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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-L0000-02

Original Effective Date: 11/15/00

Reviewed: 01/22/15

Revised: 09/15/16

Subject: Cranial Orthosis as a Treatment for Plagiocephaly

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates  
           

DESCRIPTION:

NOTE: Coverage for cranial orthotic devices (helmets or bands) is subject to the member’s benefit terms. Refer to specific contract language regarding cranial orthotic devices.

Plagiocephaly can be subdivided into synostotic and non-synostotic types. Synostotic plagiocephaly describes an asymmetrically shaped head due to premature closure of the sutures of the cranium. In plagiocephaly without synostosis, the sutures remain open. Plagiocephaly without synostosis, also called positional or deformational plagiocephaly, 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. The incidence of plagiocephaly and brachycephaly has increased rapidly in recent years as a result of the “Back to Sleep” campaign recommended by the American Academy of Pediatrics, in which a supine sleeping position is recommended to reduce the risk of sudden infant death syndrome (SIDS). It is estimated that one of every 60 neonates may have some degree of plagiocephaly or brachycephaly. Positional plagiocephaly typically consists of right or left occipital flattening with advancement of the ipsilateral ear and prominence of the ipsilateral frontal region, 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. Assessment of plagiocephaly and brachycephaly are based on anthropomorphic measures of the head, using anatomical and bony landmarks.

Plagiocephaly without synostosis is a particular concern in infants with the following conditions:

There are 3 basic options for treating plagiocephaly and brachycephaly:

POSITION STATEMENT:

NOTE: Coverage for cranial orthotic devices (helmets or bands) is subject to the member’s benefit terms. Refer to specific contract language regarding cranial orthotic devices.

A cranial orthotic device (i.e., cranial remodeling band or helmet) meets the definition of medical necessity when used as an adjunct postoperative therapy for plagiocephaly with synostosis (i.e., craniosynostosis) after surgery.

A cranial orthotic device meets the definition of medical necessity when used in the treatment of moderate to severe plagiocephaly or brachycephaly without synostosis (i.e., craniosynostosis) as evidenced by cranial asymmetry substantiated by a cephalic index* of more or less than 2 standard deviations from the mean for the gender/age OR asymmetry of 12 mm or more in the measurement of the cranial vault, skull base, or orbitotragial depth when ALL of the following criteria are met:

*Cephalic Index: Evaluation of cranial asymmetry may be based on the cephalic index, which is a ratio between the width and length of the head. The head width is calculated by subtracting the distance from euryon (eu) on one side of the head to euryon on the other side of head, then multiplying by 100. Head length is generally calculated by measuring the distance from glabella point (g) to opisthocranion point (op). The cephalic index is then calculated as: Head width (eu – eu) x 100 divided by Head length (g – op).

The cephalic index is considered abnormal if it is two standard deviations (SD) above or below the mean measurements (American Academy of Orthotists and Prosthetists [AAOP], 2004). The indices for infants up to 12 months may be found on the following table:

Table

Cephalic Index Gender

Age

-2 SD

-1SD

Mean

+1SD

+2SD

Male

16 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

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

A second cranial remodeling band or helmet meets the definition of medical necessity for children who met the above criteria at the beginning of therapy if the cranial asymmetry has not resolved or significantly improved after 2-4 months.

Cranial remodeling bands or helmets are contraindicated for children 2 years of age and older.

Cranial orthosis, utilizing a cranial remodeling band or helmet, does not meet the definition of medical necessity when used as a non-surgical treatment for plagiocephaly or brachycephaly without synostosis (positional plagiocephaly) when used primarily to improve cranial asymmetry for cosmetic outcomes.

The use of these devices to treat or prevent loss of function does not meet the definition of medical necessity, as there are no conclusive data to support the use of dynamic orthotic cranioplasty devices for improving function or preventing loss of function.

BILLING/CODING INFORMATION:

HCPCS Coding:

S1040

Cranial remolding orthosis, pediatric rigid, with soft interface material, custom fabricated, includes fitting and adjustment(s)

LOINC Codes:

The following information may be required documentation to support medical necessity: Physician history and physical, physician treatment notes to included documented failed conservative treatment and photographs, treatment plan, operative reports, physical therapy notes (if applicable).

Documentation Table

LOINC Codes

LOINC
Time Frame
Modifier Code

LOINC Time Frame Modifier Codes Narrative

Physician history and physical

28626-0,

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Physician treatment/ visit notes including documentation of failure of conservative medical management

18733-6

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Treatment plan

18776-5

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Physician operative note

28573-4

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Physical therapy notes

28579-1

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline reviewed date.

DEFINITIONS:

Asymmetry: uneven, unlike; lack or absence of symmetry.

Brachycephaly: refers to a head shape that is not asymmetric but is disproportionately short.

Cranial sutures: the lines of junction between the bones of the skull.

Cranioplasty: any plastic operation on the skull; surgical correction of defects of the skull.

Craniosynostosis: plagiocephaly with synostosis.

Euryon: a point on either parietal bone marking either end of the greatest transverse diameter of the skull.

Glabella point: the smooth area between the eyebrows just above the nose; the most forward projecting point of the forehead in the midline of the supraorbital ridges.

Ipsilateral: situated or appearing on or affecting the same side of the body.

Opisthocranion: the point in the midline of the cranium that projects farthest backward.

Orthotic: a rigid or semi-rigid device used to support, restore, or protect body function. Orthotics may also redirect or restrict motion of an impaired body part.

Plagiocephaly: asymmetrically shaped cranium (head).

Synostosis: osseous (boney) union between the bones of a joint.

Torticollis: contracted state of the cervical muscles, producing twisting of the neck and an unnatural position of the head.

RELATED GUIDELINES:

Orthotics, 09-L0000-03

OTHER:

Other terms describing cranial orthoses:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of
one product over another, and is not intended to represent a complete listing of all products available.

Dynamic Orthotic Cranioplasty (DOC) Band™
Gillette Children's Craniocap
Helmet therapy
Skull molding caps
STARband™ Cranial Headband.

REFERENCES:

  1. American Academy of Orthotists and Prosthetists. Cephalic Index Table. 2004. Accessed 11/12/12.
  2. American Academy of Pediatrics Policy Statement. The Changing Concept of Sudden Infant Death Syndrome; Diagnostic Coding Shifts, Controversies Regarding the Sleeping Environment, and New Variables to Consider in Reducing Risk. Pediatrics Vol. 116 No. 5 Nov 2005, pp. 1245-1255.
  3. American Academy of Pediatrics, Clinical Report “Prevention and Management of Positional Skull Deformities in Infants”; PEDIATRICS Vol. 112 No. 1 July 2003, pp. 199-202 (accessed 11/03/10).
  4. American Medical Association CPT Coding (current version).
  5. Blue Cross Blue Shield Association Medical Policy Reference Manual – Treatment of Plagiocephaly without Synostosis 1.01.11 (05/22/14).
  6. Blue Cross Blue Shield Association TEC Evaluations (1999, Tab 21).
  7. Center for Medicare and Medicaid Services (CMS) HCPCS Level II Coding (current version).
  8. ClinicalTrials.gov. Clinical Study of Muenke Syndrome (FGFR3-Related Craniosynostosis), NCT00106977 (verified 01/10).
  9. Cranial Technologies, Inc., manufacturer of the DOC Band. Tempe, AZ: Cranial Technologies; 2002. (accessed 11/13/10).
  10. Cummings C. Positional plagiocephaly. Pediatric Child Health. 2011 Oct;16(8):493-6.
  11. ECRI Institute. Windows on Technology. “Cranial Orthosis for the Treatment of Deformational Plagiocephaly” (11/05).
  12. ECRI Technology Update, “Evidence Still Lacking on Orthotic Helmets for Deformational Plagiocephaly” (12/03).
  13. HAYES Brief – “Endoscopic Strip Craniectomy with Cranial Helmet Molding for Primary Craniosynostosis”, (05/13/07).
  14. HAYES Medical Technology Directory – "Cranial Orthotic Devices" (CRAN0201.39 – 03/05/04; updated 05/07/08).
  15. InterQual® Clinical Decision Support Criteria, 2010 Durable Medical Equipment, Cranial Remodeling Orthosis: General.
  16. Laughlin J, Luerssen TG, Dias MS. Prevention and management of positional skull deformities in infants. Pediatrics 2011; 128(6):1236-41.
  17. Leo A, et al. Effect of Pediatric Physical Therapy on Deformational Plagiocephaly in Children with Positional Preference. A Randomized Controlled Trial. Arch Pediatr Adolesc Med. 162:8. Aug 2008.
  18. National Guideline Clearinghouse. Evidence-based care guideline for therapy management of congenital muscular torticollis in children age 0 to 36 months (Guideline Summary NGC-7301) (12/21/09).
  19. National Guideline Clearinghouse. Best evidence statement (BESt). Prognosis of infant development with plagiocephaly, torticollis (Guideline Summary NGC-8583) (06/03/11).
  20. National Guideline Clearinghouse. Best evidence statement (BESt). Use of care giver education to prevent positional plagiocephaly. (Guideline Summary NGC-9158) (06/06/12).
  21. National Institute of Neurological Disorders and Stroke. NINDS Craniosynostosis Information Page. Updated 09/16/11. Accessed 12/02/14.
  22. National Institutes of Health Public Access. 3D Head Shape Quantification for Infants with and without Deformational Plagiocephaly. Cleft Palate Craniofac J. 2010 July; 47(4): 368-377. doi:10.1597/09-059.1.
  23. National Institutes of Health; Eunice Kennedy Shriver National Institute of Child Health and Human Development. Positional Plagiocephaly (03/20/07).
  24. NHS Quality Improvement Scotland. Evidence Note. The use of cranial orthosis treatment for infant deformational plagiocephaly (05/07).
  25. van Wijk RM, van Vlimmeren LA, Groothuis-Oudshoorn CG et al. Helmet therapy in infants with positional skull deformation: randomised controlled trial. BMJ 2014.
  26. US Food and Drug Administration (FDA). Cope of Federal Regulations Title 21, Chapter I, Subchapter H, Part 882, Subpart F Neurological Therapeutic Devices, Section 882.5970 Cranial orthosis. (04/01/10).

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 01/22/15.

GUIDELINE UPDATE INFORMATION:

11/15/00

New Medical Coverage Guideline.

12/06/01

Reviewed – no changes.

10/01/02

4th quarter HCPCS coding changes.

12/15/02

Reviewed and changed from "cosmetic and non-covered" to "investigational".

12/15/03

Reviewed; revision to statement regarding When Services Are Not Covered.

12/15/04

Scheduled review; no change in coverage statement.

01/01/06

Scheduled review and annual HCPCS coding update (add 97762; delete 97703); no change in coverage statement.

05/15/06

Unscheduled review and revision to guideline consisting of addition of coverage statement regarding cranial orthoses as adjunct therapy following endoscopic surgery for plagiocephaly with synostosis.

01/01/07

Annual HCPCS coding update (S1040 revised).

05/15/07

Scheduled review; reformatted guideline; removed restriction of “endoscopic” from coverage statement; removed investigational statement regarding use of these devices as an adjunct postoperative therapy for plagiocephaly with synostosis after surgery is done endoscopically; updated references.

07/15/08

Scheduled review; position statement unchanged; references updated.

06/15/09

Scheduled review; position statement unchanged; references updated.

12/15/10

Reviewed; position statement revised; formatting changes.

09/15/11

Revision; formatting changes.

01/15/13

Scheduled review; position statement updated; references updated; formatting changes.

02/15/14

Scheduled review; position statement unchanged; Program Exceptions section updated; references updated.

02/15/15

Annual review; position statements unchanged; references updated.

09/15/16

Revision; coding section updated.

Date Printed: October 20, 2017: 11:54 AM