Effective 6/18/2011 Article A24990 was retired and the information between the brackets below was removed

[ 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. Super-imposition of Doppler velocity recordings (with volumetric flow calculations) provides an integrated picture of cardiac structure, function, and adaptation to both normal and abnormal physiology. The proximal great vessels and the pericardium can also be directly visualized.

Although echocardiography is widely used to assess left ventricular function, up to 10% of routine and 33% of stress echocardiograms are suboptimal, with poor image quality yielding non-diagnostic results. Advances in the technology include transient harmonic imaging, intermittent imaging, and the development of newer contrast agents. Currently, two contrast agents are FDA approved for use in the United States, but others are on the horizon. Because it produces better image quality, Optison has rendered Albumenex virtually obsolete. By using contrast agents, the diagnostic utility of echocardiography is improved, providing:

• Clearer delineation of left ventricular border;
• Identification of under-perfused myocardium;
• Assessment of coronary flow reserve;
• Detection and evaluation of collateral flow. ]

The plethora of structural and functional information provided by TTE is unique among diagnostic testing modalities. The rapid and noninvasive acquisition of this information has contributed to exponential application, and to potential over utilization. This policy addresses the medically necessary and appropriate application of TTE.

For information on transesophageal echocardiography (TEE), see Medicare Advantage Medical Policy Bulletin X-61.

The clinical use of contrast echocardiography is appropriate in selected patients to:

• Evaluate myocardial ischemia;
• Quantify myocardial perfusion during stress;
• Identify the “area at risk” during acute myocardial infarction;
• Determine the success of reperfusion interventions;
• Assess myocardial viability.

Ventricular Function and Cardiomyopathies
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. Without clinically documented, discrete (abrupt change in signs and symptoms) episodes of deterioration, it is not generally medically necessary to repeat TTE assessments more frequently than annually, unless done to evaluate the response to therapeutic intervention.

Although TTE is used in the assessment of ventricular diastolic function, reproducible pathognomonic findings are not well established. In individuals with signs and/or symptoms suggestive of ventricular dysfunction, the demonstration by TTE of normal systolic function and/or ventricular hypertrophy may suggest the presence of diastolic functional abnormalities. Because the TTE findings suggesting diastolic dysfunction are less well established, when this application of TTE is the primary indication for the test, it will be expected to be performed by examiners recognized as experts in assessment and treatment of ventricular diastolic dysfunction.

Evaluation of diastolic filling parameters by Doppler echocardiography is being used to help establish the prognosis in patients with congestive heart failure and systolic dysfunction as well as to evaluate appropriate parameters of medical treatment.

Hypertensive Cardiovascular Disease
When there are no signs or symptoms of heart disease, the use of TTE is not covered for hypertension. Hypertension with clinical evidence of heart disease is a covered indication for TTE evaluation. Left ventricular hypertrophy (LVH) correlates with prognosis in hypertensive cardiovascular disease. Certain anti-hypertensive medications have been reported to stabilize and possibly contribute to the regression of LVH. The decision to commit certain individuals with insidiously progressive borderline hypertension to long-term anti-hypertensive therapy may be determined by the presence of LVH. TTE (code 93308) may assist in the decision to treat through the formulation and analysis of a treatment program. Baseline TTE (code 93308) and serial annual assessments may be medically appropriate. More frequent assessments should have explicit contemporaneous medical necessity documentation.

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. In the setting of acute infarction, repeat study will typically be dictated by the clinical course. If available, the use of contrast agents may improve diagnostic efficiency, and eliminate the need for additional radionuclide testing. Without clinical deterioration or unclear examination findings, repeat assessment is typically performed at discharge. The medical record must document the medical necessity of more frequent TTE assessments.

The role of TTE in the emergency room assessment of individuals presenting with chest pain is not defined at this time. This use is not accepted as a standard-of-care. For TTE to be allowed clinical findings supporting myocardial dysfunction must be present. When these findings are not present, this use is not covered.

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. Baseline assessment, bimonthly during and at six (6) months following therapy is generally considered medically appropriate for exposure to many cardiotoxic agents. Following accidental exposure to known myocardial toxic agents, without abrupt change in clinical signs and/or symptoms, and when cardiac damage has been identified, annual assessment may be considered reasonable and necessary.

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 decreasing frequency over time. Without acute rejection episodes, approximately two (2) TTE examinations are typically performed yearly in chronic transplant recipients. TTE of cardiac allografts is appropriately performed serially 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.

Native Valvular Heart Disease
Detection of mitral stenosis was among the first practical clinical applications of TTE. TTE is well established as the technique of 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, especially interventions for mitral stenosis. Absent acute intervention, or a discrete change in otherwise stable clinical signs and symptoms, TTE is used annually in follow-up of chronic valvular disease to document the course over time. Generally, it is not medically necessary to repeat these examinations more frequently than annually. When the patient’s plan of care includes imminent valvular surgery, more frequent exams may be necessary.

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) is appropriate. Thereafter, absent discretely defined clinical events or obvious change in physical examination findings, annual stability assessment is considered medically reasonable and appropriate. For certain indications, transesophageal echocardiography (TEE) may be the preferred modality for evaluation. (Please refer to separate TEE policy.)

Acute Endocarditis
Transesophageal echocardiography (TEE) has a high degree of sensitivity for endocarditis evaluation, and is typically the diagnostic test of choice. 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. Acutely, examination frequency is dictated by the individual clinical course. When the acute process has been stabilized, the frequency of serial TTE evaluation will be dictated by the residual pathophysiology and discrete clinical events, analogous to the serial assessment of chronic valvular dysfunction and/or normally functioning prosthetic valves.

Pericardial Disease
Detection and quantitation of the amount of pericardial effusion were among the first, and remain important, applications of TTE. Pericardial fluid accumulations as small 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 a reliable indication of cardiac tamponade. TTE can be a valuable adjunct during the removal of pericardial fluid and creation of pericardial windows by balloon techniques. Acutely, clinical status will dictate examination frequency. Absent acute pathophysiology, serial assessment of chronic stable pericardial effusion by TTE is not usually medically necessary. In a patient with evolving pericardial pathology, a limited focused TTE exam may be appropriate. TTE/Doppler findings have moderate specificity and sensitivity and can be useful in the differential diagnosis of chronic pericardial constriction.

Aortic Pathology
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. Frequency of repeat study should be guided by the pathophysiology. In some individuals, such as those with Marfan’s disease or atherosclerotic aneurysms, a focused limited follow-up exam to serially measure aortic diameters and arch diameters may be appropriate.

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 selected individuals. When the disease process and therapy are stable, serial assessment by TTE requires medical necessity documentation, if the frequency exceeds an annual evaluation.

Suspected Cardiac Thrombi and Embolic Sources
TTE is sensitive in the detection of ventricular thrombi and potentially embolic material. Limited visualization of atrial interstices 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 individuals with cardiac pathology associated with a high incidence of thromboemboli (valvular heart disease, arrhythmias -especially atrial fibrillation, cardiomyopathies and ventricular dysfunction), TTE usually provides adequate supplemental data for therapeutic decision making. It merits emphasis that a negative examination (TTE or TEE) does not exclude a cardiac embolus and the findings of thrombus or vegetation does not establish a cardiac embolic source. Repeat examinations are not generally medically required in the absence of finding potentially embolic material.

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. These acute pathologies are not typically followed serially. In specific situations, such as when a tumor is not removed at surgery, and when the patient has had cardiac myxoma removed serial TTEs may be medically necessary to monitor for tumor size or recurrence.

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 clinical situation.

Arrhythmias and Palpitations
TTE 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 clinical suspicion of arrhythmia, or evidence of heart disease, is not a covered indication for transthoracic echocardiography.

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 structurally normal hearts 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, when other findings are suggestive of valvular heart disease or obstructive cardiomyopathy.

Pulmonary
Right heart failure manifesting as edema or ascites may be due to pulmonary hypertension. Pulmonary heart disease may result from acute changes in the pulmonary circulation (e.g., pulmonary embolus) or chronic changes produced by chronic hypoxia that 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 clots in the right atrium or ventricle.

Follow-up Studies or Limited Studies
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 is described by codes 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 code 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 code 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.

Doppler Color Flow Velocity Mapping (code 93325)
Doppler color flow-velocity mapping is an appropriate addition to an echocardiogram when the examination is expected to contribute significant information relative to the patient’s condition or treatment plan. Typically, color flow-velocity mapping is indicated in the evaluation of the symptoms of syncope and dyspnea, some heart murmurs, valvular problems, suspected congenital heart disease, complications of myocardial infarction, or cardiomyopathy. Color flow velocity mapping is not cover when performed routinely with all echocardiographic exams (i.e., without a clinical indication). This is true even when the results of the test reveal abnormalities. If an unsuspected finding on TTE indicates medical necessity for additional study with Doppler color flow velocity mapping, it can be covered. When the test is performed without a specific indication, it is considered routine screening, and must be billed with a screening diagnosis code to indicate the reason for the test.

Stress Echocardiography (code 93350, 93351, 93352)
Stress Echocardiography may be necessary when the evaluation could contribute significant information to the patient’s condition or treatment plan. Typically, one stress imaging study (stress echocardiography or nuclear imaging) is adequate to accomplish the assessment. When two (or more) imaging studies are routinely billed (i.e., without a supporting clinical indication), only one of the services will be allowed and the other(s) will be denied as not medically necessary. Pharmacologically induced stress testing is also subject to medical necessity

Indications and limitations for stress echocardiography (code 93350, 93351, 93352):

1. Acute Myocardial Infarction
   Stress echocardiography is not typically performed during the acute phase of a MI when a diagnosis has been established by other methods. In selected patients, stress echocardiography may be necessary when the evaluation could contribute significant information to the patient’s condition or treatment plan.
   
   
2. Unstable Angina
   Stress echocardiography may be useful as an adjunct to other tests in the diagnosis or treatment of unstable angina only when the combination of history and other tests are not diagnostic. In selected patients, stress echocardiography may be necessary when the evaluation could contribute significant information (e.g. assessment of LV function) to the patient’s condition or treatment plan.
   
   
3. Chronic Ischemic Heart Disease
   Stress echocardiography may be useful as an adjunct to other tests in the diagnosis or treatment of chronic ischemic heart disease only when the combination of history and other tests are not contributory. In selected patients (e.g. assessment of post-CABG symptoms for ischemia, follow-up of patients with symptomatic ischemic heart disease, or asymptomatic patients requiring follow-up that is customized to their condition and disease process) stress echocardiography may be necessary when the evaluation is expected to contribute significant additional information relating to the patient’s condition or treatment plan.
   
   
4. Dilated Cardiomyopathies or Hypertrophic Cardiomyopathy
   Stress echocardiography may be useful in the evaluation of cardiomyopathy when the evaluation could reasonably be expected to contribute significant information to the patient’s condition or treatment plan.
   
   
5. Post-Transplant Cardiac Disease
   Stress echocardiography may be useful in the evaluation of ventricular dysfunction with post-transplant rejection when the evaluation could reasonably be expected to contribute significant information to the patient’s condition or treatment plan.

Pharmacological Stress Agents (codes A9700, J0152, J0280, J0461, J1245, J1250)
For those patients who are unable to obtain 75-100% of their age-predicted maximum heart rate through physiologic exercise, vasodilation can be achieved with the use of either dipyridamole or adenosine. Dobutamine may be used to effect myocardial stress via its inotropic effect.

1. Dipyridamole is administered intravenously at 0.56 mg/Kg over a 4-minute period. The maximum dose should not exceed 60 mg. Since the dilation effect persists, its effect typically is reversed with intravenous aminophylline, which must be available to reverse ischemia when it occurs.
   
   Dipyridamole is relatively contraindicated in patients with:
   
   •  Known bronchospastic lung disease (asthma)
   •  Systemic hypotension (systolic BP below 100 mm Hg)
   •  Acute MI (less than 48 hours)
   •  Unstable angina
     
     
2. Adenosine is administered intravenously at 140 mcg/Kg/min over six minutes (total of 0.84 mg/Kg). The vasodilation effect of adenosine is short-lived. Adenosine is contraindicated in patients with:
   
   • Second- or third degree AV block
   • Sinus node disease except in patients with a functioning artificial pacemaker
   • Known or suspected bronchoconstrictive or bronchospastic lung disease
   • Known hypersensitivity to adenosine
     
     
3. Dobutamine is administered intravenously starting with 5 or 10 mcg/Kg/min and titrated to reach the maximum heart rate for 2-5 minutes. The maximum dose administered is up to 50 mcg/Kg. Atropine may be added in appropriate doses IV. Dobutamine is contraindicated in patients with:
   
   • Idiopathic hypertrophic subaortic stenosis
   • Acute myocardial infarction

Physician Supervision Requirements
The technical component of TTE must be done under the general supervision of a qualified physician, appropriately trained and skilled in the performance and interpretation of echocardiography. Stress echocardiography is covered only when performed under the direct supervision of a qualified physician who provides:

• Medical expertise required for the performance of the test;
• Medical treatment for complications and side effects of the test;
• Medical services required as part of the test, for example, injections or the administration of medications;
• Medical expertise in the interpretation of the test, some of which has to be provided during the test and before the patient is discharged from the testing suite.

Reasons for Noncoverage

Echocardiograms are not covered when performed with equipment that provides limited evaluations. Such evaluations typically do not provide a permanent image and complete interpretation is not performed. These tests have demonstrated value in screening-type evaluations, although they are then considered part of the physician’s exam, similar to a blood-pressure measurement.

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). Screening service for high-risk patients is considered good medical practice but is not covered. When a screening test is performed, use the appropriate screening diagnosis code to indicate the test is being done for screening purposes. 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. Symptoms or an existing condition must be present to meet medical necessity. A provider can bill the member when an echocardiogram is performed for screening purposes.

Diagnostic injection services are an integral part of a contrast procedure and are not separately payable.

Services performed for excessive frequency are not medically necessary. Frequency is considered excessive when services are performed more frequently than generally accepted by peers and the reason for additional services is not justified by documentation.

Services performed for conditions not covered by this policy will be considered not medically necessary. A provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

Documentation Requirements

• The patient's medical record must document the medical necessity of services performed for each date of service submitted on a claim, and documentation must be available upon request.
• When pharmacologic stress is used, the record must show clinical evidence supporting the reason exercise was not possible.
• The medical record must document when significant resting ECG abnormalities are present, or a medication that would interfere with interpretation of a stress ECG is being used and cannot be withdrawn, resulting in the selection of a stress echocardiogram.
• When TTE is performed in the emergency room assessment of a patient presenting with chest pain, clinical findings indicative of myocardial dysfunction must be present.
• When TTE is performed to assess exposure to a cardiotoxic agent, the name of the cardiotoxic agent must be indicated.
• When TTE is performed as the initial test to evaluate syncope, clinical findings indicative of valvular heart disease or obstructive cardiomyopathy must be documented.
• Services submitted for echocardiography with stress tests performed as preoperative evaluations of patients without symptoms of CAD who are deemed to be at moderate risk must document one of the following at risk conditions in the medical record: Diabetes mellitus with complications, Peripheral vascular disease, Aortic aneurysm, or Cerebrovascular disease.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Effective 6/18/2011 Article A24990 was retired and the information between the brackets below was removed

[ The following coding information is specific to Transthoracic Echocardiography:

• Separate payment is allowed for drugs used in testing. The name and dosage of the drug must be indicated.
• When the test is for screening purposes and a denial is required, report diagnosis code  V81.0.
• Code 93350 is a global code and must be billed with modifier 26 when performed in a hospital setting.
• A physician who supervises and interprets a stress test performed with an echocardiogram must report code 93015 when the test is performed in a freestanding clinic or the office setting. Do not use a modifier with code 93015.
• Report the professional component of the stress test (codes 93016 or 93018) for hospital inpatient and outpatient studies.
• For supervision without interpretation and report code 93016.
• For interpretation and report without supervision use code 93018.
• When a limited service is performed, or the patient's condition requires only a limited examination, codes 93308 or 93321 must be used to indicate the appropriate service.
• Diagnosis code V72.85 should be used to report a baseline TTE performed prior to exposure to cardiotoxic agent.
• Code 995.20 or 995.29 should be used to report follow-up TTE performed after exposure to cardiotoxic agent.
• When reporting code A9700 the name and dosage of the contrast agent must be submitted with the claim.
• When code A9700 is reported for a contrast agent other than Perflutren Lipid Microsphere or Optison, an invoice indicating the name, dosage and cost of the contrast agent will be needed to process the claim. ]

Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

CMS Online Manual Pub. 100-03, Chapter 1, Section 220.5

Use of these codes does not guarantee reimbursement. The patient’s medical record must document that the coverage criteria in this policy have been met.


Applicable to codes 93303 and 93304

Applicable to codes 93306, 93307, 93308, 93320, 93321

Effective 10/01/2010 codes 275.0 and 276.6 were removed

Applicable to code 93325

Effective 10/01/2010 codes 275.0 and 276.6 were removed

Applicable to codes 93350, 93351, 93352