Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Ventricular Assist Devices (VADs)

Policy #:11.02.16r

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

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 waiting for a heart transplant or individuals who will be evaluated for heart transplant after a period of multiorgan improvement
  • As destination therapy (i.e., permanent implantation) for individuals with New York Heart Association (NYHA) Class IV end-stage heart failure who are ineligible for a heart transplant, and who meet all of the following criteria:
    • The symptoms of heart failure have failed to respond to optimal medical management, including beta-blockers and angiotensin-converting enzyme (ACE) inhibitors (if tolerated) for at least 45 of the last 60 days, or have been balloon pump--dependent for 7 days or intravenous inotrope--dependent for 14 days.
    • The individual has a left ventricular ejection fraction (LVEF) of less than 25 percent.
    • The individual has a demonstrated functional limitation with a peak oxygen consumption of 14 mL/kg/min or less, unless the individual is balloon pump or inotrope dependent or physically unable to perform the test.

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:
    • Reversible ventricular dysfunction
    • Postcardiotomy for individuals who cannot be weaned off cardiopulmonary bypass
    • Myocarditis
    • Individuals who have low cardiac output and poor hemodynamics after cardiac surgery

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 as a bridge to heart transplantation when performed at a facility that has an active heart transplant program approved by United Network for Organ Sharing (UNOS) when the infant/child meets either of the following criteria:
  • Child between 5 and 16 years of age with end-stage left ventricular failure or another type of ventricular failure (e.g., the anatomic absence of a left ventricle) that requires temporary mechanical blood circulation until heart transplantation is performed.
  • Pediatric individual weighing 3-60 kilograms with severe isolated left ventricular or biventricular dysfunction that requires temporary mechanical blood circulation until heart transplantation is performed.

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:
    • Individuals undergoing unprotected left main coronary artery or last-remaining-coronary conduit PCI with ejection fraction less than 35 percent
    • Individuals with triple vessel disease** with end diastolic ejection fraction less than 30 percent

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 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 intra aortic balloon pump.

**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 02/25/2004, 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 meter squared [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 12/16/2011, the Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD) was approved by the FDA under the HDE process, followed by FDA premarket approval on 06/06/2017 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 01/23/2015, the Impella RP® System was approved by the FDA under the HDE process, followed by FDA premarket approval on 09/20/2017 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.

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 (LVAD), the right ventricle (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 six months to a 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 02/25/2004 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 or equal to 0.7 meter squared (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 system’s components are external to the body are for short-term stabilization (6 hours to 14 days), due to the increased risk of infection and need for careful, in-hospital monitoring. Percutaneous VADs 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 aortic balloon pump, and in individuals undergoing high-risk cardiac interventions such as percutaneous coronary intervention 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 intra-aortic balloon pumps for cardiogenic shock. For individuals undergoing high-risk cardiac interventions, 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 post-implantation 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.

PROFESSIONAL ORGANIZATIONS
National Institute for Health and Clinical Excellence (NICE) (2016) states that the Impella® 2.5 could be used as an alternative to an intra aortic balloon pump to provide hemodynamic support for suitable individuals before, during, or after elective or urgent high risk percutaneous coronary intervention.

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 to pharmacologic therapy. This is particularly apparent for the Impella® and Tendem 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 US Food and Drug Administration (FDA) through the Humanitarian Device Exemption (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. Since 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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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(R) 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 March 06, 2018.

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 March 06, 2018.

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.

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.

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 CandidatesResults of the INTrEPID Trial. Journal of the American College of Cardiology. 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.

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.

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, 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). Journal of the American College of Cardiology. 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 March 06, 2018.

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.

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 March 06, 2018.

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 March 06, 2018.

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 March 06, 2018.

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 March 06, 2018.

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 March 06, 2018.

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 March 06, 2018.

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 March 06, 2018.

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 March 06, 2018.

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 May 31, 2017.

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 March 06, 2018.

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 March 06, 2018.

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 March 06, 2018.

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 March 06, 2018.

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 March 06, 2018.

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 March 06, 2018.

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 March 06, 2018.

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 March 06, 2018.

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 March 06, 2018.

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 March 06, 2018.

US Food and Drug Administration (FDA). Medical Devices. HeartWare™ HVAD™ - P100047/S090. [FDA Web site]. 09/27/2017. Available at:
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm581473.htm. Accessed March 06, 2018.

US Food and Drug Administration (FDA). Medical Devices. Impella RP® System - P170011. [FDA Web site]. 09/20/2017. Available at:
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm581165.htm. Accessed March 06, 2018.

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:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p140003. Accessed March 06, 2018.

US Food and Drug Administration (FDA). Medical Devices. Impella Ventricular Support Systems - P140003/S018. [FDA Web site]. 02/07/2018. Available at: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceA
pprovalsandClearances/Recently-ApprovedDevices/ucm598801.htm
. Accessed March 06, 2018.

US Food and Drug Administration (FDA). Medical Devices. Impella 2.5 & Impella CP Systems. P140003/S027. [FDA Web site]. 02/08/2018. Available at:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140003S027. Accessed March 06, 2018.

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 March 06, 2018.

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:
https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170011B.pdf. Accessed March 06, 2018.

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:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=H140001
Accessed March 06, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Impella RP® System. FDA Executive Summary. [FDA Web site]. 04/12/2016. Available at:https://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/pediatricadvisorycommittee/ucm494527.pdf. Accessed March 06, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Impella 2.5® and Impella CP® Systems. Premarket approval (PMA) monthly approvals. [FDA Web site]. 02/08/2018. Available at:
https://www.fda.gov/downloads/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/pmaapprovals/ucm599568.pdf. Accessed March 06, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Heartware Ventricular Assist System. Premarket approval (PMA) Database. FDA Web site]. 11/20/2012. Updated 04/09/2018. Available at:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100047. Accessed April 09, 2018.

VanderPluym CJ, Fynn-Thompson F, Blume ED. Ventricular assist devices in children: Progress with an orphan device application. Circulation. 2014;129 (14):1530-1537.

Ventura PA, Alharethi R, Budge D, et al. Differential impact on post-transplant outcomes between pulsatile- and continuous-flow left ventricular assist devices. Clin Transplant. 2011; 25(4)E390-5.

Wieselthaler GM, Schima H, Lassnigg AM, et al. Lessons learned from the first clinical implants of the DeBakey ventricular assist device axial pump a single center report. Ann Thorac Surg. 2001;71(3 Suppl)S139-43;discussion S44-6.

Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA Guideline for the Management of Heart FailureA Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Journal of the American College of Cardiology. 2013;62(16):e147-e239.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

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


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


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

Not Eligible for Reimbursement

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

Coding and Billing Requirements


Cross References


Policy History

11.02.16r:
01/07/2019This version of the policy will become effective 01/07/2019.
The criteria section has been updated to address percutaneous ventricular assist devices as medically necessary with criteria.

11.02.16q:
01/01/2018This policy has been identified for the HCPCS code update, effective 01/01/2018.
The following HCPCS code has been added to this policy: Q0477


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 01/07/2019
Version Issued Date: 01/07/2019
Version Reissued Date: N/A

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