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http://aetnet.aetna.com/mpa/cpb/1_99/0095.html[10/16/2017 10:51:30 AM] Clinical Policy Bulletin: Orthognathic Surgery Additional Information Number: 0095 Policy *Please see amendment for Pennsylvania Medicaid at the end ofthis CPB. Certain jaw and cranio-facial deformities may cause significant functional impairment. These deformities include apertognathia (either lateral or anterior not correctable by orthodontics alone), significant asymmetry of the lower jaw, significant class 2 and class 3 occlusal discrepancies, and cleft palate. Aetna considers orthognathic surgery medically necessary for correction of the following skeletal deformities of the maxilla or mandible when it is documented that these skeletal deformities are contributing to significant dysfunction, and where the severity of the deformities precludes adequate treatment through dental therapeutics and orthodontics alone: I. Maxillary and/or Mandibular Facial Skeletal Deformities Associated with Masticatory Malocclusion Aetna considers orthognathic surgery medically necessary for correction of skeletal deformities of the maxilla or mandible when it is documented that these skeletal deformities are contributing to significant masticatory dysfunction, and where the severity of the deformities precludes adequate treatment through dental therapeutics and orthodontics: A. Antero-posterior discrepancies 1. Maxillary/mandibular incisor relationship: overjet of 5 millimeter (mm) or more, or a 0 to a negative value (norm 2 mm), 2. Maxillary/mandibular antero-posterior molar relationship discrepancy of 4 mm or more (norm 0 to 1 mm). Note: These values represent 2 or more standard deviations (SDs) from published norms. B. Vertical discrepancies 1. Presence of a vertical facial skeletal deformity which is 2 or more SDs from published norms for accepted skeletal landmarks 2. Open Bite a. No vertical overlap of anterior teeth greater than 2 mm b. Unilateral or bilateral posterior open bite greater than 2 mm 3. Deep overbite with impingement or irritation of buccal or lingual soft tissues of the opposing arch
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Page 1: Clinical Policy Bulletin: Orthognathic Surgery evidence from prospective clinical studies in the peer-reviewed published medical literature of the effectiveness of orthognathic surgery

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Clinical Policy Bulletin: Orthognathic Surgery

Additional Information

Number: 0095

Policy

*Please see amendment for Pennsylvania Medicaid at the end ofthis CPB.

Certain jaw and cranio-facial deformities may cause significant functional impairment. These deformities include apertognathia (either lateral or anterior not correctable by orthodontics alone), significant asymmetry of the lower jaw, significant class 2 and class 3 occlusal discrepancies, and cleft palate. Aetna considers orthognathic surgery medically necessary for correction of the following skeletal deformities of the maxilla or mandible when it is documented that these skeletal deformities are contributing to significant dysfunction, and where the severity of the deformities precludes adequate treatment through dental therapeutics and orthodontics alone:

I. Maxillary and/or Mandibular Facial Skeletal Deformities Associated with Masticatory Malocclusion

Aetna considers orthognathic surgery medically necessary for correction of skeletal deformities of the maxilla or mandible when it is documented that these skeletal deformities are contributing to significant masticatory dysfunction, and where the severity of the deformities precludes adequate treatment through dental therapeutics and orthodontics:

A. Antero-posterior discrepancies

1. Maxillary/mandibular incisor relationship: overjet of 5 millimeter (mm) or more, ora 0 to a negative value (norm 2 mm),

2. Maxillary/mandibular antero-posterior molar relationship discrepancy of 4 mm ormore (norm 0 to 1 mm).

Note: These values represent 2 or more standard deviations (SDs) from published norms.

B. Vertical discrepancies

1. Presence of a vertical facial skeletal deformity which is 2 or more SDs frompublished norms for accepted skeletal landmarks

2. Open Bite

a. No vertical overlap of anterior teeth greater than 2 mmb. Unilateral or bilateral posterior open bite greater than 2 mm

3. Deep overbite with impingement or irritation of buccal or lingual soft tissues of theopposing arch

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4. Supraeruption of a dento-alveolar segment due to lack of opposing occlusioncreating dysfunction not amenable to conventional prosthetics.

C. Transverse discrepancies

1. Presence of a transverse skeletal discrepancy which is 2 or more SDs frompublished norms.

2. Total bilateral maxillary palatal cusp to mandibular fossa discrepancy of 4 mm orgreater, or a unilateral discrepancy of 3 mm or greater, given normal axialinclination of the posterior teeth.

D. Asymmetries

1. Antero-posterior, transverse or lateral asymmetries greater than 3 mm with concomitant occlusal asymmetry.

II. Facial Skeletal Discrepancies Associated with Documented Sleep Apnea, Airway Defects, and Soft Tissue Discrepancies

Aetna considers orthognathic surgery medically necessary in cases where it is documented thatmandibular and maxillary deformities are contributing to airway dysfunction, where suchdysfunction is not amenable to non-surgical treatments, and where it is shown that orthognathicsurgery will decrease airway resistance and improve breathing.

For example, studies demonstrate that persons with vertical hyperplasia of the maxilla have anassociated increase in nasal resistance, as do persons with maxillary hypoplasia with or withoutclefts. Following orthognathic surgery, such individuals routinely demonstrate decreases innasal airway resistance and improved respiration.

Aetna considers orthognathic surgery medically necessary for members with underlying craniofacial skeletal deformities that are contributing to obstructive sleep apnea. See CPB 0004 - Obstructive Sleep Apnea in Adults. Before surgery, such individuals should be properly evaluated to determine the cause and site of their disorder and appropriate non-surgical treatments attempted when indicated.

III. Temporomandibular Joint Pathology

Aetna considers orthognathic surgery for correction of temporomandibular joint disease or myofascial pain dysfunction experimental and investigational because its effectiveness for these indications has not been established. See CPB 0028 - Temporomandibular Disorders.

IV. Speech Impairments

Aetna considers orthognathic surgery medically necessary for treatment of speech impairmentsaccompanying severe cleft deformity. Orthognathic surgery may help to reduce the flattening ofthe face that is characteristic of severe cleft deformity. By using osteotomy techniques alongwith bone and cartilage grafts, the upper and lower jaws and facial skeletal framework aremoved and appropriately reconstructed. Pre-surgical orthodontic treatment is usuallyrecommended.

Aetna considers other orthognathic surgeries experimental and investigational for correction ofarticulation disorders and other impairments in the production of speech because there isinadequate evidence from prospective clinical studies in the peer-reviewed published medicalliterature of the effectiveness of orthognathic surgery for this indication.

Aetna considers orthognathic surgery for correction of distortions within the sibilant sound class

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or for other distortions of speech quality (e.g., hyper-nasal or hypo-nasal speech) not medically necessary as these distortions do not cause functional impairment.

V. Unaesthetic Facial Features and Psychological Impairments

Aetna considers orthognathic surgery cosmetic for correction of unaesthetic facial features, regardless of whether these are associated with psychological disorders.

Mentoplasty or genial osteotomies/ostectomies (chin surgeries) are always considered cosmetic when performed as an isolated procedure to address genial hypoplasia, hypertrophy, or asymmetry, and may be considered cosmetic when performed with other surgical procedures.

No benefits are available for orthognathic surgery performed primarily for cosmetic purposes. See Aetna CPB 0031 - Cosmetic Surgery.

VI. Aetna considers the use of condylar positioning devices in orthognathic surgery experimental and investigational because their effectiveness in orthognathic surgery has not been established.

VII. Aetna considers orthognathic surgery experimental and investigational for all indications other than those listed above because their effectiveness for indications other than the ones listed above has not been established.

VIII. Aetna considers three-dimensional virtual treatment planning of orthognathic surgery experimental and investigational because its effectiveness has not been established.

Note: Precertification requests or claims for orthognathic surgery are subject to review by Aetna's Oral and Maxillofacial Surgery Unit.

Orthodontic Treatment Prior to Orthognathic Surgery

Note: Expenses associated with the orthodontic phase of care (both pre- and post-surgical) are considered dental in nature and are not covered under Aetna's medical plans. See CPB 0082 - Dental Services and Oral and Maxillofacial Surgery: Coverage Under Medical Plans.

Orthodontic treatment may be needed prior to orthognathic surgery to position the teeth in a manner that will provide for an adequate occlusion following surgical repositioning of the jaws. For plans that require precertification, orthognathic surgery must be precertified prior to pre-surgical orthodontic treatment. The interim occlusion that is achieved by orthodontic treatment may be dysfunctional prior to the completion of the orthognathic surgical phase of the treatment plan. Therefore, all requests for orthognathic surgery must be reviewed/precertified by the Aetna Oral and Maxillofacial Surgery Unit prior to the initiation of pre-surgical orthodontic care. Failure to obtain precertification of orthognathic surgery prior to orthodontic care may result in the denial of benefits.

Documentation Requirements

Note: Orthognathic surgery may be subject to precertification review in plans that include precertification requirements. The following documentation should be forwarded to Aetna's Oral and Maxillofacial Surgery Unit for review: a written explanation of the member's clinical course, including dates and nature of any previous treatment; physical evidence of a skeletal, facial or craniofacial deformity defined by study models and pre-orthodontic imaging; and a detailed description of the functional impairment considered to be the direct result of the skeletal abnormality.

See also CPB 0082 - Dental Services and Oral and Maxillofacial Surgery: Coverage Under Medical Plans.

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Background

Orthognathic surgery is the revision by ostectomy, osteotomy or osteoplasty of the upper jaw (maxilla) and/or the lower jaw (mandible) intended to alter the relationship of the jaws and teeth. These surgical procedures are intended (i) to correct skeletal jaw and cranio-facial deformities that may be associated with significant functional impairment, and (ii) to reposition the jaws when conventional orthodontic therapy alone is unable to provide a satisfactory, functional dental occlusion within the limits of the available alveolar bone. Congenital or developmental defects can interfere with the normal development of the face and jaws. These birth defects may interfere with the ability to chew properly, and may also affect speech and swallowing. In addition, trauma to the face and jaws may create skeletal deformities that cause significant functional impairment. Functional deficits addressed by this type of surgery are those that affect the skeletal masticatory apparatus such that chewing, speaking and/or swallowing are impaired.

During the procedure, an oral and maxillofacial surgeon repositions the affected areas (mentum, mandible and/or maxilla) to approximate normal alignment and structure; sometimes adding, removing or reshaping bone. Synthetic prosthetic materials may be used along with surgical plates, screws, wires and rubber bands to hold the jaws into the new position. The most common surgical technique is known as the LeFort I (though there are variations of this technique that may be performed, depending on the exact indications for the surgery).

There is limited evidence of the effectiveness of orthognathic surgery on temporomandibular disorders. Abrahamsson et al (2007) examined if orthognathic surgery does affect the prevalence of signs and symptoms of temporomandibular disorders (TMDs). A literature survey in the PubMed and Cochrane Library electronic databases was performed and covered the period from January 1966 to April 2006. The inclusion criteria were controlled, prospective or retrospective studies comparing TMDs before and after orthognathic surgery in patients with malocclusion. There were no language restrictions, and 3 reviewers selected and extracted the data independently. The quality of the retrieved articles was evaluated by 4 reviewers. The search strategy resulted in 467 articles, of which 3 met the inclusion criteria. Because of few studies with unambiguous results and heterogeneity in study design, the scientific evidence was insufficient to evaluate the effects that orthognathic surgery had on TMD. Moreover, the studies had problems with inadequate selection description, confounding factors, and lack of method error analysis. The authors concluded that to obtain reliable scientific evidence, additional well-controlled and well-designed studies are needed to determine how and if orthognathic surgery alters signs and symptoms of TMD.

Lindenmeyer et al (2010) performed a systematic review of the best available research literature investigating the relation of oral and maxillofacial surgical procedures to the onset or relief of chronic painful TMD. A comprehensive review of the databases CINAHL, Cochrane Library, Embase, Medline, NHS Evidence--Oral Health, PsycINFO, Web of Knowledge, and MetaLib was undertaken by 2 authors up to June 2009 using search terms appropriate to establishing a relation between orofacial surgical procedures and TMD. The search was restricted to English-language publications. Of the 1,777 titles reviewed, 35 articles were critically appraised, but only 32 articles were considered eligible. These were observational studies that fell into 2 groups; 9 were seeking to establish a surgical cause for TMD. Of these, only 2 of a series of 3 claimed that there was a significant link, but this claim was based on weak data (health insurance records) and was abandoned in a subsequent report. Twenty- three studies were seeking to achieve relief by orthognathic surgical intervention. These were also negative overall, with 7 articles showing varying degrees of mostly non-significant improvement, whereas 16 showed no change or a worse outcome. No published report on the putative effect of implant insertion was found. The authors concluded that these apparently contradictory approaches underline a belief that oral surgical trauma or gross malocclusion has a causative role in the onset of TMD. However, there was no overall evidence of a surgical causal etiology or orthognathic therapeutic value. This review emphasized that it is in the patients' best interest to carry out prospective appropriately controlled randomized trials to clarify the situation.

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In a Cochrane review, Luther et al (2010) examined the effectiveness of orthodontic intervention in reducing symptoms in patients with TMD (compared with any control group receiving no treatment, placebo treatment or reassurance) and investigated if active orthodontic intervention leads to TMD. The Cochrane Oral Health Group's Trials Register, CENTRAL, MEDLINE and EMBASE were searched. Hand-searching of orthodontic journals and other related journals was undertaken in keeping with the Cochrane Collaboration hand-searching program. No language restrictions were applied. Authors of any studies were identified, as were experts offering legal advice, and contacted to identify unpublished trials. Most recent search was April 13, 2010. All randomized controlled trials (RCTs) including quasi-randomized trials assessing orthodontic treatment for TMD were included. Studies with adults aged equal to or above 18 years old with clinically diagnosed TMD were included. There were no age restrictions for prevention trials provided the follow-up period extended into adulthood. The inclusion criteria required reports to state their diagnostic criteria for TMD at the start of treatment and for participants to exhibit 2 or more of the signs and/or symptoms. The treatment group included treatment with appliances that could induce stable orthodontic tooth movement. Patients receiving splints for 8 to 12 weeks and studies involving surgical intervention (direct exploration/surgery of the joint and/or orthognathic surgery to correct an abnormality of the underlying skeletal pattern) were excluded. The outcomes were: how well were the symptoms reduced, adverse effects on oral health and quality of life. Screening of eligible studies, assessment of the methodological quality of the trials and data extraction were conducted in triplicate and independently by 3 review authors. As no 2 studies compared the same treatment strategies (interventions) it was not possible to combine the results of any studies. The searches identified 284 records from all databases. Initial screening of the abstracts and titles by all review authors identified 55 articles that related to orthodontic treatment and TMD. The full articles were then retrieved and of these articles only 4 demonstrated any data that might be of value with respect to TMD and orthodontics. After further analysis of the full texts of the 4 studies identified, none of the retrieved studies met the inclusion criteria and all were excluded from this review. The authors concluded that there are insufficient research data on which to base clinical practice on the relationship of active orthodontic intervention and TMD. There is an urgent need for high quality RCTs in this area of orthodontic practice.

There is a lack of evidence to support the use of condylar positioning devices in orthognathic surgery. Costa et al (2008) stated that in the past few years, many devices have been proposed for preserving the pre-operative position of the mandibular condyle during bilateral sagittal split osteotomy. The authors stated that accurate mandibular condyle re-positioning is considered important to obtain a stable skeletal and occlusal result, and to prevent the onset of TMD. Condylar positioning devices (CPDs) have led to longer operating times, the need to keep inter-maxillary fixation as stable as possible during their application, and the need for precision in the construction of the splint or intra-operative wax bite. The authors reviewed the literature concerning the use of CPDs in orthognathic surgery since 1990 and their application to prevent skeletal instability and contain TMD since 1995. They concluded that there is no scientific evidence to support the routine use of CPDs in orthognathic surgery.

Stokbro et al (2014) stated that numerous publications regarding virtual surgical planning protocols have been published, most reporting only 1 or 2 case reports to emphasize the hands-on planning. None had systematically reviewed the data published from clinical trials. This systematic review analyzed the precision and accuracy of three-dimensional (3D) virtual surgical planning of orthognathic procedures compared with the actual surgical outcome following orthognathic surgery reported in clinical trials. These researchers performed a systematic search of the current literature to identify clinical trials with a sample size of more than 5 patients, comparing the virtual surgical plan with the actual surgical outcome. Search terms revealed a total of 428 titles, out of which only 7 articles were included, with a combined sample size of 149 patients. Data were presented in 3 different ways: intra-class correlation coefficient, 3D surface area with a difference less than 2mm, and linear and angular differences in 3D. Success criteria were set at 2 mm mean difference in 6 articles; 125 of the 133 patients included in these articles were regarded as having had a successful outcome. Due to differences in the presentation of data, meta-analysis was not possible. The authors concluded that

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virtual planning appears to be an accurate and reproducible method for orthognathic treatment planning; a more uniform presentation of the data is necessary to allow the performance of a meta-analysis. Moreover, they stated that currently the software system most often used for 3D virtual planning in clinical trials is SimPlant (Materialise); more independent clinical trials are needed to further validate the precision of virtual planning.

Adolphs et al (2014) stated that within the domain of craniomaxillofacial surgery, orthognathic surgery is a special field dedicated to the correction of dentofacial anomalies resulting from skeletal malocclusion. Generally, in such cases, an inter-disciplinary orthodontic and surgical treatment approach is needed. After initial orthodontic alignment of the dental arches, skeletal discrepancies of the jaws can be corrected by distinct surgical strategies and procedures in order to achieve correct occlusal relations, as well as facial balance and harmony within individualized treatment concepts. To transfer the pre-operative surgical planning and re-position the mobilized dental arches with optimal occlusal relations, surgical splints are typically used. For this purpose, different strategies have been described which use 1 or more splints. Traditionally, these splints are manufactured by a dental technician based on patient-specific dental casts; however, computer-assisted technologies have gained increasing importance with respect to pre-operative planning and its subsequent surgical transfer. In a pilot study of 10 patients undergoing orthognathic corrections by a 1-splint strategy, 2 final occlusal splints were produced for each patient and compared with respect to their clinical usability. One splint was manufactured in the traditional way by a dental technician according to the preoperative surgical planning. After performing a CBCT scan of the patient's dental casts, a second splint was designed virtually by an engineer and surgeon working together, according to the desired final occlusion. For this purpose, RapidSplint, a custom-made software platform, was used. After post-processing and conversion of the datasets into .stl files, the splints were fabricated by the PolyJet procedure using photo polymerization. During surgery, both splints were inserted after mobilization of the dental arches then compared with respect to their clinical usability according to the occlusal fitting. Using the workflow described above, virtual splints could be designed and manufactured for all patients in this pilot study. Eight of 10 virtual splints could be used clinically to achieve and maintain final occlusion after orthognathic surgery. In 2 cases virtual splints were not usable due to insufficient occlusal fitting, and even two of the traditional splints were not clinically usable. In five patients where both types of splints were available, their occlusal fitting was assessed as being equivalent, and in one case the virtual splint showed even better occlusal fitting than the traditional splint. In 1 case where no traditional splint was available, the virtual splint proved to be helpful in achieving the final occlusion. The authors concluded that the findings of this pilot study demonstrated that clinically usable splints for orthognathic surgery can be produced by computer-assisted technology. Virtual splint design was realized by RapidSplint®, an in-house software platform which might contribute in future to shorten pre-operative workflows for the production of orthognathic surgical splints. The preliminary findings from this pilot study need to be validated by well-designed studies.

Swennen (2014) evaluated the timing for 3D virtual treatment planning of orthognathic surgery in the daily clinical routine. A total of 350 consecutive patients were included in this study. All patients were scanned following the standardized "Triple CBCT Scan Protocol" in centric relation. Integrated 3D virtual planning and actual surgery were performed by the same surgeon in all patients. The authors concluded that although clinically acceptable, still software improvements especially toward 3D virtual occlusal definition are mandatory to make 3D virtual planning of orthognathic surgery less time-consuming and more user-friendly to the clinician.

Austin et al (2015) compared the effectiveness of distraction osteogenesis to orthognathic surgery (OS) for the treatment of maxillary hypoplasia in individuals with cleft lip and palate. These investigators performed a systematic review of prospective randomized, quasi-randomized or controlled clinical trials. Medline, Embase, Scopus, Web of Science, CINAHL, CENTRAL, trial registers and grey literature were searched. Hand-searching of 5 relevant journals was completed. 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. A total of 5 publications all reporting different outcomes of a single RCT were included within the review. The

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quality of the evidence was low with a high risk of bias. Both surgical interventions produced significant soft tissue improvement. Horizontal relapse of the maxilla was statistically significantly greater following OS. There was no statistically significant difference in speech and velo-pharyngeal function between the interventions. Maxillary distraction initially lowered social self-esteem, but this improved with time resulting in higher satisfaction with life in the long-term. The authors concluded that the low quality of evidence included within the review meant 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. They stated that there is a need for further high-quality RCTs to allow conclusive recommendations to be made.

Olsen et al (2016) evaluated the effectiveness of hemostatic adjuncts on intra-operative blood loss (IOBL) in OS detected by RCTs of the highest quality. A search of the Medline, Cochrane, Embase, and Web of Science databases was performed in January 2015, and the risk of bias was assessed using the Jadad and Delphi scales. The predictor variable was the hemostatic measures, and the main outcome variable was the total IOBL volume. The secondary outcome variables were the hemoglobin and hematocrit and operating time. A total of 11 trials were included for review. The individual trials demonstrated the effects on IOB from hypotensive anesthetic regimens, the use of aprotinin, and the herbal medicine Yunnan Baiyao. Six studies of tranexamic acid (TXA), with 288 patients, were suitable for a meta-analysis of continuous data. Tranexamic acid reduced IOBL by an average of 171 ml (95 % confidence interval [CI]: -230 to -112; p < 0.00001). Its topical use yielded similarly significant results (mean difference -197, 95 % CI: -319 to -76; p < 0.001). A subgroup analysis showed a decreased operating time in the TXA groups by an average of 15 minutes (mean difference -14.78, 95 % CI: -22.21 to -7.35; p < 0.0001). The authors concluded that efficient hemostatic adjuncts exist for OS. The findings of this meta-analysis showed that TXA significantly reduced IOBL by an average of 1/3, regardless of whether it was given intravenously (IV) or applied topically. They stated that additional RCTs are needed to confirm the effect of topical TXA in OS, and larger studies of intravenous administration are needed before any routine recommendations. No hemostatic effect of hypotensive anesthesia was found, mainly owing to imprecise descriptions of the blinding procedures. Transparent and uniform trial reporting is thus encouraged in future studies.

Borba and colleagues (2016) stated that the sequencing of bi-maxillary orthognathic surgery remains controversial, although the traditional maxilla-first approach is performed routinely. The se investigators presented a systematic review of the mandible-first sequence in bi-maxillary orthognathic surgery, provided data that may assist in the decision as to which jaw should undergo osteotomy first in bi-maxillary orthognathic surgery cases. A literature search was conducted for articles published in the English language, reporting the use of the altered sequence for bi-maxillary orthognathic surgery (mandible-first), using the following descriptors: “orthognathic” and “double-jaw”, “orthognathic” and “two-jaw”, “orthognathic” and “mandible-first”, “orthognathic” and “bi-maxillary”. A total of 887 abstracts were initially identified and were evaluated for inclusion according to the proposed inclusion criteria. After evaluation of these abstracts and relevant references, 6 publications met the criteria for consideration. Performing mandible-first surgery in bi-maxillary orthognathic cases dated back to the 1970s; however the decision regarding the jaw to be operated on first appeared to rely on accurate pre-operative planning based upon the surgeon's experience and preference. While there appeared to be significant theoretical advantages to support the use of the altered orthognathic sequence (mandible-first), future prospective studies on its reliability, accuracy, and short- and long-term outcomes are needed.

Posnick et al (2016) examined operative time, peri-operative airway management, early post-operative cardio-pulmonary health, need for blood transfusion, and in-hospital stay associated with simultaneous bi-maxillary, intra-nasal, and osseous genioplasty surgery. These investigators performed a retrospective cohort study derived from patients treated by 1 surgeon at a single institution from 2009 through 2014. The sample consisted of a consecutive series of patients with symptomatic chronic obstructed nasal breathing and a dento-facial deformity (DFD). All underwent at least a Le Fort I osteotomy, sagittal ramus osteotomies, septoplasty, inferior turbinate reduction, and osseous

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genioplasty. For each patient, the design of the osteotomies and the fixation techniques were consistent. The outcome variables included need for blood transfusion, operating time, success of naso-tracheal intubation, time and place of extubation, early post-operative cardio-pulmonary health, length of in-hospital stay, and need for re-admission after surgery. For the 166 patients studied, the average age was 25 years (range of 13 to 65; 87 female patients [52 %]). The primary patterns of presenting DFD included long face (43 of 166, 26 %), maxillary deficiency (41 of 166, 25 %), asymmetric mandibular excess (37 of 166, 22 %), short face (28 of 166, 17 %), and mandibular deficiency (15 of 166, 9 %); 42 patients (25 %) were confirmed to have symptomatic obstructive sleep apnea (OSA). The open wound operating time averaged 2 hours 59 minutes (SD = 32 minutes). Only 3 of the 166 patients (1.8 %) received blood transfusions. All patients underwent successful naso-tracheal intubation; 96 % of patients were extubated in the operating room and the remaining 4 % were extubated in the recovery room. No patients required re-intubation or tracheostomy; 137 patients (83 %) were discharged after a 1- or 2-night in-hospital stay; 25 (15 %) required a 3-night stay; and 4 (2 %) required a 4-night hospital stay to achieve adequate oral intake; none of the patients required re-admission. The authors concluded that the findings of this study confirmed efficient surgical and anesthesia care for patients undergoing simultaneous bi-maxillary orthognathic, intra-nasal, and osseous genioplasty, and anticipating safe naso-tracheal intubation with extubation soon after surgery and a limited need for blood transfusion has proved to be the norm. They stated that this study confirmed an average in-hospital stay of 2 nights after complex orthognathic surgery without need for re-admission.

CPT Codes / HCPCS Codes / ICD-10 Codes

Information in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by "+":

CPT codes covered if selection criteria are met:

21083 Impression and custom preparation; palatal lift prosthesis

21084 speech aid prosthesis

21085 oral surgical splint

21088 facial prosthesis

21141 Reconstruction midface, Lefort I; single piece, segment movement in any direction (e.g., for Long Face Syndrome), without bone graft

21142 2 pieces, segment movement in any direction, without bone graft

21143 3 or more pieces, segment movement in any direction, without bone graft

21145 single piece, segment movement in any direction, requiring bone grafts (includes obtaining graft)

21146 2 pieces, segment movement in any direction, requiring bone grafts (includes obtaining autografts) (e.g., ungrafted unilateral alveolar cleft)

21147 3 or more pieces, segment movement in any direction, requiring bone grafts (includes obtaining autografts) (e.g., ungrafted bilateral alveolar cleft or multiple osteotomies)

21150 Reconstruction midface, Lefort II; anterior intrusion (e.g., Treacher-Collins Syndrome)

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21151 any direction, requiring bone grafts (includes obtaining autografts)

21154 Reconstruction midface, Lefort III (extracranial), any type, requiring bone grafts (includes obtaining autografts); without Lefort I

21155 with Lefort I

21159 Reconstruction midface, Lefort III (extra and intracranial) with forehead advancement (e.g., mono bloc), requiring bone grafts (includes obtaining autografts): without Lefort I

21160 with Lefort I

21181 Reconstruction by contouring of benign tumor of cranial bones (e.g., fibrous dysplasia), extracranial

21182 Reconstruction of orbital walls, rims, forehead, nasoethmoid complex following intra- and extracranial excision of benign tumor of cranial bone (e.g., fibrous dysplasia) with multiple autografts (includes obtaining grafts); total area of bone grafting less than 40 sq cm

21183 total area of bone grafting greater than 40 sq cm but less than 80 sq cm

21184 total area of bone grafting greater than 80 sq cm

21188 Reconstruction midface, osteotomies (other than Lefort type) and bone grafts (includes obtaining autografts)

21193 Reconstruction of mandibular rami, horizontal, vertical, C, or L osteotomy; without bone graft

21194 with bone graft (includes obtaining graft)

21195 Reconstruction of mandibular rami and/or body, sagittal split; without internal rigid fixation

21196 with internal rigid fixation

21198 Osteotomy, mandible, segmental;

21199 with genioglossus advancement

21206 Osteotomy, maxilla, segmental (e.g., Wassmund or Schuchard)

21208 Osteoplasty, facial bones; augmentation (autograft, allograft, or prosthetic implant)

21209 reduction

21210 Graft, bone; nasal, maxillary or malar areas (includes obtaining graft)

21215 mandible (includes obtaining graft)

21230 Graft; rib cartilage, autogenous, to face, chin, nose or ear (includes obtaining graft)

21235 ear cartilage, autogenous, to nose or ear (includes obtaining graft)

21240 Arthroplasty, temporomandibular joint, with or without autograft (includes obtaining graft)

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Orthognathic Surgery

21242 Arthroplasty, temporomandibular joint, with allograft

21243 Arthroplasty, temporomandibular joint, with prosthetic joint replacement

21247 Reconstruction of mandibular condyle with bone and cartilage autografts (includes obtaining grafts) (e.g., for hemifacial microsomia)

21255 Reconstruction of zygomatic arch and glenoid fossa with bone and cartilage (includes obtaining autografts)

21270 Malar augmentation, prosthetic material

21275 Secondary revision of orbitocraniofacial reconstruction

21295 Reduction of masseter muscle and bone (e.g., for treatment of benign masseteric hypertrophy); extraoral approach

21296 intraoral approach

42200 - 42281 Repair of palate

CPT codes not covered for indications listed in the CPB:

21125 Augmentation, mandibular body or angle; prosthetic material

21127 with bone graft, onlay or interpositional (includes obtaining autograft)

Other CPT codes related to the CPB:

21110 Application of interdental fixation device for conditions other than fracture or dislocation, includes removal

21120 - 21123 Genioplasty

HCPCS codes covered if selection criteria are met:

D5954 - D5959 Palatal augmentation and lift prosthesis

D7940 - D7955 Other repair procedures

Other HCPCS codes related to the CPB:

D8010 - D8999 Orthodontics

ICD-10 codes covered if selection criteria are met:

G47.33 Obstructive sleep apnea (adult) (pediatric) [associate with facial skeletal deformitites]

M26.00 - M26.59, Dentofacial anomalies [including malocclusion] and other disorders of jaw M26.70 - M26.9 [except TMJ disorders]

Q35.1 - Q37.9 Cleft lip and cleft palate

ICD-10 codes not covered for indications listed in the CPB:

M26.601 -M26.609

Temporomandibular joint disorders

Z41.1 Encounter for cosmetic surgery

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Orthognathic Surgery

The above policy is based on the following references:

1. McCarthy JG, Stelnicki EJ, Grayson BH. Distraction osteogenesis of the mandible: A ten-year experience. Semin Orthod. 1999;5(1):3-8.

2. Baker NJ, David S, Barnard DW, et al. Occlusal outcome in patients undergoing orthognathic surgery with internal fixation. Br J Oral Maxillofac Surg. 1999;37(2):90-93.

3. Bennett ME, Phillips CL. Assessment of health-related quality of life for patients with severe skeletal disharmony: A review of the issues. Int J Adult Orthodon Orthognath Surg. 1999;14(1):65-75.

4. Cope JB, Samchukov ML, Cherkashin AM. Mandibular distraction osteogenesis: A historic perspective and future directions. Am J Orthod Dentofacial Orthop. 1999;115(4):448-460.

5. Drew SJ, Schwartz MH, Sachs SA. Distraction osteogenesis. N Y State Dent J. 1999;65(1):26-29.

6. Buttke TM, Proffit WR. Referring adult patients for orthodontic treatment. J Am Dent Assoc. 1999;130(1):73-79.

7. Davies J, Turner S, Sandy JR. Distraction osteogenesis--a review. Br Dent J. 1998;185(9):462-467.

8. American Society of Plastic and Reconstructive Surgeons (ASPRS). Orthognathic Surgery: Recommended Criteria for Third-Party Payer Coverage. Arlington Heights, IL: ASPRS; September 1997.

9. Barkate HE. Orthognathic surgery by distraction osteogenesis: A literature review. Dentistry. 1997;17(3):14, 16-18.

10. Lupori JP, Van Sickels JE, Holmgreen WC. Outpatient orthognathic surgery: Review of 205 cases. J Oral Maxillofac Surg. 1997;55(6):558-563.

11. Tompach PC, Wheeler JJ, Fridrich KL. Orthodontic considerations in orthognathic surgery. Int J Adult Orthodon Orthognath Surg. 1995;10(2):97-107.

12. Ruhl CM, Bellian KT, Van Meter BH, et al. Diagnosis, complications, and treatment of dentoskeletal malocclusion. Am J Emerg Med. 1994;12(1):98-104.

13. Sinn DP, Ghali GE. Advances in orthognathic surgery. Curr Opin Dent. 1992;2:38-41. 14. Hunt OT, Johnston CD, Hepper PG, et al. The psychosocial impact of orthognathic surgery: A

systematic review. Am J Orthod Dentofacial Orthop. 2001;120(5):490-497. 15. Koh H, Robinson PG. Occlusal adjustment for treating and preventing temporomandibular joint

disorders. Cochrane Database Syst Rev. 2003;(1):CD003812. 16. American Academy of Oral and Maxillofacial Surgeons (AAOMS). Criteria for orthognathic

surgery. Reimbursement and Appeal Resources. Health Policy and Third Party Payor Relations Resources. Rosemont, IL: AAOMS; 2002. Available at: http://www.aaoms.org/allied/allied_template.asp?content_type_id=126&entity_id=122. Accessed April 15, 2003.

17. Tulloch JF, Proffit WR, Phillips C. Outcomes in a 2-phase randomized clinical trial of early Class II treatment. Am J Orthod Dentofacial Orthop. 2004;125(6):657-667.

18. Van Lierde KM, Schepers S, Timmermans L, et al. The impact of mandibular advancement on articulation, resonance and voice characteristics in Flemish speaking adults: A pilot study. Int J Oral Maxillofac Surg. 2006;35(2):137-144.

19. Chanchareonsook N, Samman N, Whitehill TL. The effect of cranio-maxillofacial osteotomies and distraction osteogenesis on speech and velopharyngeal status: A critical review. Cleft Palate Craniofac J. 2006;43(4):477-487.

20. Fedorowicz Z, Nasser M, Newton T, Oliver R. Resorbable versus titanium plates for orthognathic surgery. Cochrane Database Syst Rev. 2007;(2):CD006204.

21. Hassan T, Naini FB, Gill DS. The effects of orthognathic surgery on speech: A review. J Oral Maxillofac Surg. 2007;65(12):2536-2543.

22. Abrahamsson C, Ekberg E, Henrikson T, Bondemark L. Alterations of temporomandibular disorders before and after orthognathic surgery: A systematic review. Angle Orthod. 2007;77(4):729-734.

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Orthognathic Surgery

23. Lye KW. Effect of orthognathic surgery on the posterior airway space (PAS). Ann Acad Med Singapore. 2008;37(8):677-682.

24. Won CH, Li KK, Guilleminault C. Surgical treatment of obstructive sleep apnea: Upper airway and maxillomandibular surgery. Proc Am Thorac Soc. 2008;5(2):193-199.

25. Costa F, Robiony M, Toro C, et al. Condylar positioning devices for orthognathic surgery: A literature review. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008;106(2):179-190.

26. Kang SH, Yoo JH, Yi CK. The efficacy of postoperative prophylactic antibiotics in orthognathic surgery: A prospective study in Le Fort I osteotomy and bilateral intraoral vertical ramus osteotomy. Yonsei Med J. 2009;50(1):55-59.

27. Danda AK, Wahab A, Narayanan V, Siddareddi A. Single-dose versus single-day antibiotic prophylaxis for orthognathic surgery: A prospective, randomized, double-blind clinical study. J Oral Maxillofac Surg. 2010;68(2):344-346.

28. Dan AE, Thygesen TH, Pinholt EM. Corticosteroid administration in oral and orthognathic surgery: A systematic review of the literature and meta-analysis. J Oral Maxillofac Surg. 2010;68(9):2207-2220.

29. Garg M, Cascarini L, Coombes DM, et al. Multicentre study of operating time and inpatient stay for orthognathic surgery. Br J Oral Maxillofac Surg. 2010;48(5):360-363.

30. Lindenmeyer A, Sutcliffe P, Eghtessad M, et al. Oral and maxillofacial surgery and chronic painful temporomandibular disorders -- a systematic review. J Oral Maxillofac Surg. 2010;68(11):2755-2764.

31. Luther F, Layton S, McDonald F. Orthodontics for treating temporomandibular joint (TMJ) disorders. Cochrane Database Syst Rev. 2010;(7):CD006541.

32. Pineiro-Aguilar A, Somoza-Martín M, Gandara-Rey JM, Garcia-Garcia A. Blood loss in orthognathic surgery: A systematic review. J Oral Maxillofac Surg. 2011;69(3):885-892.

33. Danda AK, Ravi P. Effectiveness of postoperative antibiotics in orthognathic surgery: A meta-analysis. J Oral Maxillofac Surg. 2011;69(10):2650-2656.

34. Mattos CT, Vilani GN, Sant'Anna EF, et al. Effects of orthognathic surgery on oropharyngeal airway: A meta-analysis. Int J Oral Maxillofac Surg. 2011;40(12):1347-1356.

35. Stokbro K, Aagaard E, Torkov P, et al. Virtual planning in orthognathic surgery. Int J Oral Maxillofac Surg. 2014;43(8):957-965.

36. Adolphs N, Liu W, Keeve E, Hoffmeister B. RapidSplint: Virtual splint generation for orthognathic surgery - results of a pilot series. Comput Aided Surg. 2014;19(1-3):20-28.

37. Swennen GR. Timing of three-dimensional virtual treatment planning of orthognathic surgery: A prospective single-surgeon evaluation on 350 consecutive cases. Oral Maxillofac Surg Clin North Am. 2014;26(4):475-485.

38. 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.

39. 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.

40. Kloukos D, Fudalej P, Sequeira-Byron P, Katsaros C. Maxillary distraction osteogenesis versus orthognathic surgery for cleft lip and palate patients. Cochrane Database Syst Rev. 2016;9:CD010403.

41. Borba AM, Borges AH, Ce PS, et al. Mandible-first sequence in bimaxillary orthognathic surgery: A systematic review. Int J Oral Maxillofac Surg. 2016;45(4):472-475.

42. Arnaud E, Paternoster G, James S, et al. Craniofacial strategy for syndromic craniosynostosis. Ann Chir Plast Esthet. 2016;61(5):408-419.

43. Posnick JC, Adachie A, Choi E. Segmental maxillary osteotomies in conjunction with bimaxillary orthognathic surgery: Indications - safety - outcome. J Oral Maxillofac Surg. 2016;74(7):1422-1440.

44. Posnick JC, Choi E, Chavda A. Operative time, airway management, need for blood transfusions, and in-hospital stay for bimaxillary, intranasal, and osseous genioplasty surgery: Current clinical practices. J Oral Maxillofac Surg. 2016;74(3):590-600.

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Orthognathic Surgery

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.

CPT only copyright 2015 American Medical Association. All Rights Reserved.

Copyright 2001-2017 Aetna Inc.Web Privacy Statement | Legal Statement | Privacy Notices | Member Disclosure

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AETNA BETTER HEALTH® OF PENNSYLVANIA

Amendment toAetna Clinical Policy Bulletin Number: 0095 Orthognathic Surgery

There are no amendments for Medicaid.

www.aetnabetterhealth.com/pennsylvania updated 03/07/2017


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