Humana Ventricular Assist Device Total Artificial Heart Form

Description Ventricular Assist Device

A ventricular assist device (VAD) is a mechanical pump that compensates for the diminished ability of a weakened heart, by assisting or replacing the function of the left or right ventricle. A left VAD (the most commonly used) provides blood flow throughout the body while the right VAD supports the pulmonary (lung) circulation. VADs may be utilized for an individual suffering from reversible cardiac dysfunction, to support an individual who is awaiting heart transplantation or to provide permanent circulatory support with end-stage heart failure in those who are not a candidate for transplantation (known as destination therapy).

There are many VADs available for use. Important characteristics of these systems include: location of the pumping chamber, the specific ventricles that are supported, the pumping mechanism and how long support (temporary or long-term) is indicated. Typically, short-term devices are extracorporeal (located outside the body) and long-term use are implantable systems. Generally these devices are placed via a sternotomy; however, some have received US Food & Drug Administration (FDA) approval for placement via a thoracotomy (eg, HeartMate 3).

FDA-approved VADs include, but may not be limited to, the following:

• Bridge to transplant: CentriMag Circulatory Support System, HeartMate II LVAD, HeartMate 3 LVAD.
• Destination therapy: HeartMate II LVAD, HeartMate 3 LVAD.
• Pediatric bridge to transplant: EXCOR Pediatric VAD, HeartAssist 5 Pediatric VAD, HeartMate 3 LVAD
• Pediatric destination therapy: HeartMate 3 LVAD
• Short-term bridge to recovery: CentriMag Circulatory Support System, HeartMate 3 LVAD.

The HeartWare HVAD has been voluntarily recalled by the manufacturer due to neurological complications with the device and is no longer being sold/distributed.

Percutaneous ventricular assist devices (pVADs)

differ from other types of VADs as they can be placed via cardiac catheterization without the need for open-chest surgery, which avoids potential difficulties in crossing the aortic valve.

pVADs are utilized for short-term bridge to recovery (eg, less than or equal to 4 hours for Impella 2.5 and Impella CP with SmartAssist, less than or equal to 6 hours for Impella 5.0/LD, LifeSPARC system and TandemHeart and up to 14 days for the Impella 5.5 with SmartAssist).

Examples of pVADs include, but may not be limited to:

• Aortix Percutaneous Mechanical Circulatory Support (pMCS) (Refer to Coverage Limitations section)
• Impella 2.5 System
• Impella 5.0 (LP/LD)
• Impella 5.5 with SmartAssist

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Impella CP with SmartAssist*
• LifeSPARC system
• TandemHeart

*SmartAssist technology is designed to provide physicians with weaning algorithms as well as additional data such as left ventricular (LV) pressure, end diastolic pressure and cardiac output with the intent of optimizing survival and recovery. The data can be accessed via an online database.

The CentriMag Circulatory Support System is indicated for temporary circulatory support for up to 30 days for one or both sides of the heart to treat postcardiotomy individuals who fail to wean from cardiopulmonary bypass. This provides a bridge to decision when it is unclear whether the individual's heart will recover or whether the individual will need alternative, longer-term therapy.81

The Impella RP System is indicated for providing temporary right ventricular support for up to 14 days in individuals with a body surface area ">=1.5 m², who develop acute right heart failure or decompensation for less than 48 hours following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery, without the presence of profound shock, end organ failure, or acute neurologic injury.99 In addition, the Impella RP Flex is implanted via the internal jugular (IJ) vein, which purportedly enables patient mobility, and has dual- sensor technology designed to optimize patient management.

Total Artificial Heart

A total artificial heart (TAH) is a device that replaces the two lower chambers of the heart and is available to individuals with end-stage heart failure.

The SynCardia temporary TAH-t is intended for an individual who is on a heart transplant list and are so critically ill that death is imminent without use of this as a bridge until a heart transplant is available. The SynCardia TAH-t is an implantable device that is driven by compressed air and replaces the function of the ventricles. It attaches to the individual's atria after the damaged ventricles are removed. Each ventricle of the TAH is connected to a driveline that is tunneled through the chest wall and attached to an external bedside console that supplies pulses of pneumatic pressure to the left and right drivelines, which are connected to the air chambers of their respected ventricles. These air pulses distend the diaphragms ejecting blood from the left ventricle and right ventricle synchronously to the systemic and pulmonary circulation.40 The SynCardia 70cc TAH-t is intended to support individuals with a body surface area (BSA) greater than or equal to 1.7m². The 50cc TAH-t is also available, which is designed for an individual that is smaller in stature with a BSA less than or equal to 1.85m².

Traditionally, artificial heart technology has used large, hospital-based pneumatic driver systems, which require an individual to be hospitalized while awaiting a donor heart. However, the Freedom portable driver has been developed, which purportedly enables a stable individual to be discharged from the hospital to await a suitable donor heart at home.

(Refer to Coverage Limitations section) Permanently implantable aortic counterpulsation ventricular assist devices as a bridge to recovery are being investigated using surgically implanted counterpulsation devices that are placed in or around the aorta. This treatment is based on the scientific principle of an intraaortic balloon pump (IABP) that provides counterpulsation, which is theorized to stimulate the work and reduce the afterload of the left ventricle. The balloon inflates during diastole and deflates in early systole, thereby increasing blood flow to the coronary arteries and decreasing the workload required to pump blood throughout the body. There are currently no FDA-approved continuous internal pulsation devices. Examples of devices in development or in clinical trials include, but may not be limited to: CardioVAD, C-pulse heart assist system, NuPulse iVAS, PULVAD device and the Symphony counterpulsation device.50

(Refer to Coverage Limitations section) Absorbable antibacterial wraps or envelopes have been suggested to reduce the risk of infection after cardiac devices have been implanted. These products consist of a bioabsorbable mesh that elutes minocycline and rifampin to the surgical site for at least 7 days and is fully absorbed by the body in approximately 9 weeks. An example of an antibacterial wrap or envelope is the TYRX antibacterial envelope.27,78

For information regarding antibacterial envelopes for cardioverter defibrillator placement, please refer to Cardioverter Defibrillators/Cardiac Resynchronization Therapy Medical Coverage Policy.

Ventricular Assist Device, Total Artificial Heart Effective Date:

03/23/2023

Revision Date:

03/23/2023

Review Date:

03/23/2023

Policy Number:

HUM-0421-032

Page: 5 of 28

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.

Coverage Determination

Commercial Plan members: requests for VADs and TAHs require review by a medical director.

Commercial Plan members: requests for young adults (generally defined as 18-21 years) to undergo VAD or TAH placement at non-Medicare approved facilities (eg, for continuity of care) require review by a Medical Director.

For information regarding coverage determination/limitations of clinical trials, please refer to Clinical Trials Medical Coverage Policy.

Refer ALL questions and service requests for TAHs and VADs, with the exception of pVADs, to the Humana Transplant Department at 1-866-421-5663. pVADs follow normal clinical review processes and are not managed by the Humana Transplant Department.

VADs Humana members may be eligible under the Plan for a VAD as a bridge to recovery when ALL of the following criteria are met:

• Device has FDA approval for bridge to recovery and is used according to the FDA-approved indications; AND
• Individual has acute, but potentially reversible, heart failure due to myocardial infarction, acute myocarditis or for an individual following open-heart surgery (also referred to as postcardiotomy) who cannot be weaned from cardiopulmonary bypass

Note: The criteria for VADs are not consistent with the Medicare National Coverage Policy and therefore may not be applicable to Medicare members.

Refer to the CMS website for additional information.

Adult Bridge to Heart Transplantation

Humana members may be eligible under the Plan for a VAD as a bridge to transplantation when ALL of the following criteria are met:

• Individual is approved and listed as a candidate for heart transplantation; AND

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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.

• VAD must be used in accordance with the FDA-approved indications, which means the VAD is used as a temporary mechanical circulatory support for approved transplant candidates as a bridge to heart transplantation

Note: The criteria for bridge to transplant VADs in adults are not consistent with the Medicare National Coverage Policy and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Pediatric Bridge to Heart Transplantation or Destination Therapy

Humana members may be eligible under the Plan for the following FDA-approved pediatric VADs (including humanitarian device exemptions [HDE]) as a bridge to transplant or destination therapy (eg, HeartMate 3) when ALL of the following criteria are met:

EXCOR Pediatric VAD

• Able to tolerate systemic anticoagulation therapy; AND
• Body weight of 3 to 60 kilograms; AND
• Listed candidate for heart transplant; AND
• Requires mechanical circulatory support until a donor heart can be found; AND
• Severe isolated left ventricular or biventricular dysfunction

HeartAssist 5 Pediatric VAD

• Between 5 and 16 years of age; AND
• Body surface area (BSA) between 0.7 m2 and 1.5 m2; AND
• Class IV end-stage heart failure symptoms refractory to medical therapy; AND
• Listed candidate for heart transplant; AND
• Requires temporary left side mechanical circulatory support until a donor heart can be found

HeartMate 3 Left Ventricular Assist System

• Able to tolerate systemic anticoagulation therapy; AND either of the following:

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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.

• Short-term mechanical circulatory support (eg, bridge to transplant or myocardial recovery) for an individual with advanced refractory left ventricular heart failure86; OR
• Long-term mechanical circulatory support (eg, destination therapy) for an individual with advanced refractory left ventricular heart failure86

Destination Therapy

Humana members may be eligible under the Plan for a VAD for destination therapy when ALL of the following criteria are met:

• Class IV heart failure symptoms that have failed to respond to optimal medical management below:
  • Beta-blockers and one of the following for least 45 of the last 60 days (if not contraindicated):
    • Angiotensin-converting enzyme (ACE) inhibitor
    • Angiotensin II receptor blocker (ARB)
    • Angiotensin Receptor-Neprilysin Inhibitor (ARNi); OR
  • Have been balloon pump dependent for 7 days; OR
  • Intravenous inotrope dependent for 14 days; AND
• Demonstration of functional limitation with a peak oxygen consumption of 14 ml/kg/min unless dependent on temporarily placed balloon pump or intravenous inotrope or physically unable to perform the test; AND
• Left ventricular ejection fraction (LVEF) less than 25%; AND
• NOT a candidate for heart transplantation; AND
• VAD must have FDA approval and be used in accordance to the FDA labeling instructions

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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.

Note: The criteria for destination therapy VADs are not consistent with the Medicare National Coverage Policy and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Right VADs

Humana members may be eligible under the Plan for the Impella RP system/ Impella RP Flex when the criteria are met:

• Individuals who develop acute right heart failure or decompensation for less than 48 hours following:
  • Heart transplant; OR
  • LVAD implantation; OR
  • Myocardial infarction; OR
  • Open heart surgery; AND all of the following:
• May be utilized for a maximum period of 14 days; AND
• Pediatric or adult individual with a BSA greater than or equal to 1.5m2; AND
• Without the presence of profound shock, end organ failure, or acute neurologic injury

Note: The criteria for RVADs are not consistent with the Medicare National Coverage Policy and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Left and/or Right Sided VAD

Humana members may be eligible under the Plan for the CentriMag Circulatory Support System when the following criteria are met:

• Individual following open-heart surgery who cannot be weaned from cardiopulmonary bypass; AND
• May be utilized for a maximum period of 30 days

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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.

Percutaneous VADs (pVADs)

Humana members may be eligible under the Plan for a pVAD (eg, Impella 2.5, Impella 5.0 (LP/LD), Impella 5.5 with SmartAssist, Impella CP with SmartAssist, LifeSPARC system or the TandemHeart) for the following indications:

• Acute myocardial infarction (AMI) with hemodynamic instability (eg, systolic blood pressure (SBP) less than 100, heart rate greater than 100 or less than 60 or other evidence of end organ hypoperfusion); OR
• Bridge to transplant; OR
• High risk percutaneous coronary interventions (PCI) for the following indications:
  • Three vessel disease and EF less than or equal to 35% with the Impella device or less than or equal to 25% with the TandemHeart system; OR
  • Unprotected left main or last patent conduit and EF less than or equal to 35% with the Impella device or less than or equal to 25% with the TandemHeart system; OR
  • Ongoing cardiogenic shock that occurs as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures**;
• AND one of the following:
  • Cardiomyopathy, including peripartum cardiomyopathy or myocarditis; OR
  • Less than 48 hours following AMI or open heart surgery; 90 OR
  • Severe decompensated heart failure; OR
  • Short-term circulatory support in cardiogenic shock

**Optimal medical management and conventional treatment measures include volume loading and use of pressors and inotropes, with or without the use of a temporarily placed IABP.

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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.

TOTAL ARTIFICIAL HEART

Humana members may be eligible under the Plan for the 50cc or 70cc SynCardia TAH-t as a bridge to transplantation for the following indications:

• Listed candidate for heart transplant and in imminent danger of dying within 48 hours or becoming ineligible for transplant; AND
• Maximal intravenous inotropic support/medical management; AND
• New York Heart Association Class IV; AND
• Presence of biventricular failure and rapid decompensation; AND
• Unavailability of heart donor and likelihood that condition will deteriorate before donor can be identified

Note: The criteria for total artificial heart are not consistent with the Medicare National Coverage Policy, and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Coverage Limitations

Humana members may NOT be eligible under the Plan for the following devices for any indications other than those listed above:

• pVAD
• TAH
• VAD

These are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for the following devices for any indications:

• Aortix pMCS device
• Permanently implantable aortic counterpulsation ventricular assist device

Ventricular Assist Device, Total Artificial Heart Effective Date: 03/23/2023 Revision Date: 03/23/2023 Review Date: 03/23/2023 Policy Number: HUM-0421-032 Page: 11 of 28

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.

• SynCardia freedom driver system

These are 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.

Absorbable antibacterial wraps or envelopes are considered integral to the primary procedure and not separately reimbursable.

Additional information about heart failure may be found from the following websites:

Background

• American Heart Association
• National Heart, Lung and Blood Institute
• National Library of Medicine

Medical Alternatives

Alternatives to VADs include, but may not be limited to:

• Heart transplantation

Physician consultation is advised to make an informed decision based on an individual's health needs.

Humana may offer a disease management program for this condition. The member may call the number on his/her identification card to ask about our programs to help manage his/her care.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.