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Clinical Policy Bulletin:
Cranial Remodeling
Number: 0379


Policy

  1. Aetna considers cranial remodeling bands (or helmets) as medically necessary orthoses for treatment of moderate-to-severe positional head deformities associated with premature birth, restrictive intra-uterine positioning, cervical abnormalities, birth trauma, torticollis (shortening of the sternocleidomastoid muscle) and sleeping positions in children when banding is initiated at 3 to 12 months of age and the following conditions are met:

    1. A 2-month trial of conservative therapy consisting of re-positioning the child's head such that the child lies opposite to the preferred position, has failed to improve the deformity and is judged to be unlikely to do so, and

    2. One of the following must be met:

      1. Anthropometric data (measurements used to evaluate abnormal head shape by measuring the distance in mm from one pre-designated point on the face or skull to another, comparing the right and left sides) verifies that a moderate-to-severe plagiocephaly is documented by a physician experienced in such measurement.  (Note: These measurements are generally obtained by the orthotist fitting the band or helmet).  The most significant measurements used in this initial evaluation are skull base asymmetry, cranial vault asymmetry, orbitotragial depth, and cephalic index.

        DIAGRAM:

        A difference of asymmetry greater than 6 mm between anthropometric measurements (see diagram above) in any of the anthropometric data in the first column of the following table warrants coverage of a trial of orthotic banding to correct the craniofacial deformity:

        Anthropometric Data

        Measurement

        Measures

        Cranial base
        (sn-t on same side)
        from right and left subnasal point (sn) to tragus (t) measures maxillary depth or right and left morphological face height
        Cranial vault
        (fz R-euL, fz L-euR)
        from frontozygomaticus point (fz) on one side of face to euryon (eu) measures cranial vault asymmetry
        Orbitotragial depth
        (ex-t, R, L)
        from exocanthion point (ex) to tragus (t) measures orbito-tragion depth (exocanthion)

         

      2. For brachycephaly evaluation, a cephalic index of 2 standard deviations (SDs) below mean (head narrow for its length) or 2 SDs above mean (head wide for its length) warrants coverage of a trial of orthotic banding to correct the craniofacial deformity in a child after 4 months of age and before 12 months of age.  (Note: These measurements are generally obtained by the orthotist fitting the band or helmet).

        Head width
        (eu - eu)
        from euryon (eu) on one side of head to euryon (eu) on the other side measures greatest transverse diameter or maximal head width
        Head length
        (g-op)
        from glabella point (g) to opisthocranion (op) measures maximal head depth or length

         

        Cephalic index = Head width (eu - eu) x 100 
                                           Head length (g - op) 

        Sex

        Age  -2 SD   -1 SD   Mean   +1 SD   +2 SD 
        Male 16 days to 6 months

        63.7

        68.7

        73.7

        78.7

        83.7

         

        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

          6 to 12 months

        69.5

        74.0

        78.5

        83.0

        87.5

         

      3. Infants who develop significant plagiocephaly secondary to a constant head position required for long-term hyperalimentation who do not respond to simple changing of the catheter location allowing the head to be re-positioned.
      4. Members with excess frontal bossing secondary to sagittal synostosis
      5. Premature infants with dolichocephalic head shape who have developed a mis-shapen head secondary to sustained head position.

      A second cranial remodeling band or helmet is considered medically necessary for children who met the aforementioned criteria at the initiation of therapy if the asymmetry has not resolved or significantly improved after 2 to 4 months such that the severity of head deformity indicates another orthosis and the orthosis becomes ill-fitting after attempts to adjust and leaves little or no room for new growth. A second orthosis may be medically necessary to prevent regression of head shape in very young infants (8 months or younger) who met the aforementioned criteria at the initiation of therapy, who have outgrown the initial orthosis, and have not developed midline head control, rolling, or sitting. Note: remodeling bands (or helmets) are contraindicated and considered not medically necessary after 2 years of age).

  2. Aetna considers the use of a cranial remodeling band (or helmet) cosmetic for persons not meeting the afore-mentioned criteria. 

  3. Aetna considers use of a cranial remodeling band (or helmet) medically necessary for infants with synostotic plagiocephaly to correct continued asymmetry following surgery (i.e., a trial of conservative therapy is not needed when the cranial remodeling band is used following surgery for synostotic plagiocephaly). 

    Aetna considers the use of a cranial remodeling band or helmet without surgery to correct asymmetry in infants with synostotic plagiocephaly as experimental and investigational; craniosynostosis that is not surgically corrected is a contraindication to use of cranial remodeling bands or helmets.

  4. Aetna considers the use of sleep positioning wrap for the treatment of infants with positional head shape deformities experimental and investigational because its effectiveness has not been established.

  5. Aetna considers intra-operative indocyanine green angiography to evaluate scalp perfusion during cranial vault remodeling in infants experimental and investigational because the effectiveness of this approach has not been established.

Note: Aetna considers cranial removeling helmets and bands contraindicated and not medically necessary in unshunted or uncontrolled hydrocephalus..



Background

Plagiocephaly (an asymmetrical head shape) is most often the result of an infant spending extended periods of time on their back, typically during sleep.  Plagiocephaly can also occur as a feature of other disorders (e.g., craniofacial disorders, torticollis, cervical anomalies) and is categorized as either positional or synostotic (premature union of cranial sutures).  Although 1 in 300 infants exhibit variable degrees of plagiocephaly, true sutural synostosis, which interferes with cranium development and may cause increased intra-cranial pressure, occurs in only 0.4 to 1 per 1,000 live births.

Positional plagiocephaly is treated conservatively and many cases do not require any treatment as the condition may resolve spontaneously when the infant begins to sit up.  When the deformity is moderate or severe and a trial of re-positioning the infant has failed, a pediatric neurologist, neurosurgeon or other appropriate specialist in craniofacial deformities may prescribe a cranial remodeling band to remodel the misshapen head.  The custom molded orthotic is designed to fit a child’s head for 2 to 4 months.

Examples of brands of cranial remodeling bands and helmets include the DOC BAND®, Gillette Children's Craniocap, and the STARband™ Cranial Headband.  Average treatment time with the cranial remodeling band or helmet is 4.5 months.

A systematic evidence review of cranial orthosis treatment for infant deformational plagiocephaly prepared for the UK National Health Services (NHS QIS, 2007) found no randomized controlled trials assessing the effectiveness of cranial orthoses for the treatment of deformational plagiocephaly were identified.  The assessment stated that no evidence-based conclusions can be reached on the effectiveness of cranial orthoses due to the limited methodological quality of the available trials.  "Further research in the form of a randomised controlled trial is needed to determine the true effectiveness of cranial orthoses."

While infants with positional plagiocephaly may be treated with head positioning and/or helmeting, the standard treatment for synostotic plagiocephaly (asymmetrical head caused by premature closure of the cranial sutures) is surgery.  There is some evidence suggesting that a cranial remodeling band (or helmet) may improve outcomes following surgery to treat synostotic plagiocephaly.  Seymour-Dempsey et al (2002) retrospectively reviewed the results of surgery alone (n = 6) versus surgery and post-operative banding (n = 15) in treating children diagnosed with sagittal synostosis.  The investigators reported that correction toward a normal cephalic index was seen in the banded group throughout the course of treatment, while this trend was not present in the non-banded group.

Cranial rmodeling bands and helmets are contraindicated in infants older than 24 months. The skulls of these children have finished growing and no longer have the pliability and plasticity necessary to create a change in shape.

In a randomized controlled trial, Hutchison et al (2010) examined the effectiveness of the Safe T Sleep positioning wrap in infants with positional head shape deformities. A total of 126 infants presenting to a plagiocephaly clinic were randomized to either positioning strategies or to positioning plus the use of a Safe T Sleep™ positioning wrap.  Head shape was measured using a digital photographic technique, and neck function was assessed.  They were followed-up at home 3, 6 and 12 months later.  There was no difference in head shape outcomes for the 2 treatment groups after 12 months of follow-up, with 42 % of infants having head shapes in the normal range by that time; 80 % of children showed good improvement.  Those that had poor improvement were more likely to have both plagiocephaly and brachycephaly and to have presented later to clinic.  The authors concluded that most infants improved over the 12-month study period, although the use of a sleep positioning wrap did not increase the rate of improvement.

Larsen (2004) stated that a second orthosis is rarely required but could be used in very severe head deformations, unusual circumstances (illness-negated use or if the child has serious health and/or positioning issues), or unusually high expectations of the family.  The author noted that criteria for determining a second orthosis include the following:

  • Despite every effort, the orthosis becomes ill-fitting or leaves little or no room for new growth;
  • If age and severity indicate another orthosis and parents are willing to continue; and
  • If prescribed for use as a continued post-operative adjunct or for preventative measures.

The American Academy of Orthotists and Prosthetists' draft consensus statement on "Orthotic management of deformational plagiocephaly (AAOP, 2004) stated that "very young infants who have not developed midline head control, rolling, or sitting, may require a second orthosis to prevent regression of the head shape".  The AAOP stated that a second orthosis is rarely required but may be used in cases of increased severity, extenuating circumstance (infant with multiple health issues), or a very young infant (less than 3 months).  Criteria for use of a second orthosis include ill-fitting orthosis after multiple attempts to adjust, age/severity indicators with a willingness to continue by the family, post-operative adjunct/ preventative measures.  The guideline also noted that termination of the orthotic treatment program is recommended, without weaning, when head shape falls within normal limits.  If unresolved torticollis exists or if sleeping patterns are poor (same side as flatness), use is continued for an additional 2 to 4 weeks.  Furthermore, unshunted or uncontrolled hydrocephalus as well as craniosynostosis are contraindications for cranial remolding orthosis.

Chan and colleagues (2013) noted that craniosynostosis results in characteristic skull deformations.  Correction of craniosynostosis has traditionally involved an open cranial vault remodeling (CVR) procedure.  A technique recently developed endoscope-assisted craniectomy (EAC) repair in conjunction with a post-operative molding helmet to guide cranial growth.  Few studies compared these 2 approaches to the treatment of the various forms of craniosynostosis.  These investigators presented a single institution's experience with open CVR and EAC.  This study was a retrospective review of 57 patients who underwent craniosynostosis repair by either the endoscope-assisted or open techniques; and compared operating room times, blood loss, volume of transfused blood, length of hospital stay, and overall costs.  The endoscopic technique was performed on younger children (4.7 months versus 10.6 months, p = 0.001), has shorter operating room times (2 hours 13 minutes versus 5 hours 42 minutes, p = 0.001), lower estimated blood loss (74.4 ml versus 280.2 ml, p = 0.001), less transfused blood (90.6 ml versus 226.9 ml), shorter hospital stays (1.2 days versus 4.9 days, p = 0.001), and decreased cost ($24,404 versus $42,744, p = 0.008) relative to the traditional open approach.  The authors concluded that issues with the endoscope-assisted procedure primarily concerned the post-operative helmet regimen, specifically patient compliance (17.1 % non-compliance rate) and minor skin breakdown (5.7 %).  The endoscope-assisted repair with post-operative helmet molding therapy was a cost-effective procedure with less operative risk and minimal post-operative morbidity.  This was a valuable treatment option in younger patients with compliant care-givers.

Vogel and associates (2014) stated that the surgical management of infants with sagittal synostosis has traditionally relied on open CVR techniques; however, minimally invasive technologies, including EAC repair followed by helmet therapy (HT, EAC+HT), is increasingly used to treat various forms of craniosynostosis during the 1st year of life.  These researchers determined the costs associated with EAC+HT in comparison with those for CVR.  They performed a retrospective case-control analysis of 21 children who had undergone CVR and 21 who had undergone EAC+HT.  Eligibility criteria included an age less than 1 year and at least 1 year of clinical follow-up data.  Financial and clinical records were reviewed for data related to length of hospital stay and transfusion rates as well as costs associated with physician, hospital, and outpatient clinic visits.  The average age of patients who underwent CVR was 6.8 months compared with 3.1 months for those who underwent EAC+HT.  Patients who underwent EAC+HT most often required the use of 2 helmets (76.5 %), infrequently required a 3ird helmet (13.3 %), and averaged 1.8 clinic visits in the first 90 days after surgery.  Endoscope-assisted craniectomy plus HT was associated with shorter hospital stays (mean of 1.10 versus 4.67 days for CVR, p < 0.0001), a decreased rate of blood transfusions (9.5 % versus 100 % for CVR, p < 0.0001), and a decreased operative time (81.1 versus 165.8 minutes for CVR, p < 0.0001).  The overall cost of EAC+HT, accounting for hospital charges, professional and helmet fees, and clinic visits, was also lower than that of CVR ($37,255.99 versus $56,990.46, respectively, p < 0.0001).  The authors concluded that EAC+HT were a less costly surgical option for patients than CVR.  Furthermore, EAC+HT were associated with a lower utilization of peri-operative resources.  The authors stated that these findings suggested that EAC+HT for infants with sagittal synostosis may be a cost-effective 1st-line surgical option.

Hinchcliff et al (2013) stated that the current treatment of craniosynostosis is open surgical excision of the prematurely fused suture and CVR.  Due to the change in skull morphology and the increase in volume, some tension on the skin flaps is noted with closure.  Although complete wound breakdown is rare, it can be a devastating complication.  These researchers presented their experience with the use of the SPY imaging system (Lifecell Corporation, Branchburg, NJ) to visualize and record blood flow within the flaps of a 1-year old patient with anterior plagiocephaly.  The authors concluded that intra-operative indocyanine green angiography has the potential to be a significant advantage in such cases, providing a safe and objective method to assess intra-operative scalp perfusion, allowing the surgeon to take additional measures to ameliorate any ischemic problems.

 
CPT Codes / HCPCS Codes / ICD-9 Codes
CPT codes not covered for indications listed in the CPB:
92240
Other CPT codes related to the CPB:
97762
HCPCS codes covered if selection criteria are met:
D5924 Cranial prosthesis
L0112 Cranial cervical orthosis, congenital torticollis type, with or without soft interface material, adjustable range of motion joint, custom fabricated
L0113 Cranial cervical orthotic, torticollis type, with or without joint, with or without soft interface material, prefabricated, includes fitting and adjustment
S1040 Cranial remolding orthosis, pediatric, rigid, with soft interface material, custom fabricated, includes fitting and adjustment(s)
HCPCS codes not covered for indications listed in the CPB:
C9733 Non-ophthalmic fluorescent vascular angiography
ICD-9 codes covered if selection criteria are met:
754.0 Certain congenital musculoskeletal deformities of skull, face, and jaw
756.0 Other congenital musculoskeletal anomalies of skull and face bones [craniosynostosis that is not surgically corrected is a contraindication to use of cranial remodeling bands or helmets]
ICD-9 codes not covered for indications listed in the CPB (not all inclusive):
331.3 Communicating hydrocephalus [unshunted or uncontrolled]
331.4 Obstructive hydrocephalus [unshunted or uncontrolled]
331.5 Idiopathic normal pressure hydrocephalus [INPH] [unshunted or uncontrolled]
741.00 - 741.03 Spina bifida with hydrocephalus [unshunted or uncontrolled]
742.3 Congenital hydrocephalus [unshunted or uncontrolled]
Other ICD-9 codes related to the CPB:
723.5 Torticollis, unspecified
738.19 Other specified deformity of head
738.2 Acquired deformity of neck
744.89 Other specified anomalies of face and neck
754.1 Certain congenital musculoskeletal anomalies of sternocleidomastoid muscle
765.00 - 765.19 Extreme immaturity and other preterm infants
767.8 Other specified birth trauma
V53.7 Fitting and adjustment of orthopedic devices


The above policy is based on the following references:
  1. Moss SD. Nonsurgical, nonorthotic treatment of occipital plagiocephaly: What is the natural history of the misshapen neonatal head? J Neurosurg. 1997;87(5):667-670.
  2. Fredrick DR, Mulliken JB, Robb RM. Ocular manifestations of deformational frontal plagiocephaly, J Pediatr Ophthalmol Strabismus. 1993;30(2):92-95.
  3. Ripley CE, Pomatto J, Beals SP, et al. Treatment of positional plagiocephaly with dynamic orthoticcranioplasty. J Craniofacial Surg. 1994;5(3):150-159.
  4. Orthomerica Products, Inc. The Global Orthotic Solution [website]. Newport Beach, CA: Orthomerica; 2002. Available at: http://www.orthomerica.com/. Accessed May 16, 2002.
  5. Cranial Technologies, Inc. Welcome to Cranial Technologies, Inc., Manufacturer of the DOC Band [website]. Tempe, AZ: Cranial Technologies; 2002. Available at: http://www.cranialtech.com/. Accessed May 16, 2002.
  6. Orthomerica Products, Inc. The STARband™ Cranial Remolding Orthosis [website]. Newport Beach, CA: Orthomerica; 2003. Available at: http://www.orthomerica.com/products/cranial/starband.htm. Accessed May 13, 2004.
  7. Gillette Children's Specialty Healthcare. Craniocap™ [website]. St. Paul, MN: Gillette; 2003, 2004. Available at: http://www.gillettechildrens.org/. Accessed May 13, 2004.
  8. Persing J, James H, Swanson J, et al. Prevention and management of positional skull deformities in infants. The American Academy of Pediatrics. Clinical report. Guidance for the clinician in rendering pediatric care. Pediatrics. 2003;112(1):199-202.
  9. Institute for Clinical Systems Improvement (ICSI). Cranial orthoses for deformational plagiocephaly. ICSI Technology Assessment Reports. TA #082. Bloomington, MN: ICSI; March 2004.Availableat:http://www.icsi.org/knowledge/detail.asp?catID=107&itemID=1495. Accessed May 3, 2004.
  10. Pollack IF, Losken HW, Fasick P. Diagnosis and management of posterior plagiocephaly. Pediatrics. 1997;99(2):180-185.
  11. Wolfe A, Rubenstein A. Congenital, Syntoses. eMedicine Plastic Surgery Topic 190. Omaha, NE: eMedicine.com; updated May 14, 2003. Available at: http://www.emedicine.com/plastic/topic190.htm. Accessed December 14, 2004. 
  12. Seymour-Dempsey K, Baumgartner JE, Teichgraeber JF, et al. Molding helmet therapy in the management of sagittal synostosis. J Craniofac Surg. 2002;13(5):631-635.
  13. de Ribaupierre S, Vernet O, Rilliet B, et al. Posterior positional plagiocephaly treated with cranial remodeling orthosis. Swiss Med Wkly. 2007;137(25-26):368-372.
  14. Govaert B, Michels A, Colla C, van der Hulst R. Molding therapy of positional plagiocephaly: Subjective outcome and quality of life. J Craniofac Surg. 2008;19(1):56-58.
  15. NHS Quality Improvement Scotland (NHS QIS). Evidence note 16: The use of cranial orthosis treatment for infant deformational plagiocephaly. Glasgow, Scotland: NHS QIS; 2007.
  16. Bialocerkowski AE, Vladusic SL, Howell SM. Conservative interventions for positional plagiocephaly: A systematic review. Develop Med Child Neurol. 2005;47(8):563-570.
  17. Lee RP, Teichgraeber JF, Baumgartner JE, et al. Long-term treatment effectiveness of molding helmet therapy in the correction of posterior deformational plagiocephaly: A five-year follow-up. Cleft Palate Craniofac J. 2008;45(3):240-245.
  18. 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.
  19. Feijen MM, Claessens EA, Dovens AJ, et al. Babies with cranial deformity. Ned Tijdschr Geneeskd. 2009;153:A368.
  20. Hutchison BL, Stewart AW, De Chalain TB, Mitchell EA. A randomized controlled trial of positioning treatments in infants with positional head shape deformities. Acta Paediatr. 2010;99(10):1556-1560.
  21. Larsen J. Orthotic treatment protocols for plagiocephaly. JPO. 2004;16(4S):31-34. Available at: http://www.oandp.org/jpo/library/2004_04S_031.asp. Accessed August 27, 2012.
  22. American Academy of Orthotists and Prosthetists Third Consensus Conference. Orthotic management of deformational plagiocephaly (Draft). April 7 - 9, 2004. Available at: http://www.oandp.org/assets/pdf/CSOP3_Draft_Final_Report.pdf. Accessed August 27, 2012.
  23. The American Academy of Orthotists & Prosthetists. Orthotic treatment of deformational plagiocephaly, brachycephaly, and scaphocephaly. AAOP: Washington, D.C. Available at: http://www.oandp.org/olc/lessons/html/200508-22/section_10.asp?frmCourseSectionId=E890A87B-BC57-49D4-AE5C-A038F14CB207. Accessed March 27, 2013.
  24. Ridgway EB, Berry-Candelario J, Grondin RT, et al. The management of sagittal synostosis using endoscopic suturectomy and postoperative helmet therapy. J Neurosurg Pediatr. 2011;7(6):620-626.
  25. Hinchcliff KM, Yao A, Taub PJ. Laser-assisted indocyanine green imaging to assess perfusion of scalp closure in an infant. J Craniofac Surg. 2013;24(6):2004-2006.
  26. 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.
  27. Vogel TW, Woo AS, Kane AA, et al. A comparison of costs associated with endoscope-assisted craniectomy versus open cranial vault repair for infants with sagittal synostosis. J Neurosurg Pediatr. 2014;13(3):324-331.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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