Transthoracic Echocardiography (TTE)

LCD Information Document Information Source LCD ID N/A LCD ID L34338 Original ICD-9 LCD ID Not Applicable LCD Title Transthoracic Echocardiography (TTE) Proposed LCD in Comment Period N/A Source Proposed LCD DL34338 Opens in a new window Original Effective Date For services performed on or after 10/01/2015 Revision Effective Date For services performed on or after 10/02/2025 Revision Ending Date N/A Retirement Date N/A Notice Period Start Date 04/13/2023 Notice Period End Date 05/27/2023 CPT codes, descriptions, and other data only are copyright 2025 American Medical Association. All Rights Reserved. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. 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Issue Issue Description Coverage and appropriate application of TTE, including stress echocardiography as outlined in the coverage and limitations section. Issue - Explanation of Change Between Proposed LCD and Final LCD CMS National Coverage Policy Language quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See Section 1869(f)(1)(A)(i) of the Social Security Act.Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:Title XVIII of the Social Security Act (SSA):Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Section 1862(a)(7) of Title XVIII of the Social Security Act excludes routine physical examination, unless otherwise covered by statute.Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim. Code of Federal Regulations: 42 CFR, Section 410.32, indicates that diagnostic tests may only be ordered by the treating physician (or other treating practitioner acting within the scope of his or her license and Medicare requirements) and the results must be used in the management of the patient. 42 CFR 410.33 provides credentialing requirements for testing performed in an IDTF by technicians.CMS Publications:CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 9: 100 General Billing Requirements CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 12: Coverage Indications, Limitations, and/or Medical Necessity 19. CAMZYOS™ (mavacamten) treatmentPatients with symptomatic obstructive hypertrophic cardiomyopathy NYHA Class II-III may be prescribed mavacamten by a certified and enrolled provider and pharmacy through a restricted program called the CAMZYOS Risk Evaluation and Mitigation Strategy (REMS) program.1,2 This requirement is due to serious risk of heart failure due to systolic dysfunction associated with this agent in this population, however there are few options for treatment and improvement in health status on this agent in select patients leading to the REMS program to provide treatment while furthering understanding of the risk: benefit ratio.1,3,4This program requires echocardiograms at:i. Prior to enrollment ii. 4, 8, and 12 weeks after treatment initiation, then every 12 weeks thereafteriii. 4 weeks after interruption of treatment iv. 4 and 12 weeks after any dose change (including restart of treatment) v. 4 and 12 weeks after initiating a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor LIMITATIONS: 1. Echocardiography performed for screening purposes is not covered. Screening includes testing performed on patients who present with risk factors (including the risk factor as having a positive family history, e.g., familial history of Marfan's disease). A screening service for high-risk patients is considered good medical practice but is not covered by Medicare. When the result of the test is abnormal, subsequent services may be billed with the test-result diagnosis; however, the initial screening test must be listed as screening, even though the result of the screening test may be a covered condition. To detect coronary artery disease in patients presenting with chest pains including atypical chest pains and exertional dyspnea when the suspicion of CAD is high. To assess prognosis and functional capacity in patients following an acute myocardial infarction. To evaluate the extent of exercise induced ischemia in patients who have had a revascularization procedure (PCTA, stent or coronary bypass) or patients who have known CAD disease. In women, stress imaging has been recommended as the "initial test." To evaluate a prior nondiagnostic or abnormal ECG exercise test as a substitute for a nuclear perfusion study. To evaluate patients who are at high risk for myocardial infarction prior to a scheduled major surgical procedure (e.g., aneurysm, vascular surgery, surgeries with large volume shifts, etc) or transplant procedure. To evaluate patients presenting with various arrhythmias (atrial and/or ventricular) or syncope (near or pre), when the suspicion of occult coronary artery disease is high. To evaluate patients when an indicated standard exercise ECG is likely to be non-diagnostic, including patients with an abnormal resting ECG, orthostatic or hyperventilation induced ECG changes, non specific ST-T abnormalities due to ventricular hypertrophy drugs or associated intraventricular conduction defect. To assess myocardial viability (hibernating myocardium) for planned revascularization or functional significance of coronary lesions (if not already known) in planning percutaneous transluminal coronary angioplasty. To evaluate cardiomyopathy when the evaluation could reasonably be expected to contribute significant information regarding the patient'’s condition or treatment plan. To evaluate ventricular dysfunction due to post-transplant rejection when the evaluation could reasonably be expected to contribute significant information regarding the patient's condition or treatment plan. To evaluate congenital heart disease, when stress echocardiography helps to determine systemic and right ventricular function at rest and following stress and the presence of any other structural abnormalities, including valvular lesions that may be accentuated with stress. Additionally the test may combined with Doppler intervention to evaluate exercise hemodynamics in patients with mitral stenosis, mitral regurgitation, pulmonary hypertension, aortic stenosis/regurgitation, prosthetic valves and other conditions where symptoms suggest a more severe impairment than the assessment done at rest. Dobutamine stress echo may be indicated to detect low gradient, low output (aortic stenosis) or clinically silent transplant coronary disease. LIMITATIONS Stress echocardiography used as a screening test for ischemic heart disease in a patient without signs or symptoms is not covered. "An echocardiographic study is not indicated when the pathology and/or systolic ventricular function have been adequately defined by other techniques, making the echocardiographic study redundant." (ACC/AHA/ASE 2003 Guideline Update, pg. 5) Since echocardiography, nuclear testing, magnetic resonance imaging (MRI), and positron emission tomography can yield overlapping if not identical information, often with similar or comparable accuracy, when two or more of these tests provide equivalent information, one (but not both/all) will be covered when medically necessary. Stress tests by multiple modalities (e.g. stress echocardiography, nuclear SPECT) for the same clinical event are covered only if the preceding test was inconclusive or uninterpretable. Studies with or without contrast will be considered a single study, whether performed on the same or subsequent days. Contrast echocardiography is not covered when used to evaluate perfusion. Contrast is not indicated unless more than two (2) contiguous segments of the left ventricular border are not visualized. A stress test must be ordered by a physician or qualified non-physician provider. The resting 12 lead EKG and rhythm strip are considered to be part of the stress test. These services are not separately reimbursable. The initiation of an intravenous line and infusion of a pharmacological agent are considered to be a part of the test, and are not separately reimbursable. Stress testing should be conducted by well trained personnel. Only technicians and physicians familiar with normal and abnormal responses during exercise are trained to recognize or prevent untoward events. Equipment, medications and personnel trained to provide cardiopulmonary resuscitation (CPR) must be readily available. , an acceptable level of competence is fulfilled when the image acquisition is obtained under any one of the following conditions: The service is performed by a physician; or The technical service is performed by an individual who is credentialed as either a Registered Diagnostic Cardiac Sonographer (RDCS) through the American Registry of Diagnostic Medical Sonographers or as a Registered Cardiac Sonographer (RCS) through the Cardiovascular Credentialing International; or The service is performed at a laboratory (e.g. office, IDTF), credentialed by the Intersocietal Commission for the Accreditation of Echocardiography Laboratories (ICAEL). Any non-physician personnel used by an IDTF to perform tests must demonstrate the basic qualifications to perform the tests in question and have training and proficiency as evidenced by licensure or certification by the appropriate State health or education department. In the absence of a State licensing board, the technician must be certified by an appropriate national credentialing body. The IDTF must maintain documentation available for review that these requirements are met. For the professional portion, an acceptable level of competence is fulfilled when the interpretation is performed by a physician meeting any one of the following requirements: The physician is board certified in Cardiovascular Diseases; or The physician has Level II training in transthoracic echocardiography, as defined by the American College of Cardiology/American Heart Association/ American College of Physicians Task Force on Clinical Competence in Echocardiography, or the equivalent of Level II training as set forth in that document. For Facilities, quality requirements should encompass approved ACC/AHA/ASE training standards for physicians, accreditation by ICAEL for facilities, and certification of cardiac sonographers by recognized national credentialing organizations as the appropriate quality standards. Summary of Evidence N/A Analysis of Evidence (Rationale for Determination) The policy is updated to address echocardiograms for symptomatic obstructive hypertrophic cardiomyopathy and administration of mavacamten (CAMZYOS) as enrolled in the FDA CAMZYOS REMS program2 and meet all requirement of this program.