**Abstract:**  
  
Echocardiography is the ultrasonic examination of the heart. Transthoracic
echocardiography (TTE) affords unique insight into cardiac structure and
function. Two-dimensional (2D) imaging defines the configuration and changing
dimensions of the chambers, dynamic cyclic variation in myocardial thickness,
and the associated valvular motions throughout the cardiac cycle. The proximal
great vessels and the pericardium can also be directly visualized, although
transesophageal echocardiography (TEE) often permits better visualization of
the thoracic aorta and great veins than does TTE. (ACC/AHA/ASE 2003 Guideline
Update for the Clinical Application of Echocardiography [hereafter referred to
as the "ACC/AHA/ASE Guideline Update"], pg. 41).  
  
A Doppler examination is a valuable adjunct to a complete echocardiographic
examination. The basic principle utilizes the changes in frequency when a
transmitted ultrasound wave is reflected from moving surfaces (e.g., heart
valves, red blood cells), allowing the capability of measuring normal and
abnormal velocities of blood flow. Such data may lead to the calculation of
valvular stenosis, valvular regurgitation, cardiac output, intracardiac
pressures or intracardiac shunts.  
  
Some cardiac ultrasound machines have become increasingly compact and
portable. Certain "hand carried" scanners are "full featured" and permit a
skilled examiner to image and record permanent records of all of the
tomographic images and Doppler data (both color and spectral) needed to
perform a complete transthoracic echocardiographic examination that may be
quite comparable, in diagnostic value, to that obtained with a larger, "state
of the art" instrument. In order to qualify as a valid echocardiographic
service, the study must be done for an accepted clinical indication by a
properly trained examiner and must include a permanent record of the findings,
data sufficient to support the conclusions and an appropriate interpretation
and written report. Such a study would meet the standards required for a
complete echocardiographic examination, regardless of the size of the
instrument used to perform the study.  
  
All echocardiography services require a referral or an order from a treating
physician.  
  
This policy addresses the medically necessary and appropriate application of
TTE, including stress echocardiography. Transesophageal echocardiography (TEE)
is the subject of a separate policy statement.  
  
 **Indications:**  
  
Echocardiography is indicated in the evaluation of derangements of valvular,
myocardial and pericardial structure and function. The general applications
for coverage include:  
  
 **A. Transthoracic Echocardiogram**  
  
INDICATIONS:  
  
1\. **Ventricular Function, Cardiomyopathies and Heart Failure**  
Changes in myocardial thickness (hypertrophy and thinning), in derived
parameters of contractility, and in chamber volume and morphology, can be
quantitated and charted over time by TTE. Cardiac responses to volume
perturbations, chronic pressure excess and therapeutic interventions can be
monitored. Recognition of the relative contributions of myocardial and
valvular functional perturbations to a clinical presentation is facilitated.
TTE aids in the recognition of myopathies and their classification into
hypertrophic, dilated and restrictive types. Absent clinically documented,
discrete (abrupt change in signs and symptoms) episodes of deterioration, it
is not generally medically necessary to augment clinical assessments with TTE
measurements at more frequent than annual examinations.  
  
There is increasing data to support the prognostic value of diastolic function
parameters in patients with systolic dysfunction. "When the etiology is in
doubt, echocardiography can document or rule out the common cardiac causes of
pulmonary congestion: left-sided valvular disease, depressed systolic or
diastolic function, and cardiomyopathy. In this regard, echocardiography is
the preferred initial diagnostic test when the history, physical examination,
and routine laboratory tests suggest (or cannot eliminate) cardiac disease."
(ACC/AHA/ASE 2003 Guideline Update, pg. 35) "Echocardiography is recommended
for patients with edema with clinical signs of elevated central venous
pressure when a potential cardiac etiology is suspected or when central venous
pressure cannot be estimated with confidence and clinical suspicion of heart
disease is high." TTE is also recommended for patients experiencing "dyspnea
with clinical signs of heart disease."(ACC/AHA/ASE 2003 Guideline Update, pg.
37) "Echocardiography is not recommended in patients with edema when the
jugular venous pressure does not appear to be elevated." (ACC/AHA/ASE 2003
Guideline Update, pg. 35).  
  
2\. **Hypertensive Cardiovascular Disease**  
"Echocardiography is the noninvasive procedure of choice in evaluating the
cardiac effects of systemic hypertension, the most common cause of LV
hypertrophy and congestive heart failure in adults." (ACC/AHA/ASE 2003
Guideline Update, pg. 42) Left ventricular hypertrophy (LVH) correlates with
prognosis in hypertensive cardiovascular disease. However, "the usefulness of
echocardiography in an individual patient with hypertension without suspected
concomitant heart disease depends on the clinical relevance of the assessment
of LV mass or function in that patient. Thus, not every patient with
hypertension should have resting LV function assessed (Class I), but if such
an assessment is relevant, echocardiography is a well-documented and accepted
method by which to achieve it. The value of repeated studies in asymptomatic
hypertensive patients with normal LV function is not clearly established."
(ACC/ AHA 2003 Guideline Update, pg. 42).  
  
Certain antihypertensive medications have been reported to stabilize and
possibly contribute to the regression of left ventricular hypertrophy and the
insidiously progressive development of left ventricular dysfunction and
dilatation. In young individuals and in individuals with borderline
hypertension, the decision to commit to long-term antihypertensive therapy may
be determined by the presence of left ventricular hypertrophy and /or left
ventricular mass calculation.  
  
3\. **Acute Myocardial Infarction and Coronary Insufficiency**  
TTE can detect ischemic and infarcted myocardium. Regional motion, systolic
thickening perturbations and mural thinning can be quantitated and global
functional adaptation assessed. The relative contributions of right
ventricular ischemia and/or infarction can be evaluated. Complications of
acute infarction (e.g., mural thrombi, papillary muscle dysfunction and
rupture, septal defects, true or false aneurysm and myocardial rupture) can be
diagnosed and their contribution to the overall clinical status placed in
perspective. Following an initial TTE in the setting of acute infarction,
repetition frequency will typically be dictated by the acute clinical course.
The medical record should document the medical necessity of the frequency for
TTE assessment.  
  
"Evaluation of chest pain in patients with suspected acute myocardial
ischemia, when baseline ECG and other laboratory markers are nondiagnostic and
when study can be obtained during pain or within minutes after its abatement"
is recommended in the ACC/AHA/ASE 2003 Guideline Update. "The use of
echocardiography for diagnosis of acute myocardial infarction provides the
greatest amount of incremental information when the clinical history and ECG
findings are nondiagnostic." (ACC/AHA/ASE 2003 Guideline Update, pg. 15) This
application may be used as part of a thoughtful clinical evaluation,
especially as a triage decision on chest pain syndrome.  
  
4\. **Exposure to Cardiotoxic Agents (chemotherapeutic and external)**  
Measures of myocardial contractility, thinning and dilatation are important in
the titration of therapeutic agents with known myocardial toxicity. When
echocardiography is used to monitor cardiac toxicity of chemotherapeutic
agents (e.g., degenerative cardiomyopathy produced by doxorubicin therapy), an
initial complete TTE may be performed prior to first administration of the
agent with the frequency of repeat studies determined by the patient's
clinical course and the toxicity profile of the agent being administered,
although tests performed bimonthly during chemotherapy and at six (6) months
following therapy are generally considered medically appropriate.  
  
5\. **Cardiac Transplant and Rejection Monitoring**  
TTE is an integral part of the cardiac donor-selection and donor-recipient
matching process. Evaluation focuses on analysis of ventricular function and
valvular integrity. TTE is also incorporated into the management of allograft
recipients. Myocardial thickness, refractile properties, contractile patterns
and indices, restrictive hemodynamics, and the late development of pericardial
fluid may alert the clinician to a rejection episode. None of these findings
has achieved diagnostic sensitivity or specificity. Typically, TTE is
performed weekly for the first four to eight (4-8) weeks following transplant,
with decremental frequency over time. Absent acute rejection episodes,
approximately two (2) TTE examinations are typically performed yearly in
chronic transplant recipients. TTE of cardiac allografts is most appropriately
serially performed at transplant centers by examiners with expertise in the
management of cardiac allograft recipients. Uses in excess of the generally
accepted frequency will be expected to have appropriate medical necessity
documentation provided.  
  
6\. **Native Valvular Heart Disease**  
TTE is well established as a technique of primary choice for the evaluation of
valvular pathology and its effect upon global myocardial function. The
relative severity of multi-valve pathologies can be quantified. Visualization
of the valve and valvular apparatus facilitates therapeutic decisions when
competing therapeutic options exist. For example, noninvasive TTE remains the
study of choice for monitoring chronic aortic pathology with images suitable
for serial quantitation. In some patients, Doppler echocardiography is the
only noninvasive method capable of identifying the cause of a heart murmur.
(ACC/AHA/ASE 2003 Guideline Update, pg. 7) Absent acute intervention, or a
discrete change in otherwise stable clinical signs and symptoms, it is not
medically necessary to repeat these examinations more frequently than
annually. when the patient's clinical status shows evidence of change or the
plan of care includes consideration for imminent valvular surgery, more
frequent exams may be necessary.  
  
7\. **Prosthetic Heart Valves (Mechanical & Bio-prostheses)**  
TTE assessment soon after prosthetic valve implant is important in
establishing a baseline structural and hemodynamic profile unique to the
individual and the prosthesis. Size, position, underlying ventricular function
and concomitant valve pathologies all impact this unique profile. Reassessment
following convalescence (3-6 months) for establishment of a baseline is
appropriate. Thereafter, re-evaluation of patients with suspected dysfunction,
thrombosis or a change in clinical status or symptoms is indicated.  
  
8\. **Acute Endocarditis**  
TTE can provide diagnostic information; larger vegetations may be directly
visualized; and valvular anatomy and ventricular function directly assessed.
The complications or sequelae of acute infective endocarditis can be detected
and monitored over time. Examination frequency in the acute phase of illness
is dictated by the individual clinical course. When the acute process has been
stabilized, the frequency of serial TTE evaluation will be determined by the
residual pathophysiology and discrete clinical events, analogous to the serial
assessment of chronic valvular dysfunction and/or normally functioning
prosthetic valves.  
  
9\. **Pericardial Disease**  
Detection and quantitation of the amount of pericardial effusion were among
the first, and remain important, applications of TTE. Pericardial fluid
accumulations of as little as twenty (20) milliliters have been reliably
diagnosed by TTE. Cardiac motion and blood flow patterns demonstrated by TTE
characterize the hemodynamic consequences of pericardial fluid accumulation. A
collage of TTE findings has been found to be reliable indices of cardiac
tamponade. TTE can be a valuable adjunct during the removal of pericardial
fluid and creation of pericardial windows. The acute clinical status will
dictate examination frequency. In a patient with evolving pericardial
pathology, a limited focused TTE exam may be appropriate. TTE and Doppler
techniques are quite helpful in identifying pericardial constriction and
differentiating it from restrictive myocardial disease.  
  
10\. **Abnormalities of the Great Vessels**  
Aorta: TTE can provide valuable information when acute or chronic aortic
pathology is present; however, the posterior window of TEE, coupled with the
more posterior position of the thoracic aorta, has rendered TEE a more
determinative study. Noninvasive TTE remains the study of choice for chronic
aortic pathology when images suitable for serial quantitation can be obtained.
Routine (yearly) evaluation is indicated in patients with severe aortic
stenosis or regurgitation, in whom the information obtained will be used in
determining or modifiying the plan of care. In some individuals, such as those
with ascending aortic dilatation or aneurysms, a focused limited follow-up
exam (93308) to serially measure ascending aortic diameters may be indicated.
Although TTE may visualize the intimal flap in patients with aortic
dissection, TEE has proved to be a far more sensitive diagnostic procedure.
TEE is the technique that is indicated in examination of the entire aorta,
especially in emergency situation.  
Pulmonary Artery: It is also indicated for visualization of the main pulmonary
artery segment and the proximal right and left pulmonary arteries.  
  
Venae Cavae: Echocardiography is indicated for visualizing the vena cavae and
diagnosing various congenital and acquired abnormalities such as vena caval
thrombosis, vena caval dilation, and thrombosis or extension of tumors from
the inferior vena cava to the right-heart chambers.  
  
11\. **Congenital Heart Disease**  
In children and small adults TTE provides accurate anatomic definition of most
congenital heart diseases. Coupled with Doppler hemodynamic measurements, TTE
usually provides accurate diagnosis and noninvasive serial assessment. A
technically adequate TTE can obviate the need for preoperative catheterization
in select individuals. When the disease process and therapy are stable, serial
assessment by TTE requires contemporaneous medical necessity documentation, if
the frequency exceeds an annual evaluation. In asymptomatic patients following
repair of ASD, PFO, VSD or PDA follow up examination is only indicated within
the first year after correction.  
  
12\. **Suspected Cardiac Thrombi and Embolic Sources**  
TTE is indicated for the evaluation for cardiovascular source of embolic
events (PFO/ASD, atrial or ventricular thrombus, intracardiac tumor) in
evaluation for patients with abrupt occlusion of a major peripheral or
visceral artery or for with neurological events without evidence of
cerebrovascular disease or other obvious cause. Limited visualization of
atrial appendages and the more peripheral and superior portions of the atria
render TTE less sensitive than TEE in the detection of atrial thrombus and
potentially embolic material. In those instances where the precise diagnosis
and localization of potentially embolic material is of paramount therapeutic
importance and the information so obtained will potentially and substantively
alter therapy, or the risk of anticoagulants is inordinately high,
consideration should be given to TEE if TTE provides inadequate decisional
information.  
  
13\. **Cardiac Tumors and Masses**  
Infiltrative and ventricular tumors and masses can be visualized, their extent
quantitated and their hemodynamic consequences assessed by TTE. Right atrial
space-occupying masses are usually well visualized by TTE. TEE provides a more
detailed view of the left atrium and is more sensitive in quantifying mass
characteristics (solid, cystic, etc.), extensions and attachments. Serial TTEs
may be medically necessary to monitor tumor size or tumor recurrence.  
  
14\. **Critically Ill and Trauma Patients**  
There is a role for echocardiography in the management of critically ill
patients and trauma victims. The diagnosis of suspect aortic or central
pulmonary pathology, cardiac contusion, or a pericardial effusion may be
confirmed. Perturbations of volume status may be more completely defined and
management strategies modified. The frequency of these typically acute studies
will be dictated by the exigencies of the clinical milieu.  
  
15\. **Arrhythmias and Palpitations**  
Transthoracic echocardiography is useful in defining cardiac function in which
arrhythmias occur, and may be useful in the management of cardiac arrhythmias.
Some arrhythmias are frequently associated with underlying organic heart
disease or may predispose the patient to hemodynamic deterioration. Atrial
fibrillation and atrial flutter are examples of arrhythmias in which
echocardiography may be appropriate to assess the underlying disorder.
Echocardiographic studies are appropriate only when there is evidence of heart
disease. Palpitations without evidence of arrhythmias, or minor arrhythmias
(e.g., isolated APC's or VPC's) without evidence of heart disease, are not
covered indications for transthoracic echocardiography.  
  
16\. **Syncope**  
Determination of the etiology of syncopal episodes can be a difficult clinical
problem. The origin may be cardiac, neurological, or due to other causes.
Syncope due to cardiac origin is most commonly related to vasodepressor
reflexes, bradyarrhythmias, or tachyarrhythmias. Syncope is less commonly
caused by cardiac structural disorders. Patients with a structurally normal
heart generally have a much more benign prognosis than those with underlying
structural coronary artery disease or cardiomyopathic disease.
Echocardiography is only appropriate as the initial evaluation, and when other
findings are suggestive of valvular heart disease or obstructive
cardiomyopathy.  
  
17\. **Pulmonary**  
Pulmonary heart disease may result from acute changes in the pulmonary
circulation (e.g., pulmonary embolus), or chronic changes produced by chronic
hypoxia which may cause significant right ventricular dysfunction and
hypertrophy. Echocardiography may assess right ventricular size and
performance, and quantify the severity of pulmonary hypertension using Doppler
interrogation of valvular flow signals. Indications include unexplained
pulmonary hypertension, and pulmonary emboli with suspected right atrial or
right ventricular sources of emboli.  
  
18\. **Contrast Echocardiography**  
Contrast echocardiography is indicated when a conventional study has failed to
provide adequate and critically needed information on left ventricular
function. A contrast agent is considered medically necessary when it is used
to improve the delineation of the left ventricular endocardial borders in a
patient whose non-contrast study is inadequate or suboptimal, and for whom the
LV function information is essential to the management of the patient.
Contrast is indicated when more than two (2) contiguous segments of the left
ventricular border are not visualized.

19\. CAMZYOSTM (mavacamten) treatment  
Patients with symptomatic obstructive hypertrophic cardiomyopathy NYHA Class
II-III may be prescribed mavacamten by a certified and enrolled provider and
pharmacy through a restricted program called the CAMZYOS Risk Evaluation and
Mitigation Strategy (REMS) program.1,2 This requirement is due to serious risk
of heart failure due to systolic dysfunction associated with this agent in
this population, however there are few options for treatment and improvement
in health status on this agent in select patients leading to the REMS program
to provide treatment while furthering understanding of the risk: benefit
ratio.1,3,4This program requires echocardiograms at:  
i. Prior to enrollment  
ii. 4, 8, and 12 weeks after treatment initiation, then every 12 weeks
thereafter  
iii. 4 weeks after interruption of treatment  
iv. 4 and 12 weeks after any dose change (including restart of treatment)  
v. 4 and 12 weeks after initiating a weak CYP2C19 inhibitor or a moderate
CYP3A4 inhibitor

LIMITATIONS:

1\. Echocardiography performed for screening purposes is not covered.
Screening includes testing performed on patients who present with risk factors
(including the risk factor as having a positive family history, e.g., familial
history of Marfan's disease). A screening service for high-risk patients is
considered good medical practice but is not covered by Medicare. When the
result of the test is abnormal, subsequent services may be billed with the
test-result diagnosis; however, the initial screening test must be listed as
screening, even though the result of the screening test may be a covered
condition.

_The following indications (#2-15) are deemed to be not medically necessary
and are therefore not reimbursable:_  
  
2\. Routine (yearly) evaluation of asymptomatic patients with corrected ASD,
VSD or PDA more than one year after successful correction.  
  
3\. Routine (yearly) re-evaluation of mitral valve prolapse in patients with
no or mild mitral regurgitation and no change in clinical status.  
  
4\. Routine (yearly) re-evaluation of an asymptomatic patient with mild native
aortic stenosis or mild-moderate native mitral stenosis and no change in
clinical status.  
  
5\. Routine (yearly) re-evaluation of native valvular regurgitation in an
asymptomatic patient with mild regurgitation, no change in clinical status and
normal left ventricular size.  
  
6\. Routine (yearly) evaluation of a patient with a prosthetic valve in whom
there is no suspicion of valvular dysfunction and no change in clinical
status.  
  
7\. Routine (yearly) re-evaluation of patients with heart failure (systolic or
diastolic) in whom there is no change in clinical status.  
  
8\. Routine (yearly) evaluation of hypertrophic cardiomyopathy in a patient
with no change in clinical status.  
  
9\. Patients who have isolated APC or VPC without other evidence of heart
disease.  
  
10\. Evaluation of LV function with prior ventricular function within the past
year with normal (such as prior echocardiogram, left ventriculogram, SPECT,
cardiac MRI) in patients in whom there has been no change in clinical status.  
  
11\. Initial evaluation of patient with suspected pulmonary embolism in order
to establish diagnosis.  
  
12\. Evaluation of native and/or prosthetic valves in patients with transient
fever but without evidence of bacteremia or new murmur.  
  
13\. Re-evaluation of a patient with known hypertensive heart disease without
a change in clinical status.  
  
14\. Routine evaluation of patients with systemic hypertension without
suspected hypertensive heart disease.  
  
15\. Evaluation of a patient with atrial fibrillation/flutter for left atrial
thrombus or spontaneous contrast when a decision has been made to
anticoagulate and not to perform cardioversion.  
  
[Items 2-15, see ACCF/ASE/ACEP/ASNC/SCAI/SCCT/SCMR 2007 Appropriateness
Criteria for Transthoracic and Transesophageal Echocardiography, JACC 2007].  
16\. Echocardiograms for symptomatic obstructive hypertrophic cardiomyopathy
and administration of mavacamten must be enrolled in the FDA CAMZYOS REMS
program2 and meet all requirement of this program. Echocardiograms used
outside of the protocol will not be covered.  
 **B. Follow-up Studies or Limited Studies**  
  
INDICATIONS AND LIMITATIONS  
  
A complete study includes a full evaluation of all aspects of the heart,
including the cardiac chambers, valves, blood flow, and great vessels. The
images are reviewed, measured, analyzed and interpreted by the physician. A
report is prepared for the patient's record. When a less than complete
examination is performed for the purpose of evaluation of one specific cardiac
problem, or region of the heart, the service performed is described by codes
93304, 93308 and 93321, follow-up or limited studies. When a limited service
is performed, or the patient's condition requires only a limited examination,
these codes must be used to indicate the appropriate service.  
  
Examples of appropriate use of 93308: a follow-up study of a patient with
pericardial effusion following heart surgery, to evaluate progression or
resolution of the effusion; or a serial evaluation of left ventricular
function during antineoplastic chemotherapy.  
  
Examples of appropriate use of 93321: recording tricuspid regurgitant velocity
in order to estimate pulmonary artery systolic pressure; or sequential
evaluation of the transmitral velocity profile in a patient with mitral
stenosis, in order to evaluate for a change in gradient or valve area.  
  
 **C. Doppler Color Flow Velocity Mapping**  
  
INDICATIONS AND LIMITATIONS  
Spectral Doppler echocardiography and Doppler color flow-velocity mapping
(93320, 93321, 93325) may be necessary in addition to an echocardiogram when
the examination could contribute significant information to the patient's
condition or treatment plan (For Dates of service on or after 01/01/2009, code
93306 should be used when Doppler is combined with a complete echocardiogram).
Typically, Doppler is indicated in the evaluation of some heart murmurs,
valvular problems, shunts, suspected congenital heart disease, complications
of myocardial infarction, or cardiomyopathy. Doppler should be medically
necessary for the evaluation and management of the patient.  
  
"Color/spectral Doppler may not be useful or appropriate in certain relatively
small and well-defined patient populations when there is a recent
comprehensive examination and the test is being ordered for re-evaluation of a
limited problem." (ASE comment).  
  
The use of the Doppler is inherent in the ultrasonic cardiac evaluation.
However, if the test reports fail to document the use of this technique to
assess these structures and function (e.g., measurement of valvular
insufficiency or stenosis, myocardial diastolic function, etc. as described by
the ASE), or if the medical records fail to document that the examination was
"clinically necessary" (e.g., follow-up of pericardial effusion size) then the
Doppler portion of the test may be considered medically unnecessary and
denied.  
  
 **D. Limited Capability Ultrasound Scanners**  
  
INDICATIONS AND LIMITATIONS  
  
Some small scanners have more limited capabilities and lack either the
permanent recording capabilities or some of the functional capabilities needed
to perform a complete examination. Such a study may be quite useful as an
extension of the physical examination. However, an examination that does not
meet the standards required for a complete diagnostic echocardiographic
examination - whether performed with a "conventional" scanner or a limited
capability ultrasound scanner - will not be recognized as a valid
echocardiographic service and will be non-covered.  
  
 **E. Stress Echocardiography**  
  
Stress Echocardiography may be necessary when the evaluation could contribute
significant information to the patient's condition or treatment plan. A
nonimaging stress test focuses on the hemodynamic and electrocardiographic
responses to stress. To enhance the diagnostic specificity, the stress test
may be combined with echocardiographic imaging or scintigraphic imaging. A
contrast agent may be used with echocardiographic imaging to enhance
endocardial visualization and diagnostic accuracy. When two (or more) imaging
studies (e.g., ultrasound and scintigraphy) are billed without a supporting
clinical indication for each, one of the services will be denied as not
medically necessary.  
This section addresses the echocardiographic imaging that is done in
association with a stress test.  
  
INDICATIONS  
  
Stress echocardiography may be indicated in the care of patients with real or
suspected ischemic heart disease in the following clinical settings:

  * To detect coronary artery disease in patients presenting with chest pains including atypical chest pains and exertional dyspnea when the suspicion of CAD is high.
  * To assess prognosis and functional capacity in patients following an acute myocardial infarction.
  * To evaluate the extent of exercise induced ischemia in patients who have had a revascularization procedure (PCTA, stent or coronary bypass) or patients who have known CAD disease.
  * In women, stress imaging has been recommended as the "initial test."
  * To evaluate a prior nondiagnostic or abnormal ECG exercise test as a substitute for a nuclear perfusion study.
  * To evaluate patients who are at high risk for myocardial infarction prior to a scheduled major surgical procedure (e.g., aneurysm, vascular surgery, surgeries with large volume shifts, etc) or transplant procedure.
  * To evaluate patients presenting with various arrhythmias (atrial and/or ventricular) or syncope (near or pre), when the suspicion of occult coronary artery disease is high.
  * To evaluate patients when an indicated standard exercise ECG is likely to be non-diagnostic, including patients with an abnormal resting ECG, orthostatic or hyperventilation induced ECG changes, non specific ST-T abnormalities due to ventricular hypertrophy drugs or associated intraventricular conduction defect.
  * To assess myocardial viability (hibernating myocardium) for planned revascularization or functional significance of coronary lesions (if not already known) in planning percutaneous transluminal coronary angioplasty.
  * To evaluate cardiomyopathy when the evaluation could reasonably be expected to contribute significant information regarding the patient''s condition or treatment plan.
  * To evaluate ventricular dysfunction due to post-transplant rejection when the evaluation could reasonably be expected to contribute significant information regarding the patient's condition or treatment plan.
  * To evaluate congenital heart disease, when stress echocardiography helps to determine systemic and right ventricular function at rest and following stress and the presence of any other structural abnormalities, including valvular lesions that may be accentuated with stress.
  * Additionally the test may combined with Doppler intervention to evaluate exercise hemodynamics in patients with mitral stenosis, mitral regurgitation, pulmonary hypertension, aortic stenosis/regurgitation, prosthetic valves and other conditions where symptoms suggest a more severe impairment than the assessment done at rest.
  * Dobutamine stress echo may be indicated to detect low gradient, low output (aortic stenosis) or clinically silent transplant coronary disease.
  * LIMITATIONS 
    * Stress echocardiography used as a screening test for ischemic heart disease in a patient without signs or symptoms is not covered.
    * "An echocardiographic study is not indicated when the pathology and/or systolic ventricular function have been adequately defined by other techniques, making the echocardiographic study redundant." (ACC/AHA/ASE 2003 Guideline Update, pg. 5) Since echocardiography, nuclear testing, magnetic resonance imaging (MRI), and positron emission tomography can yield overlapping if not identical information, often with similar or comparable accuracy, when two or more of these tests provide equivalent information, one (but not both/all) will be covered when medically necessary. Stress tests by multiple modalities (e.g. stress echocardiography, nuclear SPECT) for the same clinical event are covered only if the preceding test was inconclusive or uninterpretable.
    * Studies with or without contrast will be considered a single study, whether performed on the same or subsequent days.
    * Contrast echocardiography is not covered when used to evaluate perfusion. Contrast is not indicated unless more than two (2) contiguous segments of the left ventricular border are not visualized.
    * A stress test must be ordered by a physician or qualified non-physician provider.
    * The resting 12 lead EKG and rhythm strip are considered to be part of the stress test. These services are not separately reimbursable.
    * The initiation of an intravenous line and infusion of a pharmacological agent are considered to be a part of the test, and are not separately reimbursable.   
Stress testing should be conducted by well trained personnel. Only technicians
and physicians familiar with normal and abnormal responses during exercise are
trained to recognize or prevent untoward events. Equipment, medications and
personnel trained to provide cardiopulmonary resuscitation (CPR) must be
readily available.

    * **F. 3-Dimensional Echocardiography**  
  
INDICATIONS AND LIMITATIONS  
  
New techniques for the 3-dimensional echocardiography have been reported.
Initially these reports are mostly related to mitral valve dysfunction
(stenosis and prolapse) and measurement of left ventricular volumes. Three-
dimensional echocardiography appears to be of clinical value in the pre-
operative planning of mitral valve repair for prolapse, and the accurate
calculation of mitral valve area. Although it provides improved calculation of
volumetric studies when compared to 2D echocardiography, when compared to
cardiac MRI, its value in affecting clinical outcomes is not yet proven. When
performed in conjunction with transthoracic echocardiography (93303, 93304,
93306, 93307, 93308) it is indicated only for pre-operative planning in those
patients in whom surgery is already planned and for monitoring the mitral
valve area in patients with moderate to severe mitral stenosis.  
  
 **G. Training Requirements**  
  
While it is not the Contractor's intention or jurisdiction to credential
providers, Medicare does expect a satisfactory level of competence from
providers who submit claims for services rendered. It is well known that
substandard studies often lead to preventable repetition of studies and
overutilization of services.  
  
The acceptable levels of competence are outlined as follows:  
  
_For the technical portion_ , an acceptable level of competence is fulfilled
when the image acquisition is obtained under any one of the following
conditions:  
  

        * The service is performed by a physician; or   
  

        * The technical service is performed by an individual who is credentialed as either a Registered Diagnostic Cardiac Sonographer (RDCS) through the American Registry of Diagnostic Medical Sonographers or as a Registered Cardiac Sonographer (RCS) through the Cardiovascular Credentialing International; or   
  

        * The service is performed at a laboratory (e.g. office, IDTF), credentialed by the Intersocietal Commission for the Accreditation of Echocardiography Laboratories (ICAEL). _Any non-physician personnel used by an IDTF to perform tests must demonstrate the basic qualifications to perform the tests in question and have training and proficiency as evidenced by licensure or certification by the appropriate State health or education department. In the absence of a State licensing board, the technician must be certified by an appropriate national credentialing body. The IDTF must maintain documentation available for review that these requirements are met._
        *   
_For the professional portion_ , an acceptable level of competence is
fulfilled when the interpretation is performed by a physician meeting any one
of the following requirements:  
  

          * The physician is board certified in Cardiovascular Diseases; or   
  

          * The physician has Level II training in transthoracic echocardiography, as defined by the American College of Cardiology/American Heart Association/ American College of Physicians Task Force on Clinical Competence in Echocardiography, or the equivalent of Level II training as set forth in that document.
          *   
_For Facilities_ , quality requirements should encompass approved ACC/AHA/ASE
training standards for physicians, accreditation by ICAEL for facilities, and
certification of cardiac sonographers by recognized national credentialing
organizations as the appropriate quality standards.

The submission of claims for echocardiography will be considered an
attestation that both the technical and professional components of the service
were provided within the context of the above stated credentials.  
  
CGS providers submitting claims for these services will be allowed a 2-year
grace period (until 07/01/2011) to meet these standards.  
  
**Other Comments:**  
  
For claims submitted to the Part A MAC: this coverage determination also
applies within states outside the primary geographic jurisdiction with
facilities that have nominated CGS Administrators, LLC to process their
claims.  
  
Bill type codes only apply to providers who bill these services to the Part A
MAC. Bill type codes do not apply to physicians, other professionals and
suppliers who bill these services to the carrier or Part B MAC.  
  
Limitation of liability and refund requirements apply when denials are likely,
whether based on medical necessity or other coverage reasons. The
provider/supplier must notify the beneficiary in writing, prior to rendering
the service, if the provider/supplier is aware that the test, item or
procedure may not be covered by Medicare. The limitation of liability and
refund requirements do not apply when the test, item or procedure is
statutorily excluded, has no Medicare benefit category or is rendered for
screening purposes.  
  
For dates of service prior to April 1, 2010, FQHC services should be reported
with bill type 73X. For dates of service on or after April 1, 2010, bill type
77X should be used to report FQHC services.  
  
For outpatient settings other than CORFs, references to "physicians"
throughout this policy include non-physicians, such as nurse practitioners,
clinical nurse specialists and physician assistants. Such non-physician
practitioners, with certain exceptions, may certify, order and establish the
plan of care as authorized by State law. (See Sections 1861[s][2] and
1862[a][14] of Title XVIII of the Social Security Act; 42 CFR, Sections
410.74, 410.75, 410.76 and 419.22; 58 FR 18543, April 7, 2000.)

The policy is updated to address echocardiograms for symptomatic obstructive
hypertrophic cardiomyopathy and administration of mavacamten (CAMZYOS) as
enrolled in the FDA CAMZYOS REMS program2 and meet all requirement of this
program.