Total Artificial Hearts and Implantable Ventricular Assist Devices

POLICY NUMBER

A.7.03.11

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.

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. 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). 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% of transplants performed in 2022. The number of candidates for transplants exceeds the supply of donor organs; thus the interest in the development of mechanical devices.

Devices

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

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

Ventricular Assist DevicesImplantable ventricular assist devices (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. Ventricular assist devices 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 recent devices may use a pump, which provides continuous-flow. Continuous devices may move blood in rotary or axial flow.

Surgically-implanted ventricular assist devices 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. Ventricular assist devices 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 LVADs. 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.

Table 1. Available Ventricular Assist Devices

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

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

FDA: U.S. Food and Drug Administration; PMA: premarket approval.

POLICY

No benefits will be provided for a covered transplant procedure or a transplant evaluation unless the Member receives prior authorizationthrough Case Management from Blue Cross & Blue Shield of Mississippi.

Long-Term Devices

Destination Therapy

Implantable ventricular assist devices with FDA approval or clearance may be considered medically necessary as destination therapy for adult individuals with end-stage heart failure 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:

  • 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

  • Advanced heart failure for at least 14 days and dependent on intra-aortic balloon pump for ≥7 days.

Short-Term Devices

Bridge to Transplantation

Implantable ventricular assist devices 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.

Implantable ventricular assist devices 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 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, who 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 ventricular assist devices with FDA approval or clearance may be considered medically necessary in the post-cardiotomy setting in individuals who are unable to be weaned off cardiopulmonary bypass.

Other Indications

Other applications of implantable ventricular assist devices or total artificial hearts are considered investigational, including, but not limited to, the use of total artificial hearts as destination therapy. The use of non-FDA approved or cleared implantable ventricular assist devices or total artificial hearts is considered investigational.

Percutaneous ventricular assist devices (pVADs) are considered investigational for all indications.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

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.

Some ventricular assist devices (VADs) have approval from the U.S. Food and Drug Administration (FDA) for the pediatric population. The DeBakey® VAD Child device and the Berlin Heart EXCOR Pediatric VAD have FDA approval through the humanitarian device exemption process. The DeBakey VAD is indicated for use in children ages 5 to 16 years who are awaiting a heart transplant (i.e., a bridge to transplant) while the Berlin Heart EXCOR® VAD is indicated for children with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant and require circulatory support. The HeartMate3™ received approval for expanded approval for pediatric patients with advanced refractory left ventricular heart failure in 2020.

In general, candidates for bridge-to-transplant implantable ventricular assist devices (VADs) are those who are considered appropriate heart transplant candidates but who are unlikely to survive the waiting period until a human heart donor is available. Some studies have included the following hemodynamic selection criteria: either a left atrial pressure of 20 mm Hg or a cardiac index of less than 2.0 L/min/m while receiving maximal medical support. Individuals with VADs are classified by the United Network for Organ Sharing (UNOS) as Status I (ie, persons who are most ill and are considered the highest priority for transplant).

The median duration for time on the device is between 20 and 120 days.

Contraindications for bridge to transplant VADs and total artificial hearts include conditions that would generally exclude individuals for heart transplant. Such conditions are chronic irreversible hepatic, renal, or respiratory failure; systemic infection; coagulation disorders, and inadequate psychosocial support. Due to potential problems with adequate function of the ventricular assist device (VAD) or TAH, implantation is also contraindicated in individuals with uncorrected valvular disease. See the Heart Transplant  policy for further discussion of heart transplant candidacy.

The Centers for Medicare and Medicaid Services requires that “Beneficiaries receiving a VAD must be managed by an explicitly identified, cohesive, multidisciplinary team of medical professionals with appropriate qualifications, training, and experience. The team embodies collaboration and dedication across medical specialties to offer optimal patient-centered care. Collectively, the team must ensure that patients and caregivers have the knowledge and support necessary to participate in informed decision making. The team members must be based at the facility and must include individuals with experience working with patients before and after placement of a VAD.

The team must include, at a minimum:

• At least 1 physician with cardiothoracic surgery privileges and individual experience implanting at least 10 durable, intracorporeal, left ventricular assist devices over the course of the previous 36 months with activity in the last year.

• At least 1 cardiologist trained in advanced heart failure with clinical competence in medical- and device-based management including VADs, and clinical competence in the management of patients before and after placement of a VAD.

• A VAD program coordinator.

• A social worker.

• A palliative care specialist.”

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

8/1998: Approved by Medical Policy Advisory Committee (MPAC).

2/14/2002: Investigational definition added.

3/2003: Reviewed by MPAC; Policy title "Ventricular Assist Devices as a Bridge to Heart Transplantation" renamed "Ventricular Assist Devices," LVAD as a "destination" therapy considered investigational. FEP exception added.

7/24/2003: Code References section updated, ICD-9 procedure code 37.61 deleted, ICD-9 diagnosis 428.20, 428.21, 428.22, 428.23, 428.30, 428.31, 428.32, 428.33, 428.40, 428.41, 428.42, 428.43, 428.9 added covered codes, ICD-9 diagnosis 038.0-038.9, 042, 090.0-097.9, 112.5, 117.5, 280.0-282.63, 282.69-289.51, 289.59-289.9, 404.02, 404.03, 404.12, 404.13, 404.92, 404.93, 518.83, 518.84, 570, 571.0, 571.1, 571.2, 571.3, 572.4, 572.8, 585 added non-covered codes.

3/2004: Reviewed by MPAC, coverage remains as written with policy statement added to limit medically necessary indications to FDA approved ventricular assist devices, total artificial hearts are considered investigational, Policy title “Ventricular Assist Devices” renamed “Ventricular Assist Devices and Total Artificial Hearts," Description section revised to be consistent with BCBSA policy # 7.03.11, FEP exceptions added, Sources added, “contraindications” moved from Policy to Policy Guidelines section.

10/13/2004: Code Reference section updated, CPT code 0048T, 0049T, 0050T added covered codes, CPT 33975, 33976, 33977, 33978 description revised, ICD-9 procedure code 37.62, 37.63, 37.66 description revised, ICD-9 procedure code 37.68 added, ICD-9 diagnosis 428.20, 428.21, 428.22, 428.23, 428.30, 428.31, 428.32, 428.33, 428.40, 428.41, 428.42, 428.43, 428.9 deleted covered codes, CPT 0051T, 0052T, 0053T added non-covered codes, ICD-9 procedure code 37.52, 37.53, 37.54 added non-covered codes, ICD-9 diagnosis 038.0-038.9, 042, 090.0-097.9, 112.5, 117.5, 280.0-282.63, 282.69-289.51, 289.59-289.9, 404.02, 404.03, 404.12, 404.13, 404.92, 404.93, 518.83, 518.84, 570, 571.0, 571.1, 571.2, 571.3, 572.4, 572.8, 585 deleted non-covered codes.

11/11/2005: Code Reference section updated, HCPCS codes Q0480-Q0505 added.

4/10/2006: Policy reviewed, no change to policy. Q0480-Q0505 already added to policy.

9/6/2006: Policy updated to include information on the AbioCor artificial heart.

9/18/2006: Coding revised. ICD-9 2006 revisions added to policy.

5/7/2008: Policy description updated. Total artificial hearts changed from investigational to medically necessary for FDA-approved devices as a bridge to heart transplantation. Ventricular assist devices as destination therapy with end-stage heart failure changed from investigational to medically necessary for FDA-approved devices in patients ineligible for human heart transplant. Other policy statements revised for clarity; coverage remains the same. CPT codes 0051T-0053T moved to covered. ICD-9 procedure codes 37.52-37.54 moved to covered.

9/22/2008: Annual ICD-9 updates effective 10-1-2008 applied.

12/31/2008: Code Reference section updated per 2009 CPT/HCPCS revisions.

8/19/2009: Policy reviewed, no changes.

03/12/2010: Coding Section revised for 2010 CPT4 and HCPCS revision.

12/30/2010: Policy description re-written. Policy statements revised to address only implantable VADs and total artificial hearts.

03/09/2011: Added new HCPCS codes Q4078 and Q4079 to the Code Reference section.

12/13/2011: Policy description and statement updated regarding percutaneous ventricular assist devices. Added the following policy statement:  Percutaneous ventricular assist devices (pVADs) are considered investigational for all indications.

11/30/2012: Added the verbiage "or are undergoing evaluation to determine candidacy for heart transplantation" to the policy statement regarding total artificial hearts. 

01/07/2013: Added the following new 2013 CPT codes to the Code Reference section: 33990, 33991, 33992, and 33993.

07/18/2013: Policy statement revised to delete Peak O-2 consumption ≤14 ml/kg criteria from the policy statement regarding “REMATCH Study.” Policy guidelines updated regarding available devices and candidate selection.

05/23/2014: Added "Implantable" to the policy title. Policy description updated regarding available devices. Added the following headings to the policy statement: Postcardiotomy Setting/Bridge to Recovery, Bridge to Transplantation, Destination Therapy, and Other Indications. Replaced "cleared devices" with "clearance." Added "Implantable" to the beggining of the policy statement under the Bridge to Transplantation section. Policy statement on implantable VADs as a bridge to heart tranplantation in children was revised to change the age range from "5 to 16" to "16 years old or younger," reflecting the approval of the BERLIN heart EXCOR device for pediatric patients. Policy guidelines updated to include coagulation disorders and inadequate psychosocial support as contraindications for bridge to transplant VADs and TAH. Removed deleted CPT codes 0048T and 0050T from the Code Reference section.

07/07/2015: Code Reference section updated to add Investigational Codes table. CPT codes 33990, 33991, 33992, 33993 and ICD-9 procedure code 37.68 moved from Covered to Investigational.

08/27/2015: Code Reference section updated for ICD-10. Removed deleted CPT code Q0505.

09/30/2015: Policy description updated regarding devices. Policy statements unchanged. Policy Guidelines updated to add medically necessary and investigative definitions.

06/01/2016: Policy number A.7.03.11 added.

09/22/2016: Policy title changed from "Implantable Ventricular Assist Devices and Total Artificial Hearts" to "Total Artificial Hearts and Implantable Ventricular Assist Devices." Policy description updated regarding devices. Policy statements unchanged.

09/20/2017: Policy description updated regarding candidates for transplants. Investigational statement regarding other applications updated to change "left ventricular devices" to "ventricular assist devices." Policy statements reordered.

09/29/2017: Code Reference section updated to revise code descriptions for ICD-10 procedure codes 02HA0RS, 02HA3RS, 02HA4RS, 02HA0RZ, 02HA3RZ, 02HA4RZ, 02WA0RZ, 02WA3RZ, 02WA4RZ, 02PA0RZ, 02PA3RZ, 02PA4RZ, and ICD-10 diagnosis code I50.1. Added new ICD-10 procedure codes 02WA0RS, 02WA3RS, 02WA4RS, 02PA0RS, 02PA3RS, 02PA4RS, 02HA0RJ, 02HA3RJ, 02HA4RJ, and ICD-10 diagnosis codes I50.810, I50.811, I50.812, I50.813, I50.814, I50.82, I50.83, I50.84, I50.89. Effective 10/01/2017.

12/21/2017: Code Reference section updated to add new 2018 CPT codes 33927, 33928, 33929 and new 2018 HCPCS code Q0477.

09/04/2018: Policy description updated regarding heart transplant survival rates and devices. Policy statements unchanged.

12/20/2018: Code Reference section updated to add new HCPCS code L8698, effective 01/01/2019.

09/13/2019: Policy description updated regarding devices. Policy statements unchanged. Code Reference section updated to remove deleted CPT codes 0051T, 0052T, and 0053T.

09/18/2020: Policy reviewed; no changes.

12/16/2020: Code Reference section updated to revise code descriptions for CPT codes 33990, 33991, 33992, 33993 and to add new CPT codes 33995 and 33997, effective 01/01/2021.

04/15/2022: Policy description updated regarding devices. Revised medically necessary criteria for destination therapy. Policy Guidelines updated regarding intent of treatment and requirements by The Centers for Medicare and Medicaid Services.

11/15/2022: Policy description updated regarding new data for heart failure. Policy statements updated to change "patients" to "individuals."

09/29/2023: Code Reference section updated to add new ICD-10 procedure codes 02HW3RZ, 02PW3RZ, and 02WW3RZ, effective 10/01/2023.

10/09/2023: Policy description updated. Medically necessary policy statement regarding total artificial hearts updated for clarity. Policy statement and Policy Guidelines updated to change "patients" to "individuals."

10/22/2024: Policy description updated regarding new heart failure data and ventricular assist devices. Policy statements unchanged. Policy Guidelines updated regarding devices.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.03.11

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy. 

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

Investigational Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.