Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Cranial Remolding Orthoses (Helmets)

Policy #:05.00.25h

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

Pediatric cranial remolding orthoses (helmets) are considered medically necessary and are, 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 three to 18 months of age.
    • The infant has not responded to an eight-week trial of head repositioning 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 deviant from the mean

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 two to four 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. This policy is consistent with Medicare's documentation requirements, including the following required documentation:

PRESCRIPTION (ORDER) REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete 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 order at the time of an audit or after an audit for submission as an original order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY
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 DME supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES
The durable medical equipment (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 seven 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 five days before the individual would exhaust their on-hand supply.

If required documentation is not available on file to support a claim at the time of an audit or record request, the durable medical equipment (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 VaultLeft frontozygomatic point (fz) to right euryon (eu) minus right frontozygomatic point (fz) to left euron (eu)
Cranial BaseSubnasal point (sn) to left tragus (t) minus subnasal point (sn) to right tragus (t)
Orbitotragial DepthLeft exocanthion point (ex) to left tragus (t) minus right exocanthion point (ex) to right tragus (t)




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

Gender
Age
-2SD
-1SD
Mean
+1SD
+2SD
Male16 days--6 months
63.7
68.7
73.7
78.7
83.7
6--12 months
64.8
71.4
78.0
84.6
91.2
Female16 days--6 months
63.9
68.6
73.3
78.0
82.7
6--12 months
69.5
74.0
78.5
83.0
87.5


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
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 auto-correct 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 three 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 American Academy of Pediatrics’ (AAP) 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 three and 18 months of age and is worn for an average of two to four months. Adjustments to the helmet need to be made every one to two 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, there is some evidence suggesting 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 et al, 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]. 2019. Available at: https:www.aans.org/Patients/Neurosurgical-Conditions-and-Treaments/Craniosynostosis-and-Craniofacial-Diorders. Accessed January 11, 2019.

American Academy of Neurological Surgeons (AANS). Positional plagiocephaly. [AANS Website]. 2019. Available at: https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Positional-Plagiocephaly. Accessed January 11, 2019.

Baird LC, Klimo P Jr, 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.

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 January 11, 2019.

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: http://books.nap.edu/openbook.php?record_id=11815&page=29 Accessed January 11, 2019.

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]. 2016. Available at: https://www.cns.org/guidelines-management-patients-positional-plagiocephaly. Accessed January 11, 2019.

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. Also available on the Pediatrics Web site at: http://pediatrics.aappublications.org/cgi/reprint/112/4/e316. Accessed January 11, 2019.

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.

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

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

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: http://pediatrics.aappublications.org/cgi/content/full/110/6/e72. Accessed January 11, 2019.

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 January 11, 2019.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. CranioCap™ Cranial Orthosis. 510(k) summary. [FDA Web site]. 01/13/2014. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=700. Accessed January 11, 2019.

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 January 11, 2019.

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 January 11, 2019.

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 January 11, 2019.

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;162:712–718.

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





Coding

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

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

MEDICALLY NECESSARY

M95.2 Other acquired deformity of head

Q67.3 Plagiocephaly

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

Q75.0 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


Cross References


Policy History

05.00.25h
04/01/2019This version of the policy will become effective 04/01/2019.

The policy was updated with medical necessity language regarding the coverage of subsequent cranial remolding orthoses. The following ICD-10 codes have been added to this policy: M95.2 and Q67.4.(Medically Necessary).

Revisions from 05.00.25g
03/28/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on Cranial Remolding Orthoses (Helmets).


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 04/01/2019
Version Issued Date: 04/01/2019
Version Reissued Date: N/A

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