Medical Policies Online - Policy #: 05.00.25e

Medical Policy Bulletin

Title:

Cranial Remolding Orthoses (Helmets)

Policy #:

05.00.25e

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.

Intent

The intent of this policy is to communicate the medical necessity criteria for the use of pediatric cranial remolding orthoses (helmets).

This policy does not address protective helmets.

For information on policies related to this topic, refer to the Cross References section in this policy.

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 (ie, 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.

SYNOSTOTIC PLAGIOCEPHALY

In synostotic plagiocephaly (ie, craniosynostosis), 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 diagnosis of synostotic plagiocephaly is made after a clinical evaluation and diagnostic testing. Surgery is typically the recommended treatment. 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 three months of age. However, there is no upper age limit to surgery, and in some instances children may need minor surgical follow-up at four to five years of age.

NONSYNOSTOTIC PLAGIOCEPHALY

In nonsynostotic 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, and sleeping position. The treatment modalities for nonsynostotic plagiocephaly include head repositioning, cranial remolding orthoses (helmets), surgery, or any combination of these. Helmet therapy is currently the treatment of choice in children with moderate-to-severe nonsynostotic plagiocephaly. However, according to the American Academy of Pediatrics (AAP) (Persing et al, 2003), there are rare instances when surgery may be indicated if the nonsynostotic plagiocephaly deformities are severe and/or resistant to nonsurgical measures.

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 fit a child's head for a duration of two to four months. 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). Treatment usually begins at five to six months of age and continues for four to five months, with the helmet being worn for 23 hours per day. In addition, the AAP Committee on Practice and Ambulatory Medicine (Persing et al, 2003) reports that the use of cranial remolding helmets seems to be beneficial primarily for individuals who have not responded to mechanical adjustments and exercises (eg, head repositioning, neck exercises).

Policy

Pediatric cranial remolding orthoses (helmets) (Healthcare Common Procedure Coding System [HCPCS] code S1040) 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 eight-week trial of head repositioning or other conservative therapies, 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) (HCPCS code S1040) are considered medically necessary and, therefore, covered when they are used in accordance with the medical necessity criteria outlined above and there is a change in the individual's condition that requires a replacement remolding helmet (eg, 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 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, other health care professionals, and test reports.

An order for each item billed must be signed and dated by the physician who is treating the member and kept on file by the supplier. Medical record documentation must include a shipment confirmation or member's receipt of supplies and equipment. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

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.

MEDICARE

There is no Medicare coverage determination addressing this service; therefore, the Company policy is applicable.

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:

Head width (eu - eu) x 100
Head length (g - op)

Gender	Age	-2SD	-1SD	Mean	+1SD	+2SD
Male	16 days-6 months	63.7	68.7	73.7	7	83.7
	6-12 months	64.8	71.4	78.0	84.6	91.2
Female	16 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

References

Committee for the assessment of the NIOSH head-and-face anthropometric survey of US respirator users (2007). 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 March 15, 2010.

Fish D, Lima D. An overview of positional plagiocephaly and cranial remolding orthoses. [American Academy of Orthotists and Prosthetists (AAOP) Web site]. 2003. Available at: http://www.oandp.org/jpo/library/2003_02_037.asp. Accessed March 15, 2010.

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 March 15, 2010.

Jimenez DF, Barone CM, McGee ME, Cartwright CC, Baker CL. 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, Manwaring KH, Beals SP. Cranial growth unrestricted during treatment of deformational plagiocephaly. Pediatr Neurosurg. 1999;30(4):193-199.

Littlefield T. FDA regulation. [Plagiocephaly Web site]. 01/24/01. Available at: http://www.plagiocephaly.org/resources/fdanote.htm. Accessed March 15, 2010.

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

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

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 March 15, 2010.

Persing J, James H, Swanson J, Kattwinkel J. American Academy of Pediatrics (AAP) Committee on Practice and Ambulatory Medicine, Section on Plastic Surgery and Section on Neurological Surgery. Prevention and management of positional skull deformities in infants. Pediatrics. 2003;112(1 Pt 1):199-202. Also available on the AAP Web site at: http://aappolicy.aappublications.org/cgi/content/full/pediatrics;112/1/199. Accessed March 15, 2010.

Teichgraeber JF, Ault JK, Baumgartner J, et al. Deformational posterior plagiocephaly: diagnosis and treatment. Cleft Palate Craniofac J. 2002;39(6):582-586.

Texas Pediatric Surgical Associates. Craniosynostosis. [Texas Pediatric Surgical Associates Web site]. Available at: http://www.pedisurg.com/PtEduc/Craniosynostosis.htm. Accessed March 15, 2010.

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 March 15, 2010.

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: http://www.accessdata.fda.gov/cdrh_docs/pdf7/K072862.pdf. Accessed March 15, 2010.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. O&P Cranial Molding Helmet�. 510(k) summary. [FDA Web site]. 07/01/02.
Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063395.pdf. Accessed March 15, 2010.

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:
http://www.accessdata.fda.gov/cdrh_docs/pdf/K001167.pdf. Accessed March 15, 2010.

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 March 15, 2010.

US Food and Drug Administration (FDA). Department of Health and Human Services. Medical devices; Exemptions from premarket notification; Class II devices. [FDA Web site]. 12/26/06. Available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-22072.htm. Accessed March 15, 2010.

US Food and Drug Administration (FDA). Department of Health and Human Services. Medical devices; Neurological devices; Classification of cranial orthosis. [FDA Web site]. 07/30/98. Available at: http://www.fda.gov/ohrms/dockets/98fr/073098b.txt. Accessed March 15, 2010.

Coding Table

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.

Code System	Code Number(s) and Narrative(s)
CPT	N/A
ICD Procedure	N/A
ICD Diagnosis	USE THE FOLLOWING CODE TO REPORT PLAGIOCEPHALY 754.0: Congenital musculoskeletal deformities of skull, face, and jaw USE THE FOLLOWING CODE TO REPORT CRANIOSYNOSTOSIS 756.0: Congenital anomalies of skull and face bones USE THE FOLLOWING CODE TO REPORT A POST-OPERATIVE SURGICAL CRANIAL PROCEDURE V45.89: Other postprocedural status
HCPCS Level II	S1040: Cranial remolding orthosis, pediatric, rigid, with soft interface material, custom fabricated includes fitting and adjustment(s)
Revenue Codes	N/A

Cross References

Cross Reference Policies

05.00.44f:

Repair and Replacement of Durable Medical Equipment (DME)

Version Effective Date: 01/13/2009