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Aetna Aetna
Clinical Policy Bulletin:
Ultrasound for Pregnancy
Number: 0199


Policy

  1. Aetna considers ultrasounds not medically necessary if done solely to determine the fetal sex or to provide parents with a view and photograph of the fetus.

  2. Aetna considers a fetal ultrasound with detailed anatomic examination medically necessary to evaluate the fetus for amniotic band syndrome (also known as amniotic constriction band syndrome), choroid plexus cysts, or if there are known or suspected fetal anatomic abnormalities, including anatomic abnormalities due to genetic conditions (see attached ICD-9 coding), pregnancies resulting from advanced reproductive technology (ART), severe obesity (body mass index [BMI] of 35 or more) complicating pregnancy, or pregnancies with a fetal nuchal translucency measurement of 3.5 mm or greater in the first trimester.  More than 1 detailed ultrasound fetal anatomic examination per pregnancy per practice is considered experimental and investigational, as there is inadequate evidence of the clinical utility of multiple serial detailed fetal anatomic ultrasound examinations during pregnancy.

  3. Aetna considers detailed ultrasound fetal anatomic examination experimental and investigational for all other indications including routine evaluation of pregnant women who are on bupropion (Wellbutrin) or levetiracetam (Keppra), pregnant women with low pregnancy-associated plasma protein A, and pregnant women who smoke or abuse cannabis.  There is inadequate evidence of the clinical utility of detailed ultrasound fetal anatomic examination for indications other than evaluation of suspected fetal anatomic abnormalities.  Detailed ultrasound fetal anatomic examination is not considered medically necessary for routine screening of normal pregnancy, or in the setting of maternal idiopathic pulmonary hemosiderosis.

  4. Aetna considers three-dimensional (3D) and four-dimensional (4D) fetal ultrasounds experimental and investigational because of a lack of evidence that 3D and 4D ultrasounds alter management over standard two-dimensional (2D) ultrasounds such that clinical outcomes are improved.

For Aetna’s policy on first trimester ultrasonographic assessment of fetal nuchal skinfold thickness, see CPB 0282 - Noninvasive Down Syndrome Screening.

See also: CPB 0106 - Fetal Echocardiograms.



Background

This policy is based in part on The American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin on Ultrasonography in Pregnancy and guidelines from the Society for Maternal-Fetal Medicine (SMFM).

Ultrasonography in pregnancy should be performed only when there is a valid medical indication.  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." 

Indications for a first-trimester ultrasound (performed before 13 weeks and 6 days of gestation) include:

  • As adjunct to chorionic villus sampling, embryo transfer, or localization and removal of an intra-uterine device
  • To assess for certain fetal anomalies, such as anencephaly, in patients at high risk
  • To confirm cardiac activity
  • To confirm the presence of an intra-uterine pregnancy
  • To diagnosis or evaluate multiple gestations
  • To estimate gestational age
  • To evaluate a suspected ectopic pregnancy
  • To evaluate maternal pelvic or adnexal masses or uterine abnormalities
  • To evaluate pelvic pain
  • To evaluate suspected hydatidiform mole
  • To evaluate vaginal bleeding
  • To screen for fetal aneuploidy.

ACOG recommended that in the absence of specific indications, the optimal time for an obstetric ultrasound examination is between 18 to 20 weeks of gestation because anatomically complex organs, such as the fetal heart and brain, can be imaged with sufficient clarity to allow detection of many major malformations.  This recommendation is based primarily on consensus and expert opinion (Level C).  ACOG stated that it may be possible to document normal structures before 18 weeks of gestation but some structures can be difficult to visualize at that time because of fetal size, position, and movement; maternal abdominal scars; and increased maternal abdominal wall thickness.  A 2nd or 3rd trimester ultrasound examination, however, may pose technical limitations for an anatomic evaluation due to suboptimal imaging, and when this occurs, ACOG recommended documentation of the technical limitation and that a follow-up examination may be helpful. 

ACOG uses the terms "standard" (also called basic), "limited," and "specialized" (also called detailed) to describe various types of ultrasound examinations performed during the 2nd or 3rd trimesters.  

Standard Examination

A standard ultrasound includes an evaluation of fetal presentation, amniotic fluid volume, cardiac activity, placental position, fetal biometry, and fetal number, plus an anatomic survey.  A standard examination of fetal anatomy includes the following essential elements:

  • Abdomen (stomach, kidneys, bladder, umbilical cord insertion site into the fetal abdomen, umbilical cord vessel number)
  • Chest (heart)
  • Extremities (presence or absence of legs and arms)
  • Head, face and neck (cerebellum, choroid plexus, cisterna magna, lateral cerebral ventricles, midline falx, cavum septi pellucidi, upper lip)
  • Sex (medically indicated in low-risk pregnancies only for the evaluation of multiple gestations).
  • Spine (cervical, thoracic, lumbar, and sacral spine).

Limited Examination

A limited examination does not replace a standard examination and is performed when a specific question requires investigation (e.g., to confirm fetal heart activity in a patient experiencing vaginal bleeding or to establish fetal presentation during labor).  A limited examination may be performed during the 1st trimester to evaluate interval growth, estimate amniotic fluid volume, evaluate the cervix, and assess the presence of cardiac activity. 

Specialized Examination

A detailed or targeted anatomic examination is performed when an anomaly is suspected on the basis of history, laboratory abnormalities, or the results of either the limited or standard examination.  Other specialized examinations might include fetal Doppler ultrasonography, biophysical profile, amniotic fluid assessment, fetal echocardiography, or additional biometric measurements.  Specialized examinations are performed by an operator with experience and expertise in such ultrasonography who determines that components of the examination on a case-by-case basis.

Indications for a 2nd and 3rd trimester ultrasound include the following:

  • Adjunct to amniocentesis or other procedure
  • Adjunct to cervical cerclage placement
  • Adjunct to external cephalic version
  • Determination of fetal presentation
  • Estimation of gestational age
  • Evaluation for abnormal biochemical markers
  • Evaluation for fetal well-being
  • Evaluation for premature rupture of membranes of premature labor
  • Evaluation in those with a history of previous congenital anomaly
  • Evaluation of abdominal and pelvic pain
  • Evaluation of cervical insufficiency
  • Evaluation of fetal condition in late registrants for prenatal care
  • Evaluation of fetal growth
  • Evaluation of pelvic mass
  • Evaluation of suspected amniotic fluid abnormalities
  • Evaluation of suspected ectopic pregnancy
  • Evaluation of suspected fetal death
  • Evaluation of suspected multiple gestation
  • Evaluation of suspected placental abruption
  • Evaluation of suspected uterine abnormality
  • Evaluation of vaginal bleeding
  • Examination of suspected hydatidiform mole
  • Follow-up evaluation of a fetal anomaly
  • Follow-up evaluation of placental location for suspected placenta previa
  • Significant discrepancy between uterine size and clinical dates
  • To assess for findings that may increase the risk of aneuploidy
  • To screen for fetal anomalies.

The Society for Maternal-Fetal Medicine (SMFM) has stated that a fetal ultrasound with detailed anatomic examination (CPT 76811) is not necessary as a routine scan for all pregnancies (SMFM, 2004).  Rather, this scan is necessary for a known or suspected fetal anatomic or genetic abnormality (i.e., previous anomalous fetus, abnormal scan this pregnancy, etc.), or increased risk for fetal abnormality (e.g. AMA, diabetic, fetus at risk due to teratogen or genetics, abnormal prenatal screen).  Thus, the SMFM has stated that the performance of this scan is expected to be rare outside of referral practices with special expertise in the identification of, and counseling about, fetal abnormalities (SMFM, 2004; SMFM, 2012).

SMFM has also determined that no more than 1 fetal ultrasound with detailed anatomic examination is necessary per pregnancy, per practice, when medically necessary (SMFM, 2004; SMFM, 2012).  Once this detailed fetal anatomical examination is done, a second one should not be performed unless there are extenuating circumstances with a new diagnosis.  The SMFM has stated that it is appropriate to repeat the detailed fetal anatomical ultrasound examination when a patient is seen by another maternal-fetal medicine specialist practice, for example, for a second opinion on a fetal anomaly, or if the patient is referred to a tertiary center in anticipation of delivering an anomalous fetus at a hospital with specialized neonatal capabilities.

A focused ultrasound assessment is sufficient for follow-up to provide a re-examination of a specific organ or system known or suspected to be abnormal, or when doing a focused assessment of fetal size by measuring the bi-parietal diameter, abdominal circumference, femur length, or other appropriate measurements (SMFM, 2004).

An ultrasound without detailed anatomic examination is appropriate for a fetal maternal evaluation of the number of fetuses, amniotic/chorionic sacs, survey of intra-cranial, spinal and abdominal anatomy, evaluation of a 4-chamber heart view, assessment of the umbilical cord insertion site, assessment of amniotic fluid volume, and evaluation of maternal adenexa when visible and appropriate (SMFM, 2004).

Amniotic band sequence refers to a highly variable spectrum of congenital anomalies that occur in association with amniotic bands.  Amniotic banding affects approximately 1 in 1,200 live births.  It is also believed to be the cause of 178 in 10,000 miscarriages.  Up to 50 % of cases have other congenital anomalies including cleft lip, cleft palate, and clubfoot deformity.  Hand and finger anomalies occur in up to 80 %.  The diagnosis is based upon the presence of characteristic structural findings on prenatal ultrasound or postnatal physical examination.  The diagnosis should be suspected when limb amputations or atypical body wall or craniofacial defects are present, or when bands of amnion are seen crossing the gestational sac and adherent to the fetus.

In a practice bulletin on screening for fetal chromosomal anomalies, ACOG (2007) has stated that patients who have a fetal nuchal translucency measurement of 3.5 mm or greater in the 1st trimester, despite a negative result on an aneuploidy screen, normal fetal chromosomes, or both, should be offered a targeted ultrasound examination, fetal echocardiogram, or both, because such fetuses are at a significant risk for non-chromosomal anomalies, including congenital heart defects, abdominal wall defects, diaphragmatic hernias, and genetic syndromes.

The ACOG practice bulletin on the use of psychiatric medications during pregnancy and lactation (2008) stated that atypical anti-depressants are non-tricyclic anti-depressants and non-selective serotonin reuptake inhibitors antidepressants that work by distinct pharmacodynamic mechanisms.  The atypical anti-depressants include bupropion, duloxetine, mirtazapine, nefazodone, and venlafaxine.  The limited data of fetal exposure to these anti-depressants do not suggest an increased risk of fetal anomalies or adverse pregnancy events.  In the one published study of bupropion exposure in 136 patients, a significantly increased risk of spontaneous abortion, but not an increased risk of major malformations, was identified.  In contrast, the bupropion registry maintained at GlaxoSmithKline has not identified any increased risk of spontaneous abortion, although these data have not undergone peer review.

In a Cochrane review, Stampalija and colleagues (2010) evaluated the effects on pregnancy outcome, and obstetric practice, of routine utero-placental Doppler ultrasound in 1st and 2nd trimester of pregnancy in pregnant women at high- and low-risk of hypertensive complications.  These investigators searched the Cochrane Pregnancy and Childbirth Group's Trials Register (June 2010) and the reference lists of identified studies.  Randomized and quasi-randomized controlled trials of Doppler ultrasound for the investigation of utero-placental vessel waveforms in 1st and 2nd trimesters compared with no Doppler ultrasound were included in this review.  These researchers excluded studies where uterine vessels have been assessed together with fetal and umbilical vessels.  Two authors independently assessed the studies for inclusion, assessed risk of bias and carried out data extraction.  They found 2 studies involving 4,993 participants.  The methodological quality of the trials was good.  Both studies included women at low-risk for hypertensive disorders, with Doppler ultrasound of the uterine arteries performed in the 2nd trimester of pregnancy.  In both studies, pathological finding of uterine arteries was followed by low-dose aspirin administration.  They identified no difference in short-term maternal and fetal clinical outcomes; identified no randomized studies assessing the utero-placental vessels in the 1st trimester or in women at high-risk for hypertensive disorders.  The authors concluded that present evidence failed to show any benefit to either the baby or the mother when utero-placental Doppler ultrasound was used in the 2nd trimester of pregnancy in women at low-risk for hypertensive disorders.  However, this evidence can not be considered conclusive with only 2 studies included.  There were no randomized studies in the 1st trimester, or in women at high-risk.  They stated that more research is needed to examine if the use of utero-placental Doppler ultrasound may improve pregnancy outcome.

Three-Dimensional and Four-Dimensional Ultrasound in Obstetrics

Three-dimensional (3D) ultrasound can furnish a 3D image of the fetus. To create a 3D image, a transducer takes a series of thin slices of the subject, and a computer translates these images and presents them in 3 dimensions.

Proponents of 3D ultrasound scanning have argued that volumetric measurements from 3D ultrasound scan are more accurate and that both clinicians and parents can better appreciate a certain abnormality with a 3D scan than a standard 2-dimensional (2D) scan.  In addition, there is the possibility of increasing psychological bonding between the parents and the baby (Ji et al, 2005).

In the diagnosis of congenital anomalies, there is evidence to suggest that smaller defects such as spina bifida, cleft lip and palate, and polydactyly may be more lucidly demonstrated with 3D ultrasound (Gonçalves et al, 2005; Kurjak et al, 2007).  Other more subtle features such as low-set ears, facial dysmorphia or clubbling of feet may be better assessed, which has the potential to lead to more effective diagnoses of chromosomal abnormalities.

In addition, the use of 3D technology can reduce scanning time while maintaining adequate visualization of the fetus in obstetrical ultrasound (Benacerraf et al, 2005; Benacerraf et al, 2006).

Jones et al (2010) examined the intra- and inter-observer reproducibility of 3D power Doppler (3DPD) data acquisition from women at 12 weeks gestation, which were then subsequently measured by a single observer.  Women with an uncomplicated, viable singleton pregnancy were scanned between 12 + 0 and 13 + 6 weeks gestations with a Voluson 730 Expert. 3DPD data were acquired of the whole placenta by 2 observers: the first observer captured 2 data sets and the second a single dataset.  Each data set was analysed using VOCAL in the A plane with 9 degree rotation steps.  A total of 18 low-risk women were recruited with a total of 54 data sets analyzed.  The intra-class correlation coefficient (ICC) was highest for the vascular indices vascularization index (VI) and vascularization-flow index (VFI), greater than 0.75.  Intra-class correlation coefficient for flow index (FI) showed moderate correlation at 0.47 to 0.65.  Bland Altman plots showed the most precise vascular index to be the FI (-15 % to 10 % for inter-observer agreement).  There was no bias between datasets.  Prospective studies are now required to identify if this analysis tool and method is sensitive enough to recognise patients with early-onset placental dysfunction.

More recently, 4-dimensional (4D) or dynamic 3D scanners have come on the market, with the attraction of being able to look at fetal movements.  These have also been referred to as "reassurance scans" or "entertainment scans."  Proponents argue that 4D scans may have an important catalytic effect for mothers to bond to their babies before birth.  However, the impact of 4D scans on diagnosis and management of fetal abnormalities is unknown.

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.

Current guidelines on ultrasonography in pregnancy from ACOG (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."

Yagel et al (2009) described the state of the science of 3D/4D ultrasound (3D/4D US) applications in fetal medicine. They noted that 3D/4D US applications are many and varied.  Their use in fetal medicine varies with the nature of the tissue to be imaged and the challenges each organ system presents, versus the advantages of each ultrasound application.  The investigators stated that 3D/4D US has been extensively applied to the study of the fetus.  Fetal applications include all types of anatomical assessment, morphometry and volumetry, as well as functional assessment.  The authors concluded that 3D/4D US provides many advantages in fetal imaging; however, its contribution to improving the accuracy of fetal scanning over rates achieved with 2D US, remains to be established.

In a prospective study, Chen et al (2009) examined the feasibility and reproducibility of measurements of nasal bone length using a 3D US in the 1st trimester.  A total of 118 consecutive pregnant women attending for Down syndrome screening at 11- to 13(+6)-week were recruited.  They had successful fetal nasal bone measurement by 2D US by 4 operators.  Three-dimensional volumes were recorded in the mid-sagittal plane of fetal profile by the 5th operator and examined using multi-planar techniques.  Another independent investigator randomly compared his measurements with 1 of the 4 operators.  In the subsequent 3D examination, the nasal bone length could be examined in 94 cases (79.7 %).  The mean difference between the 2D and 3D measurements was 0.19 mm [95 % confidence interval (CI): 0.08 to 0.31] (p < 0.05).  Limits of agreement were -0.73 to 1.11.  The mean differences between these 2 observers were 0.66 mm (95 % CI: -0.47 to 0.86) (p < 0.05).  The authors concluded that there was significant inter-method difference between the results obtained by 2D and 3D, as well as substantial inter-observer variation in 3D measurement of fetal nasal bone length in the 1st trimester.  They stated that independent 3D measurement of nasal bone offers no additional advantages over 2D US.

Kurjak and colleagues (2010) stated that an evolving challenge for obstetricians is to better define normal and abnormal fetal neurological function in utero in order to better predict ante-natally which fetuses are at risk for adverse neurological outcome.  In a multi-center study, these investigators examined the use of 4D US in the assessment of fetal neurobehavior in high-risk pregnancies.  Pre-natal neurological assessment was carried out in high-risk fetuses using 4D US applying the recently developed Kurjak ante-natal neurodevelopmental test (KANET).  Post-natal neurological assessment was performed using Amiel Tison's neurological assessment at term (ATNAT) for all live-borns and general movement (GM) assessment for those with borderline and abnormal ATNAT.  Inclusion criteria were met by 288 pregnant women in 4 centers of whom 266 gave birth to a live-born baby.  It was revealed that 234 fetuses were neurologically normal, 7 abnormal and 25 borderline.  Out of 7 abnormal fetuses ATNAT was borderline in 5 and abnormal in 2, whereas GM assessment was abnormal in 5 and definitely abnormal in 2.  Out of 25 KANET borderline fetuses, ATNAT was normal in 7, borderline in 17 and abnormal in 1, whereas the GM assessment was as follows: normal optimal in 4, normal suboptimal in 20, and abnormal in 1.  In summary, out of 32 borderline and abnormal fetuses, ATNAT was normal in 7, borderline in 22 and abnormal in 3; GM assessment was normal optimal in 4, normal suboptimal in 20, abnormal in 6 and definitely abnormal in 2.  The authors concluded that 4D US requires further studies before being recommended for wider clinical practice.

Hata et al (2011) presented 2 cases of amniotic band syndrome diagnosed using 2D ultrasound with 3D/4D ultrasound in early pregnancy.  In case 1, at 13 weeks' gestation, multiple amniotic bands, acrania, the absence of fingers and amputation of the toes bilaterally were clearly shown using trans-vaginal 3D/4D ultrasound.  In case 2, at 15 weeks' gestation, several amniotic bands, acrania and a cleft lip were depicted with trans-abdominal 3D/4D ultrasound.  The spatial relationship between the amniotic bands and the fetus was clearly visualized and easily discernible by 3D/4D ultrasound.  The parents and families could readily understand the fetal conditions and undergo counseling; they then choose the option of termination of pregnancy.  The authors concluded that 3D/4D ultrasound has the potential to be a supplement to conventional 2D ultrasound in evaluating amniotic band syndrome.

In a pilot study, Antsaklis et al (2011) evaluated the use of 3D ultrasonography as an alternative for examining fetal anatomy and nuchal translucency (NT) in the first trimester of pregnancy.  A total of 199 low-risk pregnant women undergoing 1st trimester ultrasound scan for fetal anomalies were included in this study.  The NT and fetal anatomy were evaluated by 3D ultrasonography after the standard 2D examination.  The gold standard in this study was the 2D ultrasonography.  In some of the evaluated parameters, the 3D method approaches the conventional 2D results.  These parameters are the crown-rump length (CRL), the skull-brain anatomy (93.5 %), the spine (85.4 %), the upper limbs (88.4 %) and the lower limbs (87.9 %) and the examination of the fetal abdomen (98.5 %).  Some of the anatomic parameters under evaluation revealed a statistically significant difference in favor of the 2D examination.  During the 3D examination the nasal bone was identified in 62.1 % of the cases, the stomach in 85.9 %, and the urinary bladder in 57.3 % of the cases.  The NT was assessed accurately in 50 % of the cases compared to 2D examination.  The authors concluded that the 3D ultrasound is insufficient for the detailed fetal anatomy examination during the 1st trimester of pregnancy.

An UpToDate review on "Idiopathic pulmonary hemosiderosis" (Milman, 2012) does not mention the use of detailed ultrasound fetal anatomic examination.

According to the Product Insert of Keppra (Pregnancy Category C), there are no adequate and well-controlled studies in pregnant women.  In animal studies, levetiracetam produced evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human therapeutic doses.  Keppra should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.  As with other anti-epileptic drugs, physiological changes during pregnancy may affect levetiracetam concentration.  There have been reports of decreased levetiracetam concentration during pregnancy.  Discontinuation of anti-epileptic treatments may result in disease worsening, which can be harmful to the mother and the fetus.

In a Cochrane review, Grivell et al (2012) noted that policies and protocols for fetal surveillance in the pregnancy where impaired fetal growth is suspected vary widely, with numerous combinations of different surveillance methods.  These researchers evaluated the effects of ante-natal fetal surveillance regimens on important peri-natal and maternal outcomes.  These investigators searched the Cochrane Pregnancy and Childbirth Group's Trials Register (February 29, 2012).  Randomized and quasi-randomized trials comparing the effects of described ante-natal fetal surveillance regimens were selected for analysis.  Review authors independently assessed trial eligibility and quality and extracted data.  They included 1 trial of 167 women and their babies.  This trial was a pilot study recruiting alongside another study, therefore, a separate sample size was not calculated.  The trial compared a twice-weekly surveillance regimen (biophysical profile, non-stress tests, umbilical artery and middle cerebral artery Doppler and uterine artery Doppler) with the same regimen applied fortnightly (both groups had growth assessed fortnightly).  There were insufficient data to assess this review's primary infant outcome of composite peri-natal mortality and serious morbidity (although there were no peri-natal deaths) and no difference was seen in the primary maternal outcome of emergency caesarean section for fetal distress (risk ratio (RR) 0.96; 95 % CI: 0.35 to 2.63).  In keeping with the more frequent monitoring, mean gestational age at birth was 4 days less for the twice-weekly surveillance group compared with the fortnightly surveillance group (mean difference (MD) -4.00; 95 % CI: -7.79 to -0.21).  Women in the twice-weekly surveillance group were 25 % more likely to have induction of labor than those in the fortnightly surveillance group (RR 1.25; 95 % CI: 1.04 to 1.50).  The authors concluded that there is limited evidence from randomized controlled trials to inform best practice for fetal surveillance regimens when caring for women with pregnancies affected by impaired fetal growth.  They stated that more studies are needed to evaluate the effects of currently used fetal surveillance regimens in impaired fetal growth.

A choroid plexus cyst is a small fluid-filled structure within the choroid of the lateral ventricles of the fetal brain. Choroid plexus cysts are identified in approximately 1% to 2% of fetuses in the second trimester and they occur equally in male and female fetuses. According to the Society for Maternal-Fetal Medicine (SMFM, 2013), when a choroid plexus cyst is identified, the presence of structural malformations and other sonographic markers of aneuploidy should be assessed with a detailed fetal anatomic survey performed by an experienced provider. Detailed examination of the fetal heart (4-chamber view and outflow tracts view) and hands (for “clenching” or other abnormal positioning) should be included, as well as fetal biometry for assessment of intrauterine growth restriction. If no other sonographic abnormalities are present, the choroid plexus cyst is considered isolated.

Appendix

According to the Society for Maternal Fetal Medicine (SMFM, 2012), a detailed fetal anatomic ultrasound (CPT code 76811) includes all of the components of the routine fetal ultrasound (CPT code 76805), plus a detailed fetal anatomical survey. The SMFM (2012) has stated that the following are fetal and maternal anatomical components for the detailed fetal anatomic ultrasound (CPT code 76811). Not all components will be required. Components considered integral to the code are marked (*).

Evaluation of intracranial, facial and spinal anatomy:

  • Lateral ventricles*, third and fourth ventricles
  • Cerebellum*, integrity of lobes*, vermis*
  • Cavum septum pellucidum
  • Cisterna magna measurement*
  • Nuchal thickness measurement (15-20 weeks)*
  • Integrity of cranial vault
  • Examination of brain parenchyma, (e.g. for calcifications)
  • Ear position, size
  • Face
  • Upper lip integrity*
  • Palate*
  • Facial profile*
  • Evaluation of the neck (e.g. for masses)

Evaluation of the chest:

  • Presence of masses*
  • Pleural effusion*
  • Integrity of both sides of the diaphragm*
  • Appearance of ribs

Evaluation of the heart:

  • Cardiac location and axis*
  • Outflow tracts*

Evaluation of the abdomen:

  • Bowel *
  • Adrenal glands
  • Gallbladder
  • Liver
  • Spleen
  • Ascites*
  • Masses

Evaluation of genitalia:

  • Gender (whether or not parents wish to know sex of child)

Evaluation of limbs:

  • Number, size, and architecture*
  • Anatomy and position of hands*
  • Anatomy and position of feet*

Evaluation of the placenta and cord:

  • Placental cord insertion site*
  • Placental masses*
  • Umbilical-cord (number of arteries)

Evaluation of amniotic fluid:

  • Amniotic Fluid Index*
  • Evaluation of the cervix (Not required)
  • Evaluation of the maternal adnexa when feasible*

Note: If any of the required fetal or maternal components are non-visualized due to fetal position, late gestational age, maternal habitus, etc., it must be clearly noted in the ultrasound report in order to meet the requirements to bill for the service (SMFM, 2012).

Follow-up ultrasound performed after a detailed anatomic ultrasound (CPT code 76811), should be reported as CPT 76816 (Ultrasound, pregnant uterus, real time with image documentation, follow-up) (SMFM, 2012). This includes performing a focused assessment of fetal size by measuring the BPD, abdominal circumference, femur length, or other appropriate measurements, or a detailed re-examination of a specific organ or system known or suspected to be abnormal.

CPT code 76805 (Ultrasound, pregnant uterus, real time with image documentation, fetal and maternal evaluation, after first trimester (greater than or equal to 14 weeks 0 days), would be reported to determine the number of fetuses, amniotic/chorionic sacs, survey of intracranial, spinal, and abdominal anatomy, evaluation of a 4-chamber heart view, assessment of the umbilical cord insertion site, assessment of amniotic fluid volume, and evaluation of maternal adnexa when visible when appropriate (SMFM, 2012).

CPT code 76805 and ICD-9 code V28.3 are reported when performing a routine screening ultrasound (no maternal or fetal indications or abnormal findings) (SMFM, 2012).

 
CPT Codes / HCPCS Codes / ICD-9 Codes
Routine fetal ultrasounds:
CPT codes covered if selection criteria are met:
76801
+ 76802
76805
+ 76810
76815
76816
ICD-9 codes covered (for routine fetal ultrasounds) if selection criteria are met:
640.00 - 676.94 Complications of pregnancy and childbirth
V22.0 - V23.9 Supervision of pregnancy
V28.3 Encounter for routine screening for malformation using ultrasonics
V28.4 Screening for fetal growth retardation using ultrasonics
V28.81 Encounter for fetal anatomic survey
Detailed fetal ultrasounds:
CPT codes covered if selection criteria are met:
76811
+ 76812
Other specified HCPCS codes related to the CPB:
J1953 Other specified HCPCS codes related to the CPB:
ICD-9 codes covered (for detailed fetal ultrasounds) if selection criteria are met:
278.01 Morbid obesity [severe obesity with a BMI of 35 or>]
647.43 Malaria complicating pregnancy, antepartum condition or complication
647.53 Maternal rubella, antepartum
647.63 Other viral diseases complicating pregnancy, antepartum condition or complication
647.83 Other specified infectious and parasitic diseases complicating pregnancy, antepartum condition or complication
648.03 Diabetes mellitus complicating pregnancy, antepartum condition or complication
648.33 Drug dependence complicating pregnancy, antepartum condition or complication
648.53 Congenital cardiovascular disorders complicating pregnancy, antepartum condition or complication
651.03 Twin pregnancy, antepartum condition or complication
651.13 Triplet pregnancy, antepartum condition or complication
651.23 Quadruplet pregnancy, antepartum condition or complication
651.33 Twin pregnancy with fetal loss and retention of one fetus, antepartum condition or complication
651.43 Triplet pregnancy with fetal loss and retention of one or more fetus(es), antepartum condition or complication
651.53 Quadruplet pregnancy with fetal loss and retention of one or more fetus(es), antepartum condition or complication
651.63 Other multiple pregnancy with fetal loss and retention of one or more fetus(es), antepartum
653.63 Hydrocephalic fetus causing disproportion complicating pregnancy, antepartum condition or complication
653.73 Other fetal abnormality causing disproportion complicating pregnancy, antepartum condition or complication
655.03 Central nervous system malformation in fetus complicating pregnancy, antepartum condition or complication
655.13 Chromosomal abnormality in fetus complicating pregnancy, antepartum condition or complication
655.23 Hereditary disease in family possibly affecting fetus complicating pregnancy, antepartum condition or complication
655.33 Suspected damage to fetus from viral disease in the mother complicating pregnancy, antepartum condition or complication
655.43 Suspected damage to fetus from other disease in the mother complicating pregnancy, antepartum condition or complication
655.53 Suspected damage to fetus from drugs, complicating pregnancy, antepartum condition or complication
655.63 Suspected damage to fetus from radiation, complicating pregnancy, antepartum condition or complication
655.83 Other known or suspected fetal abnormality, not elsewhere classified, complicating pregnancy, antepartum condition or complication
655.93 Unspecified known or suspected fetal abnormality affecting management of mother, antepartum condition or complication
656.13 Rhesus isoimmunization complicating pregnancy, antepartum condition or complication
656.23 Isoimmunization from other and unspecified blood-group incompatibility, antepartum condition or complication
656.53 Poor fetal growth complicating pregnancy, antepartum condition or complication
657.03 Polyhydramnios complicating pregnancy antepartum condition or complication
658.03 Oligohydramnios complicating pregnancy, antepartum condition or complication
659.53 Elderly primigravida complicating pregnancy, antepartum condition or complication
659.63 Elderly multigravida complicating pregnancy, antepartum condition or complication
659.73 Abnormality in fetal heart rate or rhythm, antepartum condition or complication
663.83 Other umbilical cord complications, antepartum condition or complication
665.93 Unspecified obstetrical trauma, antepartum condition or complication
742.4 Other specified anomalies of brain [choroid plexus cyst]
793.6 Nonspecific abnormal findings on radiological and other examinations of abdominal area, including retroperitoneum
793.99 Other nonspecific abnormal findings on radiological and other examinations of body structure
V23.81 Supervision of high-risk pregnancy of elderly primigravida
V23.82 Supervision of high-risk pregnancy of elderly multigravida
V23.85 Pregnancy resulting from assisted reproductive technology
V28.1 Screening for raised alpha-fetoprotein levels in amniotic fluid
V28.2 Other antenatal screening based on amniocentesis
V85.35 - V85.45 Body mass index 35.0 - 70 and over, adult
ICD-9 codes not covered for indications listed in the CPB (not all-inclusive):
305.1 Tobacco use disorder
305.20 - 305.23 Cannabis abuse
516.1 Idiopathic pulmonary hemosiderosis
649.00 - 649.04 Tobacco use disorder complicating pregnancy, childbirth, and the puerperium
649.40 - 649.44 Epilepsy complicating pregnancy, childbirth or the puerperium [Keppra]
ICD-9 codes related to the CPB:
649.13 Obesity complicating pregnancy, childbirth or the puerperium [covered for severe obesity only]
Three-dimensional (3D) and four-dimensional (4D) fetal ultrasounds:
There are no specific codes for 3D and 4D fetal ultrasound
CPT codes not covered for indications listed in the CPB:
76376
76377


The above policy is based on the following references:
  1. Bofill JA, Sharp GH. Obstetric sonography. Who to scan, when to scan, and by whom. Obstet Gynecol Clin North Am. 1998;25(3):465-478.
  2. Wagner RK, Calhoun BC. The routine obstetric ultrasound examination. Obstet Gynecol Clin North Am. 1998;25(3):451-463.
  3. Dubbins PA. Screening for chromosomal abnormality. Semin Ultrasound CT MR. 1998;19(4):310-317.
  4. Garmel SH, D'Alton ME. Diagnostic ultrasound in pregnancy: An overview. Semin Perinatol. 1994;18(3):117-132.
  5. Seeds JW. The routine or screening obstetrical ultrasound examination. Clin Obstet Gynecol. 1996;39(4):814-830.
  6. Gebauer C, Lowe N. The biophysical profile: Antepartal assessment of fetal well-being. J Obstet Gynecol Neonatal Nursing. 1993;22(2):115-123.
  7. Salvesen K. Routine ultrasound scanning in pregnancy. BMJ. 1993;307(6911):1064.
  8. Gomez KJ, Copel JA. Ultrasound screening for fetal structural anomalies. Curr Opin Obstet Gynecol. 1993;5(2):204-210.
  9. Rodney WM, Deutchman ME, Hartman, KJ, et al. Obstetric ultrasound by family physicians. J Family Practice. 1992;34(2):186-200.
  10. Evans MI, Chervenak FA, Eden RD. Report of the Council on Scientific Affairs of the American Medical Association: Ultrasound evaluation of the fetus. Fetal Diagnosis Therapy. 1991;6(3-4):132-147.
  11. American College of Obstetricians and Gynecologists (ACOG). Multiple gestation. ACOG Technical Bulletin No.131. Washington, DC: ACOG; August 1989.
  12. American Academy of Pediatrics (AAP) and American College of Obstetricians and Gynecologists (ACOG). Guidelines for Perinatal Care. 4th ed. Elk Grove Village, IL: AAP; August 1997.
  13. American College of Obstetricians and Gynecologists (ACOG), Committee on Obstetric Practice. Guidelines for diagnostic imaging during pregnancy. ACOG Committee Opinion No. 158. Washington, DC: ACOG; September 1995.
  14. American College of Obstetricians and Gynecologists (ACOG), Committee on Practice Bulletins -- Obstetrics. ACOG Practice Bulletin. Clinical Management Guidelines for Obstetrician-Gynecologists. Prenatal diagnosis of fetal chromosomal abnormalities. Obstet Gynecol. 2001;97(5 Pt 1):suppl 1-12.
  15. Barnett SB, Maulik D; International Perinatal Doppler Society. Guidelines and recommendations for safe use of Doppler ultrasound in perinatal applications. J Matern Fetal Med. 2001;10(2):75-84.
  16. Lakhani K, Seifalian AM, Atiomo WU, Hardiman P. Polycystic ovaries. Br J Radiol. 2002;75(889):9-16.
  17. Kurjak A, Kupesic S, Simunic V. Ultrasonic assessment of the peri- and postmenopausal ovary. Maturitas. 2002;41(4):245-254.
  18. Kupesic S, Kurjak A, Hajder E. Ultrasonic assessment of the postmenopausal uterus. Maturitas. 2002;41(4):255-267.
  19. Timor-Tritsch IE, Platt LD. Three-dimensional ultrasound experience in obstetrics. Curr Opin Obstet Gynecol. 2002;14(6):569-575.
  20. Jurkovic D. Three-dimensional ultrasound in gynecology: A critical evaluation. Ultrasound Obstet Gynecol. 2002;19(2):109-117.
  21. Davies G, Wilson RD, Desilets V, et al. Amniocentesis and women with hepatitis B, hepatitis C, or human immunodeficiency virus. J Obstet Gynaecol Can. 2003;25(2):145-148, 149-152.
  22. Bricker L, Garcia J, Henderson J, et al. Ultrasound screening in pregnancy: A systematic review of the clinical effectiveness, cost-effectiveness and women's views. Health Technol Assess. 2000;4(16):i-vi, 1-193.
  23. Demianczuk NN, Van Den Hof MC, Farquharson D, et al. The use of first trimester ultrasound. Obstet Gynaecol Can. 2003;25(10):864-875.
  24. Institute for Clinical Systems Improvement (ICSI). Prenatal ultrasound as a screening test. ICSI Technology Assessment Report No. 16. Bloomington, MN: ICSI; updated October 2002.  Available at: http://www.icsi.org. Accessed March 31, 2004.
  25. Hata T, Kanenishi K, Inubashiri E, et al. Three-dimensional sonographic features of placental abnormalities. Gynecol Obstet Invest. 2004;57(2):61-65.
  26. American College of Obstetricians and Gynecologists. ACOG Committee Opinion #296: First-trimester screening for fetal aneuploidy. Obstet Gynecol. 2004;104(1):215-217.
  27. American College of Obstetricians and Gynecologists (ACOG Committee on Ethics. ACOG Committee Opinion. Number 297, August 2004. Nonmedical use of obstetric ultrasonography. Obstet Gynecol. 2004;104(2):423-424.
  28. Society for Maternal-Fetal Medicine (SMFM), Coding Committee. White paper on ultrasound code 76811. Announcements. Washington, DC: SMFM; May 24, 2004. Available at: http://www.smfm.org/index.cfm?zone=news&nav=viewnews&newsID=238&smfmon=yes. Accessed March 17, 2005.
  29. American College of Obstetricians and Gynecologists (ACOG), Committee on Practice Bulletins -- Obstetrics. Ultrasonography in pregnancy. ACOG Practice Bulletin No. 58. Washington, DC: ACOG; December 2004.
  30. Morin L, Van den Hof MC; Society of Obstetricians and Gynaecologists of Canada. SOGC clinical practice guidelines. Ultrasound evaluation of first trimester pregnancy complications. Number 161, June 2005. Int J Gynaecol Obstet. 2006;93(1):77-81.
  31. Goncalves LF, Lee W, Espinoza J, Romero R. Three- and 4-dimensional ultrasound in obstetric practice: does it help? J Ultrasound Med. 2005;24(12):1599-1624.
  32. 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.
  33. Ji EK, Pretorius DH, Newton R, et al. Effects of ultrasound on maternal-fetal bonding: A comparison of two- and three-dimensional imaging. Ultrasound Obstet Gynecol. 2005;25(5):473-477.
  34. Benacerraf BR, Shipp TD, Bromley D. How sonographic tomography will change the face of obstetric sonography: A pilot study. J Ultrasound Med. 2005;24(3):371-378.
  35. Benacerraf BR, Shipp TD, Bromley B. Improving the efficiency of gynecologic sonography with 3-dimensional volumes: A pilot study. J Ultrasound Med. 2006;25(2):165-171.
  36. Benacerraf BR, Shipp TD, Bromley B.  Three-dimensional US of the fetus: Volume imaging. Radiology. 2006;238(3):988-996.
  37. American College of Obstetricians and Gynecologists (ACOG) Committee on Health Care for Underdeserved Women; ACOG Committee on Obstetric Practice. ACOG committee opinion. Number 316, October 2005. Smoking cessation during pregnancy. Obstet Gynecol. 2005;106(4):883-888.
  38. American College of Obstetricians and Gynecologists (ACOG), Committee on Practice Bulletins -- Obstetrics. Ultrasonography in pregnancy. ACOG Practice Bulletin No. 98. Washington, DC: ACOG; October 2008.
  39. 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):800-823.
  40. 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):136-146; discussion 146.
  41. American College of Obstetricians and Gynecologists (ACOG), Committee on Practice Bulletins -- Obstetrics. Ultrasonography in pregnancy. ACOG Practice Bulletin No. 101. Washington, DC: ACOG; February 2009.
  42. ACOG Committee on Practice Bulletins -- Obstetrics. ACOG Practice Bulletin: Clinical management guidelines for obstetrician-gynecologists number 92, April 2008 (replaces practice bulletin number 87, November 2007). Use of psychiatric medications during pregnancy and lactation. Obstet Gynecol. 2008;111(4):1001-1020.
  43. Yagel S, Cohen SM, Messing B, Valsky DV. Three-dimensional and four-dimensional ultrasound applications in fetal medicine. Curr Opin Obstet Gynecol. 2009;21(2):167-174.
  44. Chen M, Wang HF, Leung TY, et al. First trimester measurements of nasal bone length using three-dimensional ultrasound. Prenat Diagn. 2009;29(8):766-770.
  45. Kurjak A, Abo-Yaqoub S, Stanojevic M, et al. The potential of 4D sonography in the assessment of fetal neurobehavior -- multicentric study in high-risk pregnancies. J Perinat Med. 2010;38(1):77-82.
  46. 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):1405-1411.
  47. Whitworth M, Bricker L, Neilson JP, Dowswell T. Ultrasound for fetal assessment in early pregnancy. Cochrane Database Syst Rev. 2010;(4):CD007058.
  48. Alfirevic Z, Stampalija T, Gyte GM. Fetal and umbilical Doppler ultrasound in normal pregnancy. Cochrane Database Syst Rev. 2010;(8):CD001450.
  49. Alfirevic Z, Stampalija T, Gyte GM. Fetal and umbilical Doppler ultrasound in high-risk pregnancies. Cochrane Database Syst Rev. 2010;(1):CD007529.
  50. Stampalija T, Gyte GM, Alfirevic Z. Utero-placental Doppler ultrasound for improving pregnancy outcome. Cochrane Database Syst Rev. 2010;(9):CD008363.
  51. ACOG Committee on Practice Bulletins. ACOG Practice Bulletin No. 77: Screening for fetal chromosomal abnormalities. Obstet Gynecol. 2007;109(1):217-227.
  52. Hata T, Tanaka H, Noguchi J. 3D/4D sonographic evaluation of amniotic band syndrome in early pregnancy: A supplement to 2D ultrasound. J Obstet Gynaecol Res. 2011;37(6):656-660.
  53. Antsaklis A, Daskalakis G, Theodora M, et al. Assessment of nuchal translucency thickness and the fetal anatomy in the first trimester of pregnancy by two- and three-dimensional ultrasonography: A pilot study. J Perinat Med. 2011;39(2):185-193.
  54. Society for Maternal Fetal Medicine (SMFM), Coding Committee. White Paper on Ultrasound Code 76811. Announcements. Washington, DC: SMFM; revised May 26, 2012. 
  55. Milman N. Idiopathic pulmonary hemosiderosis. Last reviewed October 2012. UpToDate Inc. Waltham, MA.
  56. Grivell RM, Wong L, Bhatia V. Regimens of fetal surveillance for impaired fetal growth. Cochrane Database Syst Rev. 2012;6:CD007113.
  57. Fuchs KM, Society for Maternal-Fetal Medicine (SMFM). Isolated fetal choroid plexus cysts. Their implications and outcome. Contemp Obstet Gynecol. 2013 Apr 1.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering 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 affiliates. 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.
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