Humana Code Compendium (Cardiovascular) Form

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Provider Claims Codes 33289, 93264, 93451, 93568, 93799, C2624 93050 0266T – 0273T, C1825 0541T, 0542T 0607T, 0608T 0613T 0643T 0644T 0645T 0659T 0674T – 0685T 0692T 0715T, C1761 0716T 0764T, 0765T, C9786 C9759 Section Title Wireless Pulmonary Artery Pressure Monitoring Noninvasive Measurement of Central Blood Pressure Implantable Carotid Sinus Stimulators Magnetocardiography for Detection of Cardiac Ischemia External Continuous Pulmonary Fluid Monitoring Interatrial Septal Shunt Devices Transcatheter Left Ventricular Restoration Device Percutaneous Debulking or Removal of Intracardiac Mass Transcatheter Implantation of Coronary Sinus Reduction Device Transcatheter Intracoronary Infusion of Supersaturated Oxygen Implantable Synchronized Diaphragmatic Stimulation Therapy Therapeutic Ultrafiltration Coronary Intravascular Lithotripsy Cardiac Acoustic Waveform Recording Algorithmic Risk-based Cardiac Dysfunction Assessment Transcatheter Intraoperative Blood Vessel Microinfusion Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Code Compendium (Cardiovascular) Policy Number: HUM-0579-010 Page: 2 of 35 Wireless Pulmonary Artery Pressure Monitoring Section Effective Date: 02/02/2023 Section Revision Date: 02/02/2023 Section Review Date: 02/02/2023 Change Summary: Updated References Description 33289 93264 Transcatheter implantation of wireless pulmonary artery pressure sensor for long-term hemodynamic monitoring, including deployment and calibration of the sensor, right heart catheterization, selective pulmonary catheterization, radiological supervision and interpretation, and pulmonary artery angiography, when performed Remote monitoring of a wireless pulmonary artery pressure sensor for up to 30 days, including at least weekly downloads of pulmonary artery pressure recordings, interpretation(s), trend analysis, and report(s) by a physician or other qualified health care professional 93451 Right heart catheterization including measurement(s) of oxygen saturation and cardiac output, when performed 93568 Injection procedure during cardiac catheterization including imaging supervision, interpretation, and report; for pulmonary angiography (List separately in addition to code for primary procedure) 93799 Unlisted cardiovascular service or procedure Not Covered Not Covered Not Covered if used to report Wireless Pulmonary Artery Pressure Monitoring Not Covered if used to report Wireless Pulmonary Artery Pressure Monitoring Not Covered if used to report Wireless Pulmonary Artery Pressure Monitoring See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Code Compendium (Cardiovascular) Policy Number: HUM-0579-010 Page: 3 of 35 C2624 Implantable wireless pulmonary artery pressure sensor with delivery catheter, including all system components Not Covered The CardioMEMS HF system is an implantable wireless pulmonary artery pressure monitoring device that is used to measure heart rate and pulmonary artery (PA) pressure in certain individuals with heart failure (HF). A small, paper clip-sized sensor is implanted into the pulmonary artery during a heart catheterization procedure. Once the device is implanted and the individual returns home, the Patient Electronics System uses wireless technology to read the PA pressure measurements and then transmits the information to the physician. The individual can obtain a daily reading with the system and the physician purportedly may make medication adjustments based on the information received. The device recipient must be able to tolerate two types of anticoagulation medication for one month after the implantation procedure. Coverage Determination Humana members may NOT be eligible under the Plan for wireless pulmonary artery pressure monitoring. This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language. References 1. 2. 3. American College of Cardiology (ACC). 2022 AHA/ACC/HFSA guideline for the management of heart failure. https://www.acc.org. Published May 3, 2022. Accessed December 15, 2022. American Heart Association (AHA). AHA Policy Statement. Recommendations for the implementation of telehealth in cardiovascular and stroke care. https://www.heart.org. Published February 14, 2017. Accessed December 15, 2022. ClinicalKey. Lindenfeld J, Zile M. Devices for monitoring and managing heart failure. In: Libby P, Bonow RO, Mann DL, Tomaselli GF, Bhatt DL, Solomon SD. Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine. 12th ed. Elsevier; 2022:1107-1118. https://www.clinicalkey.com. Accessed December 14, 2022. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Code Compendium (Cardiovascular) Policy Number: HUM-0579-010 Page: 4 of 35 4. 5. 6. 7. 8. ECRI Institute. Clinical Evidence Assessment. CardioMEMS HF System (Abbott Cardiovascular) for wireless monitoring of pulmonary artery pressure in heart failure patients. https://www.ecri.org. Published July 17, 2014. Updated November 3, 2022. Accessed November 29, 2022. Hayes, Inc. Health Technology Assessment. CardioMEMS implantable hemodynamic monitor (Abbott) for managing patients with heart failure. https://evidence.hayesinc.com. Published July 28, 2022. Accessed October 25, 2022. Heart Failure Society of America (HFSA). Consensus Statement. Remote monitoring of patients with heart failure: a white paper from the Heart Failure Society of America Scientific Statements Committee. https://hfsa.org. Published October 2018. Accessed December 15, 2022. UpToDate, Inc. Treatment and prognosis of heart failure with preserved ejection fraction. https://www.uptodate.com. Updated November 2022. Accessed December 12, 2022. US Food & Drug Administration (FDA). Premarket approval: CardioMEMS HF system. https://www.fda.gov. Published May 28, 2014. Accessed March 11, 2020. Noninvasive Measurement of Central Blood Pressure Section Effective Date: 02/02/2023 Section Revision Date: 02/02/2023 Section Review Date: 02/02/2023 Change Summary: Updated References Description 93050 Arterial pressure waveform analysis for assessment of central arterial pressures, includes obtaining waveform(s), digitization and application of nonlinear mathematical transformations to determine central arterial pressures and augmentation index, with interpretation and report, upper extremity artery, non-invasive Not Covered Central blood pressure is measured in the aorta, the artery that sends blood from the heart throughout the body and represents the pressure to which the vital See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Code Compendium (Cardiovascular) Policy Number: HUM-0579-010 Page: 5 of 35 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. organs (eg, heart, kidneys, brain) are exposed. This type of measurement is reported to be more precise than blood pressure obtained from the arm using a traditional blood pressure cuff. Central blood pressure and arterial pulse wave velocity, a measure of arterial stiffness, are purported to aid the clinician in managing diseases that affect cardiovascular function. The SphygmoCor CVMS and SphygmoCor XCEL use noninvasive tonometry and computerized calculations to obtain central blood pressure and pulse wave velocity from the brachial, carotid and femoral arteries. Coverage Determination Humana members may NOT be eligible under the Plan for noninvasive measurement of central blood pressure. This is considered experimental/ investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language. References 1. ECRI Institute. Product Brief (ARCHIVED). SphygmoCor system (AtCor Medical Pty Ltd.) for noninvasive central arterial blood pressure monitoring. https://www.ecri.org. Published April 18, 2016. Accessed November 29, 2022. 2. 3. Hernandez JM, Fernandez GV, Brown J, et al. Validation study to determine the accuracy of central blood pressure measurement using the SphygmoCor XCEL cuff device in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement. J Clin Hypertens. 2020;23(6):1165- 1175. https://www.ahajournals.org. Accessed December 15, 2022. US Food & Drug Administration (FDA). 510(k) summary: SphygmoCor XCEL. https://www.fda.gov. Published November 16, 2012. Accessed March 11, 2020. Implantable Carotid Sinus Stimulators Section Effective Date: 02/02/2023 Section Revision Date: 02/02/2023 Section Review Date: 02/02/2023 Change Summary: Updated Description, References See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Code Compendium (Cardiovascular) Policy Number: HUM-0579-010 Page: 6 of 35 Description 0266T 0267T 0268T 0269T 0270T 0271T 0272T 0273T Implantation or replacement of carotid sinus baroreflex activation device; total system (includes generator placement, unilateral or bilateral lead placement, intra-operative interrogation, programming, and repositioning, when performed) Implantation or replacement of carotid sinus baroreflex activation device; lead only, unilateral (includes intra-operative interrogation, programming, and repositioning, when performed) Implantation or replacement of carotid sinus baroreflex activation device; pulse generator only (includes intra-operative interrogation, programming, and repositioning, when performed) Revision or removal of carotid sinus baroreflex activation device; total system (includes generator placement, unilateral or bilateral lead placement, intra-operative interrogation, programming, and repositioning, when performed) Revision or removal of carotid sinus baroreflex activation device; lead only, unilateral (includes intra-operative interrogation, programming, and repositioning, when performed) Revision or removal of carotid sinus baroreflex activation device; pulse generator only (includes intra-operative interrogation, programming, and repositioning, when performed) Interrogation device evaluation (in person), carotid sinus baroreflex activation system, including telemetric iterative communication with the implantable device to monitor device diagnostics and programmed therapy values, with interpretation and report (eg, battery status, lead impedance, pulse amplitude, pulse width, therapy frequency, pathway mode, burst mode, therapy start/stop times each day); Interrogation device evaluation (in person), carotid sinus baroreflex activation system, including telemetric iterative communication with the implantable device to monitor device diagnostics and programmed therapy values, with Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Code Compendium (Cardiovascular) Policy Number: HUM-0579-010 Page: 7 of 35 interpretation and report (eg, battery status, lead impedance, pulse amplitude, pulse width, therapy frequency, pathway mode, burst mode, therapy start/stop times each day); with programming Generator, neurostimulator (implantable), non- rechargeable with carotid sinus baroreceptor stimulation lead(s) C1825 Not Covered Barostim Neo is an implantable carotid sinus stimulation system purported to treat heart failure (HF) or resistant hypertension (RHT). This may also be known as baroreflex activation therapy (BAT). The device consists of a lead positioned in the carotid sinus wall and a pulse generator implanted in an infraclavicular position. The system delivers electric current to baroreceptors in the carotid sinus and is proposed to initiate systemic blood pressure (BP) lowering responses.9 An alternate approach to BAT amplifies the vascular stretch signal sensed by carotid baroreceptors during systole. The MobiusHD is a device under clinical study that uses a self-expanding endovascular implant to detect signal amplification. The carotid sinus is purportedly reshaped to stimulate the baroreceptors during spontaneous changes in systolic pressure to treat resistant hypertension. Coverage Determination Humana members may NOT be eligible under the Plan for implantable carotid sinus stimulators. This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language. References 1. 2. 3. Abraham W, Zile M, Weaver F, et al. Baroreflex activation therapy for the treatment of heart failure with a reduced ejection fraction. J Am Coll Cardiol HF. 2015;3(6):487-496. Accessed December 15, 2022. American College of Cardiology (ACC). 2017 ACC/AHA/AAPA/ABC/ ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation and management of high blood pressure in adults. https://www.acc.org. Published May 15, 2018. Accessed December 15, 2022. ClinicalKey. Bakris GL, Sorrentino MJ. Systemic hypertension: mechanisms, diagnosis and treatment. In: Libby P, Bonow RO, Mann DL, Tomaselli GF, Bhatt DL, Solomon SD. Braunwald’s Heart Disease: A Textbook of Cardiovascular See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Code Compendium (Cardiovascular) Policy Number: HUM-0579-010 Page: 8 of 35 Medicine. 12th ed. Elsevier; 2022:471-501. https://www.clinicalkey.com. Accessed December 14, 2022. ClinicalKey. Lindenfeld J, Zile M. Devices for monitoring and managing heart failure. In: Libby P, Bonow RO, Mann DL, Tomaselli GF, Bhatt DL, Solomon SD. Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine. 12th ed. Elsevier; 2022:1107-1118. https://www.clinicalkey.com. Accessed December 14, 2022. ECRI Institute. Product Brief. Barostim Neo system (CVRx, Inc.) for treating heart failure. https://www.ecri.org. Published February 7, 2020. Accessed November 29, 2022. ECRI Institute. Product Brief. Barostim Neo system (CVRx, Inc.) for treating resistant hypertension. https://www.ecri.org. Published January 27, 2020. Accessed November 29, 2022. Hayes, Inc. Evolving Evidence Review. Barostim Neo System for treatment of heart failure. https://evidence.hayesinc.com. Published November 7, 2022. Accessed November 8, 2022. UpToDate, Inc. Treatment of resistant hypertension. https://www.uptodate.com. Updated November 2, 2022. Accessed December 12, 2022. US Food & Drug Administration (FDA). Premarket approval (PMA): Barostim Neo system. https://www.fda.gov. Published August 16, 2019. Accessed March 11, 2020. 4. 5. 6. 7. 8. 9. 10. US Food & Drug Administration (FDA). Summary of safety and effectiveness data: Barostim Neo system. https://www.fda.gov. Published August 16, 2019. Accessed March 11, 2020. Magnetocardiography for Detection of Cardiac Ischemia Section Effective Date: 02/02/2023 Section Revision Date: 02/02/2023 Section Review Date: 02/02/2023 Change Summary: Updated References See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Code Compendium (Cardiovascular) Policy Number: HUM-0579-010 Page: 9 of 35 Description 0541T 0542T Myocardial imaging by magnetocardiography (MCG) for detection of cardiac ischemia, by signal acquisition using minimum 36 channel grid, generation of magnetic-field time-series images, quantitative analysis of magnetic dipoles, machine learning-derived clinical scoring, and automated report generation, single study; Myocardial imaging by magnetocardiography (MCG) for detection of cardiac ischemia, by signal acquisition using minimum 36 channel grid, generation of magnetic-field time-series images, quantitative analysis of magnetic dipoles, machine learning-derived clinical scoring, and automated report generation, single study; interpretation and report Not Covered Not Covered Magnetocardiography (MCG) is a noninvasive, noncontact technology that allows for body surface recordings of magnetic fields generated by the electrical activity of the heart during the cardiac cycle. MCG recordings detect very weak magnetic fields produced by currents flowing within the myocardium during cardiac activity and may detect ST segment displacement which could potentially identify myocardial ischemia. This purportedly aids in the diagnosis of coronary artery disease at earlier stages than an electrocardiogram (ECG) reading. During this diagnostic test, an individual lies supine underneath the MCG device while it rapidly scans the chest and records the magnetic fields. Once testing is complete, the functional imaging data is sent securely to the requestor and subsequently analyzed. Examples of this device include, but may not be limited to, MagnetoCardioGraphic Diagnostic System and CardioFlux. For information regarding the use of MCG for detecting fetal arrhythmias, please refer to Noninvasive Prenatal Screening Medical Coverage Policy. Coverage Determination Humana members may NOT be eligible under the Plan for magnetocardiography. This technology is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Code Compendium (Cardiovascular) Policy Number: HUM-0579-010 Page: 10 of 35 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. References 1. ECRI Institute. Clinical Evidence Assessment. Magnetocardiography for diagnosing and assessing stable coronary artery disease. https://www.ecri.org. Published December 21, 2021. Accessed November 29, 2022. 2. 3. 4. 5. Hayes, Inc. Evidence Analysis Research Brief (ARCHIVED). Magnetocardiography for detection of cardiac ischemia. https://evidence.hayesinc.com. Published February 25, 2020. Accessed November 30, 2022. Hayes, Inc. Health Technology Brief (ARCHIVED). CMI magnetocardiograph model 2409 (CardioMag Imaging Inc.) for diagnosis of acute chest pain. https://evidence.hayesinc.com. Published September 14, 2011. Updated September 16, 2013. Accessed November 30, 2022. US Food & Drug Administration (FDA). 510(k) summary: CardioFlux. https://www.fda.gov. Published March 15, 2019. Accessed May 14, 2019. US Food & Drug Administration (FDA). 510(k) summary: CMI Magnetocardiograph. https://www.fda.gov. Published July 7, 2004. Accessed June 5, 2019. External Continuous Pulmonary Fluid Monitoring Section Effective Date: 02/02/2023 Section Revision Date: 02/02/2023 Section Review Date: 02/02/2023 Change Summary: Updated References Description 0607T Remote monitoring of an external continuous pulmonary fluid monitoring system, including measurement of radiofrequency-derived pulmonary fluid levels, heart rate, respiration rate, activity, posture, and cardiovascular rhythm (eg, ECG data), transmitted to a remote 24-hour attended surveillance center; set-up and patient education on use of equipment Not Covered See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Code Compendium (Cardiovascular) Policy Number: HUM-0579-010 Page: 11 of 35 Remote monitoring of an external continuous pulmonary fluid monitoring system, including measurement of radiofrequency-derived pulmonary fluid levels, heart rate, respiration rate, activity, posture, and cardiovascular rhythm (eg, ECG data), transmitted to a remote 24-hour attended surveillance center; analysis of data received and transmission of reports to the physician or other qualified health care professional 0608T Not Covered External continuous pulmonary fluid monitoring devices have been developed to alert physicians and other healthcare providers to signs of worsening heart failure (HF) in an individual. An example of this type of noninvasive monitor, the ZOLL HFAMS, is a patch-like device that is worn 24 hours a day. It continuously records, stores and transmits data, including lung fluid volume, heart rate, respiration rate, activity posture and heart rhythm (ECG). The Remote Dielectric Sensing (ReDs) Wearable System is another example of an external pulmonary fluid monitor; however, it is larger in size than the HFAMS. Coverage Determination Humana members may NOT be eligible under the Plan for external continuous pulmonary fluid monitoring. This technology is considered experimental/ investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language. References 1. ECRI Institute. Product Brief. ReDS wearable systems (Sensible Medical Innovations, Ltd.) for noninvasively monitoring lung fluid. https://www.ecri.org. Published March 16, 2020. Accessed November 29, 2022. 2. Hayes, Inc. Evidence Analysis Research Brief (ARCHIVED). Remote Dielectric Sensing (ReDS) system (Sensible Medical Innovations, Ltd.) for monitoring of heart failure. https://www.evidence.hayesinc.com. Published June 5, 2020. Accessed November 30, 2022. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Code Compendium (Cardiovascular) Policy Number: HUM-0579-010 Page: 12 of 35 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 3. 4. US Food & Drug Administration (FDA). 510(k) summary: ReDS System. https://www.fda.gov. Published February 28, 2019. Accessed June 17, 2020. US Food & Drug Administration (FDA). 510(k) summary: Zoll MCor Heart Failure and Arrhythmia Management System. https://www.fda.gov. Published May 11, 2018. Accessed January 7, 2022. Interatrial Septal Shunt Devices Section Effective Date: 02/02/2023 Section Revision Date: 02/02/2023 Section Review Date: 02/02/2023 Change Summary: Updated References Description Percutaneous transcatheter implantation of interatrial septal shunt device, including right and left heart catheterization, intracardiac echocardiography, and imaging guidance by the proceduralist, when performed 0613T Not Covered Interatrial shunt devices have been proposed for treatment of heart failure (HF) in an individual with preserved or mildly reduced ejection fraction who remains symptomatic on optimal medical therapy. These devices are implanted into the interatrial septum of the heart during a percutaneous, catheter-based procedure. A therapeutic left-to-right shunt is created which is purported to decrease elevated left atrial pressure and reduce pulmonary vascular congestion and resultant symptoms.5,6 Examples of devices under clinical study include InterAtrial Shunt Device (IASD) and V-Wave. Coverage Determination Humana members may NOT be eligible under the Plan for interatrial septal shunt devices. This technology is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Code Compendium (Cardiovascular) Policy Number: HUM-0579-010 Page: 13 of 35 References 1. 2. 3. 4. 5. 6. 7. ClinicalKey. Lilly S, Abraham W. Interventional heart failure. In: Topol E. Textbook of Interventional Cardiology, 8th ed. Elsevier; 2020:992-998. https://www.clinicalkey.com. Accessed December 14, 2022. ECRI Institute. Health Technology Forecast. Interatrial shunts to treat heart failure with elevated left atrial pressure. https://www.ecri.org. Published August 2, 2016. Updated November 28, 2017. Accessed November 29, 2022. ECRI Institute. Technology Forecast. InterAtrial Shunt Device (IASD) to treat heart failure. https://www.ecri.org. Published September 14, 2021. Accessed November 29, 2022. ECRI Institute. Technology Forecast. V-Wave interatrial shunt to treat heart failure. https://www.ecri.org. Published September 22, 2021. Accessed November 29, 2022. Hayes, Inc. Emerging Technology Report. InterAtrial shunt device (IASD). https://evidence.hayesinc.com. Published September 23, 2016. Updated July 24, 2020. Accessed November 30, 2022. Hayes, Inc. Emerging Technology Report. Ventura interatrial shunt for heart failure. https://evidence.hayesinc.com. Published May 25, 2021. Accessed November 30, 2022. UpToDate, Inc. Treatment and prognosis of heart failure with preserved ejection fraction. https://www.uptodate.com. Updated November 2022. Accessed December 12, 2022. Transcatheter Left Ventricular Restoration Device Section Effective Date: 02/02/2023 Section Revision Date: 02/02/2023 Section Review Date: 02/02/2023 Change Summary: Updated Description, References Description 0643T Transcatheter left ventricular restoration device implantation including right and left heart catheterization and left ventriculography when performed, arterial approach Not Covered See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Code Compendium (Cardiovascular) Policy Number: HUM-0579-010 Page: 14 of 35 Chronic systolic heart failure occurs over time, generally caused by coronary artery disease, hypertension or other cardiac conditions that may damage the heart. The left ventricle (lower chamber) pumps oxygenated blood to the body’s tissues; however, it may eventually become enlarged or change shape due to tension in the ventricle wall. This may result in the heart’s inability to effectively pump blood which leads to heart failure with reduced ejection fraction (systolic heart failure). The less invasive ventricular enhancement (LIVE) procedure uses a transcatheter left ventricular restoration device to reduce or reconstruct the left ventricle. This process purportedly decreases ventricular wall tension, improves cardiac function and reduces the symptoms of systolic heart failure. A titanium anchor is placed via the internal jugular vein and a mini-thoracotomy is performed to place an external (outside the ventricle) anchor. These anchors work to reshape and reduce the volume of the left ventricle. Ventriculography (cardiac imaging) may be used to evaluate ventricular function. Examples of devices under clinical study include the ReviventTC and the AccuCinch. Coverage Determination Humana members may NOT be eligible under the Plan for transcatheter left ventricular restoration device implantation. This technology is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language. References 1. ClinicalKey. Cerrud-Rodriguez RC, Burkhoff D, Latib A, Granada JF. A glimpse into the future of transcatheter interventional heart failure therapies. J Am Coll Cardiol Basic Trans Science. 2022;7(2):181-191. https://www.clinicalkey.com. Accessed December 14, 2022. 2. 3. ClinicalKey. Lilly S, Abraham W. Interventional heart failure. In: Topol E, Teirstein P. Textbook of Interventional Cardiology. 8th ed. Elsevier; 2020:992- 998.e2. https://www.clinicalkey.com. Accessed December 14, 2022. ECRI Institute. Clinical Evidence Assessment. AccuCinch Ventricular Restoration System (Ancora Heart, Inc.) for treating heart failure with reduced ejection fraction . https://www.ecri.org. Published November 28, 2022. Accessed November 30, 2022. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Code Compendium (Cardiovascular) Policy Number: HUM-0579-010 Page: 15 of 35 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 4. ECRI Institute. Health Technology Forecast News Brief. Investigational transcatheter device aims to reduce heart enlargement without surgery. https://www.ecri.org. Published June 2, 2016. Accessed December 1, 2022. Percutaneous Debulking or Removal of Intracardiac Mass Section Effective Date: 02/02/2023 Section Revision Date: 02/02/2023 Section Review Date: 02/02/2023 Change Summary: Updated References Description Transcatheter removal or debulking of intracardiac mass (eg, vegetations, thrombus) via suction (eg, vacuum, aspiration) device, percutaneous approach, with intraoperative reinfusion of aspirated blood, including imaging guidance, when performed 0644T Not Covered The AngioVac is an example of a catheter-based aspiration (vacuum) device for percutaneous debulking or removal of an intracardiac mass. This device is purported to remove fresh, soft thrombi, emboli or vegetation in areas of the heart such as the right atrium, right ventricle, superior vena cava and the inferior vena cava. A cannula with a funnel-shaped tip is utilized to capture the mass, and a circuit system is used to reinfuse aspirated blood. The radiopaque cannula tip is visualized by fluoroscopy during the procedure. Coverage Determination Humana members may NOT be eligible under the Plan for percutaneous debulking or removal of intracardiac mass. This technology is considered experimental/ investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language. References 1. ClinicalKey. Sauk S, Vedantham S. Mechanical interventions in arterial and venous thrombosis. In: Hoffman R, Benz E, Silberstein L, et al. Hematology: Basic Principles and Practice. 7th ed. Elsevier; 2018:2113-2121. https://www.clinicalkey.com. Accessed December 14, 2022. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Code Compendium (Cardiovascular) Policy Number: HUM-0579-010 Page: 16 of 35 2. 3. 4. 5. 6. ClinicalKey. Venturini JM, Atman PS. Vacuum extraction of intracardiac masses. In: Lang RM, Goldstein SA, Kronzon I, Khandheria BK, Saric M, Mor-Avi V. ASE’s Comprehensive Echocardiography. 8th ed. Elsevier; 2022:935-939. https://www.clinicalkey.com. Accessed December 14, 2022. ECRI Institute. Clinical Evidence Assessment. AngioVac (AngioDynamics, Inc.) for treating right-sided endocarditis. https://www.ecri.org. Published August 8, 2022. Accessed November 30, 2022. Hayes, Inc. Clinical Research Response (ARCHIVED). AngioVac system (AngioDynamics). https://evidence.hayesinc.com. Published April 10, 2019. Accessed June 9, 2021. US Food & Drug Administration (FDA). 510(k) summary: AngioVac cannula. https://www.fda.gov. Published March 5, 2014. Accessed May 4, 2021. US Food & Drug Administration (FDA). 510(k) summary: AngioVac circuit. https://www.fda.gov. Published December 11, 2014. Accessed May 4, 2021. Transcatheter Implantation of Coronary Sinus Reduction Device Section Effective Date: 06/22/2023 Section Revision Date: 06/22/2023 Section Review Date: 06/22/2023 Change Summary: Updated References Description Transcatheter implantation of coronary sinus reduction device including vascular access and closure, right heart catheterization, venous angiography, coronary sinus angiography, imaging guidance, and supervision and interpretation, when performed 0645T Not Covered Angina and anginal equivalents include pain, pressure, tightness, or discomfort in the chest, shoulders, arms, neck, back, upper abdomen, or jaw, as well as shortness of breath, nausea, sweating and fatigue.1 Angina may be triggered by the heart pumping harder during exercise or stress. Refractory angina occurs when recurrent See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Code Compendium (Cardiovascular) Policy Number: HUM-0579-010 Page: 17 of 35 episodes significantly limit activities of daily living and are uncontrolled with medication. Transcatheter implantation of a coronary sinus reduction device has been proposed as a treatment for refractory angina. This metal mesh device is purported to create a narrowing in the coronary sinus and subsequently increase pressure in the area to encourage blood flow to ischemic areas of the heart. It is implanted using standard catheter-based techniques under radiological guidance by an interventional cardiologist. The Reducer is an example of this type of coronary sinus reduction device currently under clinical study. Coverage Determination Humana members may NOT be eligible under the Plan for transcatheter implantation of a coronary sinus reduction device. This technology is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language. References 1. 2. 3. 4. American College of Cardiology (ACC). 2021 AHA/ACC/ASE/CHEST/SAEM/ SCCT/SCMR guideline for the evaluation and diagnosis of chest pain. https://www.acc.org. Published November 30, 2021. Accessed May 3, 2023. ClinicalKey. Jolicoeur EM, Henry TD. Refractory angina. In: de Lemos JA, Omland T. Chronic Coronary Artery Disease: A Companion to Braunwald’s Heart Disease. Elsevier; 2018:412-431. https://www.clinicalkey.com. Accessed May 3, 2023. ECRI Institute. Clinical Evidence Assessment. Reducer (Neovasc, Inc.) for treating refractory angina. https://www.ecri.org. Published June 28, 2018. Updated February 5, 2022. Accessed May 3, 2023. Hayes, Inc. Emerging Technology Report. Reducer coronary sinus implant (Shockwave Medical Inc.) for refractory angina. https://evidence.hayesinc.com. Published May 19, 2023. Accessed May 23, 2023. 5. UpToDate, Inc. New therapies for angina pectoris. https://www.uptodate.com. Updated April 2023. Accessed May 3, 2023. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Code Compendium (Cardiovascular) Policy Number: HUM-0579-010 Page: 18 of 35 Transcatheter Intracoronary Infusion of Supersaturated Oxygen Section Effective Date: 06/22/2023 Section Revision Date: 06/22/2023 Section Review Date: 06/22/2023 Change Summary: Updated References Description 0659T Transcatheter intracoronary infusion of supersaturated oxygen in conjunction with percutaneous coronary revascularization during acute myocardial infarction, including catheter placement, imaging guidance (eg, fluoroscopy), angiography, and radiologic supervision and interpretation Not Covered Transcatheter intracoronary infusion of supersaturated oxygen (SSO2) therapy (also known as hyperoxemic reperfusion therapy) has been proposed for use in conjunction with percutaneous coronary intervention (PCI) following an anterior acute myocardial infarction (AMI). SSO2 therapy is purported to increase diffusion of oxygen to the ischemic regions perfused by the left anterior descending coronary artery immediately following revascularization by PCI completed within 6 hours of the onset of the AMI symptoms. Imaging guidance is used to target the affected area of the heart for proper catheter placement. The TherOx DownStream SSO2 system is an example of a US Food & Drug Administration (FDA)-approved SSO2 therapy device. Coverage Determination Humana members may NOT be eligible under the Plan for transcatheter intracoronary infusion of supersaturated oxygen. This technology is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language. References 1. ClinicalKey. Ndrepepa G, Byrne R, Kastrati A. Percutaneous coronary intervention in acute ST-segment elevation myocardial infarction. In: Topol E, Tierstein P. Textbook of Interventional Cardiology. 8th ed. Elsevier; 2020:338- 383.e11. https://www.clinicalkey.com. Accessed May 3, 2023. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Code Compendium (Cardiovascular) Policy Number: HUM-0579-010 Page: 19 of 35 2. 3. 4. 5. ECRI Institute. Clinical Evidence Assessment. TherOx DownStream supersaturated oxygen therapy system (Zoll Medical Corp.) for myocardial infarction. https://www.ecri.org. Published January 27, 2021. Accessed May 3, 2023. Hayes, Inc. Emerging Technology Report (ARCHIVED). DownStream system for supersaturated oxygen therapy. https://evidence.hayesinc.com. Published April 10, 2019. Accessed May 3, 2023. UpToDate, Inc. Primary percutaneous coronary intervention in acute ST- elevation myocardial infarction: periprocedural management. https://www.uptodate.com. Updated April 2023. Accessed May 3, 2023. US Food & Drug Administration (FDA). Summary of safety and effectiveness data: TherOx Downstream System. https://www.fda.gov. Published April 2, 2019. Accessed May 13, 2022. Implantable Synchronized Diaphragmatic Stimulation Therapy Section Effective Date: 06/22/2023 Section Revision Date: 06/22/2023 Section Review Date: 06/22/2023 Change Summary: Updated References Description Laparoscopic insertion of new or replacement of permanent implantable synchronized diaphragmatic stimulation system for augmentation of cardiac function, including an implantable pulse generator and diaphragmatic lead(s) Laparoscopic insertion of new or replacement of diaphragmatic lead(s), permanent implantable synchronized diaphragmatic stimulation system for augmentation of cardiac function, including connection to an existing pulse generator; first lead Laparoscopic insertion of new or replacement of diaphragmatic lead(s), permanent implantable synchronized diaphragmatic stimulation system 0674T 0675T 0676T Not Covered Not Covered Not Covered See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Code Compendium (Cardiovascular) Policy Number: HUM-0579-010 Page: 20 of 35 for augmentation of cardiac function, including connection to an existing pulse generator; each additional lead (List separately in addition to code for primary procedure) Laparoscopic repositioning of diaphragmatic lead(s), permanent implantable synchronized diaphragmatic stimulation system for augmentation of cardiac function, including connection to an existing pulse generator; first repositioned lead Laparoscopic repositioning of diaphragmatic lead(s), permanent implantable synchronized diaphragmatic stimulation system for augmentation of cardiac function, including connection to an existing pulse generator; each additional repositioned lead (List separately in addition to code for primary procedure) Laparoscopic removal of diaphragmatic lead(s), permanent implantable synchronized diaphragmatic stimulation system for augmentation of cardiac function Insertion or replacement of pulse generator only, permanent implantable synchronized diaphragmatic stimulation system for augmentation of cardiac function, with connection to existing lead(s) Relocation of pulse generator only, permanent implantable synchronized diaphragmatic stimulation system for augmentation of cardiac function, with connection to existing dual leads Removal of pulse generator only, permanent implantable synchronized diaphragmatic stimulation system for augmentation of cardiac function Programming device evaluation (in-person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified health care professional, permanent 0677T 0678T 0679T 0680T 0681T 0682T 0683T Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Code Compendium (Cardiovascular) Policy Number: HUM-0579-010 Page: 21 of 35 implantable synchronized diaphragmatic stimulation system for augmentation of cardiac function Peri-procedural device evaluation (in-person) and programming of device system parameters before or after a surgery, procedure, or test with analysis, review, and report by a physician or other qualified health care professional, permanent implantable synchronized diaphragmatic stimulation system for augmentation of cardiac function Interrogation device evaluation (in-person) with analysis, review and report by a physician or other qualified health care professional, including connection, recording and disconnection per patient encounter, permanent implantable synchronized diaphragmatic stimulation system for augmentation of cardiac function 0684T 0685T Not Covered Not Covered Implantable synchronized diaphragmatic stimulation (SDS) therapy reportedly treats moderate to severe heart failure with reduced ejection fraction (HFrEF) and preserved ventricular synchrony. The system consists of a pulse generator placed in a subcutaneous pocket in the abdomen and two diaphragmatic leads affixed to the surface of the diaphragm. Electrical stimulation delivered to the diaphragm modulates intrathoracic pressure which reportedly results in reduced pericardial restraint and leads to improved cardiac filling and reduced afterload. The therapy is noninvasively adjusted and programmed using an external programmer. The US Food & Drug Administration (FDA) granted Breakthrough Device Designation for the VisONE system. Coverage Determination Humana members may NOT be eligible under the Plan for implantable synchronized diaphragmatic stimulation. This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Code Compendium (Cardiovascular) Policy Number: HUM-0579-010 Page: 22 of 35 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. References 1. ClinicalKey. Salah HM, Goldberg LR, Molinger J, et al. Diaphragmatic function in cardiovascular disease. J Am Coll Cardiol. 2022;80(17):1647-1659. https://www.clinicalkey.com. Accessed May 3, 2023. 2. UpToDate, Inc. Overview of the management of heart failure with reduced ejection fraction in adults. https://www.uptodate.com. Updated April 2023. Accessed May 3, 2023. Therapeutic Ultrafiltration Section Effective Date: 06/22/2023 Section Revision Date: 06/22/2023 Section Review Date: 06/22/2023 Change Summary: Updated References Description 0692T Therapeutic ultrafiltration Not Covered Therapeutic ultrafiltration (aquapheresis) involves the extracorporeal removal of excess fluid from the blood through central or peripheral access. This reportedly offers the potential for greater and more expeditious volume and sodium removal compared with conventional therapies. Ultrafiltration is generally used for decompensated heart failure where fluid overload is unresponsive to conventional medical management including diuretics. The Aquadex SmartFlow System is an example used in an outpatient or inpatient clinical setting. Coverage Determination Humana members may NOT be eligible under the Plan for therapeutic ultrafiltration. This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language. References 1. American College of Cardiology (ACC). 2022 AHA/ACC/HFSA guideline for the management of heart failure. https://www.acc.org. Published May 3, 2022. Accessed May 3, 2023. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Code Compendium (Cardiovascular) Policy Number: HUM-0579-010 Page: 23 of 35 2. 3. 4. 5. 6. 7. American Heart Association (AHA). Scientific Statement. Cardiorenal syndrome: classification, pathophysiology, diagnosis and treatment strategies. https://www.ahajournals.org. Published April 16, 2019. Accessed June 1, 2023. ECRI Institute. Clinical Evidence Assessment. Aquadex SmartFlow system (CHF Solutions, Inc.) for renal replacement therapy in children. https://www.ecri.org. Published March 19, 2021. Accessed May 3, 2023. Hayes, Inc. Medical Technology Directory (ARCHIVED). Ultrafiltration in congestive heart failure. https://evidence.hayesinc.com. Published June 6, 2013. Updated May 23, 2017. Accessed May 3, 2023. UpToDate, Inc. Cardiorenal syndrome: prognosis and treatment. https://www.uptodate.com. Updated April 2023. Accessed May 3, 2023. UpToDate, Inc. Management of refractory heart failure with reduced ejection fraction. https://www.uptodate.com. Updated April 2023. Accessed May 3, 2023. US Food & Drug Administration (FDA). 510(k) summary: Aquadex FlexFlow system 2.0 (SmartFlow). https://www.fda.gov. Published February 24, 2020. Accessed May 13, 2022. Coronary Intravascular Lithotripsy Section Effective Date: 01/01/2024 Section Revision Date: 01/01/2024 Section Review Date: 06/22/2023 Change Summary: Updated