Download National Medical Policy

National Medical Policy
Subject:
Three Dimensional (3D) Cardiac
Echocardiography
Policy Number:
NMP289
Effective Date*: July 2006
Updated:
April 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
X
Source
National Coverage Determination
(NCD)
National Coverage Manual Citation
Local Coverage Determination
(LCD)*
Article (Local)*
Other
Reference/Website Link
None
Use Health Net Policy
Medicare Fee Schedule, Payment and
Reimbursement Benefit Guideline. CPT 76376,
76377 - 3D Interpretation and Reporting of
Imaging Studies - covered DX:
http://www.medicarepaymentandreimbursemen
t.com/2011/04/cpt-76376-76377-3dinterpretation-and.html
Instructions
 Medicare NCDs and National Coverage Manuals apply to ALL Medicare members
in ALL regions.
Three D Echocardiography April 16
1



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.
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. may consider three-dimensional (3-D) echocardiography medically
necessary, on an exceptional case by case basis, for surgical treatment planning of a
complex surgical cardiac procedure, when the information produced from the 3D
echocardiogram cannot be provided by a traditional 2D echocardiogram, or other
testing (e.g. magnetic resonance imaging of the heart, Doppler study, ultrasound)
Health Net, Inc considers three-dimensional (3-D) echocardiography investigational
for all other indications as its use for clinical diagnosis and treatment has yet to be
validated in well-designed studies comparing it with its competing technology.
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 (List is not all inclusive)
745.4
745.5
746.9
Ventricular septal defect
Ostium secundum type atrial septal defect
Unspecified anomaly of the heart
ICD-10 Codes
Q21.0
Q21.1
Q20.9
Ventricular septal defect
Atrial septal defect
Congenital malformation of cardiac chambers and connections,
unspecified
Congenital malformation of heart, unspecified
Q24.9
CPT Codes
76376
3D rendering with interpretation and reporting of computed tomography,
magnetic resonance imaging, ultrasound, or other tomographic modality
with image post processing under concurrent supervision; not requiring
image post processing on an independent workstation
Three D Echocardiography April 16
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76377
3D rendering with interpretation and reporting of computed tomography,
magnetic resonance imaging, ultrasound, or other tomographic modality
with image post processing under concurrent supervision; requiring
image post processing on an independent workstation
HCPCS Codes
N/A
Scientific Rationale – Update April 2016
Park et al (2016) sought to investigate the feasibility of single-beat threedimensional echocardiography (sb3DE) for RV volume and functional assessment in
patients with dilated right ventricles. Fifty-two patients with severe tricuspid
regurgitation or atrial septal defects were enrolled. Fifty patients underwent sb3DE
and cardiac magnetic resonance (CMR) within 24 hours under a euvolemic state, and
the results of sb3DE were compared with those of CMR, the reference method.
Fifteen normal subjects were also recruited for a broader validation of sb3DE.
Of the 67 individuals, data from 59 study participants (44 patients and 15 normal
subjects) with adequate image quality were analyzed (mean age, 46.9 ± 19.3 years;
58% women). The correlation was excellent between sb3DE and CMR for measuring
RV volumes and RV ejection fraction (RVEF) (r = 0.96, r = 0.93, and r = 0.93 [P <
.001 for all] for RV end-diastolic volume, RV end-systolic volume, and RVEF,
respectively). Bland-Altman analysis revealed that RV volumes, but not RVEF, tended
to be slightly underestimated by sb3DE (-5.8 ± 9.6%, -3.8 ± 14.1%, and -1.2 ±
9.4% for RV end-diastolic volume, RV end-systolic volume, and RVEF, respectively).
Intra- and interobserver variability was acceptable for all indices (4.9% and 6.1% for
RV end-diastolic volume, 4.2% and 7.9% for RV end-systolic volume, and 5.7% and
2.8% for RVEF, respectively). Among patients with RV dilation, the difference in
RVEF between sb3DE and CMR was more pronounced in patients with atrial
fibrillation than those in sinus rhythm (-5.9% vs 0.9%, P = .041). The authors
concluded in patients with dilated right ventricles and in normal subjects, assessment
of RV volume and systolic function by sb3DE is feasible in terms of accuracy and
reproducibility. RV analysis using sb3DE can be performed in patients with atrial
fibrillation, with the possibility of RVEF underestimation.
Scientific Rationale – Update April 2014
Massaffanti et al. (2013) Right ventricular (RV) volumes and ejection fraction (EF)
vary significantly with demographic and anthropometric factors and are associated
with poor prognosis in several cardiovascular diseases. This multicenter study was
designed to establish the reference values for RV volumes and EF using transthoracic
three-dimensional (3D) echocardiography; investigate the influence of age, sex, and
body size on RV anatomy; and to develop normative equations. RV volumes (enddiastolic volume and end-systolic volume), stroke volume, and EF were measured by
3D echocardiography in 540 healthy adult volunteers, prospectively enrolled, evenly
distributed across age and sex. The relation of age, sex, and body size parameters
was investigated using bivariate and multiple linear regression. Analysis was feasible
in 507 (94%) subjects (260 women; age, 45±16 years; range, 18-90). Age, sex,
height, and weight significantly influenced RV volumes and EF. Sex effect was
significant (P<0.01), with RV volumes larger and EF smaller in men than in women.
Older age was associated with lower volumes (end-diastolic volume, -5 mLdecade;
end-systolic volume, -3 mL/decade; EF, -2 mL/decade) and higher EF (+1%
perdecade). Inclusion of body size parameters in the statistical models resulted in
improved overall explained variance for volumes (end-diastolic volume, R(2)=0.43;
end-systolic volume, R(2)=0.35; stroke volume, R(2)=0.30), while EF was
Three D Echocardiography April 16
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unaffected. Ratiometric and allometric indexing for age, sex, and body size resulted
in no significant residual correlation between RV measures and height or weight. The
presented normative ranges and equations could help standardize the 3D
echocardiography assessment of RV volumes and function in clinical practice,
considering the effects of age, sex, and body size.
Scientific Rationale - Update March 2013
Echocardiography is the major non-invasive diagnostic tool for real-time imaging of
cardiac structure and function. One of the significant advances in this field has been
the development and refinement of three-dimensional (3D) imaging. Real-time
three-dimensional (3D) echocardiography allows for rapid acquisition of images and
datasets during a single breath-hold without the need for off-line reconstruction.
Major advantages of 3D echocardiography compared to traditional two-dimensional
(2D) echocardiography are the improved accuracy of evaluation of cardiac chamber
volumes (by eliminating the need for geometric modeling as well as a reduction in
errors caused by foreshortened views) and more realistic visualization of cardiac
valves and congenital abnormalities
Per the 2008 Guidelines on Adults with Congenital Heart Disease from the American
College of Cardiology and American Heart Association, a transthoracic
echocardiography (TTE) is the primary diagnostic imaging modality for a variety of
indications, including but not limited to, atrial septal defect (ASD), ventricular septal
defect, atrioventricular septal defect, and aortic valve disease. The guidelines do not
address 3D echocardiography.
Per the ACCF/ASE/AHA/ASNC/HFSA/HRS/SCAI/SCCM/SCCT/SCMR 2011 Appropriate
Use Criteria for Echocardiography, a TTE and a TEE examination and report will
include the use and interpretation of 2-dimensional/M-mode imaging, color flow
Doppler, and spectral Doppler as important elements of a comprehensive TTE/TEE
evaluating relevant cardiac structures and hemodynamics. Stress echocardiography
will include rest and stress 2-dimensional imaging at a minimum unless performed
for hemodynamics, when Doppler must be included. The range of potential
indications for echocardiography is quite large, particularly in comparison with other
cardiovascular imaging tests. Thus, the indications are, at times, purposefully broad
to cover an array of cardiovascular signs and symptoms as well as the ordering
physician’s best judgment as to the presence of cardiovascular abnormalities. In
general, it is assumed that transesophageal echocardiography (TEE) is most
appropriately used as an adjunct or subsequent test to TTE when indicated, such as
when suboptimal TTE images preclude obtaining a diagnostic study.
A review of 3D echocardiography in Up to Date (Dec 2012) concluded:

Real-time three-dimensional (3D) echocardiography allows for rapid acquisition
of images and datasets during a single breath-hold without the need for off-line
reconstruction. Major advantages of 3D echocardiography compared to
traditional two-dimensional (2D) echocardiography are the improved accuracy of
evaluation of cardiac chamber volumes (by eliminating the need for geometric
modeling as well as a reduction in errors caused by foreshortened views) and
more realistic visualization of cardiac valves and congenital abnormalities.

Principal reasons for requesting an echocardiogram in clinical practice include the
assessment of left ventricular (LV) chamber size and systolic function. 3D
technology permits frame-by-frame detection of the 3D endocardial surface from
Three D Echocardiography April 16
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real-time 3D datasets. Nearly all studies that have directly compared the
accuracy of 3D measurements of LV volumes and LV ejection fraction have
demonstrated the superiority of the 3D approach over the traditional 2D
methodology.

Due to the complex crescent shape of the right ventricle (RV), estimation of its
volume based on geometric modeling from 2D images has been challenging. The
intrinsic ability of 3D imaging to directly measure RV volumes without the need
for geometrical modeling has resulted in significant improvements in accuracy
and reproducibility in RV volume quantification.

Assessment of regional wall motion abnormalities using 2D echocardiography is
routinely performed by visually integrating regional endocardial motion and wall
thickness. The reproducibility of this interpretation is limited due to its subjective
nature, which is also dependent upon the experience of the interpreting clinician.
Because the motion of any ventricular wall can be quantified by measuring a
variety of wall motion parameters, 3D echocardiography permits evaluation of
regional LV function and objective detection of wall motion abnormalities.

A byproduct of 3D quantification of regional LV wall motion is the ability to
quantify the timing of regional endocardial systolic contraction. Data from 3D
echocardiography can provide objective evidence of LV systolic dyssynchrony
which may serve as an additional criterion for referral for cardiac
resynchronization therapy.

Volume-rendered 3D displays of transthoracic or transesophageal images enable
improved evaluation of the anatomy of the mitral valve and its supporting
structures. 3D imaging of the mitral valve is particularly helpful to the cardiac
surgeon or interventional cardiologist to provide the most detailed anatomic and
functional information when planning an intervention on the mitral valve.

Real-time 3D transesophageal echocardiography offers detailed anatomic views
of many cardiac structures and is likely to become the preoperative and
perioperative imaging modality of choice for patients undergoing mitral valve
surgery.
Thorstensen et al (2013) aimed to compare 3D and 2D echocardiography in the
evaluation of patients with recent myocardial infarction (MI), using lateenhancement magnetic resonance imaging (LE-MRI) as a reference method.
Echocardiography and LE-MRI were performed approximately 1 month after firsttime MI in 58 patients. Echocardiography was also performed on 35 healthy controls.
Left ventricular (LV) ejection fraction by 3D echocardiography (3D-LVEF), 3D wallmotion score (WMS), 2D-WMS, 3D speckle tracking-based longitudinal,
circumferential, transmural and area strain, and 2D speckle tracking-based
longitudinal strain (LS) were measured. The global correlations to infarct size by LEMRI were significantly higher (P < 0.03) for 3D-WMS and 2D-WMS compared with
3D-LVEF and the 4 different measurements of 3D strain, and 2D global longitudinal
strain (GLS) was more closely correlated to LE-MRI than 3D GLS (P < 0.03). The
segmental correlations to infarct size by LE-MRI were also significantly higher (P <
0.04) for 3D-WMS, 2D-WMS, and 2D LS compared with the other indices. Threedimensional WMS showed a sensitivity of 76% and a specificity of 72% for
identification of LV infarct size >12%, and a sensitivity of 73% and a specificity of
95% for identification of segments with transmural infarct extension. Three-
Three D Echocardiography April 16
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dimensional WMS and 2D gray-scale echocardiography showed the strongest
correlations to LE-MRI. The tested 3D strain method suffers from low temporal and
spatial resolution in 3D acquisitions and added diagnostic value could not be proven.
Kidawa et al (2013) reported that knowledge of right ventricular (RV) function may
be crucial in diagnosis and proper management of patients with suspected acute MI.
Standard echocardiography has several drawbacks, tissue Doppler echocardiography
(TDE) and real-time three-dimensional echocardiography (RT3DE) could be used for
evaluation of the RV performance. The purpose of this study was to assess RV
function in patients with inferior wall acute MI with both TDE and RT3DE. The study
included 85 patients in the acute phase of MI complicated with right ventricular
myocardial infarction (RVMI) admitted for primary coronary intervention (PCI).
Control group was formed from 85 patients with isolated inferior wall infarction
matched to RVMI group. Before PCI all of the patients underwent echocardiografic
examination with the assessment of RV function by TDE and RT3DE. TDE derived
peak systolic velocity ', peak early diastolic velocity of RV free wall differed
significantly between groups. Three-dimensional reconstruction and calculation of the
right ventricular ejection fraction (RVEF) showed that in RVMI patients RVEF values
were lower than in the controls (41.7 ± 6.03 vs. 52.7 ± 2.3%, respectively). RVEF <
51% allowed diagnosis of RVMI with sensitivity 91% and specificity 80%.
Investigators concluded three-dimensional echocardiography is a useful method in
the estimation of RVEF, however does not perform better than TDE in diagnosis of
RVMI. Threshold of RVEF < 51% may be used for diagnosing of RVMI with adequate
sensitivity and specificity.
Ruddox et al (2013) performed a systematic review of 3D echocardiography (3DE) to
evaluate whether it provides additional information to 2DE in general hospital clinical
practice. Studies with a blinded comparison between 2DE and 3DE against a "gold
standard" were included; these studies comprised patients with well defined inclusion
and exclusion criteria. The number of patients, selection criteria, echo manufacturer,
cardiac disorder, and types of comparisons, along with "gold standard" and principal
results were compared. A total of 836 original articles were identified, of which 35
were screened for eligibility. 20 studies from 18 publications were included for
analysis. The results for LV assessment and reproducibility were clearly in favor of
3DE. In valvular heart disease the superiority of 3DE was also apparent, but was less
convincing due to patient selection, methodological problems and the application of
questionable "gold standards". The reviewers concluded in patients with a regular
heart rhythm and for whom it was possible to obtain good quality images the
introduction of 3DE has improved the accuracy and reproducibility of LV volume and
EF measurements. The results for valvular heart disease are still controversial. It
does not seem justifiable to introduce 3DE into common cardiac practice. Further
studies are needed in order to support such an implementation.
Thavendiranathan et al (2012) sought to assess the feasibility, accuracy, and
reproducibility of real-time full-volume 3-dimensional transthoracic echocardiography
(3D RT-VTTE) to measure left ventricular (LV) volumes and ejection fraction (EF)
using a fully automated endocardial contouring algorithm and to identify and
automatically correct the contours to obtain accurate LV volumes in sinus rhythm
and atrial fibrillation (AF). RT-VTTE was performed and 3D EF and volumes obtained
using an automated trabecular endocardial contouring algorithm; an automated
correction was applied to track the compacted myocardium. Cardiac magnetic
resonance (CMR) and 2-dimensional biplane Simpson method were the reference
standard. Ninety-one patients (67 in normal sinus rhythm [NSR], 24 in AF) were
Three D Echocardiography April 16
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included. Among all NSR patients, there was excellent correlation between RT-VTTE
and CMR for end-diastolic volume (EDV), end-systolic volume (ESV), and EF (r =
0.90, 0.96, and 0.98, respectively; p<0.001). In patients with EF≥50% (n = 36),
EDV and ESV were underestimated by 10.7±17.5 ml (p = 0.001) and by 4.1±6.1 ml
(p<0.001), respectively. In those with EF<50% (n = 31), EDV and ESV were
underestimated by 25.7±32.7 ml (p<0.001) and by 16.2±24.0 ml (p = 0.001).
Automated contour correction to track the compacted myocardium eliminated mean
volume differences between RT-VTTE and CMR. In patients with AF, LV volumes and
EF were accurate by RT-VTTE (r = 0.94, 0.94, and 0.91 for EDV, ESV, and EF,
respectively; p<0.001). Automated 3D LV volumes and EF were highly reproducible.
Investigators concluded rapid, accurate, and reproducible EF can be obtained by RTVTTE in NSR and AF patients by using an automated trabecular edge contouring
algorithm. Furthermore, automated contour correction to detect the compacted
myocardium yields accurate and reproducible 3D LV volumes.
Liu et al (2012) evaluated left ventricular systolic synchronization in patients
implanted with dual-chamber DDD mode cardiac pacemakers by real-time threedimensional echocardiography (RT3DE). Twenty patients implanted with DDD mode
cardiac pacemakers for 12 months and 20 healthy subjects underwent RT3DE. This
method provided left ventricular end-diastolic volume (LEDV), left ventricular endsystolic volume (LESV), stroke volume (SV), left ventricular ejection fraction (LVEF),
the mean value of the time to minimal systolic volume of the 16 left ventricular
segments (Tmean), the standard deviation of Tmean (T-SD), the maximal difference
of the time to minimal systolic volume of the 16 left ventricular segments (Tmax)
and time-volume curves of the 16 left ventricular segments. Results showed that
compared with the healthy group, LESV was significantly increased (P<0.05), SV and
LVEF were significantly decreased (P<0.05) and T-SD and Tmax were significantly
prolonged (P<0.05) in patients implanted with DDD mode cardiac pacemakers. The
time to minimal systolic volume of the 16 left ventricular segments time-volume
curves differed in patients implanted with DDD mode cardiac pacemakers.
Asynchronization of the left ventricular systolic performance in patients implanted
with DDD mode cardiac pacemakers was observed. Investigators concluded the
results showed that RT3DE is a quantitative method used to evaluate left ventricular
systolic synchronization.
Black et al (2012) reviewed the use of 3DE with multiplanar reformatting (MPR) in
children with congenital aortic stensosis undergoing percutaneous balloon aortic
valvuloplastie to assess its accuracy in measuring the aortic valve annulus and any
influence it may have on balloon sizing. All percutaneous aortic balloon
valvuloplasties performed from 01/01/2009 to 01/09/2011 were included in the
study. All imaging performed for the procedure to determine the size of the aortic
valve annulus and aid in balloon sizing was reviewed. The maximum diameter of the
aortic valve annulus using two-dimensional echocardiography (2DE), 3DE with MPR,
and angiography was recorded. The balloon size used in the procedure was recorded
and the balloon to annulus ratio was calculated. A total of 27 procedures were
included in the study. Age varied from 1 day to 156 months (mean age, 53 months)
and weight from 2.8-58 kg (mean weight, 18.6 kg). Fourteen patients had 3DE with
MPR available for analysis. The 3DE with MPR measurement (13.36 ± 5.4 mm) was
not different from angiography (13.54 ± 6.4 mm; P=.803).The 2DE measurement
was significantly different from angiography (11.72 ± 5 mm; P<.005). The balloon to
annulus ratio based on angiographic measurements did not differ significantly
between the patients with 3DE MPR and those without (0.94 ± 0.095 vs 0.91 ± 0.1;
P=.468). Reviewers concluded 3DE with MPR allows a more accurate assessment of
Three D Echocardiography April 16
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the aortic valve annulus compared to 2DE, which may reduce the tendency to
undersize balloon choice. 3DE with MPR did not significantly affect our balloon
choice, which was largely based on angiographic measurements.
Mor-Avi et al (2012) studied in a multicenter setting, the accuracy and reproducibility
of 3-dimensional echocardiography (3DE)-derived measurements of left atrial volume
(LAV) using new, dedicated volumetric software, side by side with 2-dimensional
echocardiography (2DE), using cardiac magnetic resonance (CMR) imaging as a
reference. Increased LAV is associated with adverse cardiovascular outcomes.
Although LAV measurements are routinely performed using 2DE, this methodology is
limited because it is view dependent and relies on geometric assumptions regarding
left atrial shape. Real-time 3DE is free of these limitations and accordingly is an
attractive alternative for the evaluation of LAV. However, few studies have validated
3DE-derived LAV measurements against an accepted independent reference
standard, such as CMR imaging. Investigators studied 92 patients with a wide range
of LAV who underwent CMR (1.5-T) and echocardiographic imaging on the same day.
Images were analyzed to obtain maximal and minimal LAV: CMR images using
standard commercial tools, 2DE images using a biplane area-length technique, and
3DE images using Tomtec LA Function software. Intertechnique comparisons
included linear regression and Bland-Altman analyses. Reproducibility of all 3
techniques was assessed by calculating the percentage of absolute differences in
blinded repeated measurements. Kappa statistics were used to compare 2DE and
3DE classification of normal/enlarged against the CMR reference. 3DE-derived LAV
values showed higher correlation with CMR than 2DE measurements (r = 0.93 vs. r
= 0.74 for maximal LAV; r = 0.88 vs. r = 0.82 for minimal LAV). Although 2DE
underestimated maximal LAV by 31 ± 25 ml and minimal LAV by 16 ± 32 ml, 3DE
resulted in a minimal bias of -1 ± 14 ml for maximal LAV and 0 ± 21 ml for minimal
LAV. Interobserver and intraobserver variability of 2DE and 3DE measurements of
maximal LAV were similar (7% to 12%) and approximately 2 times higher than CMR
(4% to 5%). 3DE classified enlarged atria more accurately than 2DE (kappa: 0.88
vs. 0.71). Investigators concluded that compared with CMR reference, 3DE-derived
LAV measurements are more accurate than 2DE-based analysis, resulting in fewer
patients with undetected atrial enlargement.
Tong et al (2012) assessed left and right ventricular systolic function in patients with
dilated cardiomyopathy (DCM) using RT-3DE. Fifty DCM patients and 50 normal
subjects were enrolled. Left and right ventricular systolic function parameters
including end-systolic volume (ESV) and end-diastolic volume (EDV), stroke volume
(SV) and ejection fraction (EF) were measured with RT-3DE. The
systolicdyssynchrony index (SDI) for left ventricular systolic function was also
measured in the same time. The study compared the data of the left and right
ventricular systolic function parameters between the DCM group and the control
group. Cardiac magnetic resonance (CMRI) was performed in a subgroup of the 30
DCM patients to confirm RT-3DE measurements. The results of EDV, ESV and SDI
measured by RT-3DE were significantly higher in patient group with DCM than those
in the control group (P<0.001). The result of EF was significantly lower in patients
with DCM than in normal subjects (P<0.001), but SV showed no significant
difference between the two groups (P>0.05). In the DCM group, the results showed
a significantly negative correlation between left ventricular ejection fraction (LVEF)
and SDI (r=-0.697, P<0.001), and there was also a moderate correlation between
LVEF and right ventricular ejection fraction (RVEF) (r=0.496, P<0.01). The results of
ESV, EDV and EF showed no significant differences as measured by RT-3DE or CMRI
in the patient group (P>0.05), and there was also good correlation between the two
Three D Echocardiography April 16
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measurements (LVEF: r=0.89, P<0.01; RVEF: r=0.85, P<0.01). Investigators
concluded left and right ventricular systolic function in DCM could be evaluated by
RT-3DE with left and right ventricular systolic function parameters.
Gertz et al (2012) investigated fifty elderly patients (mean 86 years, 46% female)
referred for cardiac catheterization to evaluate in aortic stenosis (AS) also underwent
transthoracic echocardiography within 24 hours. To minimize assumptions all
patients had 3-dimensional echocardiography (Echo-3D), and at catheterization
using directly measured oxygen consumption (Cath-mVo(2)) and thermodilution
cardiac output (Cath-TD). Correlation between Cath-mVo(2) and Echo-3D AVA was
poor (r=0.41). Cath-TD AVA had a moderate correlation with Echo-3D AVA (r=0.59).
Cath-mVo(2) (AVA=0.69 cm(2)) and Cath-TD (AVA=0.66 cm(2)) underestimated
AVA compared with Echo-3D (AVA=0.76 cm(2;) P=0.08 for comparison with CathmVo(2); P=0.001 for Cath-TD). Compared with Echo-3D, the sensitivity and
specificity for determining critical disease (AVA <0.8 cm(2)) were 81% and 42% for
Cath-mVo(2), and 97% and 53% for Cath-TD. The only independent predictor of the
difference between noninvasive and invasive AVA was stroke volume index (P<0.01).
Resistance, a less flow-dependent measure, showed a stronger correlation between
Echo-3D and Cath-mVo(2) (r=0.69), and Echo-3D and Cath-TD (r=0.77).
Investigators concluded standard techniques of AVA assessment for AS show poor
correlation in elderly patients, with frequent misclassification of critical AS. Less flowdependent measures, such as resistance, should be considered to ensure that only
appropriate patients are treated with aortic valve replacement.
Greupner et al (2012) compare the accuracy of 64-row contrast computed
tomography (CT), invasive cineventriculography (CVG), 2-dimensional
echocardiography (2D Echo), and 3-dimensional echocardiography (3D Echo) for left
ventricular (LV) function assessment with magnetic resonance imaging (MRI).
Cardiac function is an important determinant of therapy and is a major predictor for
long-term survival in patients with coronary artery disease. A number of methods
are available for assessment of function, but there are limited data on the
comparison between these multiple methods in the same patients. A total of 36
patients prospectively underwent 64-row CT, CVG, 2D Echo, 3D Echo, and MRI (as
the reference standard). Global and regional LV wall motion and ejection fraction
(EF) were measured. In addition, assessment of interobserver agreement was
performed. For the global EF, Bland-Altman analysis showed significantly higher
agreement between CT and MRI (p < 0.005, 95% confidence interval: ±14.2%) than
for CVG (±20.2%) and 3D Echo (±21.2%). Only CVG (59.5 ± 13.9%, p = 0.03)
significantly overestimated EF in comparison with MRI (55.6 ± 16.0%). CT showed
significantly better agreement for stroke volume than 2D Echo, 3D Echo, and CVG.
In comparison with MRI, CVG-but not CT-significantly overestimated the enddiastolic volume (p < 0.001), whereas 2D Echo and 3D Echo significantly
underestimated the EDV (p < 0.05). There was no significant difference in diagnostic
accuracy (range: 76% to 88%) for regional LV function assessment between the 4
methods when compared with MRI. Interobserver agreement for EF showed high
intraclass correlation for 64-row CT, MRI, 2D Echo, and 3D Echo (intraclass
correlation coefficient >0.8), whereas agreement was lower for CVG (intraclass
correlation coefficient = 0.58). Investigators concluded 64-row CT may be more
accurate than CVG, 2D Echo, and 3D Echo in comparison with MRI as the reference
standard for assessment of global LV function.
Anwar et al (2012) evaluated the feasibility and possible additional value of
transthoracic real-time three-dimensional echocardiography (RT3D-TTE) for the
Three D Echocardiography April 16
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assessment of cardiac structures as compared to 2D-TTE. 320 patients (mean age
45 ± 8.4 years, 75% males) underwent 2D-TTE and RT3D-TTE using 3DQ-Q lab
software for offline analysis. Volume quantification and functional assessment was
performed in 90 patients for left ventricle and in 20 patients for right ventricle.
Assessment of native (112 patients) and prosthetic (30 patients) valves morphology
and functions was performed. RT3D-TTE was performed for evaluation of septal
defects in 30 patients and intracardiac masses in 52 patients. RT3D-TTE assessment
of left ventricle was feasible and reproducible in 86% of patients while for right
ventricle, it was (55%). RT3D-TTE could define the surface anatomy of mitral valve
optimally (100%), while for aortic and tricuspid was (88% and 81% respectively).
Valve area could be planimetered in 100% for the mitral and in 80% for the aortic.
RT3D-TTE provided a comprehensive anatomical and functional evaluation of
prosthetic valves. RT3D-TTE enface visualization of septal defects allowed optimal
assessment of shape, size, area and number of defects and evaluated the outcome
post device closure. RT3D-TTE allowed looking inside the intracardiac masses
through multiple sectioning, valuable anatomical delineation and volume calculation.
Investgators concluded initial experience showed that the use of RT3D-TTE in the
assessment of cardiac patients is feasible and allowed detailed anatomical and
functional assessment of many cardiac disorders.
Scientific Rationale – Update March 2012
Two-dimensional (2-D) echocardiography provides real-time imaging of heart
structures throughout the cardiac cycle; more recently, 3-dimensional (3-D)
echocardiography has been developed. As the technology continues to evolve, it will
likely play an increasingly prominent role in echocardiographic diagnosis.
The improvement in computational techniques allow the three-dimensional
reconstruction of the heart (3D echocardiography), both by transthoracic or
transesophageal. 3D echocardiography has emerged as a clinically relevant, although
technically complex, modality, that usually requires post acquisition processing.
Per the Journal of American College of Cardiology (JACC), 3D echocardiography is
becoming increasingly prevalent and should be available in most modern training
environments. The ability to complete adequate training in echocardiography will
depend on the background and abilities of the trainee, as well as the effectiveness of
the instructor and laboratory. The current trend to introduce the fundamental
principles, indications, applications, and limitations of echocardiography into the
education of medical students and residents is encouraged and will facilitate
subsequent mastery of this discipline.
Three-dimensional (3 D) echocardiography may be useful for the assessment of the
severity of valvular stenosis or regurgitation where such information is critical for
decisions regarding the need for valve repair. 3D echography is also useful in the
evaluation of atrial and septal defects, intracardiac masses such as myxomas, and
valve lesions such as abscesses and vegetations. 3D echocardiography is useful in
assessment for the need of cardiac resynchronization therapy and is also useful for
surgical treatment planning for complex congenital heart disease.
Kurlinsky et al. (2012) Recent technologic advances in 3D echocardiography, using
parallel processing to scan a pyramidal volume, have allowed for a superior ability to
describe valvular anatomy using both transthoracic and transesophageal
echocardiography. Three-dimensional echocardiography provides unique
perspectives of valvular structures by presenting views of valvular structures,
allowing for a better understanding of the topographical aspects of pathology, and a
Three D Echocardiography April 16
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refined definition of the spatial relationships of intracardiac structures. Threedimensional echocardiography makes available indices not described by 2D
echocardiography and has been demonstrated to be superior to 2D echocardiography
in a variety of valvular disease scenarios. The information gained from 3D
echocardiography has especially made an impact in guiding clinical decisions in the
evaluation of mitral valve (MV) disease. The decision of early surgery in degenerative
MV disease is based on the suitability of repair, and the suitability of repair is
generally based on echocardiography. The superior understanding of MV anatomy
afforded by 3D echocardiography has been shown to be quite valuable in this setting.
Although 3D cardiac echocardiography has emerged as an important clinical tool in
the assessment of valvular heart disease, it is still in evolution and at an early phase
of adaptation with respect to its clinical application. This treatment needs to be
validated in well-designed studies comparing it with its competing technology, such
as magnetic resonance imaging of the heart.
Scientific Rationale – Update March 2010
Echocardiography is the major diagnostic tool for real-time imaging of cardiac
structure and function. One of the significant advances in this field has been the
development and refinement of three-dimensional (3D) imaging. Since the potential
of 3D echocardiographic imaging to overcome many of the limitations of 2D
echocardiography is being seen for the future, ultrasound imaging has gone through
multiple phases of development, each bringing this imaging technology a step closer
to real-time imaging.
Real-time three-dimensional echocardiographic reconstruction is valuable for the
assessment of cardiac morphology. Details of valve structure, the size and location of
septal defects, abnormalities of the ventricular myocardium, and details of the great
vessels can often be appreciated on 3-D echo, which may not be as readily apparent
using 2-D imaging. Reconstruction of the view that the surgeon will encounter in the
operating room, promised to make this technique a valuable adjunct for preoperative
imaging.
Early 3D echo imaging was based on computer reconstruction of contiguous 2D
cross-sectional images, and was hampered by difficulties in accurately registering the
ultrasound image data in time and space and by long image processing time.
Development of gating techniques, improved computer technology and software, and
refinement of the user interface have resulted in shorter acquisition and
reconstruction times and improved image quality. The introduction of real-time 3D
echocardiography (RT-3DE) allows the technology to complement, and enhances its
potential to eventually replace 2D echocardiography, in clinical practice. RT-3DE
sends and receives a pyramidal set of ultrasound energy data from several thousand
piezoelectric transducer elements, producing a 3D image using parallel image
processing techniques. Although spatial and temporal resolution of current RT-3DE
technology are still somewhat limited, given the rapid evolution of the technology,
image quality is certain to approach that of 2D echo in the near future.
van der Zwanze et al. (2010) completed a study to test the feasibility, accuracy, and
reproducibility of the assessment of right ventricular (RV) volumes and ejection
fraction (EF) using real-time three-dimensional echocardiographic (RT3DE) imaging
in patients with congenital heart disease (CHD), using cardiac magnetic resonance
(CMR) as a reference. RT3DE data sets and short-axis cine CMR images were
obtained in 62 consecutive patients (mean age, 26.9 ± 10.4 years; 65% men) with
Three D Echocardiography April 16
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various CHDs. RV volumetric quantification was done using semiautomated 3dimensional border detection for RT3DE images and manual tracing of contours in
multiple slices for CMR images. Adequate RV RT3DE data sets could be analyzed in
50 of 62 patients (81%). The time needed for RV acquisition and analysis was less
for RT3DE imaging than for CMR (P < .001). Compared with CMR, RT3DE imaging
underestimated RV end-diastolic and end-systolic volumes and EF by 34 ± 65 mL, 11
± 55 mL, and 4 ± 13% (P < .05) with 95% limits of agreement of ±131 mL, ±109
mL, and ±27%, as shown by Bland-Altman analyses, with highly significant
correlations (r = 0.93, r = 0.91, and r = 0.74, respectively, P < .001). Interobserver
variability was 1 ± 15%, 6 ± 17%, and 8 ± 13% for end-diastolic and end-systolic
volumes and EF, respectively. In the majority of unselected patients with complex
CHD, RT3DE imaging provides a fast and reproducible assessment of RV volumes
and EF with fair to good accuracy compared with CMR reference data when using
current commercially available hardware and software. Further studies are warranted
to confirm our data in similar and other patient populations to establish its use in
clinical practice.
In summary, there is a lack of peer-reviewed, randomized controlled trials using
three dimensional cardiac echocardiography. The majority of the studies that were
found were various author’s reviews or case reports of specific individuas who
underwent surgical procedures in which 3D cardiac echocardiography was used (i.e.
Nishimura et al. 2010, Eitel et al. 2010, Horton et al. 2010, and Novero 2010). Data
from well-designed RCTs or comparison trials are needed to validate the use of three
diminensional cardiac echocardiaography for clinical diagnosis and treatment and
compare it with procedures that are currently used (i.e. Magnetic resonance imaging
of the heart). Outcome studies are needed to support the safety and efficacy of this
procedure in the long-term.
Scientific Rationale – Initial
M-mode and two dimensional (2-D) echocardiography (echo) have made significant
contributions to the non-invasive evaluation of cardiac disease for many years and
have evolved into the most predominant non-invasive diagnostic imaging technique
in cardiology. However, current echo technology is limited by viewing and evaluating
intracardiac anatomy in only two dimensions. The interpretation of echocardiographic
images, therefore, requires a mental integration of multiple image planes for a true
understanding of anatomic and pathologic structures.
Recent advances in ultrasound instrumentation, computer and transducer
technology, and image processing has enabled computer-based 3-D reconstruction
procedures to be performed even faster and more precisely. Consequently, this has
lead to the development of two techniques: (1) 3-D reconstruction which allows the
physician to reconstruct the heart and view the structural defects at any angle; and
(2) real-time 3-D (RT3-D) volumetric imaging. The former requires extrapolation of a
series of two-dimensional (2-D) images of known orientation and location that then
is compiled into a three-dimensional data set. This process is very time-consuming
and this method still suffers from the fact that the derived data are collected at
different times, not in real time. Because the 3-dimensional data were still collected
in different cardiac cycles, unpredictable inaccuracies for quantification are probably
caused by patient motion, respiration, and the complex linear and rotational
movements of the heart between diastole and systole. Accordingly, it is difficult to
evaluate complex beat-to-beat changes of the heart. The latter, RT3-D
echocardiography, uses a 2-D matrix phased array transducer with multiple parallel
processing to produce real-time volumetric images of the heart free of geometric
Three D Echocardiography April 16
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assumptions. The main advantage of live RT3-D imaging is its ability to capture 3-D
data in real time. This technique offers hope in improving patient care by providing
more precise and rapid identification of cardiac abnormalities because it avoids the
motion artifact inherent with any reconstructive technique and permits analysis of
events during a single cardiac cycle. It is thought that the representation of images
in a 3-dimensional format more closely resembles reality and it is the real-time
aspect of live 3-D echo that enables clinicians to quickly and accurately assess and
quantify global and regional left ventricular (LV) function, LV mass, and view the
different heart chambers, all of which are critical in assessing specific conditions and
cardiac performance for obtaining a precise diagnosis. In addition, 3-dimensional
imaging allows direct calculation of volumes and is, thus, more accurate than current
models relying on geometric assumptions. However, at present, RT3-D imaging has
poorer image quality and lacks the Doppler capability.
The concept of live 3-D echo is particularly important as patients present with
multiple, complex problems. As live 3-D echo evolves as a tool for the complete
management of the cardiac patient, it is also benefiting the clinical side by verifying
much of the data obtained by 2-D echo, thereby enhancing diagnostic confidence for
more rapid diagnosis, improving patient care and peace of mind, and driving clinical
efficiencies. The continuous acquisition of volumetric data also permits structures to
be scanned rapidly, eliminating the previous lengthy steps required for data
coordination. This mechanism has the potential to provide 3-dimensional images
from which quantitative data can be derived and tissue structure recognized with
examination requirements no greater than those of 2-dimensional scanning. The
motion of all the imaged structures during the cardiac cycle can be evaluated in a
dynamic mode. In addition, one has the ability to view the heart in 2 dimensions in
any desired plane.
Numerous applications of three-dimensional echocardiography (3D-echo) have been
proposed. For example, improvements in image interpretation with 3D-echo could be
of value in the decision making and planning of cardiac surgery, and in the diagnosis
of complex congenital cardiac lesions. In addition, 3-dimensional imaging allows
quantitative parameters such as valve areas, the size of defects (atrial septal defect,
ventricular septal defect) or volumes to be obtained.
With new developments that allow system integration of 3D scanning, rapid or even
near real time 3D-reconstruction and measurements, 3D-echo is now on the verge of
becoming an integral part of an echo examination. It remains a technique in
evolution for which increases in image processing technology and speed have
allowed substantial advancement in the last several years. Even though 3D
echocardiography provides unique orientations of cardiac anatomy not obtainable by
routine 2D echocardiography, this modality has not been adopted in routine clinical
practice because of its cumbersome and time-consuming process.
In the future, with further developments that allow system integration of 3D
scanning, rapid or even near real time 3D-reconstruction and measurements, most
cardiologists feel that there are four clinical situations where live 3D echo may
impact directly on the quality of patient care. The first is the diagnosis of congenital
heart disease. Many of these disorders are caused by complex geometrical
distortions of cardiac anatomy. Currently, a combination of 2-D echocardiography
and cardiac catheterization is used to diagnose these diseases. It is reasonable to
think that real-time 3-D echocardiography will provide more detailed information
with one noninvasive test. Second, is in the planning and assessment of mitral valve
Three D Echocardiography April 16
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repair. Current 2-D echo provides good information regarding valve deformations,
but it is not uncommon for the surgeon to find different or additional abnormalities in
surgery that were not identified pre-operatively by current echo techniques. Since
these observations of surgery are made in an arrested and flaccid heart, it is
sometimes difficult for the surgeon to determine their importance to valve
competence. Real-time 3- D echo will allow a more complete ‘dynamic’ assessment
of valve dysfunction. Thirdly, real-time 3-D technology will find an important
application in the future in the guidance of percutaneous catheter-based techniques
to treat cardiovascular disease – particularly valvular heart disease. There is a huge
effort going on right now to develop catheter systems to repair and replace both the
aortic and mitral valve. Currently, many, if not all, of these techniques are hampered
by ‘positioning’ problems. That is, with current 2-D technology, it is difficult to
visualize the appropriate anatomical landmarks to use these new devices optimally.
As these technologies expand, so will the need for 3-D echocardiography. Finally, 3D echocardiography may be extremely helpful in guiding the treatment of heart
failure patients. Post-infarction heart failure affects millions of people and costs
billions of dollars to treat every year. Despite intense study, the five-year survival for
this disease is less than 50% – worse than most cancers. Real-time 3-D
echocardiography may be used to determine subtle geometrical changes in the left
ventricle that will identify patients who are at high risk for ventricular remodeling
leading to heart failure after a heart attack. Such information will allow these
patients to receive therapy earlier before symptoms occur and before this horribly
progressive disease has reached its irreversible stage. In addition, real-time 3-D
ventricular imaging may allow a better assessment of the on-going effectiveness of
heart failure therapy and allow the clinician to make more informed decisions
regarding adjustments in pharmacological and surgical therapy.
However, despite the potential of 3D-echo to visualize cardiac structures and
perform volume computations this technique has not gained wide spread acceptance
to date. This might be related to several factors: (1) 3-D echo can only visualize
what is also seen on the two dimensional image, thus, an experienced echocardiographer will obtain similar information from a conventional examination
without the need for costly instrumentation and long post-processing times; (2)
operator experience with the reconstruction and interpretation of 3-Dimages
is a must; (3) 3D-image quality greatly depends on the quality of the twodimensional image and the ability to obtain a motion and artifact free 3D-data set;
and (4) three-dimensional imaging only creates a “virtual sense of depth” on a
flat (2-dimensional) screen. And finally, manual endocardial contour tracing is still
required to obtain 3D-volumes.
Three-dimensional echocardiographic imaging has been introduced as a tool to
improve the assessment of both morphologic and functional parameters of the heart.
With the rapid advances in digital image processing, 3-D imaging is probably just at
the beginning of its evolution with a number of innovations already approaching that
will allow improved visualization of cardiac structures. The integration of 3D-systems
into conventional scanners and operator friendly applications will reduce the time and
effort required to obtain 3-D images. Improvements in 2-dimensional imaging and 3dimensional reconstruction software will lead to enhanced image quality. Novel ways
of image representation such as stereoscopy, holography or the generation of
physical 3D-models could enhance our perception of cardiac structures.
The techniques of three-dimensional echocardiography are still in the developmental
stages. Currently, the full 3-D potential of these imaging modalities cannot be
Three D Echocardiography April 16
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appreciated, since the 3-D data are presented on a flat 2D screen. Virtual dynamic
systems, known as virtual reality, can assist with the interpretation of 3-D data of
the heart in space and makes it possible to dive into the 3-D model of the heart.
Every imaging technique in cardiology aims at a complete visualization and
comprehensive assessment of cardiac morphology and pathology, as the heart is a
complex geometric structure. Analysis of the heart in motion in all three or four
(including time) dimensions can therefore further facilitate and enhance the
diagnostic capabilities of echocardiography. Three-dimensional echocardiography is
still in its evolution and at the phase of early adaptation with respect to its clinical
application. It should complement current echocardiographic techniques by providing
better understanding of the topographical aspects of pathology and refined definition
of the spatial relationships of intracardiac structures.
Review History
July 2006
March 2007
March 2008
March 2010
April 2011
March 2012
March 2013
April 2014
April 2015
April 2016
Medical Advisory Council initial approval
Coding Updates
Updated with no changes
Update. No revisions. Codes reviewed.
Updated with Medicare table
Update. No revisions
Update. Revised policy to consider 3-D echocardiography
medically necessary for surgical treatment planning of a
complex surgical cardiac procedure, on an exceptional case by
case basis. Code updates
Update – no revisions. Code updates.
Update – no revisions
Update – no revisions
This policy is based on the following evidence-based guidelines:
1. American Society of Echocardiography Indications and Guidelines for Performance
of Transesophageal Echocardiography in the Patient with Pediatric Acquired or
Congenital Heart Disease - January 2005.
2. American Society of Echocardiography Guidelines and Standards for Performance
the Fetal Echocardiogram - July 2004.
3. ACC/AHA/ASE 2003 Guideline Update for the Clinical Application of
Echocardiography: Summary Article A Report of the American College of
Cardiology/American Heart Association Task Force on Practice Guidelines.
4. Picard MH, Adams D, Bierig M, et al. American Society of Echocardiography.
Recommendations for Quality Echocardiography. Laboratory Operations.
Guidelines and Standards. January 2011.
ACCF/ASE/AHA/ASNC/HFSA/HRS/SCAI/SCCM/SCCT/SCMR 2011 Appropriate Use
Criteria for Echocardiography.
5. Warnes CA, Williams RG, American College of Cardiology; American Heart
Association Task Force on Practice Guidelines (Writing Committee to Develop
Guidelines on the Management of Adults With Congenital Heart Disease);
American Society of Echocardiography; Heart Rhythm Society; International
Society for Adult Congenital Heart Disease; Society for Cardiovascular
Angiography and Interventions; Society of Thoracic Surgeons. ACC/AHA 2008
guidelines for the management of adults with congenital heart disease: a report
of the American College of Cardiology/American Heart Association Task Force on
Practice Guidelines (Writing Committee to Develop Guidelines on the
Management of Adults With Congenital Heart Disease). Developed in
Collaboration With the American Society of Echocardiography, Heart Rhythm
Three D Echocardiography April 16
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Society, International Society for Adult Congenital Heart Disease, Society for
Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons.
J Am Coll Cardiol. 2008 Dec 2;52(23):e1-121.
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Toida R, Watanabe N, Obase K, et al. Prognostic Implication of ThreeDimensional Mitral Valve Tenting Geometry in Dilated Cardiomyopathy. J Heart
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Kurklinsky A, Mankad S. Three-dimensional Echocardiography in Valvular Heart
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Ruddox V, Mathisen M, Bækkevar M, et al. Is 3D echocardiography superior to
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23. Sudhakar S, Nanda NC. Role of live/real time three-dimensional transthoracic
echocardiography in pericardial disease. Echocardiography. 2012 Jan;29(1):98102
24. Thavendiranathan P, Liu S, Verhaert D, et al. Feasibility, accuracy, and
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measure LV volumes and systolic function: a fully automated endocardial
contouring algorithm in sinus rhythm and atrial fibrillation. JACC Cardiovasc
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25. Thorstensen A, Dalen H, Hala P, et al. Three-Dimensional Echocardiography in
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References Update - March 2010
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Perich Duran RM, Subirana Domenech MT, Malo Concepcion P. Progress in
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Valocik G, Kamp O, Visser CA. Three-dimensional echocardiography in mitral
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van den Bosch AE, Koning AHJ , Meijboom FJ, et al. Dynamic 3D
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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
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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
Three D Echocardiography April 16
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otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all
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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.
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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.
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In some
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The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to
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No Authorization or Guarantee of Coverage.
The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service
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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
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other relevant terms and conditions of coverage. In the event the Member’s contract (also known as the
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contract shall govern. The Policies do not replace or amend the Member’s contract.
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The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable
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mandates and regulatory requirements, the requirements of law and regulation shall govern.
Reconstructive Surgery
CA Health and Safety Code 1367.63 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.
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Reconstructive Surgery after Mastectomy
California Health and Safety Code 1367.6 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.
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