-Conditions-and-Treatments/Craniosynostosis-and-Craniofacial-Disorders. Accessed December 5, 2023.

American Academy of Neurological Surgeons (AANS). Positional plagiocephaly. [AANS Website]. 2023. Available at: https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Positional-Plagiocephaly. Accessed December 5, 2023.

Baird LC, Klimo P Jr., Flannery AM, et al. Congress of neurological surgeons systematic review and evidence-based guideline for the management of patients with positional plagiocephaly: the role of physical therapy. Neurosurgery. 2016;79(5):622-623.

Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Cranial Orthosis for Plagiocephaly without Synostosis. TEC Assessments. 1999;Volume 14:Tab 21.

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):170-174.

Collett BR, Gray KE, Starr Jr. Development at age 36 months in children with deformational plagiocephaly. [American Academy of Pediatrics Web site]. 01/01/2013. Available at: http://pediatrics.aappublications.org/content/131/1/e109.full.pdf+html. Accessed December 5, 2023.

Committee for the assessment of the NIOSH head-and-face anthropometric survey of US respirator users (2014). Anthropometric measurements. pgs. 29-42. [The National Academies Press Web site]. Available at: https://www.nap.edu/read/11815/chapter/4. Accessed December 5, 2023.

Congress of Neurological Surgeons (CNS). Congress of neurological surgeon systematic review and evidence-based guideline on the management of patients with positional plagiocephaly: the role of cranial molding orthosis (helmet) therapy for patients with positional plagiocephaly. [CNS Web site]. 2020. Available at: https://www.cns.org/guidelines/browse-guidelines-detail/5-role-of-cranial-molding-orthosis-helmet-therap. Accessed December 5, 2023.


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.


Farkas LG, Munro IR (editors). Anthropomorphic Facial Proportions in Medicine. 1st. edition. Springfield, IL: Charles C. Thomas; 1987.

Fowler EA, Becker DB, Pilgram TK, et al. Neurologic findings in infants with deformational plagiocephaly. J Child Neurol. 2008;23(7):742-747.


Gociman B, Marengo J, Ying J, et al. Minimally invasive strip craniectomy for sagittal synostosis. J Craniofac Surg. 2012;23(3):825-828.


Goldson E, Kelly DP. Developmental-behavior aspects of chronic conditions. In Wolraich ML, Drotar DD, Dworkin PH, Perrin EC (eds). Developmental-behavioral Pediatrics: Evidence and Practice. St. Louis, MO:Mosby;2008:301-404.


Graham JM, Jr., Gomez M, Halberg A, et al. Management of deformational plagiocephaly: repositioning versus orthotic therapy. J Pediatr. 2005;146(2):258-262.


Honeycutt JH. Endoscopic-assisted craniosynostosis surgery. Semin Plast Surg. 2014;28(3):144-149.

Hutchison BL, Hutchison LA, Thompson JM, Mitchell EA. Quantification of plagiocephaly and brachycephaly in infants using a digital photographic technique. Cleft Palate Craniofac J. 2004;42(5):539-547.

Hutchison BL, Thompson JM, Mitchell A. Determinants of nonsynostotic plagiocephaly: a case-control study. Pediatrics. 2003;112(4):e316. Available at: https://publications.aap.org/pediatrics/article/112/4/e316/63464/Determinants-of-Nonsynostotic-Plagiocephaly-A-Case. Accessed December 5, 2023.

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

Jimenez DF, Barone CM. Early treatment of anterior calvarial craniosynostosis using endoscopic-assisted minimally invasive techniques. Childs Nerv Syst. 2007;23(12):1411-1419.


Jimenez DF, Barone CM. Endoscopic technique for sagittal synostosis. Childs Nerv Syst. 2012;28(9):1333-1339.


Jimenez DF, Barone CM. Multiple-suture nonsyndromic craniosynostosis: early and effective management using endoscopic techniques. J Neurosurg Pediatr. 2010;5(3):223-231.


Jimenez DF, Barone CM, McGee ME, et al. Endoscopy-assisted wide-vertex craniectomy, barrel stave osteotomies, and postoperative helmet molding therapy in the management of sagittal suture craniosynostosis. J Neurosurg. 2004; 100(5 Suppl Pediatrics):407-417.


Kaufman BA, Muszynski CA, Matthews A, et al. The circle of sagittal synostosis surgery. Semin Pediatr Neurol. 2004;11(4):243-248.

Kelly KM, Littlefield TR, Pomatto JK, et al. Cranial growth unrestricted during treatment of deformational plagiocephaly. Pediatr Neurosurg. 1999;30(4):193-199.


Kluba S, Kraut W, Calgeer B, et al. Treatment of positional plagiocephaly--helmet or no helmet? J Craniomaxillofac Surg. 2014;42(5):683-688.


Laughlin J, Luerrsen TG, Dias MS. Prevention and management of positional skull deformities in infants. Pediatrics. 2011;128(6):1236-1241.


Loveday BP, de Chalain TB. Active counterpositioning or orthotic device to treat positional plagiocephaly? J Craniofac Surg.2001;12(4):308-313.

Losee JE, Mason AC. Deformational plagiocephaly: diagnosis, prevention, and treatment. Clin Plast Surg. 2005;32(1):53-64.

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.


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


Mulliken JB, Vander Woude DL, Hansen M, et al. Analysis of posterior plagiocephaly: deformational versus synostotic. Plast Reconstr Surg. 1999;103(2):371-380.

National Institute of Neurological Disorders and Stroke [NINDS Website]. 2023. Craniosynostosis Information Page. Available at: https://www.ninds.nih.gov/Disorders/All-Disorders/Craniosynostosis-Information-Page. Accessed December 5, 2023.


NHS Quality Improvement Scotland. The use of cranial orthosis treatment for infant deformational plagiocephaly. Evidence Note No.16. 2007.

Panchal J, Amirsheybani H, Gurwitch R, et al. Neurodevelopment in children with single-suture craniosynostosis and plagiocephaly without synostosis. Plast Reconstr Surg. 2001;108(6):1492-1498; discussion 1499-1500.

Peitsch WK, Keefer CH, LaBrie RA, Mulliken JB. Incidence of cranial asymmetry in healthy newborns. Pediatrics. 2002;110(6):e72. Also available on the Pediatrics Web site at: https://publications.aap.org/pediatrics/article-abstract/110/6/e72/64493/Incidence-of-Cranial-Asymmetry-in-Healthy-Newborns?redirectedFrom=fulltext. Accessed December 5, 2023.


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. Pediatrics. 2003;112(1 Pt 1):199-202.


Persing J, James H, Swanson J, Kattwinkel, J. Prevention and management of positional skull deformities in infants. Pediatrics. 2003;112(1 Pt 1):199-202.


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

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. 2011;8(2):165-170.

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

Stevens PM, Hollier LH, Stal S. Post-operative use of remoulding orthoses following cranial vault remodelling: a case series. Prosthet Orthot Int. 2007;31(4):327-341.


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. 2011;128(5):1030-1039.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Boston Band Cranial Remolding Orthosis. 510(k) summary. [FDA Web site]. 01/22/08. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf7/K072862.pdf. Accessed December 5, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. CranioCap™ Cranial Orthosis. 510(k) summary. [FDA Web site]. 10/30/2000. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=k000861. Accessed December 5, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. O&P Cranial Molding Helmet®. 510(k) summary. [FDA Web site]. 12/22/06. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063395.pdf. Accessed December 5, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. OPI Band. 510(k) summary. [FDA Web site]. 07/07/2000. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=k001167. Accessed December 5, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. STARlight® Cranial Remolding Orthosis. 510(k) summary. [FDA Web site]. 10/31/08. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf8/K082945.pdf. Accessed December 5, 2023.

Van Vlimmeren LA, Van der Graaf Y, et.al. Effect of pediatric physical therapy on deformational plagiocephaly in children with positional preference: A randomized controlled trial. Arch Pediatr Adolesc Med. 2008;162(8):712-718.

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

Wilbrand JF, Seidl M, et al. A prospective randomized trial on preventative methods for positional head deformity: physiotherapy versus a positioning pillow. J Pediatr. 2013;162 (6):1216-1221.


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.

Coding

CPT Procedure Code Number(s)
N/A
ICD - 10 Procedure Code Number(s)
N/A
ICD - 10 Diagnosis Code Number(s)
M95.2 Other acquired deformity of head

Q67.3 Plagiocephaly

Q67.4 Other congenital deformities of skull, face, and jaw

Q75.001 Craniosynostosis unspecified, unilateral

Q75.002 Craniosynostosis unspecified, bilateral

Q75.009 Craniosynostosis unspecified

Q75.01 Sagittal craniosynostosis

Q75.021 Coronal craniosynostosis unilateral

Q75.022 Coronal craniosynostosis bilateral

Q75.029 Coronal craniosynostosis unspecified

Q75.03 Metopic craniosynostosis

Q75.041 Lambdoid craniosynostosis, unilateral

Q75.042 Lambdoid craniosynostosis, bilateral

Q75.049 Lambdoid craniosynostosis, unspecified

Q75.051 Cloverleaf skull

Q75.052 Pansynostosis

Q75.058 Other multi-suture craniosynostosis

Q75.08 Other single-suture craniosynostosis

Q75.8 Other specified congenital malformations of skull and face bones

Q75.9 Congenital malformation of skull and face bones, unspecified

Z98.890 Other specified postprocedural states
HCPCS Level II Code Number(s)
S1040 Cranial remolding orthosis, pediatric, rigid, with soft interface material, custom fabricated includes fitting and adjustment(s)
Revenue Code Number(s)
N/A


Coding and Billing Requirements

Policy History

10/1/2023
9/29/2023
1/24/2024
05.00.25
Medical Policy Bulletin
Commercial
No
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