Pending Policies - Radiology
Three-dimensional (3D) and Four-dimensional (4D) Obstetrical Ultrasound
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Three-dimensional (3D) and four-dimensional (4D) obstetrical ultrasound is considered experimental, investigational and/or unproven.
Obstetric ultrasonography is the use of medical ultrasonography in pregnancy, in which sound waves are used to create real-time visual images of the developing embryo or fetus in its mother's uterus (womb).
Three-dimensional (3D) obstetric ultrasound imaging involves taking multiple 2-dimensional (2D) images at various angles and assembling them into a 3D image. 3D imaging is proposed as an alternative to 2D imaging for detecting fetal abnormalities. 3D obstetric ultrasound is also proposed to provide an image to the prospective parents that will increase bonding with the fetus during pregnancy (when used this way, this is often known as a “keepsake” photograph or video). In addition to potential benefits, there are also potential harms associated with 3D obstetric ultrasound including possible damage to the fetus and incidental false-positive findings. Various ultrasound devices have been approved that can work in 3D mode. In four-dimensional (4D) ultrasound, the image is moving.
According to the U.S. Food and Drug Administration (FDA), manufacturers of ultrasound imaging products are responsible for compliance with all applicable requirements of Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1000 through 1005. Numerous ultrasound devices are available for utilization by providers and facilities. FDA product code: ITX.
The policy was created in September 2014 and was based on a search of scientific peer-reviewed literature in the MedLine database. The most recent search of literature was completed through June 2016. The following is a summary of the key literature to date.
Two reviews were identified that systematically searched the literature on the utility of 3-dimensional (3D) ultrasound (US) in obstetric practice and were published in the past 10 years. Both of these reviews searched MedLine but neither conducted pooled analyses of study findings or separately discussed higher-quality studies, i.e., randomized controlled trials or controlled trials in general.
Kurjak et al. searched MedLine through January 31, 2006 and identified a total of 438 articles on 3D or 4-dimensional (4D) US. (1) Of these, 104 were clinical studies, 20 were fetal behavior studies, 4 were maternal-fetal bonding studies and the remainder were technical development studies, volumetric studies, book chapters, case reports, reviews or editorials/opinion pieces. Although the literature search was done systematically, the authors did not systematically evaluate the studies that they found, e.g., report the number of studies they found on each indication or conduct pooled analyses. Instead, they discussed selected studies in the context of potential indications described by the American Institute of Ultrasound in Medicine. The authors concluded, “For the time being, 3D and 4D US are not widely used in perinatal medicine on a routine basis and their roles are still being evaluated in several perinatal areas. However, the new diagnosis tool provides additional information for diagnosis and assessment of facial anomalies, neural tube defects, and skeletal malformations. Additional research is needed to determine the clinical role of 3D and 4D US for the diagnosis of congenital heart disease, CNS anomalies and detection of fetal neuro-developmental damage by assessing abnormal behavior in high-risk fetuses…”
Previously, Goncalves et al. searched MedLine through September 7, 2005. They identified a total of 525 articles on use of 3D or 4D US in obstetrics. (2) The number of studies they categorized as clinical studies was slightly higher than in the review by Kurjak et al., 131 compared with 104. As stated above, the authors did not report the number of randomized or non-randomized controlled trials. Also, as in the Kurjak et al. review, the authors discussed some of the studies they found, but this was not done systematically. The authors concluded, “Three-dimensional ultrasound provides additional diagnostic information for the diagnosis of facial anomalies, especially for the diagnosis of facial clefts. There also seems to be a benefit in the use of 3D US in the diagnostic evaluation of fetuses with neural tube defects and skeletal malformations. Large studies comparing the diagnostic performance of 2D US and 3D US for the diagnosis of congenital anomalies, however, have not provided conclusive results…We believe that additional research is needed regarding the role of 3D US and 4D US in improving the diagnosis of congenital anomalies…”
The most recent review of 3D obstetric US was published in 2012 by Merz and Abramowitz. (3) The authors did not conduct a systematic literature review, so the conclusions can be viewed more as opinions of the authors than as an evidence-based conclusion. The authors summarized their review as follow: “In summary, 3D/4D ultrasound expands the diagnostic possibilities in prenatal diagnosis and provides the operator with additional information compared with 2D ultrasound. This technique is therefore not only ready for routine use, but has already become part of daily routine in prenatal diagnosis in expert or referral centers. However, it should be made clear that there are still no studies comparing 2D and 3D US in centers where practitioners are not 3D experts…”
Practice Guidelines and Position Statements
American College of Obstetricians and Gynecologist (ACOG)
In 2004 (reaffirmed in 2015), the ACOG issued a statement discouraging the non-medical use of 2D or 3D obstetric ultrasonography (e.g., solely to produce a keepsake photograph or video). (4)
In 2009, ACOG issued a statement on US during pregnancy. (5) The statement on 3D US was: “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.”
American Institute of Ultrasound in Medicine (AIUM)
In 2005, the AIUM convened a consensus panel with interest and expertise in 3D obstetric US. (6) The panel concluded: “…3D ultrasound is not yet widely used on a routine basis. It has been shown to be a problem-solving tool in selected circumstances and may well become a part of many obstetric and gynecologic ultrasound examinations in the future.” At least some members of the panel found 3D ultrasound to be helpful in the following areas: (The statement noted that they are not stating that 3D is standard of care in these areas)
1. Facial anomalies (e.g., cleft lip and palate, micrognathia, abnormal midline profile, and genetic syndromes);
2. Nasal bone;
4. Central nervous system (e.g., agenesis of the corpus callosum and Dandy-Walker malformation);
5. Cranial sutures;
6. Thorax (e.g., rib evaluation, intrathoracic masses, and lung volumes);
7. Spine (e.g., level of neural tube defect and vertebral abnormalities);
8. Extremities (e.g., clubfeet, amputation defects, and skeletal dysplasia);
9. Heart (e.g., conotruncal anomalies and evaluation of normal anatomy);
10. Placenta (e.g., vasa previa) such as to determine the relationship of the vessel to the internal os;
11. Visual depiction for reassurance or demonstration of an abnormality for consulting clinicians and patients;
12. Extent of anomalies, such as cystic hygroma;
13. Multiple gestations (e.g., conjoined twins and vascular mapping for twin-twin transfusion); and
14. Umbilical cord (e.g., cord insertion sites or cord knots).
U.S. Food and Drug Administration (FDA)
In addition, the FDA has an archived statement on keepsake USs that states in part: (7) “The FDA is aware of several enterprises in the U.S. that are commercializing ultrasonic imaging of fetuses by making ‘keepsake’ videos. In some cases, the ultrasound machine may be used for as long as an hour to get a video of the fetus. We are concerned about this misuse of diagnostic ultrasound equipment…
From a medical standpoint, ultrasonic fetal scanning is generally considered safe if it is properly used when medical information on a pregnancy is needed. But ultrasound energy delivered to the fetus cannot be regarded as completely innocuous. Laboratory studies have shown that diagnostic levels of ultrasound can produce physical effects in tissue, such as mechanical vibrations and rise in temperature. Although there is no evidence that these physical effects can harm the fetus, public health experts, clinicians and industry agree that casual exposure to ultrasound, especially during pregnancy, should be avoided. Viewed in this light, exposing the fetus to ultrasound with no anticipation of medical benefit is not justified…
Persons who promote, sell or lease ultrasound equipment for making ‘keepsake’ fetal videos should know that FDA views this as an unapproved use of a medical device…”
Summary of Evidence
There are no systematic reviews of the literature on 3D or 4D obstetric US that pool study findings or systematically report on findings of controlled studies. An ACOG committee opinion states that evidence has not yet shown clinical advantage of 3D US compared to 2D US for prenatal diagnosis. An ACOG committee opinion and an FDA statement discourage the non-medical use of 3D US, e.g., to produce a “keepsake” photograph or video. A consensus statement from a panel convened by the American Institute of Ultrasound in Medicine identified a number of obstetric indications in which some of the panelists found 3D US to be helpful, but the AIUM did not consider it standard of care.
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The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.
A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.
1. Kurjak A, Miskovic B, Andonotopo W, et al. How useful is 3D and 4D ultrasound in perinatal medicine? J Perinat Med. 2007; 35(1):10-27. PMID 17313305
2. Goncalves LF, Lee W, Espinoza J, et al. Three- and 4-dimensional ultrasound in obstetric practice: does it help? J Ultrasound Med. Dec 2005; 24(12):1599-624. PMID 16301717
3. Merz E, Abramowicz JS. 3D/4D ultrasound in prenatal diagnosis: is it time for routine use? Clin Obstet Gynecol. Mar 2012; 55(1):336-51. PMID 22343249
4. American College of Obstetricians Gynecologists (ACOG). ACOG Committee Opinion No. 297 (August 2004, reaffirmed 2015): Nonmedical use of Obstetric Ultrasonography. Available at <http://www.acog.org> (accessed on July 5, 2016).
5. American College of Obstetricians Gynecologists (ACOG). ACOG Practice Bulletin No. 101: Ultrasonography in pregnancy. Obstet Gynecol. Feb 2009; 113(2 Pt 1):451-61. PMID 19155920
6. Benacerraf BR, Benson CB, Abuhamad AZ, et al. Three- and 4-dimensional ultrasound in obstetrics and gynecology: proceedings of the American Institute of Ultrasound in Medicine Consensus Conference. J Ultrasound Med. Dec 2005; 24(12):1587-97. PMID 16301716
7. FDA – Fetal Keepsake Videos (archived material). Prepared by the U.S. Food and Drug Administration (FDA). Available at <http://www.fda.gov> (accessed on July 5, 2016).
|12/1/2017||Reviewed. No changes.|
|9/1/2016||Document updated with literature review. Coverage unchanged.|
|7/15/2015||Document updated with literature review. Coverage unchanged.|
|9/15/2014||New medical document. Three-dimensional (3D) and four-dimensional (4D) obstetrical ultrasound is considered experimental, investigational and/or unproven.|
|Title:||Effective Date:||End Date:|
|Three-dimensional (3D), Four-dimensional (4D), and Five-dimensional (5D) Obstetrical Ultrasound||01-01-2022||12-31-2022|
|Three-dimensional (3D), Four-dimensional (4D), and Five-dimensional (5D) Obstetrical Ultrasound||01-15-2021||12-31-2021|
|Three-dimensional (3D), Four-dimensional (4D), and Five-dimensional (5D) Obstetrical Ultrasound||07-15-2019||01-14-2021|
|Three-dimensional (3D) and Four-dimensional (4D) Obstetrical Ultrasound||12-01-2017||07-14-2019|
|Three-dimensional (3D) and Four-dimensional (4D) Obstetrical Ultrasound||09-01-2016||11-30-2017|
|Three-dimensional (3D) and Four-dimensional (4D) Obstetrical Ultrasound||07-15-2015||08-31-2016|
|Three-dimensional (3D) and Four-dimensional (4D) Obstetrical Ultrasound||09-15-2014||07-14-2015|