National Medical Policy

National Medical Policy Subject: Policy Number: Cleft Palate and other Craniofacial Disorders NMP113 Effective Date*: May 2015 Updated: May 2016 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State s Medicaid manual(s), publication(s), citation(s), and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link National Coverage Determination (NCD) National Coverage Manual Citation X Local Coverage Determination (LCD)* Plastic Surgery: http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx X Article (Local)* Cosmetic vs. Reconstructive Surgery: http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx Other None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) Cleft Palate and other Craniofacial Disorders May 16 1

If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Please review state specific mandates and the member s Evidence if Coverage /Certificate of Insurance for specific coverage of reconstructive surgery including medical and dental services. Various states ( i.e.california) require dental and orthodontia coverage under the member s medical benefits for craniofacial disorders such as cleft palate conditions when these services are considered an integral part of reconstructive surgery. Effective January 2013, Oregon (ORS 743.730) mandates coverage for dental and orthodontic services to restore function. Current Policy Statement Most individuals with craniofacial abnormalities such as cleft lip and cleft palate require the coordinated care of providers in a number of specialties such as medicine and dentistry, speech pathology, otolaryngology, audiology, genetics, nursing, mental health, and social medicine. A team approach is required for optimal care. Major components in the surgical treatment of these patients include surgery to repair the cleft lip and palate, bone grafting to stabilize the dental arch, orthodontics, orthognathic surgery to correct any skeletal deformities, restorative dentistry, facial reconstruction of lip/nose deformities, and correction of speech problems. Cleft lip and palate defects come in a variety of degrees of severity and treatment is individually based. In general, the primary surgery is undertaken in stages to repair the cleft lip/palate deformity and to place a bone graft in an alveolar cleft. Secondary surgery may be needed to correct the residual deformities in the lip or nose. The most common surgical procedures for a child with a cleft lip and palate anomaly are as follows: Repair of the cleft lip Repair of the cleft palate Revision of the cleft lip Closure and bone grafting of the alveolar cleft Closure of palatal fistulae Palatal lengthening Pharyngeal flap Pharyngoplasty Columellar lengthening Cleft lip/palate rhinoplasty and septoplasty Lip scar revision LeFort I maxillary osteotomy Dental and Orthodontic Services Medical management of children with cleft palate conditions may involve what might otherwise be considered dental or orthodontic care if an integral part of the reconstructive surgery. Orthodontic treatment may be needed prior to surgery to position the teeth in a manner that will provide for an adequate occlusion following surgical repositioning of the jaws. Coverage under the medical benefit is limited to services essential for the surgery to take place, or essential for the surgery itself. The most common orthodontic elements of the oral cleft repair procedure that are considered medically necessary are described below. Pre-surgical orthodontics (such as nasoalveolar moulding) within the first month of life in a patient born with oral clefts may be performed. These Cleft Palate and other Craniofacial Disorders May 16 2

treatments include frequent adjustments, every 1 to 2 weeks, until the cleft lip is repaired. Maxillary expansion and braces (with or without head gear) to prepare for the alveolar bone graft. Expansion is started once permanent molars have erupted and continues for a variable period of time. The child is usually aged 8 or 9 years when these treatments begin. The alveolar bone graft surgery follows completion of the orthodontic treatments. The alveolar bone graft splint is medically necessary to protect the graft site after surgery. A fistula closure splint is medically necessary in the event that a complication of palate surgery, an oronasal fistula, occurs. This can happen at any age (at initial palate repair, during speech surgery, or a failed alveolar bone graft). Though not required in all circumstances, maxillary distraction and mandibular osteogensis are often medically necessary. Maxillary distraction preserves vision. Mandibular osteogenesis relieves upper airway obstruction. Often, mandibular osteogenesis is performed during infancy, but may be performed any time a child with a small mandible develops obstructive sleep apnea. (Refer to Health Net s Orthognathic Surgery Medical Policy) Dental or Orthodontic Care Various states require dental and orthodontia coverage under the member s medical benefits when they are considered an integral part of or are related to reconstructive surgery, or when medically necessary to restore function. Please check state regulations for more detail. Not Covered Surgery is considered cosmetic when performed solely to alter or reshape normal structures in the body in order to improve appearance. Surgery is not considered reconstructive surgery if the procedure, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery, offers only a minimal improvement in the appearance of the enrollee. Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures have been replaced by ICD-10 code sets. ICD-9 Codes 749.00 Unspecified cleft palate 749.01 Unilateral cleft palate, complete 749.02 Unilateral cleft palate, incomplete 749.03 Bilateral cleft palate, complete 749.04 Bilateral cleft palate, incomplete 749.10 Unspecified cleft lip 749.11 Unilateral cleft lip, complete 749.12 Unilateral cleft lip, incomplete 749.13 Bilateral cleft lip, complete Cleft Palate and other Craniofacial Disorders May 16 3

749.14 Bilateral cleft lip, incomplete 749.20 Unspecified cleft palate with cleft lip 749.21 Unilateral cleft palate with cleft lip, complete 749.22 Unilateral cleft palate with cleft lip, incomplete 749.23 Bilateral cleft palate with cleft lip, complete 749.24 Bilateral cleft palate with cleft lip, incomplete 749.25 Other combinations of cleft palate with cleft lip ICD-10 Codes Q35.1- Cleft Palate Q35.9 Q36.0- Cleft lip Q36.9 Q37.0- Cleft palate with cleft lip Q37.9 CPT Codes for Specific to Cleft Palate 40700 Plastic repair of cleft lip/nasal deformity; primary bilateral, one stage procedure 40701 Plastic repair of cleft lip/nasal deformity; primary bilateral, one of two stages 40702 Plastic repair of cleft/lip nasal deformity; secondary, by recreation of defect and reclosure 42200 Palatoplasty for cleft palate, soft and/or hard palate only 42205 Palatoplasty for cleft palate, with closure of alveolar ridge; soft tissue only 42210 Palatoplasty for cleft palate, with closure of alveolar ridge; with bone graft to alveolar ridge (includes obtaining graft) 42215 Palatoplasty for cleft palate; major revision 42220 Palatoplasty for cleft palate; secondary lengthening procedure 42225 Palatoplasty for cleft palate; attachment pharyngeal flap Secondary Procedures 30460 Rhinoplasty for nasal deformity secondary to congenital cleft lip and/or palate, including columellar lengthening; tip only 30462 Rhinoplasty for nasal deformity secondary to congenital cleft lip and/or palate, including columellar lengthening; tip, septum, osteotomies 21141- Orthognathic procedures 21147 HCPCS codes covered if the diagnosis code related to cleft lip/palate is present D4210 - Dental procedures, surgical services (including usual postoperative D4261, care) D4268, D4249,D4260,D4261 (Revised 2015) D4274 D7210 - Dental procedures, surgical extractions (includes local anesthesia, D7250 suturing, if needed, and routine postoperative care) D7410 - Surgical excision of reactive inflammatory lesions (scar tissue or D7415 localized congenital lesions D7471 - Excision of bone tissue D7490 D7510 - Surgical incision D7560 D7910 Suture of recent small wounds up to 5 cm Cleft Palate and other Craniofacial Disorders May 16 4

D7911 - Complicated suturing (reconstruction requiring delicate handling of D7912 tissues and wide undermining for meticulous closure D7920 - Other repair procedures D7951, D7960 - D7998 D8060 Interceptive orthodontic treatment of the transitional dentation D8070 Comprehensive orthodontic treatment of the transitional dentation D8080 Comprehensive orthodontic treatment of the adolescent dentation D9220 D9220 Deep sedation/general anesthesia - first 30 minutes (Code deleted in 2016) D9221 Deep sedation/general anesthesia each additional 15 minutes ((Code deleted in 2016- use D9223) D9230 Inhalation of nitrous oxide/analgesia, anxiolysis D9241 Intravenous conscious sedation/analgesia - first 30 minutes (Code deleted in 2016) D9242 Intravenous moderate (conscious) sedation/analgesia - each additional 15 minutes (Code deleted in 2016- use D9243) D9248 Non-intravenous conscious sedation (Revised 2016) 2016 HCPC Code D9223 Deep sedation/general anesthesia each 15 minute increment D9243 Intravenous moderate (conscious) sedation/analgesia each 15 minute increment Related Health Net Medical Policies Orthognathic Surgery Genetic Counseling Septoplasty/Rhinoplasty Cosmetic and Reconstructive Surgery Speech Therapy Dental Services Benefit Policy Scientific Rationale Updated May 2016 Austin et al. (2015) completed a systematic review of prospective randomized, quasi-randomized or controlled clinical trials, to compare the effectiveness of distraction osteogenesis to orthognathic surgery for the treatment of maxillary hypoplasia in individuals with cleft lip and palate. Two reviewers independently completed inclusion assessment. Data extraction and risk of bias assessment were completed by a single reviewer and checked by a second reviewer. Five publications all reporting different outcomes of a single randomized controlled trial are included within the review. The quality of the evidence was low with a high risk of bias. Both surgical interventions produce significant soft tissue improvement. Horizontal relapse of the maxilla was statistically significantly greater following orthognathic surgery. There was no statistically significant difference in speech and velo-pharyngeal function between the interventions. Maxillary distraction initially lowered social selfesteem, but this improved with time resulting in higher satisfaction with life in the long term. The low quality of evidence included within the review means there is insufficient evidence to conclude whether there is a difference in effectiveness between maxillary distraction and osteotomy for the treatment of cleft-related maxillary hypoplasia. There is a need for further high-quality randomized controlled trials to allow conclusive recommendations to be made. Scientific Rationale - Initial There are numerous types of congenital craniofacial anomalies, the most common of which is cleft lip and/or palate (CL/P). This birth defect affects about one in 750 Cleft Palate and other Craniofacial Disorders May 16 5

newborns in the United States annually. Approximately one-half of these infants have associated malformations, either minor or major, occurring in conjunction with the cleft that can range from just an opening at the back of the soft palate to a nearly complete separation of the roof of the mouth The problems associated with oral clefts include the following: breathing, skeletal growth and development, hearing, speech and language ability, learning difficulties, and social integration. Social integration problems are due both to having a severe chronic condition in general and the effect of disfigurement, especially among school-age children. A cleft palate (palatoschisis) occurs in early pregnancy when separate areas of the face have developed individually do not join together properly. The palate is very important in directing air out the mouth rather than the nose when speaking also acts to prevent food and liquids from going up into the nose when eating. Palate cleft can occur as complete (soft and hard palate, possibly including a gap in the jaw) or incomplete (a 'hole' in the roof of the mouth, usually as a cleft soft palate). When cleft palate occurs, the uvula is usually split. It occurs due to the failure of fusion of the lateral palatine processes, the nasal septum, and/or the median palatine processes that form the secondary palate. Submucous cleft palate (SMCP) can also occur, which is an occult cleft of the soft palate that is covered over by the mucous membranes in the mouth with a classic clinical triad of bifid uvula, a furrow along the midline of the soft palate, and a notch in the posterior margin of the hard palate. A cleft lip does not affect the palate structure of the mouth. It is formed in the top of the lip as either a small gap or an indentation in the lip (partial or incomplete cleft) or it continues into the nose (complete cleft). Lip cleft can occur as a one sided (unilateral) or two sided (bilateral). It is due to the failure of fusion of the maxillary and medial nasal processes that form the primary palate. The etiology of CL/P is complex and it is thought that both genes and environmental factors acting either independently or in combination are responsible for facial clefting. If parents without a cleft have a child with a cleft, the chance that a subsequent baby will have a cleft is only two to four percent. If either parent has a cleft, the relative risks become about four to five percent for having a baby with a cleft. If both parents have clefts, the risks are much greater. Antiseizure/anticonvulsant medications, acne medications containing Accutane or methotrexate, cigarette smoking and alcohol taken during pregnancy may cause cleft lip and cleft palate. Cleft lip and cleft palate may also occur as a result of exposure to viruses or chemicals during fetal development. Cleft lip and palate defects come in a variety of degrees of severity and treatment is individually based. Children with cleft lip with or without cleft palate face a variety of challenges related to their defect, depending on the type and severity of the cleft. Children are may experience abnormal growth and development secondary to poor nutrition and are also susceptible to repeated middle ear infections, problems with tooth development, speech and language problems and psychosocial challenges. Nasoalveolar molding (NAM) is a tissue-expansion procedure performed by dentists prior to a surgical repair for cleft lip and palate. The purpose of the NAM technique is to mold the abnormally formed nasal cartilage into a more optimal relationship prior to surgery. It process usually begins within 1-2 weeks after birth. An impression of the cleft is taken then a molding plate is then fabricated and inserted. The molding plate causes no pain and is attached with small rubber bands taped to the face. Cleft Palate and other Craniofacial Disorders May 16 6

Adjustments to the molding plate/nasal portion are done weekly, or every other week, depending on the progress. Each adjustment is very small, but it starts to guide the baby's gums, lip, and nasal cavities as they are growing. At the conclusion of nasoalveolar molding (in unilateral cases, it is approximately four months and in bilateral cases, six months), the nasal cartilages, columella, philtrum, and alveolar segments should be aligned to facilitate the surgical restoration of a child's facial features to normal configurations. Cheiloplasty, or cleft lip repair, is usually performed between birth and 3 months of age. The goal is to close the opening in the lip. If the cleft is bilateral, closure may be performed on both sides simultaneously, or the surgeon may repair the lip one side at a time in separate surgeries. In some cases, when the deformity is severe, a preliminary operation to bring the two sides of the gap closer may be needed. The preliminary procedure can be either a lip adhesion) or the insertion of an appliance to mechanically approximate the lip and gums. Palatoplasty, or cleft palate repair, is performed to close the opening in the palate. This is usually performed when the child is about one year of age. It may be completed in two stages, the soft palate first, followed by the hard palate. Methods for repairing a cleft palate may vary widely in terms of when they are performed and what techniques are used. In a typical repair, incisions are made in the palate to provide sufficient tissue to close the defect. This tissue is moved to the mid-line or the center of the mouth to reconstruct the palate, join the muscles and provide adequate length to the soft palate. Children with a cleft palate are particularly prone to ear infections because the cleft can interfere with the function of the middle ear. To permit proper drainage and air circulation, the child may require the placement of a small plastic ventilation tube inserted in the eardrum. This relatively minor operation may be done at the same time of the cleft repair. Children with clefts involving the alveolar dental arch will require bone grafting to maintain the dental arch and allow the ingrowth of teeth immediately adjacent to or within the cleft. The timing of this procedure varies but is at approximately age six to eight and is determined by dental x-rays which show the development of the permanent teeth. Cancellous bone from the iliac crest will be inserted into the alveolus once the dental team has aligned the arch or growth and lip closure have brought the alveolar ends into approximation. At this time, any residual oronasal fistulas can be closed as well. Autogenous cancellous bone is the grafting material of choice in the alveolar cleft, particularly if the teeth are to be orthodontically moved into the cleft or eruption of teeth through the cleft is anticipated In a small percentage of cases, some children, in spite of cleft palate repair, will continue to exhibit hypernasal speech. The condition known variously as velopharyngeal insufficiency (VPI) or velopharyngeal dysfunction (VPD) may be seen after cleft palate surgery or noted after adenoidal tissue undergoes involution as the child grows. In some patients who have undergone palatal repair, short sentences may sound relatively normal. Long, sustained speech, however, may deteriorate, resulting in increasing hypernasality as the palate tires. Surgical procedures for correction of velopharyngeal insufficiency include pharyngeal flaps, in which the posterior pharyngeal wall is elevated and sutured to the soft palate, thereby reducing the gap present from the short or poorly functioning soft palate. The age and timing of this surgery varies and has been reported in very young children before school age and late in teen years. Other surgical approaches may be used which involve some alteration of the anatomy surrounding the soft palate and posterior pharyngeal wall (pharyngoplasty). Cleft Palate and other Craniofacial Disorders May 16 7

As a result of all these factors, moderate to severe deformities of the jaws can develop, affecting not only the basal bone and alveolus, but also the alignment and position of the primary and permanent dentition, as well as the overlying soft tissues. In adolescents and adults who have undergone cleft defect repair, common consequences include anterior and posterior crossbites; midface hypoplasia; anteroposterior, vertical, and transverse maxillary deficiency; residual lip and nasal deformities; and speech problems. Orthodontic treatment is usually required before surgical correction of jaw deformities. A number of dental considerations must be assessed prior to proceeding with orthodontics, including 1) dental alignment issues, such as crowding, rotations, malposition, and crossbites; 2) approximation of teeth to the alveolar cleft; 3) missing, supernumerary, or malformed teeth; and 4) periodontal disease or defects, oral hygiene, and dental caries. The basic orthodontic principles are to align and level teeth over the basal bones of the maxilla and mandible. If the lateral incisor tooth is missing (a common occurrence in patients with a cleft), then the posterior bone segment and teeth in unilateral clefts or the bilateral posterior bone segments and teeth in bilateral clefts can be advanced forward to close the space, Stabilization of maxillary osteotomies is more difficult in the patient with a cleft defect than in the patient without a cleft. Since orthognathic surgery (corrective jaw surgery) can have a significant untoward effect on facial growth and development in patients with cleft lip and palate, endstage reconstruction should be considered when these patients have completed most of their facial growth, which is usually age 15 years for females and 17 to 18 years for males. If surgery is done prior to completion of facial growth, the subsequent adverse effect on maxillary growth and continued growth of the mandible will result in recurrence of the facial deformity and malocclusion. However, delaying surgery until growth is complete can result in worsening of the facial deformity, creating major functional, aesthetic, and psychosocial problems at an important stage in human psychosocial development. If such problems are severe, surgery can be done at an earlier age with the understanding that it may need to be repeated after growth is complete. Since the face grows until a child has reached maturity (girls 16 and boys 19), children born with cleft lips and palates require monitoring, and additional procedures may be required to correct residual deformities or deformities which worsen with age. Patients with cleft deformities also have distortion of the nose. Cleft lip rhinoplasty is necessary to improve nasal function and correct the distortion. In the case of a severe nasal deformity, reconstructive rhinoplasty may be done in the child's early years. However, in other cases it is recommended that the operation be performed in the child's middle teenage years, when the nose has attained its maximum growth. Secondary surgery to achieve optimum reconstruction is common. In adolescents and adults with a cleft defect, it is usually best to correct the underlying dental, maxillary, mandibular, and infraorbital deformities before other functional soft tissue repairs. This sequencing allows the overlying soft tissues to adjust to the altered underlying dento-osseous structures. For predictable results, external nasal reconstruction and lip revisions are preferably done as a secondary procedure. However, concomitant orthognathic surgery, lip revisions, and major rhinoplasty surgery can be performed in selected patients with unilateral clefts. In patients with bilateral clefts, particularly those with coexisting bilateral alveolar clefts, it is important to stage the lip/ nose and external rhinoplasty procedures separately from the orthognathic procedures so that the vascular supply to the anterior portion of the maxilla (premaxilla) is not jeopardized. Cleft Palate and other Craniofacial Disorders May 16 8

Review History March 2010 Medical Advisory Council Initial Review for implementation on July 2010 Implementation of policy approved for DOS July 1, 2010 May 2012 Update. No revisions. Dec 2012 Added reference to Oregon (ORS 743.730) mandate for dates of service starting Jan 2013 May 2013 Update - No revisions. Code updates May 2014 Update No revisions. Code updates May 2015 Update No revisions. Code updates May 2016 Update No revisions. Code updates This policy is based on the following evidenced-based guidelines: 1. The American Academy of Pediatrics (AAP). The American Academy of Pediatric Dentistry (AAPD). Policy on Management of Patients with Cleft Lip/Palate and Other Craniofacial Anomalies. 2003. 20085. 2012. Available at: http://www.aapd.org/media/policies_guidelines/e_cleftlip.pdf 2. American Cleft Palate-Craniofacial Association (ACPCA). Parameters for Evaluation and Treatment of Patients with Cleft Lip/Palate or Other Craniofacial Anomalies. November 2009. Available at: http://www.acpacpf.org/uploads/site/parameters_rev_2009.pdf References Update May 2016 1. Austin SL, Mattick CR, Waterhouse PJ. Distraction osteogenesis versus orthognathic surgery for the treatment of maxillary hypoplasia in cleft lip and palate patients: A systematic review. Orthod Craniofac Res. 2015;18(2):96-108. 2. Olsen JJ, Skov J, Ingerslev J, et al. Prevention of bleeding in orthognathic surgery -- A systematic review and meta-analysis of randomized controlled trials. J Oral Maxillofac Surg. 2016;74(1):139-150. References Update May 2015 1. Lu XC, Yu W, Tao Y, et al. Contribution of transforming growth factor α polymorphisms to nonsyndromic orofacial clefts: a HuGE review and metaanalysis. Am J Epidemiol 2014; 179:267. 2. Skuladottir H, Wilcox AJ, Ma C, et al. Corticosteroid use and risk of orofacial clefts. Birth Defects Res A Clin Mol Teratol 2014; 100:499. References Update May 2014 1. Buchanan EP, Cole P, Hollier LH. Syndromes with craniofacial abnormalities. UpToDate. February 13, 2013. 2. Butali A, Little J, Chevrier C, et al. Folic acid supplementation use and the MTHFR C677T polymorphism in orofacial clefts etiology: An individual participant data pooled-analysis. Birth Defects Res A Clin Mol Teratol 2013; 97:509. References Update May 2013 1. Doucet JC, Herlin C, Bigorre M et al. Effects of growth on maxillary distraction osteogenesis in cleft lip and palate. J Craniomaxillofac Surg. 2013 Mar 28. 2. Rychlik D, Wójcicki P, Koźlik M. Osteoplasty of the alveolar cleft defect. Adv Clin Exp Med. 2012 Mar-Apr;21(2):255-62 References Update May 2012 1. Grosen D, Chevrier C, Skytthe A, et al. A cohort study of recurrence patterns among more than 54,000 relatives of oral cleft cases in Denmark: support for the multifactorial threshold model of inheritance. J Med Genet 2010; 47:162. Cleft Palate and other Craniofacial Disorders May 16 9

2. Maarse W, BergéSJ, Pistorius L, et al. Diagnostic accuracy of transabdominal ultrasound in detecting prenatal cleft lip and palate: a systematic review. Ultrasound Obstet Gynecol. 2010;35(4):495. 3. Mailáth-Pokorny M, Worda C, Krampl-Bettelheim E, et al. What does magnetic resonance imaging add to the prenatal ultrasound diagnosis of facial clefts? Ultrasound Obstet Gynecol 2010; 36:445 4. Stal S, Hollier LH, Cole P. Syndromes with craniofacial abnormalities. October 12, 2011. 5. Wilkins-Haug L. Etiology, prenatal diagnosis, obstetrical management, and recurrence of orofacial clefts. UpToDate. April 21, 2011. Updated February 2014, S Updated 2015 References Inital 1. American Academy of Pediatric Dentistry Clinical Affairs Committee, American Academy of Pediatric Dentistry Council on Clinical Affairs (AAPD). Policy on management of patients with cleft lip/palate and other craniofacial anomalies. Pediatric Dentistry 2005-2006; 27(7 Suppl): 187-188. 2. American Cleft Palate-Craniofacial Association (ACPA). Parameters for evaluation and treatment of patients with cleft lip/palate or other craniofacial anomalies. Chapel Hill, NC: American Cleft Palate-Craniofacial Association; 1993, Rev. 2007. 3. Cleft Lip and Palate Critical Elements of Care 2003 Accessed February 5, 2010 http://www.cleftadvocate.org/clp5-03.pdf 4. Bearn D, Mildinhall S, Murphy T, et al. Cleft lip and palate care in the United Kingdom the clinical standards advisory group (CSAG) study. Part 4: Outcome comparisons, training, and conclusions. Cleft Palate-Craniofacial Journal. 2001;38:38-43. 5. Cleft Palate Foundation (CPF). About Cleft Lip and Palate. 2008. Available at: www.cleftline.org/parents. 6. Gluchacki B, Meara JG, Mason WH, Barry T, Reinisch JF. Improving care after primary cleft palate surgery. Journal for Healthcare Quality. 2002;24:4-9; quiz 9-10. 7. Guidelines for Patients with Cleft Lip/Palate or other Craniofacial Anomalies American Academy of Pediatric Dentistry. 8. Gorlin RJ, Cervenka J, Pruzansky S. Facial clefting and its syndromes. In Bergsma D, ed. The Clinical Delineation of Birth Defects. Part XI, Orofacial Structures. Baltimore: Williams & Wilkins, 1971:7:3 46. 9. Subtelny JD. Width of the nasopharynx and related anatomic structure in normal and unoperated cleft palate children. Am J Orthod 1955;41:889 909. Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language Cleft Palate and other Craniofacial Disorders May 16 10

prevails. Medical policy is not intended to override the policy that defines the member s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. In some states, prior notice or website posting is required before an amendment is deemed effective. No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member s Contract Controls Coverage Determinations. Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member s contract shall govern. The Policies do not replace or amend the Member s contract. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Reconstructive Surgery CA Health and Safety Code 1367.63 requires health care service plans to cover reconstructive surgery. Reconstructive surgery means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or (2) To create a normal appearance, to the extent possible. Reconstructive surgery does not mean cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery. Reconstructive Surgery after Mastectomy California Health and Safety Code 1367.6 requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. Policy Limitations: Medicare and Medicaid Cleft Palate and other Craniofacial Disorders May 16 11

Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation. Cleft Palate and other Craniofacial Disorders May 16 12