280 Form

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Medical Policy Total Artificial Hearts and Implantable Ventricular Assist Devices
Table of Contents • Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History

Policy Number: 280 BCBSA Reference Number: 7.03.11 (For Plan internal use only) NCD/LCD: N/A Related Policies
• Heart/Lung Transplant, #269 • Heart Transplant, #197 • Extracorporeal Membrane Oxygenation, #726
Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity
Medicare HMO BlueSM and Medicare PPO BlueSM Members

Destination Therapy Implantable ventricular assist devices (VADs) with FDA approval or clearance may be considered MEDICALLY NECESSARY as destination therapy with end-stage heart failure adult individuals who meet the following criteria: • New York Heart Association (NYHA) Class III heart failure with dyspnea upon mild physical activity or NYHA Class IV;
• Left ventricular ejection fraction ≤ 25%; • Inotrope-dependent; OR cardiac index <2.2 liters/min/m2, while not on inotropes and also meeting one of the following: o On optimal medical management, based on current heart failure practice guidelines for at least 45 of the last 60 days and are failing to respond OR o Advanced heart failure for at least 14 days and dependent on intra-aortic balloon pump for ≥7 days.

Bridge to Transplantation Implantable ventricular assist devices (VADs) with FDA approval or clearance may be considered MEDICALLY NECESSARY as a bridge to heart transplantation for individuals who are: • Currently listed as heart transplantation candidates and not expected to survive until a donor heart can be obtained, OR • Are undergoing evaluation to determine candidacy for heart transplantation.

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Implantable (VADs) with FDA approval or clearance, including humanitarian device exemptions, may be considered MEDICALLY NECESSARY as a bridge to heart transplantation in children 16 years old or younger who are: • Currently listed as heart transplantation candidates and not expected to survive until a donor heart can be obtained, OR
• Are undergoing evaluation to determine candidacy for heart transplantation.

Total artificial hearts (TAHs) with FDA-approved devices may be considered MEDICALLY NECESSARY as a bridge to heart transplantation for individuals with biventricular failure who: • Have no other reasonable medical or surgical treatment options, are ineligible for other univentricular or biventricular support devices, and are currently listed as heart transplantation candidates, OR
• Have no other reasonable medical or surgical treatment options, are ineligible for other univentricular or biventricular support devices, are undergoing evaluation to determine candidacy for heart transplantation, and not expected to survive until a donor heart can be obtained.

Postcardiotomy Setting/Bridge to Recovery Implantable VADs with FDA approval approval or clearance may be considered MEDICALLY NECESSARY in the postcardiotomy setting in individuals who are unable to be weaned off cardiopulmonary bypass.

Other Indications Other applications of ventricular assist devices (VADs) or total artificial hearts (TAHs) are considered INVESTIGATIONAL, including, but not limited to, the use of TAHs as destination therapy.

The use of non-FDA approved or cleared implantable VADs or TAHs is considered INVESTIGATIONAL.

Percutaneous VADs are considered INVESTIGATIONAL for all indications.

Prior Authorization Information
Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

Outpatient Commercial Managed Care (HMO and POS) This procedure is performed in the inpatient setting. Commercial PPO and Indemnity This procedure is performed in the inpatient setting. Medicare HMO BlueSM This procedure is performed in the inpatient setting. Medicare PPO BlueSM This procedure is performed in the inpatient setting.

CPT Codes / HCPCS Codes / ICD Codes Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

The following codes are included below for informational purposes only; this is not an all-inclusive list.

The above medical necessity criteria MUST be met for the following codes to be covered for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue:

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CPT Codes CPT
codes:

Code Description 33975 Insertion of ventricular assist device; extracorporeal, single ventricle
33976 Insertion of ventricular assist device; extracorporeal, biventricular 33977 Removal of ventricular assist device; extracorporeal, single ventricle
33978 Removal of ventricular assist device; extracorporeal, biventricular 33979 Insertion of ventricular assist device, implantable intracorporeal, single ventricle 33980 Removal of ventricular assist device, implantable intracorporeal, single ventricular 33981 Replacement of extracorporeal ventricular assist device, single or biventricular, pump(s), single or each pump
33982 Replacement of ventricular assist device pump(s); implantable intracorporeal, single ventricle, without cardiopulmonary bypass
33983 Replacement of ventricular assist device pump(s); implantable intracorporeal, single ventricle, with cardiopulmonary bypass
33990 Insertion of ventricular assist device, percutaneous, including radiological supervision and interpretation; left heart, arterial access only 33991 Insertion of ventricular assist device, percutaneous, including radiological supervision and interpretation; left heart, both arterial and venous access, with transseptal puncture 33992 Removal of percutaneous left heart ventricular assist device, arterial or arterial and venous cannula(s), at separate and distinct session from insertion 33993 Repositioning of percutaneous right or left heart ventricular assist device with imaging guidance at separate and distinct session from insertion 33995 Insertion of ventricular assist device, percutaneous, including radiological supervision and interpretation; right heart, venous access only 33997 Removal of percutaneous right heart ventricular assist device, venous cannula, at separate and distinct session from insertion 33927 Implantation of a total replacement heart system (artificial heart) with recipient cardiectomy 33928 Removal and replacement of total replacement heart system (artificial heart) 33929 Removal of a total replacement heart system (artificial heart) for heart transplantation (List separately in addition to code for primary procedure) ICD-10 Procedure Codes ICD-10-PCS procedure codes: Code Description 02RK0JZ Replacement of Right Ventricle with Synthetic Substitute, Open Approach 02HA0QZ Insertion of Implantable Heart Assist System into Heart, Open Approach 02HA0RS Insertion of Biventricular External Heart Assist System into Heart, Open Approach 02HA0RZ Insertion of External Heart Assist System into Heart, Open Approach 02HA3QZ Insertion of Implantable Heart Assist System into Heart, Percutaneous Approach 02HA3RS Insertion of Biventricular External Heart Assist System into Heart, Percutaneous Approach 02HA3RZ Insertion of External Heart Assist System into Heart, Percutaneous Approach 02HA4QZ Insertion of Implantable Heart Assist System into Heart, Percutaneous Endoscopic Approach 02HA4RS Insertion of Biventricular External Heart Assist System into Heart, Percutaneous Endoscopic Approach 02HA4RZ Insertion of External Heart Assist System into Heart, Percutaneous Endoscopic Approach

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02RK4JZ Replacement of Right Ventricle with Synthetic Substitute, Percutaneous Endoscopic Approach 02RL0JZ Replacement of Left Ventricle with Synthetic Substitute, Open Approach 02RL4JZ Replacement of Left Ventricle with Synthetic Substitute, Percutaneous Endoscopic Approach 02UA0JZ Supplement Heart with Synthetic Substitute, Open Approach 02UA3JZ Supplement Heart with Synthetic Substitute, Percutaneous Approach 02UA4JZ Supplement Heart with Synthetic Substitute, Percutaneous Endoscopic Approach 02WA0JZ Revision of Synthetic Substitute in Heart, Open Approach 02WA0QZ Revision of Implantable Heart Assist System in Heart, Open Approach 02WA3QZ Revision of Implantable Heart Assist System in Heart, Percutaneous Approach 02WA3RZ Revision of External Heart Assist System in Heart, Percutaneous Approach 02WA4QZ Revision of Implantable Heart Assist System in Heart, Percutaneous Endoscopic Approach 5A02116 Assistance with Cardiac Output using Other Pump, Intermittent 5A02216 Assistance with Cardiac Output using Other Pump, Continuous

Description Heart Failure According to a 2024 report from the American Heart Association and based on data collected from 2017 to 2020 , roughly 6.7 million Americans ages 20 years or older had heart failure during that time frame.1, Prevalence of heart failure is projected to affect more than 8 million people 18 years of age and older by the year 2030. Between 2015 and 2018, the prevalence of heart failure was highest in non-Hispanic Black males. Based on data from the Multi-Ethnic Study of Atherosclerosis (MESA), in those without baseline cardiovascular disease, Black individuals had the highest risk of developing heart failure (4.6 per 1000 person-years), followed by Hispanic (3.5 per 1000 person-years), White (2.4 per 1000 person-years), and Chinese individuals (1.0 per 1000 person-years).2, Similar findings were demonstrated in the Atherosclerosis Risk in Communities (ARIC) Community Surveillance data, in which Black men and women had the highest burden of new-onset heart failure cases and the highest-age adjusted 30-day case fatality rate in comparison to White men and women. Higher risk reflected differential prevalence of hypertension, diabetes, and low socio-economic status.

Heart failure may be the consequence of a number of etiologies, including ischemic heart disease, cardiomyopathy, congenital heart defects, or rejection of a heart transplant. The reduction of cardiac output is considered to be severe when systemic circulation cannot meet the body's needs under minimal exertion. Heart transplantation improves quality of life and had a reported survival rate of nearly 92% or transplants performed in 2022.3, The number of candidates for transplants exceeds the supply of donor organs; thus the interest in the development of mechanical devices.

Devices and Regulatory Status A number of implantable ventricular assist devices (VADs) and artificial heart systems have been U.S. Food and Drug Administration (FDA) approved through a Humanitarian Device Exemption, 510(k), or premarket approval regulatory pathway. This section discusses currently marketed devices.

FDA maintains a list of recent device recalls at https://www.fda.gov/medical-devices/medical-device- safety/medical-device-recalls.

Ventricular Assist Devices Implantable VADs are attached to the native heart, which may have enough residual capacity to withstand a device failure in the short term. In reversible heart failure conditions, the native heart may regain some function, and weaning and explanting of the mechanical support system after months of use has been described. VADs can be classified as internal or external, electrically or pneumatically powered, and pulsatile or continuous-flow. Initial devices were pulsatile, mimicking the action of a beating heart. More

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recent devices may use a pump, which provides continuous flow. Continuous devices may move blood in a rotary or axial flow.

Surgically implanted VADs represent a method of providing mechanical circulatory support for patients not expected to survive until a donor heart becomes available for transplant or for whom transplantation is contraindicated or unavailable. VADs are most commonly used to support the left ventricle but right ventricular and biventricular devices may be used. The device is larger than most native hearts, and therefore the size of the patient is an important consideration; the pump may be implanted in the thorax or abdomen or remain external to the body. Inflow to the device is attached to the apex of the failed ventricle, while outflow is attached to the corresponding great artery (aorta for the left ventricle, a pulmonary artery for the right ventricle). A small portion of the ventricular wall is removed for insertion of the outflow tube; extensive cardiotomy affecting the ventricular wall may preclude VAD use.

The intent of treatment may evolve over the course of treatment; for example, there is not necessarily a strict delineation between bridge to transplant and destination therapy, and transplant eligibility can change.

Table 1 lists the VADs currently available in the US. The HeartWare VAD System was discontinued in June 2021 due to evidence from observational studies demonstrating a higher frequency of neurological adverse events and mortality with the system compared to other commercially available left VADs. The HeartMate II and HeartMate 3 left VAD systems were recalled in April 2024 due to extrinsic outflow graft obstruction that can obstruct the device making it less effective. The recall was a corrective recall, and the devices remain on the market.4,

Table 1. Available Ventricular Assist Devices Device Manufacturer Approval Date FDA Clearance PMA, HDE or 510(k) No. Indication DeBakey VAD Child MicroMed Feb 2004 HDE H030003 Bridge to transplant in children 5-16 y HeartMate II Thoratec (Abbott) Apr 2008 PMA P060040 Bridge to transplant and destination CentriMag Thoratec (Abbott) Dec 2019 PMA P170038 Postcardiotomy, bridge to decision Berlin Heart EXCOR Pediatric VAD Berlin Jun 2017 PMA P160035 Bridge to transplant or recovery HeartMate 3 Left Ventricular Assist System Thoratec (Abbott) Aug 2017 Oct 2018 PMA PMA P160054 P160054/S008 Bridge to transplant Destination FDA: U.S. Food and Drug Administration; HDE: humanitarian device exemption; PMA: premarket approval; VAD: ventricular assist device. Total Artificial Heart The total artificial heart (TAH) is a biventricular device that completely replaces the function of the diseased heart. An internal battery requires frequent recharging from an external power source. Many systems use a percutaneous power line, but a transcutaneous power-transfer coil allows for a system without lines traversing the skin, possibly reducing the risk of infection. Because the native heart must be removed, failure of the device is synonymous with cardiac death.

Currently the Syncardia Temporary Total Artificial Heart (Syncardia Systems) is the only Total Artificial Heart available in the US (Table 2). The AbioCor Total Artificial Heart was FDA approved under the Humanitarian Device Exemption program in 2006, but is no longer being marketed or in development.

Table 2. Available Total Artificial Heart

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Device Manufacturer Approval Date FDA Clearance PMA No. Indication SynCardia Temporary Total Artificial Heart (Formerly CardioWest Total Artificial Heart and Jarvik Total Artificial Heart) SynCardia Systems 2004 510(k) P030011 Bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure FDA: U.S. Food and Drug Administration; PMA: premarket approval.

Percutaneous Ventricular Assist Devices Some circulatory assist devices are placed percutaneously (i.e., are not implanted). They may be referred to as percutaneous VADs (pVADs). Two different pVADs have been developed, the TandemHeart and the Impella device (Table 3). In the TandemHeart System, a catheter is introduced through the femoral vein and passed into the left atrium via transseptal puncture. Oxygenated blood is then pumped from the left atrium into the arterial system via the femoral artery. The Impella device is introduced through a femoral artery catheter. In this device, a small pump is contained within the catheter placed into the left ventricle. Blood is pumped from the left ventricle, through the device, and into the ascending aorta. Devices in which most of the system's components are external to the body are for short-term use (6 hours to 14 days) only, due to the increased risk of infection and need for careful, in-hospital monitoring. Adverse events associated with pVAD include access site complications such as bleeding, aneurysms, or leg ischemia. Cardiovascular complications can also occur, such as perforation, myocardial infarction, stroke, and arrhythmias.

Table 3. Available Percutaneous Ventricular Assist Devices Device Manufacturer Approval Date FDA Clearance PMA, 510(k) No. Indication TandemHeart Cardiac Assist (LivaNova) Sep 2011 510(k) K110493 Temporary left ventricular bypass of ≤6 h Impella CP Abiomed Nov 2016 PMA P140003 • Temporary (≤6 hours) ventricular support devices indicated for use during high-risk PCI • Temporary ventricular support for ≤4 days in cardiogenic shock

Impella 5.5 Abiomed Nov 2016 PMA P140003 Temporary ventricular support for ≤14 days in cardiogenic shock FDA: U.S. Food and Drug Administration; PMA: premarket approval.

Summary Description A ventricular assist device (VAD) is mechanical support attached to the native heart and vessels to augment cardiac output. The total artificial heart (TAH) replaces the native ventricles and is attached to the pulmonary artery and aorta; the native heart is typically removed. Both the VAD and TAH may be used as a bridge to heart transplantation or as destination therapy. The VAD has also been used as a bridge to recovery in individuals with reversible conditions affecting cardiac output.

Summary of Evidence Ventricular Assist Device

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For individuals who have end-stage heart failure who receive a ventricular assist device (VAD)VAD as a bridge to transplant, the evidence includes a randomized controlled trial (RCT) single-arm trials, and observational studies. Relevant outcomes are overall survival (OS) symptoms, functional outcomes, quality of life (QOL) and treatment-related mortality and morbidity. There is a substantial body of evidence from clinical trials and observational studies supporting implantable VADs as a bridge to transplant in patients with end-stage heart failure, possibly reducing mortality as well as improving QOL. These studies have reported that substantial numbers of patients have survived to transplant in situations in which survival would not be otherwise expected. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have end-stage heart failure who receive a VAD as destination therapy, the evidence includes RCTs and multiple single-arm studies. Relevant outcomes are OS, symptoms, functional outcomes, QOL, and treatment-related mortality and morbidity. A well-designed trial with 2 years of follow- up data has demonstrated an advantage of implantable VADs as destination therapy for patients ineligible for a heart transplant. Despite an increase in adverse events, both mortality and QOL appear to be improved for these patients. A more recent trial comparing VADs has broader inclusion criteria and supports that criteria move away from use of transplant ineligibility, as treatment may evolve over the course of treatment. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Total Artificial Heart For individuals who have end-stage heart failure who receive a total artificial heart (TAH) as a bridge to transplant, the evidence includes case series. Relevant outcomes are OS, symptoms, functional outcomes, QOL, and treatment-related mortality and morbidity. Compared with VADs, the evidence for TAHs in these settings is less robust. However, given the lack of medical or surgical options for these patients and the evidence case series provide, TAH is likely to improve outcomes for a carefully selected population with end-stage biventricular heart failure awaiting transplant who are not appropriate candidates for a left VAD. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have end-stage heart failure who receive a TAH as destination therapy, the evidence includes 2 case series. Relevant outcomes are OS, symptoms, functional outcomes, QOL, and treatment- related mortality and morbidity. The body of evidence for TAHs as destination therapy is too limited to draw conclusions. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Percutaneous Ventricular Assist Device For individuals with cardiogenic shock who receive a percutaneous VAD (pVAD) the evidence includes RCTs, observational studies, and a systematic review. Relevant outcomes are OS, symptoms, morbid events, functional outcomes, QOL, and treatment-related mortality and morbidity. Four RCTs of pVAD versus intra-aortic balloon pump (IABP) for patients in cardiogenic shock failed to demonstrate a mortality benefit and reported higher complication rates with pVAD use. Comparative observational studies and a long-term follow-up study were consistent with the RCT evidence. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who undergo high-risk cardiac procedures who receive a pVAD, the evidence includes RCTs, observational studies, and systematic reviews of these trials. Relevant outcomes are OS, symptoms, morbid events, functional outcomes, QOL, and treatment-related mortality and morbidity. Randomized controlled trials, controlled and uncontrolled observational studies, and systematic reviews of these studies have generally not demonstrated a benefit of pVAD used as ancillary support for patients undergoing high- risk cardiac procedures. Additionally, 2 nonrandomized studies have compared ventricular tachycardia (VT) ablation with pVAD or IABP. Both studies demonstrated that patients who had pVAD support spent less time in unstable VT than patients without pVAD support. However, the current evidence does not support conclusions about the use of pVAD for VT ablation. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

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For individuals with cardiogenic shock refractory to IABP therapy who receive a pVAD, the evidence includes case series. Relevant outcomes are OS, symptoms, morbid events, functional outcomes, QOL, and treatment-related mortality and morbidity. Case series of patients with cardiogenic shock refractory to IABP have reported improved hemodynamic parameters following pVAD placement. However, these uncontrolled series do not provide evidence that pVADs improve mortality, and high rates of complications have been reported with pVAD use. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Policy History Date Action 1/2026 Annual policy review. References updated. Policy statements unchanged. 3/2025 Clarified coding information. 10/2024 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 10/2023 Annual policy review. References added. Editorial refinements to policy statements for clarity; intent unchanged. 10/2022 Annual policy review. References added and updated. Minor editorial refinements to policy statements; intent unchanged. 10/2021 Annual policy review. Evidence review revised substantially to increase clarity. Policy statement revised to remove outdated eligibility criteria, but intent unchanged. 1/2021 Medicare information removed. See MP #132 Medicare Advantage Management for local coverage determination and national coverage determination reference.
1/2021 Clarified coding information. 10/2020 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 10/2019 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 10/2018 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 1/2018 Clarified coding information. 10/2017 Annual policy review. Policy statements were reordered; wording of statements unchanged.
10/2016 Annual policy review. New references added. 7/2015 Annual policy review. New references added. 7/2014 Annual policy review. New references added. Coding information clarified. 6/2014 Updated Coding section with ICD10 procedure and diagnosis codes, effective 10/2015. Coding information clarified. 8/2013 Annual policy review. Policy statement on children amended; age range changed from 5-16 to 0-16. Effective 8/1/2013. 1/2013 Updated to add new CPT codes 33990-33993. 11/2011-4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates.
No changes to policy statements.
4/2011 Reviewed - Medical Policy Group - Cardiology and Pulmonology. No changes to policy statements. 1/2011 New policy posted 1/2011. Same information removed from policy #388, Total Artificial Hearts and Ventricular Assist Devices. 4/2010 Reviewed - Medical Policy Group - Cardiology. No changes to policy statements.

Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process

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Medical Technology Assessment Guidelines

References

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39. Topkara VK, Garan AR, Fine B, et al. Myocardial Recovery in Patients Receiving Contemporary Left Ventricular Assist Devices: Results From the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). Circ Heart Fail. Jul 2016; 9(7). PMID 27402861
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