Document Information
Source LCD ID
N/A
LCD ID
L35083
Original ICD-9 LCD ID
Not Applicable
LCD Title
Cardiology Non-emergent Outpatient Stress Testing
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL35083
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 04/25/2021
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
03/11/2021
Notice Period End Date
04/24/2021
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Issue
Issue Description
Issue - Explanation of Change Between Proposed LCD and Final LCD
CMS National Coverage Policy
This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for cardiology non-emergent outpatient stress testing. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for cardiology non-emergent outpatient stress testing and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site. IOM Citations: Social Security Act (Title XVIII) Standard References: Code of Federal Regulations (CFR) References:
Coverage Guidance
Coverage Indications, Limitations, and/or Medical Necessity Compliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits. History/Background and/or General InformationNoninvasive testing in the outpatient setting to assess for coronary artery disease (CAD) and left ventricular (LV) dysfunction may be accomplished by utilizing conventional exercise stress testing without imaging or by utilizing exercise or pharmacologic stress testing with imaging. Cardiovascular stress testing, also referred to as exercise stress test (EST), exercise electrocardiogram, exercise treadmill test (ETT), graded exercise test, or stress electrocardiogram (ECG), is used to provide information about how the heart responds to exertion. Types of stress testing with imaging addressed in this LCD include stress echocardiography, single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI), positron emission tomography (PET) MPI, and cardiac magnetic resonance imaging (CMR). Stress testing with imaging can be performed with maximal exercise or chemical stress (dipyridamole, dobutamine, adenosine, regadenoson, or other provocative agents).1,2 Stress echocardiography, SPECT MPI, PET MPI and CMR are considered equivalent diagnostic tests. However, in addition to myocardial ischemia, stress echocardiography can provide information that is not obtainable with MPI, such as valve function, assessment of pulmonary pressure, and assessment of dynamic obstruction. The most commonly performed myocardial perfusion imaging are single (at rest or stress) and multiple (at rest and stress) SPECT studies. The CMR can also distinguish scar from hibernating myocardium, provide information about valvular function, the presence of myocardial fibrosis, the presence of morphological abnormalities, and provide an assessment of dynamic obstruction without radiation exposure. This is especially valuable in patients in whom good quality echocardiography images could not be obtained due to technically difficult acoustic windows.3,4In many instances, EST may be combined with imaging procedures, such as MPI, echocardiography, or other imaging procedures. A pharmacologic stress test may be performed when patients are unable to exercise. This test involves the administration of a medication that is designed to make the heart respond as if the patient was exercising. The pharmacologic testing allows the provider to determine how the heart responds to stress in the absence of exercise. Imaging of myocardial perfusion can also be combined with myocardial metabolism imaging with fluorodeoxyglucose (F-18 FDG) for the assessment of myocardial viability in areas of resting hypoperfusion and dysfunctional myocardium. The stress protocols are, for the most part, similar for all cardiac PET perfusion agents. The specific differences in acquisition protocols for rubidium (Rb-82) and ammonia N-13 are related to the duration of uptake and clearance of these radiopharmaceuticals and their physical half-lives. Covered Indications Stress testing without cardiac imaging will be considered medically reasonable and necessary for: The following are considered not medically reasonable and necessary: Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.
Stress testing with cardiac imaging will be considered medically reasonable and necessary for:
Limitations
Provider QualificationsExercise testing must be supervised consistent with the CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 80. The appropriately trained provider in exercise testing must be capable of recognizing signs and symptoms of cardiac disease and capable of interpreting the exercise test findings. Exercise testing in selected patients may be conducted by a healthcare professional that has training in a related health area, has appropriate training in the supervision of exercise stress tests, and is capable of performing cardio-pulmonary resuscitation.3,50
Summary of Evidence Multiple guidelines and appropriate use criteria are available for cardiovascular stress testing with and without cardiac imaging. Pretest probability is used to determine if cardiovascular stress testing is appropriate and whether cardiac imaging is also appropriate.5-10,15 The pretest probability of CAD is based on age, gender, and symptoms.5Evidence-based guidelines Exercise stress testing without cardiac imaging Fleisher et al19 recommends pre-operative cardiac evaluation in patients undergoing noncardiac surgery with an intermediate risk for surgery (cardiac risk 1-5%) or with a high risk for surgery (> 5% cardiac risk) and the results will affect patient management decisions. In this regard, exercise stress testing is recommended for patients who are able to exercise and pharmacologic stress testing for patients who are unable to exercise. Stress testing with cardiac imagingPharmacological imaging studies may be appropriate for those patients who are unable to reach 75–100 percent of their age-predicted maximum heart rate by physiologic exercise. The SPECT MPI is highly accurate to diagnose flow-limiting CAD and to stratify risk of ischemic heart disease events.9 A strength of SPECT is the availability of robust software programs for the interpretation of MPI. Hendel et al17 provided a multicenter assessment of the use of single-photon emission computed tomography myocardial perfusion imaging with appropriateness criteria. Dorbala et al24 has also provided SPECT MPI guidelines. Consistent with these guidelines, stress testing with cardiac imaging is recommended for patients without cardiac symptoms who underwent a PCI (with stent) procedure or a CABG more than 2 years prior and have not undergone an evaluation for CAD within the past 2 years [stress echocardiogram, SPECT MPI, PET MPI, CMR, coronary computed tomography angiography (CCTA), cardiac catheterization] and are unable to exercise.6-8,15,17,18 A stress test with cardiac imaging is also recommended for patients with cardiac symptoms who had a PCI procedure (with stent) or a CABG procedure more than 5 years ago and who have not undergone an evaluation for CAD within the past 2 years [stress echocardiogram, SPECT MPI, PET MPI, CMR, CCTA, cardiac catheterization].6-8,15,17Evidence-based guidelines also recommend stress testing with cardiac imaging for patients experiencing new, recurrent, or worsening cardiac symptoms, including otherwise unexplained angina equivalent symptoms, and any of the following: a) Physical inability to perform a maximum exercise workload,2,5,6,8-10,15,20 b) New or previously unrecognized uninterpretable ECG,2,5,6,8-10 c) ECG is uninterpretable for ischemia due to any one of the following2,5,8,9,15,21: 1) Complete left bundle branch block (right bundle branch does not render ECG uninterpretable for ischemia); 2) Ventricular paced rhythm; 3) Pre-excitation pattern such as Wolff-Parkinson-White; 4) A > 1 mm ST segment depression (Not nonspecific ST/T wave changes); 5) Left ventricular hypertrophy (LVH) with repolarization abnormalities, also called LVH with strain (Not without repolarization abnormalities or by voltage criteria); or 6) Patient on digoxin therapy. Stress testing with cardiac imaging is also recommended for patients with a history of CAD based on a prior anatomic evaluation of the coronary arteries or a history of CABG or PCI.6,8,15Consistent with evidence-based guidelines, stress testing with cardiac imaging is recommended for patients with the following conditions: a) Evidence or high suspicion of ventricular arrhythmias,6-8,10 b) Worsening or continuing symptoms in a patient who had a normal or submaximal exercise stress test and there is suspicion of a false negative result,20,22 c) Patients on beta blocker, calcium channel blocker, and/or antiarrhythmic medication when the documentation supports that an adequate workload may not be attainable to enable a fully diagnostic exercise study,2,5 d) History of false positive exercise stress test (e.g., one that is abnormal, but the abnormality does not appear to be due to macrovascular CAD),22 e) Evaluation of chest pain syndrome after revascularization or in patients with intermediate to high pre-test probability for CAD regardless of ECG interpretability or ability to exercise,7,8 and f) High pre-test probability for CAD regardless of ECG interpretability or the ability to exercise, and a decision to perform cardiac catheterization or other angiography has not already been made.7,8,10,15Meta-AnalysisStress testing with cardiac imaging The Kazmirczak et al article found that regadenoson stress CMR imaging is safe and well tolerated in heart transplant recipients.36 An abnormal regadenoson stress CMR identifies heart transplant recipients at a higher risk for major adverse cardiovascular events. Also, Kan and Bangalore found that among renal transplant recipients, SPECT-MPI predicted risk of cardiovascular death and cardiovascular hospitalization events.38 The Sade et al article also concluded that echocardiographic coronary flow reserve is very sensitive for detecting cardiac allograft vasculopathy and increases the diagnostic accuracy of dobutamine stress echocardiography in heart transplant recipients.39 Additionally, Elhendy et.al found dobutamine stress myocardial perfusion imaging is a safe and feasible method for evaluation of coronary artery disease in heart transplant recipients.40 Evidence-based guidelines10 also recommend stress imaging prior to planned cardiac or other solid-organ transplant. Situations in which cardiovascular stress testing is not recommendedStress testing with or without imaging for pre-operative evaluation of asymptomatic patients undergoing intermediate or high risk noncardiac surgery would not be expected for patients 12 months following a normal stress echocardiography, SPECT MPI, PET MPI, CMR, coronary computed tomography angiography (CCTA), or cardiac catheterization.7,10,19 Also, utilization of SPECT MPI, PET MPI, stress echocardiography or CMR for the pre-operative evaluation of planned intermediate or high risk, noncardiac surgery, in the patient with normal or minor changes in resting ECG would not be expected for patients with no contraindications to exercise6-8,17,19The review of the American Diabetes Association standards of medical care in diabetes 2018 states routine screening for CAD in asymptomatic patients is not recommended as it does not improve outcomes if atherosclerotic cardiovascular disease risk factors are treated. Screening is not recommended in part because high risk patients should already be receiving intensive medical therapy-an approach that provides benefit similar to that of invasive revascularization.11 The review states to consider investigations for CAD in the presence of atypical symptoms, signs and symptoms of associated vascular disease, or electrocardiogram abnormalities. Absolute and relative contraindications to exercise testing are addressed by Henzlova and Gibbons.2,5 Although exercise testing is generally a safe procedure, both myocardial infarction and death have been reported at a rate of approximately 1 per 2500 tests. Therefore, it is vital to use good clinical judgement in decisions regarding which patients should undergo exercise testing. Qaseem et al49 discussed the clinical practice guideline for diagnosis of stable ischemic heart disease and indicated pharmacologic stress imaging by MPI, echocardiography, or CMR are not recommended for patients with an interpretable ECG and who are able to exercise. Cardiovascular stress testing with or without cardiac imaging is also not recommended when a decision to perform cardiac catheterization or other angiography has already been made or for pre-operative evaluation for low risk noncardiac surgery. Also, only one type of stress test should be performed in patients who recently demonstrated coronary stenosis of uncertain functional significance in a major coronary branch on an anatomic imaging study (coronary angiogram or CCTA). Additionally, consistent with evidence-based guidelines, exercise testing or radiologic imaging performed within 2 years of PCI without specific symptoms (e.g., chest pain, ECG changes, etc.) is not recommended.8,17,18
Exercise stress testing without cardiac imaging for patients who can exercise and stress testing with cardiac imaging for patients who are unable to exerciseMultiple articles address that the confounders of stress ECG interpretation include resting ST-segment depression, left ventricular hypertrophy with repolarization abnormalities, left bundle branch block, various medications, pre-excitation pattern such as Wolff-Parkinson-White, and ventricular paced rhythm.2,5,8,9,15,21 An exercise or pharmacological imaging study should be considered for patients with an abnormal resting ECG due to left bundle branch block, pre-excitation syndrome, left ventricular hypertrophy (LVH), new-onset atrial fibrillation, or digoxin therapy, because the accuracy of the exercise ECG in detecting provocable ischemia is reduced.2,5,10,12,13 An exercise or pharmacological imaging study should also be considered for patients with disease conditions associated with CAD (e.g., atherosclerotic abdominal aortic aneurysm, peripheral vascular disease, carotid artery disease, chronic renal failure) with no evaluation performed within the preceding 2 years.5,7,10,17Shen et al16 provided the 2017 American College of Cardiology/American Heart Association guideline for the evaluation and management of patients with syncope. Stress testing is recommended for patients with an intermediate or high CHD risk (ATP III risk criteria) who have experienced syncope (an abrupt, transient, complete loss of consciousness) when cardiac etiology is suspected based on an initial evaluation, including history, physical examination, or ECG. An exercise stress test is recommended for patients who can exercise and pharmacological stress imaging is recommended for patients who are unable to exercise.6,8,10,15,16The guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery states perioperative cardiac and long-term risks are increased in patients who are unable to perform 4 METs of work during daily activities.19 Perioperative myocardial ischemia and cardiovascular events were more common in those with poor functional status. Patients undergoing low-risk noncardiac surgery and patients undergoing elevated risk noncardiac surgery with moderate or greater functional capacity do not require cardiovascular stress testing. For patients undergoing elevated risk noncardiac surgery with poor (<4 METs) or unknown functional capacity and further testing will impact decision making or perioperative care, it may be reasonable to perform cardiovascular stress testing.
The Lipinski et al article was a meta-analysis which showed that stress CMR provided excellent prognostic stratification of patients with known or suspected CAD.1 Patients with a negative stress CMR had a <1% annualized event rate for cardiovascular death or nonfatal myocardial infarction. Patients with a positive stress CMR had a 5% annualized event rate. The presence of late gadolinium enhancement (LGE) during CMR suggested an increased risk for major adverse cardiovascular events. This imaging modality not only provides assessment of ischemia and recognition of LGE but can also identify valvular heart disease and assess cardiac structure and function. Stress CMR is considered to be comparable to other stress testing modalities in patients who cannot exercise. The Leiner et al position paper supports that in addition to assessing for myocardial ischemia, CMR can also distinguish scar from hibernating myocardium, provide information about valvular function, the presence of myocardial fibrosis, the presence of morphological abnormalities, and provide an assessment of dynamic obstruction. This is especially valuable in patients in whom good quality echocardiography images could not be obtained due to technically difficult acoustic windows.3,4 The 2020 AHA/ACC Guideline for the Diagnosis and Treatment of Patients With Hypertrophic Cardiomyopathy indicates that while echocardiography continues to be the foundational imaging modality for patients with HCM, CMR will also be helpful in many patients, especially those in whom there is diagnostic uncertainty, poor echocardiographic imaging windows, or where uncertainty persists regarding decisions around implantable cardioverter-defibrillator (ICD) placement.4The appropriate use criteria for echocardiography is a meta-analysis that addresses appropriate use of echocardiography.6 Stress echocardiography is recommended for asymptomatic patients with a coronary calcium Agatston score >400, for patients with new or worsening symptoms with a previous abnormal stress test and the inability to exercise. A stress echocardiography is also recommended for evaluating inducible ischemia in patients with an intermediate risk for coronary artery blockages and have established CAD, experienced an ACS event (STEMI, NSTEMI, or unstable angina) within the past 90 days provided that they did not undergo coronary angiography at the time of the acute event and are currently clinically stable. Additionally, stress echocardiography is recommended to assess chronic valvular disease, pulmonary hypertension, new, recurrent, or worsening left ventricular dysfunction/congestive heart failure, to assess patients without clear cardiac symptoms in the presence of an elevated cardiac troponin, and to evaluate patients with recent equivocal or borderline testing where ischemia remains a concern. Stress echocardiography, as well as myocardial perfusion imaging or cardiac magnetic resonance is also recommended to assess myocardial viability in patients with significant ischemic ventricular dysfunction (suspected hibernating myocardium) and persistent symptoms or heart failure such that revascularization would be considered.49 In addition, the guideline for the diagnosis and treatment of hypertrophic cardiomyopathy (HCM) addresses the use of stress echocardiography for the detection of dynamic LVOT obstruction.14 Cardiac involvement in sarcoidosis may lead to adverse outcomes such as advanced heart block, arrhythmias, cardiomyopathy, or death. Multiple articles support F-18 FDG PET MPI is indicated to diagnose cardiac sarcoidosis in patients who are unable to undergo MRI, have inconclusive MRI findings, or when high probability of disease exists even after a negative MRI. The PET MPI is also indicated to determine response to immunosuppressive therapy in patients diagnosed with cardiac sarcoidosis.15,41-48 The PET MPI can be safely performed on patients with intracardiac devices and advanced renal disease and is considered to be an appropriate tool to predict and assess response under therapy.41,44,46,47,51-53Multiple articles address the increased risk for premature cardiovascular disease following organ transplantation.10,27-35 There are unique factors in organ transplant recipients that include underlying comorbidities and metabolic effects of immunosuppression.27 In this regard, the Ducloux et al study demonstrates the cumulative impacts of traditional and nontraditional cardiovascular risk factors in renal transplant recipients.28 Also, according to Gamba et al, cyclosporine, regardless of the blood cyclosporine levels, is the main risk factor for coronary artery disease.29 Additionally, Tepperman et.al noted that although immunosuppressive agents are sufficient to minimize allograft rejection and promote short-term survival after transplantation, a major limitation to longer-term survival is the development of allograft vasculopathy.30 Central to development of allograft vasculopathy is endothelial damage and subsequent dysfunction. The factors contributing to endothelial dysfunction include organ preservation solutions, ischemia and reperfusion injury, acute allograft rejection episodes, dyslipidemia, hypertension, diabetes mellitus, and the use of immunosuppressive drugs. Notably, many of the currently used immunosuppressants cause endothelial dysfunction after transplantation.
Analysis of Evidence (Rationale for Determination) Cardiac stress tests play an important role in the diagnosis and management of cardiovascular disease. Pretest probability is used to establish if cardiovascular stress testing or cardiac imaging is appropriate. Multiple guidelines and appropriate use criteria are available for cardiovascular stress testing with and without cardiac imaging. Meta-analyses of literature offer recommendations regarding the suitable use of exercise stress testing and pharmacologic stress testing in the diagnosis and treatment of symptomatic or asymptomatic patients with known or suspected CAD. Pharmacologic imaging studies may be appropriate for those patients who are unable to reach 75–100 percent of their age-predicted maximum heart rate by physiologic exercise. The various guidelines and literature also address absolute and relative contraindications to exercise testing. Studies have shown that perioperative myocardial ischemia and cardiovascular events were more common in those with poor functional status. Therefore, it may be reasonable to perform cardiovascular stress testing in patients undergoing high risk noncardiac surgery with poor (<4 METs) or unknown functional capacity as this information could possibly impact decision making or perioperative care. However, consistent with evidence-based guidelines, patients who will be undergoing low-risk noncardiac surgery and patients who will be undergoing elevated risk noncardiac surgery with moderate or greater functional capacity do not require cardiovascular stress testing. The SPECT MPI is highly accurate to diagnose flow-limiting CAD and to stratify risk of ischemic heart disease events. A strength of SPECT is the availability of robust software programs for the interpretation of MPI. Studies have also shown that the SPECT-MPI has successfully predicted risk of cardiovascular death and cardiovascular hospitalization events in renal transplant recipients. Additionally, studies have indicated that dobutamine stress MPI is a safe and feasible method for evaluation of coronary artery disease in heart transplant recipients. Studies show that patients with a negative stress CMR had a <1% annualized event rate for cardiovascular death or nonfatal myocardial infarction whereas patients with a positive stress CMR had a 5% annualized event rate suggesting that the stress CMR provides an excellent prognostic stratification of patients with known or suspected CAD. The stress CMR not only provides assessment of ischemia and identifies the presence of LGE but can also recognize valvular heart disease and assess cardiac structure and function. Stress CMR also seems to be comparable to other stress testing modalities. Studies have shown that an abnormal regadenoson stress CMR identifies heart transplant recipients at a higher risk for major adverse cardiovascular events. Studies indicate CMR imaging is safe and well tolerated as a prognostic stratification tool for recognizing valvular heart disease, assessing cardiac structure and function and identifying heart transplant recipients at a higher risk for adverse cardiovascular events. Stress echocardiography is used for patients with known or suspected CAD who are symptomatic or asymptomatic. Stress echocardiography is used to assess chronic valvular disease and pulmonary hypertension and for the detection of LVOT obstruction. Also, studies have found that the echocardiographic coronary flow reserve is very sensitive for detecting cardiac allograft vasculopathy and increases the diagnostic accuracy of dobutamine stress echocardiography in heart transplant recipients. The F-18 FDG PET MPI is indicated to diagnose cardiac sarcoidosis in patients who are unable to undergo MRI, have inconclusive MRI findings, or when high probability of disease exists even after a negative MRI. The PET MPI is also indicated to determine response to immunosuppressive therapy in patients diagnosed with cardiac sarcoidosis. The PET MPI can be safely performed on patients with intracardiac devices and advanced renal disease and is considered to be an appropriate tool to predict and assess response under therapy. Stress echocardiography, SPECT MPI, PET MPI and CMR are considered equivalent diagnostic tests. However, in addition to myocardial ischemia, stress echocardiography can provide information that is not obtainable with MPI, such as valve function, assessment of pulmonary pressure, and assessment of dynamic obstruction.
