First Issued: 12/19/2007 Revisions: 8/12/2009, 11/09/2010, 3/1/2015

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1 U n i t e d H e a l t h C a r e G u i d e l i n e Division UnitedHealthcare Departments Community Plan Products Children s Rehabilitative Services (CRS) State :Arizona Title: CRS Maxillo Mandibular Osteodistraction Practice Guideline Originator: UnitedHealthcare Community Plan CRS First Issued: 12/19/2007 Revisions: 8/12/2009, 11/09/2010, 3/1/2015 Effective: 5/1/2015 Initial Approver: Children s Rehabilitative Services Administration Michael Clement, M.D, Chief Medical Officer CRS, BH/AZDHS Current Approver: Leslie K Paulus M.D., UnitedHealthcare Community Plan CRS Medical Director Committee Review: UHC Medical Technology Assessment Committee; UHC National Medical Management; UHC Community Plan Arizona Provider Advisory Committee GUIDELINE STATEMENT This guideline outlines the management of children with severe maxillary or mandibular deformity who require Maxillo Mandibular Osteodistraction as required by the Children s Rehabilitative Services Program, Arizona Health Care Cost Containment System, State of Arizona. Clinical guidelines are not used PURPOSE Clinical Practice Guidelines represent the minimum requirements for providing care for individuals with certain craniofacial anomalies and treatment should be provided in a manner that includes adherence to and consistency with the following Guideline. DEFINITIONS: Children s Rehabilitative Services (CRS): An AHCCCS program for children with certain diagnoses which provides services using an integrated family-centered, culturally competent, multi-specialty,interdisciplinary approach. Multi Specialty Interdisciplinary Clinic (MSIC): The Specialty Medical Home for the members with diagnoses as designated by the Arizona Administrative Code (AAC) R (R , ).

2 I. Patient Selection Criteria: Children with severe maxillary or mandibular deformity for which no other osteotomy technique is appropriate and who have at least one of the following: 1. Respiratory problems to the extent of producing clinically significant dynamic or static airway obstruction. 2. Serious verbal communication disturbance as determined by a speech therapist. The report must indicate that the deformity is the primary etiology for the speech impairment and that speech therapy alone cannot further improve speech. 3. Mastication abnormality affecting the nutritional status of the individual resulting in growth abnormalities. II. Protocol: 1. Children who meet selection criteria for maxillo-mandibular osteodistraction shall be scheduled for consultation with the interdisciplinary craniofacial team at the CRS Multispecialty Interdisciplinary Clinic (MSIC) site where the procedure is to be performed. 2. Pre-procedure status is to be documented by chart photographs, 3D CT scan and/or 1 CAT and when appropriate, speech tape. 3. All patients undergoing distraction need pre-operative orthodontic treatment for appropriate alignment of dentition. 4. Out of Region Patients: a. Prior to scheduling the procedure, the procedure site interdisciplinary team shall consult with the home site team to ensure home site CRS clinic involvement and follow up. If there are no obvious contraindications to proceedings with osteodistraction related to inter-site management, all information from the procedure site team shall be forwarded to the Contractor Medical Director for approval. b. The purpose of the interdisciplinary evaluation at procedure and home sites shall be an attempt to clearly establish that the member and family are capable of accepting and following through with the extensive post- operative care, procedure modifications, and therapy. Ill. Interdisciplinary Team Membership: The team shall include: Craniofacial surgeon Nutritionist Oral surgeon Orthodontist Pediatrician Psychologist Social Worker Speech Pathologist

3 Clinics Interdisciplinary Team Members Interdisciplinary Team Members Available During Specialty Clinics As Needed Plastics Surgery Clinic Plastic Surgeon Registered Nurse Speech Therapist Dental/Orthodontia Dentist/Orthodontist Dental Technician Child Life Specialist Educator Otolaryngologist Social Worker Translator Audiologist Wound Specialist Advocate Child Life Specialist Educator Social Worker Translator Advocate IV. Outcome Evaluation: It shall be the responsibility of the craniofacial surgeon managing the osteodistraction procedure to provide periodic outcome progress reports at intervals determined by the craniofacial team, but at a minimum of 6, 12, 24 and 48 months post procedure. Reports must include documentation of: Any change in airway status Any change in speech status Any change in mastication status Photographs of facial reconstruction References:. 1. Klein C, Howaldt HP. Correction of mandibular hypoplasia by means of bidirectional callus distraction. J Craniofac Surg. 1996;7: Swennen G, Schliephake H, Dempf R, et al. Craniofacial distraction osteogenesis: A review of the literature: Part 1: Clinical studies. Int J Oral Maxillofac Surg. 2001;30(2): Swennen G, Dempf R, Schliephake H. Cranio-facial distraction osteogenesis: A review of the literature. Part II: Experimental studies. Int J Oral Maxillofac Surg. 2002;31(2): Imola MJ, Hamlar DD, Thatcher G, et al. The versatility of distraction osteogenesis in craniofacial surgery. Arch Facial Plast Surg. 2002;4(1):8-5. American Association of Oral and Maxillofacial Surgeons (AAOMS). Distraction osteogenesis. Statements by the American Association of Oral and Maxillofacial Surgeons Concerning the Management of Selected Clinical Conditions and Associated Clinical Procedures. Rosemont, IL: AAOMS; July Available at: Accessed October 16, 2003.

4 6. Shaw WC, Mandall NA, Mattick CR. Ethical and scientific decision making in distraction osteogenesis. Cleft Palate Craniofac J. 2002;39(6): Denny AD, Kalantarian B, Hanson PR. Rotation advancement of the midface by distraction osteogenesis. Plast Reconstr Surg. 2003;111(6): ; discussion Figueroa AA, Polley JW, Friede H, Ko EW. Long-term skeletal stability after maxillary advancement with distraction osteogenesis using a rigid external distraction device in cleft maxillary deformities. Plast Reconstr Surg. 2004;114(6): ; discussion Rubio-Bueno P, Naval L, Rodriguez-Campo F, et al. Internal distraction osteogenesis with a unidirectional device for reconstruction of mandibular segmental defects. J Oral Maxillofac Surg. 2005;63(5): Erler K, Yildiz C, Baykal B, Reconstruction of defects following bone tumor resections by distraction osteogenesis. Arch Orthop Trauma Surg.2005;125(3): Cano J, Campo J, Moreno LA, Bascones A. Osteogenic alveolar distraction: A review of the literature. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006;101(1): Chanchareonsook N, Samman N, Whitehill TL. The effect of craniomaxillofacial osteotomies and distraction osteogenesis on speech and velopharyngeal status: A critical review. Cleft Palate Craniofac J. 2006;43(4): Ow AT, Cheung LK. Meta-analysis of mandibular distraction osteogenesis: Clinical applications and functional outcomes. Plast Reconstr Surg. 2008;121(3):54e-69e. 14. Genecov DG, Barceló CR, Steinberg D, et al. Clinical experience with the application of distraction osteogenesis for airway obstruction. J Craniofac Surg. 2009;20 Suppl 2: Chua HD, Hägg MB, Cheung LK. Cleft maxillary distraction versus orthognathic surgery which one is more stable in 5 years? Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010;109(6): Sabharwal S. Enhancement of bone formation during distraction osteogenesis: Pediatric applications. J Am Acad Orthop Surg. 2011;19 (2): Meling TR, Hogevold HE, Due-Tonnessen BJ, Skjelbred P. Midface distraction osteogenesis: Internal vs. external devices. Int J Oral Maxillofac Surg. 2011;40(2): Kolstad CK, Senders CW, Rubinstein BK, Tollefson TT. Mandibular distraction osteogenesis: At what age to proceed. Int J Pediatr Otorhinolaryngol. 2011;75(11):

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