Commercial

Medical Policy

Notification

Ventricular Assist Devices (VADs)

Notification Issued Date: 2/28/2023 11:00 AM

This version of the policy will become effective 05/29/2023.

The intent of this policy remains unchanged; however, the criteria section of the policy for Percutaneous Ventricular Assist Devices (pVADs) has been revised to address updated labeling for the Impella® RP System from the US Food and Drug Administration (FDA)and in consideration of the Impella® RP System final post-approval study (PAS) results.

In addition, the guidelines section of the policy has been updated to incorporate the US Food and Drug Administration (FDA) updated labeling for the Impella® RP System.

Title:

Ventricular Assist Devices (VADs)

Policy #:

11.02.16u

Policy

IMPLANTABLE VENTRICULAR ASSIST DEVICES (VADs)

MEDICALLY NECESSARY
Implanted ventricular assist devices (VADs), when used in accordance with their US Food and Drug Administration (FDA)–labeled indication and intended purpose, are considered medically necessary and, therefore, covered for any of the following when performed at a facility that has received VAD certification by the Joint Commission under the Disease Specific Certification Program for Ventricular Assist Devices, or is a Medicare-approved heart transplant facility, or a facility with a United Network for Organ Sharing (UNOS)–approved heart transplant program:

As a bridge to 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
As destination therapy (i.e., permanent implantation) for individuals with end-stage heart failure who meet all of the following criteria:

New York Heart Association (NYHA) Class III heart failure with dyspnea upon mild physical activity or Class IV
Have a left ventricular ejection fraction (LVEF) ≤25%
Are inotrope dependent; OR have a cardiac index (CI) <2.2 L/min/m², while not on inotropes, AND meet one of the following:

Are on optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and are failing to respond; OR
Have advanced heart failure for at least 14 days and are dependent on an intra-aortic balloon pump (IABP) or similar temporary mechanical circulatory support for at least 7 days

Additionally, VADs, when used in accordance with their FDA-labeled indication and intended purpose, are considered medically necessary and, therefore, covered for any of the following:

As a bridge to recovery for short-term stabilization of individuals with any of the following:

Implantable Pediatric VADs

Implantable pediatric VADs, when used in accordance with their FDA-labeled indication and intended purpose, are considered medically necessary and, therefore, covered when the infant/child has documented end-stage left ventricular or another type of ventricular failure (e.g., the anatomic absence of a left ventricle, biventricular failure); and meets EITHER of the following:

As a bridge to heart transplantation when performed at a facility that has an active heart transplant program approved by UNOS
When used as a permanent alternative (destination therapy) in children who have been evaluated and determined not to be eligible for a heart transplant

EXPERIMENTAL/INVESTIGATIONAL

All other uses for implantable VADs are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

PERCUTANEOUS VENTRICULAR ASSIST DEVICES (pVADs)

MEDICALLY NECESSARY
The use of FDA-approved percutaneous left ventricular assist devices (pVADs) (e.g., TandemHeart®, Impella®) are considered medically necessary and, therefore, covered for the treatment of either of the following:

Short-term circulatory support in cardiogenic shock due to ventricular failure that is not responsive to optimal medical management and conventional treatment measures*
As an adjunct to percutaneous coronary intervention (PCI) in high-risk individuals when used in either of the following conditions:

The Impella® RP System (percutaneous right VAD) is considered medically necessary and, therefore, covered for up to 14 days in pediatric and adult individuals with a body surface area (BSA) ≥1.5 m² who develop acute right heart failure or decompensation for less than 48 hours and without the presence of profound shock, end-organ failure, or acute neurologic injury as a result of any of the following circumstances:

Following left ventricular assist device (LVAD) implantation
Cardiogenic shock due to acute myocardial infarction, heart transplant, or cardiotomy that is not responsive to optimal medical management and conventional treatment measures*

*Optimal medical management and conventional treatment measures include volume loading and use of vasopressors and inotropes, with or without IABP.

**Triple vessel disease defined as at least one significant stenosis (i.e., 50 percent or greater stenosis by diameter) in all three major epicardial territories: left anterior descending artery (LAD) and/or side branch, left circumflex artery (LCx) and/or side branch, and right coronary artery (RCA) and/or side branch. In the case of left coronary artery dominance, a lesion in the LAD and the proximal LCx qualifies as triple-vessel disease.

EXPERIMENTAL/INVESTIGATIONAL

All other uses for pVAD are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to, records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

SUPPLIES IN THE OUTPATIENT SETTING 

VAD replacement supplies, as defined by the coding table in this policy, for use in the outpatient setting are eligible for separate reimbursement when the individual meets the medical necessity criteria for a VAD that has been approved by the FDA for use in the outpatient setting.

The HCPCS codes in the coding table represent replacement equipment, with the exception of Q0478, Q0507, and Q0508, which are also eligible for separate reimbursement when the individual meets the medical necessity criteria for a VAD that has been approved by the FDA for use in the outpatient setting. HCPCS codes Q0507 and Q0508 can represent initial or replacement equipment, and requests for authorization must include a detailed description of the Supply or Accessory being billed under Q0507 or Q0508. Reimbursement is limited to supplies and accessories for use with an external or implanted VAD, and not for a maintenance service for such equipment and supplies.

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, ventricular assist devices (VADs) are covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

Subject to the terms and conditions of the applicable benefit contract, devices that are used for the US Food and Drug Administration (FDA)–approved humanitarian device exemption (HDE) indications listed in this policy are covered under the medical benefits of the Company's products.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous VADs approved by the FDA for adults, including left, right, biventricular, and percutaneous VADs.

On February 25, 2004, the HeartAssist® 5 Pediatric VAD (formerly the DeBakey VAD Child Left Ventricular Assist System) was approved by the FDA under the HDE process for use as a temporary left side mechanical circulatory support as a bridge to cardiac transplantation for pediatric individuals (5-16 years old, with body surface area [BSA] greater than or equal to 0.7 m² and less than 1.5 m²) who are in New York Heart Association (NYHA) Class IV end- stage heart failure, are refractory to medical therapy, and who are listed candidates for cardiac transplantation.

On December 16, 2011, the Berlin Heart EXCOR® Pediatric VAD was approved by the FDA under the HDE process, followed by FDA premarket approval on June 6, 2017, for use as mechanical circulatory support as a bridge to cardiac transplantation in pediatric individuals with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant and require circulatory support.

On January 23, 2015, the Impella RP® System was approved by the FDA under the HDE process, followed by FDA premarket approval on September 20, 2017, for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m² who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. On December 5, 2022, the FDA approved updated labeling for the Impella RP® System, based on the post-approval study (PAS) results, with an update to the indications for use statement to better reflect the characteristics of the individuals who may benefit the most from treatment with the device. The updated indication for use is limited to individuals who have developed acute right heart failure or decompensation for less than 48 hours following left ventricular assist device implantation, myocardial infaction, heart transplant, or open-heart surgery without the presence of profound shock, end-organ failure, or acute neurologic injury.

On August 23, 2017, the HeartMate™ 3 Left Ventricular Assist System (LVAS) was approved by the FDA premarket approval process for short-term hemodynamic support (bridge to transplant or bridge to myocardial recovery) in individuals with a BSA greater than or equal to 1.2 m² who have advanced refractory left ventricular heart failure. On October 18, 2018, the FDA expanded approval of the HeartMate™ 3 LVAS for long-term mechanical circulatory support (destination therapy) in individuals with advanced refractory left ventricular heart failure. On December 17, 2020, the FDA approved updating labeling for the HeartMate 3 LVAS for providing short- and long-term mechanical circulatory support in the pediatric population with advanced refractory left ventricular heart failure and an appropriate BSA.

Description

VENTRICULAR ASSIST DEVICES (VADs)

Ventricular assist devices (VADs) are mechanical pumps that help maintain circulation when a weak or damaged heart is unable to generate adequate cardiac output. A VAD does not replace the heart. Instead, the VAD is connected to the cardiac chambers and major arteries to assist with the function of the left ventricle (left ventricular assist device [LVAD]), the right ventricle (right ventricular assist device [RVAD]), or both (biventricular assist system).

VADs may be necessary for short-term (hours to weeks) or intermediate and long-term (months to years) use. Devices for short-term use are inserted surgically (e.g., centrifugal pumps) or percutaneously (e.g., Tandem Heart; Impella; Centrifugal pumps). Short-term assisted circulation facilitates the performance of complex coronary interventional procedures performed in the catheterization laboratory as a bridge to recovery for indications such as, but not limited to, postcardiotomy for individuals who cannot be weaned off cardiopulmonary bypass; resuscitation of individuals in cardiogenic shock; individuals with low cardiac output after cardiac surgery; individuals with acute rejection after heart transplant; or individuals with myocarditis.

Devices for intermediate and long-term use are implanted (implantable devices) either as intracorporeal devices (inside the thorax) or as paracorporeal devices (the actual pump is outside the thorax but is connected with cables and tubing to the cardiac chambers and the major arterial vessels inside the thorax). Intermediate and long-term use devices (implanted paracorporeal or intrathoracic devices) are commonly used for the following indications:

As a bridge to transplantation (a temporary means of maintaining heart function for individuals waiting for a heart transplant)
As a bridge to recovery when heart transplantation is not indicated or when it is anticipated that the individual may recover and will not need a heart transplant (usually 6 months to 1 year)
As destination therapy (permanent implantation)

Thus, VADs may facilitate myocardial recovery for individuals with reversible ventricular dysfunction, temporarily maintain circulation until transplant, or extend the life expectancy of the terminally ill. Several adult VADs have received US Food and Drug Administration (FDA) approval. Currently, two pediatric VADs have received FDA premarket approval: the Berlin Heart EXCOR® Pediatric Ventricular Assist Device, and the Impella RP® System. The HeartAssist® 5 Pediatric VAD (formerly the DeBakey VAD Child Left Ventricular Assist System) received a Humanitarian Device Exemption (HDE) on February 25, 2004, for use as a temporary left side mechanical circulatory support as a bridge to cardiac transplantation for pediatric individuals (5-16 years old, with body surface area [BSA] greater than or equal to 0.7 m² and less than 1.5 m²) who are in New York Heart Association (NYHA) Class IV end-stage heart failure, are refractory to medical therapy, and who are listed candidates for cardiac transplantation.

PERCUTANEOUS VENTRICULAR ASSIST DEVICES

Percutaneous VADs (pVADs) have been proposed as an alternative to the traditional intra-aortic balloon pump (IABP). Percutaneous VADs are minimally invasive and are placed using femoral or axillary vascular access. Most of the pVADs systems' components are external to the body and are for short-term stabilization (6 hours to 14 days), due to the increased risk of infection and need for careful, in-hospital monitoring. The pVADs provide continuous forward blood flow independent of the individual having any intrinsic cardiac output or rhythm. This is different from IABPs, which provide pulsed therapy. Percutaneous VADs have the potential to increase overall cardiac output and improve oxygenation while protecting the heart muscle.

Two examples of left pVADs are TandemHeart® and the Impella®. In the TandemHeart®, 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® 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. Adverse events associated with pVADs include access-site complications such as bleeding, aneurysms, or leg ischemia. Cardiovascular complications can also occur, such as perforation, myocardial infarction, stroke, and arrhythmias.

Percutaneous VADs have been tested in randomized controlled trials (RCTs) and uncontrolled studies of individuals with cardiogenic shock, including those refractory to intra IABP, and in individuals undergoing high-risk cardiac interventions such as percutaneous coronary intervention (PCI) and ventricular tachycardia ablation. For individuals with cardiogenic shock, systematic reviews include three RCTs demonstrating an improvement in left ventricular hemodynamics in the pVAD group for cardiogenic shock. Mortality outcomes were similar between individuals who received pVADs as an alternative to IABPs for cardiogenic shock. For individuals undergoing high-risk cardiac interventions, the PROTECT II trial (O'Neill et al. 2012), planned as an RCT, compared the Impella system with IABP in individuals undergoing high-risk PCI procedures. At 30 days, there was no significant difference in the occurrence of major adverse events of individual hospital death, stroke, or myocardial infarction for individuals with IABP or Impella 2.5 hemodynamic support. However, trends for improved outcomes were observed for Impella 2.5–supported individuals at 90 days.

The Impella® RP System is a right pVAD device indicated for individuals with right ventricular failure refractory to medical management who require hemodynamic support. The Impella® RP System is inserted via the femoral vein, into the right atrium, and through to the pulmonary artery. The prospective RECOVER RIGHT pivotal study (Anderson et al. 2015) evaluated individuals who developed signs of right heart failure within 48 hours postimplantation of an FDA-approved implantable surgical LVAD or subsequent surgery or myocardial infarction. In summary, the Impella® RP System provided adequate circulatory support to reverse shock and restore normal hemodynamic parameters, and achieve an overall survival rate of 73 percent at 30 days discharge.

The final post-approval study (PAS) results for the Impella® RP System show that survival rate for the subgroup of PAS individuals who would have met the enrollment criteria for the premarket clnical studies is consistent with premarket clinical studies survival rate and further confirms that the device is safe and effective when used for the currently approved indication.

PROFESSIONAL ORGANIZATIONS
The National Institute for Health and Clinical Excellence (NICE) (2016) states that the Impella® 2.5 could be used as an alternative to an IABP to provide hemodynamic support for suitable individuals before, during, or after elective or urgent high-risk PCI.

The 2015 Society for Cardiovascular Angiography and Interventions/American College of Cardiology/Heart Failure Society of America/Society for Thoracic Surgeons (SCAI/ACC/HFSA/STS) consensus statement on the use of percutaneous mechanical circulatory support states that percutaneous mechanical circulatory support provides superior hemodynamic support compared with pharmacologic therapy. This is particularly apparent for the Impella® and Tandem Heart® devices (Rihal 2015).

A report of the American College of Cardiology Foundation/American Heart Associate Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions (ACCF/AHA/SCAI) indicates that elective insertion of an appropriate percutaneous hemodynamic support device as an adjunct to PCI may be reasonable in carefully selected high-risk individuals as a Class IIb recommendation (Levine 2011).

HUMANITARIAN DEVICE EXEMPTION (HDE)

In rare instances, certain medical devices intended to be used for humanitarian purposes are evaluated by the FDA through the HDE process. The FDA’s humanitarian use device (HUD) designation permits the use of certain medical devices when there is no comparable device available to treat or diagnose a disease or condition affecting fewer than 4,000 individuals annually. Because clinical investigation demonstrating the device's efficacy is not feasible (given the low prevalence of the disease in the population), an HDE grants manufacturers an exemption from the usual premarket approval process and allows marketing of the device only for the FDA-labeled HDE indication(s).

Under FDA requirements, an HUD may only be used after institutional review board (IRB) approval has been obtained for the use of the device in accordance with the FDA-labeled indication(s) under HDE.

References

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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):546-553.

Kirklin JK, Pagani FD, Goldstein DJ, et al. American Association for Thoracic Surgery/International Society for Heart and Lung Transplantation guidelines on selected topics in mechanical circulatory support. J Heart Lung Transplant. 2020;39(3):187-219.

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):1065-1072.

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. 2015;28(1):32-40.

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

Levine G, Bates E, Blakenship J, et al. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Circulation. 2011;124(23):e574-651.

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.

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

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)133-138.

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. 2012;80(5):717-725.

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

Mehra MR, Uriel N, Naka Y, et al. A fully magnetically levitated left ventricular assist device - Final Report. N Engl J Med. 2019;380(17):1618-1627.

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.

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

Morgan JA, John R, Rao V, et al. Bridging to transplant with the HeartMate left ventricular assist device. The Columbia Presbyterian 12-year experience. J Thorac Cardiovasc Surg. 2004;127(5)1309-1316.

National Institute for Health and Clinical Excellence (NICE). Impella 2.5 for haemodynamic support during high-risk percutaneous coronary interventions. [NICE Web site]. November 2016. Available at: https://www.nice.org.uk/advice/mib89/chapter/Summary. Accessed January 5, 2023.

National Heart, Lung, and Blood Institute (NHLBI). Ventricular Assist Device. [NHLBI Web site]. Available at: https://www.nhlbi.nih.gov/health/health-topics/topics/vad. Accessed January 5, 2023.

Nativi JN, Drakos SG, Kucheryavaya AY, et al. Changing outcomes in patients bridged to heart transplantation with continuous- versus pulsatile-flow ventricular assist devices: an analysis of the registry of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2011;30(8):854-861.

Novitas Solutions, Inc. Local Coverage Article. A54910: Ventricular assist device (VAD) supply or accessory. [Novitas Solutions Web site]. Effective: 11/21/2019. Available at: https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleid=54910&ver=12&bc=CAAAAAAAAAAA. Accessed January 5, 2023.

O'Connor MJ, Lorts A, Davies RR, et al. Early experience with the HeartMate 3 continuous-flow ventricular assist device in pediatric patients and patients with congenital heart disease: A multicenter registry analysis. J Heart Lung Transplant. 2020;39(6):573-579.

O'Neill WW, Kleiman NS, Moses J, et al. A prospective, randomized clinical trial of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump in patients undergoing high-risk percutaneous coronary intervention: the PROTECT II study. Circulation. 2012;126(14):1717-1727.

O'Neill WW, Schreiber T, Wohns DH, et al. The current use of Impella 2.5 in acute myocardial infarction complicated by cardiogenic shock: results from the USpella Registry. J Interv Cardiol. 2014;27(1):1-11.

Ouweneel DM, de Brabander J, Karami M, et al. Real-life use of left ventricular circulatory support with Impella in cardiogenic shock after acute myocardial infarction: 12 years AMC experience. Eur Heart J Acute Cardiovasc Care. 2019; 8(4):338-349.

Ouweneel DM, Eriksen E, Sjauw KD, et al. Percutaneous mechanical circulatory support versus intra-aortic balloon pump in cardiogenic shock after acute myocardial infarction. J Am Coll Cardiol. 2017;69(3):278-287.

Pagani FD, Mehra MR, Cowger JA, et al. Clinical outcomes and healthcare expenditures in the real world with left ventricular assist devices - The CLEAR-LVAD study. J Heart Lung Transplant. 2021;40(5):323-333.

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.

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.

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. 2012;126(22):2648-2667.

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):319-325.

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

Rihal CS, Naidu SS, Givertz, et al. 2015 Society for Cardiovascular Angiography and Interventions/American College of Cardiology/Heart Failure Society of America/Society for Thoracic Surgeons (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 Assocation, 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). Catheter Cardiovasc Interv. 2015;85(7):175-196.

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.

Rose EA, Gelijns AC, Moskowitz AJ, et al. Long-term mechanical left ventricular assistance for end-stage heart failure. N Engl J Med. 2001;345(20)1435-1443.

Schafer A, Werner N, Burkhoff D, et al. Influence of timing and predicted risk on mortality in Impella-treated infarct-related cardiogenic shock patients. Front Cardiovasc Med. 2020;7:74.

Schmitto JD, Pya Y, Zimpfer D, et al. Long-term evaluation of a fully magnetically levitated circulatory support device for advanced heart failure-two-year results from the HeartMate 3 CE Mark Study. Eur J Heart Fail. 2019;21(1):90-97.

Schrage B, Ibrahim K, Loehn T, et al. Impella support for acute myocardial infarction infarction complicated by cardiogenic shock. Circulation. 2019;139(10):1249-1258.

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. 2008;52(19):1584-1588.

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.

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):158-164.

Sieweke JT, Berliner D, Tongers J, et al. Mortality in patients with cardiogenic shock treated with the Impella CP microaxial pump for isolated left ventricular failure. Eur Heart J Acute Cardiovasc Care. 2020;9(2):138-148.

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. 2009;54(25):2430-2434.

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. 2013;32(7):675-683.

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):2241-2251.

Starling RC, Estep JD, Horstmanshof DA, et al. Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients: The ROADMAP Study 2-Year Results. JACC Heart Fail. 2017;5(7):518-527.

Starling RC, Naka Y, Boyle AJ, et al. Results of the Post-U.S. Food and Drug Administration-Approval Study With a Continuous Flow Left Ventricular Assist Device as a Bridge to Heart Transplantation: A Prospective Study Using the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support). J Am Coll Cardiol. 2011;57(19):1890-1898.

Stiles S. FDA expands Impella pump indications in high-risk PCI, cardiogenic shock. [Medscape Web site]. 02/14/2018. Available at:https://www.medscape.com/viewarticle/892711[via subscription]. Accessed January 5, 2023.

Struber M, Sander K, Lahpor J, et al. HeartMate II left ventricular assist device; early European experience. Eur J Cardiothorac Surg. 2008;34(2):289-294.

Strueber M, O'Driscoll G, Jansz P, et al. Multicenter evaluation of an intrapericardial left ventricular assist system. J Am Coll Cardiol. 2011;57(12):1375-1382.

Takayama H, Soni L, Kalesan B, et al. Bridge-to-decision therapy with a continuous-flow external ventricular assist device in refractory cardiogenic shock of various causes. Circ Heart Fail. 2014;7(5):799-806.

Thiele H, Sick P, Boudriot E, et al. Randomized comparison of intra-aortic balloon support with a percutaneous left ventricular assist device in patients with revascularized acute myocardial infarction complicated by cardiogenic shock. Eur Heart J. 2005;26(13)1276-1283.

Torregrossa G, Morshuis M, Varghese R, et al. Results with SynCardia total artificial heart beyond 1 year. ASAIO J. 2014;60(6):626-634.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD). HDE approval letter. [FDA Web site]. 12/16/2011. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf10/H100004a.pdf?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=Berlin Heart'sEXCOR&utm_content=6. Accessed January 5, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). CardiacAssist TandemHeart Transseptal Cannula Set. 510(k) summary. [FDA Web site]. 01/17/2006. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/K052570.pdf. Accessed January 5, 2023.

US Department of Health and Human Services. U.S. Organ Procurement and Transplantation Network (OPTN) and the Scientific Registry of Transplant Recipients (SRTR). 2008 OPTN/SRTR Annual Report 1998-2007.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). CardiacAssist Transseptal Cannula Set. 510(k) summary. [FDA Web site]. 05/23/2003. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf3/k030398.pdf. Accessed January 5, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). DeBakey VAD® Child Left Ventricular Assist System. HDE approval letter. [FDA Web site]. Original 02/25/2004. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf3/H030003a.pdf. Accessed January 5, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Impella Recover® LP 2.5 Percutaneous Cardiac Support System. 510(k) summary. [FDA Web site]. 5/19/2009. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063723.pdf. Accessed January 5, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Medical device recalls Class 2 recall Thoratec Heartmate II Left Ventricular Assist System. [FDA Web site]. 12/22/2008. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/resCollection_2.cfm?ID=74710&CREATE_DT=2008-12-22. Accessed January 5, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Thoratec HeartMate II Left Ventricular Assist System (LVAS). Premarket approval letter. [FDA Web site]. 04/21/2008. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf6/p060040a.pdf. Accessed January 5, 2023.

US Food and Drug Administration (FDA). CentriMag Right Ventricular Assist System labeling. [FDA Web site]. October 2008. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf7/H070004c.pdf. Accessed January 5, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). HeartAssist® 5 Pediatric VAD. 510 (k) summary. [FDA Web site]. 04/15/2010. Available at:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=375908. Accessed January 5, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Impella Recover® RP System. HDE approval letter. [FDA Web site]. 01/23/2015. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf14/H140001a.pdf. Accessed January 5, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Impella Recover® RP System. 510(k) summary. [FDA Web site]. 01/23/2015. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=375581. Accessed January 5, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). EXCOR Pediatric Ventricular Assist Device. Premarket Approval (PMA) Database. [FDA Web site]. 06/06/2017. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=P160035. Accessed January 5, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Impella 2.5® with the Automated Impella® Controller Circulatory Support System. Instructions for use and clinical reference manual. [FDA Web site]. March 2015. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140003C.pdf. Accessed January 5, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Impella 2.5®, Impella 5.0®, Impella LD®, and Impella CP® (shock) Impella 2.5® and Impella CP® (HRPCI). Instructions for use and clinical reference manual. [FDA Website]. February 2018. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140003S018D.pdf. Accessed January 5, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Impella® RP System with Automated Impella® Controller. Instructions for use and clinical reference manual. [FDA Website]. March 2017. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170011C.pdf. Accessed January 5, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Impella Ventricular Support Systems. Premarket approval (PMA) letter. [FDA Web site]. 04/07/2016. Available at:
https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140003S005A.pdf. Accessed January 5, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Impella Ventricular Support Systems. Summary of safety and effectiveness data. [FDA Web site]. 03/23/2015. (Updated 04/07/2016). Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140003S005B.pdf. Accessed January 5, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Impella Ventricular Support Systems. Summary of safety and effectiveness data. [FDA Web site]. 02/27/2018. Available at:
https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140003S018B.pdf. Accessed January 5, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Impella ventricular support systems for use during cardiogenic shock and high-risk PCI. Impella 2.5® , Impella 5.0® , Impella LD® , and Impella CP® (Shock), Impella 2.5® and Impella CP® (HRPCI). Instructions for use and clinical reference manual. [FDA Web site]. 2017. Available at:
https://www.accessdata.fda.gov/cdrh_docs/pdf14/p140003s018d.pdf. Accessed January 5, 2023.

US Food and Drug Administration (FDA). Medical Devices. HeartWare™ HVAD™ - P100047/S090. [FDA Web site]. 09/27/2017. Available at: P100047S090b.pdf (fda.gov). Accessed January 5, 2023.

US Food and Drug Administration (FDA). Medical Devices. Impella RP® System - P170011. [FDA Web site]. 09/20/2017. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170011. Accessed January 5, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). IMPELLA 2.5® System. Premarket Approval (PMA) Database. [FDA Web site]. 03/23/2015. Available at:
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US Food and Drug Administration (FDA). Medical Devices. Impella 2.5 & Impella CP Systems. P140003/S027. [FDA Web site]. 02/08/2018. Available at:
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US Food and Drug Administration (FDA). Department of Health & Human Services. Impella RP System. HDE approval letter. [FDA Web site]. 09/20/2017. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170011a.pdf. Accessed January 5, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Impella RP® System. Summary of safety and effectiveness data. [FDA Web site]. 09/20/2017. Available at:
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US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Impella RP System. Humanitarian Device Exemption (HDE). [FDA Web site]. 01/23/2015 (Updated 03/19/2018). Available at:
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Coding

CPT Procedure Code Number(s)

33975, 33976, 33977, 33978, 33979, 33980, 33981, 33982, 33983, 33990, 33991, 33992, 33993, 33995 , 33997, 93750

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

Report the most appropriate diagnosis code in support of medical necessity as listed in the policy.

HCPCS Level II Code Number(s)

Q0477 Power module patient cable for use with electric or electric/pneumatic ventricular assist device, replacement only

Q0478 Power adapter for use with electric or electric/pneumatic ventricular assist device, vehicle type

Q0479 Power module for use with electric or electric/pneumatic ventricular assist device, replacement only

Q0480 Driver for use with pneumatic ventricular assist device, replacement only

Q0481 Microprocessor control unit for use with electric ventricular assist device, replacement only

Q0482 Microprocessor control unit for use with electric/pneumatic combination ventricular assist device, replacement only

Q0483 Monitor/display module for use with electric or electric ventricular assist device, replacement only

Q0484 Monitor/display module for use with electric or electric/pneumatic ventricular assist device, replacement only

Q0485 Monitor control cable for use with electric ventricular assist device, replacement only

Q0486 Monitor control cable for use with any type electric/pneumatic ventricular assist device, replacement only

Q0487 Leads (pneumatic/electrical) for use with any type electric/pneumatic ventricular assist device, replacement only

Q0488 Power pack base for use with electric ventricular assist device, replacement only

Q0489 Power pack base for use with electric/pneumatic ventricular assist device, replacement only

Q0490 Emergency power source for use with electric ventricular assist device, replacement only

Q0491 Emergency power source for use with electric/pneumatic ventricular assist device, replacement only

Q0492 Emergency power supply cable for use with electric ventricular assist device, replacement only

Q0493 Emergency power supply cable for use with electric/pneumatic ventricular assist device, replacement only

Q0494 Emergency hand pump for use with electric/pneumatic ventricular assist device, replacement only

Q0495 Battery/power pack charger for use with electric or electric/pneumatic ventricular assist device, replacement only

Q0496 Battery, other than lithium-ion, for use with electric or electric/pneumatic ventricular assist device, replacement only

Q0497 Battery clips for use with electric or electric/pneumatic ventricular assist device, replacement only

Q0498 Holster for use with electric or electric/pneumatic ventricular assist device, replacement only

Q0499 Belt/vest/bag for use to carry external peripheral components of any type ventricular assist device, replacement only

Q0500 Filters for use with electric or electric/pneumatic ventricular assist device, replacement only

Q0501 Shower cover for use with electric or electric/pneumatic ventricular assist device, replacement only

Q0502 Mobility cart for pneumatic ventricular assist device, replacement only

Q0503 Battery for pneumatic ventricular assist device, replacement only, each

Q0504 Power adapter for pneumatic ventricular assist device, replacement only, vehicle type

Q0506 Battery, lithium-ion, for use with electric or electric/pneumatic ventricular assist device, replacement only

Q0507 Miscellaneous Supply or Accessory for Use with an External Ventricular Assist Device

Q0508 Miscellaneous Supply or Accessory for Use with an Implanted Ventricular Assist Device

The Following HCPCS Code Should Not Be Reported

Q0509 Miscellaneous Supply or Accessory for Use with Any Implanted Ventricular Assist Device for Which Payment Was Not Made Under Medicare Part A

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Version Effective Date:

5/29/2023

Version Issued Date:

5/29/2023

Version Reissued Date: