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Total Artificial Hearts and Implantable Ventricular Assist Devices

Policy Number: MP-033

Latest Review Date: September 2019

Category: Surgery

Policy Grade: A

POLICY:

Ventricular assist device (VAD) implantation may be considered medically necessary

only when performed in a Medicare-approved heart transplant facility OR Medicare-approved VAD destination therapy facility AND follows individual criteria for specific indications listed below. A list of these facilities is maintained on the CMS web site and available at

www.cms.gov/CertificationandComplianc/Downloads/ApprovedTransplantPrograms.pdf

and www.cms.gov/Medicare/Medicare-General-Information/MedicareApprovedFacilities/VAD-Destination-Therapy-Facilities-Aug2007.html.

Bridge to Recovery

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

Percutaneous ventricular assist devices (pVAD) with FDA approval or clearance meet Blue Cross and Blue Shield of Alabama’s medical criteria for coverage for use in patients undergoing high risk percutaneous coronary intervention (PCI) when ALL of the following are met:

  • Patient has LVEF of less than 35% AND;

  • Will undergo PCI on an unprotected left main coronary artery or last patent coronary conduit.

Bridge to Transplantation

TAH

Total artificial hearts with FDA-approved devices meet Blue Cross and Blue Shield of Alabama’s medical criteria for coverage when performed in a Medicare-approved heart transplant facility as a bridge to heart transplantation when ALL of the following criteria are met:

  • Biventricular failure AND,

  • No other reasonable medical or surgical treatment options; AND

  • Are ineligible for other univentricular or biventricular support devices; AND

  • Are currently listed as heart transplantation candidates

    OR

    Are undergoing evaluation to determine candidacy for heart transplantation; AND

  • Are not expected to survive until a donor heart can be obtained.

VAD- Adult

Ventricular assist devices with FDA approval or clearance meet Blue Cross and Blue Shield of Alabama’s medical criteria for coverage as a bridge to transplantation when ALL of the following criteria are met:

  • Patient is diagnosed with severe congestive heart failure (CHF); AND

  • Is an approved heart transplant candidate by an approved heart transplant center;

    OR

    Is undergoing evaluation to determine candidacy for heart transplantation; AND

  • Is at risk of dying before a donor heart is available**; AND

  • On optimal inotropic (influencing the contractility of muscular tissue) support; AND

  • If possible, on an intra-aortic balloon pump.

    **The criteria listed below may be used as hemodynamic selection criteria:

  1. Either a left atrial pressure of 20m Hg or a cardiac index of less than 2.0L/min/m while on maximum medical support;

  2. Patients who are usually being treated as inpatients and according to the American Heart Association or comparable, as Class IV CHF;

  3. Classified as status I by the United Network for Organ Sharing (considered the highest priority for transplantation).

    Pediatric- VAD

    Ventricular assist devices with FDA approval or clearance, including humanitarian device exemptions meet Blue Cross and Blue Shield of Alabama’s medical criteria for coverage in children 16 years old and younger as a bridge to heart transplantation 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 transplant.

    Destination Therapy

    Ventricular assist devices with FDA approval or clearance meet Blue Cross and Blue Shield of Alabama’s medical criteria for coverage when used as a permanent alternative (destination therapy) for patients with end-stage heart failure and who are not candidates for heart transplantation when ALL of the following criteria are met:

  • New York Heart Association (NYHA) Class IV heart failure not responding to optimal medical management for at least 60 days,

    OR

    NYHA Class III/IV for at least 28 days and received ≥ 14 days support with an intra-aortic balloon pump

    OR

    NYHA Class III/IV for at least 28 days and dependent on intravenous (IV) inotropic agents, with two failed weaning attempts; AND

  • Left ventricular ejection fraction (LVEF) < 25%; AND

  • Patients must not be candidates for human heart transplant for one or more of the following reasons:

  • Age > 65 years; or

  • Insulin-dependent diabetes mellitus with end-organ damage; or

  • Chronic renal failure with serum creatinine > 2.5 mg/dl for ≥ 90 days; or

  • Other clinically significant condition.

    Other Indications

    Total artificial hearts including, but not limited to, the use of total artificial hearts as destination therapy does not meet Blue Cross and Blue Shield of Alabama’s medical criteria and is considered investigational for all other indications.

    Ventricular assist devices and percutaneous ventricular assist devices do not meet Blue Cross and Blue Shield of Alabama’s medical criteria for coverage and are considered investigational for all other indications.

    Use of a non-FDA approved ventricular assist device does not meet Blue Cross and Blue Shield of Alabama’s medical criteria for coverage and is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Mechanical devices to assist or replace a failing heart have been developed over many decades of research. A ventricular assist device (VAD) is a 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 in those who are not candidates for transplantation. The VAD has also been used as a bridge to recovery in patients with reversible conditions affecting cardiac output.

Heart Failure

Heart failure may be the consequence of a number of differing 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 has survival rates at 1-, 3-, and 5-years of 91%, 85%, and 78%, respectively. The number of candidates for transplants exceeds the supply of donor organs; thus the interest in the development of mechanical devices.

Treatment

Ventricular Assist Devices (VAD)

Implantable ventricular assist devices are attached to the native heart, which may have enough residual activity to withstand a device failure in the short term. In reversible conditions of heart failure, 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 utilize a pump which provides continuous flow. Continuous devices may move blood in rotary or axial flow.

At least one VAD system has been developed that is miniaturized and generates an artificial pulse, the HeartMate III LVAD (St. Jude Medical, Pleasanton, California). The HeartMate® III was FDA approved August 23, 2017.

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 otherwise contraindicated or unavailable. They 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 left ventricle, pulmonary artery for right ventricle). A small portion of ventricular wall is removed for insertion of the outflow tube; extensive cardiotomy affecting the ventricular wall may preclude VAD use.

Total Artificial Heart (TAH)

Initial research into mechanical assistance for the heart focused on the total artificial heart, a biventricular device which completely replaces the function of the diseased heart. An internal battery required frequent recharging from an external power source. Many systems utilize 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.

A fully bioprosthetic TAH, which is fully implanted in the pericardial sac and is electrohydrolically actuated, has been developed and tested in 2 patients, but is currently experimental.

Percutaneous Ventricular Assist Devices (pVADs)

Devices in which the majority of the system’s components are external to the body are for short-term use (six hours to 14 days) only, due to the increased risk of infection and need for careful, in-hospital monitoring. Some circulatory assist devices are placed percutaneously, (i.e., are not implanted). These may be referred to as percutaneous VADs (pVADs). The pVADs are placed through the femoral artery. Two different pVADs have been developed, the TandemHeart™, and the Impella® device. 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 that is placed into the left ventricle. Blood is pumped from the left ventricle, through the device, and into the ascending aorta. 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 (MI), stroke, and arrhythmias.

KEY POINTS:

The most recent literature search was performed for the period through June 10, 2019.

Summary of Evidence

Ventricular Assist Device

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

For individuals who have end stage heart failure who receive VADs as destination therapy, the evidence includes one clinical trial and multiple single arm studies. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, treatment-related mortality, and treatment-related morbidity. A well-designed clinical trial, with two years of follow-up data, demonstrates an advantage of implantable ventricular assist devices as destination therapy for patients who are ineligible for heart transplant. Despite an increase in adverse events, both mortality and quality of life appear to be improved for these patients. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome.

Total Artificial Heart

For individuals who have end stage heart failure who receive total artificial hearts (TAHs) as bridge to transplant, the evidence includes case series. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, treatment-related mortality, and treatment-related morbidity. Compared with VADs, the evidence for total artificial heart in these settings is less robust. However, given the limited evidence from case series and the lack of medical or surgical options for these patients, 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 an LVAD. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome.

For individuals who have end stage heart failure who receive TAHs as destination therapy, the evidence includes 2 case series. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, treatment-related mortality, and treatment-related morbidity. The body of evidence for TAHs as destination therapy is very limited. The evidence is insufficient to determine the effects of the technology on health outcomes.

Percutaneous Ventricular Assist Device

For individuals with cardiogenic shock or who undergo high-risk cardiac procedures who receive a pVAD, the evidence includes RCTs, observational studies, and systematic reviews. The relevant outcomes are OS, symptoms, morbid events, functional outcomes, QOL, and treatment-related mortality and morbidity. Four RCTs of pVAD vs IABP for patients in cardiogenic shock failed to demonstrate a mortality benefit and reported higher complication rates with pVAD use. Comparative observational studies were consistent with the RCT evidence. RCTs, controlled and uncontrolled observational studies, and systematic reviews of these studies have not demonstrated a benefit of pVAD used as ancillary support for patients undergoing high-risk cardiac procedures. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with cardiogenic shock refractory to IABP therapy who receive a pVAD, the evidence includes case series. The 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 the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

Society for Cardiovascular Angiography and Interventions et al

In 2015, the Society for Cardiovascular Angiography and Interventions (SCAI), the Heart Failure Society of America (HFSA), the Society of Thoracic Surgeons (STS), the American Heart Association (AHA), and the American College of Cardiology (ACC) published a clinical expert consensus statement on the use of percutaneous mechanical circulatory support (MCS) devices in cardiovascular care. This statement addressed intra-aortic balloon pumps (IABPs), left atrial (LA)-to-aorta assist device (e.g., TandemHeart®), left ventricle (LV)-to-aorta assist devices (e.g., Impella®), extracorporeal membrane oxygenation (ECMO), and methods of right-sided support. Specific recommendations were not made, but the statement reviews the use of MCS in patients undergoing high-risk percutaneous intervention, those with cardiogenic shock, and those with acute decompensated heart failure:

  1. “Percutaneous MCS provides superior hemodynamic support compared to pharmacologic therapy. This is particularly apparent for the Impella® and TandemHeart® devices. These devices should remain available clinically and be appropriately reimbursed.

  2. Patients in cardiogenic shock represent an extremely high risk group in whom mortality has remained high despite revascularization and pharmacologic therapies. Early placement of an appropriate MCS may be considered in those who fail to stabilize or show signs of improvement quickly after initial interventions.

  3. MCS may be considered for patients undergoing high-risk PCI, such as those requiring multivessel, left main, or last patent conduit interventions, particularly if the patient is inoperable or has severely decreased ejection fraction or elevated cardiac filling pressures.”

    American College of Cardiology Foundation et al

    The American College of Cardiology Foundation, American Heart Association (AHA), and Heart Failure Society of American (2017) published a focused update of the 2013 recommendations released by the American College of Cardiology Foundation and AHA. Left ventricular assist device was one of several treatment options recommended for patients with refractory New York Heart Association class III or IV heart failure (stage D). If symptoms were not improved after guidelines directed management and therapy, which included pharmacologic therapy, surgical management and/or other devices, then left ventricular assist device would be an additional treatment option.

    The 2017 update focused on changes in sections regarding biomarkers, comorbidities, and prevention of heart failure, while many of the previous recommendations remained unchanged. The American College of Cardiology Foundation and AHA (2013) released guidelines for the management of heart failure that included recommendations related to the use of MCS, including both durable and nondurable MCS devices. The guidelines categorized percutaneous ventricular assist devices (pVADs) and extracorporeal VADs as nondurable MCS devices.

    American College of Cardiology and American Heart Association

    The American College of Cardiology and American Heart Association (ACC/AHA) released guidelines for the management of heart failure in October 2013 that include recommendations related to the use of for mechanical circulatory support (MCS), including both durable and nondurable MCS devices. The guidelines categorize pVADs and extracorporeal VADs as nondurable MCS devices. The following class IIA guidelines are made related to MCS devices:

    • MCS is beneficial in carefully selected patients with stage D heart failure with reduced ejection fraction (HFrEF) in whom definitive management (e.g., cardiac transplantation) or cardiac recovery is anticipated or planned. (Level of Evidence: B)

    • Nondurable MCS, including the use of percutaneous and extracorporeal VADs, is reasonable as a “bridge to recovery” or “bridge to decision” for carefully selected patients with HFrEF with acute, profound hemodynamic compromise. (Level of Evidence; B)

    • Durable MCS is reasonable to prolong survival for carefully selected patients with stage D HFrEF. (Level of Evidence: B)

      The AHA/ACC guidelines note:

      “Although optimal patient selection for MCS remains an active area of investigation, general indications for referral for MCS therapy include patients with LVEF <25% and NYHA Class III–IV functional status despite GDMT, including, when indicated, CRT, with either high predicted one to two year mortality (e.g., as suggested by markedly reduced peak oxygen consumption and clinical prognostic scores) or dependence on continuous parenteral inotropic support. Patient selection requires a multidisciplinary team of experienced advanced HF and transplantation cardiologists, cardiothoracic surgeons, nurses, and ideally, social workers and palliative care clinicians.”

      In 2012, AHA published recommendations for the use of MCS. These guidelines define nondurable MCS as intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation, extracorporeal VADs, and pVADs. The following recommendations were made regarding indications for use of MCS, including durable and nondurable devices:

    • MCS for bridge-to-transplant indication should be considered for transplant-eligible patients with end-stage heart failure who are failing optimal medical, surgical, and/or device therapies and at high risk of dying before receiving a heart transplantation. (Class I; Level of Evidence B).

    • Implantation of MCS in patients before the development of advanced heart failure… is associated with better outcomes. Therefore, early referral of heart failure patients is reasonable. (Class IIa; Level of Evidence B).

    • MCS with a durable, implantable device for permanent therapy or destination therapy is beneficial for patients with advanced heart failure, high one year mortality resulting from heart failure, and the absence of other life-limiting organ dysfunction; who are failing medical, surgical, and/or device therapies; and who are ineligible for heart transplantation. (Class I; Level of Evidence B).

    • Elective rather than urgent implantation of destination therapy can be beneficial when performed after optimization of medical therapy in advanced heart failure patients who are failing medical, surgical, and/or device therapies. (Class IIa; Level of Evidence C).

    • Urgent nondurable MCS is reasonable in hemodynamically compromised heart failure patients with end-organ dysfunction and/or relative contraindications to heart transplantation/durable MCS that are expected to improve with time and restoration of an improved hemodynamic profile. (Class IIa; Level of Evidence C).

    • These patients should be referred to a center with expertise in the management of durable MCS and patients with advanced heart failure. (Class I; Level of Evidence C).

  • Patients who are ineligible for heart transplantation because of pulmonary hypertension related to heart failure alone should be considered for bridge to potential transplant eligibility with durable, long-term MCS. (Class IIa; Level of Evidence B).

Heart Failure Society of America

The Heart Failure Society of America published guidelines in 2010 on surgical approaches to the treatment of heart failure. The following recommendations were made regarding left ventricular assist devices:

  • Patients awaiting heart transplantation who have become refractory to all means of medical circulatory support should be considered for a mechanical support device as a bridge to transplant. (Strength of Evidence = B)

  • Permanent mechanical assistance using an implantable assist device may be considered in highly selected patients with severe HF [heart failure] refractory to conventional therapy who are not candidates for heart transplantation, particularly those who cannot be weaned from intravenous inotropic support at an experienced HF center. (Strength of Evidence = B)

  • Patients with refractory HF and hemodynamic instability, and/or compromised end-organ function, with relative contraindications to cardiac transplantation or permanent mechanical circulatory assistance expected to improve with time or restoration of an improved hemodynamic profile should be considered for urgent mechanical circulatory support as a "bridge to decision." These patients should be referred to a center with expertise in the management of patients with advanced HF. (Strength of Evidence = C)

U.S. Preventive Services Task Force Recommendations

Not applicable

KEY WORDS:

Ventricular assist device, biventricular support, BIVAD, cardiac support, heart transplantation (transplant), LVAD, VAD, destination therapy, HeartWare®, Impella LV®, Impella 2.5, Impella 2.5 circulatory assist device, DeBakey, percutaneous ventricular assist device, pVAD, TandemHeart®, Berlin Heart EXCOR®, Impella RP, Carmat, bioprosthetic artificial heart, HeartMate III, Total Artificial Heart, TAH, CardioWest Total Artificial Heart, HeartMate II®, SynCardia artificial heart, Right Ventricular Assist Device, RVAD, PediMag®, short-term continuous flow ventricular assist devices, STCF-VADs, intraluminal axial support

APPROVED BY GOVERNING BODIES:

A number of mechanical circulatory support devices have received approval or clearance for marketing by FDA. These devices are summarized in Table 1, and described further in the sections below.

Table 1: Available Mechanical Circulatory Support Devices

Device

Manufacturer

Approval Date

FDA Clearance

PMA, HDE, or

510(k) No.

Indication

Thoratec® IVAD

Thoratec

Aug 2004

PMA supplement

P870072

Bridge to transplant and postcardiotomy

DeBakey VAD®

Child

MicroMed

Feb 2004

HDE

H030003

Bridge to transplant in children 5-16 years of age

HeartMate II®

Thoratec

Apr 2008

PMA

P060040

Bridge to transplant and destination therapy

Centrimag®

Levitronix

Oct 2008

HDE

H070004

Postcardiotomy

Berlin Heart EXCOR®

Pediatric VAD

Berlin

Dec 2011

HDE

H100004

Bridge to transplant

HeartWare® Ventricular Assist System

HeartWare

Dec 2012

PMA

P100047

Bridge to transplant, and destination therapy

HeartMate III™

Left Ventricular Assist System

Thoratec

Aug 2017

PMA

P160054

Bridge to transplant, and destination therapy

FDA: Food and Drug Administration; HDE: humanitarian device exemption; PMA: premarket approval

Ventricular Assist Devices

In December 1995, the Thoratec® Ventricular Assist Device System (Thoratec Corp., Pleasanton, CA) was approved by the FDA through the premarket approval process for use as a bridge to transplantation in patients suffering from end-stage heart failure. The patient should meet all of the following criteria:

  • candidate for cardiac transplantation,

  • imminent risk of dying before donor heart procurement, and

  • dependence on, or incomplete response to, continuous vasopressor support.

In May 1998, supplemental approval for the above device was given for the indication for postcardiotomy patients who are unable to be weaned from cardiopulmonary bypass. In June 2001, supplemental approval was given for a portable external driver to permit excursions within a 2-hour travel radius of the hospital in the company of a trained caregiver. In November 2003, supplemental approval was given to market the device as Thoratec® Paracorporeal VAD. In August 2004, supplemental approval was given to a modified device to be marketed as the Thoratec® Implantable VAD for the same indications. In January 2008, supplemental approval was given to delete Paracorporeal VAD use.

In February 2004, the FDA approved the DeBakey VAD® Child under the HDE approval process. According to the FDA, this device is indicated under HDE for both home and hospital use for children who are between ages 5 and 16 years and who have end-stage ventricular failure requiring temporary mechanical blood circulation until a heart transplant is performed.

In April 2008, continuous flow device HeartMate II® LVAS (Thoratec, Pleasanton, CA) was approved by the FDA through the premarket approval process for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from nonreversible left ventricular failure. The Heartmate II® LVAS is intended for use both inside and outside the hospital. In January 2010, the device received the added indication as destination therapy for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure who have received optimal medical therapy for at least 45 of the last 60 days and are not candidates for cardiac transplantation.

In October 2008, device Centrimag® Right Ventricular Assist Device (Levitronix, Zurich) was approved by the FDA under the HDE to provide temporary circulatory support for up to 14 days for patients in cardiogenic shock due to acute right-sided heart failure.

In December 2011, the Berlin Heart EXCOR® Pediatric VAD was approved via HDE. The indications for this device are pediatric patients with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant and require circulatory support.

In December 2012, device HeartWare® Ventricular Assist System (HeartWare, Inc., Framingham, Mass.) was approved by the FDA using the INTERMACS registry as a control. INTERMACS registry was established in 2005 as a joint effort involving the FDA, National Heart, Lung and Blood Institute (NHLBI), Centers for Medicare and Medicaid Services (CMS), clinicians, scientists, and industry. This was the first time the FDA approved an LVAD using registry data as a control. INTERMACS is managed by the University of Alabama at Birmingham.

In August 2016, HeartWare® recalled its VAD Pumps due to a design flaw that was deemed by FDA as potentially causing serious injuries or death (class I recall). The devices affected were manufactured and distributed from March 2006 and May 2018. FDA product codes 204 and 017.

In September 2017, HeartWare® Ventricular Assist System (HeartWare, Inc., Framingham, Mass.) was approved by the FDA for providing long-term hemodynamic support (e.g., destination therapy) in patients with advanced heart failure.

In August 2017, the HeartMate 3 Left Ventricular Assist System (Thoratec Corp., Pleasanton, CA) was approved by the FDA for providing short-term hemodynamic support (e.g., bridge to transplant or bridge to myocardial recovery) in patients with advanced refractory left ventricular heart failure.

In October 2018, the HeartMate 3 Left Ventricular Assist System (Thoratec Corp., Pleasanton, CA) was approved by the FDA for providing long-term hemodynamic support (e.g., destination therapy) in patients with advanced heart failure.

A class I recall was issued for the HeartMate 3™ in April 2018 affecting all manufacturing dates. FDA product code: DSQ.

Total Artificial Heart

In 2004, the temporary CardioWest™ Total Artificial Heart (SynCardia Systems) was approved by FDA through the premarket approval process for use as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure. This device is also intended for use inside the hospital. In 2010, FDA approved a name change to SynCardia Temporary Total Artificial Heart. FDA product code: LOZ.

In 2006, the AbioCor® Implantable Replacement Heart System (Abiomed) was approved by FDA through the humanitarian device exemption (H040006) process in severe biventricular end-stage heart disease patients who are not cardiac transplant candidates and who:

  • are younger than 75 years of age;

  • require multiple inotropic support;

  • are not treatable by left VAD destination therapy; and

  • are not weanable from biventricular support if on such support.

In addition to meeting other criteria, patients who are candidates for the AbioCor® TAH must undergo a screening process to determine if their chest volume is large enough to hold the device. The device is too large for about 90% of women and for many men.

**NOTE: The Carmat bioprosthetic total artificial heart has not been FDA approved.

Percutaneous VADs (Circulatory Assist Devices)

Table 2. Available Mechanical Circulatory Support Devices

Device

Manufacturer

Approval

Date

FDA

Clearance

PMA,

510(k) No.

Indication

TandemHeart®

Cardiac Assist

Sep 2005

510(k)

K110493

Temporary left ventricular bypass of ≤6 h

Impella® Recover LP 2.5

Abiomed

May 2008

510(k)

K063723

Partial circulatory support using extracorporeal bypass control unit for ≤6 h

Impella® 2.5 System

Abiomed

Mar 2015

PMA

P140003

Temporary ventricular support for ≤6 h

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

Comparative Efficacy of Left VAD Devices

The mechanism of operation of left VADs has changed since their introduction. The earliest devices were pulsatile positive displacement pumps. These pumps have been largely replaced by axial continuous-flow pumps. More recently centrifugal continuous-flow pumps have also been introduced.

The evidence of the comparative efficacy of centrifugal continuous-flow vs axial continuous-flow devices consists of 2 randomized controlled trials of 2 different centrifugal continuous-flow devices.4,5 The MOMENTUM 3 trial compared HeartMate III centrifugal continuous-flow device with the HeartMate II® axial continuous-flow device in patients indicated for circulatory support as a bridge to transplant or destination therapy. HeartMate III received PMA approval in August 2017 but was recalled in April 2018. The ENDURANCE trial compared HeartWare® centrifugal continuous-flow device with the HeartMate II® axial continuous-flow device in patients indicated for circulatory support as destination therapy. HeartWare® is FDA-approved as a bridge to transplantation device. Both trials found the centrifugal device to be noninferior to the axial device for the primary, composite outcome including measures of survival, freedom from disabling stroke, and freedom from device failure. While there are fewer device failures with the centrifugal devices without a significant increase in disabling stroke, the HeartWare® device was associated with increased risk of any stroke over a period of 2 years.

The evidence on the comparative efficacy of continuous-flow vs pulsatile-flow devices consists of a randomized controlled trial and several nonrandomized comparative studies.6-10 The randomized controlled trial reported fairly large differences in a composite outcome measure favoring the continuous-flow devices, with increases in revision and reoperation rates for the pulsatile device group being the largest factor driving the difference in outcomes. Other nonrandomized comparative studies, including a database study with large numbers of patients, have not reported important differences in clinical outcomes between devices.

Percutaneous Ventricular Assist Devices (circulatory assist devices)

The Impella® Recover LP 2.5 Percutaneous Cardiac Support System (Abiomed, Aachen, Germany) received FDA 510(k) approval in May 2008 for short-term (less than six hours) use in patients requiring circulatory support.

In March 2015, the Impella® 2.5 System received approval through the PMA process for temporary ventricular support during high-risk percutaneous coronary interventions.

The TandemHeart® (Cardiac Assist, Pittsburgh) received a similar 510(k) approval for short-term circulatory support in September 2005.

Several other devices are in clinical trials or awaiting FDA review.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING:

CPT codes:

 

33927 Implantation of a total replacement heart system (artificial heart) with recipient cardiectomy (Effective 01/01/18)
33928 Removal and replacement of total replacement heart system (artificial heart) (Effective 01/01/18)
33929 Removal of a total replacement heart system (artificial heart) for heart transplantation (List separately in addition to code for primary procedure) (Effective 01/01/18)
33975 Implantation of ventricular assist device; extracorporeal, single ventricle
33976 Implantation 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 ventricle
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; arterial access only
33991 Insertion of ventricular assist device, percutaneous including radiological supervision and interpretation; both arterial and venous access, with transseptal puncture
33992 Removal of percutaneous ventricular assist device at separate and distinct session from insertion
33993 Repositioning of percutaneous ventricular assist device with imaging guidance at separate and distinct session from insertion
93750 Interrogation of ventricular assist device (VAD), in person, with physician or other qualified health care professional analysis of device parameters (e.g., drivelines, alarms, power surges), review of device function (e.g., flow and volume status, septum status, recovery), with programming, if performed, and report

HCPC Codes:

L8698 Miscellaneous component, supply or accessory for use with total artificial heart system (Effective 01/01/2019)

ICD-10-CM

 

I09.81 Rheumatic heart failure
I11.0 Hypertensive heart disease with heart failure
I13.0 Hypertensive heart and chronic kidney disease with heart failure and stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease
I13.2 Hypertensive heart and chronic kidney disease with heart failure and with stage 5 chronic kidney disease, or end stage renal disease
I50.1-I50.9 Heart failure code range
I97.0 Postcardiotomy syndrome

PREVIOUS CODES:

0051T Implantation of a total replacement heart system (artificial heart) with recipient cardiectomy (Deleted 12/31/17)

0052T Replacement or repair of thoracic unit of a total replacement heart system (artificial heart) (Deleted 12/31/17)

0053T Replacement or repair of implantable component or components of total replacement heart system (artificial heart) excluding thoracic unit (Deleted 12/31/17)

REFERENCES:

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  19. Blue Cross Blue Shield Association, Technology Evaluation Center (TEC) Assessment 1996: Ventricular assist devices in bridging to heart transplantation. 1996; Volume 11;Tab 26.

  20. Blue Cross Blue Shield Association. Left-ventricular assist devices as destination therapy for end-stage heart failure. Technology Evaluation Center (TEC) Assessment, December 2002, Vol. 17, No. 19.

  21. Blue Cross Blue Shield Association. Ventricular assist devices and total artificial hearts. Medical Policy Reference Manual, September 2010.

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  35. De Robertis F, Birks EJ, Rogers P et al. Clinical performance with the Levitronix Centrimag short-term ventricular assist device. J Heart Lung Transplant 2006; 25(2):181-6.

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  45. FDA information: FDA approves pump for heart failure patients awaiting heart transplant. Available online at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm328818.htm. November 20, 2012.

  46. FDA information: Thortec Heartmate II. Available online at: www.accessdata.fda.gov/cdrh_docs/pdf6/P060040b.pdf. Last reviewed March 2012.

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  49. Frazier OH, Gemmato C, Myers TJ et al. Initial clinical experience with the HeartMate II axial-flow left ventricular assist device. Tex Heart Inst J 2007; 34(3):275-81.

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  51. Frieden J. FDA panel gives okay to pediatric use of LVAD. July 2011, www.medpagetoday.com/Cardiology/HeartTransplantation/27738.

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  56. Heart Failure Society of America, Lindenfeld J, Albert NM, et al. HFSA 2010 Comprehensive Heart Failure Practice Guideline. J Card Fail. Jun 2010;16(6):e1-194.

  57. Hunt SA, Abraham WT, Chin MH et al. 2009 focused update incorporated into the ACC/AHA 2005 Guidelines for the Diagnosis and Management of Heart Failure in Adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the International Society for Heart and Lung Transplantation. Circulation 2009; 119(14):e391-479.

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  65. Kar B, Gregoric ID, Basra SS et al. The percutaneous ventricular assist device in severe refractory cardiogenic shock. J Am Coll Cardiol 2011; 57(6):688-96.

  66. Kato TS, Chokshi A, Singh P et al. Effects of continuous-flow versus pulsatile-flow left ventricular assist devices on myocardial unloading and remodeling. Circ Heart Fail 2011; 4(5):546-53.

  67. Kirklin JK, Naftel DC, Stevenson LW et al. INTERMACS database for durable devices for circulatory support: first annual report. J Heart Lung Transplant 2008; 27(10):1065-72.

  68. Korfer R, et al. Temporary pulsatile ventricular assist devices and biventricular assist devices. Annual of Thoracic Surgery 1999;68(2): 678-83.

  69. Koul B, et al. Temporary pulsatile ventricular assist devices as bridge to heart transplantation. Annals of Thoracic Surgery, January 1998, 65:1625-30.

  70. Kovacic JC, Kini A, Banerjee S, et al. Patients with 3-vessel coronary artery disease and impaired ventricular function undergoing PCI with Impella 2.5 hemodynamic support have improved 90-day outcomes compared to intra-aortic balloon pump: a sub-study of the PROTECT II trial. J Interv Cardiol. Feb 2015; 28(1):32-40.

  71. Kovacic JC, Nguyen HT, Karajgikar R, et al. The Impella Recover 2.5 and TandemHeart ventricular assist devices are safe and associated with equivalent clinical outcomes in patients undergoing high-risk percutaneous coronary intervention. Catheter Cardiovasc Interv. Jul 01 2013; 82(1):E28-37.

  72. Lauten A, Engstrom AE, Jung C, et al. Percutaneous left-ventricular support with the Impella-2.5-assist device in acute cardiogenic shock: results of the Impella-EUROSHOCK-registry. Circ Heart Fail. Jan 2013;6(1):23-30.

  73. Lemaire A, Anderson MB, Lee LY, et al. The Impella device for acute mechanical circulatory support in patients in cardiogenic shock. Ann Thorac Surg. Jan 2014; 97(1):133-138.

  74. Lemaire A, Anderson MB, Lee LY, et al. The Impella device for acute mechanical circulatory support in patients in cardiogenic shock. Ann Thorac Surg. Jan 2014; 97(1):133-138.

  75. Lim KM, Constantino J, Gurev V et al. Comparison of the effects of continuous and pulsatile left ventricular-assist devices on ventricular unloading using a cardiac electromechanics model. J Physiol Sci 2012; 62(1):11-19.

  76. Lindenfeld J, Albert NM, Boehmer JP et al. HFSA 2010 Comprehensive Heart Failure Practice Guideline. J Card Fail 2010; 16(6):e1-194.

  77. Long JW, Kfoury AG, Slaughter MS et al. Long-term destination therapy with the HeartMate XVE left ventricular assist device: improved outcomes since the REMATCH study. Congest Heart Fail 2005; 11(3):133-8.

  78. Maini B, Naidu SS, Mulukutla S, et al. Real-world use of the Impella 2.5 circulatory support system in complex high-risk percutaneous coronary intervention: the USpella Registry. Catheter Cardiovasc Interv. Nov 1 2012;80(5):717-725.

  79. Maybaum S, Mancini D, Xydas S, et al. Cardiac improvement during mechanical circulatory support: a prospective multicenter study of the LVAD Working Group. Circulation. May 15 2007;115(19):2497-2505.

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  82. Mehra MR, Naka Y, Uriel N, et al. A fully magnetically levitated circulatory pump for advanced heart failure. N Engl J Med. Feb 02 2017; 376(5):440-450.

  83. Miller LW, Pagani FD, Russell SD et al. Use of a continuous-flow device in patients awaiting heart transplantation. N Engl J Med 2007; 357(9):885-896.

  84. Mohamedali B, Bhat G, Yost G, et al. Survival on biventricular mechanical support with the Centrimag(R) as a bridge to decision: a single-center risk stratification. Perfusion. Apr 2015; 30(3):201-208.

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  91. Park SJ, Tector A, Piccioni W et al. Left ventricular assist devices as destination therapy: a new look at survival. J Thorac Cardiovasc Surg 2005; 129(1):9-17.

  92. Patel NJ, Singh V, Patel SV et al. Percutaneous coronary interventions and hemodynamic support in the USA: A 5 year experience. J Interv Cardiol. 2015 Dec; 28(6):563-73.

  93. Patel ND, Weiss ES, Schaffer J et al. Right heart dysfunction after left ventricular assist device implantation: a comparison of the pulsatile HeartMate I and axial-flow HeartMate II devices. Ann Thorac Surg 2008; 86(3):832-40; discussion 32-40.

  94. Peura JL, Colvin-Adams M, Francis GS, et al. Recommendations for the use of mechanical circulatory support: device strategies and patient selection: a scientific statement from the American Heart Association. Circulation. Nov 27 2012;126(22):2648-2667.

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  96. Ponikowski P, Voors AA, Anker SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. Jul 14 2016; 37(27):2129-2200.

  97. Pruijsten RV, Lok SI, Kirkels HH et al. Functional and haemodynamic recovery after implantation of continuous-flow left ventricular assist devices in comparison with pulsatile left ventricular assist devices in patients with end-stage heart failure. Eur J Heart Fail 2012; 14(3):319-25.

  98. Reddy YM, Chinitz L, Mansour M, et al. Percutaneous left ventricular assist devices in ventricular tachycardia ablation: multicenter experience. Circ Arrhythm Electrophysiol. Apr 2014;7(2):244-250.

  99. Rihal CS, Naidu SS, Givertz MM, et al. 2015 SCAI/ACC/HFSA/STS Clinical Expert Consensus Statement on the Use of Percutaneous Mechanical Circulatory Support Devices in Cardiovascular Care: Endorsed by the American Heart Association, the Cardiological Society of India, and Sociedad Latino Americana de Cardiologia Intervencion; Affirmation of Value by the Canadian Association of Interventional Cardiology-Association Canadienne de Cardiologie d'intervention. J Am Coll Cardiol. May 19 2015; 65(19):e7-e26.

  100. Rogers JG, Butler J, Lansman SL, et al. Chronic mechanical circulatory support for Inotrope-dependent heart failure patients who are not transplant candidates- Results of the INTREPID Trial. J Am Coll Cardiol. 2007; 50(8):741-747.

  101. Rogers JG, Pagani FD, Tatooles AJ, et al. Intrapericardial left ventricular assist device for advanced heart failure. N Engl J Med. Feb 02 2017; 376(5):451-460.

  102. Romeo F, Acconcia MC, Sergi D, et al. Percutaneous assist devices in acute myocardial infarction with cardiogenic shock: Review, meta-analysis. World J Cardiol. Jan 26 2016; 8(1):98-111.

  103. Rose EA, Gelijns AC, Moskowitz AJ, et al. Long-term use of a left ventricular assist device for end-state heart failure. The New England Journal of Medicine, November 2001, Vol. 345, No. 20: 1435-43.

  104. Schreiber T, Wah Htun W, Blank N, et al. Real-world supported unprotected left main percutaneous coronary intervention with impella device; data from the USpella Registry. Catheter Cardiovasc Interv. Apr 18 2017;90(4):576-581.

  105. Seyfarth M, Sibbing D, Bauer I, et al. A randomized clinical trial to evaluate the safety and efficacy of a percutaneous left ventricular assist device versus intra-aortic balloon pumping for treatment of cardiogenic shock caused by myocardial infarction. J Am Coll Cardiol. Nov 4 2008; 52(19):1584-1588.

  106. Shuhaiber JH, Hur K, Gibbons R. The influence of preoperative use of ventricular assist devices on survival after heart transplantation: propensity score matched analysis. BMJ 2010; 340:c392.

  107. Shuhaiber JH, Jenkins D, Berman M et al. The Papworth experience with the Levitronix CentriMag ventricular assist device. J Heart Lung Transplant 2008; 27(2):158-64.

  108. Sjauw KD, Konorza T, Erbel R, et al. Supported high-risk percutaneous coronary intervention with the Impella 2.5 device the Europella registry. J Am Coll Cardiol. Dec 15 2009; 54(25):2430-2434.

  109. Slaughter MS, Pagani FD, McGee EC, et al. HeartWare ventricular assist system for bridge to transplant: combined results of the bridge to transplant and continued access protocol trial. J Heart Lung Transplant. Jul 2013; 32(7):675-683.

  110. Slaughter MS, Rogers JG, Milano CA et al. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med 2009; 361(23):2241-51.

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POLICY HISTORY:

TEC, March 1999

Medical Policy Administration Committee, February 2002

Medical Review Committee, March 2004

Medical Policy Group, May 2004 (1)

Medical Review Committee, May 2004

Medical Policy Administration Committee, June 2004

Available for comment June 28-August 11, 2004

Medical Policy Group, March 2006 (1)

Medical Policy Group, April 2008 (2)

Medical Policy Group, August 2009 (1)

Medical Policy Administration Committee, September 2009

Available for comment September 4-October 19, 2009

Medical Policy Group, October 2010 (1): Description, Key Points and Governing Body Approval updated

Medical Policy Group, November 2010 Reference Update

Medical Policy Administration Committee November 2010

Available for comment November 4 – December 20, 2010

Medical Policy Group, September 2011 (1): Update to Description, Key Points and References; Entire policy reformatted, no changes to policy statements

Medical Policy Group, December 2011 (3): Update to Approved by Governing Bodies & References (FDA Approval of EXCORE)

Medical Policy Group, March 2012 (3): Updated coverage for total artificial heart for bridge to transplant. Added other specialty recommendations and references.

Medical Policy Administration Committee March 2012

Available for comment March 15 – April 30, 2012

Medical Policy Group, November 2012 (3): 2012 Update to Key Points, Governing Bodies, and References

Medical Policy Group, November 2012: 2013 Coding Update-Added Codes 33990 - 33993; deleted Codes 0048T & 0050T effective 1/1/2013

Medical Policy Group, December 2012 (3): Update to Approved by Governing Bodies & References (FDA Approval of HeartWare)

Medical Policy Group, December 2012 (3): 2013 Coding update – Verbiage change to Code 93750-added “or other qualified health care professional”

Medical Policy Panel, February 2013

Medical Policy Group, February 2013 (3): Updated policy statement on children – amended age range from 5-16 years to 0-16 reflecting approval of the BERLIN heart EXCOR device for pediatric patients age 0-16; and clarified info on Medicare-approved heart transplant facility requirement for total artificial hearts; and Medicare-approved heart transplant facility OR Medicare-approved VAD destination facility requirement for VADs

Medical Policy Administration Committee March 2013

Available for comment March 12 through April 25, 2013

Medical Policy Group, August 2013 (4): Added verbiage to BTT policy section “Or a patient who is undergoing evaluation to determine candidacy for heart transplantation.

Medical Policy Administration Committee August 2013.

Available for comment August 22 through October 5, 2013

Medical Policy Group, February 2014 (5): Added ICD-9 and ICD-10-CM diagnosis under Coding; no change to policy statement.

Medical Policy Panel, February 2014

Medical Policy Group, February 2014 (4): Updated description. NO changes to the policy statement.

Medical Policy Group, March 2015 (4): Added Impella RP to Key Words and Approved Governing Bodies.

Medical Policy Panel, May 2015

Medical Policy Group, May 2015 (4): Updates to Key Points, Approved Governing Bodies, and References. Added policy statements to include total artificial hearts and pVADs are considered investigational for all other indications. Also, rearranged policy statements for ease of reading. Policy statement intents unchanged.

Medical Policy Panel, August 2016

Medical Policy Group, August 2016 (4): Updates to Description, Key Points, Key Words, Approved Governing Bodies and References. No change to current policy statement. Removed policy statement section for “effective dates prior to February 2012”.

Medical Policy Panel, August 2017

Medical Policy Group, September 2017 (4): Updates to Description, Key Points, Approved by Governing Bodies, and References. No change to policy statement.

Medical Policy Group, December 2017: Annual Coding Update 2018. Added new codes 33927 – 33929 effective 01/01/18 to Current Coding. Moved deleted codes 0051T – 0053T to Previous Coding.

Medical Policy Group, April 2018 (4): corrected typo.

Medical Policy Panel, August 2018

Medical Policy Group, August 2018 (3): Updates to Title, Description, Key Points, References, Approved By Governing Bodies, and Key Words; added: AbioCor® Total Artificial Heart, CardioWest Total Artificial Heart, HeartMate II®, SynCardia® Artificial Heart, Right Ventricular Assist Device, RVAD, PediMag®, Short-Term Continuous Flow Ventricular Assist Devices, STCF-VADs, intraluminal axial support, Impella® LV, and BIVAD. No changes to policy statement or intent.

Medical Policy Group, October 2018 (3): Updated to reflect the FDA approval of the HeartMate III device and the HeartWare® Ventricular Assist System for providing long-term hemodynamic support (e.g., destination therapy) in patients with advanced heart failure.

Medical Policy Group, December 2018: 2019 Annual Coding Update. Added HCPC code L8698 to the Current coding section.

Medical Policy Panel, August 2019

Medical Policy Group, September 2019 (3): 2019 Updates to Key Points. No changes to policy statement or intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.