BlueCross and BlueShield of Montana Medical Policy/Codes
Cranial Remolding Orthosis (CRO)
Chapter: Durable Medical Equipment
Current Effective Date: December 27, 2013
Original Effective Date: March 05, 2010
Publish Date: December 27, 2013
Revised Dates: April 29, 2011; June 26, 2012; December 10, 2013
Description

The cranial remodeling orthosis (CRO) is a headband (helmet) appliance used to treat variable degrees of cranial asymmetry or abnormal head shape, known as plagiocephaly, by redirecting growth.  These abnormalities are due to premature fusion of the seams between the bony plates of the skull known as synostotic plagiocephaly (craniosynostosis), or non-synostotic plagiocephaly (open sutures) known as positional or deformational plagiocephaly.  These positional conditions or misshapen appearance can be derived from environmental factors such as:

  • Premature birth,
  • Restrictive intrauterine environment,
  • Birth trauma,
  • Shortening of the sternocleidomastoid neck muscle (known as torticollis),
  • Cervical anomalies,
  • Medical treatment, such as long-term hyperalimentation, requiring constant head positions for catheter placement,
  • Sleeping positions,
  • Infant/child carrier systems that increase supine positioning, or
  • From the interaction of any of these conditions. 

In effect, the continuous pressure on one side of the cranium causes all the bones on the same side to progress forward, creating asymmetry and sometimes a realignment of the facial structures as well.

Infants with hydrocephalus have an abnormal excessive accumulation of cerebrospinal fluid (CSF) resulting in the dilation of the cerebral ventricles of the brain caused by a disturbance in CSF circulation or an over-production of CSF.  Hydrocephalus raises the intracranial pressure and results in abnormal head enlargement with possible brain atrophy.  A CRO device may be used in conjunction with surgical treatment of hydrocephalus.

Infants with positional plagiocephaly may exhibit complex and multiple asymmetries affecting the cranial vault, skull base, and face, such as unilateral flattening or bossing (protruding) of head areas with or without head tilting.  The first step in determining whether a CRO device is needed is to complete craniofacial anthropometric measurements and calculate the cephalic index, in addition to standard or routine measurements of the head circumference.  The measurements may be done manually or by using a specialized laser digitalized scanner.

The craniofacial anthropometric measurement of the head (skull and face) is the comparison of right and left sides by measuring the distance in millimeters from one side of the face or skull to another.  The primary areas measured and asymmetry (a discrepancy of 6-12 mm) is calculated, as shown in the following table:

Craniofacial Area

Anthropometric Measurement

Determines Asymmetry

Calculated

 

Cranial (skull) base

from right and left  subnasal (sn) point (midline under the nose) to tragus (t) (the cartilaginous projection in front of the external auditory canal)

upper jaw depth or right and left face height

sn to left t minus 

sn to right t

Cranial vault

from right and left frontozygomaticus (fz) point (forehead just above the eye orbit) to right and left euryon (eu) (most lateral point of the head)

bones of the skull enclosing the brain

left fz to right eu minus right fz to left eu

Orbitotragial depth or distances

from right and left exocanthion (ex) point (outer point of the eye where the eyelids meet) to tragus (t)

cheek bones below the eyes

left ex to left t minus right ex to right t

The cephalic index is the ratio of the width of the head to its length, using head width measurement from euryon (eu) on one side of head to eu on other side of head versus head length measurement from glabella (g) point to opisthocranion (op).  Expressed in a percentile number, the cephalic index is calculated by head width multiplied by 100 and divided by head length, as shown in the following equation:

(Head width [eu to eu] x 100)  divided by  (Head length [g to op])

The cephalic index is considered abnormal (the head shape may not be asymmetrical) if it is two standard deviations (SD) above or below the mean measurements (mean being appropriate to gender/age). Therefore, cephalic indices are categorized as a measurement of:

  • Above 80 is considered being brachycephalic or broad (head width wider for head length);
  • Between 75 and 80 is considered being mesaticephalic (head of medium width and length); and,
  • Below 75 is considered being dolichocephalic or long (head width narrow for head length). 

The ± standard deviations with the mean of cephalic indices are shown on the following table:

Gender

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

The cranial index is the same ratio taken on the skull.

The CRO device has also been proposed as a postoperative complement for those patients undergoing surgery for synostotic plagiocephaly or hydrocephalus.

The CRO device is customized to the patient's head shape.  It is fabricated either from a plaster of paris impression, or by computer models from scanned measurements using a semi-rigid outer shell bonded to a foam inner lining.  This lightweight cranial headband applies dynamic pressure to the elevated areas, while leaving space for growth and remodeling of the flattened areas.  The average treatment timeline using a CRO device is approximately four to five months and is typically initiated around five to six months of age.  Both helmets and cranial bands are recommended for wear 23 hours per day.  As the infant ages, the helmet or band will require adjustments or replacement to accommodate the cranial growth.  Throughout the treatment course, the head shape may be compared to a computer model from the manual or scanned measurements.  An exit head casting is done at the completion of the therapy course.

The CRO device is known by several different names, such as:

  • DOC Band™ (Dynamic Orthotic Cranioplasty Band),
  • STARband™ or STARlight™,
  • PAP Orthosis (Plagiocephalic Applied Pressure Orthosis),
  • CSO (Cranial Solutions Orthosis),
  • Cranial Shaping/Molding Helmet,
  • Cranial Band,
  • Cranial Symmetry System,
  • CranioCap™.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions.  Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coverage 

As a non-surgical treatment of non-synostotic positional plagiocephaly, a cranial remodeling orthosis (CRO) will be eligible for coverage when banding is initiated at four to eighteen months of age for moderate to severe positional head deformities. 

All requests seeking coverage (if there are no benefit restrictions) of a CRO for a non-surgical indication must include all required documentation before a medical necessity determination can be made:

  • Failed conservative therapy of no less than two months by:
    1. Repositioning the infant’s head to the opposite of the infant’s preferred position when either lying down, reclined, or sitting; AND
    2. Performing neck exercises at each diaper change; AND
    3. Repositioning the infant’s bed encouraging the infant to look away from the flattened side to view individuals in the room; and
  • Either one of the following sets of measurements or indications:
    1. Asymmetrical appearance confirmed by a right/left discrepancy of greater than 6 mm in any craniofacial anthropometric measurement; OR
    2. Brachycephalic or dolichocephalic disproportion (comparison of head length versus head width) confirmed by a cephalic index of two standard deviations above mean or two standard deviations below mean.

NOTE:  Measurements are usually obtained by the physician or orthotist fitting the helmet or headband.

As an adjunctive postsurgical therapy for synostotic plagiocephaly or hydrocephalus, a CRO may be considered medically necessary.

Rationale

Although there is limited published data from uncontrolled case series, the literature describes the effectiveness of the CRO device as a nonsurgical alternative or as an adjunctive to infant cranial surgery.  In order to validate the treatment, a controlled group case series is considered particularly important to compare outcomes since mild positional molding may self-correct over time or become inapparent due to hair growth.  One needs only to examine the heads in the adult population to realize that the number of appreciable asymmetry is far less in this age range than in the neonatal population.  The deduction is that the natural remodeling process of the human head must correct many of the deformities seen in childhood.  Repositioning has been shown to be as effective in restoring symmetry to the cranium.

There are case studies of infants with mild to moderate abnormalities exhibiting successful correction of asymmetries when using a CRO device.  Moderate to severe abnormalities may require a combination use of surgery and a CRO device to prevent regression of the repair post-operatively.  Positional plagiocephaly does not pose a threat to the child's physical health.   There are no published data on the effects of positional plagiocephaly on neuropsychological deficits, developmental delay, temporomandibular joint disorders, or psychosocial concerns related to a perceived abnormal appearance.  The major reason for intervention is to optimize the cranial contour to achieve an acceptable appearance, not to prevent or correct adverse developmental consequences.

The incidence of positional plagiocephaly has increased rapidly in recent years as a result of the “Back to Sleep” campaign recommended by the American Academy of Pediatrics (AAP), in which a supine sleeping position is recommended to reduction of the risk of sudden infant death syndrome (SIDS).  It is estimated that one of every 60 newborns may have some degree of plagiocephaly.

There are three basic options for treating plagiocephaly:

  • No therapy,
  • Repositioning (increased “tummy time”) therapy, or
  • Helmet or Cranial band orthosis therapy.

Helmet or cranial band orthosis is generally considered after a failure of an initial trial of repositioning.  However, some providers recommend early helmet or cranial banding earlier on older infants as the orthosis therapy may be increasingly less effective in the older infant when their cranial sutures begin to close.  Therefore, requiring a two month trial of repositioning therapy in children older than six to nine months may limit the effectiveness of the helmet or cranial band therapy.  Furthermore, reposition therapy may be less effective in older infants who are increasingly more mobile and do not maintain a single sleeping position.

In 2003, the AAP issued a policy indicating that improvement in skull shape is usually seen in two to three months with exercise and repositioning of the infant.  The AAP indicated that the use of skull-molding helmets seems to be beneficial primarily when there has been a lack of response to mechanical adjustments and exercises.  However, the AAP noted further studies are needed to identify outcome with and without skull-molding helmets.  Furthermore, the AAP did not report any functional impairment associated with plagiocephaly.

July 2007 Update:

A MEDLINE search for the period 2005 through July 2007 identified the absence of controlled studies and the relationship between deformational plagiocephaly and functional defects.  This relationship remains controversial in the scientific literature.

A number of publications discuss an increase in the prevalence of positional plagiocephaly coincident with national recommendations for infants to sleep in the supine position (to reduce the potential for SIDS).  One of these reports suggests that referrals for plagiocephaly-associated torticollis may be rising at the same rate.  Retrospective chart review found that 95% of referrals to a tertiary care center with a primary diagnosis of torticollis (110 of 139 referred infants had adequate records for review) also presented with plagiocephaly or facial asymmetry.  Based on clinical evidence of differing etiologies, the authors concluded that 88% of the torticollis cases were secondary to plagiocephaly.  Since head tilt and occipital flattening may both exacerbate maintenance of an abnormal head position, the authors suggest that an early active program for treatment for both the plagiocephaly and torticollis be instituted.  Additional studies are needed to confirm this association.

As technology advances, clinical questions persist about the most accurate documentation of three-dimensional head shape measurements.  Plank and colleagues studied a method of quantifying head shape and used that method to evaluate the success of orthotic treatment.  Two hundred twenty-four infants diagnosed with deformational plagiocephaly received either a CRO or a repositioning program with no CRO intervention.  Data from 25 head shape variables were collected using a noninvasive laser shape digitalizer.  The study identified four variables as particularly important in assessing the head shape of infants with plagiocephaly: the cranial vault asymmetry index, radial symmetry index, posterior symmetry ratio, and overall symmetry ratio.  Ninety-six percent or more of the subjects in the treatment group (CRO intervention) showed improvement in each of the variables. 

2013 Update

A search of peer reviewed literature through June 2013 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy.  They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers.  Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes
93.29, 754.0, 756.0, V45.89, V48.6, V58.9
ICD-10 Codes
Q67.3, Q75.0 
Procedural Codes: 97799, S1040
References
  1. Ripley, C.E., Pomatto, J., et al.  Treatment of Positional Plagiocephaly with Dynamic Orthotic Cranioplasty.  The Journal of Craniofacial Surgery (1994 July) 5(3):150-9.
  2. Syndromal Craniosynostosis - AMA Practice Parameters.  Arlington Heights, Illinois: The American Society of Maxillofacial Surgeons Practice Parameters (1994 September):1-11.
  3. Plagiocephaly, Etiology - Unilateral Coroneal Synostosis - AMA Practice Parameters.  Arlington Heights, Illinois: The American Society of Maxillofacial Surgeons Practice Parameters (1994 September):1-9.
  4. Trigonocephaly, Etiology - Metopic Synostosis - AMA Practice Parameters.  Arlington Heights, Illinois:  The American Society of Maxillofacial Surgeons Practice Parameters (1994 September):1-9.
  5. Scaphocephaly, Etiology - Sagittal Synostosis - AMA Practice Parameters.  Arlington Heights, Illinois: The American Society of Maxillofacial Surgeons Practice Parameters (1994 September):1-9.
  6. Brachycephaly, Etiology - Bilateral Coronal Synostosis - AMA Practice Parameters.  Arlington Heights, Illinois: The American Society of Maxillofacial Surgeons Practice Parameters (1994 September):1-9.
  7. Kane, A.A., Mitchell, L.E., et al.  Observations on a recent increase of plagiocephaly without synostosis.  Pediatrics (1996 June) 97(6 Part 1):877-85.
  8. Farkas, L.G. and C.K. Deutsch.  Anthropometric determination of craniofacial morphology.  American Journal of Medical Genetics (1996 October 2) 65(1):1-4.
  9. Neurosurgery – Cranial Therapies Etiology of positional plagiocephaly in triplets and treatment using a dynamic orthotic cranioplasty device; report of three cases.  Cranial Therapies, Inc. On-Line Journal (1997 January):1-6.  Available at http://www.cranialtherapies.com (accessed on 1999 September 2).
  10. Pollack, I.F., Losken, H.W., et al.  Diagnosis and management of posterior plagiocephaly.  Pediatrics (1997 February) 99(2):180-5.
  11. Moss, S.D.  Nonsurgical, non orthotic treatment of occipital plagiocephaly: What is the natural history of the misshapen neonatal head?  Journal of Neurosurgery (1997 November) 87(5):667-70.
  12. Code of Federal Regulations.  Cranial orthosis.  Title 21, Volume 8, Section 882.5970. Washington, D.C.:(1998).
  13. Littlefield, T.R., Beals, S.P., et al.  Treatment of Craniofacial Asymmetry with Dynamic Orthotic Cranioplasty.  Journal of Craniofacial Surgery (1998 January) 9:11-7; discussion 18-9.
  14. Blecher, J.C. and H.P. Howaldt.  Treatment of non-synostotic, pediatric skull deformities with dynamic head orthosis.  Mund Kiefer Gesishtschir (1998 May) 2 Supplement 1:S81-5 (Published in German).
  15. Rekate, H.L.  Occipital plagiocephaly: a critical review of literature.  Journal of Neurosurgery (1998 July) 89(1):24-30.
  16. Ward, R.E., Jamison, P.L., et al.  Craniofacial variability index: A simple measure of normal and abnormal variation in the head and face.  American Journal of Medical Genetics (1998 November 16) 80(3):232-40.
  17. State of Texas. Insurance Code.  Coverage for Craniofacial Abnormalities.  Article 21.53W: 969. Austin, Texas:1999.
  18. Kelly, K.M., Littlefield, T.R., et al.  Cranial growth unrestricted during treatment of deformational plagiocephaly.  Pediatric Neurosurgery (1999) 30:193-9.
  19. Mulliken, J.B., Vander Woude, D.L., et al.  Analysis of posterior plagiocephaly: Deformational versus synostotic.  Plastic and Reconstructive Surgery (1999 February) 103(2):371-80.
  20. Kelly, K.M., Littlefield, T.R., et al.  Importance of early recognition and treatment of deformational plagiocephaly with orthotic cranioplasty.  Cleft Palate-Craniofacial Journal (1999 March) 36(2):127-30.
  21. Cranial Orthosis for Plagiocephaly without Synostosis.  Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Center Assessment Program (2000 February) 14(21): 1-21.
  22. Miller, R.I., and S.K. Clarren.  Long-term developmental outcomes in patients with deformational plagiocephaly.  Pediatrics (2000 February) 105(2):E26.
  23. Dynamic Orthotic Cranioplasty as a Treatment of Plagiocephaly.  Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2000 April 30) Durable Medical Equipment 1.01.11.
  24. Vles, J.S., Colla, C., et al.  Helmet versus non-helmet treatment in nonsynostotic positional posterior plagiocephaly.  Journal of Craniofacial Surgery (2000 November) 11(6):572-4.
  25. Loveday, B.P., and T.B. de Chalain.  Active counter-positioning or orthotic device to treat positional plagiocephaly.  Journal of Craniofacial Surgery (2001 July) 12(4):308-13.
  26. Panchal, J., Amirsheybani, H., et al.  Neurodevelopment in children with single-suture craniosynostosis and plagiocephaly without synostosis.  Plastic and Reconstructive Surgery (2001 November) 108(6):1492-8; discussion 1499-500.
  27. Deformational Plagiocephaly: Guidelines for Diagnosis and Treatment – Position Paper. Burbank, California: Cranial Therapies, Inc. (2002):1-2.
  28. Littlefield, T.R., Kelly, K.M., et al.  Multiple-birth infants at higher risk for development of deformational plagiocephaly: II. Is one twin at greater risk?   Pediatrics (2002 January) 109(1):19-25.
  29. Neurosurgery – Occipital Plagiocephaly American Association of Neurological Surgeons/Congress of Neurological Surgeons (2002 April 10).  Available at http://www.neurosurgery.org (accessed on 2002 April 10).
  30. Balan, P., Kushnerenko, E., et al.  Auditory ERPs reveal brain dysfunction in infants with plagiocephaly.  Journal of Craniofacial Surgery (2002 July) 13(4):520-5; discussion 526.
  31. Teichgraeber, J.F., Ault, J. K., et al.  Deformational posterior plagiocephaly: Diagnosis and treatment.  Cleft Palate-Craniofacial Journal (2002 November) 39(6):582-6.
  32. American Academy of Orthotists and Prosthetists – An Overview of Positional Plagiocephaly and Cranial Remolding Devices.  Journal of Prosthetics and Orthotics (2003) 15(2):37-47.  Available at http://www.oandp.org (accessed on 2002 April 10).
  33. Gupta, P.C., Foster, J., et al.  Ophthalmologic findings in patients with nonsyndromic plagiocephaly.  Journal of Craniofacial Surgery (2003 July) 14(4):529-32.
  34. Persing, J., James, H., 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 July) 112 (1 Part 1):199-202.
  35. Cranial Orthoses for Deformational Plagiocephaly.  Bloomington, Minnesota: Institute for Clinical Systems Improvement – Technology Assessment Abstract (2004 March) 82:1-13.
  36. NCG – Prevention and Management of Positional Skull Deformities in Infants National Guideline Clearinghouse (2004 February 20).  Available at http://www.guidelines.gov (accessed on 2005 April 18).
  37. BioAnth – Craniofacial Anthropometry.  Anthropology on the Internet (2003 May 19).  Available at http://www.bioanth.org (accessed on 2005 April 19).
  38. Kabbani, H., and T.S. Rahuveer. Craniosynostosis. American Family Physician (2004 June 15) 69(12):2863-70.
  39. Graham, J.M., Gomez, M., et al.  Management of deformational plagiocephaly: Repositioning versus orthotic therapy.  Journal of Pediatrics (2005 February) 146(2):258-62.
  40. de Chalain, T.M., and S. Park.  Torticollis associated with positional plagiocephaly: a growing epidemic.  Journal of Craniofacial Surgery (2005 May) 16(3):411-8.
  41. Siatkowski, R.M., Fortney, A.C., et al.  Visual field defects in deformational posterior plagiocephaly.  Journal of the American Association for Pediatric Ophthalmology and Strabismus (2005 June) 9(3):274-8.
  42. Kordestani, R.K., Patel, S., et al.  Neurodevelopmental delays in children with deformational plagiocephaly.  Plastic and Reconstructive Surgery (2006 January) 117(1):207-18; discussion 219-20.
  43. Plank, L.H., Giavedoni, B., et al.  Comparison of infant head shape changes in deformational plagiocephaly following treatment with a cranial remolding orthosis using a noninvasive laser shape digitalizer.  Journal of Craniofacial Surgery (2006 November) 17(6):1084-91.
  44. Adjustable Cranial Orthoses for Positional Plagiocephaly and Craniosynostoses.  Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (March 2013) Durable Medical Equipment 1.01.11.
History
April 2011  Policy statements on cranios ynostoses added; considered medically necessary following cranial vault remodeling. Title changed to “Helmet Therapy - Adjustable Cranial Orthoses for Positional Plagiocephaly and Craniosynostoses”
June 2012 Policy updated with literature review through January 2012; references 11 and 30 added and references reordered; policy statements unchanged
December 2013 Policy formatting and language revised.  Title changed from "Adjustable Cranial Orthosis for Positional Plagiocephaly and Craniosynostoses" to "Cranial Remodeling Orthosis (CRO)".  Removed CPT codes 97703 and 97762.  Added medical necessity criteria for non-surgical indications.
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Cranial Remolding Orthosis (CRO)