Upload
others
View
0
Download
0
Embed Size (px)
Citation preview
Prior Authorization Review Panel MCO Policy Submission
A separate copy of this form must accompany each policy submitted for review. Policies submitted without this form will not be considered for review.
Plan: Aetna Better Health Submission Date:10/01/2019
Policy Number: 0549 Effective Date: Revision Date: 09/05/2013
Policy Name: Distraction Osteogenesis for Craniofacial Defects
Type of Submission – Check all that apply:
New Policy Revised Policy* Annual Review – No Revisions Statewide PDL
*All revisions to the policy must be highlighted using track changes throughout the document.
Please provide any clarifying information for the policy below:
CPB 0549 Distraction Osteogenesis for Craniofacial Defects
Clinical content was last revised on 09/05/2013. No additional non-clinical updates were made byCorporate since the last PARP submission.
Name of Authorized Individual (Please type or print):
Dr. Bernard Lewin, M.D.
Signature of Authorized Individual:
Revised July 22, 2019
http://www.aetna.com/cpb/medical/data/500_599/0549.html
Page 1 of 18
(https://www.aetna.com/)
Distraction Osteogenesis forCraniofacial Defects
Clinical Policy Bulletins Medical Clinical Policy Bulletins
Pol icy History Last
Review
10/10/2018
Effective: 08/14/2000
Next Review:
05/23/2019
Review History
Definitions
Additional Information
Number: 0549
Policy *Please see amendment for Pennsylvania Medicaid at the end of this CPB.
I. Aetna considers distraction osteogenesis (distraction histogenesis)
medically necessary for the correction of functional impairments
accompanying the following congenital craniofacial skeletal deformities:
Cleft lip and palate; or
Correction of hemifacial microsomia, in children with sufficient bone to
allow for a corticotomy and/or osteotomy and placement of pins for
external or internal distraction devices (i.e., Pruzansky Grade I and IIa
type mandibular deformity); or
Correction of severe congenital mandibular deficiency requiring
lengthening of the mandible of greater than 10 mm (orthognathic
surgery is able to correct smaller mandibular deformities); or
Correction of severe micrognathia (such as accompanying Pierre Robin
syndrome or Treacher Collins syndrome) in infants and children with
airway obstruction; or
Lengthening of a short mandibular ramus (stretching of
pterygomasseteric sling); or
09/23/2019
http://www.aetna.com/cpb/medical/data/500_599/0549.html
Page 2 of 18
Non-syndromic craniosynostosis -- coronal (bilateral or unilateral) or
sagittal; or
Syndromic craniosynostosis -- Apert, Crouzon, and Pfeiffer syndromes;
or
Widening of a narrow mandible or maxilla.
Upon review by Aetna's Oral and Maxillofacial Surgery (OMS) Unit, distraction
osteogenesis may be considered medically necessary for correction of functional
impairments accompanying other congenital craniofacial anomalies where it is
determined that distraction osteogenesis can uniquely produce a degree of improvement
unavailable with other standard techniques.
II. Aetna considers distraction osteogenesis experimental and investigational
for acquired craniofacial defects (e.g., reconstruction of defects following
tumor (e.g., osteosarcoma) resection, or ablative head and neck surgery),
obstructive sleep apnea, and all other craniofacial indications because of
insufficient evidence regarding the clinical value of this approach for these
indications.
III. Aetna considers enhancement of bone formation by means of bone
morphogenetic proteins and local injection of bone marrow aspirate and
platelet gel at the osteotomy site during distraction osteogenesis
experimental and investigational because of insufficient evidence in the
peer-reviewed literature.
IV. Aetna does not cover distraction osteogenesis (distraction histogenesis) in
preparation for dental implants or orthodontic care under plans that
exclude dental implants or orthodontic care. Please check benefit plan
descriptions. See
CPB 0082 - Dental Services and Oral and Maxillofacial Surgery - Coverage
under Medical Plans (../1_99/0082.html)
V. Aetna considers distraction osteogenesis for the sole purpose of improving
individual appearance and profile cosmetic.
See also CPB 0004 - Obstructive Sleep Apnea in Adults (../1_99/0004.html),
CPB 0095 - Orthognathic Surgery (../1_99/0095.html)
09/23/2019
http://www.aetna.com/cpb/medical/data/500_599/0549.html
Page 3 of 18
, CPB 0220 - Distraction Osteosynthesis (../200_299/0220.html),
CPB 0244 - Wound Care (../200_299/0244.html)
CPB 0411 - Bone and Tendon Graft Substitutes and Adjuncts
, (../400_499/0411.html)
, and CPB 0752 - Obstructive Sleep Apnea in Children (../700_799/0752.html).
Background
Orthognathic surgery is the surgical correction of skeletal anomalies or
malformations involving the midface, mandible and maxilla. These malformations
may be present at birth, or may become evident as the patient grows and
develops. Jaw malformations can cause chewing and eating difficulties, abnormal
speech patterns, early loss of teeth, and disfigurement and dysfunction of the
maxilla and mandible. Mal-occlusion may be caused by a deficiency or excess of
bony tissue in one or both jaws, or by trauma to the facial bones.
In orthognathic surgery, an osteotomy is made in the affected jaw, and the bones
are repositioned in a more physiologic alignment. Generally, the bones are held in
their new positions with plates, screws and wires. The patient may also need arch
bars placed on both jaws to add stability (a procedure called intermaxillary
fixation). For patients with deformities affecting both jaws, either simultaneous or
staged osteotomies may be undertaken to achieve correction. Patients with
deficient bone tissue may require grafts from their ribs, hips or skull. Alloplastic
replacement of missing bone may also be required.
Indications for orthognathic surgery include: (i) mandibular prognathism; (ii)
mandibular retrognathia; (iii) maxillary excess; (iv) maxillary deficiency; and (v)
apertognathia (open bite deformity). In some cases, adjunctive procedures such
a reconstructive rhinoplasty, malar and chin osteoplasty, and bone grafting are
needed to correct deformities; however these procedures require evaluation by the
Oral and Maxillofacial Surgery Unit to determine coverage. These adjunctive
procedures are typically considered cosmetic in nature.
Distraction osteogenesis, initially developed by Ilizarov for limb lengthening has
recently been applied to the correction of severe congenital or acquired craniofacial
deformities as an early alternative to orthognathic surgery. Distraction
osteogenesis involves the lengthening and re-shaping of deformed bone by
09/23/2019
http://www.aetna.com/cpb/medical/data/500_599/0549.html
Page 4 of 18
surgical fracture and gradual separation of bony segments. The surgeon lengthens
and re-shapes deformed bone by surgically fracturing the bone and slowly
separating (distracting) the resultant segments with specially fabricated hardware.
The bony fragments are held in place during the first week following surgical
fracture to allow callus to form between the fragments. During the next several
weeks, the fragments are gradually separated at a rate of 1 to 2 millimeters per
day, up to a pre-determined length (e.g., 20 days for 20 millimeters or 5/8 inches).
The bone segments are moved gradually to allow callus formation and adaptation
of fibromuscular attachments. Once the desired length and shape is achieved, the
hardware is left in place for an additional 6 weeks until the newly formed bone
calcifies.
The specially fabricated hardware used for the distraction process can be internal
or external. Advantages of external devices include ease of placement and
removal. In addition, some external devices allow multi-dimensional control.
External devices, however, are very conspicuous and are more likely to cause
traction scars than internal devices. Internal devices are less visible than external
devices, and directly transmit force to the bone. Internal devices, however, are only
uni-directional and require a subsequent surgical procedure for their removal.
The primary advantage claimed in connection with distraction osteogenesis is that it
allows major reshaping of the facial bones without bone grafts or jaw wiring.
Proponents claim that distraction osteogenesis may be safer than other methods of
facial reconstruction, since it can involve less blood loss and a lower risk of
infection. However, according to available literature, distraction osteogenesis has
several drawbacks. If the bone ends are moved apart too slowly, callus may calcify
too soon, preventing further distraction. If the bone ends are moved apart too
rapidly, callus may become too fibrous and fail to mature into solid bone.
Therefore, the rate and rhythm of distraction is important to the quality and quantity
of bone that is formed.
The published literature regarding the effectiveness of distraction osteogenesis for
craniofacial anomalies has focused on its use in repair of congenital conditions in
young children. The published clinical literature on distraction osteogenesis for
developmental and acquired craniofacial deformities is more limited, and consists
primarily of case series reporting on its technical feasibility, peri-operative morbidity,
and short-term outcomes. Orthognathic surgery is the established method of
correcting developmental mandibular deficiencies, maxillary deficiencies and other
09/23/2019
http://www.aetna.com/cpb/medical/data/500_599/0549.html
Page 5 of 18
developmental and acquired craniofacial deformities. More investigation is
necessary to refine distraction osteogenesis technique, to help define its role in
craniofacial surgery, and to improve the design and reliability of distraction devices
in repairing developmental and acquired deformities in older children and adults
whose growth is at or near completion. Moreover, there are insufficient published
data on the long-term effectiveness of this procedure for these indications,
especiallyon the rate of skeletal relapse.
According to a position statement from the American Association of Oral and
Maxillofacial Surgeons (AAOMS, 2003), “the indications for distraction involving the
jaws are limited to conditions in which this technique may be uniquely able to
produce significant improvement over more traditional therapy.” According to the
AAOMS (2003), examples of these situations are as follows:
Narrow mandible that must be widened. There has been little success in
widening the mandible with conventional surgery prior to the advent of
distraction. Distraction techniques offer a better way to address this problem
Need for lengthening of a short mandibular ramus. According to the AAOS, the
nature of distraction osteogenesis is well-suited for stretching of the
pterygomasseteric sling, which is not easily overcome by conventional
procedures.
Severe deficiency of either jaw with early correction indicated (e.g., an infant
with Pierre Robin with mandibular deficiency so severe that tracheostomy is
required and advancement of the mandible is the only way to correct an
obstructive situation).
Severe mandibular deficiency requiring lengthening of the mandible of greater
than 10 mm. Growth modification via orthodontics generally produces no more
than 5 mm differential growth and conventional orthognathic procedures
become more difficult and less predictable when greater than 8 to 10 mm
advancement is needed.
The AAOMS guidelines also list alveolar deficiency among examples of established
indications for distraction osteogenesis for craniofacial anomalies. However, there
is insufficient published evidence of the effectiveness of distraction osteogenesis for
vertical augmentation of the alveolar ridge in comparison with grafting techniques
for this indication.
09/23/2019
http://www.aetna.com/cpb/medical/data/500_599/0549.html
Page 6 of 18
The AAOMS guidelines list “[w]idening of the maxilla in an adult” among
established indications for distraction osteogenesis. However, surgically assisted
palatal expansion, which is analogous to distraction osteogenesis, has been utilized
to overcome this problem for decades with very desirable and stable results".
AAOMS guidelines note that, “[a]s with any procedure, distraction osteogenesis
should be utilized primarily when superior results can be achieved com pared to
conventional techniques” (AAOMS, 2003).
Although the AAOMS guidelines do not distinguish between congenital and
developmental and acquired conditions, the published evidence to date has
focused on repair of congenital conditions. There is insufficient evidence of the
effectiveness of distraction osteogenesis for developmental and acquired
craniofacial anomalies.
Schreuder et al (2007) noted that bilateral sagittal split osteotomy (BSSO) and
distraction osteogenesis are the most common techniques currently applied to
surgically correct mandibular retrognathia. These investigators reviewed the
literature on BSSO and mandibular distraction osteogenesis with emphasis on the
influence of age and post-surgical growth, damage to the inferior alveolar nerve,
and post-surgical stability and relapse. Although randomized clinical trials are
lacking, some support was found in the literature for distraction osteogenesis
having advantages over BSSO in the surgical treatment of low and normal
mandibular plane angle patients needing greater advancement (greater than 7
mm). In all other mandibular retrognathia patients the treatment outcomes of
distraction osteogenesis and BSSO seemed to be comparable. Distraction
osteogenesis is accompanied by greater patient discomfort than BSSO during and
shortly after treatment, but it is unclear if this has any consequences in the long-
term. There is a need for randomized clinical trials comparing the 2 techniques in
all types of mandibular retrognathia, in order to provide evidence-based guidelines
for selecting which retrognathia cases are preferably treated by BSSO or distraction
osteogenesis.
Sacco and Chepeha (2007) stated that earlier work has reported encouraging
results regarding the translation of distraction osteogenesis from animal studies to
human uses, with particular success in the un-radiated setting. The major
challenge surrounding the use of this technology in head and neck oncological
reconstruction will be the effect of radiotherapy on the regenerate bone in patients
09/23/2019
http://www.aetna.com/cpb/medical/data/500_599/0549.html
Page 7 of 18
who have received or will need radiotherapy as part of their treatment. Although
distraction osteogenesis provides an attractive option for reconstructing mandibular
defects, large human studies are needed to further evaluate the use of this
technology and its role in the treatment for mandibular neoplasms.
Ow and Cheung (2008) stated that mandibular distraction osteogenesis has been
used effectively to treat syndromic craniofacial deformities. In recent years, its
scope of application has widened to include treatment of airway obstruction in
adults and children as well as non-syndromic class II mandibular hypoplasia. So
far, there has been no evidence-based review of mandibular distraction
osteogenesis for mandibular lengthening. These investigators carried out a meta-
analysis of mandibular distraction osteogenesis. Two rounds of searches were
performed by 2 independent assessors. The first-round PubMed search used the
keywords "mandible" and "distraction osteogenesis". In the second-round search,
the reference lists of the articles were retrieved. For both rounds, abstracts and
then full articles were reviewed and selected on the basis of a set of inclusion and
exclusion criteria. The 178 retrieved articles yielded 1,185 mandibular distraction
osteogenesis patients: 539 received unilateral mandibular distraction osteogenesis
and 646 received bilateral mandibular distraction osteogenesis. Mandibular
distraction osteogenesis was reported to improve facial asymmetry and
retrognathia (50.1 %), correct the slanted lip commissure (24.7 %), and improve or
level the mandibular occlusal plane (11.1 %) in unilateral asymmetry cases,
whereas bilateral mandibular distraction osteogenesis was shown to be effective in
preventing tracheostomies for 91.3 % of neonates or infants with respiratory
distress, and in relieving symptoms of obstructive sleep apnea for 97.0 % of
children and 100 % of adult patients. The authors concluded that mandibular
distraction osteogenesis is effective in treating craniofacial deformities, but further
clinical trials are needed to evaluate the long-term stability and to compare the
treatment with conventional treatment methods, especially in cases of obstructive
sleep apnea or class II mandibular hypoplasia.
In a retrospective medical review spanning a 9-year period, Kolstad and colleagues
(2011) examined if there is a difference in mandibular distraction osteogenesis
(MDO) treatment success rates and adverse outcomes in newborns, early infants,
and older pediatric patients. Ten newborn (less than or equal to 35 days old), 5
early infant (36 days to 5 months) and 8 older pediatric (greater than 5 months)
patients underwent MDO for treatment of micrognathia with a severe tongue-based
obstruction. Success was defined as avoidance of tracheostomy or continuous
09/23/2019
http://www.aetna.com/cpb/medical/data/500_599/0549.html
Page 8 of 18
positive airway pressure, and de-cannulation of patients with tracheotomies. Post-
operative complications were grouped into minor and major. MDO successfully
treated 90 % of newborns, 100 % of early infants and 100 % of older pediatric
patients. There was no difference in the rates of success (p = 0.48), minor (p =
1.00) and major (p = 1.00) post-operative complications between newborns and
early infants. Older pediatric patients had no treatment failures, tended to have
fewer minor (p = 0.18) and significantly fewer major (p = 0.04) post-operative
complications compared to younger patients. The distractor pin mobility (9 %) and
scar revisions (13 %) were uncommon. The authors concluded that MDO is a
reliable method for relieving severe tongue-based obstructions in pediatric
patients. When comparing newborns and early infant patients, treatment success
rates and the occurrence of complications were not found to be different. Older
pediatric patients had no treatment failures, and tended to have fewer post-
operative complications compared to younger patients.
Pluijmers et al (2014) provided an overview of the surgical correction of the
mandible in unilateral craniofacial microsomia (UCM) performed i n the growing
patient, and its long-term outcome and stability. The following databases were
searched: PubMed, Embase, Cochrane, and Web of Science. Articles reporting
prospective and retrospective studies of patients not older than 16 years (n ≥ 4)
who had undergone surgical correction of a craniofacial microsomia spectrum
condition using gr afts, osteotomies, distraction, or combinations of these, were
reviewed. The period of follow-up was selected to be greater than or equal to 1
year. After inclusion, the articles were evaluated on short- and long-term
outcomes, relapse, and any increase in asymmetry following t reatment; 30 of 1,611
articles were included in the qualitative synthesis. Analysis of the surgical
mandibular correction of UCM showed that the outcome is not so much treatment-
dependent, but patient-dependent, i.e., deformity gradation-dependent. The type I
and type IIa Pruzansky-Kaban patient had the best results with regard to minimal
relapse and/or minimal increase i n asymmetry. Single-stage correction of the
asymmetry should be pos tponed until the permanent dentition stage. The authors
concluded that in the treatment of the severely hypoplastic mandible, the patient will
benefit from a multi-stage treatment protocol if indicated for functional or
psychological problems.
Tahiri et al (2014) stated that distraction osteogenesis is an effective technique for
elongating the deficient mandible. These investigators evaluated its effectiveness
in the treatmentof airway obstruction in pediatric patients with mandibular
09/23/2019
http://www.aetna.com/cpb/medical/data/500_599/0549.html
Page 9 of 18
hypoplasia. A comprehensive literature review of the National Library of Medicine
(PubMed) database was performed. English-language studies involving isolated
distraction of the pediatric mandible (younger than 18 years) with descriptive
reporting of airway changes were included. Extracted data included demographics,
initial diagnosis, distractor type, distraction protocol, pre-distraction and post-
distraction airway status, and complications. A total of 74 articles met the inclusion
criteria, resulting in 711 patients with craniofacial abnormalities who underwent
mandibular distraction osteogenesis. Mean age at the time of distraction was 18.1
months. The most common diagnoses were isolated Pierre Robin sequence (52.9
%), syndromic Pierre Robin sequence (7 %), and Treacher Collins syndrome (6.8
%). Mandibular distraction osteogenesis successfully treated airway obstruction in
89.3 % of cases. Success was defined as either de-cannulation of tracheostomy,
avoidance of tracheostomy or continuous positive airway pressure, or alleviation or
significant improvement of obstructive sleep apnea (OSA) symptoms. A total of
171 (84.2 %) of the 203 tracheostomy-dependent patients were successfully de-
cannulated. Among the 181 patients with OSA, mandibular distraction
osteogenesis successfully allowed for either complete resolution or significant
improvement of symptoms in 95.6 %. A 23.8 % overall complication rate was
noted. The mean follow-up time was 28.7 months. The authors concluded that in
addition to its positive effect on facial appearance, mandibular distraction
osteogenesis is an effective procedure for the treatment of airway obstruction
associated with congenital craniofacial defects involving mandibular hypoplasia in
appropriately selected patients.
Bone Morphogenetic Proteins
Sabharwal and colleagues (2011) notd that delayed bone healing during distraction
osteogenesis negatively affects clinical outcome. In addition to autologous bone
grafting, several mechanical, chemical, biologic, and external treatment modalities
may be employed to promote bone growth during distraction osteogenesis in the
pediatric patient. Mechanical approaches include compressive loading of the
distraction regenerate, increased frequency of small increments of distraction, and
compression-distraction. Intra-medullary nailing and sub-muscular plating can
reduce the time in external fixation; however, these techniques are associated with
technical difficulties and complications. Exogenous application of low-intensity
pulsed ultrasound or pulsed electromagnetic fields may shorten the duration of
external fixation. Other promising modalities include diphosphonates,physician-
directed use (off-label use) of bone morphogenetic proteins, and local injection of
09/23/2019
http://www.aetna.com/cpb/medical/data/500_599/0549.html
Page 10 of 18
bone marrow aspirate and platelet gel at the osteotomy site. The author concluded
that well-designed clinical studies are needed to establish safe and effective
guidelines for various modalities to enhance new bone formation during distraction
osteogenesis in children.
Terbish and colleagues (2015) evaluated the effect of recombinant human bone
morphogenetic protein-2 (rhBMP-2) on the quality and quantity of regenerated bone
when injected into distracted alveolar bone. A total of 16 adult beagle dogs were
assigned to either the control or rhBMP-2 group. After distraction was completed,
an rhBMP-2 dose of330 μg in 0.33 ml was injected slowlyinto the distracted
alveolar crest of the mesial, middle, and distal parts of the alveolar bone in the
experimental group. Histologic and micro-computed tomographyanalyses of
regenerated bone were done after 2 and 6 weeks of consolidation. After 6 weeks
of consolidation, the vertical defect height in the middle of the regenerated bone
was significantly lower in the rhBMP-2 group (2.2 mm) than in the control group (3.4
mm) (p < 0.05). Additionally, the width of the regenerated bone was significantly
greater in the rhBMP-2 group (4.3 mm) than in the control group (2.8 mm) (p <
0.05). The bone density and volume of regenerated bone in the rhBMP-2 group
were greater than in the control group after 6 weeks of consolidation (p < 0.001).
The authors concluded that injection of rhBMP-2 into regenerated bone after a
distraction osteogenesis procedure significantly increased bone volume in the
dento-alveolar distraction site and improved both the width and height of the
alveolar ridge and increased the bone density. These preliminary findings from a
canine model need to be examined in human subjects.
Distraction Osteogenesis of the Irradiated Craniofacial Skeleton
Momeni and colleagues (2017) stated that craniofacial DO is a common treatment
modality today. Despite its numerous advantages, however, concerns have been
expressed regarding the use of DO in the irradiated setting. A systematic review
was performed to identify all published reports of patients who underwent DO of the
irradiated craniofacial skeleton. The following parameters were of particular
interest: post-operative complications, specifically, insufficient bone formation,
fracture, and hardware exposure (intra-oral and cutaneous), as well as the need for
additional bone grafting. The initial search retrieved a total of 183 articles of which
20 articles (38 patients) met pre-determined inclusion criteria. The most common
site of distraction was the mandible (76.3 %). The median radiation dose was 50.7
Gy (range of 30 to 70 Gy). Bone defects ranged from 30 to 80 mm (median of42.5
09/23/2019
Page 11 of 18
mm). Complications were encountered in 19 patients (50 %), with insufficient bone
formation being most common (9 patients; 23 %). The overall incidence of
complications was not significantly associated with radiation dosage (p =0.79). The
remaining procedural and demographic variables also failed to meet statistical
significance when compared against the overall complication rate (p =0.27 to
0.97). The authors concluded that the complication rate associated with
craniofacial DO of the irradiated skeleton did not appear to be substantially higher
than what was reported for DO in the non-irradiated setting. As such, patients
should be offered this treatment modality, particularly in light of the fact, that it
offers the option to decrease patient morbidity as well as treatment complexity.
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:
CPT codes not covered for indications listed in the CPB:
Other CPT codes related to the CPB:
http://www.aetna.com/cpb/medical/data/500_599/0549.html 09/23/2019
http://www.aetna.com/cpb/medical/data/500_599/0549.html
Code
Page 12 of 18
Code Description
20939 Bone marrow aspiration for bone grafting, spine surgery only, through
separate skin or fascial incision (List separately in addition to code for
primary procedure)
21110 Application of interdental f ixation device for conditions other than
fracture or dislocation, includes removal
21120 - 21196 Repair, revision, and/or reconstruction bones of face
21206 Osteotomy, maxilla, segmental (e.g., Wassmund or Schuchard)
21210 Graft, bone; nasal, maxillary or malar areas (includes obtaining graft)
21247 Reconstruction of mandibular condyle w ith bone and cartilage autografts
(includes obtaining grafts) (eg, for hemifacial microsomia)
30400 - 30462 Rhinoplasty
42200 - 42225 Palatoplasty
HCPCS codes not covered for indicationslisted in the CPB:
S9055 Procuren or other grow th factor preparation to promote w ound healing
Other HCPCS codes related to the CPB:
D6010 - D6199 Implant services
D7946 - D7949 LeFort procedures I, II, or III
D8010 - D8999 Orthodontic dental procedures
ICD-10 codes covered if selection criteria are met:
M26.00 -
M26.59
Dentofacial anomalies [including malocclusion]
Q35.1 - Q35.9 Cleft palate
Q37.0 - Q37.9 Cleft palate w ith cleft lip
Q67.0 - Q67.4 Congenital deformities of skull, face and jaw
Q75.0 - Q75.9 Congenital malformation of skull and face bones [includes hemifacial
microstomia]
Q87.0 Congenital malformation syndromes predominantly affecting facial
appearance
ICD-10 codes not covered for indications listed in the CPB:
G47.33 Obstructive sleep apnea (adult) (pediatric)
M95.2 Other acquired deformity of head [acquired craniofacial defects]
Z41.1 Encounter for cosmetic surgery
09/23/2019
http://www.aetna.com/cpb/medical/data/500_599/0549.html
Z46.3
Z46.4
Page 13 of 18
The above policy is base d on the following re fe re nces:
1. Van Sickels JE. Distraction osteogenesis versus orthognathic surgery. Am J
Orthod Dentofacial Orthop. 2000;118(5):482-484.
2. Rachmiel A, Aizenbud D, Eleftheriou S, et al. Extraoral vs. intraoral
distraction osteogenesis in the treatment of hemifacial microsomia. Ann
Plast Surg. 2000;45(4):386-394.
3. Gateno J, Teichgraeber JF, Aguilar E. Distraction osteogenesis: A new
surgical technique for use with the multiplanar mandibular distractor.
Plast Reconstr Surg. 2000;105(3):883-888.
4. Oda T, Sawaki Y, Ueda M. Experimental alveolar ridge augmentation by
distraction osteogenesis using a simple device that permits secondary
implant placement. Int J Oral Maxillofac Implants. 2000;15(1):95-102.
5. Marquez IM, Fish LC, Stella JP. Two-year follow-up of distraction
osteogenesis: Its effect on mandibular ramus height in hemifacial
microsomia. Am J Orthod Dentofacial Orthop. 2000;117(2):130-139.
6. van Strijen PJ, Perdijk FB, Becking AG, et al. Distraction osteogenesis for
mandibular advancement. Int J Oral Maxillofac Surg. 2000;29(2):81-85.
7. Jensen OT. Distraction osteogenesis and its use with dental implants. Dent
Implantol Update. 1999;10(5):33-36.
8. Tillery DE Jr. Advances in orthognathic surgery. Dent Today. 1998;17(8):90
92.
9. Gaggl A, Schultes G, Karcher H. Distraction implants: A new operative
technique for alveolar ridge augmentation. J Craniomaxillofac Surg.
1999;27(4):214-221.
10. Cohen SR, Burstein FD, Williams JK. The role of distraction osteogenesis in
the management of craniofacial disorders. Ann Acad Med Singapore.
1999;28(5):728-738.
11. Diner PA, Tomat C, Soupre V, et al. Intraoral mandibular distraction:
Indications, technique and long-term results. Ann Acad Med Singapore.
1999;28(5):634-641.
09/23/2019
http://www.aetna.com/cpb/medical/data/500_599/0549.html
Page 14 of 18
12. Mehrara BJ, Longaker MT. New developments in craniofacial surgery
research. Cleft Palate Craniofac J. 1999;36(5):377-387.
13. Figueroa AA, Polley JW. Management of severe cleft maxillary deficiency
with distraction osteogenesis: Procedures and results. Am J Orthod
Dentofac Orthop. 1999;115:1-12.
14. Guerrero CA, Bell WH, Contasti GI, et al. Mandibular widening by intraoral
distraction osteogenesis. Br J Oral Maxillofac Surg. 1997;35:383-392.
15. Liou EJ, Huang CS. Rapid canine retraction through distraction of the
periodontal ligament. Am J Orthod Dentofac Orthop. 1998;114:372-382.
16. Samchukov ML, Cope JB, Harper RP, et al. Biomechanical considerations of
mandibular lengthening and widening by gradual distraction using a
computer model. J Oral Maxillofac Surg. 1998;56(1):51-59.
17. Mommaerts MY. Reliability and validity of a backlighted digitizer when
used for craniofacial measurements. J Craniofac Surg. 1997;8:222-228.
18. Klein C, Howaldt HP. Correction of mandibular hypoplasia by means of
bidirectional callus distraction. J Craniofac Surg. 1996;7:258-266.
19. 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):89-103.
20. 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):123-135.
21. Imola MJ, Hamlar DD, Thatcher G, et al. The versatility of distraction
osteogenesis in craniofacial surgery. Arch Facial Plast Surg. 2002;4(1):8-19.
22. Patel PK, Han H. Craniofacial, distraction osteogenesis. eMedicine Plastic
Surgery, Topic 459. Omaha, NE: eMedicine.com; updated February 1, 2002.
23. Imola MJ. Craniofacial distraction osteogenesis. eMedicine Otolaryngology
and Facial Plastic Surgery, Topic 702. Omaha, NE: eMedicine.com; updated
May 14, 2002.
24. 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 2003. Available at:
http://www.aaoms.org/allied/pdfs/distraction.pdf. Accessed October 16,
2003.
09/23/2019
http://www.aetna.com/cpb/medical/data/500_599/0549.html
Page 15 of 18
25. Shaw WC, Mandall NA, Mattick CR. Ethical and scientific decision making in
distraction osteogenesis. Cleft Palate Craniofac J. 2002;39(6):641-645.
26. Denny AD, Kalantarian B, Hanson PR. Rotation advancement of the
midface by distraction osteogenesis. Plast Reconstr Surg. 2003;111
(6):1789-1799; discussion 1800-1803.
27. 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):1382-1392; discussion 1393-1394.
28. Shirai T, Tsuchiya H, Yamamoto N, et al. Successful management of
complications from distraction osteogenesis after osteosarcoma
resection: A case report. J Orthop Sci. 2004;9(6):638-642.
29. Raghoebar GM, Jansma J, Vissink A, Roodenburg JL. Distraction
osteogenesis in the irradiated mandible. A case report. J Craniomaxillofac
Surg. 2005;33(4):246-250.
30. Matsubara H, Tsuchiya H, Sakurakichi K, et al. Distraction osteogenesis of
a previously irradiated femur with malignant lymphoma: A case report. J
Orthop Sci. 2005;10(4):430-435.
31. 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):598-608.
32. Erler K, Yildiz C, Baykal B, Reconstruction of defects following bone tumor
resections by distraction osteogenesis. Arch Orthop Trauma Surg.
2005;125(3):177-183.
33. Kunkel M, Wahlmann U, Reichert TE, et al. Reconstruction of mandibular
defects following tumor ablation by vertical distraction osteogenesis using
intraosseous distraction devices. Clin Oral Implants Res. 2005;16(1):89-97.
34. Enislidis G, Fock N, Ewers R. Distraction osteogenesis with subperiosteal
devices in edentulous mandibles. Br J Oral Maxillofac Surg. 2005;43(5):399
403.
35. 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):11-28.
36. 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.
09/23/2019
http://www.aetna.com/cpb/medical/data/500_599/0549.html
Page 16 of 18
37. Sacco AG, Chepeha DB. Current status of transport-disc-distraction
osteogenesis for mandibular reconstruction. Lancet Oncol. 2007;8(4):323
330.
38. Ow AT, Cheung LK. Meta-analysis of mandibular distraction osteogenesis:
Clinical applications and functional outcomes. Plast Reconstr Surg.
2008;121(3):54e-69e.
39. 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 2:1817-1821.
40. Verstraaten J, Kuijpers-Jagtman AM, Mommaerts MY, et al.; Eurocran
Distraction Osteogenesis Group. A systematic review of the effects of
bone-borne surgical assisted rapid maxillary expansion. J Cranio-Maxillo-
Facial Surg. 2010;38(3):166-174.
41. 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):803-814.
42. Sabharwal S. Enhancement of bone formation during distraction
osteogenesis: Pediatric applications. J Am Acad Orthop Surg. 2011;19
(2):101-111.
43. Meling TR, Hogevold HE, Due-Tonnessen BJ, Skjelbred P. Midface
distraction osteogenesis: Internal vs. external devices. Int J Oral Maxillofac
Surg. 2011;40(2):139-145.
44. Kolstad CK, Senders CW, Rubinstein BK, Tollefson TT. Mandibular
distraction osteogenesis: At what age to proceed. Int J Pediatr
Otorhinolaryngol. 2011;75(11):1380-1384.
45. Pluijmers BI, Caron CJ, Dunaway DJ, et al. Mandibular reconstruction in the
growing patient with unilateral craniofacial microsomia: A systematic
review. Int J Oral Maxillofac Surg. 2014;43(3):286-295.
46. Saltaji H, Altalibi M, Major MP, et al. Le Fort III distraction osteogenesis
versus conventional Le Fort III osteotomy in correction of syndromic
midfacial hypoplasia: A systematic review. J Oral Maxillofac Surg. 2014;72
(5):959-972.
47. Tahiri Y, Viezel-Mathieu A, Aldekhayel S, et al. The effectiveness of
mandibular distraction in improving airway obstruction in the pediatric
population. Plast Reconstr Surg. 2014;133(3):352e-359e.
09/23/2019
http://www.aetna.com/cpb/medical/data/500_599/0549.html
Page 17 of 18
48. Terbish M, Yoo SH, Kim HJ, et al. Accelerated bone formation in distracted
alveolar bone after injection of recombinant human bone morphogenetic
protein-2. J Periodontol. 2015;86(9):1078-1086.
49. Breik O, Tivey D, Umapathysivam K, Anderson P. Mandibular distraction
osteogenesis for the management of upper airway obstruction in children
with micrognathia: A systematic review. Int J Oral Maxillofac Surg. 2016;45
(6):769-782.
50. Breik O, Umapathysivam K, Tivey D, Anderson P. Feeding and reflux in
children after mandibular distraction osteogenesis for micrognathia: A
systematic review. Int J Pediatr Otorhinolaryngol. 2016;85:128-135.
51. Momeni A, Januszyk M, Wan DC. Is distraction osteogenesis of the
irradiated craniofacial skeleton contraindicated? J Craniofac Surg. 2017;28
(5):1236-1241.
09/23/2019
Page 18 of 18
Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administer ing 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 aff iliates. 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.
Copyright © 2001-2019 Aetna Inc.
http://www.aetna.com/cpb/medical/data/500_599/0549.html 09/23/2019
AETNA BETTER HEALTH® OF PENNSYLVANIA
Amendment to Aetna Clinical Policy Bulletin Number: 0549 Distraction
Osteogenesis for Craniofacial Defects
There are no amendments for Medicaid.
www.aetnabetterhealth.com/pennsylvania annual 10/01/2019