National Medical Policy

Transcription

1 National Medical Policy Subject: Policy Number: Three Dimensional Obstetric Ultrasound NMP30 Effective Date*: September 2003 Updated: January 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), citations(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 Local Coverage Determination (LCD)* Article (Local)* Other X 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) 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. Three Dimensional Obstetric Ultrasound Jan 16 1

2 If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Current Policy Statement Health Net, Inc. considers three dimensional (3D) ultrasound investigational. Although 3D ultrasound is technically a promising imaging tool for any number of diseases or conditions, the role of this technology in reaching the correct diagnosis has not been clearly translated into clinical improvement of patient outcome. In addition, the most updated recommendation per ACOG (2009, reaffirmed 2014) states, Three-dimensional ultrasound appears to have been useful in research on fetal embryology. However, there is no evidence that the results of 3D ultrasound alter clinical management over standard 2D ultrasound such that clinical outcomes are improved. Whether 3D ultrasound will provide unique, clinically relevant information remains to be seen. Studies on 3-D Obstetrical Ultrasound continue to be done. 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 V22.0-V22.2 V23.0-V23.9 ICD-10 Codes Z34 Z34.0-Z34.03 OØ9 Normal pregnancy Supervision of high-risk pregnancy Encounter for supervision of normal pregnancy Encounter for supervision of other normal pregnancy Supervision of high-risk pregnancy CPT Codes D rendering with interpretation and reporting of computed tomography, magnetic resonance imaging, ultrasound, or other tomographic modality postprocessing under concurrent supervision; not requiring image postprocessing on an independent workstation D rendering with interpretation and reporting of computed tomography, magnetic resonance imaging, ultrasound, or other tomographic modality postprocessing under concurrent supervision; requiring image post processing on an independent workstation HCPCS Codes N/A Three Dimensional Obstetric Ultrasound Jan 16 2

3 Scientific Rationale Update January 2014 The ACOG Practice Bulletin on Ultrasonography in Pregnancy, Number 101, was reaffirmed in 2014, and remains the same. It continues to note that Until clinical evidence shows a clear advantage to conventional two-dimensional ultrasonography, three-dimensional ultrasonography is not considered a required modality at this time. Scientific Rationale Update January 2013 Although not a new technique, the indications for a three dimensional ultrasound s use have not been well-defined. Three-dimensional ultrasound appears to be highly promising in the clinical setting of fetal growth restriction (FGR) because it appears to provide more precise information regarding structural abnormality, organ volumetry, estimated fetal weight (EFW) and oligohydramnios than standard twodimensional techniques. However, this modality is not widely available and has not been adequately assessed in large or controlled studies. In addition, threedimensional ultrasound does not appear to improve the sonographic evaluation. Where available, magnetic resonance imaging and/or three dimensional ultrasonography are the best noninvasive means of diagnosing uterine anomalies. However, these two modalities have not been evaluated in comparative studies. Per ACOG Practice Bulletin on Ultrasonography in Pregnancy, Number 101, February 2009, Reaffirmed 2011, the following is noted: Three-dimensional ultrasonography provides an advance in imaging technology. With three-dimensional ultrasonography, the volume of a target anatomic region can be acquired. The acquired volume then can be displayed in three orthogonal twodimensional planes, representing the sagittal, transverse, and coronal planes of a reference two-dimensional image within the volume. The volume also can be displayed in its rendered format, which depicts the topographic anatomy of the acquired volume. The technical advantages of three-dimensional ultrasonography include its ability to acquire and manipulate an infinite number of planes and to display ultrasound planes traditionally inaccessible by two-dimensional ultrasonography. Despite these technical advantages, proof of a clinical advantage of three-dimensional ultrasonography in prenatal diagnosis in general is still lacking. Potential areas of promise include fetal facial anomalies, neural tube defects, and skeletal malformations where three-dimensional ultrasonography may be helpful in diagnosis as an adjunct to, but not a replacement for, two-dimensional ultrasonography. Until clinical evidence shows a clear advantage to conventional two-dimensional ultrasonography, three-dimensional ultrasonography is not considered a required modality at this time. Scientific Rationale Update January 2012 Rizzo et al. (2011) prenatal diagnosis of central nervous system (CNS) anomalies by 2-dimensional sonography is challenging because of difficulties in obtaining complete visualization of the fetal brain during routine examinations, which is necessary for identification of its axial, coronal, and sagittal planes. Three-dimensional (3D) sonography has been introduced as a tool for studying the fetal CNS because of its ability to facilitate examinations of the fetal brain. The objective of this study was to determine inter-center agreement in diagnosing CNS defects by review of 3D volume data sets. This study included 11 centers with expertise in 3D fetal neurosonography. A total of 217 fetuses with and without confirmed CNS defects were scanned after 18 Three Dimensional Obstetric Ultrasound Jan 16 3

4 weeks' gestation, and their volume data sets were uploaded onto a centralized file transfer protocol server and later analyzed by all of the centers. Intercenter agreement was determined using aκstatistic for multiple raters. All volumes were made anonymous and sent to the centers for blinded analysis with the exception of the data sets they had themselves previously uploaded. For identification of fetuses with CNS defects, the sensitivity, specificity, positive and negative predictive values, and false-positive and -negative rates were 93.3%, 96.5%, 96.5%, 93.3%, 3.5%, and 6.7%, respectively. No differences were found in the efficacy of the diagnostic indices according to either the route of acquisition (transabdominal or trans-vaginal) or the gestational age at diagnosis (18-24 or>24 weeks). Intercenter agreement was excellent (κ= 0.92; 95% confidence interval, ). Among centers with technical expertise, remote review of 3D sonographic volumes of the fetal CNS resulted in an accurate and reliable method for diagnosis of fetal brain malformations. Three-dimensional ultrasound appears to have been useful in research on fetal embryology. However, there is no evidence that the results of 3D ultrasound alters clinical management over standard 2D ultrasound such that clinical outcomes are improved. Whether 3D ultrasound will provide unique, clinically relevant information remains to be seen. In addition, as noted below, the most updated recommendation per ACOG (2009) states, Three-dimensional ultrasound appears to have been useful in research on fetal embryology. However, there is no evidence that the results of 3D ultrasound alters clinical management over standard 2D ultrasound such that clinical outcomes are improved. Whether 3D ultrasound will provide unique, clinically relevant information remains to be seen. Scientific Rationale Update July 2009 Ultrasonography in pregnancy should be performed only when there is a valid medical indication. The American College of Obstetrics and Gynecology (ACOG) [2009] stated, "The use of either two-dimensional or three-dimensional ultrasonography only to view the fetus, obtain a picture of the fetus, or determine the fetal sex without a medical indication is inappropriate and contrary to responsible medical practice." Current guidelines on ultrasonography in pregnancy from the American College of Obstetricians and Gynecologists (2009) state: "The technical advantages of 3- dimensional ultrasonography include its ability to acquire and manipulate an infinite number of planes and to display ultrasound planes traditionally inaccessible by 2- dimensional ultrasonography. Despite these technical advantages, proof of a clinical advantage of 3-dimensional ultrasonography in prenatal diagnosis in general is still lacking. Potential areas of promise include fetal facial anomalies, neural tube defects, and skeletal malformations where 3-dimensional ultrasonography may be helpful in diagnosis as an adjunct to, but not a replacement for, 2-dimensional ultrasonography. Until clinical evidence shows a clear advantage to conventional 2- dimensional ultrasonography, 3-dimensional ultrasonography is not considered a required modality at this time." Scientific Rationale Update August 2007 According to the American College of Obstetrics and Gynecology (ACOG) practice bulletin, Ultrasonography in Pregnancy, Proof of a clear advantage of 3-dimensional ultrasonography in prenatal diagnosis is not present when compared with 2- Three Dimensional Obstetric Ultrasound Jan 16 4

5 dimensional imaging by an experienced clinician. Therefore, 3-dimensional imaging is not considered a required modality at this time. Wang et al. (2007) investigated the prenatal diagnostic accuracy of two-dimensional ultrasound (2DUS) alone versus 2DUS in conjunction with three-dimensional ultrasonography (3DUS) including orthogonal display (OGD) and three-dimensional extended imaging for cleft lip and primary palate. Fetuses being suspected of having a facial cleft by previous ultrasound examination or family history were examined sequentially with 2DUS and then 3DUS. Of a total of 30 infants, 22 had cleft lip and nine also had cleft palate at birth. The use of 2DUS with or without 3DUS correctly identified all cases of cleft lips prenatally. However, the use of 2DUS in conjunction with 3DUS correctly identified more cleft primary palate than 2DUS alone (88.9% vs 22.2%). Cleft primary palate was well demonstrated in both the multi-slice view (MSV) and OGD modes. In one case, a cleft palate was shown in the MSV mode but not in the Oblique view(obv) mode. All the unaffected fetuses were reported as no cleft palate with the use of MSV mode. The investigator concluded the combined approach of 2DUS and 3DUS with both OGD and MSV modes significantly improved the prenatal detection rate for a cleft palate compared with 2DUS alone (88.9% vs 22.2%) without decreasing the specificity. Goncalves et al. (2005) performed a review of the published literature on 3- dimensional ultrasound (3DUS) and 4-dimensional ultrasound (4DUS) in obstetrics to determine whether 3DUS adds diagnostic information to what is currently provided by 2-dimensional ultrasound (2DUS) and, if so, in what areas. A PubMed search found 525 articles reporting on the use of 3DUS or 4DUS in obstetrics related to the subject of the review. Articles describing technical developments, clinical studies, reviews, editorials, and studies on fetal behavior or maternal-fetal bonding were reviewed. The reviewers found that three-dimensional ultrasound provides additional diagnostic information for the diagnosis of facial anomalies, especially facial clefts. They also found evidence that 3DUS provides additional diagnostic information in neural tube defects and skeletal malformations. Large studies comparing 2DUS and 3DUS for the diagnosis of congenital anomalies have not provided conclusive results. They noted preliminary evidence suggests that sonographic tomography may decrease the examination time of the obstetric ultrasound examination, with minimal impact on the visualization rates of anatomic structures. The reviewers concluded three-dimensional ultrasound provides additional diagnostic information for the diagnosis of facial anomalies, evaluation of neural tube defects, and skeletal malformations. Additional research is needed to determine the clinical role of 3DUS and 4DUS for the diagnosis of congenital heart disease and central nervous system anomalies. Future studies should determine whether the information contained in the volume data set, by itself, is sufficient to evaluate fetal biometric measurements and diagnose congenital anomalies. In a prospective randomized pilot study among low risk women with singleton fetuses in the second and third trimester, Lapaire et al. (2007) assessed the impact of three-dimensional (3D) versus two-dimensional (2D) ultrasound (US) on maternal-fetal bonding. Sixty women were randomized to either 2D US or 3D US and the effects were recorded with standardized questionnaires. Although the quality of 2D US, assessed by the examinator, was superior to 3D US, maternal recognition was higher with 3-D US. With 2D US, nulliparous patients had significantly more difficulties visualizing the fetus, than multiparous. However, the maternal preference of 3D US had no significant impact on maternal-fetal bonding. The investigator concluded ultrasound had no significant effect on maternal-fetal Three Dimensional Obstetric Ultrasound Jan 16 5

6 bonding. Three-dimensional images may facilitate recognition of the fetus, but 3D US did not have higher impact on maternal-fetal bonding. This finding may be a reason not to consider 3D ultrasound for routine scanning According to the American Institute of Ultrasound in Medicine, Currently, twodimensional (2D) gray-scale real-time sonography is the primary method of medically indicated anatomic imaging with ultrasound. The term three-dimensional (3D) ultrasound refers to the acquisition of imaging data from a volume of tissue. This volumetric data can be displayed as slabs of varying thickness, multiplanar reconstruction or as a rendered image. The 2D display remains the primary method of image presentation regardless of the method of acquisition. While 3D ultrasound may be helpful in diagnosis, it is currently an adjunct to, but not a replacement for 2D ultrasound. As with any developing technology, its clinical value may improve and its diagnostic role will be periodically re-evaluated Scientific Rationale Two-dimensional (2D) sonography is the traditional way we have been using ultrasound in all areas of medicine to display normal and abnormal anatomy. More recently, three dimensional (3D) ultrasound has emerged as the novel sonographic method that can enhance diagnostic capability over standard 2D ultrasound. Even though this ability to display a 3D image may become one of the most powerful recent advances in sonography, critics of the technique feel that three-dimensional ultrasound has been over rated and that the training afforded to 2D sonographers enables them to perform 3D reconstructions in their mind s eye, with similar results as those described with actual 3D displays. Numerous studies conducted on the use of 3D ultrasound demonstrate that this noninvasive method is technically feasible and suggest potential benefits for some of the proposed indications. However, there is a paucity of high quality direct evidence demonstrating the impact on diagnostic thinking and therapeutic decision-making. In addition, the techniques of acquiring the capabilities to perform 3D ultrasound, appropriate patient selection criteria, and interpreting the results are not well standardized. There is no adequate evidence that 3D ultrasound can prevent or retard the development and/or progression of the long-term complications of any diseases or conditions; nor is there evidence that 3D ultrasound can prolong the life of patients. Prospective clinical studies are needed to determine the clinical value of 3D ultrasound over standard 2D ultrasound in the assessment of patients. The following enumerates the potential uses of 3D ultrasound. 2D ultrasound is used routinely in obstetrics and gynecology. Today, nearly all pregnant women undergo at least one ultrasound during her pregnancy. These ultrasounds are designed to assess fetal well-being and gestational age. The traditional 2D ultrasound uses high-frequency sound waves to bounce off the surfaces and structures of the fetus producing echos, which can be assessed on the video screen. Although clinicians are generally adept at using this information, the image remains distorted and vague to say the least. In the last couple of years, the creation of 3D ultrasound for use in obstetrics has come to fruition. 3D ultrasound is done the same way as the traditional ultrasound with the addition of software to enhance the image and produce a three dimensional image. A further benefit of 3D ultrasonography is that it can provide caregivers in primary facilities with less experience and expertise in ultrasonography an opportunity for Three Dimensional Obstetric Ultrasound Jan 16 6

7 remote referrals and consultations for complicated cases. 3D images can be digitally stored with the complete data set conveyed by an Internet connection from the primary caregiver to experts across the world. This allows the consultant to have an entirety of imaging information required to make a diagnosis. Furthermore, the online transmission enables feedback and interaction with a specialist at the time of or immediately after an ultrasonographic examination, thus limiting the need for further referrals. Telemedicine has only begun to demonstrate itself as a useful tool and 3D ultrasonography is ideally suited to promote this upcoming aspect of care in medicine. Imaging physicians already use 3D volume imaging techniques in CT and MR and are likely to become comfortable working in a volume or multiplanar environment in ultrasound as well. One of the most consistently used justifications for the use of obstetric ultrasonography is that accurate diagnosis of fetal malformations before delivery can provide both health care providers and parents a number of management options that before the advent of this technique were unavailable. However, reports from the Routine Antenatal Diagnostic Imaging with Ultrasound (RADIUS) trial have challenged this particular tenet. These researchers indicated that screening with ultrasonography did not significantly influence the management or outcome of pregnancies complicated by congenital malformations. Its role in gynecology has not been clearly established. It may be indicated only when equivalent information resulting in clinical improvement in fetal and maternal outcome cannot be obtained by another standard test (2D ultrasound, magnetic resonance imaging, CT Scan, angiography, etc.). 3D ultrasound may be useful in differentiating between a septate and a bicornuate uterus or to determine the exact location of a malpositioned intrauterine device (IUD). The fetal brain is one of the areas where 3D ultrasound has been most helpful. Surface rendering of the skull is instrumental in evaluating the status of cranial sutures and determining whether or not an abnormal head shape is secondary to craniosynostosis. Three-dimensional surface rendering is also particularly helpful in the evaluation of other surfaces of the fetal head and face, such as the fetal ears, which are not normally focused upon using standard 2D cross sectional imaging. Surface imaging of the fetal face using 3D sonography has probably been the most notable area of study, not only in the ultrasound literature but also in the lay press where patients have been able to see the face of their unborn baby more clearly than ever before. Everyone agrees that 3D sonography of the face is not a screening technique but an adjunct to a good 2D scan. To date, it is not yet possible to detect dysmorphologic features using 3D surface rendering although it is hoped that as the techniques improve, the dysmorphologic fetal facies will be detectable. It is the evaluation of the fetal cleft lip and palate that has gotten the most attention in the literature. Three-dimensional imaging of the normal and abnormal extremities has been studied extensively using both multi-planar reconstruction and surface rendering. Several studies have described fetal skeletal dysphasia s viewed with 3D ultrasound, where practitioners found that 3D provided additional information on affected fetuses as compared to 2D. On the other hand, other investigators have not been as enthusiastic about the role of 3D for fetuses with these malformations, thus requiring further investigation to come to a consensus. Opinions that 3D provides diagnostic details not available using two-dimensional ultrasound remains somewhat anecdotal and restricted to small case series. It is clear from several reports that although 3D made additional diagnostic information possible, the technique was not necessary for Three Dimensional Obstetric Ultrasound Jan 16 7

8 definitive diagnosis of spina bifida. 3D ultrasounds, however, did display the level of the defect more accurately than with conventional scanning. Scoliosis resulting from vertebral body anomalies was also recognized more easily on a single 3D rendered image whereas multiple standard 2D images were needed to make the same diagnosis. Evaluation of the fetal heart is an intense area of research, however, evaluation of the heart in 3D can be tricky and requires Doppler gated capabilities. There is still much work to be done to bring 3D imaging of the heart up to a standard currently possible using 2D operated by trained personnel. Other areas of investigation include fetal genital scanning where the fetal perineum can be visualized, although to date, the performance of 3D technology is reportedly not as good in evaluating fetal genitals than is 2D imaging alone. By far, the most important function of first trimester 3D scanning may become the evaluation of the nuchal translucency measurement of fetuses weeks. Another important clinical application of 3D is volume measurements calculations based on 3D volume acquisition. Current literature has demonstrated the accuracy of volume based 3D ultrasonography measurement on follicle aspiration performed using transvaginal needle guided technique. Other practitioners have also shown that 3D sonographic methods provide accurate measurements of serial fetal lung volume measurements for the prenatal detection of pulmonary hypoplasia, the fetal thoracolumbar spine as well as kidneys, brain, liver and heart. Additionally, at the current time fetal cardiac malformations, which remain the least identifiable of major malformations, have thus far had only limited benefit from this 3D technique because of motion artifact. Hypothetically, if the 3D examination demonstrates an abnormality not seen with 2D imaging, then clinical management of patients may be altered. Craniofacial abnormalities that have been identified with 3D ultrasound include cleft lip or palate, micrognathia, midface hypoplasia, facial dysmorphia, intracranial abnormalities, hypotelorism, holoprosencephaly and skull defects in the second- and third-trimester. In expert hands, a 2D ultrasound is sufficient and 3D ultrasound does not add any valuable diagnostic information. Three-dimensional ultrasound may facilitate the understanding of the lesion by the parents and facilitate communication with the plastic surgeons. However, these potential benefits need to be carefully weighed against the costs of the ultrasound instrumentation, increased examination time and training of personnel. Computer technology and software advanced sufficiently in the past five years to allow real-time reconstruction of 3D images and their visualization and manipulation on inexpensive desktop computers. Nevertheless, ultrasound imaging still suffers from several disadvantages related to its 2 dimensional nature, which 3D imaging attempts to address. Despite decades of exploration, it is only in the past five years that 3D imaging in ultrasound moved out of the research laboratory to become a commercial product for routine clinical use. A major advantage of 2D ultrasound is its flexibility, allowing the sonologist to manipulate the transducer and view the desired anatomical section. Paradoxically, this advantage is one of its weaknesses that 3D imaging attempts to address. Using conventional ultrasonography, only one thin slice of the patient can be viewed at any time, and the location of this image plane is controlled by physically manipulating the transducer orientation. It is difficult to place the 2D image plane at a particular Three Dimensional Obstetric Ultrasound Jan 16 8

9 location within an organ, and even more difficult to find the same location again later. Thus, 2D US is not optimal for planning or monitoring therapeutic procedures, or for performing quantitative prospective or follow-up studies. Consequently, the diagnostician or physician must mentally integrate many 2D images to form an impression of the 3D anatomy and pathology. This process is time-consuming and inefficient, but more important, variable and subjective. Most 3D ultrasound systems have used conventional ultrasound machines with 1D arrays to collect multiple 2D images and reconstruct them into 3D images. Two important criteria must be met to avoid inaccuracies or distortions: (1) the relative position and angulation of the acquired 2D images must be accurately known so that the reconstructed 3D image is not distorted; and (2) the image acquisition must be carried out rapidly and/or gated to avoid artifacts caused by respiratory, cardiac and involuntary motion. Although 3D ultrasound is a promising tool to image many anatomical sites in the fetus and the adult female, its clinical benefits are still being researched. There is no question that the pictures far exceed the surface detail of the traditional grainy, black-and-white, 2D ultrasound images. However, at the present time 3D ultrasound is rarely critical in reaching the correct diagnosis and it may take a few more years before the place of 3D ultrasound as a diagnostic tool can be defined more precisely. There are scant outcome studies and much research is needed as the 3D technology is further developed. Review History September 9, 2003 Medical Advisory Council July 2006 Update no revisions August 2007 Update no revisions July 2009 Update - no Revisions. Codes reviewed. April 2011 Update. Added Medicare Table. No revisions. January 2012 Update - no revisions January 2013 Update no revisions. Codes updated. January 2014 Update no revisions. Codes updated. January 2015 Update no revisions. Codes updated. January 2016 Update - This policy is based on the following evidence-based guidelines: 1. American College of Obstetrics and Gynecology. (ACOG) Practice Bulletin. Number 58. Clinical Management Guidelines for Obstetrician-Gynecologist. Ultrasonography in Pregnancy. December American Institute of Ultrasound in Medicine. 3D Technology. Nov Hayes Medical Technology Directory. Three-Dimensional and Four-Dimensional Ultrasound for Extrafetal and Maternal Structures in Pregnancy. July Updated August 13, Archived August 13, Hayes Medical Technology Directory. Three-Dimensional and Four-Dimensional Ultrasound for Diagnosis of Fetal Head Abnormalities. Nov Updated February 8, Updated August 13, Archived August 13, Hayes Medical Technology Directory. Three-Dimensional and Four-Dimensional Ultrasound for High-Risk Pregnancies and Routine Screening. Nov Updated November 17, Archived December 9, American College of Obstetricians and Gynecologists (ACOG), Committee on Practice Bulletins. Obstetrics. Ultrasonography in pregnancy. ACOG Practice. Three Dimensional Obstetric Ultrasound Jan 16 9

10 Bulletin No Washington, DC: ACOG; February Reaffirmed in Reaffirmed in References Update January Pavlova E, Ivanov S. Three- and four-dimensional (3D/4D) ultrasound in obstetric practice: review. Akush Ginekol (Sofiia). 2014;53(1): Tanaka Y, Mimura K, Kanagawa T, et al. Three-dimensional sonography in the differential diagnosis of interstitial, angular, and intrauterine pregnancies in a septate uterus. J Ultrasound Med Nov;33(11): Tonni G, Martins WP, Guimarães Filho H, Araujo Júnior E. Role of 3-D ultrasound in clinical obstetric practice: evolution over 20 years. Ultrasound Med Biol May;41(5): References Update January Gindes L, Weissmann-Brenner A, Zajicek M, et al. Three-dimensional ultrasound demonstration of the fetal palate in high-risk patients: The accuracy of prenatal visualization. Prenat Diagn. 2013;33(5): Tonni G, Grisolia G, Sepulveda W. Second trimester fetal neurosonography: Reconstructing cerebral midline anatomy and anomalies using a novel threedimensional ultrasound technique. Prenat Diagn. 2014;34(1): References Update January Mehta TS. Ultrasonography of pregnancy of unknown location. UpToDate. January 22, Connolly A, Ryan DH, Stuebe AM, Wolfe HM. Reevaluation of discriminatory and threshold levels for serum β-hcg in early pregnancy. Obstet Gynecol 2013; 121:65. References Update January Divon MY. Diagnosis of fetal growth restriction. UpToDate. October 1, Gabbe: Obstetrics: Normal and Problem Pregnancies, 6th ed Saunders, An Imprint of Elsevier. Müllerian Fusion Defects. 3. Iverson RE, DeCherney AH, Laufer MR. Clinical manifestations and diagnosis of congenital anomalies of the uterus. UpToDate. April 22, Merz E. 3D/4D ultrasound in prenatal diagnosis: is it time for routine use? Clin Obstet Gynecol. 01-MAR-2012; 55(1): Shipp TD. Ultrasound examination in obstetrics and gynecology. UpToDate. July 9, References Update January Alfirevic Z, Stampalija T, Gyte GM. Fetal and umbilical Doppler ultrasound in normal pregnancy. Cochrane Database Syst Rev Alfirevic Z, Stampalija T, Gyte GM. Fetal and umbilical Doppler ultrasound in high-risk pregnancies. Cochrane Database Syst Rev Jones NW, Raine-Fenning N, Mousa H, et al. Evaluation of the intraobserver and interobserver reliability of data acquisition for three-dimensional power Doppler angiography of the whole placenta at 12 weeks gestation. Ultrasound Med Biol. 2010;36(9): Rizzo G, Abuhamad AZ, Benacerraf BR, et al. Collaborative study on 3- dimensional sonography for the prenatal diagnosis of central nervous system defects. J Ultrasound Med 2011; 30:1003. Three Dimensional Obstetric Ultrasound Jan 16 10

11 5. Shipp TD. Ultrasound examination in obstetrics and gynecology. UpToDate. August Updated June 5, Stampalija T, Gyte GM, Alfirevic Z. Utero-placental Doppler ultrasound for improving pregnancy outcome. Cochrane Database Syst Rev Whitworth M, Bricker L, Neilson JP, et al. Ultrasound for fetal assessment in early pregnancy. Cochrane Database Syst Rev References Update April Yagel S, Cohen SM, Messing B, Valsky DV. Three-dimensional and fourdimensional ultrasound applications in fetal medicine. Curr Opin Obstet Gynecol. 2009;21(2): Chen M, Wang HF, Leung TY, et al. First trimester measurements of nasal bone length using three-dimensional ultrasound. Prenat Diagn. 2009;29(8): References Update July American College of Obstetricians and Gynecologists (ACOG), Committee on Practice Bulletins. Obstetrics. Ultrasonography in pregnancy. ACOG Practice Bulletin No. 98. Washington, DC: ACOG; October Clinical Practice Obstetrics Committee; Maternal Fetal Medicine Committee, Delaney M, Roggensack A, Leduc DC, et al. Guidelines for the management of pregnancy at 41+0 to 42+0 weeks. J Obstet Gynaecol Can. 2008;30(9): Chen M, Lee CP, Lam YH, et al. Comparison of nuchal and detailed morphology ultrasound examinations in early pregnancy for fetal structural abnormality screening: A randomized controlled trial. Ultrasound Obstet Gynecol. 2008;31(2): ; discussion 146. References Update August Wang LM, Leung KY, Tang M. Prenatal evaluation of facial clefts by threedimensional extended imaging. Prenat Diagn May 29; 2. Lapaire O, Alder J, Peukert R, Holzgreve W, Tercanli S. Two- versus threedimensional ultrasound in the second and third trimester of pregnancy: impact on recognition and maternal-fetal bonding. A prospective pilot study. Arch Gynecol Obstet Apr Goncalves LF, Lee W, Espinoza J, Romero R. Three- and 4-dimensional ultrasound in obstetric practice: does it help? J Ultrasound Med Dec;24(12): Towner D, Boe N, Lou K, Gilbert WM. Cervical length measurements in pregnancy are longer when measured with three-dimensional transvaginal ultrasound. J Matern Fetal Neonatal Med Sep;16(3): References 1. Salim R, Woelfer B, Backos M, et al. Reproducibility of three-dimensional ultrasound diagnosis of congenital uterine anomalies. Ultrasound Obstet Gynecol 2003; 21(6): Ghi T. Two-dimensional ultrasound is accurate in the diagnosis of fetal craniofacial malformation. Ultrasound Obstet Gynecol 2002; 19(6): Timor-Tritsch IE, Platt LD. Three-dimensional ultrasound experience in obstetrics. Curr Opin Obstet Gynecol 2002; 14(6): Pooh RK, Pooh K. Transvaginal 3D and Doppler ultrasonography of the fetal brain. Semin Perinatol 2001; 25(1): Kurjak A, Hafner T, Kos M, et al. Three-dimensional sonography in prenatal diagnosis: a luxury or a necessity? J Perinat Med 2000; 28(3): Three Dimensional Obstetric Ultrasound Jan 16 11

12 6. Lai TH, Chang CH, Yu CH, et al. Prenatal diagnosis of alobar holoprosencephaly by two-dimensional and three-dimensional ultrasound. Prenat Diagn 2000; 20(5): Ayida G, Kennedy S, Barlow D, et al. Contrast sonography for uterine cavity assessment: A comparison of conventional two-dimensional with threedimensional transvaginal ultrasound: A pilot study. Fertil Steril 1996; 66: Baba K, Okai T, Kozuma S, et al: Real-time processable three-dimensional US in obstetrics. Radiology 1997; 203: Brandl H, Gritzky A, Haizinger M. Three-dimensional ultrasound: A dedicated system. Eur Radiol 1999; 9(suppl 3):S331, 10. Brunner M, Obruca A, Bauer P, et al. Clinical application of volume estimation based on three-dimensional ultrasonography. Ultrasound Obstet Gynecol 1995; 6: Chang FM, Hsu KF, Ko HC, et al. Fetal heart volume assessment by threedimensional ultrasound. Ultrasound Obstet Gynecol 1997; 9: Chang FM, Hsu KF, Ko HC, et al. Three-dimensional ultrasound assessment of fetal liver volume in normal pregnancy: A comparison of reproducibility with two-dimensional ultrasound and a search for a volume constant. Ultrasound Med Biol 1997; 23: Downey DB, Fenster A. 3-D US: A maturing technology. Ultrasound Quarterly 1998;14: Feichtinger W. Transvaginal three-dimensional imaging. Fertil Steril 1998; 70: Thomas R, Pretorius N, Pretorius DH. Three-dimensional ultrasound imaging. UMB 1998; 24, Gilja OH, Hausken T, Berstad A, et al. Measurements of organ volume by ultrasonography. Proc Inst Mech Eng 1999; 213: Johnson DD, Pretorius DH, Budorick NE, et al. Three-dimesnional ultrasound of the fetal lip and primary palate. Radiology 2000; 217: Jurkovic D, Geipel A, Gruboeck K, et al. Three-dimensional ultrasound for the assessment of uterine anatomy and detection of congenital anomalies: A comparison with HSG and two-dimensional sonography. Ultrasound Obstet Gynecol 1995; 5: Jurkovic D, Gruboeck K, Tailor A, et al. Ultrasound screening for congenital uterine anomalies. Br J Obstet Gynaecol 199; 104: Kupesic S, Kurjak A. Diagnosis and treatment outcome of the septate uterus. Croat Med J 1998; 39:185, 21. Lee A, Eppel W, Sam C, et al. Intrauterine device localization by threedimensional transvaginal sonography. Ultrasound Obstet Gynecol 1997; 10: Lee A, Kratochwil A, Stumpflen I, et al. Fetal lung volume determination by three-dimensional ultrasonography. Am J Obstet Gynecol 1996; 175: Merz E. Three-dimensional transvaginal ultrasound in gynecological diagnosis. Ultrasound Obstet Gynecol 1999; 14: Merz E, Weber G, Bahlmann F, et al. Application of transvaginal and abdominal three-dimensional ultrasound for the detection or exclusion of malformations of the fetal face. Ultrasound Obstet Gynecol 1997; 9: Nelson TR, Pretorius DH. Three-dimensional ultrasound imaging. Ultrasound Med Biol 1998; 24:1243, 26. Platt LD, Santulli T, Carlson DE, et al. Three-dimensional ultrasonography in obstetrics and gynecology: Preliminary experience. Am J Obstet Gynecol 1998; 178: Session DR, Daniel SW, Dumesic DA. Three-dimensional ultrasound in gynecology. Journal of Gynecologic Techniques 1998; 4:125 Three Dimensional Obstetric Ultrasound Jan 16 12

13 28. Shih JC, Shyu MK, Lee CN, et al. Antenatal depiction of the fetal ear with threedimensional ultrasonography. Obstet Gynecol 1998; 91: Fenster A, Downey DB. 3-D ultrasound imaging: A review. IEEE Engineering in Medicine and Biology 1996; 15: Fenster A, Tong S, Sherebrin S, et al. Three-dimensional ultrasound imaging. SPIE 1995; 2432: Rankin RN, Fenster A, Downey DB, et al. Three-dimensional sonographic reconstruction: techniques and diagnostic applications. AJR 1993; 161: Sherebrin S, Fenster A, Rankin R, Spence JD. Freehand three-dimensional ultrasound: implementation and applications. SPIE Physics of Medical Imaging 1996; 2708: Pretorius DH, Nelson TR. Prenatal visualization of cranial sutures and fontanelles with three-dimensional ultrasonography. J Ultrasound Med 13: , Pretorius DH, Nelson TR. Fetal face visualization using three-dimensional ultrasonography. J Ultrasound Med 14: , Nelson TR, Pretorius DH. Three-dimensional ultrasound of fetal surface features. Ultras Obstet Gynecol 1992; 2:166. 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 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. Three Dimensional Obstetric Ultrasound Jan 16 13

14 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 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 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 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.. Three Dimensional Obstetric Ultrasound Jan 16 14