Summary Of Evidence

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Analysis of Evidence

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Abstract:
Cardiac catheterization is the introduction and positioning of a catheter into the heart to assess cardiac function and structure, for diagnosis, treatment planning or to monitor therapy. This assessment may include the measurement of intracardiac and intra-arterial pressures, obtaining blood samples for blood gas or other constituent analysis, determination of cardiac output, injection of contrast for angiography, and performing endomyocardial biopsy. The conduct and evaluation of these procedures are then documented by the physician, in a report.

Cardiac catheterization may be utilized in various clinical situations ranging from those requiring only a right heart catheterization to those requiring the performance of right and left heart catheterization with simultaneous interventional procedures including coronary and bypass angiography, angiography of the cardiac chambers, pulmonary angiography, endomyocardial biopsy, and extra-cardiac angiography. The guidelines in this policy outline the indications for coverage of each procedure.

Indications:
Right Heart Catheterization
This is the introduction of a catheter(s) into the right atrium, right ventricle and pulmonary artery. It includes hemodynamic measurements, cardiac output determination, shunt determinations, blood sampling, and hydrogen arrival time as part of the procedure. Placement of catheter(s), repositioning, and replacement with other catheters are included as part of the procedure. Cannulation of the coronary sinus is included in this procedure. Right heart catheterization is a formal diagnostic procedure (with report) performed in a catheterization or other procedure suite, as compared to Swan-Ganz catheterization which is generally performed for ongoing monitoring of the patient (after the initial diagnostic results are recorded), performed at the bedside, or in an operating room, emergency department or other intensive/critical care unit. The results of the Swan-Ganz catheterization may be recorded in the progress notes rather than by a formal report.

Right heart catheterization, performed along with left heart catheterization, coronary angiography, or both, is seldom medically reasonable and necessary unless one disease process appears to affect both sides of the heart, or a different disease process appears to affect each side of the heart.

Indications for Right Heart Catheterization
Right heart catheterization is indicated to evaluate:
1. Valvular heart disease;
2. Congestive heart failure;
3. Congenital heart disease;
4. Cor pulmonale;
5. Pulmonary hypertension;
6. Intracardiac shunts (including septal rupture) and extracardiac vascular shunts;
7. Suspected cardiomyopathy or myocarditis;
8. Endocarditis requiring valvular surgical repair;
9. Suspected rejection of a transplanted heart;
10. Suspected pericardial tamponade or constriction.

Limitations for Right Heart Catheterization
This procedure is performed in a cardiac catheterization laboratory or interventional radiology laboratory, and does not include "bedside placement" of a flow directed (Swan-Ganz type) catheter.

There is no additional reimbursement for a right heart catheterization performed in conjunction with electrophysiologic tests or interventions, HIS bundle studies, pacing studies, temporary pacemaker insertion, endomyocardial biopsy or interventional cardiac procedures, when done for reasons other than a hemodynamic evaluation. Right heart catheterization with hemodynamic measurements done at the same time as these other procedures must still meet the requirements of medical necessity. Right heart catheterization for the purpose of monitoring hemodynamic status during an electrophysiologic or other interventional cardiac procedure or angioplasty is included in that procedure and is not separately reimbursable.

There is no additional reimbursement for leaving a catheter in place for monitoring at the conclusion of a right heart catheterization or for the introduction of a Swan-Ganz type catheter at the time of a right heart catheterization, or for its subsequent removal.

Right heart catheterization is not indicated for:
1. Atherosclerotic heart disease without heart failure; or
2. Angioplasty or other interventional procedures

Swan-Ganz Catheterization
This procedure commonly includes insertion of a flexible, balloon-tipped catheter into the pulmonary artery for bedside diagnosis or hemodynamic monitoring of the critically ill patient. This procedure includes cannulation of a central vein, such as the subclavian or internal jugular vein, through which a flow-directed catheter is advanced into the right atrium (RA), right ventricle (RV), and pulmonary artery (PA). The catheter may be "wedged" briefly into a small pulmonary artery branch for estimation of the left atrial filling pressure. Direct pressure measurements are obtained in each chamber, the pulmonary artery and wedge, and recorded. In addition, other hemodynamic parameters such as the cardiac output, systemic vascular resistance (SVR), mixed venous oxygen saturation, and intrapulmonary shunt fraction may be measured and are included in the procedure. Swan-Ganz catheterization includes the insertion of a central venous line when performed via the same introducer or catheter.

Indications for Swan-Ganz Catheterization
Swan-Ganz catheterization may be indicated in the following situations:
1. Acute myocardial infarction with hemodynamic instability or septal rupture;
2. Severe hypotension of unknown etiology, especially if the response to initial therapy is inadequate (e.g., volume loading);
3. Selected cases of septic shock;
4. Adult respiratory distress syndrome, to confirm the diagnosis of non-cardiogenic pulmonary edema (normal "wedge" pressure) and to aid in subsequent fluid and ventilator management;
5. Suspected cases of cardiac tamponade, to confirm the diagnosis, monitor hemodynamics during pericardiocentesis, and follow response to therapy;
6. Suspected papillary muscle rupture;
7. Congestive heart failure responding poorly to diuretics, especially when intravascular volume status is uncertain;
8. Intraoperative monitoring of patients undergoing open heart surgery, abdominal aortic aneurysm repair, or non-cardiac surgery in high-risk patients with known severe cardiac conditions;
9. Drug overdose, especially when the risk of acute lung damage is high (e.g., heroin, aspirin);
10. Exacerbations of chronic obstructive lung disease requiring intubation; when it is anticipated that hemodynamic monitoring may detect occult or superimposed causes of respiratory failure not suspected clinically (e.g., left ventricular dysfunction);
11. End-stage liver failure with deteriorating renal function;
12. Suspected cases of pulmonary hypertension.

In general, Swan-Ganz catheterization is indicated when measurement of right atrial, pulmonary artery, and pulmonary artery wedge will significantly alter patient management.

Limitations for Swan-Ganz Catheterization
This procedure is done at the bedside in the critical care unit or the operating room.
There is no additional reimbursement for a Swan-Ganz performed in conjunction with electrophysiologic tests or intervention, HIS bundle studies, pacing studies, temporary pacemaker insertion, interventional cardiac procedures or angioplasty, and endomyocardial biopsy catheterization done for reasons other than hemodynamic evaluation. Swan-Ganz catheterization with hemodynamic measurements done at the same time as these other procedures will still have to meet the same requirements of medical necessity. Swan-Ganz catheterization for the purpose of monitoring hemodynamic status during an electrophysiologic or other interventional cardiac procedure or angioplasty is included in that procedure and is not separately reimbursable.

There is no additional reimbursement to leave a catheter in place for monitoring at the conclusion of Swan-Ganz catheterization, or for its subsequent removal. Subsequent hemodynamic measurements (including the inflation of the catheter tip balloon) and blood sampling are not reimbursable under Part B as these functions may be performed by technicians and nurses in a hospital setting and do not require the skill of a physician. Repositioning of an existing catheter is not separately reimbursable and is included in an evaluation and management code.

Swan-Ganz catheterization is not indicated for:
1. Atherosclerotic heart disease without heart failure; or
2. Angioplasty or other interventional procedures.

Left Heart Catheterization
Indications and Limitations for Left Heart Catheterization
This is the introduction of catheter(s) into left ventricle (LV). The catheter may be inserted retrograde from the brachial, axillary or femoral artery; by cutdown or percutaneously; or transseptal via a patent foramen ovale or by septal puncture. The catheterization also includes catheterization of the left atrium and aorta when performed with the LV catheterization. It includes all hemodynamic measurements (with and without maneuvers and/or infusions or medication), blood sampling and shunt determinations as part of the procedure. Placement of multiple catheters and their repositioning or replacement is included in this procedure. Injection procedures for selective opacification of cardiac chambers or structures, arteries and conduits are separately reimbursable.

There is no additional reimbursement for a left heart catheterization done for reasons other than hemodynamic evaluation or LV angiography (i.e., when performed with coronary/bypass angiography, electrophysiologic or pacing studies, or endomyocardial biopsies).

Left heart catheterization is indicated for the diagnosis of, or treatment planning in patients with myocardial abnormalities or dysfunction (including ischemic disease, myocarditis, cardiomyopathy, etc), valvular dysfunction, intracardiac shunts, congenital heart abnormalities, cardiac trauma, or pericardial tamponade.

Cardiac Angiography
Indications and Limitations for Angiography
Angiograms of the individual cardiac chambers (atria and ventricles) are indicated for the assessment of mitral or tricuspid valve function, ventricular function or morphology, suspected ventricular aneurysms, intracardiac shunts, congenital heart disease and cardiac trauma. Each procedure (atrial or ventricular angiography) may be reimbursed only once regardless of the number of injections of contrast, views or actual pictures taken.

Aortography is reimbursable only for diagnoses of aortic root and ascending aorta disease, valvular heart disease or congenital heart disease. It is not reimbursable for atherosclerotic heart disease. Angiograms to visualize the coronary ostia are included as part of coronary angiography. A diagnosis of “rule out (valvular lesion)” is not reimbursable.

Coronary angiography is billed as a single procedure and includes arteriograms of all the coronary arteries and their branches, regardless of the number of vessels selectively catheterized or visualized, with and without the administration of diagnostic or therapeutic vasoactive medications. The procedure may be reimbursed only once regardless of the number of contrast injections, views or films, or whether medications were administered. Replacement and repositioning of catheters are considered as part of the procedure, and are not reimbursable separately. The selective injection procedures may be performed without a formal left heart catheterization. Arterial conduit and venous bypass graft angiography are separately reimbursed using the same criteria as are used for the native coronary circulation (reimbursed only once regardless of the number of contrast injections, views or films, or whether medications were administered).

Coronary and bypass angiography are indicated for the diagnosis of, or treatment planning, for patients with anginal syndromes, atypical chest pain syndrome suggesting ischemia, congenital heart disease, following cardiac arrest thought to be due to ischemia or infarction, myocardial infarction, known atherosclerotic or other coronary disease, suspected graft or stent/PTCA closure, Prinzmetal’s angina, coronary shunts and fistulae, cardiac trauma and for treatment planning in patients undergoing cardiac surgical procedures. It is also indicated for treatment planning in high-risk patients with evidence of ischemic heart disease undergoing high-risk non-cardiac surgical procedures (arterial or aortic surgery, or surgery with large fluid shifts).

Pulmonary Angiography
Indications for Pulmonary Angiography
Indications for pulmonary angiography include suspected pulmonary emboli, pulmonary hypertension, pulmonary A-V malformations or shunts, pulmonary artery stenosis, and congenital heart disease affecting the pulmonary vasculature or pulmonary vasculature or pulmonary venous return.

Intra-Coronary Ultrasound and Doppler Functional Flow Reserve Studies
Indications for Intracoronary ultrasound and Doppler functional flow reserve studies
Intracoronary ultrasound may be separately covered when needed to assess the extent of coronary stenosis if equivocal on angiography, or when needed to assess the patency and integrity of a coronary artery post-intervention. Alternatively, intravascular Doppler velocity and/or pressure derived coronary flow reserve measurement may be performed to assess the degree of stenosis within a vessel.

Angioplasty/Stent Placement/Atherectomy
Indications and Limitations for Angioplasty/Stent Placement/Atherectomy

Diagnostic cardiac catheterization with coronary angiography is separately reimbursable when performed prior to an interventional procedure. It may be performed on the same day or on a previous day, when used as a diagnostic tool to evaluate the need for the intervention, but only once prior to the interventional procedure. Additionally, when the diagnostic and interventional procedures are performed on the same day, multiple surgery pricing will be applied. Angiography before, during, or after an interventional procedure to evaluate results or to guide the catheter(s) is considered incidental to the procedure and not separately reimbursable.

Performance of a diagnostic cardiac catheterization and interventional procedure on the same day is increasingly the standard of practice. While there may be reasons for delaying the interventional procedure (e.g., transfer from a community hospital to a tertiary center, excessive dye load, further treatment planning or evaluation of angiography, etc.), it is recommended that both procedures be performed during the same encounter when medically appropriate. Separation of these procedures for the purpose of circumventing the multiple surgery pricing, or for the convenience of physician or hospital scheduling, could be considered an inappropriate practice and subject the services to review and denial for medical necessity. Reasons for delaying indicated intervention should be documented in the medical record.

Cardiac catheterization requires personal (”at the elbow”) supervision of its performance by a physician. When performed in a teaching setting, the teaching physician must be present, in the room, with the resident, throughout the entire procedure. The performance of these services by the resident alone would not establish a basis for Medicare payment and will be denied as not medically necessary.

Vascular closure (with or without an implantable device or other mechanical intervention) of the puncture site is an inherent part of all procedures for arterial access. It is included in the arterial access codes for all angiographic and catheterization procedures, and may not be billed separately.

Extra-Cardiac Angiography performed with Cardiac Catheterization.
Extra-cardiac angiography (e.g., injection of the abdominal aorta, carotid, ileofemoral or renal arteries) is sometimes performed during the same session with cardiac catheterization.

These procedures are generally not indicated during cardiac catheterization and will be denied unless there are specific medical conditions that would have been appropriate to require angiography independent of cardiac catheterization being performed during the same encounter (i.e., these extra-cardiac angiograms would have been performed at this point in the patient's medical course even if cardiac catheterization had not been performed). The determination of medical necessity will require that there are reasonably anticipated therapeutic implications for which these angiograms will be used. These extra-cardiac angiographic services must be specifically requested (and documented in the patient’s medical record) by the treating physician. Extra-cardiac angiography performed during an encounter other than with cardiac catheterization is not subject to the indications and limitations of this LCD.

Dye injection during catheterization or angiographic procedures for the purpose of guiding the catheter placement is an integral part of the procedures and is not separately reimbursable.

Other Non-covered Procedures During Catheterization

1. Prophylactic insertion of temporary transvenous pacemaker;

2. Assistant at surgery;

3. Right heart catheterization solely for the purpose of inserting a temporary pacemaker, performing endomyocardial biopsy or performing electrophysiologic studies;

4. Standby anesthesia or surgeon during angioplasty;

5. Repositioning and replacement of catheters;

6. Administration of medications during catheterization;

7. Insertion or use of percutaneous vascular closure devices;

8. Anesthesia;

Training Requirements
The American College of Cardiology (ACC) and the American Heart Association (AHA) have issued joint guidelines on training in cardiac catheterization and interventional cardiology. Providers who submit claims for diagnostic catheterization services must have a minimum of Level 2 training as outlined by the ACC/AHA Task Force 3. Submission of claims will be viewed as an attestation that the provider has met these requirements.