![]() | Medical Policy |
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Description/Scope |
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This document addresses the use of three-dimensional (3-D) and four-dimensional (4-D) fetal ultrasound in maternity care and does not apply to ultrasound performed for non-pregnancy related conditions. Fetal ultrasound is a test performed during pregnancy, either to assess the gestational age or to evaluate fetal size, position, heartbeat, congenital malformations, suspected multiple fetuses or placental abnormalities. Two-dimensional (2-D) ultrasound is most commonly used. The 3-D and 4-D ultrasounds create computer-generated images viewed on a video monitor that provide more detail and almost life-like images of the fetus.
Note: Please see the following related document for additional information:
Position Statement |
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Investigational and Not Medically Necessary:
The use of 3-D or 4-D fetal ultrasound is considered investigational and not medically necessary in all cases.
Rationale |
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Although 3-D fetal ultrasound can produce more "realistic" and recognizable images than conventional 2-D ultrasound, the clinical significance of this remains unclear. The perceived superiority of 3-D ultrasound for a number of fetal abnormalities has not been definitively established, and 2-D imaging remains the principal diagnostic modality (Meyer-Wittkopf, 2003; Schellpefeffer, 2013; Voss, 2015).
Michailidis and colleagues (2002) noted that real-time 2-D ultrasound is the best way to examine fetal anatomy in the first trimester. A comparison of the diagnostic capabilities of 2-D and 3-D sonography for the study of conjoined twins revealed that 2-D sonography provided more definitive and specific information about shared organs and 2-D sonography is the primary modality for diagnosing and evaluating conjoined twins.
Pretorius (2001) reports that although 3-D ultrasound may be useful in evaluating abdominal abnormalities such as bowel obstruction, gastroschisis, omphalocele, and wall defects secondary to bands, the advantages compared with 2-D ultrasound have not been identified. While 3-D ultrasound may be superior to 2-D ultrasound in demonstrating cleft lip or palate and for accurate identification of the level of spine involvement by a neural tube defect, the significance of this in terms of improved clinical outcomes has not been demonstrated. Dyson and colleagues (2000) performed 3-D ultrasound imaging on 63 women in whom a 2-D study suggested an anomaly and 3-D imaging was thought likely to provide useful information. Obstetrical management was said to "change" in three women (5%) based on the additional information provided by the 3-D study. Two of these "changes" referred to the women's decision regarding termination of the pregnancy because of better clarification of a cleft lip and palate and in the third, where the level of a neural tube defect was better identified, there is no information as to management decisions taken.
Several authors (Timor-Tritsch, 2000; Bubb, 2004) have noted that it is difficult to evaluate the net effect of 3-D ultrasound on obstetric practice and on outcome. They also note that no comparative studies are available to support the superiority of 3-D ultrasound versus 2-D for evaluation of the central nervous system. Although the uterine cervix in pregnancy has become a focus of 3-D ultrasound, insufficient data is available to fully assess the additional clinical advantage of 3-D ultrasound in this context.
While fetal ultrasound may be viewed as a benign imaging format, Whitworth and colleagues (2010) point out that there is still debate concerning the long-term outcomes associated with fetal exposure to ultrasound, particularly when associated with multiple exposures or the use of color Doppler in the first trimester.
Schellpfeffer (2013) states the following about 3-D/4-D fetal ultrasound and souvenir or keepsake fetal imaging:
Unfortunately, 3-D/4-D technology has also spurned a huge industry of non-medical imaging of fetuses, so-called "souvenir imaging of the fetus" or "keepsake fetal imaging." This type of imaging is not condoned by any of the national or international ultrasound organizations for a number of reasons, but continues to flourish throughout the world.
The American Congress of Obstetricians and Gynecologists (ACOG) and the American Institute of Ultrasound in Medicine guideline on ultrasonography in pregnancy (December 2016) include the following:
The technical advantages of three-dimensional ultrasonography include its ability to acquire and manipulate a large 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, fetal tumors, and skeletal malformations for which three-dimensional ultrasonography may be helpful in diagnosis as an adjunct to, but not a replacement for two-dimensional ultrasonography.
In 2012, the United States Food and Drug Administration (FDA) noted the following regarding fetal ultrasound:
Because of the particular concern for fetal exposures, national and international organizations have advocated prudent use of ultrasound imaging. Furthermore, the use of diagnostic ultrasound for non-medical purposes such as fetal keepsake videos has been discouraged.
The Institute for Clinical Systems Improvement (ICSI) (2012) guideline on prenatal care states that 3-D/4-D ultrasound is considered investigational and is not routinely recommended at this time.
In summary, although 3-D and 4-D ultrasound may provide improved imaging for certain areas of fetal anatomy and abnormalities, it has not been demonstrated in clinical studies to result in improved health outcomes when compared to conventional 2-D ultrasound imaging.
Background/Overview |
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3-D or volume ultrasonography acquires a volume (rather than slice) of ultrasonographic data allowing one to see width, height and depth of images. The images can be captured and saved for later review. This stored data can be reformatted and analyzed in numerous ways. For example, surface rendering involves projecting the surface of a structure onto the screen, which allows curved structures, such as the fetal face, to be viewed in a single image that appears photographic in nature.
Suggested advantages of 3-D ultrasound compared to 2-D ultrasound in obstetrics include the following:
Limitations of 3-D ultrasound of the fetus are as follows:
4-D ultrasonography refers to real-time visualization of 3-D images. The time vector (the fourth dimension) makes it possible to perceive a rapid update of the successive individual images displayed on the monitor at very short intervals which creates the impression of a real time. Fetal movements can be seen, providing a "live action" view. Proposed uses include study of fetal movement, fetal heart, and fetal behavioral states. 4-D ultrasonography is also known as dynamic 3-D sonography.
Definitions |
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Ultrasound:A screening or diagnostic technique in which very high frequency sound waves are passed into the body, and the reflected echoes are detected and analyzed to build a picture of the internal organs or of a fetus in the uterus.
Coding |
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The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
When services are Investigational and Not Medically Necessary:
For the following procedure and diagnosis codes, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.
CPT | |
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76376 | 3D rendering with interpretation and reporting of computed tomography, magnetic resonance imaging, ultrasound, or other tomographic modality with image postprocessing under concurrent supervision; not requiring image postprocessing on an independent workstation |
76377 | 3D rendering with interpretation and reporting of computed tomography, magnetic resonance imaging, ultrasound, or other tomographic modality with image postprocessing under concurrent supervision; requiring image postprocessing on an independent workstation |
76499 | Unlisted diagnostic radiographic procedure [when specified as 4-D rendering of fetal ultrasound] |
ICD-10 Diagnosis | |
O09.00-O09.93 | Supervision of high-risk pregnancy |
O10.011-O16.9 | Edema, proteinuria and hypertensive disorders in pregnancy, childbirth and the puerperium |
O20.0-O29.93 | Other maternal disorders predominantly related to pregnancy |
O30.001-O30.93 | Multiple gestation |
O31.00X0-O31.8X99 | Complications specific to multiple gestation |
O32.0XX0-O32.9XX9 | Maternal care for malpresentation of fetus |
O33.0-O33.9 | Maternal care for disproportion |
O34.00-O34.93 | Maternal care for abnormality of pelvic organs |
O35.0XX0-O35.9XX9 | Maternal care for known or suspected fetal abnormality and damage |
O36.0110-O36.93X9 | Maternal care for other fetal problems |
O40.1XX0-O40.9XX9 | Polyhydramnios |
O41.00X0-O41.93X9 | Other disorders of amniotic fluid and membranes |
Z03.71-Z03.79 | Encounter for suspected maternal and fetal conditions ruled out |
Z34.00-Z34.93 | Encounter for supervision of normal pregnancy |
Z36 | Encounter for antenatal screening of mother |
References |
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Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
Index |
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3-D Ultrasound in Obstetrics
4-D Ultrasound in Obstetrics
Dynamic Three-Dimensional Fetal Sonography
Four-Dimensional Ultrasound in Obstetrics
HD Live or HDlive Ultrasound
Three-Dimensional Ultrasound in Obstetrics
Document History |
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Status | Date | Action |
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Reviewed | 05/04/2017 | Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Rationale and Reference sections. |
Reviewed | 05/05/2016 | MPTAC review. Updated Description, Rationale, Background, Index and Reference sections. Removed ICD-9 codes from Coding section. |
Reviewed | 05/07/2015 | MPTAC review. Description, Rationale and Reference sections updated. Websites section removed. |
Reviewed | 05/15/2014 | MPTAC review. Description, Rationale, Background, Definition, Reference and Index sections updated. |
Reviewed | 05/09/2013 | MPTAC review. Description, Rationale and Reference sections updated. |
Reviewed | 05/10/2012 | MPTAC review. Rationale and References updated. |
Reviewed | 05/19/2011 | MPTAC review. References updated. |
10/01/2010 | Updated Coding section with 10/01/2010 ICD-9 changes. | |
Reviewed | 05/13/2010 | MPTAC review. References updated. |
Reviewed | 05/21/2009 | MPTAC review. References and coding updated. |
Reviewed | 05/15/2008 | MPTAC review. References updated. |
02/21/2008 | The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." This change was approved at the November 29, 2007 MPTAC meeting. | |
Reviewed | 05/17/2007 | MPTAC review. References and coding updated; removed CPT 76375 - deleted 12/31/2005. |
Reviewed | 06/08/2006 | MPTAC review. References updated. |
01/01/2006 | Updated Coding section with 01/01/2006 CPT/HCPCS changes | |
Revised | 07/14/2005 | MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization. |
Pre-Merger Organizations | Last Review Date | Document Number | Title |
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Anthem, Inc. | 04/27/2004 | RAD.00013 | Nuchal Translucency and Use of 3-D and 4-D Ultrasound in Maternity Care |
WellPoint Health Networks, Inc. | 09/23/2004 | 4.09.04 | Three-Dimensional Ultrasound in Obstetrics |