Medical Policy: 04.01.06
Original Effective Date: April 1999
Reviewed: June 2016
Revised: June 2016
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
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 ultrasound is most commonly used. Three dimensional (3-D) and four dimensional (4-D) ultrasound create computer generated images viewed on video monitor that provide more detail and can produce more life-like images of the fetus. This policy addresses the use of 3-D and 4-D fetal ultrasound in maternity care.
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 established, and 2-D imaging remains the principal diagnostic modality.
Three dimensional (3-D) or volume ultrasonography acquires a volume (rather than a slice) of ultrasonographic data allowing one to see width, height and depth of images which is then stored. The 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:
- Three-dimensional ultrasound appears to be less operator dependent and provides a superior display of structures with complex anatomy compared to conventional ultrasonography.
- Orientations and planes are not available with two-dimensional ultrasound, because of anatomic constraints for fetal position are available with three-dimensional ultrasound.
- Volume data may be reviewed by millimeter after acquisition, simulating real-time scanning.
- Archived volume data with suspected fetal anomalies may be reviewed with other physicians after completion of the ultrasound and data may be transmitted via the internet to other locations.
- Three-dimensional ultrasound has improved accuracy of volume measurements to measure regular and irregular objects.
- Volume rendered images re easily recognizable by both parents and physicians, which may facilitate decisions by families regarding continuing or terminating the pregnancy and are also said to enable parents to bone more effectively with the fetus. It may also assist them with the making lifestyle changes, such as stopping smoking or excessive alcohol intake.
Limitations of 3-D ultrasound of the fetus are as follows:
- Suboptimal volume rendered images are obtained if there are inadequate amniotic fluids surrounding the structure of interest. This is a major limitation with oligohydramnios and as the fetus progresses towards term. The adjacent structures cannot be excluded from the rendered volume in these cases and this interferes with surface rendering.
- Unacceptable surface rendering occurs with unfavorable fetal position and with adjacent or superimposed structures (e.g. limbs).
- Image processing of the volume data may take additional time on the part of the examiner.
- Real-time capacity is not generally available with three-dimensional ultrasound.
Four dimensional (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 real-time. Fetal movements can be seen, providing a "live action" view. 4-D ultrasonography is also known as dynamic 3-D sonography.
Practice Guidelines and Position Statements
The American College of Obstetricians and Gynecologists (ACOG)
2009 ACOG guideline on Ultrasonography in Pregnancy including the following: 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 2-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.
2012 ACOG reaffirmed their committee opinion regarding “Non-Medical use of Obstetric Ultrasonography”: ACOG has endorsed the following statement from the American Institute of Ultrasound in Medicine (AIUM) discouraging the use of obstetric ultrasonography for non-medical purposes (e.g., solely to create keepsake photographs or videos):
The AIUM advocates the responsible use of diagnostic ultrasound. The AIUM strongly discourages the non-medical use of ultrasound for psychosocial or entertainment purposes. The use of either two dimensional (2-D) or three dimensional (3-D) ultrasound to only view the fetus, obtain a picture of the fetus or determine the fetal gender without a medical indication is inappropriate and contrary to responsible medical practice. Although there are no confirmed biological effects on patients caused by exposures from present diagnostic ultrasound instruments, the possibility exists that such biological effects may be identified in the future. Thus ultrasound should be used in a prudent manner to provider medical benefit to the patient.
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 amaging.
American College of Radiology (ACR)-American College of Obstetricians and Gynecologists (ACOG)-American Institute of Ultrasound in Medicine (AIUM)- Society of Radiologist in Ultrasound (SRU)
ACR-ACOG-AIUM-SRU Practice Parameter for the Performance of Obstetrical Ultrasound (amended 2014):
Equipment specifications: These studies should be conducted with real-time scanners, using a transabdominal and/or transvaginal approach. A transducer of appropriate frequency should be used. Real time sonography is necessary to confirm the presence of fetal life through observation of cardiac activity and active movement.
Classification of Fetal Sonographic Examinations
First Trimester Ultrasound Examination: A standard obstetrical sonogram in the first trimester includes evaluation of the presence, size, location, and number of gestational sac(s). The gestational sac is examined for the presence of the yolk sac and embryo/fetus. When and embryo/fetus is detected, it should be measured and cardiac activity recorded by 2D video clip or M-Mode. Use of spectral Doppler is discouraged, The uterus, cervix, adnexa and cul de sac region should be examined.
Standard Second or Third Trimester Examination: A standard obstetrical sonogram in the second or third trimester includes an evaluation of fetal presentation, amniotic fluid volume, cardiac activity, placental position, fetal biometry, and fetal number, plus an anatomic survey. The maternal cervix and adnexa should be examined as clinically appropriate when technically feasible.
Limited Examination: A limited examination is performed when a specific question requires investigational. For example, in most routine nonemergency cases a limited examination could be performed to confirm fetal heart activity in a bleeding patient, or to verify a fetal presentation in laboring patient. In most cases limited sonographic examination are appropriate only when a prior complete examination is on record.
Specialized Examination: A detailed anatomic examination is performed when an anomaly is suspected on the basis of history, biochemical abnormalities, or the results of either the limited or standard scan. Other specialized examinations might include fetal doppler ultrasound, biophysical profile, fetal echocardiogram, or additional biometric measurements.
This guideline does not mention or indicate the use of 3D or 4D ultrasound.
Institute for Clinical Systems Improvement (ICSI)
2012 The Institute for Clinical Systems Improvement (ICSI) Health Care Guideline for Routine Prenatal Care, states three dimensional (3-D) and four dimensional (4-D) ultrasound is considered investigational and is not routinely recommended at this time.
The FDA considers such use of ultrasounds for keepsake video purposes to be an unauthorized use of a medical device and these vendors have largely been eliminated as a result of enforcement efforts. However, some clinicians continue to market them as a way to enhance prenatal bonding despite a lack of clinical evidence to support this claim.
The use of three dimensional (3-D) or four dimensional (4-D) fetal ultrasounds is considered investigational for all indications.
Two dimensional (2-D) ultrasound remains the primary method of obstetric imaging. There is insufficient evidence in the peer reviewed medical literature to support the use of three dimensional (3-D) or four dimensional (4-D) ultrasound. Although 3-D and 4-D ultrasound may provide improved imaging for certain areas of the fetal anatomy and abnormalities, it has not been demonstrated in clinical studies to result in improved outcomes or impacts treatment decisions when compared to conventional 2-D ultrasound imaging. Additional studies are needed to support this technology as a replacement for 2D ultrasound. Therefore, the use of 3-D or 4-D ultrasound is considered investigational for all indications.
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- 76376 and 76377 may be used for 3-D fetal ultrasound
- 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 independing workstation.
- 76377 requiring image postprocessing on an independent workstation
- 76499 Unlisted diagnostic radiographic procedure (when specified as 4-D fetal ultrasound)
- Bofill, JA, Sharp, GH. Obstetric Sonography; Who to Scan, When to Scan, and by Whom. Obstetrics and Gynecology Clinics of North America: September 1998; 25 (3);465-478.
- Skukpski, DW, Chervenak FA, McCullough, LB. Is Routine Ultrasound Screening For All Patients? Clinics in Perinatology, December 1994; 21 (4) :707-722.
- Routine Ultrasound in Low-Risk Pregnancy- American College of Obstetricians and Gynecologists- ACOG Practice Patterns, Number 5, August 1997.
- Scharf A, Ghazwiny MF, Steinborn A, Baier P, Sohn C. Evaluation of two-dimensional versus three-dimensional ultrasound in obstetric diagnostics: a prospective study. Fetal Diagn Ther. 2001 Nov-Dec;16(6):333-41.
- American Institute of Ultrasound in Medicine. AIUM Practice Guidelines for the Performance of Antepartum Obstetric Ultrasound Examination. Copyright AIUM; 2003.
- American Institute of Ultrasound in Medicine. Policy Statement on 3-D Ultrasound Technology. Approved October 18, 1999.
- Canadian Coordinating Office for health Technology Assessment (CCOHTA): Technology Assessment Committee. Prenatal Ultrasound as a Screening Test. Ottawa, Canada: October 2002.
- Institute for Clinical Systems Improvement (ICSI). Prenatal ultrasound as a screening test. ICSI Technology Assessment Report No. 16 Updated October 2002. Accessed 11/2006 Available at URL address:http://www.icsi.org/knowledge/detail.asp?catID=107&itemID=607.
- Goncalves LF, Lee W, Espinoza J, Romero R. Three and 4-dimensional ultrasound in obstetric practice: does it help? J Ultrasound Med. 2005 Dec; abstract
- ICSI Health Care Guideline: Routine Prenatal Care, 14th ed. July 2010.
- Merz E & Abramowicz JS. 3D/4D ultrasound in prenatal diagnosis: is it time for routine use? Clin Obstet Gynecol. 2012 Mar;55(1):336-51.
- Clayton DB & Brock JW 3rd. Prenatal ultrasound and urological anomalies. Pediatr Clin North Am. 2012 Aug;59(4):739-56.
- Kirk E. Ultrasound in the diagnosis of ectopic pregnancy. Clin Obstet Gynecol. 2012 Jun;55(2):395-401.
- Society for Maternal Fetal Medicine (SMFM), Coding Committee. White Paper on Ultrasound Code 76811. Announcements. Washington, DC: SMFM; revised May 26, 2012.
- National Institute of Health and Clinical Excellence (NICE) Antenatal care, Issued March 2008 last modified: June 2010.
- Institute for Clinical Systems Improvement, Health Care Guidelines, Routine Prenatal Care. Akkerman D, Cleland L, Croft G, Eskuchen K, Heim C, Levine A, Setterlund L, Stark c, Vickers J, Westby E. Updated July 2012
- The American College of Obstetricians and Gynecologists (ACOG) Committee Opinion, Number 297, August 2004, Reaffirmed 2012, Nonmedical Use of Obstetric Ultrasonography.
- American Institute of Ultrasound MedicineExternal Site (AIUM) Official Statement, Keepsake Fetal Imaging, Approved 4/1/2012.
- American Institute of Ultrasound MedicineExternal Site (AIUM) 2013 Practice Guideline for Obstetric Ultrasound Examinations.
- The American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin 101. Ultrasonography in Pregnancy. Obstet Gynecol. 2009; 113(2 Pt 1):451-461
- ACRExternal Site-ACOG-AIUM-SRU Practice Parameter for the Performance of Obstetrical Ultrasound, Amended 2014.
- UpToDateExternal Site. Routine Prenatal Ultrasonography as a Screening Tool. Anna K Sfakianaki M.D., Joshua Copel M.D.. Topic last updated October 30, 2015.
- UpToDateExternal Site. Fetal Growth Restrictions: Diagnosis. Michael Y Divon M.D.. Topic last updated December 8, 2015.
- UpToDateExternal Site. Prenatal Diagnosis of the Lethal Skeletal Dysplasias. Phyllis Glanc M.D., FRCPC, David Chitayat M.D., FABMG, FACMG, FCCMG, FRCPC. Topic last updated September 8, 2015.
- UpToDateExternal Site. Ultrasonography of Pregnancy of Unknown Location. Tejas S. Mehta M.D., MPH. Topic last updated November 20, 2015.
- Whitworth M, Bricker L, Neilson JP. et. al. Ultrasound for fetal assessment in pregnancy. Cochrane Database Syst Rev. 2010 Apr 14; (4): CD007058. PMID 20393955
- Whitworth M, Bricker L, Mullan C. Ultrasound for fetal assessment in early pregnancy. Cochrane Database Syst Rev 2015 Jul 14;7: CD007058. PMID 2617896
- Benacerraf BR, Shipp TD, Bromley B. Three-dimensional US of the fetus: volume imaging. Radiology 2006 Mar 238(3):988-96. PMID 16424249
- Yagel S, Cohen SM, Messing B, et. al. Three-dimensional and four-dimensional ultrasound application in fetal medicine. Curr Opin Obstet Gynecol 2009 Apr:21(2):167-74. PMID 19996869
June 2016 - Annual review, Policy revised
July 2015 - Annual review, Policy renewed
August 2014 - Annual review, Policy revised
October 2013 - Annual review, Policy revised
December 2012 - Annual review, Policy renewed
December 2011 - Annual review, Policy renewed
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*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.