Cardiac Catheterization - Medicare Advantage Form

Related Medicare Advantage Medical/Pharmacy Coverage Policies

Percutaneous Coronary Intervention
Transcatheter Valve Procedures

Related Documents

Please refer to CMS website for the most current applicable National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/CMS Online Manual System/Transmittals.

Applicable States/Territories

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Administrative Contractors (MACs)

• LCA for Coronary Angiography - ID 133557 A52850, Jurisdiction J6 - National Government Services, Inc. (Part A/B MAC), Applicable States IL, MN, WI
• LCD LCA Cardiac Catheterization and Coronary Angiography - ID 133959 A56500, Jurisdiction J15 - CGS Administrators, LLC (Part A/B MAC), Applicable States KY, OH
• LCD LCA for Cardiac Catheterization and Coronary Angiography - ID 133557 A52850, Jurisdiction JK - National Government Services, Inc. (Part A/B MAC, Applicable States CT, NY, ME, MA, NH, RI, VT

Description

Cardiac catheterization is an invasive procedure that is used to diagnose certain cardiovascular conditions. A catheter (thin, hollow tube) is inserted into the body through a blood vessel in the arm, groin or neck, then guided to the heart. Pumping ability, pressure and oxygen content in the aorta, pulmonary artery and cardiac chambers (left and right atria, left and right ventricles) may be measured. X-ray images of the coronary arteries, valves and heart chambers are taken after an injection of contrast dye has been administered to allow visualization. The heart valves (aortic, mitral, pulmonary and tricuspid) may be evaluated for leakage or narrowing that decreases heart function.

Cardiac catheterization includes, but may not be limited to, the following specific procedures:

• Bypass graft angiography – X-ray images are obtained of surgically created coronary artery bypass grafts to evaluate graft patency.
• Coronary angiography (angiogram) – A catheter is inserted from an artery in the arm, groin or wrist and into one or more of the coronary arteries to obtain x-ray images using an injection of contrast dye. The images may reveal a narrowing or blockage that reduces blood flow.
• Coronary aortography – X-ray images are obtained of the aorta and its branches to detect abnormalities.
• Intravascular (endoluminal) imaging is used to allow visualization of coronary vessel or graft lesions during a diagnostic or therapeutic cardiac catheterization procedure in order to guide treatment decisions. Techniques include:
  • Intravascular ultrasound (IVUS) allows visualization of the coronary artery wall by utilizing ultrasound to delineate plaque morphology and distribution and to provide guidance for transcatheter coronary intervention.
• Optical coherence tomography (OCT) relies on the reflection of light to obtain cross-sectional detailed images of the coronary artery to characterize the structure and extent of atherosclerosis and assess acute stent placement.
• Left heart catheterization – A catheter is inserted into an artery in the arm, groin or wrist and guided to the left ventricle of the heart to measure pressures or to obtain an angiogram. This procedure is most commonly used to assess coronary anatomy and the presence of coronary artery disease, left ventricular pressure and function and valvular heart disease.
• Right heart catheterization – A catheter is inserted into a vein in the arm, groin or neck and guided to the right-sided heart chambers (right atrium, right ventricle) and the pulmonary artery.

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Pressures and blood oxygen saturations are measured in the chambers, and angiogram images of the right ventricle and pulmonary artery may be obtained. This procedure is often performed as a diagnostic test to evaluate heart failure, valvular heart disease and congenital heart disease.

• Pulmonary artery catheterization (eg, Swan-Ganz catheterization) – Pulmonary artery catheters (PACs) obtain direct measurements of central venous, pulmonary artery, pulmonary artery occlusion and right- sided intracardiac pressures. Cardiac output, systemic and pulmonary vascular resistance as well as mixed venous oxyhemoglobin saturation, oxygen delivery, and oxygen uptake can be estimated using PACs in the evaluation and/or management of an individual with unexplained or unknown volume status in severe cardiogenic shock, shock and suspected or known pulmonary artery hypertension (PAH).58
• Trans-septal catheterization – A catheter enters the left atrium from the right atrium by puncturing through the septum (wall between the left and right atrium) to measure pressures or obtain angiogram images of the left atrium or left ventricle.

If abnormalities (eg, vessel blockage) are revealed during cardiac catheterization, treatment may occur immediately. Percutaneous coronary intervention (PCI) treats an arterial blockage or narrowing using several techniques during the cardiac catheterization procedure which include, but may not be limited to:

• Balloon angioplasty – A deflated balloon is threaded via a catheter through the coronary artery to the region of narrowing or blockage. The balloon is inflated to widen the blocked areas where blood flow has been reduced or cut off. A stent may then be inserted to keep the artery open and reduce the potential for recurrent blockage. For information regarding coronary stents and angioplasty, please refer to Coronary Stents and Angioplasty Medicare Medical Coverage Policy.
• Atherectomy – A rotating shaver is attached to the catheter tip to cut plaque away from the artery to restore optimal blood flow.

Other interventions that may occur during cardiac catheterization include, but may not be limited to:

• Biopsy – A sample of heart tissue or cells is removed to allow evaluation and diagnostic study.

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• Transcatheter heart valve repair or replacement– A catheter-based procedure that repairs or replaces an abnormal or diseased heart valve to restore valve function.

For information regarding transcatheter valve procedures, please refer to Transcatheter Valve Procedures Medicare Medical Coverage Policy.

Coverage Determination

Humana follows the CMS requirement that only allows coverage and payment for services that are reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare.

In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the criteria contained in the following:

Right Heart Catheterization

RIGHT heart catheterization will be considered medically reasonable and necessary when one or more or the following requirements are met:

• Congenital heart disease, known or suspected and one or more of the following:
  • Direct measurement of cardiac chamber pressures or oxygen saturations needed (eg, for intracardiac shunt, valvular heart disease); OR
  • Invasive cardiovascular procedure planned, and preoperative or postoperative catheterization or angiographic imaging needed (eg, for pressure or gradient measurements); OR
  • Known supravalvular aortic stenosis and coronary imaging is needed due to symptoms of coronary ischemia (eg, chest pain or anginal equivalent*, syncope, arrhythmia); OR
  • Noninvasive imaging is nondiagnostic or discordant with physical examination findings; OR
• Congestive heart failure (CHF), as indicated by one or more of the following:
  • Associated with chest pain or anginal equivalent*; OR
  • Constrictive pericarditis; OR
  • Episodic heart failure with preserved ejection fraction on noninvasive testing; OR
  • Left ventricular ejection fraction (LVEF) less than 45%, unexplained by noninvasive testing; OR
  • Post myocardial infarction ventricular aneurysm; OR
  • Post myocardial infarction when LVEF less than or equal to 35%; OR
  • Preoperative planning needed before cardiac transplant or mechanical circulatory support; OR
  • Restrictive cardiomyopathy; OR
  • Reversible ischemia on stress echocardiogram or myocardial perfusion imaging and revascularization (eg, coronary artery bypass graft [CABG], PCI) being considered; OR
  • Wall motion abnormality involving more than 2 segments with low dose dobutamine or at heart rate less than 120 beats per minute; OR
• Cor pulmonale, at initial diagnosis or with worsening symptoms; OR
• Endocarditis requiring valvular surgical repair³²; OR
• Intracardiac shunts (including septal rupture) and extracardiac vascular shunts³²; OR
• Pulmonary hypertension³²; OR
• Repeat evaluation of specific area or structure with same imaging modality, as indicated by one or more of the following:
  • Change in clinical status (eg, worsening symptoms or new associated symptoms); OR
  • Need for interval reassessment that may impact treatment plan; OR
  • Need for re-imaging either prior to or after performance of invasive procedure; OR
• Surveillance of cardiac allograft vasculopathy and acute rejection following cardiac transplant; OR
• Suspected disease or infection of the myocardium (including myocarditis and cardiomyopathy); OR
• Suspected pericardial tamponade or constriction³²; OR
• Valvular heart disease, known or suspected, as indicated by one or more of the following:
  • Atrial myxoma when transesophageal echocardiography (TEE) is indeterminate; OR
  • Individual is symptomatic and echocardiographic findings are equivocal for valve disease severity; OR
  • Mild to moderate valvular heart disease, as indicated by one or more of the following:
    • Canadian Cardiovascular Society class II, III or IV chest pain; OR
    • Ejection fraction less than or equal to 45%; OR
    • Heart failure; OR
    • Ischemia documented by noninvasive testing; OR
  • Noninvasive test results are inconclusive, inconsistent or discordant with individual’s symptoms; OR
  • Preoperative planning needed before Ross procedure to identify coronary orifices if not identified noninvasively; OR
  • Preoperative, preprocedural or intraprocedural planning needed for indicated valve surgery, transcatheter valve replacement or repair, as indicated by one or more of the following:
    • Coronary artery disease (CAD), known or suspected (due to risk factors, symptoms or noninvasive testing); OR
    • Ejection fraction less than 55%; OR
    • Transcatheter aortic valve replacement or percutaneous mitral valve repair, and need to evaluate concomitant coronary artery disease as demonstrated by coronary computed tomography angiography (CCTA); OR
  • Severe aortic or mitral regurgitation on echocardiography;
    AND EITHER:
    • Physical examination findings discordant with echocardiographic or other noninvasive imaging findings; OR
    • Pulmonary hypertension

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  Left Heart Catheterization

  LEFT heart catheterization will be considered medically reasonable and necessary when one or more of the following requirements are met:

  • Cardiac trauma³²; OR
  • Congenital heart disease, known or suspected and one or more of the following:
    • Direct measurement ...

      Stable Chest Pain

      Stable chest pain occurs when symptoms are chronic and associated with consistent precipitants such as exertion or emotional stress.¹¹**GDMT represents individualized optimal medical therapy and lifestyle modifications for CAD and may include antianginal, antihypertensive, antiplatelet and statin or other lipid-lowering therapies along with diet modification, physical activity and smoking cessation.²⁸

      Coronary and Bypass Angiography

      Coronary and bypass angiography will be considered medically reasonable and necessary when one or more of the following requirements are met:

      • Anginal syndromes³³; OR
      • Atypical chest pain* suggesting ischemia³³; OR
      • Cardiac trauma³³; OR
      • Congenital heart disease³³; OR
      • Coronary shunts and fistulae³³; OR
      • Following cardiac arrest suspected to be caused by myocardial ischemia or infarction³³; OR
      • High-risk individual with evidence of ischemic heart disease undergoing high-risk non-cardiac surgical procedures (arterial or aortic surgery, or surgery with large fluid shifts)³³; OR
      • Individual is undergoing a cardiac surgical procedure; OR
      • Known atherosclerotic or other coronary disease³³; OR
      • Myocardial infarction³³; OR
      • Prinzmetal’s angina³³; OR
      • Repeat evaluation of specific area or structure with same imaging modality, as indicated by one or more of the following:
        • Change in clinical status (e.g., worsening symptoms or new associated symptoms); OR
        • Need for interval reassessment that may impact treatment plan; OR
        • Need for re-imaging either prior to or after performance of invasive procedure; OR
      • Surveillance of cardiac allograft vasculopathy and acute rejection following cardiac transplant³³; OR
      • Suspected graft or stent (percutaneous transluminal coronary angioplasty [PTCA]) closure³³

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      Swan-Ganz Catheterization

      Swan-Ganz catheterization will be considered medically reasonable and necessary when one or more of the following requirements are met:

      • Acute myocardial infarction with hemodynamic instability or septal rupture³³; OR
      • Adult respiratory distress syndrome, to confirm the diagnosis of non-cardiogenic pulmonary edema (normal "wedge" pressure) and to aid in subsequent fluid and ventilator management³³; OR
      • Congestive heart failure responding poorly to diuretics, especially when intravascular volume status is uncertain³³; OR
      • Drug overdose, especially when the risk of acute lung damage is high (e.g., aspirin, heroin)³³; OR
      • End-stage liver failure with deteriorating renal function³³; OR
      • 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)³³; OR
      • Intraoperative monitoring of patients undergoing open heart surgery, abdominal aortic aneurysm repair, or non-cardiac surgery in high-risk patients with known severe cardiac conditions³³; OR
      • Selected cases of septic shock (e.g., receiving vasoactive therapy)³³; OR
      • Severe hypotension of unknown etiology, especially if the response to initial therapy is inadequate (e.g., volume loading)³³; OR
      • Suspected cases of cardiac tamponade, to confirm the diagnosis, monitor hemodynamics during pericardiocentesis, and follow response to therapy³³; OR
      • Suspected cases of pulmonary hypertension³³; OR
      • Suspected papillary muscle rupture³³

      Intracoronary Ultrasound

      Intracoronary ultrasound will be considered medically reasonable and necessary when one or more of the following requirements are met:

      • Assessment of the extent of coronary stenosis if equivocal on angiography³²; OR
      • Assessment of the patency and integrity of a coronary artery post-intervention³²

      Doppler Functional Flow Reserve Studies

      Doppler functional flow reserve studies will be considered medically reasonable and necessary when used to assess the degree of stenosis within a vessel.³²

      The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms.

      Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy.

      Coverage Limitations

      US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage